VAERS: COVID-19 "vaccines" and miscarriages
This information comes directly from the Vaccine Adverse Event Reporting System (VAERS) which is compiled by the CDC and FDA. This information is accurate as of 27-Jun-2021.
It must be understood that, according to a Harvard paper, less than 1% of adverse reactions resulting from vaccines are actually reported to VEARS. It isn't difficult to understand why this is when one understands that doctors typically receive only a few hours of training regarding vaccines; that they are told that vaccines are safe and effective and that any serious reaction to a vaccine cannot be caused by the vaccine; that many doctors are not even aware of the existence of VAERS; that doctors have been pressured by hospitals and the CDC to not report adverse events, etc..
This query of the VAERS database was limited to abortions related to the COVID-19 "vaccines" (they are, by definition, NOT vaccines). I've been hearing many reports of miscarriages and wanted to find out how many were reported to VAERS. The following criteria was used to produce the results:
| Symptoms: | ABORTED PREGNANCY; ABORTION; ABORTION COMPLETE; ABORTION EARLY; ABORTION INCOMPLETE; ABORTION INDUCED; ABORTION LATE; ABORTION MISSED; ABORTION OF ECTOPIC PREGNANCY; ABORTION SPONTANEOUS; ABORTION SPONTANEOUS COMPLETE; ABORTION SPONTANEOUS INCOMPLETE; ABORTION THREATENED |
|---|---|
| Vaccine Products: | COVID19 VACCINE (COVID19) |
| VAERS ID: | All |
| Group By: | VAERS ID |
| Show Totals: | False |
| Show Zero Values: | False |
My query produced 582 events. Following are the event descriptions for all of them...
| 0917350-1 | 27Dec2020 - patient developed some swelling (went about 1 inch out from injection site) and discomfort at the injection site - had taken Advil and was using a cool compress. 29Dec2020 - patient had to leave work early since she was not feeling well - very fatigued and a little dizzy (able to eat/drink) - denied any COVID illness s/s (no cough, fever, loss of taste/smell, etc). She ended up going to the local ED - since she was still very fatigued and was feeling like she was going to pass out - blood work and U/S done - this is where she found out she had been pregnant but had lost the pregnancy (no heart beat). Per her report - all other blood work was unremarkable. No other medications given to her during this visit and was just told that she would be 'passing the products of conception within this next week'. |
|---|---|
| 0917595-1 | I was about 6 weeks pregnant when I received the vaccine on 12/26/20. I had a miscarriage on 1/1/21. I have a pregnancy history of one prior healthy full term pregnancy in 2019. |
| 0922289-1 | I suffered a miscarriage on 12/31/2020. I was at 5 weeks gestation. This was my first pregnancy. I had uterine bleeding and abdominal cramps on 12/31/2020 and underwent evaluation by my Obstetrician and was diagnosed with a miscarriage after ultrasound. |
| 0923743-1 | I had a miscarriage on 01/01/2021 Estimated date of Delivery 09/7/ 2021 |
| 0924247-1 | I was 5.5 weeks pregnant when I revived the Pfizer Covid Vaccine. Everything was seemingly going fine with my pregnancy until about 4 hours after receiving the vaccine when I went to the bathroom nd wiped and saw pink discharge on the toilet paper. I then began to have mild low abdominal cramping. The abdominal cramping and vaginal bleeding steadily increased in severity over the next 24 hours until I eventually had an obvious miscarriage the evening of 12/31/2020. I cant help but think the vaccine in some way caused my body to reject the pregnancy. Along with the miscarriage, I also had extreme tiredness with GI upset 12/31/20 - 1/02/2021. |
| 0925639-1 | Miscarriage; patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; This is a spontaneous report from a contactable Other Health Professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly on 22Dec2020 06:00 AM at single dose at Arm Right at Hospital for COVID. Medical history included ongoing sleep apnoea. There were no concomitant medications. There were no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced miscarriage on 29Dec2020 13:00. The patient was pregnant while taking BNT162B2. The patient was 4 Weeks pregnant at the onset of the event. Patient last menstrual period date was 24Nov2020. The Pregnancy due to deliver was on 07Sep2021. The pregnancy resulted in spontaneous abortion. Since the vaccination, the patient has been tested for COVID-19 on an unknown date with unknown results. Nasal Swab on 28Dec2020 was Negative. There was no treatment received for the adverse event. The outcome of event was recovering.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agency, Ethics Committees, and Investigators, as appropriate. |
| 0926723-1 | I suffered from a miscarriage. 12 weeks along. It had been a healthy pregnancy otherwise. |
| 0928892-1 | I was approximately six weeks pregnant at time of my first vaccine. At subsequent OB visit three weeks later I had miscarried. It may not be related to the vaccine at all, but given this is a new vaccine and not studied in pregnant women I thought it was best to report it. |
| 0932028-1 | Miscarriage at 6 weeks pregnant |
| 0932107-1 | Pfizer-BioNTech COVID-19 Vaccine EUA Miscarriage - (date of vaccination 1/6/21, miscarriage symptoms (cramping) started 1/8/21, confirmed 1/10/21; estimated date of delivery 8/30/21) |
| 0936919-1 | G3 P1 mother, estimated gestational age of baby = 4 weeks. On day 4 post-vaccine (1/11/21) started with heavy bleeding and labs confirmed miscarriage. |
| 0941086-1 | Miscarriage |
| 0943837-1 | Approximately 5 days after administration at 6 weeks pregnant, I began bleeding. The following day (6 days after administration) miscarriage was confirmed via ultrasound |
| 0947745-1 | When this individual received her Moderna Covid-19 vaccine (Dose #1) on 12-29-2020 she did not know her pregnancy status. She did not think she was pregnant. On Thursday 1-7-2021 around 4 AM she started experiencing severe abdominal pain. She did not go to work that day but did go in on Friday 1-8-2021. On Saturday 1-9-2021 she woke up with significant vaginal bleeding. On Monday 1-11-2021 she went to the OB/GYN and there she had a positive pregnancy test. The diagnosis of miscarriage was made at that time. A couple of days later, a repeat pregnancy test resulted in a negative reading. |
| 0949729-1 | Miscarriage. Expected due date in August 2021. No prior pregnancy history. |
| 0950091-1 | I was 5 weeks pregnant when I got my first dose of the Pfizer covid-19 vaccine. I miscarried 4 days later. I do not know if the vaccine contributed to my miscarriage but wanted to contribute to the existing data. I had no other side effects or symptoms other than soreness at the injection site. There were no complications with the miscarriage. |
| 0950562-1 | 9 days after vaccine, I had a miscarriage. I was 5 weeks pregnant at that time. I had confirmation lab test 2 weeks prior of pregnancy and had labs with bhcg lower at time of bleeding to confirm miscarriage |
| 0953086-1 | I had a very early miscarriage at five weeks; I had a very early miscarriage at five weeks; I had a very early miscarriage at five weeks; This is a spontaneous report from a contactable Physician (patient). A 31-year-old female patient received BNT162B2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJI685) intramuscular at arm right on 19Dec2020 06:30 at single dose for covid-19 immunization. Facility type vaccine was hospital. Medical history was none. The patient had no known allergies or other medical history. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. The patient experienced a very early miscarriage at five weeks on 01Jan2021. The event result in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the event miscarriage was recovered in Jan2021. No covid prior vaccination and no covid tested post vaccination.; Sender's Comments: All pregnancies have a risk of birth defect, loss, or other adverse outcomes. The data on BNT162B2 administered to pregnant women is insufficient to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. |
| 0953737-1 | 3 weeks pregnant at time of first dose on 12/21/2020. Due date would have been 09/09/2021. Miscarriage on 01/14/2021 at 6 weeks. |
| 0955432-1 | I had vaginal bleeding and receive a Ultra sound. Which I had a miscarriage. My estimated delivery was August 25,2021. |
| 0958501-1 | Client was pregnant at time of vaccination. She had consulted with 2 OBGYNS that are following her concerning if she should receive the covid vaccine. They both stated yes. She received her 1st covid vaccination to her left deltiod between 12pm - 1300 on 1/14/21. She did not experience any complications or feel any side effects immediately after vaccination. She was monitored by nursing staff for over 30 min to be prudent. On 1/16/21 the Sat following vaccination she began experiencing cramping in her stomach and began to bleed vaginally. She consulted w her OBGYN and was monitored. She miscarried on 1/19/21. |
| 0959645-1 | I started having cramps Friday night and Saturday morning I started bleeding, by Saturday evening I was passing clots and tissue. ER doctor and nurses did tests and found I was having a miscarriage. |
| 0960019-1 | miscarriage, estimated 5 weeks |
| 0962952-1 | Miscarriage |
| 0964070-1 | Hi, I actually not sure if the couse of my problem was couse by the Vaccine given to me on January 17 2021. At the time of the injection given to me I was pregnant don't know how long because I just had found out about it. I took the injection because I wanted to be safe for the health of my baby and my family..am just curious about the side effect of this covi19 vaccine. On January 19 I started seen some spot of blood at first I thought it was nothing to worried about but then around 8am I that day I saw that I was bleeding more and more not a crazy bleeding but I ended up at the emergency room on January 19 around 3:45pm. To find out that I was having a miscarriage..so now I don't know if this was couse by the injection or not. Am just worried that these is a side effect of this injection and nobody knows about it. Please reply me back I want to know more I already have both covi19 vaccine. |
| 0965558-1 | Miscarriage; pregnant patient received the vaccine; pregnant patient received the vaccine; This is a spontaneous report from a contactable nurse (patient). This pregnant 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EK5730), intramuscular at single dose in the left arm on 20Dec2020 for COVID-19 immunisation. Medical history included none. Concomitant medication included venlafaxine. The patient experienced miscarriage (medically significant) on 09Jan2021 with outcome of recovering. Treatment unknown. The event required a visit to the emergency room. The patient was pregnant while taking BNT162B2. The patient was 4 weeks pregnant at the onset of the event. Patient last menstrual period date was 27Nov2020. The pregnancy due to deliver was on 03Sep2021. The vaccine was administered at Workplace Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. She received the second dose of BNT162B2 (Lot number EL0142), intramuscular in the left arm on 13Jan2021.; Sender's Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be complete excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. |
| 0966887-1 | Miscarried at 7.5 weeks between vaccination #1 and #2. I do not believe the vaccine was a cause, however, it was recommended to report just in case. This was a second pregnancy, first miscarriage. EDD was 9-1-2021. First pregnancy was uncomplicated. Pregnancy tests were negative prior to receiving the first vaccine and then turned positive on 12-29-2020 (5 days after getting first vaccine.) |
| 0967169-1 | Miscarriage? around 7 weeks pregnant at the time of vaccine, estimated delivery date was 8/19/2021 |
| 0968006-1 | Miscarriage on 01/03/21 (due date 08/08/21) 2 previous pregnancies with live births (2006,2010) |
| 0970490-1 | Miscarriage |
| 0970929-1 | A miscarriage was determined on 1/18/2021. There is no history of miscarriages. |
| 0975126-1 | G2P0, 5w5d; The patient is calling with vaginal bleeding in pregnancy. Calling with c/o dizziness with headache; Has a history of migraines; States she has subclinical hypothyroidism. Has tried Tylenol 500 mg for headache that worked for a little while; She denies vomiting, but does have nausea; Will try to increase water and protein intake; Will let us know if she gets worse/vision changes and will check in with PCP as they wanted to do a VV if dizziness got worse. Bleeding continued into following day. Documented as likely / threatened miscarriage. |
| 0975155-1 | LMP was 12/15/2020. Vaccine given on 12/22/2020. 3 positive pregnancy tests on 01/16/2021. Miscarried on 01/20/2021 as confirmed by serial quantitative hcg testing. Estimated 4-5WGA. Expectant management at home only |
| 0979951-1 | I was about 3 weeks pregnant at time of vaccination (Due date 9/3/2021). I experienced spontaneous abortion at 6 weeks gestation. Uncomplicated, no doctors visits or hospitalization required (though I am a physician so tracked HCG levels throughout). G3P1, one prior missed spontaneous abortion 2017, one live birth 2019. |
| 0980140-1 | Unexplained Pregnancy loss |
| 0981097-1 | "A large area around my injection site was red, swollen, warm to touch, firm and itchy covering 3/4 of my upper arm into my underarm and lymph nodes. I received my first vaccine on 12/23/20 several days after injection the site became very itchy, red and swollen but in a much smaller area and persisted for several days leaving a small area of skin hyper pigmented for ~2 weeks. However I did not think it was considered an ""Adverse"" event and would have not reported it if the second dose was to a similar scale. Also, when I received first vaccine I did not know I was pregnant at the time. When I went to the doctor on 1/23/21 I was told I was 7.5 weeks pregnant, but there was no heart beat and I had miscarried. Being that I am over the age of 40 and a high risk for pregnancy and miscarriage I am unsure if my miscarriage is directly related to the vaccine but I felt it should add it to the report. My first vaccine was administered on 12/23/20 @ 5:30pm at Hospital" |
| 0981111-1 | "My second dose was on 1/25/21 . One day after my 3/4 of my upper arm into my axillary area became red, swollen, warm to touch, tender to touch, firm and itchy. My axillary lymph nodes were also swollen and tender to touch. My first vaccine was on 12/23/20. Several days after a small area around the injection site became swollen and itchy. I also had a small palpable lump under my skin at the injection and my skin had a small area of hyper pigmentation for ~2 weeks. Again the area was much smaller and I did not think it would be considered an ""Adverse"" effect. I was also unaware that I was several weeks pregnant at the time of my first vaccine. when I went to the doctors office on 1/23/21 I was told I was 7.5 weeks pregnant, there was no heartbeat and I had miscarried." |
| 0981360-1 | Patient reported history as noted above. She relayed a coincident IVF cycle pregnancy loss. Further clinical details unknown by this facility. Submitted for consideration of possible association and further discussion with treating providers. |
| 0985511-1 | 1/4 - RECEIVED MODERNA VACCINE, PREGNANCY TEST CAME OUT NEGATIVE. 1/8 - PREGNANCY TEST CAME OUT POSITIVE 1/18 - HAD MISCARRIAGE, SAW TISSUE, NEGATIVE PREGNANCY HOME TEST, NEGATIVE HCT |
| 0985993-1 | Previously G1P1, delivered normal healthy baby July 20, 2020. Second pregnancy conception 12/15/2020. First vaccine dose 12/22/2020. Vaginal bleeding started 1/2/2021 and tapered down 1/4/2021. Light bleeding continued 1/4/2021 - 1/18/2021. Second vaccine dose administered 1/12/2021. Bleeding increased from light/none to medium flow on 1/19/2021 - 1/22/2021. Home urine pregnancy tests positive x 2 on 1/22/2021. HCG 56 mIU/mL and progesterone 0.5 ng/mL on 1/22/2021. HCG 17 mIU/mL and progesterone <0.5 ng/mL on 1/25/2021. Bleeding decreased to light flow 1/22-1/25 and gone 1/26/2021. Dr. diagnosed as early pregnancy loss/miscarriage. |
| 0987914-1 | Received COVID vaccine on Friday afternoon, 1/22, developed some slight abdominal cramping 1/24 and 1/25, had severe abdominal and back pain resulting in miscarriage evening of 1/25. Estimated date of delivery: August 27, 2020 Also had known subchorionic hematoma, diagnosed on 1/19 via ultrasound at physician's (OBGYN) office |
| 0988935-1 | Became pregnant 12/17/20 and miscarried at gestational age of 6 weeks. Received first vaccine dose on 12/31/20 Received second dose on 1/19/21 Began to miscarry on 1/30/21 |
| 0988939-1 | Pregnancy confirmed 1/28/2021, 5 weeks 5 days. Pregnancy lost 1/31/2021. Symptoms after Moderna vaccine were low fever and pain at injection site. |
| 0990450-1 | Miscarriage after 2nd vaccine.; Miscarriage after 2nd vaccine.; Miscarriage after 2nd vaccine.; Miscarriage after 2nd vaccine.; This is a spontaneous report from a contactable nurse reported for herself. This 33-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Es1686), via intramuscular at left arm on 11Jan2021 08:00 am at single dose for COVID-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685) intramuscular at left arm on 21Dec2020 10:15 AM for COVID-19 immunisation. The patient had no known allergies. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient was pregnant. Last menstrual date was 14Dec2020. Delivery due date was 16Sep2021. Gestation period was 3 weeks. The patient experienced miscarriage on 16Jan2021 after 2nd vaccine. AE resulted in congenital anomaly or birth defect. The patient had no COVID prior vaccination. The patient had COVID tested/nasal swab post vaccination with negative results on 11Jan2021 and 13Jan2021. Outcome of the events was unknown.; Sender's Comments: Based on the available information, a causal relationship between event miscarriage after the second COVID-19 vaccination and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. |
| 0992848-1 | Pt is G1P0. EDD was 8/15 by LMP. The patient had an ultrasound on 1/6 showing a live intrauterine pregnancy with crown rump length measuring 8 weeks 0 days. She had covid vaccine 1/7. Came in with vaginal bleeding 1/29 and found to have missed abortion on ultrasound (no heart tones, crown rump length measuring 8 weeks 3 days). Underwent D&C 2/1. |
| 0994135-1 | I am 38 years old with no history of medical problems. I do NOT have a history of miscarriages and have one healthy child who is 22 months old. On 1/13/21, I took a home pregnancy test which came back positive. At that time, I had a missed period but also had several common pregnancy symptoms such as bloating, acne, fatigue and tender breast. later that week, I called OB/Gyn and spoke to an RN to schedule my 8/9 week ultrasound and to inquiry about the vaccine during pregnancy since I had no clue whether it was recommended/safe or not. the RN, very confident and without any disclaimer, stated that hospital is recommending all of their pregnant patients to receive the vaccine. Obviously, I decided to trust this medical professional who was so confident in her response. My normal pregnancy symptoms continued. On 1/19/21, I was 5 weeks pregnant and received my first dosage of the vaccine. felt fine other than a sore left arm. on 1/20/21, I woke up with a lot of abdominal cramping and pain. It was new to me but assumed it was normal. My cramping and pain continued until 1/21/21. On 1/21/21, I woke up without the cramping and pain. But, I also noticed that my breast were no longer tender and my skin had completely cleared up. I became concerned but prayed everything was fine since my home pregnancy test was still positive. On 1/22/21, by cramps continued once again but more mild. My pregnancy symptoms seemed as if they were no longer present but remained hopeful. On 1/23/21, I woke up with light spotting that only lasted through the morning. Soon after, I started having extreme abdominal pains. I prayed everything was fine. The pain continued and became worse. That night, the pain was so bad that I just went to bed. Right before going to bed, I noticed I had started spotting again. A little heavier than in the morning. I made sure to lay on my left side, hoping it was normal in pregnancy. On 1/24/21, I woke up with heavy bleeding and clotting. I went to the doctor and got an ultrasound and blood test. I was told by the doctor at Hospital that I had a miscarriage. |
| 0995325-1 | I took an at-home pregnancy test on 1/26/21 and 1/27/21 after a missed period of which both were positive. On Saturday 1/30/21, I began to have heavy bleeding of which lasted through the weekend. I also experienced cramping and low back pain. On 2/1/21 I had an Hcg lab value of 3.5 confirming I had miscarried. This has lasted through 2/2/21. |
| 0995875-1 | Miscarriage Estimated date of delivery 09/12/2021 I was give IV fluids |
| 0995949-1 | Miscarriage reported |
| 0997660-1 | My right arm presented with a large round lump that was red, irritated and bumpy. The following day, it continued to grow to the size of a baseball. It was warm to the touch and sensitive. As of today, the swelling has gone down significantly (although it's still swollen) it is still visibly red, however, no longer sensitive to the touch. |
| 1004202-1 | Presumed miscarriage; human chorionic gonadotropin decreased; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 31-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced vaccine exposure during pregnancy, human chorionic gonadotropin decreased and presumed miscarriage. The patient's medical history was not provided. The patient's prior history of pregnancies were two miscarriages (2013 and 2015) and two full term births (2017 and 2019) were reported. The patient's last menstrual period was 25 Nov 2021. The estimated due date was 1 Sep 2021. Concomitant medications included sertraline hydrochloride and vitamins. On 27 Dec 2020, the patient found out she was pregnant, but she already had some bleeding. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On undisclosed date, after receiving the vaccine her human chorionic gonadotropin (hCG) levels went down to 0. Her health care professional presumed it was a miscarriage. Treatment for the event was not reported. On 19th Jan 2021, her hCG levels started to climb back up again. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, presumed miscarriage, and human chorionic gonadotropin decreased was unknown. The outcome of the event, vaccine exposure during pregnancy, was resolved on 28 Dec 2020.; Reporter's Comments: This spontaneous report concerns a 31-years-old, G5P2 female patient who experienced vaccine exposure during pregnancy and presumed miscarriage. The patient's last menstrual period was 25-Nov-2020 with estimated date of delivery as 01-Sep-2021. One day after the patient discovered she was pregnant; she received the first dose of mRNA-1273 vaccine (lot # 026L20A expiration date unknown). The event of presumed miscarriage (human chorionic gonadotropin (hCG) levels went down to 0) was diagnosed on an unknown date after vaccine administration. The HCG level began to climb up again 22 days after the vaccine administration. Based on the information provided which includes, the patient's obstetric history, vaginal bleeding the day prior to mRNA-1273 vaccination and without definitive confirmation of pregnancy loss, there is not enough evidence to assess that that there was a miscarriage and is also unlikely to be associated with mRNA-1273 administration. The event of vaccine exposure during pregnancy is considered not applicable |
| 1006011-1 | Miscarriage; The mother reported she became pregnant while taking bnt162b2; The mother reported she became pregnant while taking bnt162b2; This is a spontaneous report from a contactable consumer reported for herself. A 27-year-old female patient (Pregnant) received first dose of bnt162b2 (lot number: EL3248), via an unspecified route of administration in left arm on 16Jan2021 16:30 at single dose for covid-19 immunization. Medical history included asthma, covid-19 from an unknown date and unknown if ongoing. The patient's concomitant drug included prenatal vitamins. The patient experienced miscarriage on 21Jan2021 with outcome of recovering. The event was reported as non-serious. The adverse event result in emergency room/department or urgent care. No treatment received for the adverse event. The mother reported she became pregnant while taking bnt162b2. The mother was 8 weeks pregnant at the onset of the event. The mother was due to deliver on 19Aug2021. Last menstrual date: 22Nov2020. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Not known allergies to medications, food, or other products. |
| 1006169-1 | I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware of the pregnancy. I was diagnosed with COVID on 12/28/20, but was first symptomatic on 12/24. I attributed my s/s initially to the vaccine. I was eventually tested on 12/28/20, as my symptoms worsened and I was positive for COVID. On 1/14/21 I received my second dose, my COVID s/s had been resolved since 1/4/21. On the evening of 1/18/21 I started experiencing mild abdominal pain. This progressed, on the evening 1/20 the pain was no longer tolerable. I went to the ER where I hemorrhaged and needed emergency surgery and a blood transfusion for a miscarriage. The surgery ultimately took place in the early morning hours of 1/22/21, followed by the blood transfusion. |
| 1006634-1 | Spontaneous abortion. Pt was 9w1d at time of first Moderna COVID vaccine (EDD 8/9/2021). Two weeks later she began bleeding and was found to have an incomplete abortion with embryo measuring 9w1d. Proceeded to bleed heavily and D&C performed. Uncomplicated recovery. Genetic studies in process. Unknown if SAB is related to vaccine, though it appears embryonic demise occurred within a few days of vaccine administration. |
| 1007832-1 | I developed swelling and hives over 75% of my body and was given a shot of Epi shot because my throat closed. I developed a weakened immune system from the vaccine. I am 8 week pregnant and developed a Blighted Ovum and I am currently going through a miscarriage to date. Rather not release any info regarding the pregnancy |
| 1008618-1 | I was pregnant, embryo estimated 6 weeks gestation. I started having spotting approximately 34 hours after the 2nd dose. I went to my OB for heavy vaginal bleeding with an ultrasound completed 49 hours post vaccine with no concerns visually. Estimated miscarriage <72 hours after vaccine administration with confirmation via ultrasound 1 week and 2 days after vaccine. |
| 1010028-1 | The day I got the first shot of Moderna Covid19 vaccine I was 4 weeks pregnant. Starting week 6 I start to have symptoms of miscarriage (January 14 2021). This continued until January 18 when I lost the baby. I was due in September 2, 2021. |
| 1010113-1 | Miscarriage - first vaccine at 10 weeks and 3 days with prior proof of heartbeat/movement, second vaccine at 13 weeks and 3 days; learned of miscarriage at 14 weeks 3 days with measurements of 12 weeks 3 days on U/S |
| 1010528-1 | unfortunately she had a miscarriage about 5-6 days before her second dose; positive pregnancy test a few days after the first dose.; positive pregnancy test a few days after the first dose.; This is a spontaneous report from a contactable consumer. A 32-year-old female patient (3 weeks pregnant at time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included iron and minerals nos, vitamins nos (PRENATAL VITAMINS). The patient had a negative pregnancy test in 2020 before getting the first vaccine dose, but then had a positive pregnancy test in Jan2021 a few days after the first dose, but unfortunately she had a miscarriage in Jan2021, about 5-6 days before her second dose. She has an appointment scheduled with OBGYN for the miscarriage. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the miscarriage was recovering.; Sender's Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. |
| 1011050-1 | Positive pregnancy test 1/10/21. EDD 9/18/21 based on LMP (12/12/21). Woke up extremely dizzy and could not get out of bed without almost falling over and very nauseated. Symptoms eventually subsided around 10:00 am. Did not have dizziness again. Had a confirmatory Ultrasound on 2/4/21 which measured 5weeks, 5 days and no yolk sac. Was supposed to be 7 weeks, 5 days. Determined that I miscarried. |
| 1015666-1 | patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; Miscarriage 11 days post vaccine; This is a spontaneous report from a contactable Nurse. A 39-year-old female nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142), into the left arm on 28Dec2020 at 07:30 AM at single dose for COVID-19 immunization. Medical history included asthma and eosinophilic esophagitis and allergies to Keflex ASA. Concomitant drugs were none. At the time of vaccination the patient was pregnant, her last menstrual date was on 20Nov2020, gestational period 6. The patient reported that on 08Jan2021 at 12:00 PM she had miscarriage 11 days post vaccine. The patient was seen at Doctor or other healthcare professional office/clinic visit. At the time of reporting the patient was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported miscarriage. However, information is limited, and miscarriage is multifactorial event. In the general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15% to 20%. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. |
| 1016753-1 | 42yo G2P0010 at 3+6 weeks GA by LMP 1/1/2021 with EDD 10/8/2021 on day of Vaccine Dose #2 (1/28/2021), positive urine pregnancy test on 1/30/21. Bleeding began on 2/4/2021, and complete miscarriage occurred on 2/5-2/6. |
| 1017013-1 | Gravida 1 with last menstrual period of 12/05/2020. Patient received 2nd dose of vaccine on 01/19/2021. Patient had fever and body aches the next day 1/20/2021 and subsequently (3 weeks later) was diagnosed with a miscarriage of pregnancy at 6 weeks 4 days, which exactly corresponds with the date of the vaccine and symptoms. |
| 1018222-1 | I found out I was pregnant the day after receiving the first dose of the COVID-19 vaccine. My last period was on December 8th and I received the vaccine on Dec 30th. I developed a fever and muscle aches after the first dose, but was managed with Tylenol. I received the second dose on January 22nd and again developed a fever that was managed by Tylenol. I began having vaginal bleeding on 24th. I had an ultrasound revealing a heartbeat on the 25th. After continually bleeding, another ultrasound a week later on Feb. 2nd confirmed a miscarriage. I've had two healthy pregnancies prior to this one. |
| 1019778-1 | Miscarriage 1 week post getting dose 1 of vaccine. Estimated due date was 08/18/2021. Previous pregnancy history is 3 pregnancies, with 3 full term live births, no complications. |
| 1020661-1 | I was 6 weeks pregnant when I got my first dose of the vaccine. I spoke with my OBGYN prior to the vaccine and she said it was safe t get. The day after the vaccine (2/4) I started having some vaginal bleeding, confirmed with ultrasound. This progressed to having a miscarriage, confirmed via ultrasound 2/9. My OBGYN said she does not think they are related, but there is no way to tell. Until 2/4, I had no issues with my pregnancy. |
| 1020758-1 | I was 5 weeks 5 days pregnant with a EDD of 9/17/2021 at the time of my 2?d covid19 vaccine on 1/20/21. On 2/8/21 I found out that my fetus stopped growing at 6w1d, documented on US without heartbeat in the ER. I had a spontaneous miscarriage on 2/9/21. |
| 1020877-1 | I was a healthy pregnant woman age 43 who was 11 weeks 2 days pregnant. I was having a normal pregnancy with no complications. I'm in healthcare and in the operating often for airway and ENT procedures. I received my shot at 9:00am on 1/29/20201 and began spotting at 11:00am. The spotting continued (very light) until 9:00pm. I decided to go to bed since I wasn't feeling well. I woke at 2:00am with contractions and heavy bleeding. I went to the ED at 3:00am on 1/30 to confirm my miscarriage. I weighed 121 at the ED when triaged. My EDD was 08/19/2021 |
| 1021115-1 | I found out I was pregnant between dose 1 and 2 of the vaccines. I received dose 1 on 12/23/21 and had a positive pregnancy test on 1/2/21. I had my 2nd dose on 1/13 at 5w6 days based on LMP. I had my first prenatal visit on 2/10/21 at which time US showed twin gestation but neither fetus had a heartbeat. |
| 1022165-1 | PATIENT HAD A MISSED ABORTION, FOUND OUT 6DAYS AFTER VACCINATION. HAD HISTORY OF PREVIOUS MISCARRIAGES. WAS ON PROGESTERONE PESSARIES AND ASPIRIN. FETAL HEART BEAT MISSING ON ROUTINE REVIEW. GESTATION 10WEEKS+4DAYS. REQUIRED MEDICAL TERMINATION OF PREGNANCY. |
| 1023866-1 | Miscarriage at 6 weeks 1 day. Vaginal bleeding and decline in HCG hormone. Pregnancy not viable. |
| 1025363-1 | About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red rash across my chest up to my neck and under both breasts. All symptoms but the rash improved the following day. I went to have my 8 week pregnancy US 6 days after this second vaccine dose and there was no fetal heart rate. The baby measured 8.7mm and there should be a heart rate when the baby measures >7mm. I had all of my pregnancy symptoms up through the day of the vaccine and then they disappeared the day my vaccine symptoms improved. I do not have a history of miscarriage. |
| 1026685-1 | Arm pain and fatigue right away; January 4th I noticed I was bleeding - I had a miscarriage. Went to doctor the next day and they did lab tests and confirmed I had a miscarriage. Pregnancy - 3rd pregnancy; and it was my second miscarriage. I was about seven weeks pregnant. |
| 1026866-1 | Miscarriage- received 1st dose of vaccine when approximately 4 weeks pregnant on 1/6/21. 1st ultrasound at 7 weeks on 1/26/21. Intrauterine pregnancy with yolk sack but no fetal pole seen. 2nd dose of vaccine at approximately 9 weeks pregnant on 2/3/21. Diagnosis of miscarriage on ultrasound on 2/8/21. Due date should have been 9/13/21 |
| 1027542-1 | I conceived a pregnancy within 2 weeks of my vaccine which ultimately resulted in a miscarriage less than 6 weeks after the injection. |
| 1028368-1 | Miscarriage in first trimester. First dose received 12/22/2020 Conception date 01/03/2021 Second dose 01/27/2021 Miscarriage started 02/03/2021 First pregnancy. No other medical problems or pregnancy risks. |
| 1028576-1 | Was 5 weeks pregnant with 1st pregnancy due 10/12/21 and had a miscarriage the day after my 2nd dose. 2nd does was 2:30pm on Thursday. Had no side effects. 4:30pm the next day, Friday, began having miscarriage with no symptom warning. |
| 1028819-1 | First trimester miscarriage after receiving both vaccine doses while pregnant. Granada 5, Para 3 at time of vaccine administration. Due date 9/17/2021 |
| 1029307-1 | Missed abortion Date of last period December 1, 2020 (34 day cycle) Fetus measured 6 weeks and 4 days on 2/12/2021, but I was expected to be at 9 weeks 4 days. No heart beat. Therefore, estimated date of fetal demise is 1/22/2021 First pregnancy, estimated date of delivery 09/13/2021 Scheduled for D&E on 2/17/2021 |
| 1032993-1 | Reports she was vaccinated on 2/1/21, found out she was pregnant on on 2/3/21, and miscarried the pregnancy on 2/8/21. Additionally, she was involved in a motor vehicle accident on 2/1/21, prior to her vaccine, sustaining back pain and whiplash. Lastly, reports she began having visual changes on 2/3/21 and was diagnosed with a detached retina on 2/10/21. |
| 1033516-1 | "At the time of administration of the first does of Moderna vaccine, I was 6 weeks pregnant. I had confirmed pregnancy with home positive test and missed period. I had an estimated due date of 9/24/2021. This was my 4th pregnancy. I have had two uncomplicated pregnancies to term. In September 2020 experienced a chemical pregnancy with early pregnancy loss at 5 weeks. The first 24 hours after 1st dose of vaccine I experienced extreme arm soreness in the arm that was vaccinated, causing headache and unable to sleep. After 24 hours I felt ""normal"". 2 weeks and 3 days following the first dose of Moderna, I had a miscarriage. On the night of 2/15/21 I lost the pregnancy with vaginal bleeding, bright red blood, passing tissue, clots/ sac. I had an uneventful pregnancy up to that point, feeling well as I had with prior pregnancies." |
| 1038034-1 | Pregnancy loss; Vaginal bleeding; Vaccine exposure during pregnancy; A spontaneous report was received from a nurse practitioner who was 31-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine exposure during pregnancy, pregnancy loss (abortion spontaneous), and vaginal bleeding (vaginal hemorrhage). The patient's medical history was not provided. Concomitant medications reported as taken since conception included magnesium, prenatal vitamins, vitamin B and vitamin C. On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 10 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. On 02 Feb 2021, the patient developed vaginal bleeding, so she went to her obstetrician and had an ultrasound exam. The patient reported that there was no heartbeat at fifteen weeks and five days. No treatment information was provided. The patient's prior positive pregnancy test, last menstrual period, conception and due dates were not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, pregnancy loss and vaccine exposure during pregnancy, was considered resolved. The outcome of the event, vaginal bleeding, was unknown.; Reporter's Comments: This case concerns a 31 year old, female subject, who experienced a spontaneous abortion and drug exposure before pregnancy. Very limited information has been provided at this time. Further information has been requested |
| 1038096-1 | Pt is G1P0. At the time she received the vaccine on 1/26/21 she was 13 weeks pregnant. She had normal 1st trimester ultrasound and normal prenatal labs. Her EDD is August 5, 2021. On 2/9/21 she had a spontaneous miscarriage. No subsequent complications. No history of drug or alcohol abuse. No s/sx of other causes of a early 2nd trimester miscarriage. Of note the 1st trimester genetic testing was unable to be performed due to low fetal free cell DNA when she was at 10w. We were in the process of repeating the labs when the miscarriage happened. No history of COVID infection, no s/sx of COVID infection at the time of the miscarriage or subsequently. She was not tested. |
| 1038491-1 | Patient was newly pregnant, received 2nd dose of covid vaccine. Patient then began bleeding on 2/13/21. On 2/15/21 confirmed with OBGYN that HCG levels were low and that she was having a miscarriage. Patient has a healthy 2 year old living child. No past history of miscarriages, no family history of miscarriage. |
| 1038516-1 | Patient received the vaccine on 1/21 she presented for her first OB US on 2/4 and pregnancy was found to be nonviable; Patient has D&C scheduled for next week and more information will be available at that time |
| 1039396-1 | Miscarriage: vaginal bleeding with clots and tissue within 1 week of a positive home pregnancy test, two days after vaccination. Blood HCG take once vaginal bleeding commenced was <5. |
| 1040307-1 | Early miscarriage occurred on Sunday, 2/7/2021. No previous pregnancies |
| 1041297-1 | I started bleeding on the 4th, doctor stated threaten miscarriage. I had blood clots and vomiting'. I was taking to emergency room. I was giving a DNC because I had a miscarriage. |
| 1041373-1 | I was 4 weeks pregnant when I received the vaccine and had a miscarriage at 5 weeks 3 days. I had one healthy pregnancy to 41 weeks in 2019 and I was and still am breastfeeding. |
| 1042126-1 | Unknowingly pregnant at time of vaccination. Had a miscarriage one week later. Due on October 12. |
| 1042347-1 | Miscarriage; This is a spontaneous report from a contactable consumer(patient). This is a maternal report. A female patient of an unspecified age (Age: 29; Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that her first dose of the Pfizer vaccine was on 15Jan2021 and reported that she had a miscarriage on Thursday 04Feb2021. It was reported that the patient missed her scheduled second dose of the Pfizer COVID-19 vaccine due to a miscarriage. The event was assessed as serious (medically significant). The outcome of the event was unknown. Information on the lot/batch number has been requested. |
| 1042913-1 | Could be completely unrelated but I had a miscarriage following COVID-19 vaccination. |
| 1043944-1 | I was 5-week pregnant at the time of second COVID-19 vaccine dose. I had a gush of yellow vaginal discharge on 2/11 and subsequently spotting and bleeding up until pregnancy loss on 2/20. |
| 1044638-1 | Golf ball size lump on my arm at injection site that lasted 3 weeks and didn't reduce in size. Inability to use arm without extreme pain. Rash that felt like a burn on arm 12 weeks pregnant at the time of injection Pregnancy was lost |
| 1044756-1 | I received my first dose of the COVID19 Pfizer vaccine on 12/30/20. At this point I was 4 weeks pregnant. I received my second vaccine dose for the series on 1/22/21. At this point I was 7 weeks pregnant. On 2/18/21 I was diagnosed with a miscarriage due to no fetal heartbeat on ultrasound. I now have to undergo a D&C in the operating room. |
| 1045927-1 | positive at home pregnancy test 2/4/21 (same date as vaccine given). However, light bleeding/spotting started that night/next day but thought still normal. Heavier bleeding started 2/6/21 (Saturday) and continued through the weekend. Made appointment at hospital lab for Monday 2/8 to check HcG levels in blood. See below for details, but Dr. suggested repeat blood work on 2/10 as Hcg levels showed positive pregnancy, but very low. 2/10 Hcg levels slightly lower, which confirmed early miscarriage occurring. |
| 1046322-1 | Missed abortion - received first shot while pregnant (did not know), missed abortion of ~5 weeks gestational age, diagnosed Feb 2021 |
| 1047157-1 | Miscarriage at 8 weeks of pregnancy, 2/14/21. Tissue passed naturally without medical intervention. Hormone levels dropped without concern. The week prior to miscarriage sharp sporadic headaches (migraine-like but only lasting a few minutes at a time and coming frequently) started, and have continued daily through today (2/22/21) |
| 1047536-1 | Received vaccine on 02/02, 4 weeks pregnant on 02/03 02/03-02/05: Severe lethargy, tiredness, pain at injection sites, fever all lasting 48 hours. Symptoms subsided after taking tylenol on 02/05. I'm not attributing this to the vaccine, but on 02/12, my hcg started to plateau and decline, no egg yolk or fetal pole was seen at 6 weeks (2/17). Sac was measuring at 5 weeks. I eventually had a miscarriage on 2/21 |
| 1048833-1 | ~ 5 weeks pregnant at the time of 2nd vaccination. Miscarriage ~2 weeks later. Transvaginal ultrasound shows gestational age only 5 weeks when should have been 7. HCG level reflects only 4-5 weeks when should have been 7. |
| 1051018-1 | After the vaccine the patient miscarried the baby; This is a spontaneous report from Pfizer-sponsored program via a contactable pharmacist. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), 0.3 ml via an unspecified route of administration on 15Jan2021 at 10:00-11:30am as a single dose for COVID-19 immunization, administered in the right arm. Patient has no past medical history. Concomitant medication includes One-a-day vitamin, Ongoing. No prior Vaccinations within 4 weeks prior. First Day of Last menstrual period: 6-13 Dec2020. Patient reports one previous pregnancy: full term live birth via vaginal birth with epidural at 40 weeks and 1 day. The father used marijuana, at an unspecified frequency. Patient was unaware that she was pregnant, guesses she was about 3 weeks when she got the first shot of the vaccine. Ten days after the vaccine, the patient miscarried the baby. The clinical outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Miscarriage of pregnancy cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. |
| 1051502-1 | Approx 6 weeks at time of second administration with a due date of sept 28th. Would have been 3 weeks pregnant at time of 1st injection. 3 days after second injection, I began to miscarry. This was confirmed by declining HCG levels. Ultrasound to follow in one week. |
| 1053973-1 | Wife did not know she was pregnant at the time, had the vaccine and miscarried the child at 12 weeks. OBGYN stated baby had miscarried 2-3 weeks earlier. D&C procedure performed 2/23 to remove remains of fetus. |
| 1054987-1 | Pregnancy history: 1 previous pregnancy with healthy full term vaginal delivery. No complications. Estimated due date: Sept, 23, 2021. Symptoms: vaginal bleeding starting Jan 26th. Progressing to miscarriage on 1/29/21 |
| 1055663-1 | I was 8-weeks pregnant when I received my first dose of the Pfizer COVID-19 vaccine. This first dose was administered on Friday January 29, 2021. Three days later on Monday February 1, 2021, I was told my baby did not have a heartbeat on the ultrasound in the clinic (confirmed by radiology that day as well) and that I was having a miscarriage. I had no other signs or symptoms of miscarriage or illness. Pregnancy history - I do not have any other children yet. |
| 1056929-1 | That night my fever 102 took Tylenol to bring it down, shakes, chills , nausea, muscle aches and swollen lymph nodes (right armpit).The symptoms lasted to Sunday. My estimated date of delivery was Sept.14 I miscarried at 5 wks. |
| 1057062-1 | 1/8 vaccination 1/9 I woke up with severe HA, muscle aches, and fatigue. That evening I got chest pains. 1/10 CP resolved. Everything resolved. 1/17 positive pregnancy test 1/22 miscarriage. First pregnancy. 2/10 finally able to see dr. |
| 1057557-1 | Miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration in the left arm on 28Jan2021 08:30 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 07Jan2021 at 09:00 AM for COVID-19 immunization. Patient was pregnant. Patient has no other vaccines in four weeks and no other medications in two weeks. Patient has no COVID prior vaccination and no known allergies. On 05Feb2021 at 06:00 PM, patient experienced miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant. No treatment received for the event miscarriage. The event resulted in doctor's office/clinic visit. The patient was not tested for COVID post vaccination. The outcome of the event miscarriage was recovering. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the compatible temporal association, a possible contributory role of the vaccination with BNT162B2 in triggering the onset of miscarriage in this patient at 6 weeks pregnant cannot be excluded. Additional information regarding relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate. |
| 1058428-1 | 1/21 vaccination By that evening, I started having chills by 5pm. Began to have body aches; 7pm. Low Grade fever increased to 102 overnight. I didn't sleep at all to no avail with Tylenol and Motrin. Nauseous. 1/22 pregnancy test; positive By Friday evening, symptoms started to dissipate. 1/26 Miscarried; 4 weeks 3 days pregnant 1st pregnancy |
| 1058581-1 | Miscarriage at 6 weeks; 4 days gestation. |
| 1058751-1 | The evening of my vaccination, I began to feel feverish, weak and achy. During the night I woke with heavy bleeding and found out the following morning I had miscarried my otherwise healthy pregnancy. |
| 1058924-1 | Two weeks after the vaccine I had a miscarriage. |
| 1059615-1 | Miscarriage after receiving first Moderna vaccine dose |
| 1060131-1 | 1st vaccine: December 31 2020 2nd vaccine: January 28, 2021 Positive pregnancy test January 29 (2 positive tests on January 29, and 2 positive pregnancy tests on January 30) Estimated Due date October 8, 2021 Miscarriage on February 15, 2021 |
| 1060779-1 | At 5 weeks, 5 days pregnant I received the 1st Covid-19 dose. I started bleeding the evening of Feb. 7, 2021. The bleeding continued to increase. I visited the Emergency Department on Feb. 10, 2021 and learned my baby had died around 7 weeks into the pregnancy. |
| 1061033-1 | I was 6 weeks pregnant at the vaccine, two weeks later I started bleeding and had a miscarriage. Exactly 2 weeks after the vaccine. I left work that day to see the OB , had ultra sound, labs and a follow up a week later. |
| 1061109-1 | I was pregnant when I received my second dose of the Covid-19 Pfizer vaccine. My first Covid 19 vaccine was administered 12/28/2020. I got pregnant on 12/31/2020, received my second dose on 01/18/2021 and miscarried on 2/25/2021. I have had two prior uncomplicated pregnancies, and have never experienced a miscarriage. I gave birth to my two daughters, one at 42 weeks and one at 40 weeks and 5 days. My EDD for the pregnancy that ended in a miscarriage was due 09/23/2021. |
| 1063601-1 | COVID vaccine given Dec 24th, 2020 and second dose on Jan 16th, 2021. Conception occurred approx Jan 11th, 2021 pregnancy diagnosed Jan 26th, 2021. ED Oct 4th, 2021. US confirmation of pregnancy with gestational sac on Feb 14th, 2021. Miscarriage/SAB/pregnancy loss occurred spontaneously on Feb 18th, 2021 with bleeding, cramping. Pregnancy loss confirmed by ultrasound with OBGYN. |
| 1063971-1 | Sudden onset: Sore arm - really sore. Whole body aches. Headache and neckache. I did not have a fever. 24 hours later they all disappeared. I found out I was pregnant on the 8th. I had a normal ultrasound and a heartbeat at the end of January (the 29th) and February 8, there was no heartbeat anymore. I miscarried. This was my fifth pregnancy. I had one other miscarriage. I had a pregnancy where I had twins and one of the twins miscarried. So I have miscarried three babies. The expected date of delivery for this pregnancy was September 13, 2021. |
| 1064425-1 | I was about 9 weeks pregnant with no complications at the time of my second vaccination. Estimated due date was 08/24/2021. I began bleeding and cramping and having headaches approximately 10 days after my second dose. I sought medical attention and was told that my baby no longer had a heart beat and that growth (based on ultrasound) had stopped around the 9 week mark. I had medical assistance to physically miscarry the deceased fetus. I have one healthy living son (2 years, 4 months old) who was delivered without complications naturally. |
| 1065703-1 | Miscarriage at approximately 7 weeks pregnant |
| 1065910-1 | Miscarriage; Received vaccine when pregnant; A spontaneous report was received from a 34-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) when pregnant and experienced a miscarriage. The patient's medical history included three prior pregnancies, with two live births and one miscarriage. Products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins and doxylamine succinate/pyridoxine hydrochloride. The patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) on 30 Dec 2020. On 27 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. At 7 weeks gestation, the fetus had a normal heart beat. She reported that she had no complications with the pregnancy. On 08 Feb 2021, the patient had a miscarriage. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The events received vaccine when pregnant and miscarriage were considered recovered.; Reporter's Comments: This report concerns a 34-year-old, P2G4 who experienced miscarriage 1 month 9 days post administration of first dose and 12 days after the last dose of mRNA-1273 vaccine. There is not enough information such as the last menstrual period, estimated date of conception and delivery and gestational age at the time of miscarriage. In addition, the patient's detailed medical history including any trauma and reason for previous miscarriage is lacking. Vaccine exposure during pregnancy is assessed as not applicable. |
| 1065919-1 | miscarried; patient was pregnant at the time of the vaccine; patient was pregnant at the time of the vaccine; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration at right arm, at the age of 29-year-old, on 30Jan2021 02:00 AM, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. The patient had no known allergies. The patient did not receive any other vaccine in four weeks or any other medications in two weeks. The patient was pregnant at the time of the vaccine 30Jan2021 and miscarried on 01Feb2021. LMP was provided as 01Jan2021, gestation period was reported as 4 weeks and due date was provided as 08Oct2021. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the event miscarried. Outcome of the event miscarried was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, a possible contributory role of suspect vaccine BNT162B2 in triggering the misarrange in this 29-year-old pregnant patient cannot be excluded. Additional information regarding relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate. |
| 1066049-1 | Reported by patient to have been 9.5weeks pregnant when miscarriage happened. |
| 1069747-1 | Became pregnant end of December. Received first dose January 6 and second dose January 27. Had very bad side effects. Felt pregnancy symptoms up until February 10th. Symptoms started to linger off. Had ultrasound that showed fetus February 10. Cramping started feeling days later. Had ultrasound again February 18 showed fetus had grown. Had another ultrasound February 21 after going to ED for bad cramping and pain. fetus had no heart beat. Miscarried February 26. Contents did not pass completely, had D&C February 27. |
| 1069793-1 | 1/8 vaccination HA went away after a week bleeding in between vaccinations ultra sounds weekly, blood work 1st went to ER, 2nd bleeding episode went to PCM for same day visit 2/2 miscarriage, D&C |
| 1069850-1 | LMP 1/10/2021. Moderna vaccine #2 1/20/2021. Positive pregnancy test 2/2/2021. Confirmed loss by US 2/13/2021 and decreasing quant. D&C 2/19/2021 |
| 1070733-1 | miscarriage; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose on 08Jan2021 in right arm and 1st dose on 15Dec2020 in left arm, both via intramuscular at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously took amoxicillin and experienced allergy. Concomitant medication included prenatal vitamins. The patient experienced miscarriage on 11Jan2021 with outcome of recovered. The event resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. The mother was 11 weeks pregnant at the onset of the event. The mother was due to deliver on 07Aug2021. Date of LMP was 26Oct2020. Therapeutic measures were taken as a result of miscarriage included misoprostol (CYTOTEC). Information of lot/batch number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Considering the product-event temporal relationship, a causal association between the reported 'miscarriage' and the administration of bnt162b2 cannot be completely excluded. Case will be reassessed once with additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. |
| 1070952-1 | I was not pregnant at the time of the first vaccine, but was pregnant at the time of the second vaccine. I had a miscarriage on 2/24/2021 |
| 1071787-1 | Miscarriage after 2nd dose given |
| 1073098-1 | No adverse event occured, but I was 5 weeks pregnant at the time of the second vaccine and miscarried at 9 weeks. |
| 1073958-1 | This was an IVF pregnancy. My 2nd pregnancy. I got my first positive pregnancy test on Jan. 27th at exactly 4 weeks pregnant. I received my first vaccine at 4 weeks 4 days. I then went in for my first ultrasound at 6 weeks 5 days. The doctor told me the baby wasn?t developed normally and a miscarriage had already started. I believe the gestational sac measured about 5 weeks 3 days. |
| 1074063-1 | Miscarriage, first trimester |
| 1074149-1 | Miscarried at 6 weeks; Vaccine exposure during pregnancy; A spontaneous report was received from a healthcare professional concerning a 32 year old female patients who received Moderna's Covid 19 vaccine(mRNA1273) and experienced vaccine exposure during pregnancy and miscarried at 6 weeks. The patient's medical history was not provided. Concomitant product use was not provided. The patient received second of two planned dose of mRNA-1273 for prophylaxis of Covid 19 infection approximately 2.5 weeks before the miscarriage. The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of Moderna vaccine. The patient received both scheduled doses of mRNA-1273 prior to the events ; therefore, action taken with the drug in response to the events is not applicable. The outcome of the event, miscarriage spontaneous was considered as unknown. The outcome for the event of Vaccine exposure during pregnancy was recovered/resolved.; Reporter's Comments: This case concerns a 32 year old, female subject, who experienced a spontaneous abortion and drug exposure during pregnancy. The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of mRNA-1273. Very limited information has been provided at this time. Further information has been requested. |
| 1074467-1 | Pregnancy loss: estimated due date was September 22, 2021. The only symptoms I experienced were pelvic cramping and chills. I did not have a fever. I received both doses during pregnancy. There is no explanation for the loss of the pregnancy. The baby showed as healthy and normal with a strong heartbeat on Feb 5 and the baby stopped growing and the heart stopped beating on Feb 6. |
| 1075313-1 | miscarried at 12 weeks; received first dose of bnt162b2 on 18Dec2020, second dose on 11Feb2021; received first dose of bnt162b2 on 18Dec2020, second dose on 11Feb2021; This is a spontaneous report from a contactable nurse (Patient). A 38-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248) intramuscular in right arm on 11Feb2021 17:00 at single dose for covid-19 immunisation. No medical history. No COVID prior to vaccination. Other medications in two weeks include prenatal vitamins. Patient received first dose of bnt162b2 (lot number ek5730) on 18Dec2020 12:00 PM intramuscular in right arm. No other vaccine in four weeks. Patient's last menstrual date was 01Nov2020. Patient miscarried at 12 weeks after receiving the second dose of vaccine. Dilation and curettage performed. Outcome was recovered with sequel. Nasal Swab COVID tested negative post vaccination on 18Feb2021.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Considering the product-event temporal relationship, a causal association between the reported 'miscarried' and the administration of bnt162b2 cannot be completely excluded. Case will be reassessed once with additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. |
| 1075754-1 | I had some arm soreness that started the morning after (22nd) and that lasted until the 27th of January....it got better each day. I had fever to 102 that started on the 22nd. The fever ended on 23rd. I took Tylenol - it didn't help on the 22nd but by 23rd it did. I felt fatigue -22nd and went away on 24th. I miscarried 27th-29th -30th- that timeframe. The miscarriage prompted care. I went to Medical Center. I was not pregnant at time first vaccination. Estimated date of delivery had been - September 22, 2021; I have no prior pregnancy history. |
| 1078957-1 | Found out pregnant in between doses 1 (12/21)and (1/11). Lmp 12/13/2020. Was informed on 7 week ultrasound the fetal heart rate was low and Miscarriage likely. Miscarriage 2/4/2021. |
| 1081203-1 | Patient had LMP on 1/12/21, so was most likely early pregnant at the time of her first vaccine. She then experienced a miscarriage on 3/1/21. She was assessed in the ER and then in our OBGYN office. |
| 1082396-1 | Patient suffered a miscarriage about 9 days after getting a covid vaccine. |
| 1084690-1 | Miscarried. Due date had been Sept 16, 2021. This was my first pregnancy. |
| 1085314-1 | Exactly a week after the vaccine shot, I started a very heavy menstural period. It was not time yet. I am on birth control pills and I am very regular. It's been a week and I am still on a heavy period. It was so bad that I purchased a pregnancy test because I was having a miscarriage. Test was negative. |
| 1086384-1 | On the following day after receiving my first dose of the vaccination, my arm was throbbing, completely swollen, decreased ROM and skin was RED and severely tender to the touch. Took OTC Tylenol (2) po and had no signs of relief. Pain , swelling, and skin redness lasted for 3 days. On February 10th, 2021 I had a positive pregnancy test (confirmed by bloodwork and urine) which indicated I was 6-7 weeks pregnant and had a miscarriage on March 2021, after giving live births 3 prior times. The cause of the miscarriage is unknown. I also developed a blood clot on the arm that was inserted for an IV. I have no family history or personal history of needing blood thinners. |
| 1086484-1 | I got the Covid vaccine on 2/13/21, I lost a small clot and started to bleed on 2/19/21. I was due around Oct 4th, at the time of the vaccine I was 6 weeks pregnant. I miscarried at home on 2/25/21- I lost a very large clot and was bleeding heavily for a week. Doctor confirmed with HCG test that I miscarried. This was my second pregnancy, I had my first child 1/10/20. |
| 1086871-1 | Miscarriage; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 41-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event miscarriage/ abortion spontaneous and vaccine exposure during pregnancy. The patient's medical history included environmental allergies and an allergy to an unknown beauty product, kidney stone, endometriosis, anxiety, and paroxysmal supraventricular tachycardia. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins and escitalopram oxalate. The patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly on 14 Jan 2021. On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2020, the patient had a positive pregnancy test. The first day of the patient's last menstrual period was on 24 Dec 2020. The estimated date of conception was not provided. The due date was estimated as 30 Sep 2021. On 22 Feb 2021, the patient had a miscarriage. There was no fetal heartbeat on the ultrasound. On 24 Feb 2021, the patient underwent a procedure to complete the miscarriage. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events was considered recovered.; Reporter's Comments: This is a case of product exposure during pregnancy with an Adverse event of Spontaneous abortion for this 41-year-old female. Very limited information regarding this event has been provided at this time. Further information has been requested. |
| 1087386-1 | Patient received the Moderna COVID Vaccine on 29 January, at which time she was 7 weeks pregnant. No other comorbities noted. On 01 February she had a miscarriage. She also received the first dose while pregnant, first dose was given on 30 December 2020 and she was 3 weeks pregnant |
| 1087526-1 | I received my second vaccination in the morning on 02-04-21. I visited my OBGYN that afternoon learned that I was approximately seven weeks pregnant, and that my baby was healthy with a heartbeat, I returned to the OBGYN four weeks later for my routine visit and leaned that the fetus had died around week 8, which was approximately one week after receiving the vaccine. I had no other issues or complications that would have contributed to my miscarriage. |
| 1087557-1 | Miscarriage following COVID vaccine. |
| 1089690-1 | Miscarriage |
| 1090217-1 | Miscarriage; This is a Spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the maternal report. A 39-year-old female consumer reported that a 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9269), via an unspecified route of administration at left arm on 04Feb2021 14:00 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin. No other vaccine in four weeks. Concomitant medications included (in two weeks) Prenatal vitamin, colecalciferol (VITAMIN D), folic acid (FOLATE) and sertraline hydrochloride (ZOLOFT 25mg). The patient's last menstrual date was 14Dec2020 and the delivery date was on 17Sep2021 (Gestational period: 8, as reported). An OB exam on 03Feb2021 showed healthy baby at 7w5d- heartbeat detected 152bpm; no abnormalities identified via ultrasound, Labs and hormone levels all within normal ranges. No issues detected. Mother received 1st dose of vaccine 04Feb2021. Per ultrasound on 20Feb2021, fetus stopped growing on 09Feb2021 (8w4d); no heartbeat detected. Miscarriage occurred 22Feb2021. AE resulted in Emergency room/department or urgent care, congenital anomaly (as reported). No treatment was administered. No COVID prior vaccination. Patient not COVID tested post vaccination. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225027 fetus case |
| 1090296-1 | Miscarriage |
| 1090818-1 | My last period was Jan 7, 2021. Received Vaccine, dose 2 on 1/25/21 (I did not know I was pregnant at that time). Had a miscarriage and lost baby Feb 18-21 |
| 1094454-1 | I experienced a miscarriage on February 27th, 2021. I was approximately 10 weeks pregnant when I experienced the miscarriage. It was accompanied by severe pain/cramps in the abdomen and lower back. Expected delivery would have been in September 2021. This was my first pregnancy. |
| 1096648-1 | After my second dose Pfizer vaccine, on the day or day after I suffered a miscarriage. |
| 1096656-1 | I miscarried my baby two days after my second dose. I got pregnant between doses. |
| 1096812-1 | After my second dose I had a miscarriage but it was identified on 02/22/2021, I was 11 weeks pregnant and I had no complications with my pregnancy, Before my 1st dose my platelet blood count was at 400 then after my 1st dose it went to 538. |
| 1096971-1 | I had abdominal pain and bleeding. I suffered a miscarriage. |
| 1097090-1 | A couple of minutes of having the vaccine I started having heart palpitations. I didn't see much of it so I left but it kept on going for the next couple of days then on the following Sunday I ended up going to the urgent care & they sent me to the Emergency room from there. On march 1st I had a miscarriage I was 6 weeks pregnant, There was some questions when I found out I was pregnant to see if I was going to have some issues or not. |
| 1097833-1 | I had an IUI performed my my OB on 2/1/2021 and received the 2nd dose of the COVID vaccine on 2/4/2021. I found out I was pregnant on 2/15/2021 and found out I was miscarrying on 2/26/2021. |
| 1097975-1 | Patient started having pain prior to her injection on 3/11/21. On 3/12/21, she started bleeding, and on 3/14/21 she miscarried at 13 weeks. |
| 1098925-1 | I received the vaccination on Friday and on Sunday my bleeding increased. I already had some mild bleeding that had been constant since Feb 23rd or 24th. But I had an appointment on Feb 26th that confirmed I had a baby with a healthy heartbeat. I was also diagnosed with a very small uterine cyst. They told me the cause of the bleeding was pro ant implantation bleeding. I had light bleeding (bleeding just needing one or two pant liners each day) until Sunday the 7 when I saw an increase in bleeding. I called my doctor on Tuesday (I decided not to call Monday because I felt I would get the same answer I had already gotten, which was that everything was fine) and they had me come in die an urgent same day appointment. At that appointment I learned my baby did not have a heartbeat. The baby was measuring at just over 8 weeks. The due date given to me based on my last period was October 12th. So I was exactly 9 weeks when I went into the appointment Tuesday to find out the baby didn?t have a heartbeat. I officially miscarried the embryo and the placenta on Friday March 12th. This would have been my second baby. My first is a male and he is 18 months old. My first pregnancy didn?t have any complications. I do not have a history of miscarriage in my family, and this was the first one I have had. I did have to take 150mg of Clomid to get pregnant with this baby. |
| 1099240-1 | Complete spontaneous Miscarriage at 6 weeks and 5 days |
| 1099293-1 | I was between 4-5 weeks pregnant at the time of my 2nd Pfizer shot and miscarried 8 days after receiving the shot. I understand it is a possible coincidence however wanted to report seeing that I already carried a full healthy pregnancy to term in 2019. |
| 1100545-1 | miscarriage after receiving both doses of COVID19 vaccine; This is a spontaneous report received from Pfizer sponsored program from a contactable consumer reported for self. A female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient is pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient had a miscarriage after receiving both doses of COVID-19 vaccines. The patient received no treatment. The outcome of event was unknown. Information about lot/batch number has been requested. |
| 1101580-1 | I received my second dose Pfizer vaccine 01-27-2021. I found out I was pregnant the beginning of March 2021. On 03-10-2021, I found out I was having a miscarriage. I am in the process of recovering. |
| 1103353-1 | Miscarriage 2 weeks after receiving the first dose (March 1, 2021). Baby had a heart beat, then slowly died. Ultra Sound Showing Fetal Bradycardia on 2/26/21. |
| 1104214-1 | I was 9 weeks and 2 days pregnant with my first pregnancy (no history of miscarriages) when I received my first dose of the Moderna vaccine on 1/9/2021. I had a routine appointment with my OB-GYN the day prior, 1/8/2021, during which they completed a routine ultrasound. At that time, the ultra sound was completely normal with a healthy fetus and heart rate, and my due date was estimated to be 8/13/2021. Also at that time, I was advised by my OB-GYN to get the COVID vaccine, when offered to me, given my higher risk of contracting COVID due to my job as a healthcare worker with direct patient contact, and my higher risk for more severe illness if I contracted COVID due to pregnancy. I received the vaccine the next day with no immediate adverse reactions/events aside from some considerable arm soreness at the site of the vaccine and fatigue. Then 2 weeks and 6 days later I had another routine appointment with my OB-GYN (1/29/2021) at which point in time I was 12 weeks and 1 day pregnant. During this visit they conducted a second routine ultrasound. From this ultra sound they identified multiple abnormalities including an increased nuchal translucency of 3.5 mm, absent nasal bone, and presence of fluid around the fetus?s abdomen. These abnormalities were concerning for a chromosomal/genetic abnormality. Given these concerns I had labs drawn for maternal carrier screening (the Panorama and the Horizon 274), and I was referred to maternal fetal medicine for further imaging and testing. The results of the lab work took approximately 2 weeks to receive, but they came back normal without increased risk identified for any of the chromosomal/genetic conditions tested. I was seen by a high risk doctor and a genetic counselor within the maternal fetal medicine department on 2/2/2021. At this appointment I had a third ultrasound completed which confirmed the presence of an increased nuchal translucency now 4.3mm, and also found the presence of a cystic hygroma. These findings were again consistent with concerns for a chromosomal, genetic or other anatomical/structural condition and as such I had a chorionic villus sampling done that same day to assess the DNA of the fetus. These results also came back all normal without concern for any of the chromosomal or genetic conditions tested. I then had a follow up appointment and ultrasound with the maternal fetal medicine department on 2/19/2021, at which point I was 15 weeks and 1 day pregnant. This early anatomical scan revealed even more concerning findings with the fetus?s humerus measuring in the 1st percentile for gestational age and the fetus?s femur measuring in the 3rd percentile for gestational age. Per consultation with our genetic counselor this was indicative or some severe condition; however, it was not clear exactly what condition. Given the severity of the findings it was recommended to terminate the pregnancy. As such I had to undergo a dilation and evacuation procedure on 2/24/2021. We are currently still awaiting results of further genetic testing (exome testing), the results of which can take 2-3 months from the time of sending out the labs (sent out around 2/24/2021). |
| 1104476-1 | Miscarriage: LMP 11/17/20, diagnosis of MAB on 1/26/21. Chromosomal testing of the embryo determined cause of miscarriage to be trisomy 12. Prior to this most recent miscarriage I had 3 previous miscarriages and 1 live birth (1 living child). To be clear, I do not blame the vaccine for the miscarriage, the chromosomes of the embryo were determined before I got my first Covid vaccine. |
| 1104712-1 | Miscarriage after vaccine. I was 11 weeks pregnant. Estimated date of delivery is 9/20/21. |
| 1106171-1 | no fetal heartbeat; pregnant and received vaccine; A spontaneous report was received from a 37-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) while pregnant, and there was not fetal heartbeat. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins. The consumer received the second of the two planned doses of mRNA-1273 on 26-JAN-2021 (Batch# 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 02-MAR-2021, the patient stated her fetus had no heartbeat. No treatment information was provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events was considered recovered.; Reporter's Comments: This is a case of product exposure during pregnancy for this 37 year old woman with associated event of absent fetal heartbeat. The patient will continue to be contacted for follow-up. |
| 1106398-1 | Initial prenatal visit on 2/4/2021, pregnancy measuring 6 weeks with visible cardiac activity. Vaccine received 2/9/2021. Repeat ultrasound 2/18/2021, no cardiac activity seen, pregnancy still measuring 6 weeks. D&C procedure on 2/23/2021 for missed abortion. |
| 1106442-1 | Within 24 hour I began to bleed and ultimately had a complete miscarriage of baby. I was at 6 weeks, with 2 healthy children (3 1/2 and 1 1/2 years old) with no prior pregnancy issues or complications. |
| 1107257-1 | Miscarriage; Pregnant at time of vacciation; Pregnant at time of vacciation; This is a spontaneous report from a non-contactable consumer. A 34-year-old female patient (16 weeks pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Jan2021 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced miscarriage at a routine OBGYN visit on 19Feb2021. The patient was hospitalized for the miscarriage on an unknown date for 2 days. The clinical outcome of the event miscarriage was unknown. The patient had not had COVID prior to the vaccination and has not tested positive post vaccination. Information about lot/batch has been requested. |
| 1107944-1 | After Dose1 I was 10 weeks pregnant went to doctor for sonogram. I went to doctor heart rate 160 doctor stated everything was fine I could start telling everyone I wa pregnant. On 2/5 I started having a miscarriage the fetus was 12 weeks. My blood work was good no abnormalities from the enzymes.(estimated of delivery 8/17/2021) |
| 1108773-1 | I suffered a miscarriage at 7 weeks 4 days. Miscarriage occurred on 1/23/21. Vaccination 1 was on 12/26/20 & Vaccination 2 was 1/12/21 |
| 1109162-1 | Miscarriage of baby due on 10/3/21. |
| 1109612-1 | Missed abortion noted about one month after 1st COVID vaccination Patient was supposed to be around 11weeks pregnant. She had a prior ultrasound with a single live intrauterine pregnancy on Feb 24, 2021. EDD was October 3rd, 2021. Fetus with no heart tones noted on March 17th, 2021. Fetus measuring about 8 weeks pregnant patient only noted elevated temperature after COVID vaccination |
| 1110463-1 | Miscarriage determined at 19 weeks gestation on 3/10/2021. |
| 1111960-1 | Miscarriage G3P2 2002 |
| 1113620-1 | I was trying for a pregnancy and was likely pregnant but not detectable at vaccine number 1. Found out about pregnancy a week or so before vaccine 2. (I was likely about 5 weeks pregnant then based on LMP of dec 22 with avg cycles of 35 days. Decided to get vaccine due to general advice that it is okay during pregnancy. (No known adverse effects). After dose 2, had about 10-12 hours of chills without fever and general fatigue. Shortly afterwards experienced mild cramps. This is my 5th pregnancy and I have no history of complications of any sort. Cramps are not usual for my pregnancies but I know it can be normal so I did not think anything of it. Mild spotting occurred but again did not think anything of it as I know it can be normal. I was scheduled for a first OB visit Mar 3 where I should have been 10 weeks. (Initial positive pregnancy test was Jan 29). Ultrasound showed empty 5.6 week gestational sac with a yolk sac and subchorionic hemorrhage. OB suspected pregnancy failure. We followed pregnancy with ultrasound of better quality 10 days later which showed a possible fetal pole and yolk sac but no heart beat and gestational sac measured at 6.0 weeks. Today March 18 awaiting repeat ultrasound tomorrow but started bleeding and cramping. Consistent with the start of the miscarriage. With no histories of abnormal pregnancies and with the gestational sac consistently measure at 6 weeks (matching to about the time of shot#2), I am inclined to believe that the second covid shot stopped the progression of my pregnancy. I am a huge pro vaccine health care provider but would recommend now an investigation into first trimester covid vaccinations and possibly not recommend this during that time period. |
| 1113942-1 | miscarriage; pregnant patient received BNT162B2; pregnant patient received BNT162B2; This is a spontaneous report from a non-contactable consumer. This consumer (patient) that a 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6201) at the age of 34-years, via an unspecified route of administration on 20Feb2021 at single dose for COVID-19 immunisation. Medical history was not reported. Patient was pregnant at time of vaccination, last menstrual date was 21Jan2021. No other vaccine in four weeks, no COVID-19 prior vaccination. Concomitant medication included ustekinumab (STELARA). The patient experienced miscarriage on an unspecified date (on 03Feb2021, as reported). The pregnant patient received BNT162B2 on 20Feb2021. No COVID-19 tested post vaccination. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238716 Same product and AE , different patient |
| 1114093-1 | Miscarriage |
| 1115752-1 | Pregnancy occurred within the 8 days following the vaccine. Pregnancy confirmed with positive urine pregnancy test on 03/01/2021. Some vaginal bleeding began 03/12/2021 but resolved quickly. Abdominal cramping and bleeding on 03/15/2021 and 03/16/2021. Blood work completed on 03/15/2021 and 03/17/2021 showed a decrease in pregnancy hormone and pregnancy was considered miscarried. |
| 1116359-1 | After my second vaccine, and few weeks later, I suffered a miscarriage on 02-18-2021. I went to see my OBGYN who performed an ultrasound. My baby at that time was 6 weeks old. |
| 1116526-1 | I experienced a missed miscarriage. I was pregnant during both doses of the vaccine (1st dose 1/15/21), but 2/12/21 (the day of the 2nd dose) was the day the gestational sac stopped growing. I was 8 weeks pregnant at this point. The ultrasound was on 2/17/21 and it was reported that I was supposed to be 8wk 6days, but gestational sac was only 8wk 1day. I was due on 9/23/21. My PCP encouraged me to get the vaccine, knowing that I was pregnant. So I did. Upon receiving my 2nd dose of the vaccine, I did not experience any symptoms and believe that my body was focused more on the vaccine than the development of the baby. Obviously I'm not positive that this was the cause, but I wanted to make it known, so I can hopefully prevent this from happening again, if the vaccine was indeed a contributor. |
| 1116562-1 | Patient received first dose of Moderna vaccine on 1/15/21 and was not aware of pregnancy. On 2/12/21, she called and cancelled her 2nd dose appointment because she found out she was pregnant. On 3/16/21 she contacted the pharmacy to schedule a second dose vaccine appointment because she said she had a miscarriage. Called Moderna to report it and Moderna confirmed to give second dose past the 42 days cdc recommendation instead of restarting the series. Patient received 2nd dose on 3/17/21 and has a follow up appointment with OB/GYN on 3/20/21. |
| 1117428-1 | I miscarried with a blighted ovum. Pregnancy history. I have no medical conditions and have had 2 healthy pregnancies prior. I had the first vaccine the week I ovulated and then found out I was pregnant the following month. Jan 19th was the date of my last menstrual cycle Est il mated date of delivery: oct 26, 2021 |
| 1117494-1 | I started experiencing flu-like symptoms at around 5 PM on 3/14/21. I was feverish and had chills, muscle aches, and a headache. I had very strong chills for a few hours and then I noticed that my resting heart rate was around 128 bpm at around 1:30 AM on 3/15/21. I was running a 100.6 fever at that time. My fever subsided in the morning and the headache persisted throughout the day, and I was very tired as I did not get much sleep the night before. I did not work that day (Monday, 3/15). At the time I was about 7 weeks pregnant. I noticed some very light spotting later in the day on 3/15, and then I continued spotting on 3/16. I consulted a midwife at the facility at 4 PM on 3/16/21 and took a blood test to measure my hCG hormone levels. The following day, 3/17, I received the results that I had a normal level of hCG hormone and normal hemoglobin levels. As the day continued, the spotting turned into bleeding, and eventually the bleeding became heavy starting around 4 PM. I received an ultrasound on 3/18/21 at 8 AM and later spoke with a midwife from facility at 11 AM that day, confirming that there was no viable pregnancy detected via ultrasound. I had lost quite a bit of blood at that point. I am, as of 8:35 PM on Friday, March 19th, still bleeding and experiencing the impact of miscarriage. |
| 1117511-1 | Adverse event: miscarriage Estimated date of delivery: October 2021 Pregnancy history: two previous pregnancies, carried full term, vaginal deliveries, healthy |
| 1117742-1 | Pain at injection site starting one day after 2nd pregnancy (first was miscarriage), due date November 12 |
| 1118882-1 | I had a double frozen embryo transfer on February 5th and a positive pregnancy test on February 15th. On March 4th I had my 6-week ultrasound and one embryo had implanted but did not survive and the 2nd was clearly not strong, smaller than it should have been with a fetal heartbeat only visible, not audible yet. A week later, on March 11th, the ultrasound showed only empty gestational sacs and I had miscarried both. |
| 1121865-1 | Began spotting 2 days after the vaccine, it progressed over two more days and just had first miscarriage at 2AM on 3/22/2021 |
| 1121867-1 | Received COVID vaccine on 1Feb2021 and was currently seeking to become pregnant. I concieved a child on 2Feb2021-4Feb2021. On 19March2021 it was determined that the pregnancy was abnormal and that I had miscarried, with likely diagnosis of blighted ovum. |
| 1122111-1 | Received both 1st and 2nd dose of Pfizer vaccine before learning that I was pregnant. Conception likely occurred between the two doses, but official pregnancy dating unclear. Ultrasound demonstrated unviable pregnancy on 2/8/21. |
| 1124086-1 | Miscarriage; Heart stopped on pregnancy; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 26Feb2021 06:00 PM at a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. The patient was 8 weeks pregnant at the onset of the event. Last menstrual date was on 01Jan2021. There were no concomitant medications in two weeks and no other vaccine in four weeks. The patient previously received her first dose of BNT162B2 on an unspecified date at 06:00 PM in the left arm for COVID-19 immunisation. The patient had not been diagnosed with COVID prior to vaccination. The patient experienced miscarriage and heart stopped on pregnancy on 02Mar2021 03:00 PM. Treatment was unknown. Event resulted in doctor or other healthcare professional office/clinic visit. The patient was due to deliver on an unknown date. The patient underwent Covid PCR test post vaccination on 04Mar2021, pending results. Outcome of the events was unknown. Information on lot/ batch has been requested. |
| 1124428-1 | No previous history of miscarriages. Miscarriage began 4 weeks after first covid vaccine dose. Est. Date of birth October 2021 Unusual menstrual cycles following miscarriage. Unsure if there is any relation. |
| 1124657-1 | Received 2nd dose of covid vaccine at 11 weeks, 6 days. Had follow up normal ultrasound at 12 weeks, 2 days. Missed miscarriage noted at 15 weeks, 1 day. Last measurement of baby noted to be 12 weeks, 6 days. Closely monitored during first trimester with no abnormalities noted. Normal ultrasound at 12 weeks, several days after baby stopped growing with fetal demise at some point there after |
| 1127239-1 | Miscarriage confirmed on 3/23/2021 at approximately 5 weeks and 6 days. |
| 1128192-1 | Pregnant with second child at first and second dose of the covid vaccine. Due date was 10/15/2011. I experienced a miscarriage at 9 weeks pregnant on 3/17/2021. |
| 1130755-1 | On 02-26-2021 I had a miscarriage, I found out my fetus had died during a pre-natal doctor's appointment. My fetus had expired before I received the first dose Pfizer vaccine. I believe it was coincidental and the Pfizer vaccine did not cause the miscarriage. After my miscarriage I was under heavy medication. |
| 1130798-1 | I did not know at the time of the 2nd shot, but I was pregnant. I miscarried on 3/12. I was approximately 11 weeks pregnant. |
| 1135569-1 | Early miscarriage; This is a spontaneous report from a contactable other health care professional (Patient). A 30-year-old female patient (pregnant, last menstrual date 19Jan2021, Delivery date: 26Oct2021, Gestational period 4 weeks) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9269), via an unspecified route of administration on right arm on 19Feb2021 at 15:15 at the age of 30 years old at a single dose for COVID-19 immunisation at hospital. The patient's medical history included rheumatoid arthritis. There were no known allergies. Concomitant medications included prenatal vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced early miscarriage on 01Mar2021. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the event. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Pending the limited information on clinical course, the company does not attribute the event early miscarriage to BNT162B2. The detailed document of pregnancy, relevant risk factors, status of rheumatoid arthritis are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. |
| 1136131-1 | Miscarriage at 6 weeks |
| 1137248-1 | I had a miscarriage on 3/23/2021 at 6.4 weeks pregnant. I received the vaccine when I was about 4 weeks pregnant. My estimated due date was Nov. 13, 2021. I went to the doctor to get blood drawn to test progesterone and HGC levels. That evening, I miscarried. We are doing testing to see what may have caused the miscarriage but I have not had a miscarriage in the past. On Sept 9, 2020 I experienced a chromosomal stillbirth of a baby boy. His death was due to triploidy which is a fatal chromosomal abnormality. |
| 1137811-1 | My first dose was 1/14. I found out I was pregnant on 1/26/21 and I miscarried at about 10 weeks. About 15 mins after I got the vaccine, I had a racing heartrate and my palms were hot, but it went away. Around 3pm, I had a right frontal headache. I took a nap and it went away. About 5am Fri, I woke up to severe arm pain and it felt like I was being stabbed in the stomach. I took about 400mg of Ibuprofen, went to sleep and was fine when I woke up. About 5pm Friday, I began having vaginal bleeding. I called my doctor and was able to get in on Feb 11th. At my OB/GYN appointment, they tested my blood and urine, which confirmed my pregnancy. The NP examined me and told me that the bleeding was coming from my cervix, so they sent me for an ultrasound the following week. That's when I was given my calculated date of 10 weeks. A gestational sac was observed, but they weren't sure if a fetus was present. I had to see my doctor every week since I was still bleeding and that continued until March 18th, when I lost the pregnancy completely. I took my specimen to the doctor the following day. They told me that they were sending it out to be tested, but I'm not sure if the results are back. They did confirm that it was a fetus. |
| 1138434-1 | Miscarriage at week 5 |
| 1139170-1 | I discovered I was pregnant just after receiving the 2nd dose of the Moderna vaccine. I have had one pregnancy before, six years ago, that ended in a healthy, full-term child with no complications. I received the vaccine on Thursday morning. Thursday evening - Saturday morning I had extreme body aches, fever and night sweats, headache and grogginess. On Saturday evening, my miscarriage began. The estimated date of delivery would have been November 20, 2021. |
| 1140309-1 | Last menstrual period either Nov 1-8 (light, abnormal, pregnancy symptoms) or Nov 29-12/2 (light, abnormal, pregnancy symptoms). Possible dates of conception 10/16, 10/18, 10/19, 11/14, 11/15. Negative pregnancy test on 11/26 & 11/29. +Pregnancy test 12/10. Estimated delivery dates were either 7/8/21 or 8/8/21. First covid vaccine received on 12/30. First OB ultrasound on 1/5/21, estimated to be 6 weeks + 3 days gestation, with no heartbeat. Repeat ultrasound on 1/13/21, continued to measure 6 weeks + 3 days gestation, again with no heartbeat. Spontaneous miscarriage did not occur, 1 time dose of intravaginal Cytotec was taken and medical abortion completed. |
| 1141203-1 | Moderna COVID?19 Vaccine EUA Received 1st vaccine Dec 29, 2020, received 2nd vaccine while unknowingly pregnant on January 27, 2021. Had chills, fatigue, body aches night of 2nd vaccination. Found out pregnant Feb 7, 2021 at 4 weeks pregnant. Had blighted ovum/anembryonic pregnancy with miscarriage March 12, 2021. |
| 1141764-1 | Miscarriage |
| 1142921-1 | Pregnant patient miscarried; got pregnant in between the first and second dose; A spontaneous report was received from a pharmacist ,concerning a 38-year-old, female patient , who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced getting pregnant in between the first and second doses (Exposure during pregnancy) and miscarried/abortion spontaneous. The patient's medical history was not reported. Concomitant medications were not reported. On 15 Jan 2021, patient received the first of two planned doses of mRNA-1273 (Lot/batch: unknown) vaccine intramuscularly for prophylaxis of COVID-19 infection. Between an unknown date and 17 Mar 2021, the patient become pregnant and experienced a miscarriage. On March 17 2021, the patient received the second of two planned doses of mRNA-1273 (Lot/batch: unknown) vaccine for prophylaxis of COVID-19 infection. The event, miscarriage, was medically significant. Laboratory details were not reported. Treatment information was not reported. Action taken with mRNA-1273 in response to the events was not applicable. At the time of report , the outcome of events; got pregnant in between first and second dose and pregnant patient miscarried were, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. |
| 1143480-1 | Miscarriage; spotting; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at right deltoid on 04Feb2021 at single dose for COVID-19 immunization. Medical history was reported as none. She has no known allergies and has no COVID prior to vaccination. Concomitant medications included folic acid, iron (PRENATAL) and fluoxetine. The patient has no other vaccine in four weeks. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231) at the age of 31-years-old, intramuscular at right arm on 14Jan2021 at 12:30 at single dose for COVID-19 immunization. The vaccine was administered in a hospital. The patient was pregnant, her last menstrual period was on 19Dec2020. Her expected due date is on 25Sep2021 and gestational period was 7 weeks (also reported as 3). The patient experienced miscarriage and spotting on 09Feb2021 which resulted in doctor or other healthcare professional office/clinic visit. She was not tested for COVID post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of miscarriage and vaginal hemorrhage due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. |
| 1143591-1 | ~2 weeks pregnant during time of vaccination, |
| 1145796-1 | I had never been pregnant before and have been undergoing fertility treatments for about two and a half years (6 failed IUIs followed by 2 failed frozen embryo transfers via IVF). I had my third frozen embryo transfer on 3/12, almost exactly the same time Alaska opened vaccine availability to anyone over the age of 16. Our doctor?s advice along with everything we found online showed not much was known about the vaccine, but there was no firm reason to think there would be a problem with getting it in early pregnancy. We also knew that being pregnant would mean higher likelihood of having severe symptoms if I got Covid-19, so I signed up for and was administered the first Moderna vaccine on the day of my first pregnancy test. 3/22 my beta HcG level came back at 72, confirming pregnancy. As is standard, I was asked to come back three days later to confirm appropriate growth in those numbers. By Thursday, March 25th my HcG level had fallen to 17, and by Monday, March 29th that level was less than 3. It?s impossible to know if the vaccine played a role in the early miscarriage, but I wanted to provide the data in case there are any trends or information can be learned from my experience. |
| 1145902-1 | spontaneous abortion at approximately 8 weeks gestation, 10 days after vaccine administration |
| 1146214-1 | Was 5 weeks pregnant at time of vaccine with strong HCG levels, approximately 2 weeks after vaccination patient suffered a miscarriage. Vaginal bleeding, cramping and passed large clots including a sac like tissue. |
| 1151400-1 | I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono); I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; This is a spontaneous report from a contactable Other HCP reported for herself and fetus. This is mother case. A 40-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El9266), via an unspecified route of administration on Left arm on 20Feb2021 08:00 at single dose for covid-19 immunisation administered at Hospital. Medical history includes Shellfish Allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El3248), via an unspecified route of administration on Left arm on 27Jan2021 09:30 at single dose for covid-19 immunisation. Concomitant medications in two weeks include ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, she was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono) on 24Feb2021 08:00 on visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received Dilation and curettage (D&C) treatment for the events. Last menstrual date was 04Jan2021. Delivery date is Oct2021. Gestational period was 7 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient had COVID tested/nasal swab post vaccination with results pending on12Mar2021. The outcome of event Miscarriage was resolving and for the other events it was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Induced abortion cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021278790 Same reporter/drug, different patient /event (Fetus case) |
| 1151947-1 | This is my first pregnancy. I had a normal ultrasound at my 8-week appointment, showing heartbeat and movement. My estimated delivery date was October 12, 2021. Four days after my second COVID shot, I had my 12-week checkup. They ran a urine test and asked me questions about my progress, all seemed normal. I wasn't exhibiting any side effects that would lead me to believe that I had miscarried. The OBGYN attempted to listen to the heartbeat but couldn't hear anything, so she wrote me a prescription to head over to the imaging site to get an ultrasound just in case. I drove there immediately and was given an ultrasound. They couldn't hear anything so we went ahead with a TVA. After approximately 45 minutes and no updates, the technician said that the results would be forwarded to my doctor and that they would reach out to me about the results. My doctor informed me that they could not hear a heartbeat and that I must have miscarried within the past couple days because the fetus length was as expected for 12-weeks of gestation. I am now scheduled for D&C on 4/5/21. |
| 1155161-1 | miscarriage, d&C on 3/30/21 |
| 1155730-1 | No real symptoms at time of vaccine. Pain after injection for two days. Pain in right hip for five days. Went in for ultrasound on 4/1/21 at 9 weeks 4 days and found out that there was no fetal pole. Measured at 8 weeks 3 days with gestational sac and yolk sac but no embryo. Considered an embryonic pregnancy, empty sac, or blighted ovum Approximate loss 3/24/21. Still waiting to pass tissue to fully miscarry. |
| 1156565-1 | miscarriage at 11 week gestation - exactly one week after first vaccine shot. |
| 1157569-1 | Miscarriage; Pregnancy; well past the 42 day mark; A Spontaneous report was received from a Healthcare Professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine. The patients medical history was not provided.No concomitant medication information was provided. On an unknown date in JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, The patient The patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine. Laboratory details was not provided.No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events Pregnancy and Miscarriage was resolved. The outcome of the event well past 42 days was unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with spontaneous abortion for this female (age unknown). Patient missed her second dose. She will continue to be contacted for further monitoring of AEs post abortion. . |
| 1158268-1 | Received second dose of Moderna vaccine on 1/23/21, likely conceived on 1/24/21. Lost pregnancy between 8-9 weeks with noted fetal bradycardia on during ER visit on 3/14/21 and no FHR on 3/18/21. |
| 1159039-1 | Miscarriage 6 days after vaccination |
| 1163402-1 | Miscarriage - due date was 10/16/2021 |
| 1163458-1 | 2 prior first trimester miscarriages unrelated. 1 second trimester miscarriage at 21weeks gestation in March 2021, normal weight and size at time of delivery. Vaccine was given 12/2020 and 1/2021 |
| 1163941-1 | Miscarriage |
| 1164134-1 | The day I got my shot, by 5:30pm I was to tired and week to even move. I didn?t know I was pregnant at the time because it was so early. 7 days later I found out I was pregnant, 4 weeks along. And three days later on 3/25 I miscarried. |
| 1165136-1 | Pregnancy 1 week post COVID vaccination #2. Miscarriage at 6-7weeks. Managed with expectant management. |
| 1165214-1 | I was pregnant when I received the vaccine on3/31/21 but did not know. On 4/2/21 I had a positive pregnancy test...I miscarried on 4/3/21. I do not know if this was because of the vaccine or not. I have not been to the doctor yet because today was Saturday and everything is closed. I just wanted to make sure that it was documented. Thankyou |
| 1165228-1 | no history of miscarriage until the most recent pregnancy with the COVID vaccine. I previously had 4 healthy pregnancies and 4 living children (now 5 pregnancies and 4 living children). I conceived on 12/18/2020 the day after I received my 1st covid vaccine. I began spotting blood on 3/7/2021 and miscarried an approximately 7 week old embryo. I had a D & C procedure to remove the baby that stopped growing weeks before ( I was 14 weeks and 1 day into my pregnancy before the miscarriage).Due date was sept 4th 2021. |
| 1170969-1 | I exp fatigue after Dose 2. I took a at home negative pregnancy test on 2/24 and I had positive test on 2/27. I miscarried on 3/7 which would have put me at 6 wks my estimated due date was the end of 10/2021. |
| 1171745-1 | I had a miscarriage (spontaneous abortion) on March 14, 2021. I was 12 weeks pregnant at the time of miscarriage. |
| 1171897-1 | I was eight weeks pregnant and on 3/30 exp miscarriage. My estimated date of delivery was 11/10/21. |
| 1172727-1 | The Monday I had blood test it was normal and progesterone was little low. I started miscarrying on Wed on 3/27. My estimated date of delivery would have been mid Nov. 2021. |
| 1173008-1 | I had a miscarriage on 4/2 estimated and my estimated date of delivery 11/7/2021. |
| 1174282-1 | Miscarriage. April 1st. Estimated due date was November 10, 2021. First pregnancy. |
| 1175159-1 | miscarriage/spontaneous abortion; This is a spontaneous report from a contactable nurse. A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Right on 17Feb2021 15:30 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing herpes simplex 2 and sulfa allergy. Patient previously received the first dose of bnt162b2 for covid-19 immunisation. Concomitant medication included acyclovir) taken for an unspecified indication, start and stop date were not reported. The mother was 7 Weeks pregnant at the onset of the event. The patient experienced miscarriage/spontaneous abortion on 25Feb2021 16:45. The patient was supposedly due to deliver on 18Oct2021. The with outcome of event was recovered with sequelae. No follow-up attempts are possible, information about batch/lot number has already been obtained. |
| 1175386-1 | The next morning after I had arm pain and was very fatigued which lasted about a week. On 2/27 I started experiencing on and off vaginal bleeding but drs had no treatment they could provide. I was diagnosed with a threathened miscarrage and on 3/22/2021 I miscarried. EDD-11/7/2021. There were several bouts of bloodwork perfomed which were normal until the miscarrage occurred and all ultrasounds were normal until the 3rd which showed the miscarriage. |
| 1175464-1 | At the time of my first vaccine on 1/14/21 I was 9 weeks pregnant and on lovenox for DVT and progesterone for pregnancy maintenance. On 2/5/21 I miscarried the baby and ended up hemmoraging thus requiring a blood transfusion. The fetus was sent to pathology and I was informed that at 12 weeks when I miscarried that the baby had termed at 9 weeks which was the time of my first vaccine injection. |
| 1176336-1 | Reporting as employee health: Staff member reported that she had miscarried as of 2/16/21 |
| 1176890-1 | Miscarriage of baby at 20 weeks and 3 days of gestation. Preterm labor. Due date was August 6, 2021. Baby was surgically removed on March 22, 2021. |
| 1177150-1 | I was about 4.5 weeks pregnant with the first dose of the vaccine; and 7.5 weeks with the second dose. After the first dose, my hcg beta hormone level wasn't rising as fast as it should (ie. it wasn't doubling to tripling every 2 days) so I had to continue to get blood drawn to monitor it. Then it had one big rise after 1.5 weeks; but soon after, I started spotting lightly daily. After about a week of daily light spotting, I started heavily bleeding (like a menstrual period) on 3/25 (one day before my second dose). I went for a sonogram and it was confirmed that the fetus had no heartbeat. We waited a few days after the second does to redo the sonogram but the bleeding had continued and the second sonogram showed no fetus-- meaning I had a miscarriage where the fetus was naturally eliminated through the bleeding. I am being followed on a weekly basis for blood draws by my obgyn office to ensure that my hcg hormone level falls to 0. |
| 1177795-1 | Miscarried found no fetal heartbeat at 3/11 ultrasound. D&C completed 3/19 |
| 1178047-1 | Original Due Date: 11/4/2021. Miscarriage discovered 4/5/2021 and suspected to have occurred around 3/20/2021 (baby measured 7weeks,1 day on ultrasound). There were no indications of miscarriage before the ultrasound 4/5/201. Neither me, the patient, nor my doctor believe the miscarriage was a result of the vaccine but as it occurred a few weeks after I received the second dose in the series I felt it should be reported. I was approximately 4 weeks pregnant at the time of my second dose. |
| 1178211-1 | The patient is a G3P2 with a history of 2 prior term vaginal deliveries. Her last menstrual period was 1/15/21. Estimated due date was 10/22/21 based on her last menstrual period. She had her first covid vaccine on 3/4/2021. She saw me for her first prenatal visit on 3/24/21 and was asymptomatic. Fetal heart tones were not appreciated on doppler. She was referred for a dating ultrasound, which she never completed. She began having some bleeding sometime after the appointment on 3/24. She got her 2nd covid vaccine on 4/1/21. She began having pelvic cramping on 4/3. went to emergency dept 4/4. u/s showed an 8week 2 day gestation with no heart beat. she continued to have bleeding and cramping 4/5 and likely completed the miscarriage that day. |
| 1178242-1 | This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABORTION OF ECTOPIC PREGNANCY (Miscarriage) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypospadias on 15-Jun-2019 and Pregnancy (one). Concurrent medical conditions included Subfertility (Treated since 2018). On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Jan-2021 and the estimated date of delivery was 29-Oct-2021. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). On 05-Mar-2021, the patient experienced ABORTION OF ECTOPIC PREGNANCY (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fifth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Ectopic pregnancy. On 04-Mar-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, ABORTION OF ECTOPIC PREGNANCY (Miscarriage) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion.; Sender's Comments: This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion. |
| 1179614-1 | Patient had two previous live births and two spontaneous abortions at 10 and 8 weeks prior. Reported lack of fetal movement in the last few days (not quantified). Provider note ruled as a pregnancy loss at 19 weeks of gestation. |
| 1182331-1 | Preterm premature rupture of membranes at 18 weeks gestation (due date 9/4), resulting in pregnancy loss |
| 1182483-1 | Miscarriage; This is a spontaneous report from a contactable Other HCP (Nurse), reported for herself. This 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route in the right arm, on 25Feb2021 at 17:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route in the right arm, on 19Mar2021 at 17:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. The patient was pregnant at the time of vaccination and the last menstrual date was 02Sep2020. Gestational period 5 weeks and delivery date 19Nov2021. Relevant medical history included Hashimoto's thyroiditis. Past drug history included allergy to amoxicillin and omeprazole. Relevant concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 21Mar2021 (at 14:00), the patient had miscarriage. The event required physician office visit. The patient did not receive any treatment for the event. She was recovering from the event. Information on the lot/batch number has been requested.; Sender's Comments: Pending the limited information on clinical course, the company does not attribute the event miscarriage to BNT162B2. The detailed document of pregnancy, relevant risk factors, status of Hashimoto's thyroiditis are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. |
| 1183197-1 | Missed miscarriage at 11 weeks (baby dating at 7 weeks). This was the first ultrasound so difficult to confirm if dates were accurate, but dating showed baby may have passed prior to vaccine date so might not be directly related. |
| 1184480-1 | Miscarriage |
| 1185268-1 | 3/15/2021 - Went to my midwife for my first prenatal visit and that's where I learned there was no heartbeat. 4 weeks along at the time of the vaccine and the heartbeat ended at 8 weeks along. This was my third pregnancy - and my first miscarriage. Estimated date of delivery was in October. |
| 1186005-1 | I experienced a miscarriage that started with bleeding on 3/13 and was confirmed by ongoing hcg level tests starting on 3/17. I passed a lot of blood and blood tissue in an intense event on 3/16. I did not know I was pregnant at the time and was estimated to be around 9-10 weeks (due date around October 2021) based on hcg levels. I was also breastfeeding at the time of my vaccine. I was advised to go to the emergency room if certain conditions occurred including extreme pain -- I opted to go to Urgent Care that evening to get checked out and to get a blood hcg test. Urgent care was unable to do the blood test and they recommended I call my provider the next day or go to the Emergency Department if certain symptoms occurred. |
| 1187741-1 | Miscarriage on March 30 following the vaccine. Was only approximately 5.5 weeks pregnant |
| 1191412-1 | Pregnancy began January 13th. 4 weeks pregnant at first vaccine. 7 weeks pregnant at second vaccine. Miscarriage occurred in the week following the second vaccine. Exact date that the heartbeat stopped is not able to be determined but there was a heartbeat 3/3. I got the vaccine 3/4. |
| 1195464-1 | Patient was about 15 weeks pregnant and this was her first pregnancy. Her anticipated due date was Oct 1st 2021. On April 9th 2021 during a scheduled doctor visit at 3pm both baby and mother were in good health. On the same evening after the appointment she went for vaccination at Pharmacy and received the J&J vaccine. After receiving the vaccine in about 15 mins she felt like urinating and noticed blood in the urine and felt vaginal dilation. Within the next 15 to 20 mins she started experiencing mild labor pains and contractions. In the next 30 mins she started bleeding and was immediately taken to the ER. In the ER it was confirmed that she was having a miscarriage and the fetus was delivered. She also had to undergo emergency surgery to remove any remaining placenta in the uterus. |
| 1195914-1 | Missed miscarriage. Details about the pregnancy - EDD Nov02, 2021. First pregnancy. Tracking ovulation and dates. Mar19 - first dose of Pfizer. Mar22 - first ultrasound, detected sac/fetal pole, heart rate detected by slow at 100bpm. Measuring 1 week behind, pushing EDD to Nov12 Mar29 - second ultrasound, no heartbeat detected, no growth from previous week. Still had pregnancy symptoms, did not have symptoms after vaccine dose 1. |
| 1198333-1 | I had a miscarriage on January 22, 2021 |
| 1199127-1 | Had miscarriage that started April 2, 2021 at around 11pm. It started 2 weeks after 1st does of vaccine was administered. This was my 2nd pregnancy that resulted in a miscarriage. Previous miscarriage was in Sept. 2020. Was about 6 weeks pregnant for both miscarriages with the latest one with a projected Nov. 24, 2021 Due Date. |
| 1200333-1 | I had a miscarriage 2 days after the 1st dose of covid 19 vaccine. It was an early pregnancy 4-6 weeks. I started bleeding late April 3rd and continued, so I went to the ER at hospital on April 5, 2021. |
| 1200344-1 | I am not sure if it is related but the day after receiving the vaccine I felt extremely ill. I was also pregnant at the time of receiving the shot and miscarried one week later. |
| 1201367-1 | I was approximately 6-weeks pregnant and suffered a miscarriage which began the following day after receiving the vaccine. Symptoms presented as fever (100.4), severe cramping, diarrhea, bleeding, body aches & chills, which lasted Saturday & Sunday following the vaccine (received on Friday). |
| 1202603-1 | First dose 1/27/2021, patient likely conceived 2/4/2021, received second dose 2/13/2021, positive home pregnancy test 2/14/2021, pregnancy first detected by ultrasound 3/9/2021 estimated 5 weeks gestation, second ultrasound 3/22/2021, fetal growth delayed but cardiac activity noted with HR only 78 bpm, third ultrasound 3/30/2021, confirmed no additional fetal growth, fetal pole measured 5w6d and diagnosed missed miscarriage. D&C on 3/31/2021, chromosomal testing still pending |
| 1202783-1 | I received both vaccines while pregnant and had a miscarriage at 11 weeks (found out at my 13 week appointment). I had COVID in November 2020. |
| 1204891-1 | Miscarriage/spontaneous abortion |
| 1205095-1 | 6hrs after the vaccine I started having chills, body aches, light headed, & headache. Also at the same time I started spotting which I found out it was the symptoms of a miscarriage. On 04/11/2021 I continued with the same symptoms then later on that night i started feeling dizzy the bleeding continued. Around 2am on 4/12/2021 I was bleeding a lot & at 7am I went to the ER and they confirmed I had a miscarriage. I was 11 weeks pregnant. My estimated delivery date was 10/28/2021. On my previous appointments they said everything was going good with my pregnancy the only complication was hyperthyroidism which I had been taking medication for. |
| 1205316-1 | Was pregnant at time of vaccine, and later miscarried |
| 1205521-1 | I had a light fever on 04/07/2021. It lasted less than 24hrs. On 04/08/2021 I started having symptoms of a miscarriage. On 04/12/2021 I was confirmed I had a miscarriage. My doctor told me to go to the ER and that's where they confirmed it. I was 7 weeks pregnant my due date was 11/26/2021. They did said I was at high risk because I had a copper IUD that was removed. |
| 1205793-1 | Wife got pregnant in between the 2 shots. She had a miscarriage. |
| 1206919-1 | spontaneous miscarriage; conceived following second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (spontaneous miscarriage) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pregnancy loss (first trimester loss) on 01-Jun-2013 and Pregnancy loss (first trimester loss) on 23-Sep-2019. Concurrent medical conditions included Anxiety disorder, Drug allergy (sulfa), Drug allergy (cephalosporins) and Drug allergy (codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D [VITAMIN D NOS], DOCOSAHEXAENOIC ACID (DHA), BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTIC BLEND), LORATADINE and MAGNESIUM for an unknown indication. On 19-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PREGNANCY (conceived following second dose). On 06-Mar-2021, the patient experienced ABORTION SPONTANEOUS (spontaneous miscarriage) (seriousness criterion medically significant). On 06-Mar-2021, PREGNANCY (conceived following second dose) had resolved. At the time of the report, ABORTION SPONTANEOUS (spontaneous miscarriage) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pregnancy test: positive (Positive) positive. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Date of last menstrual period was 29Jan2021 This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (spontaneous miscarriage) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pregnancy loss (first trimester loss) on 01-Jun-2013 and Pregnancy loss (first trimester loss) on 23-Sep-2019. Concurrent medical conditions included Anxiety disorder and Drug allergy (sulfa, cephalosporins, codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D [VITAMIN D NOS], DOCOSAHEXAENOIC ACID (DHA), BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTIC BLEND), LORATADINE and MAGNESIUM for an unknown indication. On 19-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PREGNANCY (conceived following second dose). On 06-Mar-2021, the patient experienced ABORTION SPONTANEOUS (spontaneous miscarriage) (seriousness criterion medically significant). On 06-Mar-2021, ABORTION SPONTANEOUS (spontaneous miscarriage) and PREGNANCY (conceived following second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pregnancy test: positive (Positive) positive. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Date of last menstrual period was 29 Jan 2021. This is a case of product exposure during pregnancy (5 weeks gestational age) with spontaneous abortion for this 39-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: This is a case of product exposure during pregnancy (5 weeks gestational age) with spontaneous abortion for this 39-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded |
| 1207875-1 | Miscarriage. vaccinated December 19th. no Side effects. noticed a bit of pleuritic chest pain. was not bothersome and resolved with ibuprofen. I was pregnant at the time of first vaccine but did not know. had second vaccine 3 weeks after my first without issue. Went to OBGYn for 10 week appointment and there was no fetal pole. Fetus stopped developing at likely 6-7 weeks. I likely miscarried shortly after my second vaccine. . |
| 1208734-1 | This is 32 years old,Unfortunately i had a worst experience with my first dose of Moderna, I got my first dose of Moderna on March 29 2021, My dizziness started 5 hours after getting the vaccine, and then i was feeling nausea, a day after on March 30 i felt a lot of pain under my belly, I did Urine pregnancy test at home and it was Positive, On April 1 My blood test pregnancy result was Positive too and showed i am 4 weeks pregnant, Everything was ok until April 10 that i realized I?m bleeding so much, It was Saturday i went to ER , They did blood test and Ultrasound and said you had a Miscarriage ????????? without any medical problem, Your blood test is completely normal and Ultrasound doesn?t show any problem like cyst or anything, I told them that the only reason is could be my vaccine and they said i should reported to CDC. I am vvery very healthy person, No alcohol, No drug, don?t tell pregnant people this vaccine is safe please please. |
| 1208930-1 | Pregnancy history: 2 previous healthy children. Current pregnancy was to be due Nov. 4, 2021, had second shot when 7 weeks pregnant, heard heartbeat at 8 weeks, went to get checked at 11 weeks and it was measured that I miscarried at 8 weeks, exactly one week after receiving the second shot. |
| 1209173-1 | I was 7 weeks pregnant and assured by everyone that it would be safe to get vaccinated. I have had one healthy pregnancy 10 years ago. I found out I miscarried yesterday (4/13/21). I can?t help but feel that it was related to the vaccine & am devastated. I don?t want any other mothers to experience this if it was indeed related so I am reporting this. |
| 1209601-1 | miscarriage a week after receiving Janssen vaccine |
| 1209945-1 | The minute after the vaccination I had fainted, vision went, low blood pressure, after laying down became better. Rested almost an hour in order to be able to walk. next day, I had severe headache, with nausea, and a day later I had bleeding. Bleeding became severe, I had miscarriage. I was 7 weeks pregnant. |
| 1210176-1 | Patient had miscarriage with 5 month stillborn baby |
| 1210781-1 | Had a early pregnancy loss at 7th week gestation, Spontaneous abortion, Having regular check ups and follow up with the doctors |
| 1211156-1 | Fetal renal anomaly, bilateral MCDK resulting in pregnancy termination at 21 weeks. Delivery date was estimated on July 15 |
| 1212100-1 | Moderna Covid 19 vaccine dose 1 -12/29/2020 Positive pregnancy test 1/28/2021 (approximately day 14 gestation) Moderna Covid 19 vaccine dose 2-1/28/2021 12 week nuchal translucency test Maternal fetal medicine doctor diagnosed giant omphalocele (3/23/2021). Follow up visit at 14 weeks (4/6/2021) confirmed giant omphalocele as well as large Ventral septal defect, and spinal abnormalities; diagnosis of Pentalogy of Cantrell; pregnancy terminated |
| 1212515-1 | Patient was pregnant. Had a viable pregnancy confirmed on 3/17/2021 with a 9wk gestation fetus and + cardiac activity and no abnormalities noted. Patient returned for prenatal visit on 4/14/21 and was confirmed to have had a miscarriage with no cardiac activity noted and a fetus measuring 12wks 0 days gestation. |
| 1212797-1 | Chills, high fever started 6 hours after the injection. Had to take 650 mg Tylenol every 4 hours to keep the fever a bit low (the fever would not go below 101.5). After 20 hours, could control the fever with every 6 hours of Tylenol (650 mg). Took medication for 40 hours. The fever went down but had chills for 3 days. less than 72 hours after the injection had a miscarriage. Was 5 weeks pregnant at the time of miscarriage. |
| 1213206-1 | Friday morning, I started to spot/bleeding. Saturday morning, I had heavy bleeding and I am still bleeding. I had a phone call and I have a doctor visit today. I had a miscarriage. I'm at the end of it. Tomorrow it should be complete. This is my fifth pregnancy - this is my third miscarriage - I have two children live births. December 6, 2021 - was estimated Date of birth. |
| 1214827-1 | Missed AB diagnosed 4/7/21 via ultrasound. Pregnancy initially confirmed via serum HCG 2/24/21. Ultrasound Confirmed and dated at 6w5d with heartbeat on 3/10/21 with an EDD of 10/29/21. Covid Vaccine administered 3/17/21. Next appointment 4/7/21 no visible heartbeat w/ ultrasound. Suction D&C performed 4/9/21. Sent for pathology and chromosomal testing, results pending as of 4/15/21. |
| 1215397-1 | 4/1/2021 patient received JNJ Vaccine 4/12/2021 Miscarriage was confirmed on Ultrasound done by and also Right Pelvic vein thrombosis seen. 4/13/2021 Patient placed on Anticoagulation. |
| 1216055-1 | I received the vaccine and was unknowingly pregnant. My first shot was on 1/6/2021 and my second shot was on 1/27/2021. I conceived on 1/25/2021. I ended up miscarrying the child and when they sent it in for testing it had 2 abnormal chromosomes. One of which they said is very rare and they have no idea how or why the baby had this. I was told that the vaccine was supposed to be safe for pregnant people but with no family history of anything like this happening and no history of any children being born with mutations I believe this happened from the vaccine. Possibly caused by the spike in temperature I experienced after the second shot. I should have been due to deliver 10/2021. |
| 1218658-1 | I tested positive for pregnancy on March 17, 2021. on March 24th I got my first dose of the Pfizer vaccine for COVID. On April 4, 2021 I had my first appointment with my OB / GYN. The doctor did an ultrasound and found that everything was fine with the baby. The baby was the right size and had a heartbeat. April 14th I got my second dose of Covid's vaccine. After an hour I started having cramps. Around 1:15 PM I had a bleed (light red). Around 2:00 pm I was seen at the doctor's office. She did a new ultrasound. The doctor said she couldn't find a heartbeat during the ultrasound exam and that I was having a miscarriege |
| 1219039-1 | After 2nd shot I had a fever (>101), headache, chills, fatigue & weakness. This went on for about 24 hours. I also had a miscarriage, diagnosed on 3/25/21. My due date was supposed to be 11/14/21. |
| 1219154-1 | 38 yo healthy pt had sure LMP of 1/30/21, and 1st Moderna COVID vaccine given 2/13/21 and 2nd one given 3/13/21. she had non viable pregnancy found on 4/14/21 (1st ultrasound) - she thought she was 10 wks and she was found to be 5 wks and no fetal pole nor yolk sac then. she did have a non viable pregnancy as well 10/30/20, so not sure if COVID vaccine was related or not. she has no health issues besides being an older female. she works as a high school teacher for hybrid in person school, so really wanted the COVID vaccine. |
| 1219427-1 | Miscarriage at 5wks 2 days. |
| 1220313-1 | Spontaneous Abortion. Miscarriage started on it's own at home. Bleeding lasted 14 days, then turned to excessive hemorrhaging and ended up getting an emergency D&C. Was 10 weeks pregnant at time of miscarriage. EDD was 10/23/2021. |
| 1220453-1 | Suffered a miscarriage. My due date was 10/1/21 |
| 1225179-1 | Miscarriage 2 months after vaccine |
| 1226011-1 | Miscarriage at 25 weeks. No hx of pregnancy related issues. No hx of miscarriage. Reason for miscarriage not established/no clear reason for miscarriage. |
| 1226022-1 | Miscarriage diagnosed at 14 weeks 0 days. At the time of diagnosis, fetus was measuring 13 weeks 0 days. Fetus was viable with + fetal heart rate of 165 at 13 weeks 5 days at routine prenatal visit. |
| 1226240-1 | 3/18 vaccination 3/21 bleeding 3/22 Ultra sound with low fetal HR. 3/22-/3/23 passing of gestational sac I went back Wed and had another lab work done to compare the levels from Monday to Wed. No other lab work done. 2nd pregnancy, 1 live birth, DOD 11/5/2021 |
| 1228555-1 | my baby died |
| 1228794-1 | Was unknowingly pregnant at the time of first and second shot. Found out I was pregnant and miscarrying the day of the second shot (4/6/21). Don?t know if the vaccine caused the miscarriage but I thought i should report it. Started bleeding within hours of the second shot and blood tests on 4/15 and 4/17 showed I was losing the pregnancy. |
| 1229114-1 | This is my first pregnancy and I got pregnant on January 20th of 2021 and I miscarried on April 9th 2021 after my first dose of the Covid vaccine |
| 1230473-1 | Patient was about 4 weeks pregnant at the time of the shot. Her due date was Dec. 13, 2021. About a week after taking the shot, her HCG levels stopped rising, and she ultimately miscarried. |
| 1230916-1 | Prior to my current miscarriage I had 3 pregnancy?s, 3 vaginal births (all pregnancy?s made it to term with healthy babies). My estimated due date for current pregnancy was 11/1/2021. I had an ultrasound at 8 weeks 0 days which was 3 weeks after my 2nd vaccine. The ultrasound showed a healthy heartbeat. 2.5 weeks later I had a second ultrasound that showed no heartbeat or movement. The baby measured at 8 weeks 4 days during the 10 week ultrasound. I have not delivered the miscarriage yet. |
| 1231961-1 | I received my second vaccine dose on Friday, 4/16. At the time I was 6 weeks and 4 days pregnant. I woke up at three o'clock in the morning on Saturday, 4/17 sweating with chills, body aches and a headache. When I went to the bathroom at six o'clock AM I noticed that I was bleeding. I called my doctor and she told me to monitor the bleeding over the weekend and to call first thing Monday morning for an ultrasound. I continued bleeding throughout the weekend and yesterday (4/19) my doctor confirmed that I was experience a miscarriage. |
| 1232831-1 | I had a missed miscarriage at my 15 week check up. Baby had passed away in the weeks prior. I found out about March 10. Pregnancy history - 2nd one - 2016 - normal pregnancy; this was my second pregnancy; due date was August 19th. I do have to have repeat testing in three months to confirm lupus anti-coagulants result from April 2nd. |
| 1234210-1 | The patient received the first vaccine on 03MAR21 and began spotting on 10MAR21. A miscarriage was confirmed on 19MAR21. At the time of the first vaccine (03MAR21) the patient was unaware that she was pregnant as she had a negative home pregnancy test on 02MAR21. She was told by her OB/GYN to inform us of her miscarriage. |
| 1234530-1 | Was not aware I was pregnant until shortly after my first vaccine dose. Would have been between 3-5 weeks pregnant at first vaccine and 6-8 weeks at second vaccine. According to ultrasounds, my pregnancy never progressed beyond 6 weeks. |
| 1234601-1 | Pregnancy miscarriage -- 3.5 weeks pregnant at the time of vaccination and experienced a miscarriage one week later (at 4.5 weeks pregnant) |
| 1235494-1 | "pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information provided mentioned ultrasound and cytotec. Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a ""genetic issue. This case was linked to MOD-2021-060699 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded." |
| 1236339-1 | LMP 2/10/2021. Estimated due date 11/17/2021. Received vaccine on 3/23/2021. During initial prenatal visit 4/1/2021 there was no reported heartbeat and baby was measuring later than calculated based on LMP. On next appointment 4/8/2021 heartbeat was found and baby was estimated to be due on 11/21/2021. On follow up appointment 4/15/2021 baby no longer had heartbeat based on measurement was due 11/21/2021. Doctor noted a missed miscarriage on 4/15/2021. On appointment 4/19/2021 still no heartbeat and no growth. D&C took place 4/21/2021. |
| 1237194-1 | Miscarriage |
| 1237754-1 | MISCARRIAGE- Conceived and got pregnant March 28. Received 2nd dose of Pfizer vaccine April 2. Found out I was pregnant April 14th, and confirmed it with blood test taken April 15th. HCG levels at 57, putting me at around 3 weeks pregnant. Started bleeding April 18th and doctor confirmed a miscarriage is taking place. |
| 1239091-1 | 04/21/2021- ct 6-7 wks preg when rec'vd 1st dose Pfizer on 04/16/21, c/o 'little' stomach ache/ dizzy/myalgia that night. 04/17/21-8:30am , vag blding/'little' abd pain,- went to ER- U/S, bld work, urine test done-dx miscarriage. 4/18-4/20-pain in hip/waist, little nausea, today blding stopped, still a little nausea/ little pain in hip. EOC was approx 12/09/2021, ct has hx cervical medical issues this past year. |
| 1240248-1 | Miscarriage at approximately 11 weeks 2 days. 1st pregnancy. Estimated due date Oct 7, 2021. |
| 1240260-1 | Miscarriage at the 11th week of pregnancy. 1st pregnancy; no previous pregnancies, miscarriages or abortions. Estimated due date Oct 7, 2021. |
| 1241670-1 | Miscarriage |
| 1242154-1 | I received my second dose of the Pfizer vaccine on February 23rd 2021. That same day I discovered I was pregnant. On March 26th 2021 at my 9 week appointment ultrasound I discovered that my baby had no heartbeat. |
| 1242256-1 | I found out that I was pregnant four weeks after the second dose. I started to itch all over my body four weeks after the shot. I did not have a visible rash, but my dermatologist said it was a histamine reaction. I was intensely itchy for three days and then it went away after five days. I had a miscarriage five weeks after the second dose which was a week after the itch started. I saw my OBGYN, PCP ER , Gastroenterologist and Dermatologist. Due Date: 12/11/2021 Pregnancy Third Pregnancy |
| 1242508-1 | After receiving first dose of vaccine, patient discovered she was pregnant. The pregnancy ended in a missed AB 04/14/2021 with D&C procedure on 04/16/21 |
| 1243135-1 | Spontaneous abortion at 7 weeks LMP 2/18/21 |
| 1243183-1 | reported to ED on 4/3 with miscarriage, abdominal pain, vaginal bleeding. I don't have the info on date of delivery it isn't in the ED providers note. |
| 1243299-1 | I was 4 weeks and 3 days pregnant at time of Covid Vaccination. On Saturday 4/10 I began to spot lightly, and called my doctor on Monday morning, who recommended I come in for a blood test. I received a beta HCG blood pregnancy test Monday 4/12 and Wednesday 4/14. On Wednesday 4/14, I miscarried at 6pm. |
| 1243908-1 | I was 4 weeks pregnant at the time of my second dose. I miscarried at around 7weeks 6 days. It was suggested due to potential Triploidy but I thought it would be informative that you know. |
| 1244332-1 | Pt did not know she was pregnant until a day after the vaccination. She as 6 weeks pregnant. On the morning of March 28th, 3 days after the vaccine, pt miscarried. |
| 1247382-1 | Had a miscarriage (due date was 12/02/21) Have had high blood pressure which required er visit since getting vaccine |
| 1251729-1 | At the time I received the vaccine I was almost 5 weeks pregnant (due date 12/4/21). On 4/11 I started to have cramping and bleeding and proceeded to miscarry the pregnancy. |
| 1253852-1 | I was exactly 4 weeks pregnant at the time of my second vaccination. On March 23 I started to develop cramping in uterus. On March 25 or March 26 (I cannot remember exactly which day here) I started spotting, and then by the next day I was bleeding. On March 29 I saw my OBGYN who diagnosed me with a miscarriage. I continued to bleed for approximately 10 days, as well as dizziness, and feeling very faint. I have had 2 very healthy pregnancies in the past and no health issues. This could be absolutely unrelated, as early miscarriages are almost impossible to pinpoint, but I did feel this should be reported for researching purposes. |
| 1254933-1 | spotting vaginally; miscarriage; Following the vaccine on 18Mar; This is a spontaneous report from a contactable consumer (patient). A pregnant 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 18Mar2021 at 17:00 (at the age of 31 years old) (Lot Number: EN6204, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included anxiety. No known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO) and unspecified prenatal vitamins. The patient reported that following the vaccine on 18Mar2021 at 23:00 (11:00 pm), she began spotting vaginally which persisted for two weeks and resulted in a miscarriage at 7 weeks pregnant. The patient is pregnant on 04Jan2021. The mother was supposed to deliver on 19Nov2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not have other vaccine in four weeks. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected. |
| 1255216-1 | Late-term miscarriage; This is a spontaneous report from a contactable consumer (patient). A 31-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198), via an unspecified route of administration on 18Mar2021 as single dose for COVID-19 immunization in a hospital. The patient's medical history was not reported. There were no concomitant medications. The patient had no other vaccines in four weeks and no other medications in two weeks. The patient has not had COVID prior to vaccination and has not been tested for COVID post vaccination. The patient experienced late-term miscarriage on 22Mar2021 that required physician clinic visit and hospitalization for 1 day. The mother was 15 weeks pregnant at the onset of the event. Gestation period at exposure was not reported. Pregnancy due date was reported to be scheduled on 07Sep2021. The pregnancy resulted in spontaneous abortion. Fetal outcome was not reported. Therapeutic measures were taken as a result of late-term miscarriage which includes dilation and evacuation (D&E). The outcome of the event was unknown. |
| 1256052-1 | Vaccine administered 4/5/21 at 7WGA and fetus stopped growing at 7w1d (4/6/21) Miscarriage completed 4/20/21 |
| 1258913-1 | "I become pregnant within 30 days of my 2nd vaccine (last menstrual period (LMP) was February 3rd and I ovulated around February 18th). I then miscarried at 6 weeks and 1 day (3/18/21). I found out I miscarried at 9 weeks and 2 days (4/9/21), but I had a ""missed miscarriage"" and the baby stopped growing with no heartbeat at 6 weeks and 1 day (3/18/21). My due date would have been November 10th 2021." |
| 1259263-1 | Sore arm and fatigue that first evening. I had those for about 24 hours. Miscarriage - I had my first doctor's appt on 4/14/2021 and I found out that there was no embryo - Anembryonic pregnancy (blighted ovum)- my body thought it was pregnant but there was no embryo. I had to take medication to induce the miscarriage - I took that last week on the 20th. I've passed all the tissue but I have to wait for it stop cramping now. |
| 1259439-1 | Gravida 2 Para 1 Estimated due date 11/1/2021 Received Pfizer dose # 1 on 3/26/2021 . Relates she started spotting 4/14/21. Was seen by OB 4/15/21 and no heartbeat detected. Patient relates OB advised her to complete covid vaccination as scheduled Pfizer dose # 2 was given 4/16/21 Relates she miscarried on 4/17/21 and was seen in ER. |
| 1260398-1 | Miscarriage of pregnancy; Hemorrhage vaginal; This is a spontaneous report from a contactable consumer(patient) received from The regulatory authority report number is GB-MHRA-WEBCOVID-202104191303576540. The female patient of an unspecified age received BNT162B2, dose 1 via an unspecified route of administration on 16Feb2021 (Lot Number: Not known) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. She became pregnant while taking bnt162b2. The patient experienced miscarriage of pregnancy on 21Feb2021 with outcome of recovered on 21Feb2021 , hemorrhage vaginal on 21Feb2021 with outcome of recovered with sequelae in 2021. The events led to hospitalization, life threatening. It was stated that she received the pfizer vaccine on the 16th of February currently pregnant with everything seeming to be well at her 12 week scan a few weeks previous. 5 days later on the 21st(on 21Feb2021) she woke up to blood pouring from her. She was hemorrhaging and she lost her baby at 17 weeks gestation. Lab data also included COVID-19 virus test: negative on 21Feb2021. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. |
| 1261506-1 | Miscarriage; Patient was unaware that she was pregnant; This spontaneous case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pregnancy test (Negative home pregnancy test.) on 02-Mar-2021. On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient was unaware that she was pregnant). On 19-Mar-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and EXPOSURE DURING PREGNANCY (Patient was unaware that she was pregnant) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No treatment or concomitant mediation were reported. |
| 1262037-1 | MISCARRIAGE; VACCINE EXPOSURE DURING PREGNANCY; BODY ACHES; FEVER; This spontaneous report received from a consumer (company representative) concerned an female of unspecified age. The patient's height, and weight were not reported. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the patient experienced body aches and fever. On 10-APR-2021, the patient was pregnant when she had vaccine. On 12-APR-2021, the patient experienced hemorrhage, miscarriage (spontaneous abortion) and was hospitalized (date unspecified). The duration of hospitalization was not reported. The date of patient's last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, miscarriage and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). .; Sender's Comments: V0: -covid-19 vaccine ad26.cov2.s-miscarriage, vaccine exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS |
| 1262568-1 | Spontaneous abortion, hives, headache |
| 1264239-1 | Was pregnant at time of second vaccine should have been approximately 4 weeks but was not aware I was pregnant. At viability ultrasound there was no heart beat and it did not match with how far along i should have been. Repeat ultrasound a week later showed no growth and was diagnosed with a missed miscarriage. |
| 1264894-1 | Early Miscarriage after vaccine. About 5 weeks pregnant when miscarriage happened. |
| 1265118-1 | "Date of last missed period (LMP) was 3/11/2021, so the pregnancy was approx 5 weeks at the time of my second dose (positive pregnancy test on 4/9/21). I got the injection of the second dose on 4/15/21 around 11 am and began bleeding and cramping due to miscarriage about 27 hours later. Miscarriage confirmed by OBGYN on monday 4/19/21. I am blood type o-negative. Will be tested for blood clotting disorder as possible cause of early pregnancy loss. I should also state that I had a pretty severe case of ""moderna arm"" within just a few hours of the vaccination, maybe 4 hours, with approx 70% of my upper arm covered in deep red, hot, raised, swollen, and itchy skin that lasted several days. I also got a fever of approx 101 degrees F about 20 hours after the vaccination." |
| 1265469-1 | I received the first dose the the pizer vaccine on december 18th and did not know I was pregnant at the time. A couple weeks later I found out I was pregnant and due date was September 7th. Hence, my conception was likely within a week of receiving my first dose. We later found out our baby had turners syndrome and have since lost the baby. Obviously it is unclear the cause but I wanted to report it . |
| 1265524-1 | Miscarriage; Maternal exposure during pregnancy; This is a spontaneous report downloaded from the Healthcare Products Regulatory Agency. Regulatory authority number: IE-HPRA-2021-064934. A contactable physician reported that a 28-year-old female patient received first dose bnt162b2 (COMIRNATY; Lot/Batch Number: EM0477) intramuscularly on 12Jan2021 as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was not taking any concomitant medication. On 12Jan2021, the patient was vaccinated with first dose of Comirnaty. The patient deferred second dose offered on 02Feb2021 as she had found out she was pregnant in the interim. She was noted to be in her 1st trimester at the time of exposure. This event was noted to be serious by the reporter due to being a medically important condition. As of 12Apr2020, it was reported that the patient had a miscarriage on 29Mar2021. The fetal outcome is neonatal death. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Follow-up (12Apr2020): New information from a contactable physician downloaded from the Regulatory Authority-WEB IE-HPRA-2021-064934 includes: new event (miscarriage), reporter details and correct world wide identifier was reflected. No follow-up attempts are possible. No further information is expected. |
| 1265911-1 | miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable consumer (patient's husband). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 13:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing colitis. Concomitant medications included mesalazine (MESALAMINE) taken for colitis from an unspecified start date and ongoing and other unspecified medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 19Mar2021 (at the age of 39-year-old) for COVID-19 immunization and patient received first dose of BNT162B2 while pregnant. On 09Apr2021, it was reported that the patient experienced sore arm. On 10Apr2021 she was super tired and super sore. On 11Apr2021, patient reportedly had miscarriage. The mother was 3 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The events reportedly resulted to emergency room visit. The patient underwent lab tests and procedures which included blood test on 11Apr2021 showing she was only 3 weeks pregnant and sonogram: no fetal heartbeat on 11Apr2021. The event miscarriage was treated with 10 pills of Hydrocodone. Outcome of event miscarriage was unknown while for all other events was not recovered. |
| 1266322-1 | patient was pregnant at time shot was given . She came in for her second dose and reported she had miscarriage |
| 1266336-1 | Pt. started having fever that evening, headache, and lower back pain (significant). Yesterday drove to ER due to continued severe lower back pain and pubic pain. On the way to the ER, she started bleeding a lot. At the hospital, she had a sono and was told she had an abortion. They performed a D&C. She was 10wks. This is 2nd pregnancy, which was uncomplicated pregnancy. |
| 1267354-1 | Patient reseived Moderna 1st dose on 4/11/21 at Pharmacy. Developed some abdominal pain after 3 days on 4/14/21, and had miscarriage on 4/22/21, Estimated delivery date was 11/18/2021 |
| 1267543-1 | Pregnant at the time of vaccination. Miscarriage did occur. |
| 1267942-1 | Received 1st dose approx 6 weeks gestation. Fetal development stopped later same week. Missed miscarriage discovered at 8 week 3 days. Complete miscarriage at 8 weeks 5 days. |
| 1268488-1 | light bleeding in early pregnancy; Maternal exposure during pregnancy; Miscarriage; first dose of bnt162b2 on 12Jan2021; second dose of bnt162b2 on 16Mar2021; first dose of bnt162b2 on 12Jan2021; second dose of bnt162b2 on 16Mar2021; This is a spontaneous report from a contactable consumer received from the Regulatory authority report number is GB-MHRA-WEBCOVID- 202104121308456100, Safety Report Unique Identifier is GB-MHRA-ADR 25125239. A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER1741, Expiry date not reported), via an unspecified route of administration at single dose on 16Mar2021 for COVID-19 immunization. Medical history included vitamin supplementation (Folic acid supplementation) from an unknown date and unknown if ongoing. Patient had not had symptoms associated with COVID-19. Patient had not had a COVID-19 test. Patient was pregnant at vaccination, but no longer pregnant at the time of reporting. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation (folic acid supplementation), start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (lot number: EE8493) on 12Jan2021 for COVID-19 immunization. The patient experienced light bleeding in early pregnancy on an unspecified date with outcome of unknown, maternal exposure during pregnancy on an unspecified date with outcome of unknown, and miscarriage on 09Apr2021 with outcome of recovering. The patient underwent lab tests and procedures which included scan: viable pregnancy on scan at 6 weeks on an unspecified date. The events were reported as serious, medically significant. Narrative case summary and further information: Case narrative: Miscarriage on 9Apr2021, approx 7-8 weeks problems. I do not think the vaccine cause the miscarriage. Patient had not tested positive for COVID-19 since having the vaccine. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Light bleeding in early pregnancy, scan at 6 weeks showed viable pregnancy; vaccine administered week 5. No follow-up attempts are possible. No further information is expected. |
| 1270339-1 | Missed miscarriage at 5 weeks gestation, I?m unsure if vaccine related it just happened around the same time. Due date was calculated Nov 3rd. |
| 1270535-1 | On April 3 symptoms of miscarriage (pain, bleeding began). Was approximately 8 weeks pregnant. Symptoms worsened across next week. Miscarriage was confirmed by sonogram + quantitative HCG levels, resulting in a D&C on 4/14 to evacuate remaining uterine contents. |
| 1271868-1 | I was 7 and half weeks pregnant when I received the second covid vaccine, then a week later, I began to have vaginal bleeding. 5 days after bleeding began, I miscarried while at home, passing a lot of tissue and lost a lot of blood, had to go the ER, had a syncopal episode due to blood loss and had to have an emergency D & C. |
| 1272057-1 | Miscarriage at 7 weeks in pregnancy. No other history of miscarriage and very sudden. Decidual cast. |
| 1272099-1 | Patient is a 36 y/o F G1P0 who had the Moderna COVID vaccine on 3/19/21 and 4/16/21. Stating 4/6/21 she had vaginal spotting. The spotting continued intermittently. She had ultrasounds which showed On 4/16/21, she suffered a miscarriage, when she would have been about 7w4d gestation. |
| 1272966-1 | RECEIVED THE VACCINE WITH NO ISSUES. ONE WEEK LATER, BABY STOPPED GROWING. MISCARRIAGE CONFIRMED ON APRIL 16, 2021 |
| 1273835-1 | Missed Miscarriage discovered at routine pregnancy ultrasound on 4/6/2021 (12 weeks 5 days pregnant) Deceased fetus measured at 9 weeks 5 days D&C performed as a result on 4/7/2021 Estimated due date was 10/14/2021 |
| 1274336-1 | Healthy young women of 25 years of age with spontaneous pregnancy. Regular period prior to becoming pregnant. Patient had miscarriage on 04/29/21 with anembryonic pregnancy. Anembryonic pregnancy confirmed by ultrasound on 4/23/21. Covid vaccine received on 4/8/21. Patient roughly 4 wks pregnancy at time of vaccine dose. |
| 1274550-1 | Loss of 5 week embryo, which had been PGS-tested without any genetic abnormalities and transferred via IVF on April 14, 2021. Have had one successful pregnancy in past and four other miscarriages, though this is first through IVF with PGS testing. |
| 1275689-1 | MISCARRIAGE; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-070421. This is a report received from the Ireland's Health Products Regulatory Authority (HPRA). This is a maternal report. A 32-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 22Feb2021 (Batch/Lot Number: 1063487) as 0.3 mL single, and dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as 0.3 mL single both for covid-19 immunisation . Medical history included covid-19 from Nov2020 to an unknown date detected 26Nov2020. The patient's concomitant medications were not reported. The patient previously took quadrivalent influenza vaccine for prophylaxis. The patient was unaware of pregnancy when 2nd dose was received , she also experienced a miscarriage on 22Mar2021. The mother reported she became pregnant while taking bnt162b2. The mother was 1 Trimester pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. No follow-up attempts are possible. No further information is expected. |
| 1276464-1 | 03/01/2021: Positive pregnancy test 03/31/2021: 8 weeks gestation based on LMP; US showed fetus measuring 6w1d, fetal heartbeat 81 04/07/2021: 9 weeks gestation based on LMP; US showed fetus measuring 6w1d, no fetal heart tones 04/09/2021: D&C performed for missed abortion |
| 1277327-1 | I was on my 4th week pregnancy. The next day I took my second dose I had spotting and the third day I'm having a miscarriage. ( this is my third pregnancy); I was on my 4th week pregnancy. The next day I took my second dose; I was on my 4th week pregnancy. The next day I took my second dose; This is a spontaneous report from a contactable Other HCP (patient). A 43-year-old female patient (pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534), second dose via an unspecified route of administration, administered in Arm Left on 13Apr2021 14:45 (at 43 years old, pregnant), single dose for covid-19 immunisation. The patient's medical history included that this was her third pregnancy. The patient's concomitant medications were not reported. The patient had his first dose of bnt162b2 on 23Mar2021 14:45 for covid-19 immunisation, left arm, lot number EP7534. Patient was on her 4th week pregnancy. The next day, she took her second dose, she had Spotting and the third day (also reported as 14Apr2021 15:00) she was having a miscarriage. Treatment was Received. The outcome of the event Miscarriage of pregnancy was recovering. No covid prior vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Allergies to medications, food, or other products.; Sender's Comments: Based on the information currently available and known safety profile of the drug, a possible contributory role of suspect product Bnt162b2 to the reported events can not be ruled out. But product is not indicated in this population group. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. |
| 1278735-1 | I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor's office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered. Information about the Lot/batch number has been requested. |
| 1279188-1 | had a natural miscarriage; This is a spontaneous report from a contactable consumer (patient). A 40-year-old pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: G06026), via an unspecified route of administration, administered in Arm Left on 10Mar2021 16:00 as single dose for COVID-19 immunization in an public health clinic. The patient's medical history was not reported. No known allergies. The patient's concomitant medication includes an unspecified multivitamin. The patient previously received the first dose of bnt162b2 (lot number: not reported) on an unspecified date for COVID-19 immunization. No other vaccinations in four weeks. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. The patient's last menstrual period was on 25Jan2021 with gestation age at exposure reported as 6 weeks. Expected due date was on 08Nov2021. On 09Apr2021, the patient visited the emergency room and physicians office and it was reported that the patient had a natural miscarriage, do not know if it was related to the vaccine. Baby stopped developing around time of vaccination at 10 weeks of gestation. The pregnancy resulted in spontaneous abortion. It was unknown if the patient received any treatment. The fetal outcome is intrauterine death. The outcome of the patient was recovering. No follow-up attempts are possible. No further information is expected. |
| 1279405-1 | miscarriage of the 16-17 week fetus; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number : ER8730), via an unspecified route of administration, administered in the left arm on 26Mar2021 at 16:30 as a single dose for COVID-19 immunization. The patient had no medical history and no known allergies. The patient's concomitant medications included unspecified prenatal vitamins. The patient did not have other vaccines in four weeks prior to the COVID vaccine. On an unspecified date in Mar2021, the patient had a miscarriage of the 16-17 week fetus. The patient had surgery to remove the fetus and tissue. The mother was due to deliver on 09Sep2021. The outcome of the event was recovering. The patient had a nasal swab COVID-19 test on 22Apr2021 with a result of negative. The event was reported as life-threatening. |
| 1279468-1 | Low risk pregnancy, due date 9/10/2021, complications caused an infection that resulted in termination of pregnancy. |
| 1280830-1 | Next day diarrhea and vomiting every hour. Lasted until Thursday with symptoms lessening after Tuesday. Out of work whole week. Went to Dr. on Wed 04/14/21 and had COVID and flu test per doctor. Have not received results. Same day had pregnancy test which was positive, possible around 8 weeks. Vaginal bleeding started 04/15/21. Appointment with Dr set at Clinic for 04/19/21. Saturday 04/17/21 early morning heavy vaginal bleeding and debilitating abdominal pain started persisted throughout weekend. Confirmed miscarriage at appointment 04/19/21 and given medication to help with pain. Appt made for D&C 04/12/21 and procedure done. Out of work rest of week. Unknown if all due to COVID vaccine but everything started the day after the first one was administered. Pregnancy History before: Abortion around July of 2018. Miscarriage September 2020. Please not Pregnancies from 2020 and 2021 were not planned to be ended, was wanting to have children. Note - have received second vaccine today, 05/02/2021 at 3:15pm and so far a sore arm. Has been about 6 hours at this point. |
| 1281477-1 | patient miscarried on 4/30/2021 |
| 1281629-1 | Estimated due date of pregnancy was november 2021. We experienced a miscarriage during the vaccine symptoms of the first shot. The second dose of vaccine was way worse than the first. I got a sore arm, aches, a headache, nausea, a fever, chills, pins and needles feelings in my hands and feet, heartburn, and dizziness. I kept feeling like I might throw up and I developed a great big rash on my arm again, called covid arm. I spent the entire day on the couch next to a bucket because if I got up, I was too light headed and nauseated to do anything. It lasted 24 hours or so. By day 3 after the shot, I felt okay other than soreness, a headache, and a big itchy rash at the injection site. We are concerned about the miscarriage but don't know if it was or wasn't related to the vaccine. I did have a big reaction and we wonder if my immune system gearing up targeted the very early fetus as an intruder. We are deeply saddened by our loss. |
| 1282397-1 | Patient received the first dose 3/26/21 and believes she conceived 3/10/21. She began spotting on 4/5/21 and the bleeding continued getting heavier until 4/19/21. The OB confirmed miscarriage on 4/28/21. |
| 1282583-1 | Miscarriage. I was 5 weeks pregnant at the time of the 2nd Pfizer COVID vaccine on 4/23/21. On 4/22/21, the pregnancy was confirmed by Ob/Gyn through a blood test, urine sample, and ultrasound. I was at the time and am a healthy 30 year old woman without pre-existing medical conditions or any conditions that would put me into a high-risk pregnancy category. The estimated due date was 12/20/21. Received 2nd COVID on 4/23/21. At 3:30pm on 4/28/21, I began miscarrying the pregnancy. On the same day at 4pm, I was at Ob/Gyn and they confirmed that the pregnancy was likely miscarrying through an ultrasound and blood tests. IMPORTANT: On 4/28/21, the pregnancy measured exactly the same in size as it did on 4/22/21. In other words, the pregnancy either STOPPED growing the SAME DAY it was confirmed or the EXTACT NEXT DAY, which was the day I received the 2ND COVID VACCINE. I discussed with my Doctor wither to proceed with the 2nd Covid vaccine and it was suggested that while it hasn?t been tested extensively in pregnancy, it was thought to be safe. |
| 1283215-1 | I (unknowingly at the time) was pregnant at the time of my vaccine administration. I didn?t find out until a week or 2 later. My estimate due date was 12/26/2021. I did end up miscarrying this pregnancy on 4/22/2021. |
| 1283486-1 | Spontaneous abortion (miscarriage) on April 15th, approximately 8 weeks pregnant (was due in November). No previous miscarriages and I have 2 healthy children. |
| 1283500-1 | Conceived 1 week after second dosage, had a miscarriage around 8 weeks pregnant |
| 1284722-1 | went through a miscarriage on 23APR2021, after receiving the first dose; feeling abdomen pain lightly two to three days later; could not left her arm after the injection; injection site was sore,could not lift her arm after the injection; found pregnant on 07MAR2021,first vaccine dose 11APR2021; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Feb-2021 and the estimated date of delivery was 20-Nov-2021. On 11-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021). On 13-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection). On 14-Apr-2021, the patient experienced ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later). On 23-Apr-2021, the patient experienced ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the eighth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, miscarriage on 23-Apr-2021. On 11-Apr-2021, EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021) had resolved. On 23-Apr-2021, ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) had resolved. At the time of the report, ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later), VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The reporter stated that his wife was found pregnant on 07Mar2021. She had normal back pain and normal pregnancy pain during her pregnancy. My wife could not left her arm after the injection and the injection site was sore on 13-Apr-2021. After taking the Moderna vaccine she started to have abdomen pain lightly for two to three days on 14-Apr-2021. On 22-Apr-2021, she started to feel unbearable pain. On Friday 23-Apr-2021 she had a miscarriage. No treatment product information was not provided Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up had NNI; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. |
| 1284748-1 | Cervical insufficiency in pregnancy resulting in loss of pregnancy; Cervical insufficiency in pregnancy resulting in loss of pregnancy; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810) at the age of 31-years-old, via an unspecified route of administration in left arm on 23Feb2021 at 08:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. She has no COVID prior to vaccination, no other vaccines in four weeks, and no other medications in two weeks. The patient was pregnant. Her last menstrual date was on 11Oct2020. Her delivery date is on 18Jul2021. The patient received her COVID-19 vaccine in a hospital. She experienced cervical insufficiency in pregnancy resulting in loss of pregnancy on 03Mar2021 at 15:00. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization from 2021 to 2021 for 1 day. There was no treatment given in response to the events. She was not tested got COVID post vaccination. She received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) at the age of 31-years-old, via an unspecified route of administration in right arm on 16Mar2021 at single dose for COVID-19 immunization. The outcome of the events was unknown.; Sender's Comments: The information available is limited. The etiology for the reported events could be multifactorial in nature. However until more information is available the contributory role of the suspect product BNT162B2 cannot be completely ruled out based on the potential temporal association noted. This case will be updated when more information is available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. |
| 1285077-1 | miscarriage; This is a spontaneous report from a contactable physician downloaded from The regulatory authority number is IT-MINISAL02-704737. A 41-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: EP2166), via an unspecified route of administration, administered in the left arm (also reported as left shoulder), on 04Mar2021, as single dose, for COVID-19 immunisation. Medical history included autoimmune thyroiditis, psoriatic arthritis (currently not active and not even symptomatic therapy), got pregnant in 2019 (induced delivery to term-live birth, no previous miscarriages). Concomitant medications included thyroid (THYREOIDINUM) taken for autoimmune thyroiditis, and folic acid (FOLIC ACID), taken for an unspecified indication, both start and stop dates were not reported. The patient previously took apremilast (OTEZLA) for psoriatic arthritis; and estrogen-progestogen therapy many years ago. Historical vaccine included the first dose of BNT162B2 (COMIRNATY, lot number: EL0725), on 11Feb2021, for COVID-19 immunisation and experienced exposure during pregnancy. The patient's last menstrual period was on 17Jan2021, gestation period was 7 weeks, due date was 24Oct2021. On 06Mar2021, symptoms (unspecified) started. On 07Mar2021, the patient experienced miscarriage. The patient recovered from the event on an unspecified date. Health Authority Comment: first dose 11Feb2021, second dose 04Mar2021, symptoms start on 06Mar2021, miscarriage on 07Mar2021. No follow-up attempts possible. No further information expected. |
| 1285423-1 | Patient developed spotting within 3-4 hours of vaccine administration, and miscarried approximately 24 hours later. Patient was about 7 weeks pregnant at the time of vaccination. |
| 1285496-1 | On April 9th received 1st dose of vaccine, approx. 12 hours later experienced bright red spotting, called MD and was seen and fetal heart tone was present on April 12th. Received 2nd dose of vaccine on May 1st and and approx. 12 hours later started to have bright red vaginal bleeding which then turned into spotting. On May 3rd at 1130pm started to have bright red bleeding and water broke. Came to the emergency room for evaluation where I was told I had lost the baby, no fetal heart tone present. I am experiencing a miscarriage @ 15 weeks gestation and 6 days today on May 4th 2021. |
| 1285973-1 | Patient received dose 2/2 of Pfizer vaccine on 2/25/2021. She had an IUI procedure done in (country) on 12/14/2020, which was confirmed to be successful at her follow up OB/Gyn visit- then returned to (country) . Patient returned to (country) on Feb 8, 2021 for 10 week US and was found to have no fetal heart tone, missed spontaneous abortion at approximately 7w5d. This timing would draw into question the timing of the vaccine administration. |
| 1286456-1 | pt says she took a pregnancy test before taking the covid vax that read positive. she had a sore left arm for about 2 days. On 4/5/2021 she had some vaginal spotting but pregnancy test was still showing positive. On 4/7/2021 she went to her PCP. They gave her a pregnancy test that was positive. They expect she was about 4 weeks along. She was referred to her OB/GYN. On 4/10/2021 she had vaginal bleeding. She contacted her PCP and was instructed to go to the ER. She went to Medical ER. they did a vaginal US, US on her stomach along w/ urine test. She was told that all results were negative and there was no longer a fetus. She was about 5 weeks along at this point. She has never been pregnant before but hormone levels are great before this incident. |
| 1286496-1 | I pregnant when receiving the first dose of the Covid vaccine. Est due date of November 12th. This was my first pregnancy. Early April (1-2 weeks later) I started experiencing some bleeding and has a miscarriage within a week from the first symptoms. |
| 1286536-1 | 2nd Trimester Miscarriage of Healthy Baby 2nd pregnancy, no hx of miscarriage prior, full term pregnancy with first. All genetic testing on mom and additional health screens of baby were normal. On 4/25/21, lost mucus plug in the AM at 17 weeks pregnant with no other issues, concerns, abnormalities, etc. At 3:50AM on 4/27/21, ruptured membrane/water broke. Hospital testing confirmed 100% break of amniotic fluid with nothing left to sustain baby who had normal heartbeat and was still alive - measuring on target. Induced at 11:20pm on the 27th and delivered at 5:30am on 4/28/21 at 17 weeks and 3 days a baby boy measuring 8.25 inches and 5.6 ounces. No placental infection or abnormalities. Pathology noted an abruption hematoma that could have resulted from induced labor. No trauma, blood work, or other explanations for early rupture of what was a perfectly healthy and growing baby. |
| 1287331-1 | Pt with miscarriage at approx 7-8 weeks GA after J&J covid vaccine 3/26/21 LMP 2/27/21 |
| 1287567-1 | Abortion held for suspected molar pregnanc; Abortion held for suspected molar pregnanc; This is a spontaneous report received from a contactable consumer, the patient, based upon information downloaded via the Regulatory Authority-WEB: IT-MINISAL02-716876. A 33-year-old pregnant adult female received the second dose of intramuscular BNT162B2 (COMIRNATY, solution for injection; Lot EJ6797 expiry information not provided) as a single dose in the right arm on 27Jan2021 for COVID-19 immunization. The patient was pregnant at the time of vaccination. Relevant medical history included GRAVIDA 2 PARA 2 (two previous pregnancies without incident), penicillin allergy, and drug allergy (paracetamol and cephalosporins). There were no concomitant medications reported. On an unspecified date the mother experienced maternal exposure during pregnancy, first trimester; which was considered serious (hospitalization). On 12Apr2021 the patient experienced abortion held for suspected molar pregnancy; which was considered serious (hospitalization). The patient received unspecified treatment. The outcome of the events abortion held for suspected molar pregnancy was recovered with sequelae (possible subsequent chemotherapy) on an unspecified date in Apr2021. Reporter comment: The adverse reaction led to other clinically relevant conditio. -Allergies: Paracetamol, penicillin, cephalosporins - Sent by VigiCovid19-form 16Apr2021 RLFV [Local Pharmacovigilance Manager]: contacted reporter who stated that they have already had two previous pregnancies without problems; resolution with sequelae is due to the possible subsequent chemotherapy therapy. Expiry date not provided and not possible to obtain; No follow-up attempts possible. No further information expected. |
| 1289122-1 | After the vaccine, I began to have fever and body ache for a couple of days. The next week, 04/20/2021 I began to have abdominal pain and blood in my urine. I went to the doctor. The diagnosis was that I was having a miscarriage. I was supposed to have 7 weeks of pregnancy. The embryo appeared to have about 5 weeks. It appears that after the vaccine the embryo stop developing. On 04/21/2021 the miscarriage took place without any medication taken to accelerate the process. Before my schedule second dose for the vaccine, I called the clinic and asked for a doctor appt. I wanted to talk to a doctor regarding my early pregnancy stage and the upcoming vaccine. At first I was denied. Then after a struggle I was provided with a lab test to confirm my pregnancy. On 04/12/2021 in the morning, I called the clinic to speak with a doctor and ask his/her opinion about the vaccine and my early pregnancy. After an struggle, the receptionist told me that the nurse who had the results of my pregnancy was busy. She would call me later on the date. That been pregnant or not, the vaccine was secure. I asked that I wanted to have a talk so I can make my decision. But the receptionist repeated the same. And after I said thank you but the phone was cut. That is when I decided not to miss my vaccine appt. |
| 1289290-1 | On 3/4/21, I was informed that I was pregnant with my 4th child. On 4/12/21, I was scheduled for my 1st dose of the Moderna as well as having a first trimester NCIT testing being done. At that exam, my provider was able to find a fetal heart rate (177), he was dated to be approximately 12 weeks and 6 days, and there were no concerns at that time regarding physical abnormalities or brain deformities. Additionally, I was sent out for bloodwork to rule out Trisomies and determined gender of the baby. The results of that lab work came back as negative and we were expecting our first son October 19, 2021. However, yesterday, 5/4/21, I attended my monthly prenatal appointment and the provider informed me that she could not find a heartbeat. She used a doppler scanner and then the in office ultrasound machine; neither of which detected a heartbeat. I was sent out to Radiology for a formal scan to refute or affirm the findings. Sadly, the results came back that I had lost my child. There was no heartbeat found and the results showed that my child stopped growing and remained 12 weeks in size. I am scheduled to have my pregnancy evacuated Friday, 5/7/21 at 1040a. While I am aware that miscarriage in 1 in 4 women, I cannot in good faith say that the vaccine may have contributed to my pregnancy loss. The only change in my routine was the addition of the vaccine. I am hopeful that this pain will not be felt by others and can be researched further to ensure fertility loss or future pregnancy loss isnt a norm following this vaccine. Additionally, I have had 3 full term, healthy pregnancies prior to this miscarriage. None of these pregnancies had complications and the children were birthed without issue. |
| 1289453-1 | I was on birth control for 15 years and never had an issue. After getting the covid vaccine I found out I was pregnant (home test April 10th). On May 1st, I had a miscarriage. |
| 1290173-1 | 7 weeks at vaccination due date 11/14/2021 was due third pregnancy had successful pregnancy, Normal pregnancy and next two days was very sick, body aches, fatigue, Tues. Tuesday 03-30-2021 she experienced bleeding and at that time was 7 weeks 2 days pregnant ER went to the doctor and they indicated that she would need to return, then on Thursday 04-01-2021 she had a miscarriage and it was confirmed that she was having a miscarriage. |
| 1290353-1 | I received the COVID19 Pfizer-BioNTech first doze on 3/28/2021 (11:30AM). On 4/5/2021 and 4/7/2021, the pregnant hcg tests were positive. The due date is 12/12/2021. On 4/16/2021, I did the first ultrasound and I was told the fetus was 5 days smaller than expected. On 4/30/2021, after doing the second ultrasound, my Doctor told me that I had a miscarriage. I will need to see my Doctor on 5/6/2021 and may need to do a surgery. |
| 1290767-1 | Forced abortion; Maternal exposure during pregnancy; Feeling unwell; Crohns flare up; Digestion issues; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CROHN'S DISEASE (Crohns flare up) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease. The patient's past medical history included No adverse event (No reported medical history). On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 04-Apr-2021, the patient experienced CROHN'S DISEASE (Crohns flare up) (seriousness criterion medically significant) and DYSPEPSIA (Digestion issues). On an unknown date, the patient experienced ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell). The delivery occurred on an unknown date. At the time of the report, CROHN'S DISEASE (Crohns flare up), DYSPEPSIA (Digestion issues), ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The fetus was exposed to maternal use of humira in utero.Physician had given a new drug to induce labor and force abortion but she went off after five days because she did not well with it. Unspecified medication for labor and force abortion was also considered suspect. No concomitant medications were reported. No treatment information was provided. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. |
| 1290907-1 | History of 3 viable pregnancies, live births. No miscarriages. 2nd vaccine 2/11/21, confirmed pregnancy 3/10/21, confirmed miscarriage 3/17/21. |
| 1292469-1 | Was 5.5 weeks pregnant. Had the shot, felt strange that night, miscarried the next day. |
| 1293007-1 | The day after the vaccine I had a headache, chills and fatigue for the whole day. The following day I felt normal. Five days after the vaccine I had a silent miscarriage and I was diagnosed on 04/19/2021. The doctor identified 04/10/2021 as the day that the fetus was no longer viable. I was in my seventh week. The Pathology returned identifying Chromosomal abnormality. Due Date-11/21/2021 First Pregnancy |
| 1293188-1 | Pregnancy termination at 18 weeks due to un-survivable . OTC Deficiency as carrier diagnose during permanency and cause of loss. |
| 1293319-1 | 5 weeks 5 days pregnant when received first covid shot. Had ultrasound on 4/8/21 at 8 weeks pregnant and found out I had a missed miscarriage. Had a D&C on 4/21/21 and we had genetic testing done on the tissue that showed no chromosomal abnormalities. |
| 1293650-1 | Miscarriage at 8 WGA |
| 1293942-1 | Early pregnancy loss 1/2021 |
| 1295420-1 | I had a missed miscarriage - the baby stopped developing but my body still thought I was pregnant. My first OB appointment was on April 19th - it was supposed to be the 8 week appointment, but the baby dated at 6 weeks exactly with no heartbeat. The doctor ordered a HCG test and a viability scan for 10 days later. I returned on April 29th for the viability scan and it showed that the baby did not develop (confirmed by two doctors). I had a dilation and cutterage procedure at the Hospital on April 30th. Last menstrual period: Feb 16, 2021 Due date: Nov 23, 2021 Missed miscarriage at 6 weeks + 0 days |
| 1296598-1 | For the next three days, I got pretty sick. Low grade fever - around 100. If I took a Tylenol it would go away for a little bit but then come back. Pain in my arm. Nausea and major, major, major migraines. I had migraines consistently - couldn't move off my couch. Those symptoms mostly went away after the third day. I saw my OB/GYN this week and they said that my fetus stopped growing about three weeks ago. Pregnancy history - my third pregnancy; none have gone to full-term. I have had a miscarriage before that was very similar to this one. Estimated date of delivery - December 2, 2021. I have recovered from the immediate side effects. I get the fetus removed next week. |
| 1296619-1 | Miscarriage at 6.5 weeks of pregnancy. Estimated due date was 12/25. First pregnancy. |
| 1297038-1 | Pregnancy history includes 4 deliveries, no complications, 1 first trimester miscarriage about 7 years ago, and this most recent 2nd trimester miscarriage. |
| 1299121-1 | The patient was pregnant at the time of vaccination; The patient was pregnant at the time of vaccination; Miscarriage; This is a spontaneous report from a contactable consumer (patient, self-reported). The patient reported information for both herself and fetus/baby. This is a maternal report. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID, prior vaccination. The patient was not tested for COVID post vaccination. The patient was pregnant at the time of vaccination. The Patient's last menstrual date was 09Jan2021 and delivery date was 16Oct2021. The mother reported she became pregnant while taking BNT162B2. The mother was 14 weeks pregnant at the onset of the event. It was reported that on 21Apr2021, the pregnancy resulted in spontaneous abortion- miscarriage and resulted in emergency room and physician visit. Outcome of the event miscarriage was reported as not recovered and for all other events, it was unknown. Information on the lot/batch number has been requested. |
| 1299199-1 | absence of heartbeat and estimated the embryo stopped growing at 7 weeks; had a very difficult time keeping her glucose levels; lightheaded; possible threatened miscarriage; persistent vertigo; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 at 11:00 (Lot Number: EN6204) as single dose for covid-19 immunisation, administered at the hospital. No other vaccine received in four weeks. Medical history included type 2 diabetes, fatty liver disease, high cholesterol, and known allergies: Pineapples and Zoloft. Concomitant medications included metformin; glipizide; escitalopram oxalate (LEXAPRO); and meclozine hydrochloride (MECLIZINE [MECLOZINE HYDROCHLORIDE]). The patient was pregnant at the time of vaccination. The patient's last menstrual period was on 03Feb2021. On 25Mar2021, 03:00 PM, patient sought treatment for persistent vertigo at a hospital and was given meclizine. On 03Apr2021, patient went to the emergency room to be assessed for a possible threatened miscarriage. They found her embryo sac and determined she was pregnant. She was released and told to go home. Patient is a type 2 diabetic and was ordered to go on insulin. On 05Apr2021, she had another threatened miscarriage and returned to the hospital. She was given an ultrasound and her due date changed from 10Nov2021 to 28Nov2021. Ultrasound discovered a heartbeat at 132 bpm. On 23Apr2021, at a routine ultrasound and OB visit, doctor discovered absence of heartbeat and estimated the embryo stopped growing at 7 weeks. She was electing for a D&C surgical procedure and requesting pathology testing to investigate the cause of death. She had a very difficult time keeping her glucose levels within the recommended pregnancy range of 90-150. She had persistent lightheaded still. Outcome of events vertigo, possible threatened miscarriage, and lightheaded was not recovered. The patient received treatment for vertigo and did not receive treatment for other events. |
| 1299210-1 | "I miscarried; bleeding really bad the 3 day.; Starting cramping the night if my second vaccine.; This is a spontaneous report from a contactable other HCP (the patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration, on 10Apr2021 at 15:30 (at the age of 39-years-old) as a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient did not have COVID-19 prior to the vaccination. The patient had not received any other vaccines within four weeks prior to the vaccination. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) on 20Mar2021 at 15:45 (at the age of 39 years old) as a single dose in the right arm. The patient previously took celecoxib (CELEXA) and experienced drug hypersensitivity and morphine and experienced drug hypersensitivity. The patient's last menstrual period was 16Feb2021. She reported that she became pregnant while taking bnt162b2. The patient was due to deliver on 23Nov2021. She stated that she was 8 weeks pregnant at the onset of the following reported events: The patient experienced ""started cramping"" the night of her second vaccine on 10 Apr2021 and the cramping lasted for two days with outcome of recovering, she started bleeding really bad the third day on 13Apr2021 with outcome of recovering and she reports that she miscarried on 13Apr2021 with outcome of recovering. The patient commented further that she mscarried right after her doctor confirmed her pregnancy was healthy and her baby had heartbeat the day before her second vaccine. The patient has not been tested for COVID-19 since vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate." |
| 1299228-1 | Bells palsy; miscarriage; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Apr2021 at 17:00 (Lot Number: ER8729) (at the age of 30-year-old) as single dose for COVID-19 immunisation. The patient was pregnant at time of vaccination, last menstrual date was 20Feb2021, due date was 27Nov2021, the patient was 6 weeks pregnant at the onset of the events. The patient did not test positive to COVID-19, pre or post vaccination. Medical history was none. No known allergies. There were no concomitant medications. On 15Apr2021 at 07:00, the patient experienced Bell's palsy and miscarriage. the events required emergency room visit and physician office visit, the patient was hospitalized for one day due to the events. Therapeutic measures were taken as a result of the events and included ultrasound. The patient outcome of the events not recovered. |
| 1299282-1 | spontaneous abortion; This is spontaneous report from a contactable nurse. A 27 year old female patient who was not pregnant at the time of vaccination received bnt162b2 (BNT162B2 Formulation: Solution for injection, Batch/Lot Number: EL3247) dose 1 intramuscular administered on Arm left on 15Feb2021 as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Seriousness criteria was reported by the patient that it was not serious, no death life-threatening or cause of prolonged hospitalisation. It was not disabling and did not have any congenital birth defect. COVID-19 vaccine was administered at the hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive medications within 2 weeks of vaccination. 12Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test negative. On 29Mar2021, the patient had spontaneous abortion and was taken to emergency room in hospital. On 25Apr2021, the device date given. vaccine facility, race and ethnicity information was available. The outcome of the event was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, spontaneous abortion cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021458221 mother/baby case |
| 1300482-1 | Miscarriage Got my first Moderna shot on 04/03/2021, second Moderna shot on 05/05/2021. Cramping on April 26, 2021 as I was 5 weeks pregnant, bleeding on 05/06/2021 confirming miscarriage. Last period was 03/25/2021, due date was planned 12/30/2021. |
| 1301074-1 | Miscarriage (chemical pregnancy). I didn?t test positive for pregnancy until a week after my vaccine so I put ?unknown? for pregnant at the time of vaccine. I then tested negative a couple days later and had the miscarriage 2 weeks and 2 days after my vaccine |
| 1301453-1 | First day of my last period was Feb 11, 2021. I was pregnant for 11 weeks, and had a miscarriage on April 29, 2021. |
| 1301673-1 | I was 14 weeks pregnant for shot 1 and 18 weeks pregnant for shot 2. My 12 week anatomy scan showed my baby was healthy, all NIPT and amnio came back clean. My baby developed Microcephaly by the next ultrasound scan, 19 weeks. Between 19-23 weeks, her brain slowed down in development even further. I terminated the pregnancy |
| 1302244-1 | positive pregnancy test 1/16/21, vaccine 1/20/21, miscarriage with spotting starting @ 6 weeks pregnant on 2/1/21 and additional bleeding 2/2/21-2/7/21. |
| 1302256-1 | I had a miscarriage at my 18 week check-up. They estimated the baby died around 16 weeks and 5 days. I had gotten my 1st covid vaccine shot at 15 weeks pregnant. My baby had been healthy with no genetic disorders detected at the time of the miscarriage. I don?t know if this could be related to the vaccine, but wanted to report. |
| 1303316-1 | Vaccine 1: 1/29/21. Vaccine 2: 2/26/21. Found out I was pregnant: 3/25/21. Miscarriage: 5/10/21. First OBGYN appointment baby was smaller than expected and had to get vaginal ultrasound. Baby was measuring at 6 weeks with no heartbeat. 10 days later repeated ultrasound and baby had not grown and still no heart beat. Baby never developed longer than 6 weeks. Adverse event: miscarriage. |
| 1304102-1 | Initial dose 1/4/2021 second 1/29/2021. I was a little over 8 weeks pregnant when I had a miscarriage on or around 2/09. I was not aware that the baby did not have a heart beat at that time but learned at an ultrasound on 3/9. I had an d and c. The baby was due on 9/23/2021. |
| 1306618-1 | No previous history of Miscarriage, one successful pregnancy. The estimated date of delivery was November 3rd, 2021. Miscarried 1 week after first covid vaccine. Ultrasound with strong heartbeat completed 4 days prior to Moderna vaccine. |
| 1306935-1 | 5 weeks pregnant, due date December 29, 2021. Next day after the vaccine fever 102.2 for 24 hrs, chills, dizziness, heavy bleeding the day after. Confirmed miscarriage on May 1st. |
| 1307381-1 | conceived 10- 12 days after vaccine shot administered and ultimately had a miscarriage in first trimester |
| 1307914-1 | Miscarriage less than a week after the second vaccine with Moderna. Estimated due date 01/07/2022, started with extreme dizziness and ended with Contraction like cramps and bleeding. History of very healthy full term pregnancies. |
| 1309565-1 | Miscarriage; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), the second dose on 08Apr2021 at 07:30 (Lot Number: ER8729) and the first dose on 16Mar2021 at 07:30 (Lot Number: EN6207), both via an unspecified route of administration, administered in the left arm, as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included sertraline (manufacturer unknown); vitamin d3 (manufacturer unknown) and folic acid, iron (PRENATAL) all taken for an unspecified indication, start and stop date were not reported. The patient had a miscarriage on 20Apr2021 at 04:30. The patient did not receive any treatment for the event. The event resulted in a visit to the doctor or health care professional office/clinic visit and hospitalization on an unspecified date. The outcome of the event was recovering. The patient had a nasal swab Covid test on 23Apr2021 with a result of negative. No follow-up attempts are needed. No further information is expected. |
| 1309633-1 | I had a very early miscarriage; This is a spontaneous report from a contactable consumer reporting for herself. This pregnant female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date after the first vaccine shot the patient had a very early miscarriage. The outcome was unknown. Information on the lot/batch number has been requested. |
| 1309753-1 | Pregnant EDD: 12/19/2021 Dx: DIC complications after miscarriage |
| 1310166-1 | Adverse event miscarriage. First pregnancy. Estimated due date middle of November. Received vaccine approximately around 7 weeks of pregnancy. Post vaccination had chills and fatigue starting 12 hours after vaccine lasting about 48 hours. |
| 1310194-1 | Patient had miscarriage after 1st dose of COVID vaccine. Vaginal bleeding and cramping started after routine check at her OB clinic 4/22 showed fetal demise , Miscarriage complete 4/22/21. Seen by provider for pregnancy care per patient. Was around 16 weeks at time of 1st moderna vaccine- G4P1031. ER visit 4/22 reports she was supposed to be 17 weeks on that date but US confirmed fetal demise at 12w6 days. RH positive |
| 1310363-1 | G2 P1 Patient with LMP of 4/2/21, EDD 1/7/21 received 2nd dose of covid vaccine and within a week experienced her first miscarriage. patient regrets getting vaccine and is upset/frustrated with the loss and concerned about future fertility |
| 1310564-1 | Rare Birth defect, Opmhocele which resulted in miscarriage 2nd trimester. Dr. covering for patient's normal Dr. stated this rare birth defect was seen twice this month. |
| 1310580-1 | Starting at about 05:00 in morning, I woke up feeling shaky and chilly. I was very achy. I had a fever. I took my temperature and it was 102 fever. I took Tylenol. (Extra Strength) I went back to sleep. I woke up about 08:00 am and I still had chills and was extremely achy and had a really bad headache. My temperature was 101.8. Then I started throwing up every 20 minutes for the whole entire day. I still had a fever. It was 102.6 at one point. I had been taking extra strength Tylenol as often as I could take it. I still had a headache was very very achy. I was throwing up constantly and couldn't get out of bed. I had my husband come home to take care of toddler. That lasted then for a full 28 hours - through the next evening. When I woke up on April 7 I had a light headache, a little achy but fever was gone. At the time of my vaccine, I was just 8 weeks pregnant. I had an ultrasound when I was seven weeks along they could hear the heartbeat. I had a miscarriage around 8 weeks and four days. It would have been about one day after the vaccine when I was having my reaction to the vaccine. I am still having bleeding from the DMC - removal - but otherwise I'm recovered. Pregnancy history - It was my second pregnancy. Estimated due date - November 15, 2021. |
| 1311231-1 | Miscarriage |
| 1311242-1 | VAGINAL BLEEDING - PREGNANT Threatened abortion |
| 1311422-1 | O20.0 - Threatened abortion O20.8 - Other hemorrhage in early pregnancy VAGINAL BLEEDING - PREGNANT |
| 1311690-1 | PELVIC PAIN VAGINAL BLEEDING O20.0 - Threatened abortion |
| 1312194-1 | Miscarriage occurred within 2 days of the vaccine. I have carried 2 out of 3 children to over 8 months, the first a live birth (greater than 7 lb) and the second ended in stillbirth (also greater than 7 lb). I have no history of miscarriage. This was my third pregnancy. I became pregnant in March with positive tests on 4/19, 4/20, and 4/21. I had the Covid vaccine 4/21 and by 4/23 was suddenly in pain and bleeding, which continued for six days, after which my body began to recover. Additionally, I began to suffer breathing trouble, waking in the night, heart pounding (no nightmares or fears) and gasping. Was prescribed two inhalers to recover. |
| 1312628-1 | Miscarriage |
| 1312872-1 | Patient Miscarried; vaccine exposure during pregnancy; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (Patient Miscarried) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030m20a) for COVID-19 vaccination. Concurrent medical conditions included Asthma. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) (seriousness criterion medically significant). On 30-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Patient Miscarried) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Patient Miscarried) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was reported. Action taken with mRNA-1273 in response to the event was Not Applicable Company Comment: This case concerns a 25-year-old who experienced vaccine exposure during pregnancy and abortion. Abortion occurred 1 month 8 days post mRNA-1273 use. Although a temporal association exist, there is still not enough information to assess the causal association with the product use. Critical details such as the obstetric history including the duration of pregnancy, antenatal history and condition at the time of abortion is lacking. Additional information has been requested.; Sender's Comments: This case concerns a 25-year-old who experienced vaccine exposure during pregnancy and abortion. Abortion occurred 1 month 8 days post mRNA-1273 use. Although a temporal association exist, there is still not enough information to assess the causal association with the product use. Critical details such as the obstetric history including the duration of pregnancy, antenatal history and condition at the time of abortion is lacking. Additional information has been requested. |
| 1313020-1 | Miscarriage; This is a spontaneous report from a contactable consumer (patient herself). A 30-year-old female patient. A 30-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right deltoid on 14Apr2021 (Batch/Lot Number: Ew0162) as 2nd dose, single for COVID-19 immunisation. Patient had no relevant medical history. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS) received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She received an unspecified vaccine on 14Apr2021 (same date) in right arm. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced miscarriage on 27Apr2021. At 6 weeks there was a heartbeat detected. Patient received her second dose and at 8 weeks there was no heartbeat. Abortion pill was reported as treatment. Event result in Doctor or other healthcare professional office/clinic visit. Patient had not been tested for COVID-19 since the vaccination. Outcome of event was recovering. |
| 1314678-1 | On 04/20/2021 I had a miscarriage I was 6 weeks pregnant. My due date was around Christmas. |
| 1314848-1 | 4/1/2021 vaccination 4/26/2021 MISCARRIAGE *Fetus died 2 days after the vaccine; 4/3/2021; per medical staff (ultra sound). Went to midwife then OB. Dr. did 2nd scan to verify the first scan. Pregnancy HX; 3rd pregnancy, 10/8/2021; 16.5 weeks pregnant at time of miscarriage |
| 1317507-1 | On 05.11.2021 I went in for an ultrasound due to spotting. I should have been 13 weeks pregnant. The fetus was measuring 9 weeks 4 days which means the fetus died on 4.22.2021. 4.7.21 - received vaccine shot 4.8.21-4.9.21 - fever (used tylonel), nausea, vomiting I had significant nausea and vomiting the week of 4.11.21 - particularly the end of the week. 4.15.21 - ultrasound (baby measuring 8 weeks, 4 day; HR -176) I continued to vomit, though I was able to hold more food down. 4.22.21 the fetus would have been 9.4 days which is when the fetus stopped developing 5.11.21 - Ultrasound discovering missed miscarriage Doctor recommended reporting due to the timing with the vaccine. |
| 1317790-1 | 4/20 vaccination 4/28 Started bleeding, cramping 4/29 persistent cramping, bleeding. I went to the ER and had had blood work done the day before positive 4.5 -5 weeks pregnant. *CHEMICAL MISCARRIAGE |
| 1319730-1 | Miscarriage occurred. First pregnancy after 6 years of trying. |
| 1320144-1 | "I know someone that just had a miscarriage from it (Covid Vaccine); This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter said: "" I know someone that just had a miscarriage from it (Covid Vaccine)"". The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained." |
| 1320533-1 | Patient sustained miscarriage. G1P0, Due Date 11/1/2021 |
| 1321201-1 | Miscarriage: I was due at the end of the year. Miscarried after 2nd shot. |
| 1321443-1 | Miscarriage at 5 weeks pregnant. Had first appointment, ultrasound and blood work on 5/11/2021. Covid vaccine on 05/12/2021, first signs of miscarriage on 05/13/2021. Bleeding was followed by cramps. I saw Dr. on 05/14/2021 for miscarriage. Due date was January 10, 2022. Fourth pregnancy. Once previous miscarriage. |
| 1321950-1 | At the time of vaccination I did not know I was pregnant. I?m not sure if the vaccine had anything to do with what happened, but I would still like to report that on May 8th 2021 I started to miscarry. Any number of reasons could have caused this, the doctors do not know why, but it?s important to know I did get the first dose during the beginning of my pregnancy. |
| 1322390-1 | First does of vaccine received April 27, 2021. Positive pregnancy test April 30, 2021. First sign of miscarriage May 8, 2021. Confirmation of pregnancy via bloodwork May 10, 2021. Abdominal sonogram May 10 shows uteri lining/pregnancy stopped forming/advancing at 4-4.5 weeks gestation which falls between the dates of April 2--May 3. 11 days after receiving first dose of vaccination. |
| 1323194-1 | Missed miscarriage. LMP March 7, positive pregnancy test on March 31. COVID vaccinations on March 18 and April 22. April 27, first ultrasound measured fetus at 6w1d (behind what was expected given LMP, should have measured 7w2d), embryonic cardiac activity was present, but could not be documented by M-mode. Provider warned 60% chance of abnormal pregnancy. BetaHCG testing results: April 27 was 28,247H; April 29 was 29,925H. A follow-up ultrasound on May 6 showed no fetal heart tones, and and fetus still measured 6w1d, unchanged from last visit. Provider prescribed misoprostol which was taken same day (May 6) to complete the miscarriage. Follow-up ultrasound May 13 showed gestational sac was gone and endometrium was less than 1cm in thickness. |
| 1323420-1 | At the time of the J&J vaccine I was 6 weeks pregnant. 3 days after my J&J vaccine, I suffered a miscarriage. |
| 1323598-1 | The day following my vaccination (4/24/21) I awoke feeling completely nauseous and dizzy. Upon getting out of bed I immediately sat on the floor due to the extreme dizziness and fear of passing out I felt. After a few minutes in this state I vomited. I had a fever which I managed with Tylenol. I felt fatigued and weak the entire day. I ran a fever the entire day, again managing it with Tylenol. The following day (4/25/2021) my fever was gone and I felt better, however about midday I began experiencing cramps and vaginal bleeding. I was 5.5weeks pregnant with an estimated due date of 12/24/2021. I went to the ER with concerns of a miscarriage. Based on abdominal ultrasound and subsequent HCGquant testing over the next week it was determined I had encountered a miscarriage and lost the baby. |
| 1324105-1 | When I got the vaccine, I had a fever, chills and cramps the day after the vaccine. It lasted for 30 hours. Three weeks after the vaccine I had a miscarriage at nine weeks gestation. I had some bleeding and I went to the doctors office between seven and eight weeks. I had chosen the J&J because it was not MNRA. Due Date-11/27/2021 Pregnancy-Third Pregnancy |
| 1324308-1 | Patient reported to us that she had a miscarriage on 5/13/21. At the time of her first shot she marked on our consent form that she was considering becoming pregnant. |
| 1325371-1 | "I want to report a miscarriage. I got the vaccine when I was 5 weeks and 1 day pregnant. I didn't know I was pregnant when I got the vaccine, but I got a positive pregnancy test 2 days after. It was a ""missed miscarriage"" because I had my 10 week ultrasound on May 10 and it showed that the embryo had died at 6 weeks and 2 days. I started miscarrying that day on May 10." |
| 1325427-1 | I had a miscarriage at 6 weeks pregnant. I have had 0 miscarriages in the past. I have 2 healthy children. |
| 1326568-1 | patient came in 5/18/21 for her second dose that informed me that she miscarried 5 days after receiving her first dose of the Pfizer vaccine on 4/27/21. |
| 1327799-1 | Baby no longer had heartbeat on 20-week ultrasound. Was only measuring 15-16 weeks. Second dose of COVID vaccine given around 14 weeks. |
| 1328510-1 | Miscarriage. Pregnancy developed to 5.5 weeks only, discovered during 6.5 week ultrasound 1 week later. (First day of last period March 1, 2021) |
| 1328511-1 | Found out I was pregnant Feb 11th, 2021, the day before my second dose of covid-19 vaccination. Started bleeding February 22nd, 2021. Went to Emergency Room and was informed may be having a miscarriage. Persisted bleeding for a week. Visited an OB throughout that week and verified I was going through a miscarriage and was approximately 4-5 weeks. First pregnancy and only pregnancy. |
| 1329420-1 | Miscarried on may 13, 2021, exactly 3 weeks later. I was 6 weeks at the time of miscarriage. I have one healthy child and no history of miscarriage. |
| 1329438-1 | Miscarriage / pregnancy loss; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the maternal report. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 30-years-old), administered in Arm Left on 23Apr2021 10:00 (Lot Number: ER8735) as 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included Nature Made Pre-Natal Vitamin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:00 (Lot Number: EL9263) as 1st dose, single for COVID-19 immunization. Confirmed pregnancy on 22Apr2021 at OBGYN via blood test, urine test, and ultrasound. Pfizer 2nd dose COVID vaccine administered on 23Apr2021. Began miscarriage on 28Apr2021. On 28Apr2021, OGBYN medical professionals detected NO GROWTH since 22Apr2021 ultrasound. Identical imagining in size. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient experienced miscarriage / pregnancy loss on 28Apr2021 15:30.No treatment received for the event. The mother reported she became pregnant while taking bnt162b2. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 20Dec2021. The pregnancy resulted in spontaneous abortion. The outcome of the event was recovering. The event was considered as serious (disability, congenital anomaly). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021497434 fetal case |
| 1329479-1 | Early pregnancy miscarriage; 2 lumps near neck; This is a spontaneous report from a contactable consumer (patient). A 31-years-old pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 16:00 (Batch/Lot Number: Unknown) 1ST DOSE, SINGLE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was a Pharmacy or Drug Store. The patient medical history was not reported. There were no concomitant medications. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 26Apr2021, The patient experienced early pregnancy miscarriage, 2 lumps near neck. The patient reported she became pregnant while taking bnt162b2. The mother was 5 Weeks pregnant at the onset of the event and was due to deliver on 22Dec2021. The adverse events resulted in a Doctor or other healthcare professional office/clinic visit. The clinical outcome of the event was reported as not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021501603 baby case |
| 1330002-1 | estimated to be due December 7, 2021. I didn't have any symptoms, I didn't feel like I lost the pregnancy, until we had ultrasound on May 14, 2021 |
| 1331106-1 | I was 4 weeks pregnant at the time I received the second dose of my Covid vaccine. This was unknown to me at the time. I had a miscarriage around 2 weeks later. |
| 1331444-1 | I don't believe this is due to the vaccine but I was still recommended to fill this out. I miscarried and my pregnancy ended in May. I got my first shot in February very early in my pregnancy when I wasn't aware I was pregnant. I then proceeded the get my second shot which at that I knew I was maybe 6 weeks into pregnancy. I've never been pregnant before and the estimated date of delivery would have been November 2021. |
| 1333918-1 | Vaccines administered 12/19/2020 and 01/06/2021. Second vaccine determined to be done in 3rd week of pregnancy (prior to positive pregnancy test). Miscarriage occurred 01/25/2021 at 6 weeks. Otherwise healthy, prenatally-optimized 34 yo woman without personal or family history of miscarriage or pregnancy complications. |
| 1334132-1 | Found out I was pregnant day after shot week later I was bleeding for 3 days kind of like a period then it stopped on the 25 I started having high fevers chills facial flushing went to walk in clinic on 27 said I have strep throat took antibiotics 5 days in still having fever chills flushing went to primary dr did blood work showed I had infection blood pressure started becoming high went to obgyn pregnancy hormone low was told not a good pregnancy on 5/14 went to have pregnancy terminated blood pressure very high on 5/17 back at primary dr with high fever chills facial flushing again blood pressure still high put on a water pill to control blood pressure went back to obgyn everything good from procedure hormone levels almost back to zero |
| 1334299-1 | That evening I had developed a pretty bad headache by that evening but it didn't go away. I went in to ER on April 19 for migraine because my that time news had come out to seek medical help and nothing was helping my migraine. They gave me via IV - migraine cocktail - Pregnancy - I think I became pregnant right after the vaccine but I'm not sure. I didn't know but at the time I was pregnant - and I'm not pregnant anymore. I had a miscarriage about two weeks ago. Now my headaches are gone. I've also been put on between my pregnancy doctor and the two doctors at the hospital - steriod pack pills; Migraine cocktail at first ER; anti-inflammatories at second ER and then Primary Care Dr put me on Prescription nasal antihistamine/steroids nasal spray and headaches have slowly stopped happening. (My allergies flared up majorly after getting the vaccine. I have) Follow up is still needed on both the head pain - need an MRI and follow up is still needed on the miscarriage - I may still need further medical intervention. I have had two previous pregnancies - were abortions - both were confirmed to be fine before that. I was scheduled for my first sonogram for my pregnancy - I'm estimating I was probably about 5 weeks. |
| 1334895-1 | I experienced a Miscarriage 03/22/2021 at five weeks pregnancy. I had gotten the second dose of the vaccine eight weeks before that. I was unaware that I was pregnant when I miscarried. I only found out I was pregnant four days before it happened. Due Date-09/18/2021 Pregnancy-Third |
| 1336048-1 | Miscarriage, injection site reaction, 6mm x 8mm hard red knot |
| 1336963-1 | Patient is a G2P1, received her second Pfizer vaccine on 4/16/21. She began having bleeding on 5/19/21 and had a completed AB confirmed on USG 5/20/21. She was 6 4/7 weeks at the time of her miscarriage. |
| 1337095-1 | I was 7 weeks pregnant at the time of receiving Dose 1 of the Moderna Covid vaccine. I began experiencing vaginal bleeding on Wednesday April 28. The bleeding continued and began heavier so I went to Urgent Care on Friday April 30. May 1 I experienced a miscarriage and lost the pregnancy. |
| 1337712-1 | I have miscarriage - they aren't sure when it happened. The heart beat had stopped when they did an ultra sound last Friday. Pregnancy history - first; Estimated date of delivery - 12/31/2021 |
| 1339093-1 | I was 7 weeks pregnant and received 2nd Pfizer vaccine, on the same day started having virginal bleeding and crumping, had miscarriage next day. |
| 1340311-1 | miscarriage; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration on 05Mar2021 15:30 (at the age of 30 years old) as a 2ND DOSE, SINGLE, for COVID-19 immunisation. Medical history included COVID prior to vaccination. The patient has no allergies to medications, food or other products. Concomitant medications included prenatal vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. LMP was on 20Jan2021. The patient experienced miscarriage on 09Apr2021. The mother was 11 Weeks pregnant (also reported as 8 weeks 1 day) at the onset of the event. The mother was due to deliver on 17Nov2021. The event resulted in Doctor or other healthcare professional office/clinic visit. Unspecified treatment was received in response to the event. The outcome of the event was unknown. The patient has not been tested for COVID since the vaccination. Information about lot/batch number has been requested. Follow-up (07May2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Miscarriage. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agency, as appropriate. |
| 1340332-1 | Miscarriage - baby stopped growing 5 days after shot, confirmed with ultrasounds on 4/26 and 5/6; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the mother report. A 35-year-old female patient (pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at the age of 35-year-old administered in arm left on 18Apr2021 09:15 (Lot Number: EW0164) at singe dose, dose 1 via an unspecified route of administration at the age of 35-year-old administered in arm left on 28Mar2021 15:00 (Lot Number: Er8732) at single dose for covid-19 immunisation. The patient medical history was not reported. There was no Covid prior vaccination. Concomitant medications included estradiol (ESTRACE), progesterone. There was no other vaccine in four weeks. On 23Apr2021, 14:00, the patient experienced miscarriage - baby stopped growing 5 days after shot, confirmed with ultrasounds on 26Apr2021 and 06May2021. The event resulted in doctor or other healthcare professional office/clinic visit. Last menstrual date was 10Mar2021. There was no Covid test post vaccination. There was no treatment for event. The outcome of event was recovering.; Sender's Comments: Linked Report(s) : PFIZER INC-2021512724 baby case |
| 1340388-1 | miscarriage; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Apr2021 16:00 (Batch/Lot Number: EW1058) as 2nd dose, single or covid-19 immunisation. The first dose was received on 15Mar2021 17:00 (lot number: ENLe208). The patient's medical history was not reported. Concomitant medications were none. No other vaccine was administered in 4 weeks. Six days after receiving the 2nd shot of the Covid vaccine from Pfizer, patient conceived on 21Apr2021. After 4 weeks and 4 days of pregnancy, patient had a miscarriage on 08May2021 14:30. While a miscarriage can happen at the early stages of pregnancy, this stage was exactly when the placenta was forming and patient was wondering that the rumors about the COVID vaccine rejecting the protein of the placenta were correct. No treatment was given. Outcome of the event was not recovered. Patient did not have covid prior to vaccination and had not been tested post-vaccination. |
| 1341092-1 | Miscarriage in first trimester of pregnancy day after receiving vaccine. |
| 1341438-1 | Received first dose on 4/17/21. Period late and not recorded on v-safe. Estimated due date was 12/21/21. Had 6 week ultra sound and bleeding shown on ultra sound. At 7 weeks light bleeding. At 8 week ultrasound no fetal pole visible. Wanted to report incident. Expecting genetic testing of embryo. |
| 1342256-1 | I received the first Pfizer dose on 4/6/21 and the second on 4/27/21. My only side effects at the time were a sore arm (both times) and tiredness/fatigue after the second dose. On May 18, I found out I had a missed miscarriage (probably in the prior week) at around 8 weeks pregnant. |
| 1343763-1 | Miscarriage 5/20/2021 |
| 1347279-1 | Was 0 weeks pregnant at the time of the first shot and 4 weeks pregnant at the time of the second dose of the moderna Covid vaccine. At the 9 week ultrasound I was diagnosed with a missed miscarriage in which the embryo died at 6 weeks gestation. Cause of the miscarriage is own known. Occurred 2 weeks after second covid vaccine dose. |
| 1347465-1 | Normal pregnancy before vaccination. After first dose I experienced vaginal bleeding and fatigue. After I fatigue, really tired that I never felt before. Felt really tired for two weeks. I miscarried my pregnancy. Baby had no heart beat and not progressing. |
| 1347515-1 | I believe I was very early on in my pregnancy (as in, implantation or first week after conception) when I received the second dose of the vaccine. EDD was January 9th, 2022. I had brown spotting every day for the duration of my pregnancy, obviously concerning and something I paid attention to (though not altogether unusual in early pregnancy). I ended up miscarrying naturally at 6 weeks. I am strongly in favor and appreciative of this vaccine and would be surprised if there was a direct link, but I do know there is a growing conversation about its impact on women's menstrual cycles. I wanted to submit my experience just in case it was in fact a trend for other trying-to-conceive or early pregnant females. |
| 1347826-1 | 24 year old female with last menstrual period 3/26/21, received Pfizer mRNA COVID vaccine on 4/20/21. she had yet to take a pregnancy test. She received her 2nd vaccine on 5/18/21. Ultrasound was done on 5/21 when patient was expected to be 8 weeks pregnant, showing pregnancy loss. |
| 1347913-1 | The first Moderna shot caused me to miss my next menstrual cycle, which had never happened to me prior to receiving the shot. In the week I received the 2nd shot on 3/13/21, I had uterine cramping that same day within a few hours of getting the shot. I also noticed a change to my cervical mucus during my ovulation cycle 2 weeks later. I then became pregnant the following month and was found to have a missed miscarriage at 6 weeks 1 day. It seems like their is a strong correlation between the side effects from the Moderna shot and the miscarriage. |
| 1348093-1 | Vaccine series in Dec/Jan. LMP Feb 11. Breast lump noticed March 2. Positive pregnancy test March 14. Bleeding April 10, miscarriage April 14. D/C April 16 |
| 1349559-1 | I had a miscarriage and they estimated the baby died at 16 weeks 5 days.; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 14:00 (Batch/Lot Number: EW0161) as single dose for COVID-19 immunization. Medical history included allergies penicillin and COVID-19. The patient's concomitant medications included bupropion hydrochloride (WELLBUTRIN) within 2 weeks of vaccination. Last menstrual period (LMP) was reported as 30Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 06May2021 16:00, the patient had a miscarriage and they estimated the baby died at 16 weeks 5 days. There were no genetic disorders detected, so the cause was unknown. Patient thought maybe the vaccine could have something to do with it. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included fetal demise removal. Outcome of the event was recovering. Information on Lot/Batch number was available. Additional information has been requested. |
| 1350861-1 | 1/20/2021 - got two 5 day old blastocysts implanted via IVF 2/3/2021 - first dose Moderna 2/16/2021 - lost female twin, had sub chorionic hemorrhage. (Both twins were repeatedly tested and had normal chromosomes) 3/3/2021 - second dose Moderna 5/20/2021 - diagnosed complete Placenta previa after bleeding 5/24/2021 - had anatomy scan, surviving male twin has only kidney (renal agenesis) |
| 1350892-1 | I was pregnant when I got my second shot (due date (1/2/2022). I subsequently had a pregnancy loss that started on 5/19/2021. |
| 1351169-1 | Received dose 2 on 1/27/2021, when I was 4w0d pregnant. Estimated date of delivery 10/06/2021. Ultrasound at 12w1d revealed increased fetal nuchal translucency of 4.56mm. Further testing revealed a de novo 16p11.2 chromosomal duplication. Ultrasound at 16w1d revealed cystic hygroma measuring 8mm with nuchal cyst/septation, and unilateral right club foot. The pregnancy was terminated for medical reasons on 4/30/2021 at 17w1d. |
| 1351372-1 | Was 6 weeks pregnant at time of the shot (4/10); missed miscarriage diagnosed on 5/10. 10 weeks. Embryo had stopped developing. 8 to 8.5 weeks (a few days after the prior ultrasound on 4/23 which still indicated normal development of the pregnancy), ca. two weeks after the vaccine. Not sure if the pregnancy loss is related to the vaccine, but reporting after being advised to do so by a representative of the v-safe program. |
| 1354261-1 | Sudden Pprom and leakage at 23week and made me do a pregnancy termination. Due date was determined sep 11,2021 and no related complication detected at 20 week ultrasound and examination It was my 2nd pregnancy ( 1 st pregnancy in 2017 with no complication , vaginal delivery full term) |
| 1355010-1 | On 5/19/2021 patient woke up around 11 pm with a sharp pain in her upper abdomen, then had emesis and the pain subsided and she went back to bed. On 5/20/2021 at approximately 7:30 pm patient started bleeding vaginally. She called the on call doctor and an ultrasound and office visit was advised for the next day. On 5/21/21, patient presented in office for Ultrasound and office visit. The Ultrasound finding were diagnosed for a missed AB (miscarriage)/fetal death in utero. Patient's due date was 11/4/2021. This was her second pregnancy, with the first being a Missed AB (miscarriage) in 7/2020. Due to CRL and failed on Miso prior, patient scheduled for D&C 5/27/21 |
| 1355547-1 | I was pregnant when I got my second dose vaccine. I was on my first trimester when I had a miscarriage. I also had high fever which I took Tylenol for pain medication even though I had hard time bringing my fever down, I also do not know if it was related to the Modena vaccine or my miscarriage. On 05-12-2021 I found out I was 11 weeks pregnant. I underwent a radiology ultrasound where it showed my fetus died at 8 and half weeks. |
| 1356101-1 | First pregnancy Weeks of brown bleeding prior to miscarriage Due 12/17/21 Miscarriage 05/22/21 at 1pm |
| 1357184-1 | miscarriage; Pregnancy at the time of vaccination: Yes; Pregnancy at the time of vaccination: Yes; This is a spontaneous report from a contactable consumer (patient). A 32-year-old pregnant female patient received BNT162B2 (brand: Pfizer), dose 1 on 17Mar2021 13:30 and dose 2 on 07Apr2021 13:30, via an unspecified route of administration in the left arm as single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a workplace clinic. Medical history was not reported. She was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included unspecified prenatal vitamin, iron supplement, and sertraline hydrochloride (ZOLOFT). No other vaccines within 4 weeks prior to the COVID vaccine. The patient was pregnant at the time of vaccination. The fetus she was pregnant with stopped growing at 5.5 weeks which happened to be the same time she had the vaccine. She ended up with a miscarriage. The adverse events resulted to doctor or other healthcare professional office/clinic visit. Treatment was received: took medicine to complete the miscarriage process. Since the vaccination, she has not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested. |
| 1357263-1 | Date of start of drug: 25Jan2021, Dose Number: 1; Date of start of drug: 18Mar2021, Dose Number: 2; Miscarriage; This is a spontaneous report from a contactable consumer (patient) reported herself. A 26-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 18Mar2021 01:00 PM (Batch/Lot Number: EN6203) as 2ND DOSE, SINGLE for covid-19 immunisation, at the age at vaccination date of 26 years old. Patient was not pregnant. Medical history reported as no. The patient's concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. No known allergies. Historical vaccine included first dose of BNT162B2 (lot number: En6203) on 25Jan2021 01:00 PM at left arm. The patient experienced miscarriage (medically significant) on 26Apr2021 with outcome of recovered, date of start of drug: 25jan2021, dose number: 1; date of start of drug: 18mar2021, dose number: 2 (non-serious) on an unspecified date with outcome of unknown. The event miscarriage resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19/ Since the vaccination, the patient has not been tested for COVID-19. Follow-up attempts completed. No further information expected. |
| 1358283-1 | Persistent pain in arm, pain when lifting arm, I believe it to be SIRVA. Also I had a miscarriage at 10 weeks pregnant (18 days after receiving second dose) although that may not be related to the vaccination. |
| 1358329-1 | Site: Pain at Injection Site-Mild, Systemic: miscarriage-Mild, Additional Details: patient had miscarraige |
| 1358410-1 | I was very fatigue after receiving the vaccine. I had chills and a fever. I was pregnant and my estimated delivery for the baby would've been May. I lost my child. |
| 1358535-1 | I did not feel adverse side effect, just sore arm. But there was bleeding that night, continuing that night and into Sunday. I went to my OB on Monday, I was 8 weeks and 4 days. They determined that the baby had stopped growing and there was no heartbeat and they declared it a miscarriage. Est due date was December 11 2021. No fever or any other side effects. |
| 1358626-1 | During the time of 1st dose dated:04/04/2021 didn't knew I was pregnant. After second dose dated: 05/4/2021 we went for first scan on May 13th ,2021 and doctor suggested that the baby growth is not as per the weeks being calculated .They suggested that this might lead to miscarriage and asked us to come after 1 week date: 05/21/2021 .But soon after the visit I started noticing bleeding and spotting , we went back on Friday next week and there was no heart beat ,so they diagnosed it to be a miscarriage and gave medications following that. My blood reports and urine reports are normal. Wanted to report the event . |
| 1358839-1 | Received second shot at 10 weeks pregnant (due 12/6/21). The night of 5/14 - started having night sweats, extreme lower back pain, nausea, and spotting from the vagina. All of these symptoms were new and none were experienced during pregnancy otherwise. (After the first shot at 7 weeks pregnant, only had a sore arm at injection site) On 5/15 - multiple episodes of vomiting, excessive exhaustion, and bleeding continued. 5/16-5/25 - bleeding increased Went to OBGYN 5/17 & 5/25 to get checked and both times they were able to locate a heartbeat, but were unsure why bleeding continued to occur. 5/25 11:30pm woke up in excessive pain and bleeding, resulting in a miscarriage. 5/26 2:00am ER confirmed miscarriage. |
| 1359722-1 | Patient reports being 6 weeks pregnant (estimated Due 12/27/21) at time of vaccination. She has been previously been pregnant 3 times with no prior miscarriages or complications. Patient reports finding out about miscarriage on 5/22 during office visit and completed miscarriage on 5/25. Patient experienced mild fever and chills approximately 6 hours after vaccine which was controlled by acetaminophen and resolved by the following morning 5/4. |
| 1359724-1 | Miscarriage on 5/17/2021 10 days after second shot |
| 1360487-1 | "My second dose of the vaccine was 10Jan2021. I conceived around 24Jan2021. I suffered a missed miscarriage detected 10May2021, then an incomplete miscarriage 14May2021.; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 10Jan2021 10:00 (lot number not reported), as 2nd dose, single dose, at age 34 years old, for covid-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications (other medications received within 2 weeks of vaccination: no). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm, on 20Dec2021 at 10:00 (lot number not reported), at age 34 years old, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, ""My second dose of the vaccine was 10Jan2021. I conceived around 24Jan2021. I suffered a missed miscarriage detected 10May2021, then an incomplete miscarriage 14May2021."" The event resulted to emergency room and physician office visits, and hospitalization (date not reported, duration: 1 day). Treatment was reported as ""incomplete miscarriage, hemorrhaged, D&C"". The patient tested negative to COVID-19 via nasal swab on 14May2021. The outcome of the event was recovered with sequel in May2021. Information on batch/lot number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate." |
| 1360595-1 | Late miscarriage at 18 weeks gestation. Fetal demise.; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced late miscarriage at 18 weeks gestation. fetal demise on 11May2021 12:00. The mother was 18 weeks pregnant at the onset of the event. The mother was due to deliver on 10Oct2021. The mother delivered the pregnancy on 11May2021. Patient had Nasal swab (NP and rapid) on 17May2021 and the result was negative. Treatment: Delivery of fetus, D&C of remaining undelivered placenta. Event resulted to doctor or other healthcare professional office/clinic visit, prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event). The outcome of the event was recovering. Information about the Lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event late miscarriage at 18 weeks gestation. fetal demise cannot be excluded based on temporal association and available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Authorities, Committees and Investigators, as appropriate. |
| 1361171-1 | I was 6 week pregnant at the time of my second vacine dose. My 8 week ultrasound found that the baby was probably 6 weeks and they couldn?t find a hear beat. The miscarriage was confirmed on the 28 of May. |
| 1361336-1 | Birthed 3 healthy children without complications (other than c section at full term) within the past 5 years. I found out I was pregnant the night I received my second dose of the covid-19 Pfizer vaccine. A little over a week later at my OBGYN appointment, I was told that there was something wrong. I was only 5 weeks pregnant. At 6 weeks and 3 days, I had a miscarriage (naturally). |
| 1361671-1 | Had my first vaccine dosage on 3/26/2021, second dosage on 4/23/2021. I did last ultrasound on 4/22/201, baby was measuring 8 weeks and 4 days with a heartbeat of 174. The baby stop growing 9 weeks and 1 day on 4/26/2021. |
| 1361967-1 | The day after I received the vaccine I was very ill. I had a fever of 103 for most of 24 hours after the shot. I had body aches and chills and just felt generally horrible. I was 8 weeks pregnant with twins at the time of the vaccine. 3 days after the vaccine I had an ultrasound which showed a large blood vessel between the twins. On March 23rd I had another ultrasound and neither of one of my twins had a heartbeat. From the measurements they could tell that I lost one twin the week of March 15th and I lost the other one the week of March 22nd. |
| 1361973-1 | Patient asked how to report a missed abortion (miscarriage) after the second dose of the Moderna vaccine since she was told by doctors to report it. Patient had a positive pregnancy test on 3/14/21 after receiving the second dose of Moderna on 3/11/21 but did not know prior to receiving the second dose. Patient stated that it was determined she was 6 weeks pregnant 6 days after the second shot. On 4/1/2021 patient had abdominal pain and bleeding so went to the emergency room and an ultrasound was performed. It was determined that the missed abortion occurred when the baby was at 6 weeks. After several doctor visits, the patient was advised to report this and that is why this was brought to our attention. She simply asked how to report this and then I asked her some questions and gathered information. She was okay and sounded fine. |
| 1362298-1 | Missed miscarriage. Ovulation 5/5/21, resulting in a miscarriage between 5-6 weeks. |
| 1362404-1 | Missed abortion diagnosed on 5/28/21 during routine ultrasound |
| 1363993-1 | Miscarriage; Electing not to receive second Moderna dose after learning she was pregnant; Pregnant when she received her first Moderna dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. The patient's past medical history included Polycystic ovarian syndrome and Hypothyroidism. Concomitant products included LEVOTHYROXINE and METFORMIN for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 08-Oct-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose). On 05-Feb-2021, the patient experienced INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant). On 27-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the first week of the pregnancy. On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose) had resolved. On 05-Feb-2021, INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant) had resolved. On 27-Apr-2021, ABORTION SPONTANEOUS (Miscarriage) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No information regarding treatment was provided. Nurse reported she was unaware she was pregnant when she received her first Moderna dose on 08-Jan-2021. Nurse reported that she discovered she was pregnant a week 29-Jan-2021 prior to her scheduled second Moderna dose on 05-Feb-2021. Testing was performed on the fetus and physicians determined the baby was a normal healthy girl with no genetic abnormalities or findings. Reportedly, she stopped metformin during her pregnancy so glucose testing could be performed. |
| 1364029-1 | First trimester miscarriage; Received the Moderna COVID-19 Vaccine while pregnant; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (First trimester miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (First trimester miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Received the Moderna COVID-19 Vaccine while pregnant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. At the time of the report, ABORTION SPONTANEOUS (First trimester miscarriage) outcome was unknown and EXPOSURE DURING PREGNANCY (Received the Moderna COVID-19 Vaccine while pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications was reported. No treatment details were provided. Company Comment : This is a case of product exposure during pregnancy with associated AEs for this female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. |
| 1364666-1 | Patient's first day of last menstrual period was 3/23/2021. Patient has a predictable monthly cycle with an average length of 30 days. Patient reports two positive at home urine pregnancy tests on 4/30/21 and 5/1/21. Conception likely occurred on or around 4/6/21. Patient reports vaginal bleeding that started on 5/14/21. Patient had transvaginal ultrasound on 5/17/21. Impression: FIRST TRIMESTER ULTRASOUND, SINGLETON An early intrauterine singleton pregnancy is visualized. A fetal pole is visualized but fetal cardiac activity is NOT present. The fetal biometry is appropriate for gestational age. Anatomic survey is precluded by early gestational age. As the CRL <7mm (measures 2.6mm) a definitive diagnosis of a missed miscarriage can not be made I would recommend a follow up ultrasound in 10-14d. Follow up ultrasound on 5/27/21 could not visualize pregnancy. Impression: The endometrium measures 14.39 mm, with heterogenous echotexture suggestive of retained products. The right and left ovaries appear normal. |
| 1365132-1 | Heart racing, shortness of breath which leads to mild headache; noticed approximately Monday, May 24 Miscarriage symptoms began on Tuesday May 25th |
| 1365462-1 | I got pregnant in May and thought I was miscarrying shortly after I took the survey. My period was a lot heavier than normal - my cramping went on for two weeks and more. I had clotting and heavy bleeding - first time clotting. More blood and heavier bleeding then I had ever experienced. It was an Ectopic pregnancy. I just got treatment yesterday so it will be awhile before I'm recovered. I was seeing midwives or OB/GYNs. |
| 1365711-1 | Missed miscarriage. Was 4 weeks pregnant at time of second shot. Estimated delivery date of Dec 26, 2021. Heartbeat at 6 week ultrasound (May 7th). No heartbeat at 8 week ultrasound (May 20th). Pregnancy through IVF - frozen embroyo transfer on April 9th. Had D&C on May 24th. |
| 1366573-1 | I got the vaccine while I was pregnant (and I had to the agent in vaccination site before) About 2 to 3 weeks later ultrasound reported abortion |
| 1367797-1 | Two days following the vaccine, I had a miscarriage . I was 8 weeks pregnant. |
| 1368076-1 | I was 4/5 days pregnant the day the first dose was administered. I was 21 days pregnant the day the second does was administered. I was supposed to be due December 31st, 2021. On my 8 week appointment check up; the OB discovered there was no longer a heartbeat they could find for baby. I subsequently went in for a recheck 1 week later ( today) to discover there was still no heartbeat for baby. I was diagnosed as having a misses miscarriage. I was given the same medication that patients receive when they want to have a medical abortion by choice. I will go back to the OB in 10 days to make sure that all of the pregnancy has vacated and the uterus is clear for a new pregnancy. |
| 1368498-1 | NAUSAU SORENESS OF ARM AND BODY ACHES Miscarriage (due date unknown) |
| 1368536-1 | 03/04/2021 I had my last period. Then I had the second dose and a month later I knew I was pregnant and then I had a missed miscarriage. They gave me misoprostol and misoprostol. After the missed miscarriage I was dizzy because I lost blood. |
| 1368613-1 | I was 6 weeks along and I was suppose to deliver in January 2022. I missed carried May 17, 2021. It can take upto 4 weeks with the miscarried. |
| 1368674-1 | Pregnancy within month after vaccine, miscarriage several weeks later |
| 1368713-1 | Fever took Tylenol Very tired Starting spotting lightly was 10 weeks pregnant The spotting became like a period Labor contractions Miscarried at 12 weeks |
| 1368795-1 | My first vaccine was: Monday, March 22 My second dose was: Monday, April 19 A blood test at the doctor confirmed we were expecting a baby on: Friday, April 16 2 previous full term deliveries, no other miscarriages My blood count was lower than expected based off of my last period date (March 3, 2021). A second blood test was done Thursday, April 29. An ultrasound was done Monday, May 10 which showed a fetal heartbeat and measurement of 5wks 5days. A second ultrasound was done Wednesday, May 19 and showed an irregular heartbeat and less growth than was expected by that point. Bleeding began on Tuesday May 11. An ultrasound on Wednesday, May 19 showed the baby had stopped growing or moving and no heartbeat was detected. On Wednesday, May 26 a D&C was performed. |
| 1368898-1 | Miscarriage, moderate bleeding, cramps |
| 1370332-1 | Missed second dose of the Moderna COVID-19 vaccine; Spontaneous abortion; Lot of pain in my whole arm; Exposure during pregnancy; Strong headache; Pain in the muscle where I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous abortion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine). On 08-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Spontaneous abortion) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine). The patient was treated with IBUPROFEN (oral) at a dose of 500 mg. At the time of the report, ABORTION SPONTANEOUS (Spontaneous abortion), PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine), PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup received contains NNI; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested. |
| 1371270-1 | I miscarried on 05/16/2021. The baby was due 12/23/2021. I currently have 2 children and had 1 miscarriage before in my life. I was at 5 weeks of pregnancy when I received my 2nd dose and 8 weeks into my pregnancy when I miscarried. After I received my 2nd dose of the vaccine, the second night I experienced chills, had a minor headache and felt very achy. They felt like flu symptoms. |
| 1371319-1 | I had an ectopic pregnancy that wasn't diagnosed and eventually ruptured, which resulted in the loss of the pregnancy. I had to have emergency surgery and my left fallopian tube had to be removed. |
| 1371436-1 | Monday April 5th I started bleeding. I thought it was my normal period. Tuesday I started having major abdomin pain. It was so bad I couldnt walk. The pain would subside and then I would bleed alot. Then the pain would start again. The pain would subside and I would start bleeding alot again. This was like labor. Wednesday I had a lot of tissue come out of me so I realized this must be a miscarriage. My doctor told me to take a pregnancy test and sure enough it tested positive I was about 5- 7 weeks pregnant. As far as pregnancy history, I also miscarried February 11th. (went in for the ultrasound and fetus wasnt moving around 9 weeks). Had first child at 35 and 2nd at 40. My instincts tell me the vaccine had something to do with my 2nd miscarriage (April 5th). |
| 1371478-1 | I lost my pregnancy in the early stages at 5 weeks. |
| 1371609-1 | After the second dose, I was sick the whole next day and I miscarried the following week. |
| 1371940-1 | I experienced a miscarriage a week after having the Pfizer to vaccine and I'm not being given much information from the vaccine facility they gave me a piece of paper with a phone number to vaers in this doesn't even look like a phone number or a fax number to their facility |
| 1371988-1 | Loss of pregnancy. I received my first dose at approximately 4 weeks pregnant on 3/30. I had a positive home pregnancy test the following day on 3/31. On 4.29, I had my first confirmation ultrasound where a heartbeat was found, but the fetus was not measuring as expected. On 4.30, I received my 2nd dose of the Moderna vaccine. A follow-up ultrasound was done on 4.12, at that time, no heartbeat was indicated and the fetus had stopped developing shortly after receiving the 2nd does on 4.30. This was my first pregnancy. |
| 1372094-1 | Patient was pregnant at time of vaccination (1 week) and proceeded to have a miscarriage 3 weeks following vaccination. |
| 1373093-1 | miscarriage 4/18/2021 - 10 weeks pregnant started bleeding on 4/17/2021 |
| 1373782-1 | Miscarriage; This is a spontaneous report from a contactable consumer (patient). This is the mother case. A 34-year-old female patient received the 1st single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in left arm on 18Apr2021 (Batch/Lot Number: Ew161), and the 2nd single dose, always in the left arm, on 02May2021 (Batch/Lot Number: Ew0171), for COVID-19 immunisation. First and second dose were administered at the age of 34 years old. Relevant medical history was reported as none. The patient's last menstrual period was on 18Feb2021 and pregnancy due date was 26Dec2021. Concomitant medications included unspecified pre-natal vitamins. Relevant past drug history included sulfa. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was never diagnosed with COVID-19, and since the vaccination the patient had not been tested for COVID-19. The patient reported having miscarriage on 13May2021, diagnosed after the 2nd shot of BNT162b2. A doctor or other healthcare professional office/clinic visit was needed. The fetus had died sometime between the 1st and 2nd shot based on gestational age. Gestation period when the event was observed was reported as 4 weeks. The patient had to undergo dilation and curettage from which the patient was recovering. The seriousness criterion was reported as 'Congenital anomaly/birth defect' (no further information reported about the congenital anomaly). Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021602308 mother/baby case |
| 1374101-1 | Systemic: Abdominal Pain-Medium, Systemic: Miscarriage-Severe, Additional Details: Pt had miscarriage after first dose of Pfizer vaccination. Bleeding started hours after shot. |
| 1374321-1 | headache pain in hip and legs pain from the waist down back pain Miscarriage (7 weeks 5-6 days pregnant) went to OB clinic Ultrasound no heartbeat 7 weeks 5-6 days Determined that the baby stop growing at 7 weeks and 5 days, which is the day I received my 2 dose of my vaccine. Friday, May 21st suggested doing a DNC of getting medication to induce at home 24th gave medication to induce problems that 28 having alot of pain miscarriage was not complete told to do another dose of medication to induce at home last week on tuesday and the miscarrige is still not complete advise to surgery of anotehr dose of medication go back next week .misscariage is not complete. |
| 1374744-1 | Patient received a two dose series of Pfizer /BioNTech vaccine. First dose March 30 , 2021 and second dose May 16, 2021. She answered no to all questions including no to pregnancy at both occurrences. There were no requests at either times for a medical evaluator to answer additional questions. The patient returned to the vaccination POD on June 3rd, 2021 claiming that she had a miscarriage some time after the second dose. She requested information about the POD but did not offer any other information. She requested that we advise people that this happened to her and that she has already alerted the local news agencies and CDC. |
| 1375791-1 | Did not know we were pregnant, received vaccine. Got positive pregnancy test a few days later and miscarried the next month at 8 weeks with baby measuring 6 weeks. Have no history of miscarriage and two full term healthy babies prior to this. Unknown if related for sure, but this is the only change and timing seems important to report as possibly correlated. |
| 1375928-1 | First dose moderna: 3/18/21 Second dose moderna: 4/15/21 Conceived: 4/14/21 Miscarriage at 7.5 weeks pregnant. Baby stopped growing at size 6 weeks pregnant. Due date: January 17 2022 Pregnancy confirmed 5/24/21. gestation age: 8 weeks 1 day based on LMP. Baby only measured 6 weeks 0 days on this date. |
| 1376421-1 | Patient called the pharmacy a few days after her 2nd Moderna vaccination and stated about a day after her shot she started experiencing abdominal cramps. Patient was pregnant so was very concerned and went to the hospital. Unsure how far along she was but she wanted us to know she had a miscarriage. We are unaware if this is linked to the vaccination but patient is stating that's the only thing that has changed since her three previous pregnancies that had no issues whatsoever. Reporting this since she called the pharmacy so we were aware and since we are not aware if the hospital filed this report. |
| 1376881-1 | Miscarriage. Had first vaccine dose about 2 weeks after a positive home pregnancy test (on 04/24/2021). Date of last period was 03/19/2021. No fertility treatments. Spontaneous pregnancy at 46 years old. Had 2 previous miscarriages - 6 months earlier and 3 years earlier. Started bleeding and cramping 05/26/2021. Went to emergency room. They checked with ultrasound and said it was probably a miscarriage. The baby should be 9 or 10 weeks, but the ultrasound showed it was much too small for that - probably stopped developing at about 6 weeks. Pregnancy hormone levels were normal, however. Followed up with OBGYN the next day - she confirmed it looked like a miscarriage. The cramping/bleeding lasted for another week. Follow-up appointment on 06/04/2021 showed the uterus had completely emptied. |
| 1377825-1 | Missed miscarriage due to nonmosaic Trisomy 22 (confirmed by genetic testing) on or around 4/28/2021 resulting in D&C procedure on 5/25/2021. I have had one other confirmed miscarriage due to blighted ovum in November 2020, a live birth in December 2018, and a live birth in April 2008. |
| 1378453-1 | after receiving vaccine on Wednesday 4/21, got positive pregnancy test on Saturday 4/24, 1 day after missed period. Estimated due date was 12/31/21. Began spotting on May 1 - approx 5 weeks pregnant. Spotted brown/pink with some clots until May 5, when I started lightly bleeding red. Beta tests on May 5 and May 7 showed 6228.7 and 6529.0, respectively. May 10 went in for viability scan - ultrasound showed gestational sac with 2 yolk sacs and 2 fetal poles, one measuring at 6 weeks and other measuring at 6w1d. No sign of misscarriage, no reason for bleeding was seen on the scan. Scan was perfect on paper. Bleeding picked up after scan and I lost the pregnancy on May 11 around 4:30pm. Bleeding continued for one week and HCG levels were low enough to show a negative test at my followup appointment 2 weeks later on May 26. |
| 1379297-1 | First shot was on 03/29.21, I didn't know but I was already pregnant about 7 weeks. Second shot was taken on 04/21/21. On 05/11/21 and 05/12/21, I checked in on Emergency Care with craps and light bleeding. A ultrasound and blood tests were done and I was informed I had had a miscarriage. We don't know if it was just a coincidence or if there is any link to the Covid19 vaccine but I was oriented by CDC to report the finding if I would like to. |
| 1380742-1 | Caused misscarrage; Vaccine exposure during pregnancy; Based on the current case data, this case has been classified as invalid. This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Caused misscarrage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Caused misscarrage) (seriousness criteria medically significant and congenital anomaly) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, ABORTION SPONTANEOUS (Caused misscarrage) outcome was unknown and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant or treatment medications were reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This is a case of product exposure during pregnancy with associated AE. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This is a case of product exposure during pregnancy with associated AE . |
| 1381144-1 | High fever that resulted in loss of pregnancy; High fever; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206), via an unspecified route of administration on 08Apr2021 12:00 (at the age of 35-year-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On an unspecified date, the patient experienced high fever that resulted in loss of pregnancy. Events caused doctor or other healthcare professional office/clinic visit. Patient received treatment for events. The mother reported she became pregnant while taking BNT162B2. The mother was 3 weeks pregnant at the onset of the event. The mother was due to deliver on 17Dec2021, and last menstrual period date was on 12Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Pregnancy loss and fever cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. |
| 1381752-1 | I was 5 weeks pregnant for my first shot and 8.5 weeks pregnant for my second. I found out I was pregnant with twins the week after my first shot at 6 weeks pregnant, but on the day of my second shot, a prenatal ultrasound found no fetal heartbeats in either fetus and determined pregnancy loss. |
| 1381776-1 | Participant was 5 weeks pregnant when she got the shot due date would have been December 9, 2021. April 17th around five o clock started to experience strange feeling so she just continued to rest, said she was spotting heavy and participant got an ultrasound 2 days later and later on during the day said she heavy bleeding still. On April the 22nd the doctor told her she had a miscarriage. |
| 1381836-1 | I was 16 weeks along when I found out I had a miscarriage. The doctors said the baby stopped growing at 15 weeks. The clinic measured the baby stopping growing at 14 weeks, right after my second dose. I?ve had 3 vaginal on time healthy deliveries. No previous pregnancy issues. This was definitely unusual. |
| 1382606-1 | embryonic demise at 9 weeks gestation first pregnancy |
| 1383404-1 | I became pregnant mid April 2021 after 3 uncomplicated pregnancies and suffered a miscarriage at approximately 10 weeks. |
| 1385395-1 | I was having light headeness and fainting. I also was having abdominal pain.I end up having a miscarriage at 8 weeks. |
| 1385542-1 | Miscarriage @ 8 weeks gestation |
| 1385852-1 | patient was found to have miscarriage on 6/8/21. Received dose 2 of vaccine at 3 weeks 5 days gestation |
| 1387039-1 | Miscarried at 6 weeks |
| 1388203-1 | The same day right after the vaccination I felt weird but I left the mall after the 15 minute period and after I went home i vommitted and had back pains and just couldn't sleep at all. At last I took Advil because I had chills. My temperature at that time was 103 I felt tired and for the next 36 hours my temperature was between 99-100 and I was in the bed the whole time I took Advil and Tylenol. I had an appointment with my doctor just to make sure everything is okay I couldn't even go. I had diareeha for the longest time and then I had nausea and it went through for the longest time and I still have most of the symptoms my stomach hurts and I have headaches constantly. My blood tests are normal but i still can't past the symptoms and my doctor says it can be related to the vaccination. On April 12 I had my periods but it was not that I just understand what that was it was really bad the blood was all over my body I went to the doctor and still nothing. I went to the emergency room for that and they gave me some medications to stop the blood but it didn't help. my doctor did a dnd procedure because of the bleeding after the procedure I got the results and my tissue was of a pregnancy and I had a miscarriage and I didn't even know. |
| 1388564-1 | O20.0 - Threatened abortion PELVIC PAIN VAGINAL BLEEDING R07.89 - Other chest pain CHEST PAIN |
| 1389119-1 | I had a miscarriage on 05-11-2021. At the time of my miscarriage I was 4 weeks pregnant. After my vaccine I was also sick for a week and a half, developed fatigued, chills, fever, headaches, left arm soreness, these symptoms lasted for nine days. |
| 1389195-1 | Miscarriage discovered on 05/19/21 |
| 1389555-1 | I had a miscarriage which started on May 27th. I believe I ovulated the day I received the shot (May 4th). My last period started on April 15th. I had a positive pregnancy test on May 22nd and bleeding began on May 27th. |
| 1390729-1 | Spontaneous miscarriage; Spontaneous miscarriage; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Spontaneous miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Spontaneous miscarriage). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. Spontaneous miscarriage. Gestation period not reported. At the time of the report, ABORTION SPONTANEOUS (Spontaneous miscarriage) and EXPOSURE DURING PREGNANCY (Spontaneous miscarriage) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not provided. Company Comment: This case concerns a female patient, unknown age, who experienced an event of drug exposure during pregnancy and also experienced an event of spontaneous abortion. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: This case concerns a female patient, unknown age, who experienced an event of drug exposure during pregnancy and also experienced an event of spontaneous abortion. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested. |
| 1391280-1 | "O20.0 - Threatened abortion ""HREATENED MISCARRIAGE ABDOMINAL CRAMPING VAGINAL BLEEDING - PREGNANT" |
| 1391282-1 | 16 week Anatomy scan showed crembrem hyplasia amnd fluid in ventricles that resulted in pregnancy termination |
| 1392742-1 | Miscarriage at 16 weeks was found on 05/13/2021. Due date was 10/31/2021. Ultrasound at 16 weeks showed baby with no heartbeat at approximately 12-13 weeks growth. |
| 1392838-1 | Miscarriage at 6 werks |
| 1394096-1 | Received first dose of vaccine on May 6th and had a miscarriage on May 18th.; This is a spontaneous report received from a contactable consumer (patient). A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06May2021 15:45 (Lot Number: ER 8735) as single dose (at the age of 33-years-old) for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included unspecified prenatal vitamins. The patient received first dose of vaccine on 06May2021 and had a miscarriage on 18May2021 00:00 (reported as 12:00 AM). The mother reported she became pregnant while taking bnt162b2. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 12Jan2022. Patient's last menstrual period date was on 07Apr2021. The pregnancy resulted in spontaneous abortion. No treatment received for the event. The outcome of the event was recovering. The event was considered as serious (medically significant). Facility where the most recent COVID-19 vaccine was administered was in Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 28May2021 No follow-up attempts are needed. No further information is expected. |
| 1394674-1 | First dose received 1/22/2021 (lot 026L20A). 2nd dose received 2/19/2021. Become pregnant between doses 1 and 2. Pregnancy was confirmed 4/1/2021 and viable with due date of 11/14/2021. On 5/18/2021, pregnancy was confirmed as missed miscarriage (at approx 8wks 4 days). All DNA tests came back negative for genetic abnormalities up to that point. |
| 1394758-1 | Had a horrible red rash down my left arm and felt sick for several days then I miscarried. |
| 1396622-1 | At the beginning of January, my husband and I had already been trying to conceive. I received my second dose vaccine on 01-07-2021. In the first week of February I found out I was pregnant. By the end of February I had a miscarriage. I had the miscarriage on 02-24-2021. The day I miscarried I was going to have my first gynecological appointment to check my baby. I do not know if the vaccine had anything to do with my miscarriage. I was hesitant to getting my second dose but I still went through with it. I just think it is important for mothers who are expecting to wait at least till their second trimester to receive the Covid 19 vaccine, my opinion. |
| 1398511-1 | had a miscarriage; had vaccine during the first 10 weeks and had a miscarriage; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (had a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (had a miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (had vaccine during the first 10 weeks and had a miscarriage). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (had a miscarriage) and EXPOSURE DURING PREGNANCY (had vaccine during the first 10 weeks and had a miscarriage) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication and treatment drug was reported. It was reported that the baby died Company comment: This is a case of product exposure during pregnancy which resulted in Spontaneous Abortion, for this female with undocumented age. Very limited information has been provided at this time.; Sender's Comments: This is a case of product exposure during pregnancy which resulted in Spontaneous Abortion, for this female with undocumented age. Very limited information has been provided at this time. |
| 1399982-1 | Chemical pregnancy experienced 3 weeks after 2nd shot in Moderna vaccination cycle. No reason to believe it was a related event, but reporting it nonetheless in case a trend emerges. Some flu-like symptoms (body aches, headache, fatigue) were experienced 24-48 hours after the shot but no fever. |
| 1402256-1 | Became pregnant after first covid vaccine given March 1, 2021. Received 2nd vaccine on March 29, 2021. Miscarriage occurred May 5th 2021 resulting in D&C and overnight hospitalization. |
| 1403517-1 | 3 days after I received a first doze of Pfizer vaccine on May 13, I found out that I was pregnant, about 5 weeks. I consulted with my OBGYN and also called CDC phone number to consult regarding getting the 2nd doze, and both encouraged me to get the 2nd doze. My bloodwork showed low levels of progestrerone, so I was prescribed it to support the pregnancy. My 2nd doze was on June 3, and on the next day after the vaccination I've experienced strong vatigue, headache, and overall low-grade fever achy sensations. On the 4th day after getting vaccinated with my 2nd doze, I got a terrible migrain that lasted for 48 hours; I was unable to keep any food or fluids in, and actually lost 7.5 lbs over the period of 2 days. A couple of days after that, I had a similar migraine that lasted by 24 hours, and I lost another 3 lbs. Today, June 16, I came in for my 1st 10-week sonogram, only to find out that I had a Blighted Ovum Miscarriage. This is make it my 3rd pregnancy and my 3rd miscarrige. My OBGYN has ordered some blood tests, and we're trying to get as much information about the possible cause on our end. In the meantime, I felt obligated to share my story in case the vaccine had any hand in this... I get the flu shot every year, and I am pro vaccination. I've been tested negative for COVID-19; prior to getting teh vcaccine I also checked for anti-bodies, and the result was negative as well. |
| 1407061-1 | Received vaccination on or about date of conception Miscarried at 3 weeks 6 days |
| 1407174-1 | The morning before my second Moderna vaccine I took a pregnancy test and it was inconclusive so I figured I wasn't pregnant and got my second vaccine (1/26/21). I missed my period and took another pregnancy test on 1/30/21 and it was positive. I went to my first ultrasound on 3/2/21 when I should have been around 8 or 9 weeks and the baby was measuring small but it had a heart beat that was in a normal range. A week later on 3/9/21 I started spotting and I called my doctor and they told me to let them know if it got worse. I went to work but by the end of my shift the bleeding had got worse and my doctor made me go to the ER so I could have another ultrasound. The ultra sound showed the baby still had a heart rate but it was low. I stayed home from work the next day to take it easy and I ended up having a miscarrage that night 3/10/21. I had a follow up ultrasound on 3/11/21 that proved it. I wasn't planning on reporting this because really anything could have caused it but I signed up for the vaccine app when I got my vaccines and answered the follow up questions. Someone called me because of how I answered my question and she recommended that I report it. |
| 1407884-1 | Patient was newly pregnant at time of vaccination. After about 2 weeks of receiving the first Moderna vaccine, patient had a miscarriage. Patient would have been between 4 to 8 weeks pregnant at time of miscarriage. |
| 1408436-1 | I was about 5 to 6 weeks pregnant and I lost the baby on June 7th. About 3 weeks after the covid shoot. I didn't even get the chance to see my Dr |
| 1410114-1 | I had the vaccine on 01/20/2021 and in 03/12/2021 I went to the doctor for my 12 week check up and they said I probably miscarried 2 weeks before. I had a D&C. The delivery date would have been on September 20, other than that I have had a normal pregnancy. |