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From the 11/19/2021 release of VAERS data:

Found 2,686 cases where Vaccine is COVID19 and Symptom is Aborted pregnancy or Abortion or Abortion complete or Abortion early or Abortion incomplete or Abortion induced or Abortion late or Abortion missed or Abortion of ectopic pregnancy or Abortion spontaneous or Abortion spontaneous complete or Abortion spontaneous incomplete or Foetal cardiac arrest or Foetal death or Premature baby death or Premature delivery or Stillbirth

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Case Details (Sorted by Onset Date)

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VAERS ID: 1445039 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Abortion threatened, Haemorrhage, SARS-CoV-2 test, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20210613; Test Name: Ultrasound; Result Unstructured Data: Test Result:showed two bleeds around the amniotic sac
CDC Split Type: GBPFIZER INC2021735852

Write-up: Threatened abortion; Heavy bleeding; miscarriage; This is a spontaneous report from a consumer. This is a report received from a regulatory authority (RA). The regulatory authority report number is, GB-MHRA-WEB COVID-202106161747296680-PJILQ. Safety Report Unique Identifier GB-MHRA-ADR 25486765. A female pregnant patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 08Jun2021 as single dose for COVID-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing. Patient had not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: unknown) for COVID-19 immunization. On 12Jun2021, the patient experienced threatened abortion, miscarriage and heavy bleeding. The patient was hospitalized for threatened abortion from 12Jun2021 to an unknown date and hospitalization was prolonged due to the events. Clinical course included: the patient had heavy bleeding at 14 weeks pregnant. Diagnosed with threatened miscarriage on arrival at hospital. Admitted to inpatient unit overnight. Ultrasound in the morning showed two bleeds around the amniotic sac but baby ok. It did not know if any link to vaccine but have not experienced this in previous pregnancy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jun2021 (No - Negative COVID-19 test) and ultrasound scan: showed two bleeds around the amniotic sac on 13Jun2021. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of event threatened abortion was resolving and for rest of the events it was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1457716 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-06-12
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001939 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS, MYALGIA and PYREXIA in a 33-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001939) for COVID-19 vaccination. No Medical History information was reported. On 14-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 12-Jun-2021, the patient experienced ABORTION SPONTANEOUS (seriousness criteria disability and medically significant), MYALGIA (seriousness criterion disability) and PYREXIA (seriousness criterion disability). The delivery occurred on an unknown date, which was reported as Unknown. At the time of the report, ABORTION SPONTANEOUS, MYALGIA and PYREXIA was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment information was not reported. 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. Events reported as serious by regulatory authority. No additional information is expected. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Translation document received on 06JUL-2021 and does not contain any new information.; Sender''s Comments: 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. Events reported as serious by regulatory authority. No additional information is expected.


VAERS ID: 1459529 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002544 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Chills, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: This regulatory authority pregnancy case was reported by a physician and describes the occurrence of ABORTION SPONTANEOUS, PYREXIA and CHILLS in a 37-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002544) for COVID-19 vaccination. No Medical History information was reported. On 12-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Jun-2021, the patient experienced ABORTION SPONTANEOUS (seriousness criteria hospitalization, medically significant and congenital anomaly), PYREXIA (seriousness criteria hospitalization and congenital anomaly) and CHILLS (seriousness criteria hospitalization and congenital anomaly). On 14-Jun-2021, ABORTION SPONTANEOUS, PYREXIA and CHILLS had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Company Comment: Very limited information regarding these events has been provided at this time. No follow up is possible.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.


VAERS ID: 1532416 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-13
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (cold-like with some coughing, loss of taste and smell)
Allergies:
Diagnostic Lab Data: Test Date: 20201102; Test Name: Covid-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202100949326

Write-up: miscarriage in the 5th week of amenorrhea; This is a spontaneous report from a contactable consumer (patient) downloaded from the WEB, regulatory authority number FR-AFSSAPS-CF20211867. A 33-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 01Jun2021 (Lot Number: FD0785) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included COVID-19 from 02Nov2020 (30Oct2020, beginning of Covid symptoms, cold-like with some coughing. On 01Nov2020, loss of taste and smell. 05Nov2020, I regained my taste and smell. I didn''t have any other symptoms). The patient''s concomitant medications were not reported. On 13Jun2021, miscarriage in the 5th week of amenorrhea. The patient was pregnant since 22May2021. The patient was not aware of the pregnancy on the day of the injection. The outcome of event was not recovered. The mother reported she became pregnant while taking bnt162b2. The mother was 5 Weeks pregnant at the onset of the event. The mother was due to deliver on 22Feb2021. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included COVID-19 test: positive on 02Nov2020 No follow-up attempts possible. No further information expected.


VAERS ID: 1546468 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100969271

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107281335290040-RXBUP, and Safety Report Unique Identifier is GB-MHRA-ADR 25720232. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Ew3143), via an unspecified route of administration on 11Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included miscarriage, pregnancy: patient no longer pregnant at the time of reporting, and folic acid supplementation. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation. The patient experienced miscarriage on 13Jun2021 with outcome of recovered (as reported). Additional information: Did the medicine have an adverse effect on any aspect of the pregnancy: Yes. Pregnancy adverse effects details: Patient believed that she started a miscarriage 2 days after having her first vaccine. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient has not tested positive for COVID-19 since having the vaccine. Patient no longer pregnant at the time of reporting. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408436 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-05-24
Onset:2021-06-14
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Na
Current Illness: None
Preexisting Conditions: None
Allergies: Gluten Soy Shellfish
Diagnostic Lab Data: Didn''t have a chance
CDC Split Type:

Write-up: 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


VAERS ID: 1410849 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-16
Onset:2021-06-14
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027B21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood pressure decreased, Bone pain, Lethargy, Pain, Pain in extremity, Pregnancy test, Sleep disorder, Vaginal haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Osteonecrosis (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: On the day of vaccine administration, I had severe body aches and my bones were hurting. I was very lethargic and blood pressure was continuing to drop. I drank about 3 bottles of energy drink to bring the blood pressure back up. I also had severe arm pain; the pain was so intense I could not lay on my left side for 3 nights. Miscarriage 4 weeks after receiving second dose of Moderna Covid-19 Vaccine. HcG beta and progesterone blood tests completed 48 hours apart to classify this as a miscarriage. Patient is having heavy vaginal bleeding and is feeling very lethargic.


VAERS ID: 1505661 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-06-14
Onset:2021-06-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal heart rate abnormal, Foetal hypokinesia, Pain in extremity, Premature delivery, Pyrexia, Stillbirth, Ultrasound antenatal screen abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal Vitamins.
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: Full genetic panel, normal, March 2021; Gestational Diabetes testing, negative, March 2021; Ultrasounds, normal, every two weeks, December to July 2021.
CDC Split Type: vsafe

Write-up: Okay well, so within 24 hours was the typical, just sore arm and fever within the first 24 hours. My fever got up to like 101 degrees and I just took Tylenol to mitigate that. Then the next thing that happened was that I gave birth to my baby that didn''t have a heartbeat anymore, that was on July 22, 2021. Her original due date was October 4, 2021. I did have a history of fibroid removal surgery and had ultrasounds every two weeks up until that point, and they were negative for genetic issues, preeclampsia and diabetes. So I was scheduled for a C-section for the week around September 20th. But yea I had to deliver July 22, 2021, I noticed a lack of movement and they did an ultrasound and noticed no heartbeat. I did not have any other symptoms, I just noticed that there was no movement.


VAERS ID: 1553820 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-28
Onset:2021-06-14
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 1 AR / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0164 / 2 AR / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: TDAP 2018, 36 years old, swollen arm and fever, pregnant at the time
Other Medications: Rizatriptan Prenatal Vitamin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarriage at 10 weeks. At the time of receiving vaccine, I was about 2.5 weeks pregnant (had not tested positive for a pregnancy test yet but did shortly after). Spotting started at week 6 and continued. Fetal growth stopped at about 8.5 weeks.


VAERS ID: 1587085 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-10
Onset:2021-06-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Condition aggravated, Exposure during pregnancy, Immediate post-injection reaction, Muscle spasms, Pain, Ultrasound foetal abnormal, Vaginal discharge
SMQs:, Dystonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: pregnancy vitamins Omeprazole 20mg x2
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: Ultrasound for pregnancy confirmed pregnancy loss
CDC Split Type:

Write-up: 10/06/21 COVID-19 1st dose 14/06/21-18/06/21 Sharp pains on left side building up everyday. 18/06/21 heavy sharp pains, cramping front and back and brown gooey stretchy substance came out which felt like when you are passing clots and tissue during miscarriage. And then pains subsided over the next few days. Ultrasound confirmed pregnancy loss. Previous missed miscarriage Dec 2019 for reference (however COVID-19 didn?t exist then nor did I take any vaccines at that time. Please concentrate on the fact that I miscarried and got miscarriage pains right after I took the COVID-19 Jab, this is NOT a coincidence).


VAERS ID: 1657548 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-04-10
Onset:2021-06-14
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: ultrasound
CDC Split Type:

Write-up: First Trimester Miscarriage after post Vaccine. Confirmed by ultrasound.


VAERS ID: 1448662 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Dysmenorrhoea, Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Miscarriage; Heavy periods; Pain menstrual; This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 31-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. The patient''s past medical history included Lactation decreased and Miscarriage. On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Pain menstrual). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On 20-Jun-2021, HEAVY MENSTRUAL BLEEDING (Heavy periods) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) had resolved and DYSMENORRHOEA (Pain menstrual) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. The concomitant medications were not reported. The treatment information was not provided. It was reported that the patient was not tested positive for covid-19.Patient was not breastfeeding and was not enrolled in clinical trial. Very limited information regarding the events has been provided at this time. Additional information required. Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2021: The followup document was received on 27-JUN-2021 and had significant data. Added events Pain menstrual.; Sender''s Comments: Very limited information regarding the events has been provided at this time. Additional information required.


VAERS ID: 1449623 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Deep vein thrombosis, Depressed mood, Headache, Illness, Lip swelling, Malaise, Maternal exposure during pregnancy, Migraine with aura, SARS-CoV-2 test, Seizure, Syncope, Thrombosis, Uterine haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: blood clot; Unwell; Maternal exposure during pregnancy; Seizures; DVT of calf; Miscarriage; Lips swelling non-specific; Headache; Fainting; Uterine bleeding; Sickness; Migraine aura; Depressed mood; This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage), THROMBOSIS (blood clot), DEEP VEIN THROMBOSIS (DVT of calf), SYNCOPE (Fainting), UTERINE HAEMORRHAGE (Uterine bleeding), SEIZURE (Seizures), MALAISE (Unwell), ILLNESS (Sickness), MIGRAINE WITH AURA (Migraine aura), DEPRESSED MOOD (Depressed mood), LIP SWELLING (Lips swelling non-specific), HEADACHE (Headache) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Pregnancy. On 13-Jun-2021, the patient received first 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 14-Jun-2021, the patient experienced SYNCOPE (Fainting) (seriousness criteria hospitalization, medically significant and congenital anomaly), UTERINE HAEMORRHAGE (Uterine bleeding) (seriousness criteria hospitalization, medically significant and congenital anomaly), ILLNESS (Sickness) (seriousness criteria hospitalization and congenital anomaly), MIGRAINE WITH AURA (Migraine aura) (seriousness criteria hospitalization and congenital anomaly), DEPRESSED MOOD (Depressed mood) (seriousness criteria hospitalization and congenital anomaly) and HEADACHE (Headache) (seriousness criteria hospitalization and congenital anomaly). On 15-Jun-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria hospitalization, medically significant and congenital anomaly) and LIP SWELLING (Lips swelling non-specific) (seriousness criteria hospitalization and congenital anomaly). On 16-Jun-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT of calf) (seriousness criteria hospitalization, medically significant and congenital anomaly). On 18-Jun-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization, medically significant and congenital anomaly). On an unknown date, the patient experienced THROMBOSIS (blood clot) (seriousness criteria hospitalization, medically significant and congenital anomaly), MALAISE (Unwell) (seriousness criteria hospitalization and congenital anomaly) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criteria hospitalization and congenital anomaly). The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), DEEP VEIN THROMBOSIS (DVT of calf), SYNCOPE (Fainting), UTERINE HAEMORRHAGE (Uterine bleeding), SEIZURE (Seizures), ILLNESS (Sickness), MIGRAINE WITH AURA (Migraine aura), DEPRESSED MOOD (Depressed mood) and HEADACHE (Headache) had not resolved, THROMBOSIS (blood clot) and MALAISE (Unwell) was resolving, LIP SWELLING (Lips swelling non-specific) had resolved with sequelae and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications reported. The reporter stated that the patient had fainted at work and hospitalized for 5 days, She was miscarried 2 days after taking the vaccine and reporter stated that she did not take folic acid supplement during pregnancy, She was exposed to the medicine first-trimester (1-12 weeks). She had a scan after fainting and pregnancy was still in belly with heartbeat, 2 days later started bleeding and miscarried. She had a suspected blood clot in the leg. Treatment medication were not reported. Company Comment This report refers to a case of Maternal exposure of mRNA 1273 during pregnancy with reported adverse events of Abortion Spontaneous and other serious adverse events.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 report refers to a case of Maternal exposure of mRNA 1273 during pregnancy with reported adverse events of Abortion Spontaneous and other serious adverse events.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.


VAERS ID: 1464251 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Headache, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: Asma
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was only 6 weeks pregnant, had fever (37,5?C), headache, lots of pai the the arm I got the shot and body pain for 2 days. Took the vaccine on june 13th and on june 26th I figured that the baby was no longer alive and had stopped living in 6 weeks?


VAERS ID: 1491990 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-14
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Axillary pain, Chills, Discomfort, Ectopic pregnancy, Pain in extremity, Pyrexia, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage (Missed miscarriage in April 2021); Pregnancy; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021854230

Write-up: missed miscarriage; uncomfortable; Armpit pain/random sudden pain experienced in the armpit; Joint pain; Painful arm; arm pain at the vaccine site; Fever; Chills; ectopic pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107050018046750-G2PGC. Safety Report Unique Identifier GB-MHRA-ADR 25593319. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, then via an unspecified route of administration on 03Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included missed miscarriage in Apr2021, pregnancy from an unknown date, and ongoing pregnancy; folic acid supplementation. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient received first dose in May2021. Pregnancy on 14Jun2021, ectopic diagnosed 28Jun2021, second dose 03Jul2021. The patient experienced missed miscarriage on an unspecified date and maternal exposure during pregnancy. Random sudden pain experienced in the armpit, generalised joint pain in the back and neck on 04Jul2021 and pain in the arm all ongoing though arm pain at the vaccine site (03Jul2021) was improving. Fever and chills about 12 hours after vaccination (on 03Jul2021) resolved over night (on 04Jul2021). All symptoms mild though uncomfortable (unspecified date), reported because of the ectopic pregnancy. The patient became pregnant while taking BNT162B2. Patient was exposed to the medicine first-trimester (1-12 weeks). The pregnancy resulted in spontaneous abortion. Patient had not tested positive for COVID-19 since having the vaccine. Just diagnosed with an ectopic pregnancy being managed naturally. The outcome of events ectopic pregnancy reported as recovered, of events armpit pain and joint pain was not recovered, of painful arm and arm pain at the vaccine site was recovering, chills and fever was recovered on 04Jul2021, of other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1503065 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-14
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021874269

Write-up: Late miscarriage; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-2021084400. A 38-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 19May2021 (Batch/Lot Number: FA7082) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced late miscarriage on 14Jun2021. On 14Jun2021, fetal death in utero between 18 and 19 amenorrhea weeks, discovered at 20 amenorrhea weeks, during obstetrical follow-up consultation. This caused hospitalization (autopsy and assessment in progress). The patient was 2nd trimester pregnant at the onset of the event. The outcome of the event was recovering. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1514161 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: USG; Result Unstructured Data: Test Result:pregnancy stopped around 5 weeks; Comments: At the first ultrasound at 8 weeks it turned out that the pregnancy stopped around 5 weeks, very coincidental
CDC Split Type: NLPFIZER INC2021895898

Write-up: Miscarriage; Vaccination during 5th week of pregnancy; This is as spontaneous report received from a contactable consumer downloaded from the WEB. The regulatory authority report number NL-LRB-00617832. A 39-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 14Jun2021 (Batch/Lot Number: FC3098) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Jun2021, the patient was vaccinated during 5th week of pregnancy and experienced miscarriage on 15Jun2021. At the first ultrasound at 8 weeks (Jul2021) it turned out that the pregnancy stopped around 5 weeks, very coincidental confounding factors. The patient has no previous COVID-19 infection. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no Miscarriage Information or disabling information: Miscarriage Additional information ADR: Around the time I got the vaccination I was 5 weeks pregnant. At the first ultrasound at 8 weeks it turned out that the pregnancy stopped around 5 weeks, very coincidental confounding factors COVID-19 vaccine exposure during pregnancy week: 5 weeks COVID19 Previous COVID-19 infection: No Other diagnostic procedures: No


VAERS ID: 1516306 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Body mass index, Intermenstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body mass index; Result Unstructured Data: Test Result:13.97
CDC Split Type: FRPFIZER INC202100941335

Write-up: Miscarriage (pregnancy not known until then, assessed at 3 weeks); Metrorrhagia; This is a spontaneous report from a contactable Consumer (patient) downloaded from the WEB. This is the second of two reports. The first report is a report from the WEB FR-AFSSAPS-PA20211170. A 39-years-old pregnant female patient received bnt162b2 (COMIRNATY), intramuscular on 13Jun2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3 ML, SINGLE for covid-19 immunisation . The patient medical history was not reported.The patient recevied the first dose of Comiranty Batch/Lot number: Unknown on 30Apr2021 and developed Metrorrhagia.The patient''s concomitant medications were not reported. The patient experienced miscarriage (pregnancy not known until then, assessed at 3 weeks) (medically significant) on 21Jun2021 with outcome of recovered , metrorrhagia (intermenstrual bleeding) (non-serious) on 14Jun2021 with outcome of unknown. The mother reported she became pregnant while taking bnt162b2. The mother was 2 Weeks pregnant at the onset of the event. The mother was due to deliver on 07Mar2022. The patient underwent lab tests and procedures which included body mass index: 13.97 on unknown date . Last menstrual period :31May2021.Additional information:No history of COVID.No obstetric history No follow-up attempts are possible. Information about batch number cannot be obtained. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021905466 Same reporter/Same patient/Same product/Different dose/Different events


VAERS ID: 1520704 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-14
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Hyperthermia, Placental disorder, Ultrasound scan
SMQs:, Accidents and injuries (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage (2 spontaneous miscarriages)
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: Echo; Result Unstructured Data: Test Result:unusual placental appearance; Comments: normal fetal appearance but unusual placental appearance with multiple intraparenchymal lacunae
CDC Split Type: FRPFIZER INC202100915853

Write-up: Foetal death in utero; unusual placental appearance with multiple intraparenchymal lacunae; Hyperthermia; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-TS20212982. A 31-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 28May2021 (Batch/Lot Number: FA8016) as dose 1, single for covid-19 immunisation. The mother was due to deliver on 29Nov2021. Medical history included spontaneous miscarriages (2 spontaneous miscarriages). The patient''s concomitant medications were not reported. The patient experienced foetal death in utero on 14Jun2021. Hyperthermia after vaccination (2021). Echo on 14Jun2021: normal fetal appearance but unusual placental appearance with multiple intraparenchymal lacunae. 18Jun2021: fetal death in utero - hospitalized for suction aspiration. In total, fetal death in utero at 18 weeks amenorrhea at day 17 of dose 1 of bnt162b2 in a woman with history of spontaneous miscarriages. Therapeutic measures were taken as a result of foetal death in utero as suction aspiration. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1532936 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-06-14
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy (first pregnancy successful in 2019); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201227; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100943577

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107231521363560-FT2Y9, Safety Report Unique Identifier GB-MHRA-ADR 25699819. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (Lot Number: ET8885) as single dose for COVID-19 immunisation. Medical history included miscarriage, pregnancy (Patient no longer pregnant at the time of reporting), suspected COVID-19 from 26Dec2020 to an unknown date, unsure when symptoms stopped, first pregnancy successful in 2019. The patient''s concomitant medications were not reported. Patient did not take folic acid supplement during pregnancy. The patient previously took folic acid. Was ovulating around the time of vaccination, conceived two days before unknowingly. Had early miscarriage in week 6. The patient was pregnant while taking BNT162B2. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient experienced miscarriage on 14Jun2021. The pregnancy resulted in spontaneous abortion. The fetal outcome is neonatal death. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 27Dec2020. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event was recovered on unknown date. The reporter was unsure if the medicine had an adverse effect on any aspect of the pregnancy. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724540 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Investigation, Maternal exposure before pregnancy, SARS-CoV-2 test, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Investigation; Result Unstructured Data: Test Result:Missed miscarriage found out about 10.5 weeks b...; Comments: Missed miscarriage found out about 10.5 weeks butbaby measured 8 weeks 5 days; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 2021; Test Name: Scan; Result Unstructured Data: Test Result:7 week scan and everything was perfectly health...; Comments: 7 week scan and everything was perfectly healthy at that point
CDC Split Type: GBPFIZER INC202101176070

Write-up: Miscarriage; Exposed to medicine before pregnancy; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109072209302830-LERFZ. Safety Report Unique Identifier is GB-MHRA-ADR 25909542. A 28-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and expiry date not reported), via an unspecified route of administration on 14Jun2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was not enrolled in clinical trial. The patient had no symptoms associated with COVID-19 and was not breastfeeding at the time of the report. Concomitant medications included folic acid (MANUFACTURER UNKNOWN) for folic acid supplementation from an unknown date. On 09Aug2021, the patient experienced miscarriage; event was reported as serious, medically significant for congenital anomaly and which required hospitalization from unspecified date in 2021. The clinical course was reported as follows: The patient reported as it was unsure if the medicine has an adverse effect on any aspect of the pregnancy. The patient was exposed to the medicine before the pregnancy. This was patient''s first pregnancy. The patient had a healthy pregnancy at the beginning. The patient had 7-week scan and everything was perfectly healthy at that point and after that, the patient was suffered with a miscarriage. The patient was found out about that at 10.5 weeks that the baby was measured 8 weeks 5 days. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the event miscarriage was recovered with sequelae on unknown date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1834771 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-14
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood urine present, Maternal exposure during pregnancy, Pain in extremity, SARS-CoV-2 test, Urine analysis, Vaccination site bruising
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage (3 previous miscarriages and 2 live births); Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Urine test; Result Unstructured Data: Test Result:Unknown results; Comments: she tested my urine due to being 7 weeks pregnant
CDC Split Type: GBPFIZER INC202101400990

Write-up: Maternal exposure during pregnancy/Patient was exposed to the medicine first-trimester; blood in urine; arm hurt I went to the walk; Early miscarriage; a bruise appeared where I had been given the vaccine; This is a spontaneous report from a contactable consumer. This is the report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202110181024264180-2CM8L, Safety Report Unique Identifier GB-MHRA-ADR 26086041. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 31May2021 as a single dose for COVID-19 immunization. Medical history included pregnancy (Patient no longer pregnant at the time of reporting), abortion (3 previous miscarriages and 2 live births), and vitamin supplementation. The patient''s historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date for COVID-19 immunization. Concomitant medications included Folic acid taken for vitamin supplementation. Patient had not been tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced blood in urine, maternal exposure during pregnancy/patient was exposed to the medicine first-trimester, and arm hurt i went to the walk on an unspecified date, early miscarriage and a bruise appeared where i had been given the vaccine on 14Jun2021. The patient underwent lab tests and procedures which included sars-cov-2 test was negative (No - Negative COVID-19 test) and urine analysis: unknown results (she tested my urine due to being 7 weeks pregnant) on an unspecified date. The outcome of the event blood in urine was not recovered, early miscarriage was recovered on 21Jun2021, outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1545058 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-05-07
Onset:2021-06-15
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Abortion induced, Exposure during pregnancy, Ultrasound foetal abnormal, Uterine dilation and curettage
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: Sulpha drugs
Diagnostic Lab Data:
CDC Split Type:

Write-up: I received my first dose when I was 17 weeks pregnant and my 12 week anatomy scam was completely normal. I got my first shot on 7th May and second dose on 29th May. I went for a anatomy scan on 15th June when the baby was detected with congenital heart defect with a bad prognosis. I took the decision of terminating the pregnancy and the D&E was done on 23rd June at 24 weeks. EOD was 8th October, 2021. I told the representative that I don''t know if CHD was due to vaccine but I was asked to report it.


VAERS ID: 1578289 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-29
Onset:2021-06-15
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 6/24/2021 confirmed spontaneous abortion
CDC Split Type:

Write-up: Spontaneous abortion as of 6/17/2021. Due date of January 2022


VAERS ID: 1653576 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-06-01
Onset:2021-06-15
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Military       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tirosint, wellbutrin
Current Illness:
Preexisting Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was around 5/6 weeks when I got the shot. I started bleeding at work, went to ER, there was no heartbeat. Lost baby according to ultrasound at 6w3d. Est due date was Feb 15, 2022.


VAERS ID: 1468066 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-15
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021795522

Write-up: Early miscarriage; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB FR-AFSSAPS-2021077939. A 37-year-old pregnant female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: FD0785), intramuscular on 04Jun2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has no history of COVID-19 infection. The patient experienced early miscarriage on 15Jun2021, a medically significant event and reported as a congenital anomaly. The patient had vaccination against COVID without knowing she was pregnant; no mention of side effects after. The patient experienced miscarriage at 6 weeks of amenorrhea (pregnancy), on Day 12 after the 1st dose of the BNT162B2 vaccine. Consultation 12 days after vaccination, with the notion of absence of fetal cardiac activity. The fetal outcome is intrauterine death. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 15Jun2021. The patient recovered from the event, early miscarriage on an unknown date. No follow-up attempts possible. No further information expected.


VAERS ID: 1480528 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-15
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021818394

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient) downloaded from the WEB, regulatory authority number RO-NMA-2021-SPCOV11717. A 32-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FC0681), intramuscular on 28May2021 (at unknown age) as Dose 2, single, intramuscular on 07May2021 (Lot Number: EY2172) as Dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Case reference number RO-NMA-2021-SPCOV11717 is a spontaneous serious adverse reaction case reported by a Consumer. On 07May2021 the patient received the 1st dose of COMIRNATY. On 28May2021, the patient received the 2nd dose of COMIRNATY. On 15Jun2021, the patient experienced miscarriage. As a corrective therapy the patient done curettage. The Reporter considered that the adverse reactions "Caused/Prolonged hospitalization". According to the patient''s statement, the vaccine had been given in the first trimester of pregnancy. At the time of reporting, the outcome was: recovered/resolved with sequelae. In the reporter''s opinion the events were related to COMIRNATY. The patient was not diagnosed with SARS-CoV-2 infection before or after vaccination. The outcome of the event was recovered on 20Jun2021. Sender Comment: No consent obtained for contacting the treating physician for obtaining additional information regarding this case.


VAERS ID: 1504118 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-15
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Dysmenorrhoea, Heavy menstrual bleeding, Pulmonary embolism, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021880130

Write-up: clots; pregnant; painful with a significant and slightly worrying amount of blood; extremely heavy with large clots; Heavy periods/Prolonged periods; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory authority. Regulatory authority report number , Safety Report Unique Identifier . A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Jun2021 (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing, suppressed lactation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced clots (pulmonary embolism) (medically significant) on an unspecified date with outcome of recovering, pregnant (medically significant) on an unspecified date with outcome of recovering, heavy periods (medically significant) on 15Jun2021 with outcome of not recovered, prolonged periods (medically significant) on 15Jun2021 with outcome of not recovered, painful with a significant and slightly worrying amount of blood (dysmenorrhoea) (medically significant) on an unspecified date with outcome of unknown, extremely heavy with large clots (thrombosis) (medically significant) on an unspecified date with outcome of unknown.The clinical course was reported as follows: The period I had just under two weeks after the first Pfizer vaccine was exceptionally heavy and painful with a significant and slightly worrying amount of blood. This is very unusual for me as I have never in my life had a period like that. The second period after the first vaccine arrived about one week early and also extremely heavy with large clots. Clots have been so significant that I have had concerns about a failed pregnancy. Although not confirmed, but I have been trying to get pregnant and one clot was roughly the shape of a kidney bead and the size of a deflated/flattened golf ball. If this continues into my next cycle, I will have to see my GP.Additional information:Patient has not had symptoms associated with COVID-19,Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeedingPatient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1629932 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3134V1209 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Heavy menstrual bleeding, Inappropriate schedule of product administration, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101029021

Write-up: miscarriage; abdominal pain; heavy period with large solid pieces of fleshy blood; dose 1 on 14Jun2021 , dose 2 on 09Aug2021; Vaginal bleeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is RA-WEBCOVID-202108092020557690-3PSFA, Safety Report Unique Identifier RA-ADR 25776848. A 40-year-old female patient received First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jun2021 (Lot Number: EW3134V1209) as dose 1, single, second dose on 09Aug2021 (Lot Number: FD8813) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased, miscarriage. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient received dose 1 on 14Jun2021 , dose 2 on 09Aug2021, and experienced miscarriage and abdominal pain both on an unspecified date with outcome of unknown , vaginal bleeding on 15Jun2021 with outcome of recovered on 18Jun2021, heavy period with large solid pieces of fleshy blood on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Jul2021. All events were assessed as serious with medically significant. The clinical course was reported as follows: Vaginal bleeded, very heavy, never experienced this before, it was like having miscarriage- a heavy period with large solid pieces of fleshy blood. Also had abdominal pain with it- like bad period pain. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No relevant investigations done. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1630755 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101016364

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00651158. A 27-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Jun2021 (Lot Number: FC3143) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included COMIRNATY, DOSE 1, SINGLE on 09May2021 for COVID-19 immunisation. It was reported that patient was no longer pregnant at the time of reporting. The patient had miscarriage and absence of menstruation on 15Jun2021. The event was assessed as serious (medically significant). The patient was 6 weeks pregnant at the onset of the event. The outcome of the event was not recovered. Follow-up attempts are not possible. No further information is expected.


VAERS ID: 1633948 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Pregnancy, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; TRAMADOL HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pain; Fibromyalgia; Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: Scan; Result Unstructured Data: Test Result:Vital pregnancy with heartbeat visible; Comments: Vital pregnancy with heartbeat visible; Test Name: Scan; Result Unstructured Data: Test Result:baby''s heart stopped beating at 8 weeks; Comments: baby''s heart stopped beating at 8 weeks
CDC Split Type: GBPFIZER INC202101034216

Write-up: pregnancy; Pregnancy loss; Maternal exposure during pregnancy/Patient was exposed to the medicine first-trimester (1-12 weeks); This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108101015249130-NUHZN. Safety Report Unique Identifier GB-MHRA-ADR 25778576. This is a maternal report. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jun2021 (at the age of 31 years) (Batch/Lot Number: EY5456) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fibromyalgia, pregnancy (Patient no longer pregnant at the time of reporting), chronic pain and folic acid supplementation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medications included folic acid taken for folic acid supplementation; tramadol hydrochloride taken for chronic pain from an unspecified start date to 01Apr2021. The patient had a scan at 6 weeks showed a vital pregnancy with heartbeat visible and everything else progressing normally. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: scan at 12-week gestation showed that baby''s heart stopped beating at 8 weeks, which dates back to 5 days after the vaccine was administered. The patient experienced pregnancy on an unspecified date and pregnancy loss on 23Jul2021. The events were assessed as serious (caused congenital anomaly). The outcome of the event pregnancy was recovered and pregnancy loss was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1778388 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-15
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101285643

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer, received via web portal. This is a maternal report. A pregnant adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration, on an unspecified date, as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient diagnosed with COVID-19. It was unknown whether the patient had been tested for COVID-19, since the vaccination. On 15Jun2021, the patient experienced miscarriage. The mother reported she became pregnant while taking bnt162b2. The mother reported that she was 12 Weeks pregnant at the onset of the event. The mother reported that she was due to deliver in 27Dec2022. The patient was not received any treatment for event. Outcome of event was unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained.


VAERS ID: 1403517 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-05-13
Onset:2021-06-16
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Fatigue, Headache, Migraine, Pain, Pyrexia, SARS-CoV-2 antibody test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 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 t
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: 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.


VAERS ID: 1456681 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-30
Onset:2021-06-16
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021775088

Write-up: Miscarriage Conceived 1 week after the second vaccine.; This is a spontaneous report from a contactable consumer (patient herself). This is a maternal report. A 35-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported at the age of 35-year-old), dose 2 via an unspecified route of administration, administered in arm left on 30Apr2021 08:00 as single for COVID-19 immunisation. The patient had no medical history. The patient concomitant medications were not reported. The patient had no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported), dose 1 via an unspecified route of administration, on an unknown date as single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced miscarriage conceived 1 week after the second vaccine on 16Jun2021. Doctor confirmed miscarriage at 7.5 weeks (8.5 weeks after second vaccine). The mother reported she became pregnant while taking bnt162b2. The mother was 7 weeks pregnant at the onset of the event. The mother was due to deliver on 27Jan2022. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment medication was received for the event. Since the vaccination, the patient had not tested for COVID-19. The outcome of the event was resolving. Information on the lot/batch number has been requested. Follow up letter has been generated for further information.


VAERS ID: 1483732 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-02-25
Onset:2021-06-16
   Days after vaccination:111
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / -

Administered by: Private       Purchased by: ?
Symptoms: Blood test normal, Exposure during pregnancy, Premature delivery, Urine analysis normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenantals, iron, vit. D, 50 mg Zoloft
Current Illness: Na
Preexisting Conditions: Na
Allergies: Na
Diagnostic Lab Data: So far nothing has come back with any answers. Blood tests, urine tests, no signs of infection.
CDC Split Type:

Write-up: I was pregnant due October 26th 2021. This was my second pregnancy. My first, I went 42+ weeks and ended up having a csection. I ended up delivering my second born on 7/6/2021. He was 24 weeks old and 700 grams.


VAERS ID: 1632508 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-01-30
Onset:2021-06-16
   Days after vaccination:137
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Maternal exposure before pregnancy, Ultrasound antenatal screen abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: prenatal vitamins and folic acid
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: I went to the emergency room that night, and to the OB 3 days post the incident. In the emergency room they did bloodwork and ultrasound and in the OB office repeated bloodwork to confirm it has occured.
CDC Split Type:

Write-up: I had a miscarriage.


VAERS ID: 1675685 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-03-31
Onset:2021-06-16
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 AR / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chromosomal analysis, Pathology test, Stillbirth
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Pathology and chromosome tests following the delivery were performed
CDC Split Type:

Write-up: At the time of my COVID-19 vaccine on March 31st, I was nearly 27 weeks pregnant with my second child. Eleven weeks later on June 16th I went into the doctor for a routine sonogram to discover the baby no longer had a heartbeat and the next day (June 17) she was delivered stillborn.


VAERS ID: 1447734 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NITROFURANTOIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abortion spontaneous incomplete
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021737763

Write-up: Miscarriage; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-TPP37295679C971605YC1623841245426. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 16Jun2021 (at the age of 36 years old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included abortion spontaneous incomplete. Concomitant medication included nitrofurantoin from 02May2021 to 09May2021. The patient previously took dose 1 of bnt162b2 for COVID-19 immunisation. On 16Jun2021 12:40, the patient experienced miscarriage post second Pfizer vaccine. The event was considered medically significant. The mother reported she became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. Outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1475026 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Early miscarriage; Vaccine exposure during pregnancy; This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Early miscarriage) in a 40-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Jun-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 22-Jun-2021, the patient experienced ABORTION SPONTANEOUS (Early miscarriage) (seriousness criterion medically significant). On 16-Jun-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Early miscarriage) had not resolved. No concomitant medications were reported. No treatment medications were reported. This is a case of product exposure during pregnancy with associated AE of Spontanoeus abortion for this 40-year-old female. No further information is expected.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AE of Spontanoeus abortion for this 40-year-old female. No further information is expected.


VAERS ID: 1476656 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-06-16
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021803942

Write-up: exposure during pregnancy; Spontaneous abortion; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-748704. This is the first of two reports. This report describes events after 2nd vaccine dose. A 34-year-old female patient received BNT162B2 (COMIRNATY), via intramuscular, administered in arm left (also reported as left shoulder) on 15May2021 10:12 (Lot Number: FA5831) as dose 2, 0.3ML single for COVID-19 immunisation. The patient was pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, Solution for injection), on 24Apr2021 at 13:35 (Lot number: EX0893) as dose 1, single for COVID-19 immunisation and experienced no ADRs. On 16Jun2021, the patient experienced spontaneous abortion. On an unspecified date, patient experienced exposure during pregnancy. It was reported gestational age 11 weeks - at 8 weeks developing embryo at 6 weeks, development stopped. Impact on quality of life (9/10). The outcome of the event spontaneous abortion was recovered. Sender''s comments: Administration of the vaccine at 10:12. No follow-up attempts are possible. No further information is expected. Information about lot number has been obtained.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-2021886050 same patient, different vaccine dose


VAERS ID: 1530319 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Pregnancy test, Ultrasound scan
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELTROXIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Test Result: Positive ; Test Name: ultrassound; Result Unstructured Data: Test Result:Positive pregnancy was not yet able to detect a fe; Comments: Positive pregnancy was not yet able to detect a fetus on the ultrasound. We know from that that it was a very early pregnancy. Only thickened endometrium and positive tests.
CDC Split Type: NLPFIZER INC202100939999

Write-up: (early) Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the WEB. The regulatory authority number NL-LRB-00631698. A 33-year-old pregnant female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 12Jun2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunization. The patient''s medical history was not reported. Concomitant medication included levothyroxine sodium (ELTROXIN) taken for an unspecified indication, start and stop date were not reported. The patient had covid-19 vaccine exposure during pregnancy week: 5 on 12Jun2021 and experienced (early) miscarriage on 16Jun2021. It was further mentioned that a few days after the vaccination the patient started bleeding and that continued into a miscarriage. The fetus was ejected on Sunday the 20th. The mother reported she became pregnant while taking bnt162b2. The mother was 5 Weeks pregnant at the onset of the event. The patient underwent lab tests and procedures on unknown date which included pregnancy test: positive and ultrasound scan showed positive pregnancy was not yet able to detect a fetus on the ultrasound and it was known from that that it was a very early pregnancy. Only thickened endometrium and positive tests. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the criteria, the reaction (early miscarriage) was considered as serious. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: Summary of reporter''s comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no - (Early) Miscarriage - COVID-19 vaccine exposure during pregnancy week: 5 Previous COVID-19 infection: No


VAERS ID: 1541531 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Investigation, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: Blighted ovum; Result Unstructured Data: Test Result:Blighted ovum
CDC Split Type: GBPFIZER INC202100961985

Write-up: Miscarriage of pregnancy; Maternal exposure during pregnancy/Patient was exposed to the medicine first-trimester (1-12 weeks); This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107272305533260-ZPT7W, Safety Report Unique Identifier GB-MHRA-ADR 25717150. A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jun2021 (at the age of 31 years old) (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included pregnancy (Patient no longer pregnant at the time of reporting); folic acid supplementation. Patient has not tested positive for COVID-19 since having the vaccine. Not had a COVID-19 test. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation. The patient experienced maternal exposure during pregnancy (medically significant) on 16Jun2021, miscarriage of pregnancy (medically significant) in Jul2021. The mother reported she became pregnant while taking bnt162b2. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations included Blighted ovum. The outcome of the event miscarriage of pregnancy was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1634333 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Maternal exposure during pregnancy, SARS-CoV-2 test, Tension headache, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VITAMIN C; VITAMIN D
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Had a healthy pregnacy in 2018); Pregnancy (Estimated due date: 27Nov2021)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021776748

Write-up: Miscarriage; Headache tension; Vaginal bleeding; Shoulder soreness; Maternal exposure during pregnancy; This report from a contactable other hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202106161512496790-2E3U0, Safety Report Unique Identifier GB-MHRA-ADR 25532532. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW3143), via an unspecified route of administration on 16Jun2021 as dose 2, single for COVID-19 immunisation. Medical history included pregnancy estimated delivery on 27Nov2021. Details of previous pregnancies: Had a healthy pregnacy in 2018. Patient last menstrual period date is 17Feb2021. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. Concomitant medications included vitamin C (ascorbic acid) for pregnancy from 12May2021 to an unspecified stop date; calcium carbonate, colecalciferol for pregnancy from 12May2021 to an unspecified stop date. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient experienced maternal exposure during pregnancy (hospitalization, medically significant) on 16Jun2021 with outcome of unknown, headache tension (hospitalization, medically significant) on 19Jun2021 with outcome of recovered on the same day, shoulder soreness (hospitalization, medically significant) on 17Jun2021 with outcome of recovered on 18Jun2021, vaginal bleeding (hospitalization, medically significant) on 18Jun2021 with outcome of not recovered miscarriage (hospitalization, medically significant) on 07Jul2021 with outcome of unknown. The mother was 17 Weeks pregnant at the onset of the event. The patient underwent lab tests and procedures which included sars-cov-2 test: negative No - Negative COVID-19 test. Patient is unsure if vaccination had an adverse effect on any aspect of the pregnancy. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events spontaneous abortion, maternal exposure during pregnancy, tension headache, arthralgia, vaginal haemorrhage cannot be 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.


VAERS ID: 1638696 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101038808

Write-up: Miscarriage after Pfizer vaccination; Vaccination during 4th week of pregnancy; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB NL-LRB-00655585. A 29-years-old female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Jun2021 (Batch/Lot Number: FC3098) at the age of 29 years as Dose 1, single for covid-19 immunisation. Medical history included pregnancy. The patient''s concomitant medications were not reported. The patient had miscarriage after pfizer vaccination on 20Jun2021 and had vaccination during 4th week of pregnancy on 16Jun2021. The event spontanoeus abortion was assessed as medically significant by the reporter. The mother reported she became pregnant while taking bnt162b2. The mother was 4 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected..


VAERS ID: 1784557 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Injected limb mobility decreased, Menstrual disorder, Menstruation delayed, Ovulation delayed, Pregnancy test, Vaccination site inflammation, Vaccination site pain, Vaccination site warmth
SMQs:, Termination of pregnancy and risk of abortion (narrow), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Pregnancy test; Test Result: Positive
CDC Split Type: NLPFIZER INC202101270618

Write-up: Miscarriage of pregnancy; Ovulation delayed; Menstruation delayed; Cycle disturbed; Inflammatory reaction at the reaction site: heat, pain; Inflammatory reaction at the reaction site: heat, pain; Inflammatory reaction at the reaction site: heat, pain; Other reaction at or around the injection site: Stiff, unable to lift arm; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number NL-LRB-00659632. A 31-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: FC3098), via an unspecified route of administration on 15Jun2021 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced miscarriage of pregnancy in Sep2021, inflammatory reaction at the reaction site: heat, pain on 16Jun2021, other reaction at or around the injection site: stiff, unable to lift arm on 16Jun2021, ovulation delayed, menstruation delayed and, cycle disturbed on 19Jun2021. The patient underwent pregnancy test: positive on an unknown date in 2021. Additional information of the events per ADR were reported as follows: The patient''s ovulation and period came 6 days later than usual in her very regular 28-day cycle. Her ovulation was supposed to take place on 19Jun2021 but took place on 25Jun2021. It was also reported that her period came 2 days later than expected. Menstruation was expected 17 days after vaccination and came 19 days after vaccination. Her cycle was not normal yet. The 2nd cycle after the vaccination also lasted a few days longer. Before the vaccination, she had a very regular cycle of exactly 28 days for 2 years. Never a day earlier or a day later. On the 3rd cycle, she and her boyfriend have been trying to conceive for the first time in the past two years. She now had an early miscarriage (a clear positive test 1 day before NOD (No period day) and finally an early miscarriage 7 days late). The outcome of the events "Miscarriage", "Ovulation delayed", and "Menstruation delayed" was recovered on an unknown date, for "Inflammatory reaction at the reaction site: heat, pain" and "Other reaction at or around the injection site: Stiff, unable to lift arm" was recovered on 17Jun2021, while for "Cycle disturbed" was not recovered.


VAERS ID: 1446113 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-27
Onset:2021-06-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: miscarriage


VAERS ID: 1454858 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-01
Onset:2021-06-17
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Wellbutrin SR - 150 mg 1 time per day; SYnthryoid - 100 mcg one time a day; Lexapro - 10 mg once a day; Aderrol XR - 15 mg one time a day; Melatonin 10 mg ER - some days was taking Calcium with Vit D (don''t take it every night); magnesium
Current Illness: no
Preexisting Conditions: Thyroid Disorder
Allergies: Penicillin; Compazine
Diagnostic Lab Data: Two ultrasounds - June 7th and 17th.
CDC Split Type: vsafe

Write-up: I found out in May22nd that I had a positive pregnancy test - five weeks pregnant - 10 days later - symptoms subsided. June 7th - Ultrasound - dated at 5/1/2 weeks and I went back 8 days later - showed pregnancy was nonviable at that point. My miscarriage symptoms on the 17th. The miscarriage was pretty much completed that day and then I bled five or six days. No complications. I didn''t need any follow up care. I had miscarriage three and half years ago and there were complications for that. I met with my midwife a few days afterwards here now but they didn''t do an examination or blood draw. Pregnancy history - 13th pregnancy - 6 miscarriages and 7 live births. Estimated date of delivery - January 22, 2022


VAERS ID: 1452264 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021747148

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-APPCOVID-20210620144215, Safety Report Unique Identifier GB-MHRA-ADR 25506012. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 14Jun2021 (Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included miscarriage. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced miscarriage on 17Jun2021 with outcome of recovered with sequelae (stop date reported as 20Jun2021). No follow-up attempts are possible. Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1459347 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Lactation decreased; Miscarriage
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20200724; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Miscarriage; Maternal exposure during pregnancy; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002621) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Pregnancy (Patient no longer pregnant at the time of reporting.) and Folic acid supplementation. Concurrent medical conditions included Miscarriage and Lactation decreased. Concomitant products included FOLIC ACID for Folic acid supplementation. On 12-Jun-2021, the patient received first 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 17-Jun-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2020, SARS-CoV-2 test: no - negative covid-19 test Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not reported. Patient was exposed to the medicine first-trimester (1-12 weeks). Based on the current available information and temporal association between the use of the product and the start date of the event of spontaneous abortion, a causal relationship cannot be excluded. The causality for the event of maternal exposure during pregnancy remains as not applicable.; 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 of spontaneous abortion, a causal relationship cannot be excluded. The causality for the event of maternal exposure during pregnancy remains as not applicable.


VAERS ID: 1475781 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-06-17
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Nausea, Ultrasound foetal
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: Ultrasound; Result Unstructured Data: Test Result:pregnancy of uncertain viability; Test Date: 20210625; Test Name: Ultrasound; Result Unstructured Data: Test Result:confirmed miscarriage
CDC Split Type: GBPFIZER INC2021809829

Write-up: nausea; Miscarriage of pregnancy; miscarriage; This is a spontaneous report. A 32-year-old female patient received BNT162B2(COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration on 22May2021 as dose 1, single for COVID-19 immunisation. Medical history included pregnancy (Patient no longer pregnant at the time of reporting). Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. On an unspecified date, the patient experienced maternal exposure during pregnancy. On an unspecified date, the patient experienced nausea on an unspecified date with outcome of recovered on an unspecified date, miscarriage on 17Jun2021 with outcome of recovered on an unspecified date, miscarriage of pregnancy on an unspecified date with outcome of not recovered. The events were reported as serious, congenital anomaly by regulatory authority. Additional Information: Last menstrual period 24th April 2021. Received vaccine 22nd May 2021 with no apparent reaction/illness, except for mild nausea directly after vaccination. Strongly positive pregnancy test 25th May 2021. Ultrasound scan after light bleeding on 15th June 2021 showed pregnancy of uncertain viability, gestational sac appeared to be showing at about 4.5wks. Miscarriage occurred on 17th June 2021, confirmed by follow up ultrasound scan on 25th June 2021 which confirmed miscarriage was complete. Patient has not tested positive for COVID-19 since having the vaccine. Did the medicine have an adverse effect on any aspect of the pregnancy: Unsure. Details of previous pregnancies: Positive test for this pregnancy on 25th May 2021. 1 previous successful pregnancy (daughter born 4th Dec 2018). Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: First dose Pfizer vaccine received 22nd May 2021. Ultrasound scan on 15th June at 6wks+6 showed pregnancy of uncertain viability and follow up on 25th June confirmed miscarriage. No follow up attempts are needed, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1479663 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test, Scan
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Headache; Miscarriage (Details of previous pregnancies: miscarriage)
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: scans or investigations; Result Unstructured Data: Test Result:miscarriage; Comments: Details of scans or investigations: miscarriage.
CDC Split Type: GBPFIZER INC2021829240

Write-up: Miscarriage/8 Weeks pregnant at the onset of the event miscarriage.; This is a solicited report from a contactable consumer. This consumer reported information for both mother and fetus. This is the first of 2 reports, the mother report, which was received from the Regulatory Agency, regulatory authority report number is GB-MHRA-YCVM-202106061533299420-ANNEC, Safety Report Unique Identifier is GB-MHRA-ADR 25577703. A 31-year-old female patient (the mother) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jun2021 (Batch/Lot Number: EW3143) as single dose for COVID-19 vaccination. The mother''s medical history included headache; folic acid supplementation; and details of previous pregnancies: miscarriage. The mother has not had symptoms associated with COVID-19. The mother is not enrolled in clinical trial. The mother is not currently breastfeeding. Concomitant medications included folic acid taken for folic acid supplementation, start and stop date were not reported; and ibuprofen from 13Jun2021 to 13Jun2021 taken for headache. The mother was pregnant while taking bnt162b2 on 06Jun2021. The mother was exposed to the vaccine first-trimester (1-12 weeks). The mother''s last menstrual period date was 20Apr2021 and the mother was due to deliver on 25Jan2022. On an unspecified date, the fetus had congenital anomaly. On 17Jun2021, the mother experienced miscarriage, which was considered as serious due to Other medically important condition by the regulatory authority. The mother was 8 Weeks pregnant at the onset of the event miscarriage. The mother underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on 15May2021; and Details of scans or investigations: miscarriage on an unspecified date. The outcome of the event miscarriage was recovered on 01Jul2021. The mother has not tested positive for COVID-19 since having the vaccine. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information, the Company considers the reported event early miscarriage is unrelated to BNT162B2 vaccination, but more likely an inter-current medical condition in this 31-year-old female patient with medical history of miscarriage.,Linked Report(s) : GB-PFIZER INC-2021892891 fetus case


VAERS ID: 1493521 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0574 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac arrest, Maternal exposure during pregnancy, Stillbirth
SMQs:, Congenital and neonatal arrhythmias (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC2021840467

Write-up: that my baby''s heart had stopped; baby was born without life with 3.3 kg; I received the vaccine on 17Jun/ I was with 37 weeks and 4 days of gestation; This is a spontaneous report from a contactable consumer or other health care professional (Parent) reported information for both mother and foetus/baby received from the Medical Information Team. This is a foetus/baby report. A foetus female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number and expiration date was not reported), via transplacental route of administration on 17Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Mother of patient received the vaccine on 17Jun and was 41 years old with 37 weeks and 4 days of gestation. On the day after the vaccination, Mother of patient felt very tired and unfortunately on the day 20Jun (Day in which 38 weeks of gestation would be completed) found out that her baby heart had stopped, probably from Friday to Saturday even she had a perfect gestation, baby was born without life with 3.3 kg. The placental analysis signals thrombus and waiting for the health plan to release my genetic exams of thrombophilia, but she believes it is important to report the case to you, so other pregnant women does not take risk, because in her heart the vaccine could have caused the reported issue. At the moment Mother of patient was using anticoagulant, for safety as well, due to the placental condition, and she was super insecure regarding receiving the second dose and hopes that soon she can have a better clarification about this fact, but she leaves here report, with a lot of pain in the heart. It was not reported if an autopsy was performed. The outcome of events baby heart had stopped and baby was born without life with 3.3 k was fatal and outcome of maternal exposure during pregnancy, third trimester was unknown.; Sender''s Comments: Linked Report(s) : BR-PFIZER INC-2021830714 Mother-Baby Case; Reported Cause(s) of Death: that my baby''s heart had stopped/ my baby born without life


VAERS ID: 1516560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021906924

Write-up: Miscarriage of pregnancy; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202107152145205660-SBTFE, Safety Report Unique Identifier GB-MHRA-ADR 25660003. A female pregnant patient received 2nd dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration at single dose on 17Jun2021 (batch/lot number was not reported) for COVID-19 immunization. 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. The patient experienced miscarriage of pregnancy on 24Jun2021 with outcome of recovered on 30Jun2021. Obviously, she couldn''t tell for sure that the vaccination caused the miscarriage, but a few women have told her they had heavy period bleeding after it and so she wanted to report it in case it helped others. The case was reported as non-serious. The patient underwent lab tests and procedures which included covid-19 virus test: no - negative covid-19 test on an unspecified date. 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. No further information is expected.


VAERS ID: 1676506 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage of pregnancy) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Jun-2021, the patient received first 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 17-Jun-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). On 13-Jul-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ABORTION SPONTANEOUS (Miscarriage of pregnancy) (seriousness criterion medically significant). The delivery occurred on 13-Jul-2021, 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 (Miscarriage of pregnancy) was resolving and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. No relevant concomitant and treatment medications were reported Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Company Comment: This is a case of product exposure during pregnancy with associated AE of spontaneous abortion for this female patient. 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. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow-up received contains significant information. Action taken with the drug is updated.Outcome of the event Maternal exposure during pregnancy is updated to Unknown. Case outcome is updated.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AE of spontaneous abortion for this female patient. 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.


VAERS ID: 1778131 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-17
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101325208

Write-up: Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110052019265890-FQUZY, Safety Report Unique Identifier GB-MHRA-ADR 26040189. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 28May2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced miscarriage of pregnancy (hospitalization, medically significant, life threatening) on 17Jun2021 with outcome of recovering. The mother reported she became pregnant while taking BNT162B2.The pregnancy resulted in spontaneous abortion. The fetal outcome is neonatal death. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1453727 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-06-10
Onset:2021-06-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Pregnancy test
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Test Result: Positive ; Test Name: pregnancy test; Test Result: Positive
CDC Split Type: USPFIZER INC2021750235

Write-up: Early Miscarriage the week following the second vaccine- following 2 previous positive pregnancy tests; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right at age of 31 years on 10Jun2021 11:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included diagnosed with COVID-19 Prior to vaccination. The patient''s concomitant medications were none, no any other vaccines within 4 weeks prior to the COVID vaccine; no any other medications the patient received within 2 weeks of vaccination. The patient previously took BNT162B2 dose 1 in left arm at age of 31 years on 21May2021 13:00. The patient experienced early miscarriage on 18Jun2021 17:00 the week following the second vaccine- following 2 previous positive pregnancy tests (Seriousness criteria reported as congenital anomaly/birth defect). Last menstrual date was 19May2021 and due to deliver on 22Feb2022. Since the vaccination, patient has not been tested for COVID-19. No treatment was received. The outcome of the event was recovered with sequelae in Jun2021. Information on the lot/batch number has been requested.


VAERS ID: 1523450 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-03-10
Onset:2021-06-18
   Days after vaccination:100
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy, Pregnancy, Pregnancy test positive, Ultrasound pelvis abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clonazepam -.5mg (as needed) Xyzal - as needed
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: Cephalexin
Diagnostic Lab Data: Pelvic ultrasound
CDC Split Type:

Write-up: Miscarriage - 6/18/21 Positive pregnancy test in early May, EDD was January 9th, 2022 Last dose received on 3/31


VAERS ID: 1526490 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-01-31
Onset:2021-06-18
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9262 / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Amniotic membrane rupture test, Caesarean section, Exposure during pregnancy, Foetal heart rate deceleration abnormality, Premature delivery, Preterm premature rupture of membranes, Ultrasound antenatal screen
SMQs:, Congenital and neonatal arrhythmias (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Levothyroxine; prenatal vitamin
Current Illness: no
Preexisting Conditions: no
Allergies: sulfa drugs
Diagnostic Lab Data: Hospital - Evergreen Medical Center - Testing - they did a test to make sure it was amniotic fluid; ultrasound - to make sure there wasn''t anything amiss with pregnancy. They checked amniotic fluid levels. Was treated with steroids, magnesium for neural protection for baby and antibiotics...and the goal was to carry to 36 weeks. I had a C-section due to fetal intolerance of labor with baby''s heart rate having deceleration.
CDC Split Type: vsafe

Write-up: I had pre-term rupture of membranes. At June 18th - 33 weeks and three days gestation. Admitted (19th) until the delivery of baby at 34 weeks and four days gestation. My baby is healthy and fine. Did have to spend 2 weeks in Neonatal unit.- Baby fine now. Pregnancy history: Prior to this pregnancy- 2 previous pregnancies - both ended miscarriages. This baby was conceived by IVF. June 26th was the actual date of birth for this baby. Baby was discharged July 8th. I had one doctor''s appt to take out my stitches. 6 week postpartum on the 12th of August.


VAERS ID: 1685593 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-03-31
Onset:2021-06-18
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BR8134 / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Anembryonic gestation, Ultrasound scan vagina abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Xyzal (not taken on vaccination days)
Current Illness:
Preexisting Conditions: Eczema
Allergies: Cephalexin
Diagnostic Lab Data: June 10 - vaginal ultrasound
CDC Split Type:

Write-up: Blighted ovum (miscarriage); found out I was pregnant on May 8, 2021; learned of blighted ovum via vaginal ultrasound on June 10, 2021; completed miscarriage on June 18th, 2021; menstrual cycle returned on July 23rd, 2021.


VAERS ID: 1523780 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002616 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Pain in extremity
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: maternal exposure during pregnancy; Abortion spontaneous; Pain in leg; This regulatory authority retrospective pregnancy case was reported by a health care professional and describes the occurrence of ABORTION SPONTANEOUS (Abortion spontaneous) in a 37-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002616) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jun-2021, the patient experienced ABORTION SPONTANEOUS (Abortion spontaneous) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in leg). On 09-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Abortion spontaneous) and PAIN IN EXTREMITY (Pain in leg) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Sender''s (Case) Safety Report Unique Identifier= FR-AFSSAPS-TO20215740 No concomitant medication details was provided. No treatment medication details was provided. This is a case of product exposure during pregnancy with the associated AEs of abortion spontaneous and pain in extremity for this 37-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. The causality for maternal exposure during pregnancy is not applicable. Further information is not expected.; Sender''s Comments: This is a case of product exposure during pregnancy with the associated AEs of abortion spontaneous and pain in extremity for this 37-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. The causality for maternal exposure during pregnancy is not applicable. Further information is not expected.


VAERS ID: 1547365 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100965413

Write-up: Miscarriages, not safely related to vaccination but miscarriages 5 days later (bleeding already occurred the day after vaccination); bleeding already occurred the day after vaccination; On 21Jun2021 the patient experienced miscarriages, she was not sure if related to vaccination but miscarriages 5 days later (medically significant), and bleeding already occurred the day after vaccination with onset 18Jun2021. The mother was due to d; This is a spontaneous report from a non-contactable consumer reporting about herself. A 36-years-old pregnant female patient received bnt162b2 (COMIRNATY, solution for injection; Lot Number: FA8016), dose 1 via an unspecified route of administration, administered in Arm Left on 17Jun2021 (Age at vaccination 36 years old) as DOSE 1, SINGLE for covid-19 immunisation. Patient had no known allergies, no relevant medical history and no concomitant medications. The patient had not received any other vaccine within 4 weeks. On 21Jun2021, the patient experienced miscarriages, she was not sure if related to vaccination but miscarriages 5 days later and bleeding already occurred the day after vaccination with onset 18Jun2021. The mother was due to deliver on 19Feb2022. Last menstrual date was 14May2021. The fetal outcome was neonatal death. Patient received no treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of events was unknown. No Follow-up attempts are possible. No further information is expected.


VAERS ID: 1575279 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Amniotic fluid volume decreased, Stillbirth
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202100986134

Write-up: It was necessary to deliver my baby by caesarean section and my son did not survive; water broke / making me stay liquid 0; This is a spontaneous report from a contactable consumer (patient herself) via regulatory authority. A pregnant 24-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in right arm, at age 24 years, on 11Jun2021 10:45 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history includes COVID-19 on an unspecified date prior to vaccination and is pregnant until 18Jun2021. Patient last menstrual date was on 07Dec2020. Patient was not allergic to any medications, food or other products. Concomitant medication included folic acid taken for pregnancy, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Delivery date was expected to be on 19Sep2021, gestation period was 26 weeks. Patient took the first dose of the Pfizer vaccine on 11Jun2021 10:45 am, so far, her pregnancy was calm, complete prenatal care. She was doing the correct monitoring and also taking folic acid for pregnancy, that is, everything as ordered her physician. It was exactly 7 days later after applying the first dose of vaccine that her water broke. It broke on 18Jun2021 at 5:00 am in the morning, making me stay liquid 0. It was necessary to deliver her baby by caesarean section, emergency caesarean delivery and her son did not survive on 18Jun2021 at 05:15 am. Patient was hospitalized for 4 days from 2021 to 2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit/ emergency room/department or urgent care / hospitalization. Since the vaccination, patient has not been tested for COVID-19. She was reporting to other mothers to not go through what she went through. The pain that she felt was so big that she could not even come here before. At the time of reporting, has been 43 days after giving birth and she does not have her baby in her arms. She cannot say that 100% was the reaction of vaccine, but she reported with tears in the eyes so investigate and not let it happen to other women. The outcome of the events was recovering (as reported) at the time of report. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : BR-PFIZER INC-202100992639 mother / fetus case


VAERS ID: 1588720 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-18
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Menstrual disorder
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101003423

Write-up: Cycle shift and miscarriage; Cycle shift and miscarriage; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority number is DE-PEI-CADR2021113336 with Sender''s Safety Report Unique Identifier: DE-PEI-202100109342. A 30-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient was pregnant at time of vaccination. The patient''s weight was 66 kg, and height was 164 cm. Medical history was not reported. No concomitant medications were reported. Historical vaccine included BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. On 18Jun2021, the patient experienced cycle shift and miscarriage. This report is serious - hospitalization. The outcome of the event was recovered/resolved with sequelae. Sender Comment: Information on risk factors or previous illnesses. None. Missed abort after two vaccinations. The HA assessed the causal relationship between bnt162b2 (COMIRNATY) and the reported events as Unclassifiable.


VAERS ID: 1824142 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004955 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Pain in extremity
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: MISCARRIAGE; pain in the arm; MATERNAL EXPOSURE DURING PREGNANCY; This case was received via regulatory authority (Reference number: SE-MPA-2021-087740) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (MISCARRIAGE), PAIN IN EXTREMITY (pain in the arm) and MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004955) for COVID-19 vaccination. No Medical History information was reported. On 18-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jun-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) (seriousness criterion medically significant). On 06-Aug-2021, the patient experienced ABORTION SPONTANEOUS (MISCARRIAGE) (seriousness criterion medically significant) and PAIN IN EXTREMITY (pain in the arm) (seriousness criterion medically significant). The delivery occurred on 06-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 18-Jun-2021, MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) had resolved with sequelae. At the time of the report, ABORTION SPONTANEOUS (MISCARRIAGE) and PAIN IN EXTREMITY (pain in the arm) had resolved with sequelae. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant and treatment medication were provided Company Comment: This is a Regulatory pregnancy case concerning a 39 year old female patient with no relevant medical history who was exposed to mRNA-1273 during pregnancy and experienced an unexpected serious event of spontaneous abortion. The patient received first dose of mRNA-1273 vaccine at 3 weeks of gestation. Spontaneous abortion occurred approximately 1.5 months after vaccination with first dose of mRNA-1273 at 9 weeks of gestation. The benefit-risk relationship of mRMA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Translation document received on 20-OCT-2021 contains significant info with regards to Dose; Sender''s Comments: This is a Regulatory pregnancy case concerning a 39 year old female patient with no relevant medical history who was exposed to mRNA-1273 during pregnancy and experienced an unexpected serious event of spontaneous abortion. The patient received first dose of mRNA-1273 vaccine at 3 weeks of gestation. Spontaneous abortion occurred approximately 1.5 months after vaccination with first dose of mRNA-1273 at 9 weeks of gestation. The benefit-risk relationship of mRMA-1273 is not affected by this report.


VAERS ID: 1446560 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-01-23
Onset:2021-06-19
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-07-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3302 / UNK RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Foetal placental thrombosis, Placental disorder, Premature delivery, SARS-CoV-2 test negative, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins, loratafine
Current Illness: None
Preexisting Conditions: None
Allergies: Nka
Diagnostic Lab Data: Maternal COVID test negative at time of delivery. No signs of infection in baby. Slightly elevated white blood cell count (14) on mom. Placenta showed acute subchorionitis grade 1 stage 1 and chorionic villi with hypomature villious morphology.
CDC Split Type:

Write-up: First pregnancy, low risk under midwife care, no genetic anomalies detected, due date oct 4 2021, spontaneous delivery on June 19 2021. Birth weight 790g, survived and receiving care at NICU.


VAERS ID: 1501798 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2020-12-29
Onset:2021-06-19
   Days after vaccination:172
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mirena IUD
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarriage. Bleeding started June 19. Lasted 2+ weeks. Pregnancy confirmed with urine sample and blood work and ultrasound at 5weeks 5 days at ER in Hospital June 22,2021. HHG the following week confirmed loss of pregnancy.


VAERS ID: 1647094 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-10
Onset:2021-06-19
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0151 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Menstruation delayed, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Ultrasound; Result Unstructured Data: Test Result:unknown result
CDC Split Type: USPFIZER INC202101041339

Write-up: maybe miscarriage; 2 months after my second vaccine shot - 17 days late period; after delay whole month heavier flows with big clots; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151), via an unspecified route of administration in Arm Left on 10Apr2021 at 15:00 (at 40 years) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies. Not pregnant at vaccination time. Previously on 20Mar2021 at 15:00 patient received first dose of bnt162b2 (BNT162B2; Lot Number: EP7534, at 40 years), in Arm Left for covid-19 immunisation.On 19Jun2021, 2 months after the second vaccine shot, she had 17 days late period, which was unusual, maybe miscarriage, and after delay whole month heavier flows with big clots. Events caused doctor or other healthcare professional office/clinic visit. Ultrasound was done on an unspecified date in 2021, no result reported. Treatment included birth control pills (as reported). Outcome of the events was not recovered


VAERS ID: 1449607 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-19
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Injection site erythema, Injection site pain, Lymphadenopathy, Maternal exposure during pregnancy, Neck pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Pregnancy; Comments: Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Miscarriage; Maternal exposure during pregnancy; Injection site pain; Injection site redness; Fatigue; Swollen glands; Neck pain; This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Injection site redness), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen glands) in a 35-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. Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not currently breastfeeding. The patient''s past medical history included Miscarriage and Pregnancy. Concomitant products included FOLIC ACID for Folic acid supplementation. On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced NECK PAIN (Neck pain), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant), INJECTION SITE ERYTHEMA (Injection site redness) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown, NECK PAIN (Neck pain), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen glands) had not resolved and INJECTION SITE PAIN (Injection site pain) and INJECTION SITE ERYTHEMA (Injection site redness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment drug information was not given. Company Comment: 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: 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.


VAERS ID: 1488415 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-19
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Rash erythematous, Serology test, Stillbirth
SMQs:, Anaphylactic reaction (broad), Termination of pregnancy and risk of abortion (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Delivery (first pregnancy, live birth of healthy, eutrophic, full term child); Psoriasis
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: serology; Result Unstructured Data: Test Result:Herpes old immunity; Comments: Parvovirus, negative chickenpox
CDC Split Type: FRPFIZER INC2021868323

Write-up: Itchy erythematous macular rash; still birth; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-MA20212455 Safety Report Unique Identifier FR-AFSSAPS-2021081867. This physician reported information for both mother and fetus/baby This is second of two reports, for the mother. A 33-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FC0681), dose 1 via an unspecified route of administration on 25May2021 (at the age of 33 years old) as single dose for covid-19 immunization. Medical history included psoriasis, delivery in 2018 (first pregnancy, live birth of healthy, eutrophic, full term child). The patient''s concomitant medications were not reported. The patient experienced itchy erythematous macular rash (medically significant) on an unspecified date, treated by levocetirizine dihydrochloride (XYZALL 5) and betamethasone dipropionate (DIPROSONE). She was vaccinated on 25May2021 at 28 amenorrhea weeks on 25May2021. Mother was pregnant while taking bnt162b2. The mother was 31 Weeks pregnant at the onset of the event. The mother was pregnant with 1 baby. The mother was due to deliver on 27Jul2021. The mother delivered the pregnancy on 19Jun2021. The baby weighed 2120 grams. The pregnancy resulted in still birth. The fetal outcome was intrauterine death. The patient underwent lab tests and procedures which included serology: herpes old immunity in 2021 with Parvovirus, negative chickenpox. The outcome of events was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021843042 baby case


VAERS ID: 1500328 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Ultrasound scan
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Echo; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: NLPFIZER INC2021864868

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00606599. A 30-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: FC3098), via an unspecified route of administration, on 16Jun2021, as dose 1, 0.3 mL, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 19Jun2021 (3 days after vaccination), the patient experienced miscarriage (other medically important condition) and maternal exposure during pregnancy following administration of COVID-19 vaccine Pfizer injection. The miscarriage (spontaneous abortion, fetal outcome was intrauterine death) occurred at a pregnancy duration of about 5 weeks. This was the first COVID-19 vaccination, which took place at a pregnancy duration of about 5 weeks. Miscarriage was treated with echo (also reported as diagnostic procedure with unknown results) in 2021. The outcome of the event was unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the HA criteria, the reaction (miscarriage) was considered as serious by the regulatory authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1525421 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-19
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal growth restriction
SMQs:, Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100924702

Write-up: Abortion spontaneous; Foetal growth restriction; This is a spontaneous report from a contactable other health professional via the Regulatory authority report number is 584530. A 43-year-old female patient received bnt162b2 (COMIRNATY), 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 patient experienced abortion spontaneous on 19Jun2021, foetal growth restriction on 19Jun2021. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1585124 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (1 child born in term in 2016)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100990338

Write-up: Miscarriage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority report number FR-AFSSAPS-PO20213817. A 31-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 09Jun2021 (Lot Number: FD0168) as dose 1, 0.3 ml, single for COVID-19 immunisation. Medical history included pregnancy in 2016 (1 child born in term in 2016). The patient''s concomitant medications were not reported. On 19Jun2021 the patient experienced spontaneous miscarriage at 6 weeks of pregnancy. The patient did not know she was pregnant. The outcome of event was recovered on 19Jun2021. No follow-up attempts are needed. No further information is expected


VAERS ID: 1586482 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5833 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage (Second miscarriage in a row when I already have 3 children.); Pregnancy (Second miscarriage in a row when I already have 3 children.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101010231

Write-up: blood loss; Miscarriage on 29Jun2021 at 3 months pregnant. The gynecologist places the stop of development of the embryo at about ten days before 29Jun2021.; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-102920. A 35 years old female patient received second dose of BNT162B2 (Comirnaty, solution for injection, lot number: FC5833) on 14Jun2021 at single dose via an unspecified route of administration for COVID-19 immunization. The patient was at 1st trimester of pregnancy at time of vaccination. The patient already have 3 children. On 29Jun2021 at 3 months pregnant the patient experienced miscarriage with blood loss. It was informed that this is a second miscarriage in a row when she already had 3 children). The gynecologist places the embryo at a standstill ten days before 29Jun2021. At the time of the reporting the patient had not yet recovered from events.


VAERS ID: 1709982 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-19
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Foetal hypokinesia, SARS-CoV-2 test, Stillbirth, Ultrasound scan
SMQs:, Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MESALAZINE; FOLIC ACID; PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Inflammatory bowel disease (Taking medicines for inflammatory bowel disease); Pregnancy; Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Date: 20201022; Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: ultrasound; Result Unstructured Data: Test Result:the baby, fluid and cord flow
CDC Split Type: GBPFIZER INC202101191534

Write-up: fetal movements reduced; Stillbirth; This is a spontaneous report from a contactable consumer. This is a report received from the the regulatory authority report number is GB-MHRA-WEBCOVID-202109112001135070-KJBAQ, Safety Report Unique Identifier GB-MHRA-ADR 25928702. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27May2021 (Lot Number: EW3143) as dose 1, single for COVID-19 immunisation. Medical history included pregnancy, patient no longer pregnant at the time of reporting, inflammatory bowel disease, and colitis ulcerative. Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included mesalazine taken for colitis ulcerative from 2012; folic acid taken for folic acid supplementation, pregnancy; ascorbic acid, betacarotene, biotin, calcium pantothenate, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, magnesium, nicotinamide, phytomenadione, pyridoxine hydrochloride, riboflavin, selenium, thiamine mononitrate, tocopheryl acid succinate, zinc (PREGNACARE ORIGINAL) taken for pregnancy from Nov2020. Patient was exposed to the medicine Third-trimester (29-40 weeks). In the morning of 10Jun2021, patient attended maternity triage at the hospital for reduced foetal movements, after a quiet early morning. The baby started moving when was hooked up to the CTG, but there was a reduction in fundal height from 33cm (as recorded during regular monitoring on 06Jun2021) to 31cm, when she was exactly 34 weeks on 10Jun2021 and so forecast to be 34cm. After good movements from the baby for the rest of Thursday and all day Friday, she was more subdued on the Saturday. At a regular midwife appointment on Sunday 13Jun2021 (at 34+3) no heartbeat could be found. Patient was walked to maternity triage and this was confirmed by a further midwife and three doctors, including ultrasound checks of the baby, fluid and cord flow. Patient was induced and gave birth at 05:01 on 19Jun2021 at 35+2. Patient has not tested positive for COVID-19 since having the vaccine. The patient has a negative COVID-19 virus test. Stillbirth 2 weeks after first doze of Pfizer Covid-19 Vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1714581 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test; Test Name: scan; Result Unstructured Data: Miscarriage
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Early miscarriage; Maternal exposure during pregnancy; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25918511) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Early miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was reported. Concomitant products included FOLIC ACID for Folic acid supplementation. On 19-Jun-2021, the patient received first 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 19-Jun-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion hospitalization). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Early miscarriage) (seriousness criteria hospitalization and medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 19-Jun-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Early miscarriage) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. On an unknown date, Scan: miscarriage (abnormal) Miscarriage. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was exposed to the medicine first-trimester (1-12 weeks). Treatment medications was not provided by the reporter. Company comment: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the unexpected events of Maternal exposure during pregnancy and Spontaneous abortion. The patient received the first dose of vaccine during the fist trimester of pregnancy. Spontaneous abortion occurred on an uknown date. Very limited information has been provided at this time.; Sender''s Comments: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the unexpected events of Maternal exposure during pregnancy and Spontaneous abortion. The patient received the first dose of vaccine during the fist trimester of pregnancy. Spontaneous abortion occurred on an uknown date. Very limited information has been provided at this time.


VAERS ID: 1413508 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-01-04
Onset:2021-06-20
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2021-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Work       Purchased by: ?
Symptoms: Echocardiogram, Exposure during pregnancy, Premature delivery
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine
Current Illness: Back pain associated with pregnancy
Preexisting Conditions: Hypothyroidism
Allergies: No
Diagnostic Lab Data: Echo 6/13/21
CDC Split Type:

Write-up: Twin pregnancy, due date 7/4/2021. Twin B born on date diagnosed with moderate sized mid muscular VSD at birth


VAERS ID: 1752851 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-01-23
Onset:2021-06-20
   Days after vaccination:148
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 029L20A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016M20A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Emotional distress, Human chorionic gonadotropin positive, Ultrasound uterus abnormal
SMQs:, Tumour markers (narrow), Depression (excl suicide and self injury) (broad), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OTC multivitamins
Current Illness: None
Preexisting Conditions: None
Allergies: Bactrim
Diagnostic Lab Data: FIRST TRIMESTER MISCARRIAGE CONFIRMED POST VACCINE BY ULTRASOUND AND Beta HCG. Patient is recovering from physical and emotional trauma. Will continue to follow.
CDC Split Type:

Write-up: Miscarriage, 06/20/2021


VAERS ID: 1759060 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-05-13
Onset:2021-06-20
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 2 AR / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 1 AR / SYR

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Atrial fibrillation, Exposure during pregnancy, Loss of personal independence in daily activities, Palpitations, SARS-CoV-2 test negative, Sleep disorder, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Pfizer Covid vaccine - Dose 1, miscarriage on 4/23/2021 after 4/21/2021 vaccine. Age 37 at vaccination
Other Medications: Advair
Current Illness: Miscarriage 2 days after (4/21/2021) first dose of vaccine, on 4/23/2021; Oral thrush (result of use of Advair) about 6/1/2021 requiring treatment
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: ECG''s (8/31/2021 and 9/9/2021), Echocardiogram (9/27/2021), Holter monitor (worn 9/9/2021 to 9/23/2021)
CDC Split Type:

Write-up: Heart palpitations, tachycardia, disturbed sleep (every night) due to atrial fibrillation, severely impacted physical activity (unable to perform basic daily routine). Symptoms worsened in August - October and are ongoing with no explanation. 3 Covid tests from May to Sep were all negative.


VAERS ID: 1462208 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8289 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021772933

Write-up: Early miscarriage/miscarriage; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106211300215240-IVGHZ. Safety Report Unique Identifier GB-MHRA-ADR 25510221. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FC8289), via an unspecified route of administration on 15Jun2021 as dose 1, single for Covid-19 immunisation. Medical history included miscarriage on Mar2021, pregnancy and folic acid supplementation. Concomitant medication included folic acid for vitamin supplementation, start and stop date were not reported. The patient was exposed to the medicine first-trimester (1-12 weeks). The patient was not aware of pregnancy at time of first dose of vaccine and on 20Jun2021, she had sustained a miscarriage. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021792967 fetus/baby case


VAERS ID: 1480126 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210611; Test Name: ultrasound; Test Result: Positive ; Comments: Positive ultrasound on June 11 with beating heart; Test Date: 20210620; Test Name: ultrasound; Result Unstructured Data: Test Result:without a beating heart
CDC Split Type: NLPFIZER INC2021781502

Write-up: Vaccination during 7th week of pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the WEB, regulatory authority number NL-LRB-00587885. This consumer reported information of mother. This is a mother case. A 36-year-old Pregnant female patient received BNT162B2 (COMIRNATY, solution for injection, Lot Number and expiration date: Not reported), via an unspecified route of administration on 16Jun2021 as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included CITALOPRAM tablet coated 30mg taken for an unspecified indication. Patient did not had COVID 19 infection. The patient had vaccination during 7th week of pregnancy on an unspecified date (4 days after administration of covid-19 vaccine pfizer injection fluid for covid 19 immunisation). She had miscarriage on 20Jun2021. The miscarriage occurred at a pregnancy duration of about 7.5 weeks. This was the first Covid vaccination, which took place at a pregnancy duration of about 7 weeks. The mother reported she became pregnant while taking bnt162b2. latency was unknown. The patient underwent lab tests and procedures which included ultrasound scan was positive on 11Jun2021, Positive ultrasound on June 11 with beating heart , ultrasound scan was without a beating heart on 20Jun2021. It went wrong just after June 11. It doesn''t have to be related, but maybe good to register anyway. The outcome of the event was unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the criteria the reaction (Miscarraige) was considered as serious by the PRIVACY. Reporter''s comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.


VAERS ID: 1513742 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8289 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Previous pregnancy successful 2 years earlier); Vitamin supplementation
Allergies:
Diagnostic Lab Data: Test Name: Scan; Result Unstructured Data: Test Result:unable to find fetus heartbeat; Comments: Scan unable to find fetus heartbeat. Bleeding then passed fetus later the same day.
CDC Split Type: GBPFIZER INC2021906841

Write-up: Miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151745184040-DBXBI, Safety Report Unique Identifier GB-MHRA-ADR 25658593. This consumer reported information for mother (patient no longer pregnant at the time of reporting). This is a {maternal} report. A 34-year-old female patient (pregnant during vaccination) received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC8289) on 20Jun2021 as dose 1, single for COVID-19 immunization. Medical history included pregnancy (previous pregnancy successful 2 years earlier) and vitamin supplementation. Concomitant medication included folic acid 400 micrograms taken for vitamin supplementation, start and stop date were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient was exposed to the vaccine during first trimester (1-12 weeks) on 20Jun2021. The mother reported she became pregnant while taking bnt162b2. It was reported that the medicine had an adverse effect on the pregnancy. On 11Jul2021 patient had miscarriage at 6 weeks pregnant and took first Covid injection 3 weeks prior. Patient had her previous pregnancy successful 2 years earlier and was trying to conceive for 14 months. All other pregnancy symptoms had as usual. No previous miscarriages. Patient had lab procedure scan investigation on unknown date and result was unable to find fetus heartbeat, bleeding then passed fetus later the same day. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Events miscarriage and bleeding then passed fetus later was medically significant. The outcome of event miscarriage was reported as recovered with sequelae on 15Jul2021. Outcome of other events was unknown. No follow up attempts are possible. No further information is expected.


VAERS ID: 1513830 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8289 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100918442

Write-up: Maternal exposure during pregnancy; passed fetus; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151745184040-DBXBI, Safety Report Unique Identifier GB-MHRA-ADR 25658593. This consumer reported information for both mother and fetus. This is a fetus report. A fetus patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via transplacental on 20Jun2021 (Lot Number: FC8289) as single dose for COVID-19 immunisation. The patient medical history included folic acid supplementation. The patient''s mother was 34-year-old female who received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FC8289) on 20Jun2021 for COVID-19 immunisation. The mother''s medical history included pregnancy and folic acid supplementation. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced passed fetus in 2021 and maternal exposure during pregnancy on 20Jun2021. Patient was exposed to the medicine first-trimester (1-12 weeks). The case was reported as serious due to other medically important condition. The patient died in 2021. It was not reported if an autopsy was performed. Outcome of events was fatal. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021906841 maternal case; Reported Cause(s) of Death: Maternal exposure during pregnancy; passed fetus


VAERS ID: 1516765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-20
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Miscarriage
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100908858

Write-up: Foetal exposure during pregnancy; Miscarriage; This is a spontaneous report received from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107162255390100-5DQV2. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on 05Jun2021, as dose 1, single for COVID-19 immunization. The patient''s medical history included miscarriage and she was a clinical trial participant. Study detail was reported as C viper, but they took patient off their system after informing them about miscarriage. The child and patient were exposed to the medicine in first trimester (1-12 weeks). The scans and investigations confirmed miscarriage. Concomitant medication included folic acid, taken for vitamin supplementation, start and stop dates were not reported. On an unspecified date, after the first dose of vaccine, the patient experienced foetal exposure during pregnancy. On 20Jun2021, 15 days after the first dose of vaccine, the patient experienced miscarriage. Patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on an unspecified date. The clinical outcome of the event miscarriage was reported as resolved and the clinical outcome of the event foetal exposure during pregnancy was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1547132 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Headache, Malaise, Myalgia, Pyrexia, Vaginal haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure
Allergies:
Diagnostic Lab Data: Test Date: 20210620; Test Name: Pyrexia; Result Unstructured Data: Test Result:38-40.5 Centigrade
CDC Split Type: NLPFIZER INC202100967073

Write-up: Miscarriage/ child died on 28Jun2021 and the patient gave birth spontaneously on 30Jun2021; Pyrexia/ Fever: 38 to 40.5 degrees Celsius; vaginal bleeding/ progressive hemorrhaging; Myalgia; Malaise; Headache; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number NL-LRB-00638542. A pregnant 31-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 19Jun2021 (Lot Number: FC3098, unknown expiration; at the age of 31 years old) as dose 1, single for COVID-19 immunisation. The patient''s medical history included maternal vaccine exposure. Concomitant medications were not reported. The patient experienced vaginal bleeding/ progressive hemorrhaging, myalgia, malaise, headache, and pyrexia on 20Jun2021, 1 day following administration of COVID-19 Pfizer vaccine injection. The vaginal bleeding started at a pregnancy duration of about 16 weeks, followed by a miscarriage (on 28Jun2021) that occurred at a pregnancy duration of about 17 weeks. This was the first COVID vaccination, which took place at a pregnancy duration of about 16 weeks. Miscarriage and vaginal bleeding are treated with spontaneous delivery. The patient underwent lab tests and procedures which included pyrexia: 38-40.5 centigrade on 20Jun2021. The patient recovered from headache, malaise, pyrexia, and myalgia on 25Jun2021. The patient also recovered from miscarriage and vaginal bleeding/progressive hemorrhaging on 30Jun2021. The event miscarriage was assessed as serious (hospitalization from 28Jun2021 to 30Jun2021; and medically significant). Sender''s comment: Seriousness of miscarriage was also classified as ''other''. Past drug therapy BioNTech/Pfizer vaccine (COMIRNATY): no. The patient had a stillbirth. Hospitalization information: during delivery 1 night/day. Additional information adverse drug reaction: the patient wonders if the symptoms of the vaccination caused the stillbirth. The patient developed progressive hemorrhaging 1 day after vaccination and eventually the child died on 28Jun2021 and the patient gave birth spontaneously on 30Jun2021. COVID-19 vaccine exposure during pregnancy week: the patient was 16 weeks pregnant. No previous COVID-19 infection. No follow-up attempts are possible; information about batch number was already obtained.


VAERS ID: 1585947 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FERPLEX FOL; CARDIOASPIRIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100988280

Write-up: there was no longer a pulse.the dimens of the fetus were stopped at 14 weeks; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-762143. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 37-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in arm left (left shoulder) on 20Jun2021 16:33 (Batch/Lot Number: FC5089; Expiration Date: 31Oct2021) at the age of 37 years old as dose 1, single for COVID-19 immunisation. The patient''s medical history was not reported. Pregnancy: yes and Impact on quality of life: 10/10. Concomitant medication(s) included calcium folinate, iron succinyl-protein complex (FERPLEX FOL) taken for pregnancy and acetylsalicylic acid (CARDIOASPIRIN) taken for an unspecified indication, both start and stop dates were not reported. The patient had exposure during pregnancy. As reported, "on 14Jul2021, I made the visit because I was in the 18th week of pregnancy and I discovered that there was no longer a pulse. The ''dimens'' of the fetus were stopped at 14 weeks, that of the first dose ''vaccin''" (congenital anomaly). The mother was 14 weeks pregnant at the onset of the event on 20Jun2021. The mother underwent therapeutic abortion on 14Jul2021. Actions taken indicated that as soon as patient visited her gynecologist, she went to the emergency room for the curettage. The consequence is that she lost the baby, coincidentally the size of the fetus was stationary at the week in which she took the first dose of the vaccine. Sender Comment: Suspected ADR after first dose of Comirnaty. Abortion after 18 weeks and 3 days with fetus of gestational age of about 14 weeks. Pregnancy with medically assisted procreation. The criterion of seriousness ''death'' was changed to ''congenital anomalies of the newborn''. 29Jun2021: First absolute attempt at pregnancy, no previous abortion and no previous hormone therapy even birth control pills. Attached are all the reports performed. in therapy with siderAL folic + cardioasp No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101025916 fetus case


VAERS ID: 1589208 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-20
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage, Pregnancy test, Scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting)
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: pregnancy tests; Test Result: Positive ; Test Date: 20210623; Test Name: scan; Result Unstructured Data: Test Result:diagnosed pregnancy unknown location; Test Date: 20210715; Test Name: scan; Result Unstructured Data: Test Result:miscarriage confirmed; Test Date: 20210715; Test Name: scan; Result Unstructured Data: Test Result:miscarriage confirmed
CDC Split Type: GBPFIZER INC202100998334

Write-up: bleeding; Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number {GB-MHRA-WEBCOVID- 202108031241281380-UJW3U} Safety Report Unique Identifier {GB-MHRA-ADR 25746562}. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Ew3143) via an unspecified route of administration on 08Jun2021 as first dose, single for COVID-19 immunisation. Medical history included miscarriage, pregnancy (at the time of vaccination, patient no longer pregnant at the time of reporting). Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medication included folic acid for folic acid supplementation. The patient experienced bleeding on unspecified date and miscarriage on 20Jun2021. The patient was unsure if the medicine had an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included pregnancy test: positive on 15Jun2021, scan: diagnosed pregnancy unknown location on 23Jun2021, and both scans on 15Jul2021 showed miscarriage confirmed. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the event miscarriage was recovered on 15Jul2021. Outcome of the event bleeding was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1669117 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101073284

Write-up: COVID-19 vaccine exposure during pregnancy week: 10 weeks; Miscarriage; This spontaneous report received from a contactable consumer reported different events for each dose of drug. This is the first of two reports. This is a spontaneous report received from the regulatory authority-WEB NL-LRB-00667462. This is case for 2nd dose. This is a maternal report. A 31-years-old pregnant female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 15Jun2021 as dose 2, 0.3 ml single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unknown route of administration on 11May2021, dose 1, 0.3 ml single for COVID-19 immunisation and experienced maternal exposure during pregnancy first trimester. The patient experienced miscarriage, covid-19 vaccine exposure during pregnancy week: 10 weeks on 20Jun2021 with outcome of unknown. The event miscarriage assessed as serious (other medically important condition) and while other event was assessed as non-serious. Drugs and latency: miscarriage, maternal exposure during pregnancy: 5 days after start. The mother reported she became pregnant while taking bnt162b2 The miscarriage occurred at a pregnancy duration of about 10 weeks. This was the second Covid vaccination. The first vaccination took place at a pregnancy duration of about 4 weeks. The pregnancy resulted in spontaneous abortion. The outcome of the events was reported as unknown. Health authority comment: Seriousness of miscarriage was changed from "death" to "other medically important condition". Reporter comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 11May2021 BSN available: yes confounding factors COVID-19 vaccine exposure during pregnancy week: 4 weeks COVID19 Previous COVID-19 infection: No No follow-up attempts are possible, information on batch number cannot be obtained.


VAERS ID: 1706169 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Haemorrhage in pregnancy, Malaise, Maternal exposure during pregnancy, Nausea, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUDESONIDE;FORMOTEROL; CETIRIZINE [CETIRIZINE HYDROCHLORIDE]; FLUTICASONE FUROATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101143281

Write-up: Miscarriage; Haemorrhage pregnancy; Malaise; Fatigue; Nausea; Reaction at or around the injection site: pain; vaccination during 4th week of pregnancy; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB NL-LRB-00673633. A 33-year-old female patient (pregnant) received second dose of BNT162B2(COMIRNATY, Lot Number: FC3098), via an unspecified route of administration at the age of 33-year-old on 20Jun2021 at single dose for covid-19 immunisation. The patient medical history was not reported. There was no previous COVID-19 infection and no diagnostic procedures. Concomitant medications included budesonide;formoterol inhalation powder; cetirizine hydrochloride (CETIRIZINE) tablet; fluticasone furoate nasal spray. The patient previously received first dose of bnt162b2 (COMIRNATY) on 16May2021 for COVID-19 immunisation and experienced pain in arm and maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: first vaccination not yet pregnant, 2nd time, 4 weeks). The patient experienced miscarriage and haemorrhage pregnancy on 04Jul2021, vaccination during 4th week of pregnancy on 20Jun2021, malaise, fatigue, nausea and reaction at or around the injection site: pain on 21Jun2021. The miscarriage occurred at a pregnancy duration of about 6 weeks. This was the second Covid vaccination, which took place at a pregnancy duration of about 4 weeks. The first Covid vaccination took place before pregnancy. The events miscarriage, haemorrhage pregnancy and vaccination during 4th week of pregnancy were serious for being medical significant. The outcome of event haemorrhage pregnancy was recovered on 04Jul2021, of events malaise and fatigue was recovered on 22Jun2021, of events nausea and reaction at or around the injection site: pain was recovered on 21Jun2021 and other events was unknown. Reporter comment: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): yes ADRs: painful arm 16May2021 Haemorrhage during pregnancy and later miscarriage. Additional information adverse drug reaction: miscarriage on 04Jul and bleeding in the meantime, confounding factors: COVID-19 vaccine exposure during pregnancy week: first vaccination not yet pregnant, 2nd time, 4 weeks. COVID19. Previous COVID-19 infection: No. Other. diagnostic procedures: no. No follow-up attempts possible. No further information expected.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): yes ADRs: painful arm 16May2021 Haemorrhage during pregnancy and later miscarriage. Additional information adverse drug reaction: miscarriage on 04Jul and bleeding in the meantime, confounding factors: COVID-19 vaccine exposure during pregnancy week: first vaccination not yet pregnant, 2nd time, 4 weeks. COVID19. Previous COVID-19 infection: No. Other. diagnostic procedures: no.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101200435 the same patient/different dose/ different adverse event


VAERS ID: 1422790 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-22
Onset:2021-06-21
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6955 / N/A LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily women?s multivitamin and vitamin D
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: HCG test to confirm miscarriage by doctor
CDC Split Type:

Write-up: Miscarriage at 6.5 weeks pregnant 6/23/21


VAERS ID: 1427389 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-03
Onset:2021-06-21
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016B21A / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Cytogenetic abnormality, Foetal heart rate abnormal, Placental transfusion syndrome, Subchorionic haemorrhage, Ultrasound antenatal screen abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: Previously reported to VAERS - subchorionic hemorrhage in the same pregnancy on May 24. (VAERS ID 1378256)
Other Medications: Progesterone, low dose naltrexone, multivitamin, lexapro, vitamin D
Current Illness: N/A
Preexisting Conditions: West Nile survivor
Allergies: Sulfa
Diagnostic Lab Data: Investigation on the cause of miscarriage is ongoing. It is suspected to be either chromosomal or twin-to-twin transfusion syndrome.
CDC Split Type:

Write-up: Missed miscarriage of 11 week old, mo/di identical twins. Discovered as lack of heartbeat on ultrasound on June 21.


VAERS ID: 1437696 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-12
Onset:2021-06-21
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: na
Current Illness: na
Preexisting Conditions: na
Allergies: na
Diagnostic Lab Data: Hospitalize 6/23
CDC Split Type:

Write-up: Miscarriage of pregnancy 9-weeks


VAERS ID: 1440848 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-06-21
Onset:2021-06-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051C21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Chills, Exposure during pregnancy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient reports fever and chills at about 7pm after receiving her covid shot. She treated fever with Tylenol. She went to the doctor the following day and found out that she lost her baby. She was 5 weeks pregnant at the time of vaccination


VAERS ID: 1441123 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-03-09
Onset:2021-06-21
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6208 / 1 RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8737 / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Premature delivery
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pre-natal vitamins, baby aspirin, iron, vitamin C, Zofran, Pepcid AC
Current Illness: Pregnancy
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: I got the vaccine when I was 20 weeks pregnant. Delivered my son at 36 weeks 6 days. He has respiratory issues and has been in the NICU for 10 days now. He is making progress but we are still days away from being released. He was born weighing 5 lbs 16 oz.


VAERS ID: 1457911 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-04-13
Onset:2021-06-21
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy, Ultrasound antenatal screen abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin
Current Illness:
Preexisting Conditions: Prior blood clot
Allergies: Sulfa
Diagnostic Lab Data: Ultrasound June 21
CDC Split Type:

Write-up: Pregnant as of May 8. Miscarriage as of June 21


VAERS ID: 1472399 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-21
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Maternal exposure during pregnancy, Off label use, Pain, Pregnancy test, Product use issue
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Test Result: Negative ; Comments: I talked to the GP and she asked me to do pregnancy test just in case if it is a miscarriage. The pregnancy test is negative.
CDC Split Type: GBPFIZER INC2021776147

Write-up: miscarriage/Her last period started on 25May2021; Exposure during breastfeeding; Exposure during breastfeeding; miscarriage; pain; Heavy periods; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106230818279150-7GQRL. Safety Report Unique Identifier (GB-MHRA-ADR 25523302). This consumer reported information for both mother and baby. This is the maternal report. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Jun2021 (Lot Number: EW3143) as single dose for covid-19 immunization. Medical history included miscarriage. The patient''s concomitant medications were not reported. The patient experienced miscarriage and pain on an unspecified date, heavy periods on 21Jun2021 and exposure during breastfeeding. She was a healthy woman aged 34. She had a 2 and half year-old baby whom she still breastfeed. On 02Jun2021 she had the first dose of Pfizer. She did not get any side effects at that time. She always had a normal menstruation cycle and periods never ever got late till now in her life and she had never missed any cycle (apart from being pregnant) and the flow was always normal. Her last period started on 25May2021. On 20Jun2021 the period started for this month. On 21Jun2021 since morning, she had heavy bleeding flow with large amounts of jelly like lumps started coming out at each visit to the washroom and later turned into excessive blood lumps/clots coming out back to back. It had never happened to her ever before. The lumps were extremely dark reddish and still came on 22Jun2021. Today was 23Jun2021 and they were still there. She didn''t have any pain. They were so big that she can feel it moving from top to bottom of the vagina and coming out. She talked to the GP and she asked her to do pregnancy test just in case if it was a miscarriage. The pregnancy test was negative and she did not even plan for a baby. She was pretty sure it was due to the side effect of the Pfizer. She didn''t have any other disease or infection. Case was reported as serious, medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of event heavy periods was not recovered and the other events were recovering. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021813728 Baby case


VAERS ID: 1489232 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AZATHIOPRINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunosuppression; Pregnancy (COVID-19 vaccine exposure during pregnancy week:8)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021843492

Write-up: Other Adverse Event_1: miscarriage; Nausea; Myalgia; COVID-19 LIM This is a non-interventional study report from a contactable consumer downloaded from the Regulatory Authority. This is a maternal report. A 41-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FC3098), first dose via an unspecified route of administration on 20Jun2021 as dose 1, single for covid-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing, COVID-19 vaccine exposure during pregnancy week: 8, immunosuppression from an unknown date and unknown if ongoing. Concomitant medications included azathioprine (tablet, 25mg) taken for an unspecified indication from 15May2010 to an unspecified stop date. The patient experienced miscarriage on an unspecified date, nausea on 21Jun2021, myalgia on 21Jun2021. The events miscarriage was serious per medically significant. The mother reported she became pregnant while taking bnt162b2. The mother was 8 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Drugs and latency: nausea: 12 hours after start; myalgia: 5 hours after start; miscarriage: 1 weeks after start. The outcome of events for nausea was resolved on 21Jun2021, for myalgia was resolved on 23Jun2021, for miscarriage was not resolved. Reporter Comment: Nausea: Reaction Treatment: No, Impact qualify of life: A little; muscle strain: Reaction Treatment: No, Impact qualify of life: A little; Other AE_1: miscarriage, Reaction Treatment: No, COVID-19 vaccine exposure during pregnancy week: 8; Previous COVID-19 infection: No. The reporter''s assessment of the causal relationship of all events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Nausea: Reaction Treatment: No, Impact qualify of life: A little; muscle strain: Reaction Treatment: No, Impact qualify of life: A little; Other AE_1: miscarriage, Reaction Treatment: No, COVID-19 vaccine exposure during pregnancy week: 8; Previous COVID-19 infection: No.; Sender''s Comments: Based on temporal association, a contributory role of bnt162b2 (COMIRNATY)to the events of miscarriage, nausea and myalgia cannot be 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.


VAERS ID: 1558606 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-06-14
Onset:2021-06-21
   Days after vaccination:372
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: Miscarriage; Result Unstructured Data: Test Result:Scan; Comments: scans or investigations.
CDC Split Type: GBPFIZER INC202100977171

Write-up: exposed to the medicine first-trimester (1-12 weeks).; Miscarriage; This is a spontaneous report from a contactable consumer or other non-health care professional. received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107310955256580-GKMIQ. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25736748. A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 14Jun2020 as dose 1, single for covid-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing and Patient was no longer pregnant at the time of reporting. Concomitant medication included folic acid (FOLIC ACID) taken for an unspecified indication, start and stop date were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient was exposed to the medicine caused maternal exposure during pregnancy first-trimester (1-12 weeks). Vaccine given at 5 weeks and Miscarried one week after vaccine on 21Jun2021. Event considered as Medically significant. Patient did not know she was pregnant otherwise she would have opted to delay her vaccine. The medicine has an adverse effect on aspect of the pregnancy which caused Miscarriage. Patient did not take folic acid supplement during pregnancy. Details of scans or investigations included miscarriage. Miscarried outcome was recovered on an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1664088 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-21
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Off label use, Pregnancy test, Product use issue, SARS-CoV-2 test, Ultrasound scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Polycystic ovarian syndrome; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210627; Test Name: Pregnancy test; Test Result: Positive ; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210630; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:showed a fetal pole and yolk sac of approximately; Comments: showed a fetal pole and yolk sac of approximately 6 weeks gestation; Test Date: 20210707; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:pregnancy not viable
CDC Split Type: GBPFIZER INC202101064744

Write-up: Vaginal bleeding; Miscarriage; ongoing breast feeding; ongoing breast feeding; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108162113058800-JOZFA. This consumer reported information for both mother and fetus/baby. This is a mother report. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05Jun2021 (Lot Number: EY5456) as single dose for covid-19 immunisation. Medical history included polycystic ovaries syndrome, miscarriage, pregnancy and Patient no longer pregnant at the time of reporting, ongoing breast feeding. Concomitant medication included folic acid taken for vitamin supplementation. The patient had maternal exposure during pregnancy, maternal exposure during breast feeding. The patient experienced vaginal bleeding and miscarriage on 21Jun2021. The mother reported she became pregnant while taking bnt162b2. The mother was 1 Trimester pregnant at the onset of the event. The patient underwent lab tests and procedures which included pregnancy test: positive on 27Jun2021, negative covid-19 test, ultrasound scan: showed a fetal pole and yolk sac of approximately 6 weeks gestation on 30Jun2021, ultrasound scan: pregnancy not viable on 07Jul2021. The patient started bleeding 21Jun2021. Positive pregnancy test 27Jun2021. Scan showed fetus of uncertain viability - too early for heartbeat 30Jun2021. Another scan showed features previously seen no longer present, confirming pregnancy not viable 07Jul2021. Misoprostol taken 09Jul2021 Incomplete miscarriage, manual extraction and further misoprostal given 16Jul2021. Bleeding continues until the present (16Aug2021), although 2 subsequent scans have shown there to be no remaining pregnancy tissue. Patient was pregnant when she got the vaccine. She was very early days. She started bleeding a few weeks later and it led to a miscarriage. She has a living 18 month old. Multiple scans- first showed fetus of uncertain viability, second (a week later) showed features had been absorbed. 5 ultrasound scans. Mild PCOS Breastfeeding. Patient has not had symptoms associated with COVID-19. On 30Jun2021 the ultrasound scan showed a fetal pole and yolk sac of approximately 6 weeks gestation and all looked as it should for the gestation. They said to come back in a week and if the pregnancy was going to be viable there by then should be a heartbeat and the correct amount of growth. The subsequent scan on 07Jul2021 showed these features to no longer be present and a mass of blood in the uterus. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The report was considered as serious as hospitalization, disability and medically significant. The outcome of event vaginal bleeding was not recovered; miscarriage was recovering and other events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101134515 mother/baby case


VAERS ID: 1787280 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Menstruation irregular, Pregnancy test, Vaccination site pain
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma (since infancy); VACTERL syndrome (since birth)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: SEPFIZER INC202101273986

Write-up: Irregular cycle (patient''s period was like a clock. now it came earlier and more sparse); suspected miscarriage (Took the injection in patient''s luteal phase and at menstrual bleeding (BIM) patient plussed as well, got miscarriage quickly); Maternal exposure during pregnancy, first trimester; PAIN AT THE VACCINATION SITE; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number SE-MPA-2021-075020. A pregnant 29-year-old female patient received 1st dose of BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 21Jun2021 (at the age of 29-year-old) as single dose for COVID-19 immunisation. Medical history included VACTERL association since birth in 1992, Asthma since infancy in 1992, both ongoing. Concomitant medications were not reported. Reported suspected adverse events were pain at vaccination site on 21Jun2021, suspected miscarriage (Took the injection in patient''s luteal phase and at menstrual bleeding (BIM) patient plussed as well, got miscarriage quickly) on 25Jun2021, Irregular cycle (patient''s period was like a clock. now it came earlier and more sparse) on 22Jul2021. The reporter stated that she was a fertile person and knew her body inside and out. Took first dose in her luteal phase and felt she was pregnant, took the test but only days later she started bleeding heavily and miscarried. The following month ovulation came as usual, but the luteal phase was very strange according to the woman, she got her period three days earlier, which never happens. Had a cycle of 27-28 days, not 24. The woman bled less and not at all as usual as her period has its flow which was always the same. All events was reported as serious (Medically Significant). The outcome of the event vaccination site pain was recovered on 24Jun2021, of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1466664 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Virginia  
Vaccinated:2020-12-18
Onset:2021-06-22
   Days after vaccination:186
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4176 / 2 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Foetal death, Foetal heart rate abnormal, Twin pregnancy, Ultrasound antenatal screen abnormal, Uterine dilation and curettage
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness: NA
Preexisting Conditions: NA
Allergies: NA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pregnancy and miscarriage. Hx: one living child born 4/19/19. No hx of miscarriage. Attempted to get pregnant ~3 months post vaccination. Taking prenatal for 3 months prior to attempt to get pregnant. Date of LMP was 3/29/2021. Found out I was pregnant was twins via vaginal US at 8 weeks. Normal growth, heartbeats present. Second OB appointment at 11 weeks 5 days. No heartbeat present with either child on US. One twin measured 9 wks 5 day, other twin measured 10 weeks. D&C completed 6/22/21. No complications.


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