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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

Government Disclaimer on use of this data



Case Details (Sorted by Onset Date)

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VAERS ID: 1546442 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
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, Platelet count, SARS-CoV-2 test, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), 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: Folic acid supplementation; Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: platelet counts; Result Unstructured Data: Test Result:Low; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: blood clots; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202100969376

Write-up: Early miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable physician received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107281129544810-PKUR7.[Safety Report Unique Identifier: GB-MHRA-ADR 25719425] A 35-year-old female patient (pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not provided) via an unspecified route of administration at the age of 35-year-old on 26May2021 at single dose for covid-19 immunisation. Medical history included lactation decreased, folic acid supplementation, pregnancy (Patient no longer pregnant at the time of reporting). Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation. The patient experienced early miscarriage on 28May2021, maternal exposure during pregnancy on 26May2021. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient say that she aborted 36 hours after receiving the vaccine. The events were serious for being medical significant. Patient was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests included COVID-19 virus test: negative on an unspecified date (reported as No - Negative COVID-19 test), blood clots: unknown results on an unspecified date, platelet counts: low on an unspecified date. The outcome of event Early miscarriage was recovered and other event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained


VAERS ID: 1624466 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C008A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion early, Fatigue, Vaccination site pain
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101017377

Write-up: Abortion early; Fatigue; Injection site pain; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021124307. A 32-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration at age of 32-years-old on 26May2021 (Lot Number: 1C008A) as 0.3ML single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fatigue on 27May2021, abortion early on 09Jun2021, injection site pain on 26May2021. The mother reported she became pregnant while taking bnt162b2. The mother was 1 Months pregnant at the onset of the event. Outcome of fatigue was recovered on 31May2021, outcome of injection site pain was recovered on 28May2021, other event was recovered on 23Jun2021. Case was reported as serious due to hospitalization. Reporter comment: Are you or the person concerned known of any allergies? If yes, which? no Information on risk factors or previous illnesses None / 8th (16Jun2021) week embryo was small, Fruit cavity misshapen, but heartbeat good. 9. Week no heartbeat. Subsequent Curettage. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Are you or the person concerned known of any allergies? If yes, which? no Information on risk factors or previous illnesses None / 8th (16Jun2021) week embryo was small, Fruit cavity misshapen, but heartbeat good. 9. Week no heartbeat. Subsequent Curettage.


VAERS ID: 1642408 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   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 EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Off label use, Pain in extremity, Product use issue, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; PREDNISOLONE
Current Illness: Breast feeding; Choroiditis (punctate inner choroidopathy); Pregnancy (Estimated due date: 2022/04/15); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201005; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101040871

Write-up: Early miscarriage; fever; Painful arm; Maternal exposure during breast feeding; Maternal exposure during breast feeding; This is a solicited report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-YCVM-202108111549301100-IOHMJ, Safety Report Unique Identifier GB-MHRA-ADR 25785273. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EW3143), dose 1 via an unspecified route of administration on 26May2021 as single dose for covid-19 immunization. Medical history included ongoing pregnancy (Estimated due date: 2022/04/15), ongoing breast feeding, suspected covid-19 on 05Oct2020, ongoing steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)), ongoing choroiditis (punctate inner choroidopathy). Steroids were for eye condition (punctate inner choroidopathy). Concomitant medications included folic acid taken for vitamin supplementation; ongoing prednisolone taken for choroiditis. The patient experienced painful arm (medical significant) on 27May2021, maternal exposure during pregnancy and maternal exposure during breast feeding on 26May2021, early miscarriage on an unspecified date of Jul2021. Pyrexia from 17Jun2021 to an unknown date (Just in case relevant the patient had another fever on 17 June for which she received a negative Covid test. The patient planed to have the flu vaccine at some point this year). The mother reported she became pregnant while taking bnt162b2. The mother was 4 Weeks pregnant at the onset of the event. The mother was due to deliver on 01Feb2022. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 05Oct2020. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was unsure if vaccination had an adverse effect on any aspect of the pregnancy. Details of previous pregnancies: Early miscarriage in the previous month (between doses). Patient was exposed to the vaccine first-trimester (1-12 weeks). Requested follow up received 19/08/2021: There was very little pain starting a few hours after vaccination (unspecified which dose) at the site of vaccination. This event did not effect her daily activity. The pain now resolved, only lasted about 24 hours. There was medication 7.5mg prednisolone daily to treat eye condition which being taken throughout the pregnancy. Confirmed her pregnancy was still ongoing (as reported), due date 15Apr2022 (as reported). It was unknown if any problems with the foetus identified before or after the pregnancy loss (e.g. Date and finding of ultrasound scans and/or additional imaging studies), since not had a scan yet. Details of any medical history/current medical condition relevant to this pregnancy included natural pregnancy. Medical illnesses requiring medication or any surgical interventions during pregnancy included Prednisolone as mentioned above. Other concomitant medicines and/or vaccines (including over the counter and herbal medicines) administered or ceased during pregnancy, including dates and dosages was none. Exposure to other substances (e.g. alcohol, tobacco smoking) was none. Details of any previous pregnancies and outcomes: First healthy child born October 2019; Early miscarriage in July 2021 (around 5 weeks). The outcome of event painful arm was recovered on 28May2021, the rest of events outcome was unknown. 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 expected.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : GB-PFIZER INC-202101108936 Baby case


VAERS ID: 1738304 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002335 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy, Menstrual disorder, Pelvic pain
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Sexual dysfunction (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: Thyroid disorder (under went left lobo-isthmectomy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Miscarriage; Disorder menstrual; Pain pelvic; Maternal exposure during pregnancy; This case was received via Regulatory Authority(Reference number: -AFSSAPS-BR20213379) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority prospective pregnancy case was reported by a physician and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3002335) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder (under went left lobo-isthmectomy). On 26-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-May-2021, after starting mRNA-1273 (Spikevax), the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure during pregnancy). On 28-May-2021, the patient experienced PELVIC PAIN (Pain pelvic). On 06-Jun-2021, the patient experienced MENSTRUAL DISORDER (Disorder menstrual). On 16-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Miscarriage), PELVIC PAIN (Pain pelvic) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure during pregnancy) had resolved and MENSTRUAL DISORDER (Disorder menstrual) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product usage were not provided. Treatment details were not provided. This case concerns a 29-year-old, female patient with no relevant medical history reported , who experienced the unexpected events MATERNAL EXPORTURE BEFORE PREGNANCY and spontaneous abortion. The patient received the first dose of vaccine at 11 days before her last menstrual period, and the Spontaneous abortion occurred approximately 1 month and 21 days after the first dose of Spikevax. The benefit-risk relationship of Spikevax in not affected by this report Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation document received on 21-SEP-2021. Medical history translated.; Sender''s Comments: This case concerns a 29-year-old, female patient with no relevant medical history reported , who experienced the unexpected events MATERNAL EXPORTURE BEFORE PREGNANCY and spontaneous abortion. The patient received the first dose of vaccine at 11 days before her last menstrual period, and the Spontaneous abortion occurred approximately 1 month and 21 days after the first dose of Spikevax. The benefit-risk relationship of Spikevax in not affected by this report


VAERS ID: 1819267 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Dizziness, Fatigue, Gait disturbance, Haemorrhage, Loss of consciousness, Malaise, Muscle spasms, Scan
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Termination of pregnancy and risk of abortion (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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: FOLIC ACID; ONDANSETRON HYDROCHLORIDE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Scan; Result Unstructured Data: Test Result:Discovered only sac
CDC Split Type: GBPFIZER INC202101359427

Write-up: felt on and off well, sick; Fatigue; Dizzy; Cramps; Bleeding; Blacked out; Felt limp; Miscarriage; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202110112015529910-RNAOO with Safety Report Unique Identifier of GB-MHRA-ADR 26062315. This consumer reported information for both mother and fetus. This is the mother report. A 35-year-old pregnant female patient received first dose of BNT162b2 (Lot Number: UNKNOWN) via an unspecified route of administration on 26May2021 (at the age of 35 years old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and had not undergone a COVID-19 test. The patient was not enrolled in the clinical trial. Concomitant medications included folic acid (MANUFACTURER UNKNOWN) as folic acid supplementation and ondansetron hydrochloride (MANUFACTURER UNKNOWN) from 04Jun2021 for sickness and hyperemesis gravidarum (HG), unknown if ongoing. The patient previously received ondansetron (MANUFACTURER UNKNOWN) for Hyperemesis gravidarum (HG) from an unknown date. On 26May2021 afternoon following vaccine, the patient took heavy cramps and bled. She had blacked out. She felt limp and dizzy and went to bed. On 27May2021, she felt fatigue. Then next week or so, the patient continued to feel dizzy and contacted her general practitioner (GP) to have bloods taken as she was concerned about blacking out and her dizziness. First week in Jun2021, the patient discovered that she was pregnant. The patient had vaccine on week 4. The patient started taking ondansetron as she suffered from hyperemesis gravidarum (HG) in pregnancy. On Jun2021, the next month, the patient felt on and off well, sick and dizzy. The patient had first scan around week 13 and they discovered only a sac and the patient was questioned if the pregnancy was viable. The patient went home for that week and went back to do follow up scan to check if anything had developed further to be sure if the fetus/sac had grown. It had not and she was to expect a miscarriage. Patient then proceeded to miscarry the pregnancy. The patient had surgery to remove the rest of the pregnancy at around week 14 gestation and her symptoms had now cleared. The patient had vaccine on week 4. The patient had not tested positive for COVID-19 since having the vaccine. All events except miscarriage, felt limp and "felt on and off well, sick" were reported as serious for being medically significant. The clinical outcome of the events bleeding, blacked out and fatigue was resolved on unspecified date in 2021; events dizzy and cramps were resolving whereas that of the events felt limp, miscarriage, "felt on and off well, sick" was unknown at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101447835 Mother / fetus


VAERS ID: 1355010 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: New York  
Vaccinated:2021-02-12
Onset:2021-05-27
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 024M20A / 1 UN / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032M20A / 2 UN / IM

Administered by: Public       Purchased by: ?
Symptoms: Abdominal pain, Abortion missed, Exposure during pregnancy, Foetal death, Vaginal haemorrhage, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: prenatal vitamins
Current Illness:
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 5/19/2021 patient woke up around 11 pm with a sharp pain in her upper abdomen, then had emesis and the pain subsided and she went back to bed. On 5/20/2021 at approximately 7:30 pm patient started bleeding vaginally. She called the on call doctor and an ultrasound and office visit was advised for the next day. On 5/21/21, patient presented in office for Ultrasound and office visit. The Ultrasound finding were diagnosed for a missed AB (miscarriage)/fetal death in utero. Patient''s due date was 11/4/2021. This was her second pregnancy, with the first being a Missed AB (miscarriage) in 7/2020. Due to CRL and failed on Miso prior, patient scheduled for D&C 5/27/21


VAERS ID: 1389555 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-04
Onset:2021-05-27
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma, but I don''t use an inhaler or take any medication for it regularly, and very rarely have any issues. It was more of an issue in childhood that I mostly "grew out of".
Allergies:
Diagnostic Lab Data: None, the miscarriage happened before I started prenatal care.
CDC Split Type:

Write-up: I had a miscarriage which started on May 27th. I believe I ovulated the day I received the shot (May 4th). My last period started on April 15th. I had a positive pregnancy test on May 22nd and bleeding began on May 27th.


VAERS ID: 1470856 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-03-12
Onset:2021-05-27
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040A21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin abnormal, Ultrasound scan vagina, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Amitriptyline 100 mg at bedtime Norethindrone 0.35 mg once daily Escitalopram 20 mg once daily Magnesium 500 mg once daily Cetirizine 10 mg once daily if needed for allergies Aimovig 140 mg subcutaneously once monthly Rizatriptan 10 mg once
Current Illness: n/a
Preexisting Conditions: Chronic migraines
Allergies: Penicillin Pepto Bismol
Diagnostic Lab Data: 5/25/21 hCG Quant : 26 IU/L 5/27/21 hCG Quant: 13 IU/L 5/27/21 hCG urine test: negative 5/27/21 US OB Transvaginal ultrasound: no evidence of gestational sac 6/30/21 hCG Quant: <1 IU/L
CDC Split Type:

Write-up: On May 21, 2021 I had a positive pregnancy test. We were preventing conception and were very surprised. On 5/27/21 at 12:30 pm I started having vaginal bleeding and went to Hospital ER where I was told I was having a miscarriage. I have had two pregnancies and 2 lives births, no previous miscarriage


VAERS ID: 1481674 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-03-11
Onset:2021-05-27
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test abnormal
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: None
Current Illness: None
Preexisting Conditions: None
Allergies: Sulfa drugs
Diagnostic Lab Data: Ultrasound to confirm pregnancy-5/10/2021 Ultrasound to confirm pregnancy- 5/18/2021 Ultrasound that identified miscarriage - 5/28/2021 Bloodwork to confirm passing of embryo - 6/1/2021 6/7/2021 6/21/2021
CDC Split Type:

Write-up: Miscarriage


VAERS ID: 1415754 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-27
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure timing unspecified, 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? 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:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative
CDC Split Type: GBPFIZER INC2021657941

Write-up: Early miscarriage; Maternal Exposure timing unspecified; 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-202106041626515500-G23HD. Safety Report Unique Identifier is GB-MHRA-ADR 25421936. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 18May2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was None, Patient has not had symptoms associated with COVID-19, Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced early miscarriage on 27May2021 with outcome of unknown. The event was serious as congenital anomaly. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date. Clinical course: the patient had the vaccine likely around the time of implantation. The patient miscarried a week later. The patient was not suggesting causation but wish to simply report as part of her duty. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1492463 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-27
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood gonadotrophin decreased, Body temperature, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery occlusion (Grandfather had a surgery for Coronary artery occlusion)
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Gonadotropin; Result Unstructured Data: Test Result:decreased; Comments: Low Gonadotropin was found by blood collection; Test Date: 20210514; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before the vaccination; Test Date: 20210521; Test Name: pregnancy; Test Result: Positive ; Test Date: 20210531; Test Name: ultrasonography; Result Unstructured Data: Test Result:No fetal buds were found
CDC Split Type: JPPFIZER INC2021848799

Write-up: genital haemorrhage, high likelihood of miscarriage, confirmed abortion; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21117896. A 31-year-old female patient received BNT162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 14May2021 15:00 (Batch/Lot Number: EW4811; Expiration Date: 31Jul2021) as single dose (age at vaccination unspecified) for COVID-19 immunisation. The patient had previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number Unknown, Expiration date Unknown) via an unspecified route of administration on 23Apr2021 for COVID-19 immunization. The patient medical history was not reported. The patient had a family history (Grandfather had a surgery for Coronary artery occlusion). The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.7 degrees centigrade. The patient experienced abortion (medically significant) on 27May2021 05:30 (13 days after the vaccination). The course of the event was as follows: On 23Apr2021 and 27May2021, the patient received the COMIRNATY. On 21May2021, the patient visited obstetrics, the patient was found pregnant (positive pregnancy test). On 27May2021 at 05:30, the patient had genital haemorrhage. On 31May2021, the patient visited obstetrics, no fetal buds were found through ultrasonography. High likelihood of miscarriage, the patient was being observing. On 04Jun2021, the patient visited obstetrics again, still cannot confirm the presence of the fetus, Low Gonadotropin was found by blood collection. This time it was confirmed the patient had abortion. As of 01Jul2021 (48 days after the vaccination), the patient was recovering from the event. The reporting physician classified the event as serious and assessed that the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1679474 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101094945

Write-up: Missed abortion/miscarriage; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100101000. A 44-year-old pregnant female patient received BNT162B2 (COMIRNATY; lot number: unknown), intramuscularly on 20May2021 (at the age of 44-year-old), dose number unknown, 0.3 mL, single for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. On 27May2021, the patient experienced miscarriage (missed abortion) at 5 weeks of gestation. It was reported that the patient had an occurrence of a missed abortion after application of the vaccine Comirnaty. The event was assessed as serious (medically significant). The outcome of the event was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.


VAERS ID: 1362404 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-09
Onset:2021-05-28
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion missed, 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? 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound on 5/28/2021
CDC Split Type:

Write-up: Missed abortion diagnosed on 5/28/21 during routine ultrasound


VAERS ID: 1381836 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-19
Onset:2021-05-28
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007CZ1A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033B21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound foetal 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Ultrasound 6/6/2021
CDC Split Type:

Write-up: I was 16 weeks along when I found out I had a miscarriage. The doctors said the baby stopped growing at 15 weeks. The clinic measured the baby stopping growing at 14 weeks, right after my second dose. I?ve had 3 vaginal on time healthy deliveries. No previous pregnancy issues. This was definitely unusual.


VAERS ID: 1427733 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-05-27
Onset:2021-05-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 RA / SYR

Administered by: Military       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pyrexia, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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? 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: Vitamin D Ceterizine
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: The first day after I received my shot I was running a fever of 102. My side effects passed by May 29th, 2021. On May 21st I went to the hospital due to vaginal bleeding. While at medical center I was told I had a miscarriage. I was showing at 4 weeks when I was supposed to be 7 weeks. I found out I was pregnant on April 30th. I got my first dose on May 5th. My first shot I just had soreness, but I?ve had a previous successful pregnancy but lost this one between my first and second dose.


VAERS ID: 1454621 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-03-31
Onset:2021-05-28
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6204 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8732 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy, Ultrasound abdomen, Ultrasound scan vagina, Urine analysis
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: Lansoprazole 30 mg; prenatal vitamin
Current Illness: None
Preexisting Conditions: Postural Orthostatic Tachycardia Syndrome (POTS); Hypermobility Ehlers-Danlos Syndrome (hEDS); GERD
Allergies: NKA
Diagnostic Lab Data: -urinalysis, blood tests (5/28/2021) -Abdominal & Transvaginal ultrasound (5/28/2021)
CDC Split Type:

Write-up: I found out I was pregnant a couple weeks after receiving my final COVID vaccine. My last menstrual cycle was on 3/9/2021 and I had a positive pregnancy test on 4/8/2021. My last pfizer vaccine was given on 3/31/2021. My estimated date of delivery was 12/15/2021. I had a pre-natal visit at approximately 10 weeks when things appeared normal. Subsequently started passing brown mucus (5/22/2021) and then bright red blood with clots (5/28/2021). Went to the hospital and no cardiac activity was detected on ultrasound and I subsequently had a D&C on 5/29/2021. I was 11 weeks +3 days (based on LMP) when no cardiac activity was detected.


VAERS ID: 1457444 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-04-06
Onset:2021-05-28
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 2 AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Blood test, Cardiac stress test, Delivery, Exposure during pregnancy, Headache, Induced labour, Oedema, Oedema peripheral, Peripheral swelling, Pre-eclampsia, Premature delivery, Protein urine present, Swelling face, Urine analysis, Visual impairment
SMQs:, Acute renal failure (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Hypertension (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: I was taking a prenatal vitamin, vitamin D3, Unisom, tums, Lexapro 10mg, Tylenol and Pepcid. I also received the T-Dap vaccine a rhogam shot.
Current Illness: I did not have any illnesses.
Preexisting Conditions: I have anxiety, chronic yeast infections, chronic bacterial infections and PCOS.
Allergies: I am allergic to Neosporin.
Diagnostic Lab Data: I had blood work done, a urinalysis, regular prenatal testing, blood pressure check, stress test (for me and the baby, which we passed), The only problem that was found was the protein in my urine and the pre-eclampsia.
CDC Split Type: vsafe

Write-up: After receiving the second dose, around May 8th, I started developing symptoms of seeing stars in my vision and I had lower extremity edema. On May 18th, I went to a regular prenatal appt and I had 2 blood pressure readings. Both readings were around 150/90. I also had hand and facial swelling and still had pitting edema in my lower extremities. When I was sent to triage, they ran standard tests and found that from the urinalysis, there was protein in my urine. I was diagnosed with pre-eclampsia without severe features and was sent home to monitor myself. On 05/26, I had a headache that would not resolve with Tylenol so I had to go back to triage. I was given a fluid bolus and the headache went away and was sent back home. On 05/28, the headache returned and would not resolve with Tylenol. I went back to triage and the midwife there decided that I was going to be induced to deliver. I had a vaginal delivery, 5 weeks early . My son weighed 6bs 8.5oz. I do not have any other children and I did not have any miscarriages. There was a threat in the early stages of my pregnancy of a miscarriage. My son had to be in the NICU for 2 weeks. When he was born he had respiratory distress, low sugar levels and that resolved within 48 hours. Then he developed jaundice and he had poor feeding. As of today, we are doing great.


VAERS ID: 1392280 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-28
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy skin, Face oedema, Foetal death, High foetal head, Palatal disorder
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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? Yes
   Date died: 2021-05-28
   Days after onset: 0
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: Skin biopsy; Result Unstructured Data: Not reported
CDC Split Type: BEJNJFOC20210615237

Write-up: DEATH; HIGH FOETAL HEAD/ EDEMATOUS ENLARGED HEAD; NOTABLE PALATE WITH OPEN MOUTH; EDEMATOUS ENLARGED HEAD; This spontaneous pregnancy report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, BE-FAMHP-DHH-N2021-94484] concerned a foetus of unspecified sex. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient''s mother received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C10-01 expiry: UNKNOWN) 1 total, dose was not reported, administered on 25-MAY-2021 for covid-19 immunisation. No concomitant medications were reported. It was reported that, the mother was 19-week pregnant and visited delivery room on 28-MAY-2021 with vaginal red blood loss and she no longer felt the child''s movement. The diagnosis was made as fetal death, high foetal head/edematous enlarged head (pre or post-mortem) and notable palate with open mouth on the same day. The examination undergone was skin biopsy genetics fetus bacteria wiper placenta. It was reported that foetus died from high foetal head/ edematous enlarged head, notable palate with open mouth, and edematous enlarged head. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This parent/child case is linked to 20210617564.; Reporter''s Comments: Treatment. Examinations placenta ADR description - (pre-of postmortem?) Sender''s Comments: V0: 20210615237-COVID-19 VACCINE AD26.COV2.S- death, high foetal head, notable palate with open mouth, edematous enlarged head. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HIGH FOETAL HEAD/ EDEMATOUS ENLARGED HEAD; DEATH; NOTABLE PALATE WITH OPEN MOUTH; EDEMATOUS ENLARGED HEAD


VAERS ID: 1396139 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-28
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Pyrexia, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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? 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: Patient was pregnant at time of vaccination: 2nd trimester (19 weeks and 4 days)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210617564

Write-up: FETAL DEATH; VAGINAL RED BLOOD LOSS; FEVER; This spontaneous pregnancy report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, BE-FAMHP-DHH-N2021-94082] concerned a 38 year old female of unspecified race and ethnicity. The patient''s weight was 102 kilograms, and height was 171 centimeters. The patient was pregnant at time of vaccination: 2nd trimester (19 weeks and 4 days). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C10-01 expiry: UNKNOWN) dose was not reported, 1 total administered on 25-MAY-2021 for covid-19 immunisation. No concomitant medications were reported. On 28-MAY-2021, the patient came to the delivery room with vaginal red blood loss and she no longer felt the child moving. The patient was diagnosed with fetal death. Edematose enlarged head and notable palate with open mouth was reported. The patient also experienced fever. The examination undergone was skin biopsy genetics fetus bacteria swab placenta. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fetal death, vaginal red blood loss and fever was not reported. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210615237.; Reporter''s Comments: Treatment - No Evolution of the ADR - Death Situations - Other: For me, no proven causal connection but perhaps still a facilitating factor. Examinations - skin biopsy genetics fetus bacterio swab placenta. Patient was 19 weeks and 4 days pregnant and came to the delivery room on 28-May-2021: vaginal red blood loss and she no longer felt the child moving. Diagnosis: Fetal death. Edematose enlarged head (pre- or post-mortem?) notable palate with open mouth.; Sender''s Comments: V0: 20210617564-COVID-19 VACCINE AD26.COV2.S - Fetal death, vaginal red blood loss. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210617564-COVID-19 VACCINE AD26.COV2.S -Fever. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1452128 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002335 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Vaccine exposure during pregnancy; This regulatory authority retrospective pregnancy case was reported by an other health care professional and describes the occurrence of FOETAL DEATH in a 35-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002335) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Obesity. On 28-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 28-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 18-Jun-2021, the patient experienced FOETAL DEATH (seriousness criteria hospitalization and medically significant). The delivery reported as Intrauterine death. The outcome was reported as Spontaneous Abortion NOS. At the time of the report, FOETAL DEATH had resolved with sequelae and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had 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 medication provided. No treatment medication provided. This is a case of product exposure during pregnancy with an associated AEs for this 35-year-old female. Very limited information regarding this event has been provided at this time. Sender''s case number: FR-AFSSAPS-2021079548; Sender''s Comments: This is a case of product exposure during pregnancy with an associated AEs for this 35-year-old female. Very limited information regarding this event has been provided at this time.


VAERS ID: 1526664 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-05-28
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Ultrasound foetal
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:
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: fetal ultrasound; Result Unstructured Data: Test Result:abnormal; Comments: with the presence of pulmonary spots
CDC Split Type: FRPFIZER INC202100949216

Write-up: Pregnancy loss/miscarriage less than 20 weeks of gestation (9 weeks and 6 days of amenorrhea); This is a spontaneous report from a contactable nurse downloaded from the WEB, regulatory authority number FR-AFSSAPS-NY20212750. This nurse reported information for both mother and fetus/baby. This is a maternal report. Spontaneous Report (regulatory authority Local Reference number: 2021092566), Initial information received on 11Jul2021, from an health professional (nurse) to the regulatory authority. A 29-year-old pregnant female patient (the mother, height: 171 cm, weight: 57 kg) received bnt162b2 (COMIRNATY), dose 1 intramuscular on 13Apr2021 (Lot Number: EW2239) (at 3 weeks of amenorrhea + 2 days) as single dose for immunisation against sars-cov-2. The mother''s medical history was not specified. Concomitant medications were not reported. The mother was pregnant while receiving bnt162b2. Pregnancy date: 3 weeks and 2 days of amenorrhea (Last menstrual period date: 20Mar2021). The mother was due to deliver on 25Dec2021. On 28May2021, the mother experienced pregnancy loss/miscarriage less than 20 weeks of gestation (9 weeks and 6 days of amenorrhea), which resulted in hospitalization. The pregnancy resulted in spontaneous abortion. The fetal outcome is congenital anomaly. The patient had fully recovered from miscarriage less than 20 weeks of gestation. The outcome of the event was recovered (assumed in 2021). Reporter Comment: 29-year-old pregnant woman, vaccinated by the first injection of the COMIRNATY vaccine at 3 weeks of amenorrhea + 2 days, who presented a miscarriage at 9 weeks of amenorrhea + 6 days, in a context of abnormal fetal ultrasound with the presence of pulmonary spots. Patient recovered. No follow-up attempts possible. No further information expected.; Reporter''s Comments: 29-year-old pregnant woman, vaccinated by the first injection of the COMIRNATY vaccine at 3 weeks of amenorrhea + 2 days, who presented a miscarriage at 9 weeks of amenorrhea + 6 days, in a context of abnormal fetal ultrasound with the presence of pulmonary spots. Patient recovered.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202100948992 fetus/mother case, same vaccine, different events


VAERS ID: 1642208 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue
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: GBPFIZER INC202101047464

Write-up: weeks/fatigue; 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-202108121103238880-CLXA6. Safety Report Unique Identifier GB-MHRA-ADR 25789124. A 12-year-old female patient (pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via an unspecified route of administration on 14May2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced fatigue for weeks (unspecified date) and had miscarriage on 28May2021 (2 weeks after vaccine administered). The events were serious medically significant (also reported as serious congenital anomaly). The outcome of fatigue was unknown; for miscarriage was recovered with sequel. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1750871 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Foetal growth restriction, Maternal exposure during pregnancy
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? 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101264073

Write-up: intratuerine death; maternal exposure during pregnancy, 2nd trimester; Foetal growth retardation; This is a spontaneous report from a contactable consumer (parent) reporting different events for mother/fetus. This is second of two reports, for the fetus. The first report was downloaded from Regulatory Authority-WEB, The regulatory authority report number FR-AFSSAPS-PA20211492. An unspecified age and gender patient (fetus) received the second dose (initial Pfizer dose) of BNT162B2 (COMIRNATY) via transplacental on 28May2021 (Batch/Lot Number: EX6537) as 0.3 ml dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced intratuerine death. In 2021, the patient experienced foetal growth retardation. On 28May2021, the patient experienced maternal exposure during pregnancy, 2nd trimester. From a fetal point of view, severe intrauterine growth retardation (below the 3rd percentile) diagnosed at 19 weeks of amenorrhea. Therapeutic measures were taken for intratuerine death. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of foetal growth retardation was not recovered. The outcome of death fetal was fatal. The outcome of Maternal exposure during pregnancy, second trimester was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101256690 mother/child, same drug; Reported Cause(s) of Death: intratuerine death


VAERS ID: 1413371 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-05-09
Onset:2021-05-29
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Uterine dilation and curettage
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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Levothyroxin
Current Illness:
Preexisting Conditions:
Allergies: Na
Diagnostic Lab Data: 2 D&C procedures
CDC Split Type:

Write-up: I had a miscarriage at 16 weeks.


VAERS ID: 1797887 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-09
Onset:2021-05-29
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016B21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood iron, Blood test abnormal, Delivery, Exposure during pregnancy, Platelet count decreased, Premature delivery, Premature separation of placenta, Ultrasound scan, Uterine dilation and curettage, Vaginal haemorrhage
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (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? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal Vit; Vit D; Vit C; Magnesium; Aspirin
Current Illness: No
Preexisting Conditions: No
Allergies: Codeine
Diagnostic Lab Data: Blood work (platelets was low,iron), DNC, Several ultrasounds
CDC Split Type: vsafe

Write-up: At the time of adverse event under 32 weeks pregnant scheduled to deliver on 7/22/2021 and I delivered on 7/03/2021. I was on a trip with my husband started to exp bleeding. We drove to hospital did ultrasound couldn''t figure out the cause of bleeding. I was hospitalized on May 29,2021 for a week given Steroid, Magnesium drip diagnosed with partial placental abruption and discharged on June 5, 2021 after a week with no additional treatment. I cointinued to bleed up to week with a vaginal delivery. Upon examination my placenta seem to be in tact. I had a DNC at Hospital.


VAERS ID: 1837052 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-05-02
Onset:2021-05-29
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017C21A / 1 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death, Laboratory test, Uterine dilation and curettage
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? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Test Placenta; D&C pregnancy.
CDC Split Type: vsafe

Write-up: I got the vaccine on May 2, 2021. On May 29, 2021 notified the baby was no longer viable and I had to go to the hospital had D&C procedure. I have 2 healthy children and no history of miscarriages. My estimated date of delivery was February 2022.


VAERS ID: 1452287 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-29
   Days after vaccination:7
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, Foetal death, Headache, Maternal exposure during pregnancy, Peripheral swelling, Pruritus, Rash erythematous, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypersensitivity (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? 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
CDC Split Type: GBMODERNATX, INC.MOD20211

Write-up: itchy; Maternal exposure during pregnancy; headache; Miscarriage; Death foetal; Red rash; Swelling arm; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) and FOETAL DEATH (Death foetal) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-May-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 29-May-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) and PERIPHERAL SWELLING (Swelling arm). On 02-Jun-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced FOETAL DEATH (Death foetal) (seriousness criterion medically significant). On 23-Jun-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (itchy), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and HEADACHE (headache). At the time of the report, ABORTION SPONTANEOUS (Miscarriage), FOETAL DEATH (Death foetal) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown, PRURITUS (itchy) and HEADACHE (headache) was resolving and RASH ERYTHEMATOUS (Red rash) and PERIPHERAL SWELLING (Swelling arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment information was provided. Reporter mentioned that the Foetal death dated at roughly 8 weeks(02-JUN-2021) which was less than 2 weeks after the 1st dose. Company Comment This is a case of product exposure during pregnancy with reported adverse events. For the reported events, based on temporal association a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up information received, events added and case upgraded to serious.; Sender''s Comments: This is a case of product exposure during pregnancy with reported adverse events. For the reported events, based on temporal association a causal relationship cannot be excluded.


VAERS ID: 1475796 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

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: Medical History/Concurrent Conditions: 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
CDC Split Type: GBPFIZER INC2021809936

Write-up: Miscarriage of pregnancy; miscarriage; 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-202106281601170500-FE1XP. Safety Report Unique Identifier: GB-MHRA-ADR 25555846. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ET8885, expiry date not reported), via an unspecified route of administration on 29May2021 (at the age of 35-year-old) as single dose for covid-19 immunisation. Medical history included pregnancy. Patient no longer pregnant at the time of reporting. 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. The patient''s concomitant medications were not reported. The patient experienced maternal exposure during pregnancy on 29May2021, miscarriage and miscarriage of pregnancy on an unspecified date. The events were reported as serious (Other medically important condition). It was reported that vaccine was administered 29May2021 and foetal heartbeat stopped approximately a week later resulting in a missed miscarriage. Patient was exposed to the medicine first-trimester (1-12 weeks). Unsure if the medicine have an adverse effect on any aspect of the pregnancy. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (no - negative covid-19 test) on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The patient recovered from miscarriage while outcome of miscarriage of pregnancy was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1475949 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-29
   Days after vaccination:11
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, Haemorrhage, Pregnancy test
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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (two previous successful pregnancies; Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210522; Test Name: pregnancy tests; Test Result: Positive ; Comments: From the 22May2021 onwards she had multiple positive pregnancy tests; Test Date: 20210529; Test Name: pregnancy tests; Test Result: Negative
CDC Split Type: GBPFIZER INC2021814136

Write-up: bleeding; Early 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-202106292151139560-NKSXL; Safety Report Unique Identifier is GB-MHRA-ADR 25564653. A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not provided), via an unspecified route of administration on 18May2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. Medical history included pregnancy (two previous successful pregnancies; Patient no longer pregnant at the time of reporting) and folic acid supplementation. Concomitant medications included folic acid (FOLIC ACID) taken for folic acid supplementation. The patient experienced bleeding and early miscarriage on 29May2021. Events were assessed as serious with criteria of Other medically important condition. Additional information: The patient has had two previous successful pregnancies and has not experienced a miscarriage before. She received her 1st dose of the vaccine on 18May2021. At this point she suspected she was pregnant but it wasn''t confirmed. From the 22May2021 onwards she had multiple positive pregnancy tests and her period didn''t arrive as it usually would on 22nd/23rd May. On the 29May2021 she started bleeding and cramping. The bleeding was heavier and more severe than her usual period. She also tested negative for pregnancy from that date. This one ended in an early miscarriage approximately 10 days after receiving the vaccine. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of any relevant investigations or tests conducted: "I did not consult a doctor". Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. It was unsure whether the medicine have an adverse effect on any aspect of the pregnancy. The outcome of the event early miscarriage was recovered on 07Jun2021; bleeding was recovering. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained.


VAERS ID: 1480122 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021770732

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB, regulatory authority number NL-LRB-00587170. A 33-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 27May2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included maternal vaccine exposure, no previous COVID-19 infection. The patient''s concomitant medications were not reported. This was the first COVID vaccination, which took place at a pregnancy duration of about 6 weeks. 2 days after administration, the patient experienced miscarriage. Outcome of the event was not recovered. The event was reported as serious with seriousness criteria of medically significant. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the critera, the reaction was considered as serious. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1480158 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-29
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021824175

Write-up: Miscarriage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00595032. A 40-year-old female patient received bnt162b2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration on 29Apr2021, dose 1, 0.3 ml, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient did not have a previous COVID-19 infection. The patient experienced maternal exposure during pregnancy following administration of COVID-19 vaccine on 29Apr2021. The first Covid vaccination took place at a pregnancy duration of about 2 weeks. A miscarriage occurred after the first vaccination at a pregnancy duration of about 6 weeks on 29May2021. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: miscarriage 29May Date: 29Apr2021 Additional information ADR: miscarriage Confounding factors: COVID-19 vaccine exposure during pregnancy week: 2 weeks Previous COVID-19 infection: No Miscarriage occurred after 1st vaccination. The 2nd vaccination Pfizer was on 03Jun2021.


VAERS ID: 1538250 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, SARS-CoV-2 antibody 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECONASE; CHLORAMPHENICOL PALMITATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Nausea (during pregnancy); Pregnancy (8 weeks 5 days); Sickness (during pregnancy)
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: covid-19 antibody test; Test Result: Positive ; Comments: revealed antibodies; Test Date: 20210604; Test Name: Scan; Result Unstructured Data: Test Result:missed miscarriage
CDC Split Type: GBPFIZER INC202100992473

Write-up: Lost my pregnancy symptoms of nausea and sickness, potentially caused my missed miscarriage; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). The Regulatory Authority report number is GB-MHRA-EYC 00257498 and Safety Report Unique Identifier GB-MHRA-ADR 25733832. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ET8885), via parenteral, on 27May2021 at single dose for COVID-19 immunisation. At the time of vaccination, the patient was pregnant 8 weeks and 5 days. Relevant medical history included COVID-19 from Jan2021, nausea and sickness both during pregnancy. Relevant concomitant medications included beclometasone dipropionate (BECONASE) and chloramphenicol palmitate. On 29May2021, the patient had a missed miscarriage. The clinical course was reported as follows: she lost her pregnancy symptoms a couple of days after her first dose of COVID 19 vaccine. She later found out that had suffered a missed miscarriage by scan on 04Jun2021. The advice she has had is that the baby could have died anywhere from 6 weeks to 8 weeks. The patient stated she had previously submitted a yellow card about this same Pfizer jab when she breastfed her 3.5 year old daughter that night and she woke up with blotchy red patches as if she''d had an allergic reaction to the vaccine through her breastmilk. Both her daughter and she had COVID in Jan2021 so they probably both already had antibodies. Antibody test on 14May2021 (when she was around 7 weeks pregnant) was positive (revealed antibodies). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593535 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-29
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Maternal exposure during pregnancy, Polymenorrhoea, Pregnancy test
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? 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: 20210728; Test Name: Blood test; Result Unstructured Data: Confirmed miscarriage; Test Date: 20210721; Test Name: Pregnancy test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: ISMODERNATX, INC.MOD20212

Write-up: This case was received via European Medicines Agency (Reference number: 4171) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (F?sturl?t) and POLYMENORRHOEA (Byrja ? bl??ingum 5 d?gum of snemma (?venjulegt fyrir mig er eins og klukka a 4 vikna fresti)) in a 38-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 29-May-2021, the patient experienced POLYMENORRHOEA (seriousness criterion congenital anomaly). On 16-Jun-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 19-Jul-2021, the patient experienced ABORTION SPONTANEOUS (seriousness criteria medically significant and congenital anomaly). 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 16-Jun-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS and POLYMENORRHOEA outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Pregnancy test: positive (Positive) positive. On 28-Jul-2021, Blood test: confirmed miscarriage (abnormal) Confirmed miscarriage. mRNA-1273 (Spikevax) (Unknown) was withdrawn on an unknown date. No concomitant medications were reported No treatment medications reported. Company Comment: 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. Events seriousness captured as per Regulatory Authority assessment in Source Document.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Events seriousness captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1738347 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood immunoglobulin M, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Spontaneous abortion (3 miscarriages at approximately 7 weeks)
Allergies:
Diagnostic Lab Data: Test Name: Immunoglobulin M anti-prothrombin antibodies; Result Unstructured Data: Test Result:presence
CDC Split Type: FRPFIZER INC202101194006

Write-up: Spontaneous abortion; Maternal Exposure During Pregnancy, first trimester; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB. Regulatory authority number is FR-AFSSAPS-GR20213629. A 34-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 29May2021 (Batch/Lot Number: Unknown, Expiry date not reported) as DOSE 1, 0.3 ML, SINGLE for COVID-19 immunization. Medical history included abortion spontaneous (3 miscarriages at approximately 7 weeks. Following an etiological assessment, the cause identified is the presence of Immunoglobulin M anti-prothrombin antibodies). The patient was pregnant at the time of vaccination. The mother was 6 weeks pregnant at the onset of the event. Concomitant medications included acetylsalicylic acid (ASPIRINE PROTECT) taken for an unspecified indication, start and stop date were not reported; hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) taken for an unspecified indication, start and stop date were not reported; levofloxacin (LOVENOX [LEVOFLOXACIN]) taken for an unspecified indication, start and stop date were not reported. The patient experienced spontaneous abortion on 07Jul2021 with outcome of not recovered and maternal exposure during pregnancy, first trimester on 29May2021 with outcome of not recovered. The patient underwent lab tests and procedures which included blood immunoglobulin m: presence on an unspecified date. The event spontaneous abortion was assessed as serious, due to hospitalization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1368898 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-04
Onset:2021-05-30
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Haemorrhage, Muscle spasms
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Blood test to verify miscarriage on 6/1/21
CDC Split Type:

Write-up: Miscarriage, moderate bleeding, cramps


VAERS ID: 1376881 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-06
Onset:2021-05-30
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal death, Muscle spasms, Ultrasound scan abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), 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: Low-dose aspirin, pre-natal vitamins, vitamin D supplement, pro-biotic digestive enzymes
Current Illness: None
Preexisting Conditions: IBS - well controlled, chronic fatigue syndrome
Allergies: Penicillin, mango, cat dander, pollen (seasonal)
Diagnostic Lab Data: 05/26/2021 - viability ultrasound. No heartbeat found. Fetus present but appeared to be about 6 weeks instead of 9 or 10 weeks 06/04/2021 - ultrasound showed all tissue had passed
CDC Split Type:

Write-up: Miscarriage. Had first vaccine dose about 2 weeks after a positive home pregnancy test (on 04/24/2021). Date of last period was 03/19/2021. No fertility treatments. Spontaneous pregnancy at 46 years old. Had 2 previous miscarriages - 6 months earlier and 3 years earlier. Started bleeding and cramping 05/26/2021. Went to emergency room. They checked with ultrasound and said it was probably a miscarriage. The baby should be 9 or 10 weeks, but the ultrasound showed it was much too small for that - probably stopped developing at about 6 weeks. Pregnancy hormone levels were normal, however. Followed up with OBGYN the next day - she confirmed it looked like a miscarriage. The cramping/bleeding lasted for another week. Follow-up appointment on 06/04/2021 showed the uterus had completely emptied.


VAERS ID: 1420781 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Montana  
Vaccinated:2021-05-14
Onset:2021-05-30
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 034C21A / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, First trimester pregnancy, Human chorionic gonadotropin decreased, 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), Normal pregnancy conditions and outcomes (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: Prenatal vitamins
Current Illness: 6 weeks pregnant at time of second vaccination.
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Beta hcg dropped from 2343 on day 3 of vaginal bleeding to 8
CDC Split Type:

Write-up: Spontaneous abortion at 7weeks gestational age.


VAERS ID: 1455940 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-25
Onset:2021-05-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Pathology test, Placental disorder
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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Placenta pathology noted inflammation and infection.
CDC Split Type:

Write-up: Missed miscarriage diagnosed at 20 weeks. The baby died 5 days after vaccine dose 2 at 16.5 weeks. No abnormalities in previous scans. Placenta pathology noted inflammation and infection.


VAERS ID: 1479059 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-28
Onset:2021-05-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 1 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Amniotic fluid index increased, Dyspnoea, Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Foetal hypokinesia, Induced labour, Pain in extremity, Polyhydramnios, Stillbirth, Ultrasound antenatal screen abnormal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 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:
CDC Split Type:

Write-up: I was pregnant with a baby boy, and the due date was 09/14/2021. I took my first vaccine of pfizer-biontech (Lot: EW0175) on 05/28/2021. On 05/30, I started feeling short of breath and soreness on both upper arms on the afternoon. The shortness of breath lasted several hours and ended before I went to bed on 05/30. The soreness on arms lasted more than 12 hours till the afternoon of 05/31. I did no take any medicine. No other obvious reaction after the night of 05/31/2021. However, I started to feel fewer activities of the baby fewer than 5 days after the vaccination. On 06/08, I went to hospital and took an ultrasound to check the status of baby for the concern of no feeling of baby movement. The examine results were read by my ob doctor as everything normal of the baby with normal-high amount of amniotic fluid that makes mom feel less movement. We did see the baby moved. But he was less active than what we saw on ultrasound before (20-week gestation). Another thing noticeable is that baby did not practice breathing during the 45 min ultrasound. The ob reads it as normal to not see it so frequently on 26-week gestation. On the evening of 06/11, I went to have an emergency care as I still could not feel the baby''s movement. The doctors confirmed that my baby boy stopped heart beating and the death time was within 2-3 days. During 06/15-06/17, I was hospitalized to do labor induction of the baby. I took oral misoprostol for inducing the labor (3 times, two pills the 1st time, three pills the 2nd and 3rd time). I took both tylenol and ibuprofen for the fever caused by misoprostol. I took epidural around 1pm of 06/16 for anesthesia. The baby came out around 5pm of 06/16 and identified as stillbirth. On 07/16, I took my second doze of pfizer-biontech vaccine (Lot: EW0191) . I am in observation of my reactions.


VAERS ID: 1554969 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-05-14
Onset:2021-05-30
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin decreased, Ultrasound pelvis, 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), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness:
Preexisting Conditions:
Allergies: None
Diagnostic Lab Data: Pelvic ultrasound showing possible empty gestational sac on 5/30/21. Serum HCG levels declined toward zero starting from labs taken on 5/30/21 and every 2 days to one week apart for the subsequent 4 weeks.
CDC Split Type:

Write-up: Patient was about 3-4 weeks pregnant at the time of second vaccine dose. She subsequently had a miscarriage which started with vaginal bleeding on May 30th in the evening. Prior to this miscarriage, she had 2 gestations which resulted in 2 full term uncomplicated deliveries.


VAERS ID: 1408581 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 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? 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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210220; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Test Date: 20210531; Test Name: Scan; Result Unstructured Data: Test Result:confirmed a viable pregancy at 6 weeks and 1 day; Test Date: 20210602; Test Name: Scan; Result Unstructured Data: Test Result:confirmed misscarriage.
CDC Split Type: GBPFIZER INC2021649199

Write-up: Early 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-202106021205488740-GFQJF. Safety Report Unique Identifier GB-MHRA-ADR 25404726. A 33-year-old female patient received bnt162b2 (BNT162B2 also reported as COVID-19 MRNA VACCINE BIONTECH, lot unknown), via an unspecified route of administration on 27May2021 as first dose, single for Covid-19 immunisation. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medication included folic acid for vitamin supplementation, start and stop date were not reported. On 27May2021, the patient experienced maternal exposure during pregnancy. The patient experienced early miscarriage on 30May2021. It was further reported that there was pain and bleeding on 30May2021. The scan on 31May2021, confirmed a viable pregnancy at 6 weeks and 1 day from the scan measurements. Patient was exposed to the medicine first-trimester (1-12 weeks). Following the scan on 31May2021 and 01Jun2021, the bleeding became worse and doubled up in pain. The scan on 02Jun 2021 confirmed miscarriage. The patient underwent laboratory test which included Sars-cov-2 test: yes positive Covid-19 test on 20Feb2021. The outcome of event early miscarriage was recovering. Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1411645 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Limb injury, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-06-07
   Days after onset: 8
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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021693010

Write-up: Miscarriage; Exhaustion; Arm injury; Swollen arm; This is a spontaneous report received from a contactable consumer or other non HCP from the Regulatory Agency (RA). The regulatory authority report number is (GB-MHRA-WEBCOVID-202106121548503420-OGSAK), Safety Report Unique Identifier GB-MHRA-ADR 25466169 A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29May2021, as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient has not tested positive for COVID-19 since having the vaccine. The patient has not had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. On 30May2021, the patient had exhaustion, arm injury, and swollen arm. On 03Jun2021, the patient had miscarriage. The patient underwent lab tests and procedures which included COVID-19 virus test: negative COVID-19 test on an unspecified date. On 07Jun2021, the patient died, and the cause of death was unknown. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1415812 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-30
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Maternal exposure during pregnancy, Off label use, Product use issue, SARS-CoV-2 test, Ultrasound scan, Urine analysis
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.); Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Name: urine tests; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC2021657850

Write-up: Maternal exposure during pregnancy; Maternal exposure during breast feeding; Maternal exposure during breast feeding; Miscarriage of pregnancy/early 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-202106042213069690-QQYGT. Safety Report Unique Identifier GB-MHRA-ADR 25424534. A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 13May2021 (Lot Number: EW4109) as single dose for COVID-19 immunisation. Medical history included ongoing breast feeding, and folic acid supplementation. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. Patient no longer pregnant at the time of reporting. The patient experienced miscarriage of pregnancy/early miscarriage on 30May2021 with outcome of recovering, maternal exposure during pregnancy, and maternal exposure during breast feeding on an unspecified date with outcome of unknown. It was reported early miscarriage, unknown cause. 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). Details of scans or investigations: miscarriage. The patient underwent lab tests and procedures which included COVID-19 virus test negative an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Other relevant investigations or tests conducted: Blood tests, urine tests, ultrasound. The seriousness was reported as medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1418897 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Asthenia, Blister, Fatigue, Rash erythematous, SARS-CoV-2 test, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Hypersensitivity (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? 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; Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021663947

Write-up: Vomiting; Blisters/blistering; Red rash; Tired out; no energy; 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-202106062100559230-I6RNQ. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included suppressed lactation, pregnancy, patient no longer pregnant at the time of reporting, vitamin supplementation. Patient had not had symptoms associated with COVID-19. 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 experienced red rash then blistering then on off vomiting very tired all time no energy on an unspecified date. Miscarriage happened 3 days after first injection (on 30May2021). Patient was exposed to the medicine first-trimester (1-12 weeks). Unsure if the medicine had an adverse effect on any aspect of the pregnancy. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: negative covid-19 test on an unspecified date. The outcome of event vomiting was recovered on an unspecified date, blisters/blistering, red rash, and tired out was not recovered, of other events was unknown. This is serious report received with serious criteria medically significant from RA. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1449225 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-30
   Days after vaccination:8
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, 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: UTROGESTAN VAGINAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 4+3); Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Maternal exposure during pregnancy; Miskraam; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miskraam) in a 41-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. The patient''s past medical history included Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 4+3) and Suspected COVID-19 on 27-Feb-2020. Concomitant products included PROGESTERONE (UTROGESTAN VAGINAL) for an unknown indication. On 22-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On 30-May-2021, the patient experienced ABORTION SPONTANEOUS (Miskraam) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 05-Jun-2021, ABORTION SPONTANEOUS (Miskraam) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided. Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Translated document was received on 1-Jul-2021 and contains no new information.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.


VAERS ID: 1498980 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: RAS
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Beta HCG; Test Result: Positive ; Comments: Beta HCG assay confirming a pregnancy at 5 weeks'' gestation.; Test Date: 20210531; Test Name: ultrasound; Result Unstructured Data: Test Result:confirmed miscarriage
CDC Split Type: FRPFIZER INC2021865223

Write-up: Pregnancy loss <20 weeks gestation; This is a spontaneous report from a contactable consumer downloaded from the WEB, regulatory authority number FR-AFSSAPS-2021082513. A 31-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 25May2021 (Batch/Lot Number: FA7082) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no history of COVID-19. The patient experienced pregnancy loss <20 weeks gestation (medically significant) on 30May2021. The next day, a consultation with a gynaecologist, ultrasound and confirmed miscarriage. Beta HCG assay confirming a pregnancy at 5 weeks'' gestation. The mother reported she became pregnant while taking bnt162b2. The mother was 5 Weeks pregnant at the onset of the event. The mother was pregnant with 1 baby. The patient was not aware that she was pregnant at the time of the vaccination. The patient underwent lab tests and procedures which included human chorionic gonadotropin: positive on 31May2021 (Beta HCG assay confirming a pregnancy at 5 weeks'' gestation); Ultrasound scan: confirmed miscarriage on 31May2021. The outcome of recovering. Reporter comment: Conclusion : Miscarriage in a 31-year-old woman who was 5 weeks pregnant (unaware of her pregnancy), 5 days after the first injection of COMIRNATY vaccine (batch FA7082). Patient in recovery. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Conclusion : Miscarriage in a 31-year-old woman who was 5 weeks pregnant (unaware of her pregnancy), 5 days after the first injection of COMIRNATY vaccine (batch FA7082). Patient in recovery.


VAERS ID: 1746948 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
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: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101222831

Write-up: Suspected miscarriage at 5 weeks pregnant; This is a spontaneous report from a contactable healthcare professional downloaded from the regulatory authority-WEB, regulatory authority number IE-HPRA-2021-082350. A 41-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), via an unspecified route of administration on 28May2021 at a single dose for COVID-19 immunisation. Medical history included pregnancy. The patient''s concomitant medications were not reported. The patient experienced suspected miscarriage at 5 weeks pregnant on 30May2021 with outcome of unknown. The mother reported she became pregnant while taking BNT162B2. The mother was 5 weeks pregnant at the onset of the event. According to the reporter, the vaccination was administered in error. It was reported that the vaccinator confirmed the patient''s eligibility for vaccination and proceeded to administer the vaccine. Meanwhile, second vaccinator was inputting data into tablet and noted that first vaccinator had identified that the patient was 5 weeks'' pregnant (and therefore ineligible for vaccination). However, it was reported that the vaccine had already been administered and the team lead was immediately made aware 2 days later, on 30May2021, the patient reported she had attended hospital with a suspected miscarriage. Outcome of the event was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1700507 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-05-17
Onset:2021-05-31
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / SYR

Administered by: Private       Purchased by: ?
Symptoms: Activated partial thromboplastin time normal, Blood fibrinogen normal, Caesarean section, Exposure during pregnancy, Foetal death, Foetal hypokinesia, Foetal vascular malperfusion, Haematocrit decreased, Haemoglobin decreased, Intensive care, International normalised ratio normal, Packed red blood cell transfusion, Postpartum haemorrhage, Premature separation of placenta, Prothrombin time normal, Toxicologic test normal, Urine protein/creatinine ratio increased, Vaginal haemorrhage
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (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), Termination of pregnancy and risk of abortion (narrow), Chronic kidney disease (broad), Myelodysplastic syndrome (broad), Proteinuria (narrow)

Life Threatening? Yes
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamin
Current Illness: gestational diabetes diagnosed in the month prior
Preexisting Conditions: Crohn''s disease
Allergies: doxycycline, Bactrim, NSAIDs
Diagnostic Lab Data: 5/31/21 Hemoglobin 8.6 on arrival 5/31/21 Hematocrit 27.5 5/31/21 PT/PTT/INR wnl, Fibrinogen 304 5/31/21 Urine protein/creatinine ratio 0.5 5/31/21 Toxicology screen negative
CDC Split Type:

Write-up: 31yo G2P1001 with estimated due date 6/29/2021, pregnancy complicated by diet-controlled gestational diabetes and Crohn''s disease. No history of trauma or drug use. Toxicology screen negative. Normotensive. Received J&J vaccine 5/17/2021. 2 weeks later (5/31/21), noticed decreased fetal movement and reported to hospital. Immediately upon arrival, developed significant vaginal bleeding. Intrauterine fetal demise and acute placental abruption diagnosed upon arrival to hospital. Delivery by cesarean section per patient request due to her h/o fissures and slow perineal healing with first delivery. At cesarean, complete placental abruption noted with 510g blood clot in retroplacental space. Postpartum hemorrhage for total of 1,500ml (including the retroplacental clot), requiring Bakri balloon, ICU admission, transfusion of 3u pRBC, 2u FFP, 1pack Platelets.


VAERS ID: 1418544 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-31
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Haemorrhage, Pregnancy test, Ultrasound scan vagina
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Blood test; Result Unstructured Data: Test Result:miscarriage announced at 5 weeks; Test Date: 20210521; Test Name: pregnancy test; Test Result: Positive ; Test Date: 20210528; Test Name: pregnancy test; Test Result: Positive ; Comments: blood pregnancy test; Test Date: 20210531; Test Name: Vaginal ultrasound; Result Unstructured Data: Test Result:miscarriage announced at 5 weeks
CDC Split Type: FRPFIZER INC2021662163

Write-up: bleeding; Early miscarriage; This is a spontaneous report from a contactable consumer (patient) downloaded from the WEB FR-AFSSAPS-2021065710. A 30-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 17May2021 (Batch/Lot Number: J07BX03) as DOSE 1, SINGLE for COVID-19 immunisation. Patient was pregnant at time of vaccination. The patient medical history was not reported. Concomitant medication included folic acid from unknown date for unspecified indication. Patient had spontaneous early miscarriage on D14 of vaccination (31May2021), onset estimated at 5 weeks of gestation. Patient made first injection on 17May2021 with the Pfizer vaccine. On 21May2021, patient performed a positive pregnancy test which was verified by a blood test on 28May2021. Patient had seen some bleeding. On 31May2021 medical consultation, emergency blood test and vaginal ultrasound: miscarriage announced at 5 weeks of gestation. Before this injection, patient never had a miscarriage. Patient had been taking folic acid for almost 4 months on prescription from gynecologist. The examinations necessary for the conception had indeed been carried out beforehand. The fetal outcome is intrauterine death. The patient underwent lab tests and procedures which included blood test: miscarriage announced at 5 weeks on 31May2021, pregnancy test: positive on 21May2021 and positive on 28May2021 (blood pregnancy test), ultrasound scan vagina: miscarriage announced at 5 weeks on 31May2021. The outcome of event early miscarriage was recovering while for event bleeding was unknown.


VAERS ID: 1462235 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-05-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-11
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, SARS-CoV-2 test, Thrombosis, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), 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: ASPIRIN [ACETYLSALICYLIC ACID]; FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage; 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
CDC Split Type: GBPFIZER INC2021773429

Write-up: Maternal exposure during pregnancy, first trimester; blood clots; extreme heavy bleeding; Early 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-202106211455440310-FN9ZA, Safety Report Unique Identifier GB-MHRA-ADR 25511655. A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30May2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing, miscarriage, and pregnancy (patient was no longer pregnant at the time of reporting). Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Concomitant medications included acetylsalicylic acid (ASPIRIN) taken for pregnancy from an unspecified start date to 2021; folic acid taken as folic acid supplementation, start and stop date were not reported. The patient experienced blood clots on an unspecified date with outcome of recovering, early miscarriage on 31May2021 with outcome of recovered on an unspecified date, maternal exposure during pregnancy, first trimester on an unspecified date with outcome of unknown, extreme heavy bleeding on an unspecified date with outcome of unknown. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient had very early miscarriage at 5 weeks (possible chemical pregnancy), however, extreme heavy bleeding. It was much heavier than previously experienced with blood clots coming out. She had experienced miscarriages before at this stage but no where near the bleeding experience on this occasion. She needed to constantly change sanitary towels. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The reporter was unsure that the medicine had an adverse effect on any aspect of the pregnancy No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1538194 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-05-31
   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 UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Chromosomal analysis, Histology, SARS-CoV-2 test, Tinnitus, Vaccination site pain, Vertigo
SMQs:, Hearing impairment (narrow), Vestibular disorders (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: Medical History/Concurrent Conditions: Congenital hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: Chromosomal analysis; Result Unstructured Data: Test Result:No aberration; Test Date: 20210623; Test Name: Histology; Result Unstructured Data: Test Result:no microscopic argument for an infectious process; Test Date: 20210621; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202100954963

Write-up: Miscarriage; Slight pain at injection site; Short bursts of tinnitus; Slight vertigo; This is as spontaneous report received from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-RS20212413. A 42-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 31May2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included congenital hypothyroidism. Concomitant medication included C-terminal-associated Peptides, folic acid. The patient previously received first dose on 05May2021 as DOSE 2, SINGLE for covid-19 immunisation. First day of last period was 08Apr2021. Start of pregnancy (+ or - 7 days) on 29Apr2021.The patient doesn''t know she is pregnant when vaccination. The patient reports slight pain at the injection site, short bursts of tinnitus and slight vertigo.2 days after the 2nd dose, on the 02Jun2021, the 34th day of pregnancy and 6 weeks and 4 days of amenorrhoea, pregnancy terminated. 9 days after Dose 2 (09Jun2021), the pregnancy termination is diagnosed (the developmental arrest corresponds to 02Jun2021). On 23Jun2021 (23 days after Dose 2), The patient is hospitalised as an outpatient for extraction. gestational process interrupted. Lack of microscopic argument for an infectious process or chromosomal aberration. Overall, miscarriage at 34th days of pregnancy, 2 days after the 2nd dose of COMIRNATY, in a 42-year-old patient. Lab data included Chromosomal analysis on 23Jun2021 included No aberration and Histology on 23Jun2021 included no microscopic argument for an infectious process, SARS-CoV-2 test on 21Jun2021 was Negative. The patient experienced miscarriage on 02Jun2021 with outcome of recovered, and assessed serious as hospitalization. The patient experienced slight pain at injection site, short bursts of tinnitus, slight vertigo on 31May2021 with outcome of unknown, all assessed non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1583988 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-05-31
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, 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
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100988603

Write-up: Vaccination on 23Apr2021 at 3 + 3 / miscarriage - missed abortion on 31May2021 at 8 + 5; Vaccination on 23Apr2021 at 3 + 3 / miscarriage - missed abortion on 31May2021 at 8 + 5; This is a spontaneous report from non-contactable consumer downloaded from the regulatory authority DE-PEI-CADR2021096808, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100089790. A 29-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: EW8904) as dose 1, single for covid-19 immunisation. Medical history included pregnancy. The patient''s concomitant medications were not reported. The patient had vaccination on 23Apr2021 at "3 + 3" and had miscarriage - missed abortion on 31May2021 at "8 + 5". The events caused hospitalization. The outcome of the events was recovered on 31May2021. Relatedness of drug to event was assessed by HA as "D. Unclassifiable". Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no Information on risk factors or previous illnesses: none / vaccination on 23Apr2021 at 3 + 3 / Miscarriage - missed abortion on 31May2021 at 8 + 5 No follow-up attempts possible. No further information expected.


VAERS ID: 1715962 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Anaemia, Blood fibrinogen, Exposure during pregnancy, HIV test, Haemoglobin, Headache, Hepatitis B virus test, Hepatitis C virus test, Hypercoagulation, Intermenstrual bleeding, Physical examination, Platelet count, Premature delivery, Prothrombin time, Retroplacental haematoma, SARS-CoV-2 test, Toxoplasma serology, Treponema test, Ultrasound Doppler, Ultrasound scan, White blood cell count
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: Pollen allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: activated partial thromboplastin time; Result Unstructured Data: Test Result:0.76; Test Date: 20210826; Test Name: activated partial thromboplastin time; Result Unstructured Data: Test Result:1.23; Test Date: 20210625; Test Name: fibrinogen; Result Unstructured Data: Test Result:5.13 g/l; Test Date: 20210826; Test Name: fibrinogen; Result Unstructured Data: Test Result:3.26 g/l; Test Date: 20210625; Test Name: Haemoglobin; Result Unstructured Data: Test Result:100 g/l; Test Date: 20210626; Test Name: Haemoglobin; Result Unstructured Data: Test Result:84 g/l; Test Date: 20210810; Test Name: Haemoglobin; Result Unstructured Data: Test Result:124 g/l; Test Name: hepatitis B virus; Result Unstructured Data: Test Result:Negative; Test Name: hepatitis C; Result Unstructured Data: Test Result:Negative; Test Name: Human Immunodeficiency Virus; Result Unstructured Data: Test Result:Negative; Test Date: 20210826; Test Name: thrombosis panel; Result Unstructured Data: Test Result:unavailable; Test Name: Anatomopathology; Result Unstructured Data: Test Result:Premature hypertrophic placenta Maternal vascular; Comments: malperfusion lesions: decidual arteriopathy; Test Date: 20210625; Test Name: platelets; Result Unstructured Data: Test Result:201 g/l; Test Date: 20210626; Test Name: platelets; Result Unstructured Data: Test Result:184 g/l; Test Date: 20210716; Test Name: platelets; Result Unstructured Data: Test Result:352 g/l; Test Date: 20210810; Test Name: platelets; Result Unstructured Data: Test Result:280 g/l; Test Date: 20210625; Test Name: prothrombin time; Test Result: 120 %; Test Date: 20210826; Test Name: prothrombin time; Test Result: 114 %; Test Date: 20210612; Test Name: COVID-19; Result Unstructured Data: Test Result:Negative; Test Name: Toxoplasma Gondii; Result Unstructured Data: Test Result:Negative; Test Name: Syphilis; Result Unstructured Data: Test Result:Negative; Test Name: uterine doppler ultrasounds; Result Unstructured Data: Test Result:Normal; Test Name: ultrasound; Result Unstructured Data: Test Result:Normal; Comments: first and second trimesters ultrasound normal; Test Date: 20210625; Test Name: leukocytes; Result Unstructured Data: Test Result:11.4 g/l; Test Date: 20210626; Test Name: leukocytes; Result Unstructured Data: Test Result:13 g/l; Test Date: 20210810; Test Name: leukocytes; Result Unstructured Data: Test Result:7.19 g/l
CDC Split Type: FRPFIZER INC202101155454

Write-up: patent became pregnant while taking bnt162b2; anaemia; abundant metrorrhagia; Retroplacental haematoma; The mother was due to deliver on 08Sep2021 but delivered the pregnancy on 25Jun2021; headache lasting 30 minutes; This is a spontaneous report from a contactable consumer or other non hcp (patient) downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LY20219869. This consumer or other non hcp reported information for both mother and baby. This is a mother case. A 38-years-old pregnant female patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection) via intramuscularly, administered in left arm on 31May2021 (Batch/Lot Number: FA4597) as single dose for covid-19 immunisation. The patient''s medical history included pollen allergy (seasonal allergy) from an unknown date and unknown if ongoing. On 25Jun2021, the patient experienced abundant metrorrhagia and discovery of a retroplacental haematoma Premature cesarean section delivery at week 29 of gestation. It was reported that the child is healthy. On 26Jun2021, the patient experienced anaemia and on 31May2021, the patient experienced headache lasting 30 minutes. The mother reported she became pregnant while taking bnt162b2. The mother was 25 Weeks pregnant at the onset of the event and patient 26 weeks pregnant at the time of the injection. The mother was due to deliver on 08Sep2021. The mother delivered the pregnancy on 25Jun2021 via cesarean delivery. The baby was delivered premature. The baby weighed 1550grams. And also reported simple surgical follow up, establishment of breastfeeding, on 17Aug2021, the child is fine, weight 3500 grams, breastfeeding without complication. Gravida3Para1, 2 spontaneous abortions, one pregnancy conducted to term (weight at birth 3.9 kilograms, arachnoid cyst seen in the third trimester, birth at 40 weeks of gestation). Pregnancy information reported that spontaneous pregnancy start date was 16Dec2020. The patient underwent lab tests and procedures which included activated partial thromboplastin time: 0.76 on 25Jun2021 and 1.23 on 26Aug2021, blood fibrinogen: 5.13 g/l on 25Jun2021 and 3.26 g/l on 26Aug2021, haemoglobin: 100 g/l on 25Jun2021, 84 g/l on 26Jun2021 and 124 g/l on 10Aug2021, tested negative for serology testes included hepatitis b virus, hepatitis c virus, toxoplasma Gondii, Syphilis and HIV test on unspecified date. Tested for hypercoagulation or thrombosis panel done on 26Aug2021 but results were unavailable. Anatomopathology (physical examination): premature hypertrophic placenta maternal vascular malperfusion lesions: decidual arteriopathy, platelet count was 201 g/l on 25Jun2021, 184 g/l on 26Jun2021, 352 g/l on 16Jul2021 and 280 g/l on 10Aug2021. Prothrombin time was 120% on 25Jun2021 and 114 % on 26Aug2021. SARS-CoV-2 test: Negative 12Jun2021. Tested negative for toxoplasma serology and treponema on unspecified date. Ultrasound doppler test or uterine doppler ultrasounds results normal on unspecified date, Ultrasound scan in first and second trimesters were normal, White blood cell count 11.4 g/l on 25Jun2021, 13 g/l on 26Jun2021 and 7.19 g/l on 10Aug2021. Therapeutic measures were taken as a result of headache lasting 30 minutes (headache) resolving after taking doliprane and anaemia requiring initiation of a treatment with Venofer. Evolution reported as good outcome of the mother and the child. No other information available. The outcome of the events retroplacental haematoma, headache was recovered. The outcome of the remaining events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1836087 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001946 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy, Menstruation irregular
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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MONTELUKAST; BECLOMETASONE;FORMOTEROL; MACROGOL
Current Illness: Disease risk factor
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20213

Write-up: In addition, also suffered a miscarriage; vaccination before the pregnancy; Unregulated menstrual cycle; This case was received via regulatory authority (Reference number: NL-LRB-00691225) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (In addition, also suffered a miscarriage) in a 27-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3001946) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: MODERNA COVID-19 VACCINE on 03-May-2021. Concurrent medical conditions included Disease risk factor. Concomitant products included MONTELUKAST, BECLOMETASONE;FORMOTEROL and MACROGOL for an unknown indication. On 31-May-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 31-May-2021, the patient experienced MENSTRUATION IRREGULAR (Unregulated menstrual cycle). On an unknown date, the patient experienced ABORTION SPONTANEOUS (In addition, also suffered a miscarriage) (seriousness criterion medically significant) and MATERNAL EXPOSURE BEFORE PREGNANCY (vaccination before the pregnancy). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (In addition, also suffered a miscarriage) and MATERNAL EXPOSURE BEFORE PREGNANCY (vaccination before the pregnancy) outcome was unknown and MENSTRUATION IRREGULAR (Unregulated menstrual cycle) had not resolved. No Treatment information was reported. This is a regulatory case that reports Maternal exposure before pregnancy and the serious unexpected event of ABORTION SPONTANEOUS in a 27 years old female with medical history of disease risk factor. Time to onset for this event is unknown. Patient?s medical history of disease risk factor could be a confounder/co-suspect for this events. The benefit-risk relationship of Spikevax in not affected by this report Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Translation received on 27-OCT-2021 includes concomitant dosage text and events translation into English.; Reporter''s Comments: Since the nature of the reported reaction does not imply seriousness according to one of the criteria, the reaction was considered as serious by the .; Sender''s Comments: This is a regulatory case that reports Maternal exposure before pregnancy and the serious unexpected event of ABORTION SPONTANEOUS in a 27 years old female with medical history of disease risk factor. Time to onset for this event is unknown. Patient?s medical history of disease risk factor could be a confounder/co-suspect for this events. The benefit-risk relationship of Spikevax in not affected by this report


VAERS ID: 1391282 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-04
Onset:2021-06-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion induced, Exposure during 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? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid baby aspirin
Current Illness: None
Preexisting Conditions: None
Allergies: Cipro
Diagnostic Lab Data: Sonogram
CDC Split Type:

Write-up: 16 week Anatomy scan showed crembrem hyplasia amnd fluid in ventricles that resulted in pregnancy termination


VAERS ID: 1449508 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021748887

Write-up: A patient had a second trimester fetal loss right after getting the Covid vaccine.; A patient had a second trimester fetal loss right after getting the Covid vaccine.; This is a spontaneous report from a contactable physician. An adult female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at an unknown dose on an unknown date via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. Medical history and concomitant drug were not provided. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had 32 weeks gestation period. Patient had a "second trimester" (as reported) fetal loss right after getting the Covid vaccine. The event onset date was Jun2021. Treatment received for the event. It was unknown if the patient diagnosed with COVID-19 prior to vaccination, and unknown if the patient been tested for COVID-19 since the vaccination. The report was assessed as serious with seriousness criteria of hospitalization. Information on lot/batch number has been requested.; Sender''s Comments: Based on available information, a possible contributory role of bnt162b2 cannot be excluded for the reported events miscarriage. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1510180 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-01-01
Onset:2021-06-01
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       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? 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2 subsequent mis carriages within 10 weeks of pregnancy


VAERS ID: 1535124 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-27
Onset:2021-06-01
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8736 / 2 AR / SYR

Administered by: Public       Purchased by: ?
Symptoms: Abdominal distension, Abortion spontaneous, Constipation, Exposure during pregnancy, Morning sickness, Pollakiuria, Ultrasound abdomen
SMQs:, Acute pancreatitis (broad), 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydroxychloroquine for pre-rheumatoid arthritis Prenatal vitamin Claritin for allergies
Current Illness: None
Preexisting Conditions: I am being treated for the beginnings of rheumatoid arthritis.
Allergies: None
Diagnostic Lab Data: Ultrasound - June 2, 2021 Ultrasound - June 13, 2021 Ultrasound - June 14, 2021
CDC Split Type:

Write-up: I was not aware I was pregnant at the time of vaccination but found out shortly after. I later suffered a miscarriage and it appears that the baby stopped developing shortly after I received this vaccine. Timeline: March 31st - received 1st dose of Covid-19 Pfizer vaccine while on my period. My period had started on March 28th. Period ended after 5-7 days as usual and then spotting returned a couple days later, which is highly unusual for me and caused concern. (No sexual activity during those few days so it couldn?t have been implantation bleeding). May 1st - Took a pregnancy test after my period was a week late and it was positive. May-early June. Began experiencing typical pregnancy symptoms (morning sickness, frequent urination, bloating, abdominal growth, constipation) and assumed I was having a normal pregnancy. June 2nd visited OBGYN for what should have been my 9 week appointment/first ultrasound. Dr could not see a fetus and the gestational sack was much smaller than expected. I was informed I had miscarried. Since we could not see any embryo, the growth likely stopped early in the pregnancy, which seems to line up with when I got the 2nd dose of the vaccine. They recommended treatments to expel the remaining tissues, which I followed in the coming weeks. Complications from excessive bleeding resulted in an ER visit and ultimately a D and C to clear remaining tissue.


VAERS ID: 1592969 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-26
Onset:2021-06-01
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6207 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood thyroid stimulating hormone normal, Chlamydia test positive, Chlamydial infection, Full blood count normal, Glycosylated haemoglobin, HIV antibody negative, Lipids normal, Metabolic function test normal, Mycobacterium tuberculosis complex test negative, Thyroxine free normal, Treponema test negative, Urine analysis normal
SMQs:, Termination of pregnancy and risk of abortion (narrow), Infective pneumonia (narrow), Opportunistic infections (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: clomiphene citrate 50mg (3 tablets by mouth daily on days 5-9 of menstrual cycle), colace 100mg daily, folic acid 1mg BID, prenatal vitamin daily, loratadine 10mg daily, metformin 1000mg BID, omeprazole 40mg daily
Current Illness:
Preexisting Conditions: Polycystic ovarian syndrome, allergic rhinitis, gastroesophageal reflux disease, migraine with aura
Allergies: none
Diagnostic Lab Data: During the pregnancy patient had the following test results through our clinic: 4/27/2021 normal urinalysis 5/5/2021 normal Hgb A1c, CMP, Lipid panel, TSH, free T4, CBC 5/18/2021 normal (negative) Rapid Plasma Reagin Syphilis, HIV 1/2 Ab scr, Chla tr + GC DNA PCR urine 5/21/2021 normal (negative) purified protein derivative for tuberculosis
CDC Split Type:

Write-up: Covid Pfizer shots 2/24/21 and 3/16/21, On metformin and clomiphene for PCOS. FDLMP 4/6/21. Normally has 39 day cycle. Had a spontaneous abortion at 8 weeks gestation (approximately 6-1-2021). Fetal tissue passed spontaneously without necessitating D&C. Doctor is OB-GYN who recommended the covid shots. Health facility administered the shots. Had never had other pregnancies. Has not yet been reported to VAERS by anyone else.


VAERS ID: 1609878 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-01
Onset:2021-06-01
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion induced, 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? 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: Metformin, Escitalopram
Current Illness: Insulin resistant
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Ultrasound
CDC Split Type:

Write-up: I had to terminate my pregnancy because the baby had anencephaly.


VAERS ID: 1646386 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-06-25
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage, Human chorionic gonadotropin, Human chorionic gonadotropin decreased, Maternal exposure during pregnancy, Muscle spasms, Ultrasound scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nickel sensitivity
Allergies:
Diagnostic Lab Data: Test Name: HCG Levels; Result Unstructured Data: Test Result:did drop/ unknown to her; Comments: HCG levels during that visit, it did drop but it is Unknown to her; Test Date: 2021; Test Name: HCG Levels; Result Unstructured Data: Test Result:started to decrease; Comments: she got the vaccine the baby stopped growing and her HCG levels started to decrease; Test Date: 202106; Test Name: HCG Levels; Result Unstructured Data: Test Result:6-7 thousand; Comments: A few days before receiving the covid vaccine her HCG levels were between 6-7 thousand; Test Date: 202106; Test Name: HCG Levels; Result Unstructured Data: Test Result:5 thousands; Comments: Then in the ER on the 28Jun2021 or 29Jun2021 it was in the 5 thousands which was slightly lower; Test Date: 20210728; Test Name: HCG Levels; Result Unstructured Data: Test Result:normal; Comments: her HCG levels were back to normal; Test Date: 2021; Test Name: Vaginal Sonogram; Result Unstructured Data: Test Result:Unknown results; Comments: They did another internal Sonogram, to make sure everything came out in its own process; Test Date: 202106; Test Name: Vaginal Sonogram; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: USPFIZER INC202100998813

Write-up: Patient received her first dose of the Pfizer BioNTech Covid 19 vaccine on 25Jun2021 while 5 weeks pregnant; Spotting; Cramping; Her HCG levels had decreased/ HCG levels were lowering; Then 2 weeks later she had the actual miscarriage; bleeding from the miscarriage.; This is a spontaneous report from a contactable consumer, the patient. A 32-years-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in left arm on 25Jun2021 (at the age of 32-years-old) as Dose 1,Single for COVID-19 immunization. The patient''s medical history included allergy to Nickel from an unknown date and unknown if ongoing. There were no concomitant medications. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No prior vaccinations within 4 weeks were taken. LMP (Last Menstrual Period) was on 25May2021 and the mother was due to deliver on 01Mar2022. Patient wanted to ask if in the clinical trial for pregnant women, are women in their first trimester included or not. Patient received her first dose of the Pfizer BioNTech Covid 19 vaccine on 25Jun2021 while 5 weeks pregnant. She received her second dose of the vaccine on 29Jul2021 after experiencing a miscarriage. A few days before her first dose, she had bloodwork done showing her HCG levels were 6000 to 7000. Three to four days after the first dose she went to the ER for spotting, cramping and ultimately a miscarriage. Her HCG levels had decreased when they were rechecked at the ER. Her doctor told her that one in four women have miscarriages but she was calling to see if spotting, cramping or miscarriage are side effects of the vaccine. Patient also stated when she received the second shot there was a question on if she was pregnant or planning to become pregnant and she asked why that one was there and if she should wait a certain amount of time before trying to get pregnant again. Patient stated that she was calling about the Covid Vaccine, when she got the vaccine, shortly after she had a miscarriage, she was 5 weeks pregnant. The baby was fine up until that point but after she got the vaccine the baby stopped growing and her HCG levels started to decrease. Then 2 weeks later she had the actual miscarriage. She went to the doctor 3 weeks after she got the vaccine. With the spotting and everything that was when the HCG levels were lowering. She just went to the doctor before getting the covid vaccine. She was not sure if there was a correlation, Miscarriages happen for all reasons, it was a first trimester pregnancy, she did not know if this was happening to other women, but she tried to research it, but for her and for pregnant women people are so strict with medicines and they were just telling pregnant women to go get the vaccine, maybe not in the first trimester, maybe she should have waited till the baby was stronger. Her First Dose was on 25Jun2021, the spotting started about 3-4 days after, because she was spotting and cramping she went into the emergency room, this was at the end of Jun2021. She was not admitted into the hospital, she came home the same day. Patient explained that right before receiving the covid vaccine she had a HCG levels test done prior, and then in the ER they did a HCG test and Vaginal Sonogram, they did both of those in the ER. A few days before receiving the covid vaccine her HCG levels were between 6-7 thousand, that was a day or 2 before she got the shot. Then in the ER on the 28Jun2021 or 29Jun2021 it was in the 5 thousand which was slightly lower, in the ER they told her that they could not say for sure, sometimes HCG levels might drop a little bit, but she needs to go back to doctor in the week. She had the doctor appointment in the first week of Jul2021, they checked the HCG levels during that visit, it did drop but it is Unknown to her, they probably told her but she was so sad that she was not paying attention. After the doctor appointment was when the actual miscarriage happened, during the doctor visit they told her it was an impending miscarriage, but she had never had a miscarriage before so she didn''t know what was looking for, she thought she was having a period then all the sudden it happened. She just stopped bleeding a week ago, clarified bleeding from the miscarriage. Patient stated that she recalled her most recent visit to the doctor being on her daughter birthday 28Jul2021, her HCG levels were back to normal, clarified with reporter what level in specific does she mean by normal, but that she did not know. They did another internal Sonogram, to make sure everything came out in its own process, patient stated that she did not know too much on the dates of the events. She just knew that she went and got the vaccine shortly after that started spotting and cramping, she did not know if there was a correlation, it could be anything, the doctor said 1 in 4 women have miscarriages but women did not talk about. When queried Medical conditions caller states that she has never had a surgery or even broken a bone. The events then 2 weeks later she had the actual miscarriage, bleeding from the miscarriage, spotting, cramping and her HCG levels had decreased/ HCG levels were lowering resulted in emergency room and physician office visit. The patient underwent lab tests and procedures which included HCG Levels: did drop/ unknown to her (HCG levels during that visit, it did drop but it is Unknown to her), 6-7 thousand on an unknown date Jun2021 (A few days before receiving the covid vaccine her HCG levels were between 6-7 thousand), 5 thousands on an unknown date Jun2021 (Then in the ER on the 28Jun2021 or 29Jun2021 it was in the 5 thousands which was slightly lower), started to decrease on an unknown date in 2021 (she got the vaccine the baby stopped growing and her HCG levels started to decrease) and normal on 28Jul2021 (her HCG levels were back to normal), vaginal sonogram: unknown results on an unknown date in 2021 (They did another internal Sonogram, to make sure everything came out in its own process) and again unknown results on an unknown date in Jun2021. The patient did not receive treatment for then 2 weeks later she had the actual miscarriage, bleeding from the miscarriage, spotting, cramping and her HCG levels had decreased/ HCG levels were lowering. Reporter seriousness for then 2 weeks later she had the actual miscarriage and her HCG levels had decreased/ HCG levels were lowering was unspecified. Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,Batch/Lot Number: not reported) via an unspecified route of administration on 29Jul2021 (at the age of 32-years-old) as Dose 2,Single for COVID-19 immunization. The outcome of the events bleeding from the miscarriage and her HCG levels had decreased/ HCG levels were lowering was recovered on an unknown date in 2021, whereas the events then 2 weeks later she had the actual miscarriage, spotting and cramping was unknown.


VAERS ID: 1742174 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: New York  
Vaccinated:2021-01-01
Onset:2021-06-01
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 1 LA / SYR

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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prozac, albuterol inhaler prn
Current Illness:
Preexisting Conditions: Eczema and asthma
Allergies: Latex, turconazole, nickel
Diagnostic Lab Data: Pregnancy test
CDC Split Type:

Write-up: Received second dose of Pfizer vaccine in January 2021. Miscarried a baby after 5 weeks in June 2021.


VAERS ID: 1750503 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-03-20
Onset:2021-06-01
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 2 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Ultrasound scan
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: Pre-natal Vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Confirmation of miscarriage via ultrasound and beta HCG.
CDC Split Type:

Write-up: Miscarriage, 06/2021; LMP 04/15/2021.


VAERS ID: 1750519 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-05-22
Onset:2021-06-01
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 RA / IM

Administered by: School       Purchased by: ?
Symptoms: Abortion spontaneous, Pregnancy test negative, Ultrasound antenatal screen abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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? 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: Confirmation of miscarriages via ultrasound and beta HCG. Patient bled heavily and symptomatic. She is very healthy fitness instructor, sadly this was her first miscarriage.
CDC Split Type:

Write-up: First miscarriage, 06/2021 Second miscarriage, 08/2021


VAERS ID: 1750598 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-03-20
Onset:2021-06-01
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036A21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038B21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage, Human chorionic gonadotropin negative, Muscle spasms, Ultrasound antenatal screen abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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)

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: FIRST TRIMESTER MISCARRIAGE CONFIRMED POST VACCINE BY ULTRASOUND AND Beta HCG. Patient is recovering from physical and emotional trauma. Will continue to follow. Patient had heavy bleeding.
CDC Split Type:

Write-up: LMP, 04/12/2021 Miscarriage / bleeding / cramping, 06/2021


VAERS ID: 1750851 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-04-10
Onset:2021-06-01
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 2 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Abnormal uterine bleeding, Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin, Ultrasound scan
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), Fertility disorders (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: FIRST TRIMESTER MISCARRIAGE CONFIRMED POST VACCINE BY ULTRASOUND AND Beta HCG. Patient is recovering from physical and emotional trauma. Will continue to follow because she continued to have dysfunctional bleeding after recovering.
CDC Split Type:

Write-up: LMP, 03/06/2021 Miscarriage, 06/2021 Prolonged bleeding since Sep 2021


VAERS ID: 1752825 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-01-26
Onset:2021-06-01
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 029604 / 1 RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036A21A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin negative, Injury, Maternal exposure before pregnancy, Thrombosis, Ultrasound scan normal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
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, as she passed heavy clots, tried to avoid surgical intervention.
CDC Split Type:

Write-up: Miscarriage, 06/2021 (-) FHT


VAERS ID: 1754555 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-05-21
Onset:2021-06-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Abortion spontaneous, Ultrasound scan 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
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: LMP 04/27/2021, Miscarriage, 06/2021.


VAERS ID: 1754743 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-01-26
Onset:2021-06-01
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL3247 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9266 / 2 RA / IM

Administered by: School       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Ultrasound scan
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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Asthma
Allergies: None
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. Patient presented also to ER and had to had medications to assist with halting her bleeding.
CDC Split Type:

Write-up: Miscarriage and heavy bleeding on 06/2021.


VAERS ID: 1762888 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-05-21
Onset:2021-06-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0164 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Pregnancy, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELINEST 0.3-30 MG-MCG per tablet Folic Acid (FOLATE PO) Inositol 500 MG TABS Prenatal Vit-Fe Fumarate-FA (PNV PRENATAL PLUS MULTIVITAMIN) 27-1 MG tablet
Current Illness: NA
Preexisting Conditions: PLAN OF CARE History of anencephaly History of cesarean delivery
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: (there is limited documentation in the electronic health record since seen at an outside facility) Patient reported that she had a miscarriage after vaccination. Vaccinated on 5.21.21 (2nd dose) Had office visit with outside organization provider - PCP on 5.21.21 - perhaps regarding irregular menstrual cycle. I do not see mention of positive pregnancy in this visit. Notes: "Here to get referral to ob due to history of c-sect and trying to get preg and wouold like trial vbac c-sect due to anencephaly. Now on folate. Discussed pregnancy and prev pregnancies. Ref to ob" There appears to be a call reporting Vaginal bleeding in pregnancy, first trimester - on 6.1.21 to MD. No notes in chart.


VAERS ID: 1438656 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-30
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: Miscarriage; Pregnancy (Patient previously had pregnancy successful and had 1 child)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021715568

Write-up: Early miscarriage; Maternal exposure during pregnancy; miscarriage; wasn ? t aware of pregnancy prior to vaccine; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106151156213550-BNLVJ. Safety Report Unique Identifier GB-MHRA-ADR 25476859. This consumer or other non hcp reported information for both mother and fetus/baby. This is a {enter maternal or fetus/baby} report. A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Jun2021 (Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included abortion spontaneous and pregnancy (Patient previously had pregnancy successful and had 1 child). Patient no longer pregnant at the time of reporting. Concomitant medication included folic acid (Patient did not take folic acid supplement during pregnancy). Patient had 1 successful pregnancy with no issues previously. Patient has not had symptoms associated with COVID-19. Patient did not have a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. On an unspecified date in Jun2021, the patient had miscarriage and was not aware of pregnancy prior to vaccine. On 03Jun2021, the patient had maternal exposure during pregnancy (maternal exposure during pregnancy. On 11Jun2021, the patient had early miscarriage. On an unknown date in jun2021, the patient wasn''t aware of pregnancy prior to vaccine, had vaccine on the Thursday (03Jun2021), found out she was expecting the following Wednesday, thought to be around 4.5 weeks on the wednesday so would have been around 4 weeks at the time of the vaccine being administered. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient miscarried on the Friday (11Jun2021). Details of scans or investigations: Miscarriage 1 week after covid jab. Wasn''t aware of pregnancy at the time but had positive test 2 days before miscarriage. Patient has not tested positive for COVID-19 since having the vaccine. Patient was unsure that the medicine had an adverse effect on any aspect of the pregnancy. Patient had another pregnancy test on Sunday (13Jun2021) and was negative. At the time of this report event early miscarriage was recovered on 12Jun2021 and other event outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be requested.


VAERS ID: 1448697 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Abscess limb, 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? 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 normal
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 202106; Test Name: 12 weeks pregnancy scan; Result Unstructured Data: Test Result:revealed a missed miscarriage; Comments: revealed a missed miscarriage
CDC Split Type: GBPFIZER INC2021765614

Write-up: Maternal exposure during pregnancy first-trimester; Abscess leg; Miscarriage; This is a spontaneous report from a contactable consumer received from a regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106221841103980-GXNB1, Safety Report Unique Identifier GB-MHRA-ADR 25521320. A 32-year-old female patient (pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Jun2021 as a single dose for COVID-19 immunisation. The patient medical history included previous successful pregnancy. Patient had no symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included folic acid 400 microgram taken as Folic acid supplementation. The patient received first dose Pfizer covid vaccine on 05Jun2021, while approximately 8.5 weeks pregnant. Patient was exposed to the medicine first-trimester (1-12 weeks). No unexpected side effects experienced at the time and no pain or bleeding experienced in pregnancy, 12 weeks scan revealed a missed miscarriage, thought to have occurred at approximately 8.5 weeks, around the time of receiving the first Pfizer covid vaccine dose. On an unspecified date in Jun2021, the patient experienced abscess leg. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 test (sars-cov-2 test) on 18Jun2021, and result was negative. The reporter assessed the events as serious (medically significant, congenital anomaly). The outcome of the event abscess leg was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1466310 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Vaccination site reaction
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 INC2021794701

Write-up: Miscarriage from Wednesday after; Injection site reaction; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-96122. A 39-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 29May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced miscarriage from Wednesday after on 02Jun2021 and injection site reaction on Jun2021. The mother reported she became pregnant while taking bnt162b2. The mother was 1 trimester pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Outcome of the events was unknown. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.


VAERS ID: 1467556 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Morning sickness, SARS-CoV-2 test, 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), 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:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Factor V Leiden heterozygote
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: ATPFIZER INC2021801270

Write-up: miscarriage; bleedings; normal symptoms of pregnancy: nausea, vomiting, fatigue,..; normal symptoms of pregnancy: nausea, vomiting, fatigue,..; This is a spontaneous report from a contactable consumer or other non hcp (patient). This consumer or other non hcp reported information for herself and her foetus. This is the maternal report. A 36-year-old pregnant female patient received BNT162B2 (COMIRNATY) (Batch/Lot Number: FC2473), dose 1, via an unspecified route of administration on 02Jun2021 (at the age of 36-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included factor v leiden mutation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took aspirin [acetylsalicylic acid] for an unknown indication with no adverse effects reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received D3 solarvit K2 within 2 weeks of vaccination. The patient reported at the time of the first vaccination, she was pregnant without knowing it (reported as early pregnancy, approximately 3-4 weeks pregnant). In the 5th week, the pregnancy was confirmed, but the fetus did not develop accordingly and ended in a miscarriage on 28Jun2021. No heartbeat of the baby when checked on 24Jun2021. Bleeding was noted from 25Jun2021, yolk sac and amniotic cavity developed well, unfortunately the foetus did not. The beta hCG level was consistently optimal. The patient experienced normal pregnancy symptoms (nausea, vomiting and tiredness). The adverse events results in a doctor or other hcp office/clinic visit. The event of miscarriage was assessed as serious (medically significant). The mother was 4 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The patient underwent lab tests and procedures which included sars-cov-2 test (Jun2021): negative. Clinical outcome of the event miscarriage was not resolved. Clinical outcome of the remaining events was unknown.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-2021883011 foetus/mother case


VAERS ID: 1479761 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-01
   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, 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: ITPFIZER INC2021654590

Write-up: miscarriage at week 7; got the vaccine she was about 4 weeks; This is a spontaneous report from a contactable consumer through the WEB. A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28May2021 as 1st dose, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. After 3 days of vaccination, she found out she was pregnant. Basically, by the time she got the vaccine she was about 4 weeks. The patient reported she became pregnant while taking bnt162b2. The patient was 1 trimester pregnant at the time of vaccination. The patient asked her family doctor and gynecologist, and no one can reassure her. She would like more info because, she could not live this moment with the joy she would like, she had so much anxiety. In Jun2021, unfortunately patient had a miscarriage at 7 weeks. It was reported that on 02Jul2021 she should have the second dose. The outcome of the event was unknown. Follow-up (03Jul2021): new information received from a contactable consumer includes: event: unfortunately I had a miscarriage at 7 weeks. Follow-up attempts completed. No further information expected.


VAERS ID: 1486748 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC2021841264

Write-up: she began to have bleeding, where it was getting worse and, she suffered a spontaneous abortion; she began to have bleeding, where it was getting worse and, she suffered a spontaneous abortion; This is a spontaneous report from a contactable consumer (patient''s boyfriend) from Pfizer medical information team. This is a maternal report. A female patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was 7-week pregnant and she took the first dose of Pfizer vaccine, on Thursday morning. On Friday night (Jun2021) she began to have bleeding, where it was getting worse and, on Tuesday, 15Jun2021, she suffered a spontaneous abortion. The outcome of the event was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1506845 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Dizziness, Fatigue, Headache, Nausea, Pelvic pain, SARS-CoV-2 test, Ultrasound uterus, Vertigo
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad), Sexual dysfunction (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: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210118; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Date: 20210624; Test Name: ultrasound; Result Unstructured Data: Test Result:no cardiac activity
CDC Split Type: FRPFIZER INC2021883017

Write-up: Miscarriage; Nausea; Vertigo; great fatigue; headaches; dizziness; pelvic pain; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB, regulatory authority number FR-AFSSAPS-2021083838. A 40-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 05Jun2021 (Lot Number: FC8736) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from 18Jan2021. The patient''s concomitant medications were not reported. The patient experienced miscarriage on 24Jun2021, nausea on 07Jun2021, vertigo on 07Jun2021. It was reported the patient was vaccinated in the first trimester of pregnancy (date of last period not specified, irregular cycles) by Comirnaty. From 1st week: the patient had great fatigue, headaches. From the 2nd week: the patient had dizziness, nausea, pelvic pain without metrorrhagia then miscarriage: ultrasound done on 24Jun2021 at 9 weeks of amenorrhea and 3 days, no cardiac activity. No treatment taken during symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Jan2021, ultrasound uterus: no cardiac activity on 24Jun2021. The outcome of events miscarriage, nausea, and vertigo was recovered; of other event was unknown.


VAERS ID: 1554834 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Abortion spontaneous, Dysmenorrhoea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnant (week 5)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202100973298

Write-up: after I took the vaccine it took a couple of days then I started to get "menstrual pain" in the back and stomach; It took a couple of days until I started to get a little stomach ache; SPONTANEOUS ABORTION; This is a spontaneous report from a non-contactable consumer (patient) downloaded from the WEB, regulatory authority number NO-NOMAADVRE-PASRAPP-2021-Uxprr7. A 34-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in arm right on 16Jun2021 15:15 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included pregnant - week 5 at the time of the vaccination. The patient''s concomitant medications were not reported. The mother was 6 weeks pregnant at the onset of the event. On Jun2021, the patient experienced spontaneous abortion, serious due to important medical event. After several days with "murmuring" she started bleeding. The reaction was considered to be spontaneous abortion. On an unspecified date, patient reported "after I took the vaccine, it took a couple of days then I started to get menstrual pain in the back and stomach, it took a couple of days until I started to get a little stomach ache." Outcome of event spontaneous abortion was recovered, while other events were unknown. Reporter Comment: Description of adverse reaction progress, diseases and other relevant information: A couple of days after the vaccine, the patient started getting "menstruation pain" in the back and stomach. After several days with "murmuring" she started bleeding. The vaccination was in ca. week 5. SPONTANEOUS ABORTION happened in week 6. Patient reports a latency being "a couple days before noticing some pain in the stomach". Sender Comment: The patient reports Uncertain dosage form/strength: Comirnaty, suspected. The case will be followed up. Upgraded to Serious due to (Other Serious (Important Medical Events)). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Description of adverse reaction progress, diseases and other relevant information: A couple of days after the vaccine, the patient started getting "menstruation pain" in the back and stomach. After several days with "murmuring" she started bleeding. The vaccination was in ca. week 5. SPONTANEOUS ABORTION happened in week 6. Patient reports a latency being "a couple days before noticing some pain in the stomach".


VAERS ID: 1558524 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-06-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Ear infection, 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? 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: FRPFIZER INC202100977449

Write-up: Miscarriage; Heavy menstrual bleeding; recurrent otitis in the left ear; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left on 23May2021 (Batch/Lot Number: Unknown) as single dose (at 31 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Jun2021, the patient experienced miscarriage (medically significant) with outcome of recovered with sequelae, heavy menstrual bleeding with outcome of unknown, recurrent otitis in the left ear with outcome of unknown. The events required a visit to the physician''s office. Therapeutic measures were taken as a result of the events included antibiotic drugs and painkiller drugs. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.


VAERS ID: 1584928 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Foetal death, Ultrasound scan
SMQs:, Guillain-Barre syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: In vitro fertilisation
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: ultrasound; Result Unstructured Data: Test Result:Nothing to report; Comments: ultrasound in 1st trimester; Test Date: 20210616; Test Name: ultrasound; Result Unstructured Data: Test Result:stop of foetal heart activity Intra uterine death; Comments: new ultrasound at 2.5 months of pregnancy
CDC Split Type: FRPFIZER INC202100996798

Write-up: Death intrauterine; Asthenia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BR20212888. This physician reported information for both mother and fetus. This is a maternal report. A 37-years-old female patient received bnt162b2 (COMIRNATY), first dose intramuscular on 11Jun2021 (Batch/Lot Number: FD0168) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included in vitro fertilisation on 30Mar2021 (Pregnancy through assisted reproduction technology in vitro fertilisation: fertilisation on 30Mar2021). The patient''s concomitant medications were not reported. The patient experienced death intrauterine (hospitalization, medically significant) on 16Jun2021 with outcome of Recovered with Sequel, asthenia for 48 hours without a fever on Jun2021 with outcome of recovered. The mother reported she became pregnant while taking bnt162b2. The mother was 13 Weeks pregnant at the onset of the event (reported as Overall, onset of intra uterine death at 2.5 months of pregnancy, 6 days after a 1st injection of COMIRNATY). The mother was due to deliver on 22Dec2021 (as expected). The mother underwent therapeutic abortion. The fetal outcome is intrauterine death. The patient underwent lab tests which included ultrasound scan: nothing to report on 10Jun2021 (ultrasound in 1st trimester), ultrasound scan: stop of foetal heart activity intra uterine death on 16Jun2021 (new ultrasound at 2.5 months of pregnancy). Last Menstrual Period on 17Mar2021. On 21Jun2021: curettage aspiration. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101039993 case created for child


VAERS ID: 1663741 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion induced, Influenza like illness, Menstrual disorder, Ovulation disorder, Presyncope
SMQs:, Anticholinergic syndrome (broad), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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:
CDC Split Type: FRPFIZER INC202101061810

Write-up: Vagal reaction; Menstrual disorder; Influenza like illness; Ovulation disorder; Pregnancy termination; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PB20215319. A 39-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Jun2021 at age of 39 years old (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications was not reported. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. First dose with influenza-like syndrome. The patient experienced, pregnancy termination in 2021, menstrual disorder on 23Jun2021, influenza like illness on 23Jun2021, vagal reaction on 23Jun2021, Ovulation disorder in Jun2021. The patient became pregnant while taking bnt162b2. The fetal outcome is intrauterine death. The first dose had caused some mild discomfort: influenza-like syndrome for 3 days. The same reoccurred after the second dose, with the addition of small vagal discomfort. Nonetheless, nothing serious in itself. The problem is that I have noticed a disturbance in my menstrual cycle, which never used to surprise me. My period, following the 2nd dose, lasted for 3 days instead of the usual 5. Most importantly, ovulation, which usually occurs 12-14 days later, seemed to occur the day after my period, if not at the very end thereof. The consequence was, as a result of a miscalculation and a wrong decision, an unwanted pregnancy and an abortion. The outcome of events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101098416 same patient, different AE and first dose


VAERS ID: 1664553 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Intermenstrual bleeding
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? 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: ISJNJFOC20210845474

Write-up: MENSTRUATION PROLONGED; BLEEDING MENSTRUAL HEAVY; MISCARRIAGE; OVULATION BLEEDING; This spontaneous pregnancy report received from a consumer via a Regulatory authority (EVHUMAN Vaccines, IS-IMA-4256) on 20-AUG-2021, concerned a 40 year old female patient of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 20-MAY-2021 for covid-19 immunisation (drug start period: 2 weeks). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, in JUN-2021, the patient experienced ovulation bleeding and had a miscarriage on 03-JUN-2021. On 29-JUN-2021, the patient experienced prolonged menstruation and heavy menstrual bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from miscarriage, ovulation bleeding, menstruation prolonged, and bleeding menstrual heavy. This report was serious (Congenital Anomaly/Birth Defect).; Sender''s Comments: V0: 20210845474-COVID-19 VACCINE AD26.COV2.S-miscarriage, ovulation bleeding, menstruation prolonged, and bleeding menstrual heavy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1668339 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-06-01
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, COVID-19, Drug ineffective, Foetal exposure during pregnancy, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Miscarriage; Pregnancy; Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101105218

Write-up: SARS-CoV-2 infection; child was exposured to the medicine: first-trimester (1-12 weeks); patient was exposed to the medicine first-trimester (1-12 weeks); SARS-CoV-2 infection; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108241323455580-FVZJH, Safety Report Unique Identifier GB-MHRA-ADR 25841145. This consumer or other non hcp reported information for both mother. This is a maternal or fetus/baby report. A 37-year-old (pregnant) female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EY5456) via an unspecified route of administration on 22May2021 as single dose for COVID-19 immunisation. Medical history included abortion spontaneous and pregnancy. Concomitant medication included folic acid was taken for an unspecified indication, start and stop date were not reported. On 01Jun2021, the patient experienced miscarriage of pregnancy. On 13Jul2021, the patient experienced sars-cov-2 infection. On an unspecified date, the patient experienced child was exposured to the medicine: first-trimester (1-12 weeks) and patient was exposed to the medicine first-trimester (1-12 weeks). The mother reported she became pregnant while taking BNT162B2. The patient also reported that shortly after receiving the vaccine, she had a miscarriage. Patient was not enrolled in clinical trial. Patient did not take folic acid supplement during pregnancy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date No - Negative COVID-19 test. The outcome of the event sars-cov-2 infection was recovered on 23Jul2021 and the outcome of the rest of the event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1675539 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101103041

Write-up: I had preterm delivery and my baby loss/I saw discharge and bleeding; Chest pain after 12 and 48 hours after vaccine; This is a spontaneous report from a contactable female consumer (patient). This consumer reported information for both mother and fetus/baby. This is a mother report. A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer reported that "On 20Jun2021 I had my first dosage of Pfizer covid vaccine while I was 23 weeks pregnant. After 12 hours I had chest pain, it took 45 min. After 48 hours from vaccine I had chest pain again for second time for whole day and 7 days after my vaccine I saw discharge and bleeding. I went to hospital and on 02Jul2021 I had preterm delivery and my baby loss. I am healthy woman without problem in this pregnancy. I think Pfizer is related to my loss." Outcome for events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : CA-PFIZER INC-202101103083 mother and baby cases


VAERS ID: 1772488 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Pregnancy test urine
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Delivery; Pregnancy normal
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: Pregnancy test urine; Test Result: Positive
CDC Split Type: EEPFIZER INC202101273749

Write-up: Abortion missed; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority, regulatory authority number EE-SAM-51112109141. A 34-year-old female patient received bnt162b2 (Solution for injection, Batch/Lot Number: EW6126), dose 1 intramuscular on 28May2021 as DOSE 1, 0.3 ML, SINGLE for covid-19 immunisation. Medical history included delivery, pregnancy normal. There have been no gynecological or other health disorders. The patient had no comorbidities or allergies. The patient''s concomitant medications were not reported. The patient experienced abortion missed (medically significant) in Jun2021. The patient became aware of the retention on 14Jul2021, but it had probably happened a week or two earlier. No subsequent fetal study was performed and it was not known whether there was a developmental disorder in the fetus. The fetal heart either did not start beating or stopped beating. At the time of retention, the fetus was approximately 1 cm in size, or about 6 or 7 weeks. The mother reported she became pregnant while taking bnt162b2. The mother was due to deliver on 12Feb2022. The mother underwent therapeutic abortion. The fetal outcome was intrauterine death. The patient underwent lab tests and procedures which included pregnancy test urine: positive on 05Jun2021. Therapeutic measures were taken: The pregnancy was terminated on 22Jul2021, medical abortion, uterine cleansing was not necessary. Sender Comment: The temporal relationship exists. The causal relationship cannot be assessed. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1783847 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
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, 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? Yes
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:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210530; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101311069

Write-up: Abortion spontaneous; Miscarriage of pregnancy; Miscarriage; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110021838207450-DKOOF. Safety Report Unique Identifier GB-MHRA-ADR 26027745. This consumer reported information for both mother and fetus/baby. This is a maternal or fetus/baby report. A 30-years-old pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot Number was unknown), via an unspecified route of administration on 01Jun2021 (at the age of 30 years) as dose 1, single for COVID-19 immunization. Medical history included pregnancy from an unknown date. The patient no longer pregnant at the time of reporting. Concomitant medication included folic acid at a dose of 400 ug, taken for folic acid supplementation, start and stop date were not reported. The patient had not had symptoms associated with COVID-19. The patient was not currently breastfeeding and had no other medical history. The medicine had an adverse effect on any aspect of the pregnancy. The patient was exposed to the medicine first-trimester (1-12 weeks). On 01Jun2021, the patient had maternal exposure during pregnancy, first trimester when she received the first dose of vaccine. On 10Sep2021, the patient experienced abortion spontaneous, miscarriage of pregnancy and miscarriage. The seriousness criteria of the events were reported as hospitalization (2021), disability, medically significant and congenital anomaly. The mother reported she became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included COVID-19 virus test (sars-cov-2 test) with negative result (No - Negative COVID-19 test), on 30May2021. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The outcome for the events abortion spontaneous, miscarriage of pregnancy and miscarriage was reported as not recovered, at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1796885 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Congenital musculoskeletal anomaly, Foetal hypokinesia, Limb malformation, Maternal exposure during pregnancy, Stillbirth, Ultrasound Doppler, Ultrasound scan
SMQs:, 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? Yes
Died? Yes
   Date died: 2021-07-19
   Days after onset: 48
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: Myopia (mother)
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: Ultrasound Doppler; Result Unstructured Data: Test Result:No movement of upper limbs; Comments: Medullary cone rather low seated (L3L4). No movement of upper limbs, with elbows and fingers in permanent flexion, and wrists in extension. Lower limbs with very reduced motility in permanent extension with an aspect of "ice axe" feet. No abnormal shape of the long bones. Amniotic fluid in normal quantity. Doppler normal. The rest of the morphology is unremarkable.; Test Date: 20210624; Test Name: 3D ultrasound; Result Unstructured Data: Test Result:immobile lower limbs; Comments: immobile lower limbs, blocked in hip flexion, knee and foot in extension. Hands are also slightly mobile on each side of the cephalic pole with extended wrist and tensed fingers. The rest of the morphology is unremarkable.
CDC Split Type: LUPFIZER INC202101351051

Write-up: musculoskeletal congenital anomaly; premature delivery of a stillborn female child; Limb malformation; Maternal exposure during pregnancy, second trimester; Fetal hypokinesia; This is a spontaneous report from a contactable consumer downloaded from the WEB (regulatory authority number: LU-ALMPS-202103054). This consumer reported information for both mother and fetus. This is the fetus report. A fetus female patient received bnt162b2 (COMIRNATY), dose 1 transplacental on 08Jun2021 (Lot Number: FA5833) as DOSE 1, SINGLE; dose 2 transplacental on 06Jul2021 (Lot Number: FC1433) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Family history included myopia (mother). The patient''s mother has relevant medical history of breast implants and myopia treated with laser. The mother''s obstetrical history: gravidity 2, parity 0, with miscarriage in 2014. The mother''s height was 165 cm, and her weight was 57 kgs. On 20Jan2021, the mother had a new pregnancy start with due date on 20Oct2021. It was reported that the fetus experienced maternal exposure during pregnancy, second trimester on 08Jun2021, musculoskeletal congenital anomaly on an unspecified date, fetal hypokinesia in Jun2021 and limb malformation on 24Jun2021. The clinical course was reported as follows: On 08Jun2021, she was vaccinated with bnt162b2 first dose (Dose 1) (lot FA5833) and second dose (Dose 2) on 06Jul2021 (lot FC1433). On 24Jun2021 (23+1 amenorrhea weeks), a 3D ultrasound was performed in a context of fetal hypokinesia: weight 554 g (33 p), immobile lower limbs, blocked in hip flexion, knee and foot in extension. Hands were also slightly mobile on each side of the cephalic pole with wrist in extension and tensed fingers. The rest of the morphology was unremarkable. On 01Jul2021 (25+1 amenorrhea weeks), ultrasound doppler: weight 605 g (5 p), medullary cone was rather low seated (L3L4). No movement of upper limbs, with elbows and fingers in permanent flexion, and wrists in extension. Lower limbs with very reduced motility in permanent extension with an aspect of "ice axe" feet. No abnormal shape of the long bones. Amniotic fluid in normal quantity. Doppler normal. The rest of the morphology was unremarkable. Conclusion: particular seriousness of the clinical picture. Indication for amniotic fluid exploration. On 07Jul2021 (26 amenorrhea weeks), collection of amniotic fluid by transabdominal non-transplacental route: 105 mL of clear fluid. Good technical conditions. Cytogenetic research for ACPA (anti-cyclic citrullinated peptide autoantibodies), DNA conservation, SMN (Spinal muscular atrophy genes), DMPK (Myotonic Dystrophy Type 1) and 15q11q12 research (awaited). On 19Jul2021, termination of pregnancy with premature delivery of a stillborn female child. Outcome of all events was fatal. An autopsy was performed (results are not available). Assessment: Comirnaty/Fetal hypokinesia, Limb malformation/NCA: C1 S1 (I1 dubious) B1 No follow-up attempts are possible, no further information is expected.; Sender''s Comments: Linked Report(s) : LU-PFIZER INC-202101351047 mother case; Reported Cause(s) of Death: Musculoskeletal congenital anomaly; fetal hypokinesia; limb malformation; premature delivery of a stillborn female child


VAERS ID: 1824997 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 043D21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Stillbirth, Vaccination site discomfort
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: LETROZOLE; BABY ASPIRIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAMODERNATX, INC.MOD20213

Write-up: This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of STILLBIRTH (lost the baby) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 043D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LETROZOLE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. The patient''s last menstrual period was on 10-Feb-2021 and the estimated date of delivery was 13-Nov-2021. In June 2021, the patient experienced VACCINATION SITE DISCOMFORT (She just had a heavy arm after the first shot). On 28-Jun-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 20-Jul-2021, the patient experienced STILLBIRTH (lost the baby) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna CoviD-19 Vaccine) beginning around the nineteenth week of the pregnancy. The delivery occurred, which was reported as Still birth. For fetus 1, The outcome was reported as Stillbirth NOS. On 28-Jun-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 20-Jul-2021, STILLBIRTH (lost the baby) had resolved. At the time of the report, VACCINATION SITE DISCOMFORT (She just had a heavy arm after the first shot) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Treatment information not provided. COMPANY COMMENT: This case concerns a 32-year-old female patient with no previous relevant medical history, who experienced Maternal exposure during pregnancy and the unexpected serious events of Stillbirth after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The patient received the first dose of the vaccine at an approximately 19 weeks of gestation. The event occurred approximately 1 month and 2 days after the first dose of Spikevax, at 24 weeks of gestation. The rechallenge is not applicable due to the nature of the event . The benefit-risk relationship of Spikevax vaccine is not affected by this report This case was linked to MOD-2021-352755 (Patient Link).; Sender''s Comments: This case concerns a 32-year-old female patient with no previous relevant medical history, who experienced Maternal exposure during pregnancy and the unexpected serious events of Stillbirth after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The patient received the first dose of the vaccine at an approximately 19 weeks of gestation. The event occurred approximately 1 month and 2 days after the first dose of Spikevax, at 24 weeks of gestation. The rechallenge is not applicable due to the nature of the event . The benefit-risk relationship of Spikevax vaccine is not affected by this report


VAERS ID: 1375928 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-18
Onset:2021-06-02
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal growth restriction, 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro Prenatal vitamin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Miscarriage confirmed via ultrasound on 6/3/21.
CDC Split Type:

Write-up: First dose moderna: 3/18/21 Second dose moderna: 4/15/21 Conceived: 4/14/21 Miscarriage at 7.5 weeks pregnant. Baby stopped growing at size 6 weeks pregnant. Due date: January 17 2022 Pregnancy confirmed 5/24/21. gestation age: 8 weeks 1 day based on LMP. Baby only measured 6 weeks 0 days on this date.


VAERS ID: 1376421 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Exposure during pregnancy
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient called the pharmacy a few days after her 2nd Moderna vaccination and stated about a day after her shot she started experiencing abdominal cramps. Patient was pregnant so was very concerned and went to the hospital. Unsure how far along she was but she wanted us to know she had a miscarriage. We are unaware if this is linked to the vaccination but patient is stating that''s the only thing that has changed since her three previous pregnancies that had no issues whatsoever. Reporting this since she called the pharmacy so we were aware and since we are not aware if the hospital filed this report.


VAERS ID: 1642280 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-01
Onset:2021-06-02
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, 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? 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: Iv contrast
Diagnostic Lab Data: Ultrasound (02-Jun-2021, 10-Jun-2021)
CDC Split Type:

Write-up: Was likely in first days of pregnancy during receipt of the second dose of Pfizer vaccine on 22/apr/21. Pregnancy was not discovered until several weeks after vaccination. At the first ultrasound (scheduled for 9 weeks from proposed date of conception?02/jun/21 the fetus was reported as measuring small and after second ultrasound the following week it was determined that the pregnancy was not viable and miscarriage began on 18-Jun and completed on 25-Jun-2021.


VAERS ID: 1657577 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-01-23
Onset:2021-06-02
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound foetal
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data: ULTRASOUND WITH POSITIVE HEART BEAT AND THEN BLED AND MISCARRIED.
CDC Split Type:

Write-up: POST VACCINE FIRST TRIMESTER MISCARRIAGE.


VAERS ID: 1750846 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-01-27
Onset:2021-06-02
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032L20A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032L20A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Emotional distress, Human chorionic gonadotropin positive, Ultrasound uterus abnormal, Uterine dilation and curettage, Vaginal discharge, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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? Yes
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: OTC multivitamins
Current Illness: None
Preexisting Conditions: None
Allergies: None
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. Patient bled and had to undergo surgery at the Hospital emergency and to OR for urgent Dilation and Curettage.
CDC Split Type:

Write-up: LMP, 02/26/2021 -- $g EDD 12/03/2021 Patient stated vaginal discharge, 06/02/2021 Miscarriage @ 13 + 5 D & C, 06/28/2021


VAERS ID: 1404354 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Dysmenorrhoea, 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: miscarriage; painful period; Exposure during Pregnancy; Vaginal bleeding; This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (miscarriage) 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. The patient''s past medical history included Lactation decreased. On 01-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 02-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding). On an unknown date, the patient experienced ABORTION SPONTANEOUS (miscarriage) (seriousness criterion medically significant), DYSMENORRHOEA (painful period) and EXPOSURE DURING PREGNANCY (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 (miscarriage) and DYSMENORRHOEA (painful period) was resolving, VAGINAL HAEMORRHAGE (Vaginal bleeding) had not resolved and EXPOSURE DURING PREGNANCY (Exposure during Pregnancy) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product use was reported. No treatment information was provided. The patient reported that, usually she has very regular periods but her period started 6 days before expected, ~36 hours after the 1st vaccine dose (Moderna). She also believed she may have conceived this month and this may be a very early miscarriage but there''s no way to prove that. Company Comment : This is a case of product exposure during pregnancy with associated AEs for this 35-year-old female. No further information is expected.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AEs for this 35-year-old female. No further information is expected.


VAERS ID: 1408830 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021648134

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EW4109), via an unspecified route of administration, administered in Arm Left on 19May2021 10:15 (at age of 34-year-old) at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 02Jun2021 12:00 (14 days after receiving first dose of BNT162B2 ), the patient experienced early miscarriage around 8 weeks (as reported). The mother reported she became pregnant while taking bnt162b2. Patient last menstrual period date 31Mar2021. The outcome of the event was unknown. This consumer reported information for both mother and fetus/baby. This is a enter maternal report. A 34-year-old female patient received the first dose of bnt162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, lot# EW4109), via an unspecified route of administration, administered in Arm Left on 19May2021 10:15 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced early miscarriage around 8 weeks, 14 days after receiving 1st. affine dose (abortion spontaneous) (congenital anomaly) on 02Jun2021 12:00 with outcome of recovering. The mother reported she became pregnant while taking bnt162b2. The mother was 9 Weeks pregnant at the onset of the event. The mother was due to deliver on 07Jan2022. Additional Information: Start Date/Time: [Pfizer bioNTec] 19May2021 10:15 AM Facility where the most recent COVID-19 vaccine was administered: Doctor''s office/urgent care Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No List of any other medications the patient received within 2 weeks of vaccination: No Reported Event: Early miscarriage around 8 weeks, 14 days after receiving 1st. Affine dose Did the adverse event result in any of the following: Doctor or other healthcare professional office/clinic visit Did the adverse event result in any of the following: Emergency room/department or urgent care Prior to vaccination, was the patient diagnosed with COVID-19: No Since the vaccination, has the patient been tested for COVID-19: No Device Date: 03Jun2021


VAERS ID: 1419085 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Body temperature, Ovulation delayed, Pain in extremity, Peripheral swelling, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (narrow), Hypersensitivity (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? 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: Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Increased
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Miscarriage; Rash; Ovulation delayed; Swollen arm; Painful arm; This regulatory authority pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Miscarriage in February 2021. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Jun-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Painful arm). On 08-Jun-2021, the patient experienced OVULATION DELAYED (Ovulation delayed). On 09-Jun-2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On 04-Jun-2021, PAIN IN EXTREMITY (Painful arm) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and OVULATION DELAYED (Ovulation delayed) had not resolved and PERIPHERAL SWELLING (Swollen arm) and RASH (Rash) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Body temperature: spiked (High) Increased. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Patient was trying for a baby, tracking temperature & doing ovulation sticks. Her temperature got spiked the day after vaccination & she had 3 days late ovulating with no signs of hormone peak. Her body temperature was back to normal later. Patient had Negative COVID-19 test on an unknown date. Concomitant medications were not provided. Treatment information was not provided.; 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 (peripheral swelling, pain in extremity, and rash), a causal relationship cannot be excluded. Very limited information regarding this event (abortion spontaneous and ovulation delayed) has been provided at this time. It is not clear if the subject was trying to become pregnant and had abortion prior to vaccination in February.


VAERS ID: 1428368 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-06-02
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EE8492 / 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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021683492

Write-up: Patient was exposed to the medicine first-trimester (1-12 weeks); Early miscarriage; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number [GB-MHRA-WEBCOVID-202106091052235290-HJ5UO], Safety Report Unique Identifier [GB-MHRA-ADR 25443293]. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 (Lot number: EE8492) as dose 2, single for COVID-19 immunisation. Medical history included miscarriage, pregnancy and folic acid supplementation, all from an unknown date and unknown if ongoing. Concomitant medications included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient experienced early miscarriage and patient was exposed to the medicine first-trimester (1-12 weeks) on an unspecified date; and early miscarriage on 02Jun2021. The events were assessed as serious (medically significant). The outcome of the event ''early miscarriage'' was recovering and event ''Patient was exposed to the medicine first-trimester (1-12 weeks)'' was unknown. The clinical course was reported as follows: Conceived around the 28Mar2021, 2nd COVID vaccine on 31Mar2021, pregnancy didn''t progress beyond yolk scan forming (around 5 weeks) and expectant miscarriage started on the 02Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. Child was exposed to the medicine: first-trimester (1-12 weeks). Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Miscarriage. Additional information: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1438525 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-30
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 breast feeding, Maternal exposure during pregnancy, Off label use, Pain in extremity, Product use issue, SARS-CoV-2 test, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal exposures via breast milk (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Medication errors (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: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Miscarriage; 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: Scan; Result Unstructured Data: Test Result:Miscarriage
CDC Split Type: GBPFIZER INC2021655352

Write-up: Maternal exposure during pregnancy; Off label use; Drug use in unapproved population; missed miscarriage; Maternal exposure during breast feeding; Painful arm; 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-202106031610291220-BKFXQ, Safety Report Unique Identifier GB-MHRA-ADR 25414346. A 33-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EY5456) via an unspecified route of administration on an unspecified date in Jun2021 as single dose for COVID-19 immunisation. The patient medical history included abortion spontaneous, pregnancy. Patient was no longer pregnant at the time of reporting, ongoing breast feeding, immunodeficiency. Has an illness or condition, not listed above, which reduces the immune response (example: immunodeficiency, vitamin supplementation. Currently suffering from a missed miscarriage. The pharmacist thought this may impact her immune response. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. On an unspecified date, the patient experienced missed miscarriage, maternal exposure during pregnancy, maternal exposure during breast feeding, off label use and drug use in unapproved population. On 02Jun2021, she had painful arm. The patient underwent lab tests which showed sars-cov-2 test as negative, no - negative COVID-19 test and scan showed miscarriage. Narrative case summary and further information included case narrative as patient has not tested positive for COVID-19 since having the vaccine. The medicine had no adverse effect on any aspect of the pregnancy. Details of previous pregnancies: One previous pregnancy. Missed miscarriage after. Details of scans or investigations: Missed miscarriage. Scan at 11 weeks 4 days, confirmed baby had not grown since 7 weeks. Outcome was not resolved for event painful arm and was unknown for rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1491784 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (Study details: Office for national statistics and ox unu)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021853622

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107032055248410-QVPJW. Safety Report Unique Identifier is GB-MHRA-ADR 25591252. This is a maternal report. A pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Et8885) via an unspecified route of administration on 26May2021 as dose 1, single for COVID-19 immunization. Medical history included clinical trial participant, study details: Office for national statistics and ox unu. Patient has not had symptoms associated with COVID-19 and she has not had a COVID-19 test. There were no concomitant medications, patient had no other meds taken at time. The patient experienced miscarriage on 02Jun2021. The event was reported as serious per hospitalization (2021) and other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. The pregnancy resulted in spontaneous abortion. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516418 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-06-02
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-30
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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
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 INC2021906904

Write-up: Miscarriage/Early miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107150852404740-WCYZS. Safety Report Unique Identifier GB-MHRA-ADR 25654438. This consumer reported information for both mother and fetus. This is the maternal report. A 34-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18May2021 (Batch/Lot Number: ET8885) as dose 1, single for COVID-19 immunization. Unsure if patient has had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for Folic acid supplementation, start and stop date were not reported. The patient experienced miscarriage/early miscarriage on 02Jun2021. The event was reported as non-serious. The clinical course was reported as follows: The patient was no longer pregnant at the time of reporting. Miscarriage. Heart stopped at 6weeks 3 days. Missed miscarriage. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The reporter 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 received vaccine at 3 weeks, scan at 9 weeks showed fetus stopped growing at 6w 3D. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on unspecified date. The outcome of miscarriage/early miscarriage was unknown. However, it was also reported that the outcome is not recovered. No follow-up attempts are possible. No further information is expected.


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