National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

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)

This is page 18 out of 27

Result pages: prev   1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27   next


VAERS ID: 1540354 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-13
Onset:2021-06-22
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Incomplete course of vaccination, 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), Medication errors (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? No
Previous Vaccinations:
Other Medications: liothyronine, levothyroxine
Current Illness: none
Preexisting Conditions: scoliosis
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was pregnant, but not aware, at time of initial Pfizer vaccine. She did not get second dose once discovering she was pregnant. She started having vaginal bleeding on 6/22/21, was sent to ER and determined to have had a spontaneous abortion.


VAERS ID: 1674482 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-02-12
Onset:2021-06-22
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 AR / SYR

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

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

Write-up: My water broke on 6/22/21 at 22 weeks and 6 days pregnant. I had my baby at 27 weeks and 4 days on 7/18/21. His estimated due date was 10/13/21.


VAERS ID: 1455888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-06-22
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ST8885 / 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? 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: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Normal delivery; Polycystic ovarian syndrome; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210622; Test Name: pregnancy scan; Result Unstructured Data: Test Result:small for gestational age foetus and no heartbeat; Comments: No foetal heart rate detected on dating scan at 12 weeks. Foetus small for dates. Waiting to miscarry.
CDC Split Type: GBPFIZER INC2021766058

Write-up: Early miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106230747037180-LWUXA and Safety Report Unique Identifier is GB-MHRA-ADR 25523039. The consumer reported both for the mother and the fetus This is the mother case. A 40-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14May2021 (Batch/Lot Number: ST8885) as dose 1, single for covid-19 immunization. Medical history included Polycystic Ovarian Syndrome, ongoing pregnancy and one previous pregnancy 10 years ago, normal pregnancy and delivery (2011). Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation. On 22Jun2021, the patient experienced early miscarriage. The clinical course was reported as follows: LMP 28.03.21. Vaccine on 14May2021. First pregnancy scan at 12 weeks (22.06.21) revealed: a small for gestational age foetus and no heartbeat. Previous pregnancy normal. Patient has not tested positive for COVID-19 since having the vaccine. Details of previous pregnancies: One previous pregnancy 10 years ago. Normal pregnancy and delivery. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: No foetal heart rate detected on dating scan at 12 weeks. Foetus small for dates. Waiting to miscarry. The case is serious (medically significant). The outcome for early miscarriage was miscarriage. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1459542 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0221 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal death, Gynaecological examination, Inappropriate schedule of product administration, Ultrasound abdomen
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: no
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: pelvic exam; Result Unstructured Data: Test Result:confirm miscarriage; Test Date: 20210623; Test Name: ultrasound; Result Unstructured Data: Test Result:confirm miscarriage
CDC Split Type: CAPFIZER INC2021782766

Write-up: The day after the vaccine my embryo died and I had an spontaneous miscarriage.; The day after the vaccine my embryo died and I had an spontaneous miscarriage.; first dose of bnt162b2 on 06Apr2021 10:00 AM, second dose on 22Jun2021 10:00 AM; This is a spontaneous report from a contactable pharmacist. A 31-years-old female patient received bnt162b2 (PFIZER MRNA BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 22Jun2021 10:00 AM (at age of 31-years-old) (Batch/Lot Number: EW0221) as single dose for covid-19 immunisation. There was no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hpv vaccine taken for immunisation on 03Jun2021. The patient previously took the first dose of bnt162b2 on 06Apr2021 10:00 AM as single dose on arm left (Batch/lot number ER1742) for covid-19 immunisation. On 23Jun2021 04:00, the day after the vaccine her embryo died and she had an spontaneous miscarriage. The events were considered as serious per disability, medically significant, congenital anomaly. The mother reported she became pregnant while taking bnt162b2. The mother was 7 weeks pregnant at the onset of the event. The mother was pregnant with 1 baby. The mother was due to deliver on 06Feb2022. The pregnancy resulted in spontaneous abortion. Confirm miscarriage ultrasound and pelvic exam on 23Jun2021. The treatment was received for the events. Since the vaccination, the patient had not been tested for COVID-19. The events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of fetal death was not recovered, of other events was unknown.; Sender''s Comments: Based on the close temporal relationship, the association between the event "her embryo died and she had a spontaneous abortion" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1471870 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time ratio, Foetal death, Glomerular filtration rate, Haemoglobin, International normalised ratio, Platelet count, Polymerase chain reaction, Prothrombin time, Ultrasound scan
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVOCETIRIZINE DIHYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Foetal death (Premature Rupture of Membranes at 22 weeks + 2 days); Gastroesophageal reflux disease; Pregnancy; Psoriasis (without treatment); Rash
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: Activated partial thromboplastin time ratio; Result Unstructured Data: Test Result:1; Test Date: 20210622; Test Name: glomerular filtration; Result Unstructured Data: Test Result:5.1; Test Date: 20210622; Test Name: Haemoglobin; Result Unstructured Data: Test Result:12.6; Test Date: 20210622; Test Name: International normalised ratio; Result Unstructured Data: Test Result:1; Test Date: 20210622; Test Name: Platelets; Result Unstructured Data: Test Result:187; Test Date: 20210622; Test Name: polymerase chain reaction test; Test Result: Negative ; Test Date: 20210622; Test Name: Prothrombin time; Result Unstructured Data: Test Result:100; Test Date: 20210408; Test Name: ultrasound; Result Unstructured Data: Test Result:healthy foetus without malformation; Comments: 51st percentile eutrophic foetus
CDC Split Type: FRPFIZER INC2021804261

Write-up: Foetal death in utero; This is a spontaneous report from a contactable other healthcare professional downloaded from the regulatory authority-WEB FR-AFSSAPS-CF20211723, Safety Report Unique Identifier FR-AFSSAPS-2021082473. A 33-year-old pregnant female patient received the second dose of BNT162B2 (COMIRNATY; Lot Number: Unknown), intramuscular on 15Jun2021 as a single dose for COVID-19 immunisation. Medical history included rash from an unknown date and unknown if ongoing , gastrooesophageal reflux disease with pregnancy from an unknown date and unknown if ongoing , psoriasis from an unknown date and unknown if ongoing without treatment , foetal death from 2020 to an unknown date (Premature Rupture of Membranes at 22 weeks + 2 days), pregnancy from an unknown date and unknown if ongoing. Concomitant medication included levocetirizine dihydrochloride for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 on 15May2021 (Lot Number: unknown) via an unspecified route of administration for COVID-19 immunisation. The patient experienced foetal death in utero (hospitalization) on 22Jun2021. A 2nd trimester ultrasound performed on 08Apr2021 found a healthy foetus without malformation. 51st percentile eutrophic foetus. On 15Jun2021, 33-year-old patient received the second intramuscular injection of COMIRNATY Covid-19 Vaccine. The 1st injection of the COMIRNATY vaccine took place 15May2021. On 22Jun2021, the patient did not feel any foetal movements. Maternity Obstetrics and hospitalisation consultation: Diagnosis of Fetal Death In Utero (MFIU) at 33 weeks + 4 days. Negative polymerase chain reaction test on 22Jun2021 at 9:30 pm. On 22Jun2021: Haemoglobin: 12.6, Platelets: 187, Prothrombin time: 100, International normalised ratio: 1, Activated partial thromboplastin time ratio: 1, glomerular filtration: 5.1, glomerular filtration: 5.1. On 23Jun2021: Vaginal birth and foetal death in utero childbirth. Examinations to be performed: placental anatomical pathology. Foetal autopsy was pending. The patient recovered from the event, foetal death in utero on an unknown date. No follow-up attempts are possible, information on batch number cannot be obtained.


VAERS ID: 1472458 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-22
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021776318

Write-up: bleeding; Early miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202106231504379760-XNJKWT4T. Safety Report Unique Identifier GB-MHRA-ADR 25526648. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 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. Patient is not enrolled in clinical trial. The patient experienced bleeding on an unspecified date, early miscarriage on 22Jun2021. The mother was 5 Weeks pregnant at the onset of the event. The patient had bleeding and then a miscarriage 18 days after her vaccination (as reported). Seriousness criteria reported as other medically important condition. She was been 5 weeks 3 days pregnant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of event bleeding was unknown, of event Early miscarriage was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1538784 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202100948840

Write-up: LATE MISCARRIAGE, 5/7 WEEKS AFTER COVID-19 VACCINATION; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IE-HPRA-2021-078726. A 40-year-old pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 17Jun2021 as dose number unknown, single for COVID-19 immunization. The patient''s medical history was not reported. The patient was not taking any concomitant medication. The patient experienced late miscarriage, 5/7 weeks after COVID-19 vaccination on 22Jun2021. The event was reported as serious per other medically important condition. The clinical course was reported as follows: On 22Jun2021, the patient was diagnosed with late miscarriage, five to seven days after vaccination. The reporter noted that the notification was completed given the interval between diagnoses, and there was no clear relationship to the vaccine. The pregnancy resulted in spontaneous abortion. At the time of reporting, the patient''s outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1585070 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1439 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Term 1 ultrasound; Result Unstructured Data: Test Result:nothing to report
CDC Split Type: FRPFIZER INC202100996414

Write-up: Pregnancy loss <20 weeks gestation; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-NT20212987. A 36-year-old female patient (64kg; 172cm) received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 19Jun2021 (Batch/Lot Number: FC1439) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no medical history of Covid-19 or Polymerase chain reaction test. The patient experienced pregnancy loss <20 weeks gestation (medically significant) on 22Jun2021. The mother reported she became pregnant while taking bnt162b2. The mother was 16 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Miscarriage at 16 weeks of amenorrhea and 3 days i.e. 48-72 hours after the vaccine. In vitro fertilization via assisted reproduction technology. Term 1 ultrasound nothing to report. Outcome of the event was reported as not resolved. No follow-up attempts possible. No further information expected.


VAERS ID: 1624879 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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 INC202101016942

Write-up: Late miscarriage; gynecological haemorrhages; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-PB20215008. A 33-year-old female patient (6 months pregnant) received the first dose of BNT162B2 (COMIRNATY, Lot number FC5435) Intramuscular at single dose for COVID-19 immunisation on 15Jun2021. There was no history mentioned. Relevant concomitant drug was unknown. The patient presented a late miscarriage on D8 of the vaccination (22Jun2021). The patient experineced gynecological haemorrhages and death of the child. Outcome of events were resolved. Additional examinations were in progress. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841164 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion early, Fatigue, Malaise, Nasopharyngitis, Oropharyngeal pain, Vaccination site pain, Vaccination site swelling
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: DEPFIZER INC202101405487

Write-up: Malaise; Abortion early; Fatigue; Head cold; Pain pharynx; Injection site pain; Injection site pain; Injection site swelling; This is a non-interventional study report from a contactable consumer (subject) downloaded from the Regulatory Agency (RA)-WEB DE-SVPEI-202100480929. This is the first of two reports. A 26-years-old pregnant female subject (vaccination age was 26 years old) received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 22Jun2021 08:30 (Batch/Lot Number: FC1436) as DOSE 2, SINGLE for covid-19 immunisation. The subject''s medical history and concomitant medications was not reported. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 11May2021 (Batch/Lot Number: EX8679) as DOSE 1, SINGLE for covid-19 immunisation, with vaccination site pain. The subject became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. The subject experienced malaise (hospitalization) on 14Aug2021 with outcome of recovering, abortion early (hospitalization) on 14Aug2021 with outcome of recovering, fatigue (hospitalization) on 14Aug2021 with outcome of recovering, head cold (non-serious) on 23Jun2021 with outcome of recovering, pain pharynx (non-serious) on 23Jun2021 with outcome of recovering, injection site swelling (non-serious) on 22Jun2021 with outcome of not recovered , injection site pain (non-serious) on 23Jun2021 with outcome of recovering , injection site pain (non-serious) on 22Jun2021 with outcome of not recovered. The casual relationship of Comirnaty and Malaise/Injection site swelling/Injection site pain/Fatigue/Injection site pain assessed as B. Indeterminate by the Agency. The casual relationship of Comirnaty and Head cold/Pain pharynx/Abortion early assessed as D. Unclassifiable by the Agency. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the events malaise, abortion early, vaccination site pain, vaccination site swelling, fatigue, pain pharynx, head cold cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-202101411662 same patient, drug and different events and dose


VAERS ID: 1776402 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: New York  
Vaccinated:2021-03-30
Onset:2021-06-23
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Twin 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:
Current Illness:
Preexisting Conditions: Migraine
Allergies:
Diagnostic Lab Data: Ultrasound (internal and external), medically diagnosed pregnancy and loss.
CDC Split Type:

Write-up: Loss of twins - one potential vanishing twin in May of 2021 and missed miscarriage of remaining twin in June of 2021. Conceived within two week window of receiving vaccine


VAERS ID: 1476511 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-23
   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 - / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROXOCOBALAMIN; PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CY
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021845675

Write-up: Intra-uterine death; This is a spontaneous report from a contactable physician. This is the [second] of [two cases] reports. The first report is a report downloaded from a regulatory authority [GB-MHRA-TPP50285778C579748YC1624450738500]). A fetus patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 transplacental on 23Jun2021 (Batch/Lot number was not reported) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included hydroxocobalamin (Manufacturer unknown) from 26Feb2020; PREGNACARE ORIGINAL ((Manufacturer unknown) from 23Apr2021 to 23May2021. The patient experienced intra-uterine death (foetal death) (death, medically significant, life threatening) on 23Jun2021. The patient died on an unspecified date. An autopsy was not performed. Narrative case summary and further information: Case narrative: Pregnant 25/40. Had 1st Pfizer Covid-19 vaccine 8/7 ago. Fetal Movements not felt 5/7, severe abdominal pain for 3/7, possible ARM type amniotic fluid leak 24 hours, no paravertebral block. Referred urgently to maternity ward today for scan possible intrauterine death. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021829300 Mother case; Reported Cause(s) of Death: Intra-uterine death


VAERS ID: 1480146 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-06-23
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-07-17
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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Disease risk factor
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Vaccinaties tijdens 3e en 9e week van zwangerschap; Miskraam bij 11 weken; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miskraam bij 11 weken) in a 36-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002537) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Disease risk factor. On 29-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Jun-2021, the patient experienced ABORTION SPONTANEOUS (Miskraam bij 11 weken) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccinaties tijdens 3e en 9e week van zwangerschap). At the time of the report, ABORTION SPONTANEOUS (Miskraam bij 11 weken) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccinaties tijdens 3e en 9e week van zwangerschap) outcome was unknown. Concomitant medication use was not provided. No Treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.


VAERS ID: 1499447 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-23
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 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? Yes
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
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021869808

Write-up: Maternal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107071632160290-FSNSK, Safety Report Unique Identifier GB-MHRA-ADR 25616335. This consumer or other non hcp reported information for both mother and fetus. This is a maternal exposure during pregnancy report. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW3143) via an unspecified route of administration on 05Jun2021 first dose, single for COVID-19 immunization. Patient was pregnant at the time of vaccination. Patient was not currently breastfeeding. Medical history included lactation decreased and folic acid supplementation. Patient was no longer pregnant at the time of reporting. Concomitant medications included folic acid (FOLIC ACID) 400ug taken for vitamin supplementation. Patient had no symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On 23Jun2021, the patient experienced miscarriage. On an unspecified date, the patient experienced maternal exposure during pregnancy. It was stated that the medicine had an adverse effect on any aspect of the pregnancy. Pregnancy adverse effects was pregnancy loss. Patient was exposed to the medicine first-trimester (1-12 weeks). Since the vaccination, the patient had not been tested positive for COVID-19. The events were serious (medically significant, disability). The patient underwent lab tests and procedures which included COVID-19 virus test negative on an unspecified date. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1517099 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-06-23
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion incomplete, Histology
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Caesarean section (gave birth to a healthy boy); Diabetes in pregnancy; Migraine; Pneumothorax spontaneous; Pregnant (gravidity); Tonsillectomy; Uterine repair
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Histology; Result Unstructured Data: Test Result:has not found any abnormality of the foetus, place; Comments: has not found any abnormality of the foetus, placenta or umbilical cord. No signs of chorioamnionitis was found.
CDC Split Type: HUPFIZER INC2021906473

Write-up: incomplete abortion; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number HU-OGYI-608921. A 30-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 16May2021 (Batch/Lot Number: FA4598) as DOSE 1, 30 ug SINGLE for covid-19 immunisation. Medical history included Tonsillectomy not ongoing, Pneumothorax spontaneous not ongoing, uterine repair in 2019 not ongoing (underwent a surgery for uterine reconstruction, because after the previous labour, her uterine was deformed, the left side fallopian tube was sutured to the uterine and atrophied, therefore she was unable for normal conception), Diabetes in pregnancy from 2016 not ongoing, migraine unknown if ongoing, caesarean section (gave birth to a healthy boy on 02Mar2016 with caesarean section), Appendectomy not ongoing, pregnancy (gravidity) from an unknown date to 02Mar2016 (birth to a healthy boy). The patient conducts a healthy lifestyle, she is not smoking or drinking alcohol; does not have any regular medicines. The patient''s concomitant medications was none. The patient experienced incomplete abortion on 23Jun2021. Detail course was provided as this is a serious, medically confirmed report for patient describes the occurrence of incomplete abortion after vaccination with COMIRNATY. On 16May2021, the 30 years old gravid (over the first trimester) female patient received the first dose of COMIRNATY. On 22Jun2021, in the afternoon during rest, the patient water has just broke in her 18th week of pregnancy. She was hospitalized in Jun2021, she had incomplete abortion which was completed with intervention. Before, the foetus and foetal movement was normal. The foetus was unviable because of immaturity. Histology in 2021 has not found any abnormality of the foetus, placenta or umbilical cord. No signs of chorioamnionitis was found. The patient family doctor suspected the contribution of vaccination to the abortion. The event outcome was recovering. Sender''s comment: Incomplete abortion is not expected adverse event of COMIRNATY. TTO was 37 days. The patient had a previous gravidity without any abnormality. After she had uterine reconstruction surgery, which might have affected her gravidity. Based on the above, causality between abortion and COMIRNATY is assessed unlikely. The case is serious because of hospitalisation and the medical importance of abortion. No further information is expected.


VAERS ID: 1517598 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage in pregnancy
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021905479

Write-up: Miscarriage; Bleeding during pregnancy; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB NL-LRB-00620225. A 31-year-old female patient received the first dose of bnt162b2 (COMIRNATY) COVID-19 vaccine Pfizer injection fluid via unknown route of administration on 19Jun2021 (lot number: FC3098) at 0.3ml single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient was during five pregnancy weeks when received COVID-19 vaccine. Patient experienced Bleeding during pregnancy on 23Jun2021 and Miscarriage on 10Jul2021. The miscarriage occurred at a pregnancy duration of about 8 weeks. This was the first Covid vaccination, which took place at a pregnancy duration of about 5 weeks. Bleeding during pregnancy happened after 4 days after vaccination and Miscarriage happened after 3 weeks after vaccination. The outcome of the event Miscarriage was unknown. The outcome of other event was not recovered. Sender Comment: Seriousness of pregnancy disorder and miscarriage was changed from "life threatening" to "other medically important condition". Reporter Comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no; Bleeding During Pregnancy And Miscarriage: Additional information ADR: 1st bleeding started 4 days after vaccination. And after 3 weeks officially a miscarriage; Personal Security Number available: yes; Confounding factors: COVID-19 vaccine exposure during pregnancy week: 5; Previous COVID-19 infection: No. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no Bleeding During Pregnancy And Miscarriage: Additional information ADR: 1st bleeding started 4 days after vaccination. And after 3 weeks officially a miscarriage Personal Security Number available: yes Confounding factors: COVID-19 vaccine exposure during pregnancy week: 5 Previous COVID-19 infection: No


VAERS ID: 1521698 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-23
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: ultrasound; Result Unstructured Data: Test Result:miscarriage
CDC Split Type: NLPFIZER INC202100920884

Write-up: miscarriage at about 8 weeks of pregnancy; This is a spontaneous report from a contactable consumer (patient) downloaded from the WEB NL-LRB-00623119, Safety Report Unique Identifier NL-LRB-00626983. A 36-year-old female patient received bnt162b2 (COMIRNATY) dose 1 via an unspecified route of administration on 20May2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No previous COVID-19 infection. The first COVID vaccination took place at a pregnancy duration of about 3 weeks. During a first ultrasound on 23Jun2021, a miscarriage (medically significant) was determined at approximately 8 weeks of pregnancy. It was not known when the pregnancy ended exactly, the miscarriage was induced with medication on 03Jul2021. The outcome of event was unknown. No follow-up attempts possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1555703 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-23
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METOPROLOL SANDOZ [METOPROLOL SUCCINATE]; FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: Pregnancy test; Test Result: Positive
CDC Split Type: NOPFIZER INC202100973198

Write-up: SPONTANEOUS ABORTION; This is a spontaneous report from a non-contactable consumer (patient) downloaded from the WEB, regulatory authority number NO-NOMAADVRE-PASRAPP-2021-Ugrq7a. A 24-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 02Jun2021 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunization. Patient was pregnant at time of vaccination. Medical history included tachycardia. Concomitant medications included metoprolol succinate (METOPROLOL SANDOZ) taken for tachycardia from Feb2021 and ongoing; and folic acid. Ovulation should have happened 04Jun2021. Pregnancy test was positive on 18Jun2021. On 23Jun2021, the patient developed spontaneous abortion. The patient''s outcome was recovered. The reaction/case was considered as serious due to other serious (important medical events). Reporter''s Comment: Contact with healthcare professionals: Physician. Ovulation should have happened 04Jun2021. Sender Comment: Upgraded to Serious due to (Other Serious (Important Medical Events)). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Contact with healthcare professionals: Physician. Ovulation should have happened 04Jun2021.


VAERS ID: 1579326 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-06-23
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, Ultrasound foetal
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? Yes
   Date died: 2021-07-28
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: Lactation decreased; Miscarriage; Pregnancy; Comments: Patient has not had symptoms associated with COVID- 19 and Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test; Test Date: 20210705; Test Name: ultrasound fetal; Result Unstructured Data: 1st scan due to a small bleed, should have been 7+2 weeks pregnant, embryo was measuring approx. . 5 wks; Test Date: 20210719; Test Name: ultrasound fetal; Result Unstructured Data: 2nd scan confirmed no growth and no heartbeat.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: 25742447) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Early miscarriage), ABORTION SPONTANEOUS (surgical miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. Patient has not had symptoms associated with COVID- 19 and Patient is not currently breastfeeding. The patient''s past medical history included Miscarriage and Pregnancy. Concurrent medical conditions included Lactation decreased. Concomitant products included FOLIC ACID for Folic acid supplementation. On 17-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 23-Jun-2021, the patient experienced ABORTION SPONTANEOUS (Early miscarriage) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced ABORTION SPONTANEOUS (surgical miscarriage) (seriousness criteria hospitalization, medically significant and congenital anomaly) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) (seriousness criteria hospitalization and congenital anomaly). The delivery occurred on 28-Jul-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. The patient died on 28-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ABORTION SPONTANEOUS (surgical miscarriage) had resolved and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, Ultrasound foetal: 5 wks 1st scan due to a small bleed, should have been 7+2 weeks pregnant, embryo was measuring approx. . 5 wks. On 19-Jul-2021, Ultrasound foetal: abnormal (abnormal) 2nd scan confirmed no growth and no heartbeat.. On 26-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was stated that patient was exposed to the medicine before pregnancy. Details of scans or investigations: Scan at 7 weeks gestation showed 5 week measurements. Further scan at 9 weeks confirmed no growth and no heartbeat. Treatment medication was not provided by the reporter. Company Comment: This is a case of product exposure during pregnancy with associated AEs for this 40-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Case is confounded by patients age and history of previous miscarriage. RA reported the event with the seriousness criteria of death which is retained as reported but probably is referring to the child and not the patient (mother).; Sender''s Comments: This is a case of product exposure during pregnancy with associated AEs for this 40-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Case is confounded by patients age and history of previous miscarriage. RA reported the event with the seriousness criteria of death which is retained as reported but probably is referring to the child and not the patient (mother).; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 1590866 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002537 / 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:
Current Illness: Peanut allergy; Plaster allergy; Shellfish allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 1.5 maand)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This case was received via regulatory authority (Reference number: 00651962) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a non-health professional and describes the occurrence of ABORTION SPONTANEOUS in a 37-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3002537) 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: 1.5 maand). Concurrent medical conditions included Shellfish allergy, Peanut allergy and Plaster allergy. On 15-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Jun-2021, the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. The delivery occurred on 23-Jun-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY had resolved. No concomitant medications reported by investigator. No treatment medications provided by the reporter. Company Comment : This is a case of product exposure during pregnancy and spontaneous abortion for this 37-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; Reporter''s Comments: Seriousness of miscarriage was changed to "other medically important condition".; Sender''s Comments: This is a case of product exposure during pregnancy and spontaneous abortion for this 37-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded


VAERS ID: 1715933 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-23
   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 - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (successful pregnancy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101155470

Write-up: Miscarriage; Vaccine exposure during pregnancy; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20214335. A 29-years-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Jun2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient''s medical history included pregnancy in 2019 to an unknown date successful pregnancy, pregnancy in 2020 to an unknown date successful pregnancy. The patient''s concomitant medications were not reported. On 17Aug2021, the patient was diagnosed with miscarriage (delivery due date was 4Mar2022) and the heart/development of the embryo had stopped at about pregnancy week 10 (9+ something). The patient had the vaccine at the very beginning of pregnancy on 23Jun2021. The mother reported she became pregnant while taking bnt162b2. The mother was 10 Weeks pregnant at the onset of the event. This was the patient''s first miscarriage. The mother was due to deliver on 04Mar2022. The patient had not recovered from the events. No follow-up attempts are possible. No further information expected.


VAERS ID: 1429571 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-01
Onset:2021-06-24
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / SYR

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

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

Write-up: Miscarriage


VAERS ID: 1475175 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-05-26
Onset:2021-06-24
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal heart rate abnormal, 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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: prenatal vitamin, albuterol inhaler, flovent inhaler
Current Illness: none
Preexisting Conditions: asthma, ulcerative colitis
Allergies: penicillins class sulfonamide antibiotics erythromycin ethylsuccinate + sulfisoxazole acetyl
Diagnostic Lab Data: bedside ultrasound 7/1/2021 with no fetal heart tones, embryo at 7 weeks 3 days gestation.
CDC Split Type:

Write-up: Pfizer COVID19 vaccinations given on 5/5/21 and 5/26/2021. Patients last menstrual period 4/27/2021 prior to pregnancy. Spontaneous abortion/miscarriage at 7 weeks gestation on 6/24/21.


VAERS ID: 1464907 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Muscle spasms, 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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Suppressed lactation
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:Baby seen on scan at 7 weeks 5 days
CDC Split Type: GBPFIZER INC2021783908

Write-up: miscarriage; Maternal exposure during pregnancy; Vaginal bleeding; cramps; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106242214215690-ZY4OH.This is a maternal report. A 29-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, batch/lot number and expiry date: not reported), dose 1 via an unspecified route of administration on 24Jun2021 (at the age of 29 years) as single dose for covid-19 immunisation. Medical history included abortion spontaneous, ongoing pregnancy, suppressed lactation. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine Concomitant medication included folic acid taken for vitamin supplementation at a dose of 400 ug. On an unspecified date, the patient experienced miscarriage, maternal exposure during pregnancy. On 24Jun2021, the patient experienced vaginal bleeding, cramps. The mother reported she became pregnant while taking bnt162b2. The mother was 12 weeks pregnant at the onset of the event. The foetal outcome is intrauterine death. The patient underwent lab tests and procedures which included scan: baby seen on scan at 7 weeks 5 days. Possible miscarriage. Vaginal bleeding and cramps occurred around 60 minutes after Pfizer vaccine. No problems had before. Details of previous pregnancies: 10 weeks 3 days pregnant. No problems. Baby seen on scan at 7 weeks 5 days. Patient was exposed to the medicine first-trimester (1-12 weeks). The reporter assessed the events as serious (medically significant). The outcome of events vaginal bleeding, cramps was reported as not recovered and for events miscarriage, maternal exposure during pregnancy was unknown. Information about lot/batch number cannot be obtained. Follow-up attempts are completed. No further information is expected


VAERS ID: 1495895 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021859606

Write-up: Miscarriage; Maternal exposure during pregnancy, miscarrying her baby at just under 7 weeks; This is a spontaneous report from a contactable consumer (patient) received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107051054003190-U5EYE, Safety Report Unique Identifier is GB-MHRA-ADR 25594997. A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Jun2021 (lot number: EW3143) as single dose for COVID-19 immunisation. The patient previously received the first dose on 20May2021 (lot number: EW4109). Medical history included lactation decreased. She has not had symptoms associated with COVID-19, not enrolled in clinical trial, and not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation. The patient experienced maternal exposure during pregnancy on 24Jun2021 and miscarriage on 28Jun2021. Case narrative: Four days after receiving her second vaccine, she started miscarrying her baby at just under 7 weeks. The medicine had an adverse effect on any aspect of the pregnancy. Pregnancy adverse effects details: Four days after vaccine, she suffered a miscarriage. She was exposed to the medicine first-trimester (1-12 weeks). No relevant investigations or tests conducted. She was no longer pregnant at the time of reporting. She underwent lab tests and procedures which included sars-cov-2 test: no - negative COVID-19 test on 30Jun2021. The outcome of miscarriage was recovering. Case was reported as serious by health authority (hospitalization and disability). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516065 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
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? 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: FIMODERNATX, INC.MOD20212

Write-up: Miscarriage; maternal exposure during pregnancy; This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 36-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 04-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred on 04-Jul-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Concomitant medications details are not provided by the Reporter. No treatment information is provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1517601 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 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 INC2021905670

Write-up: Pregnancy loss (around 6 weeks); This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB NL-LRB-00621696 A 37 years old female patient received first dose of BNT162B2 (Comirnaty, solution for injection, lot number: FC5089) on 22Jun2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. At the time of vaccination patient was pregnant at 6 weeks. Two days after vaccination patient experienced pregnancy loss (around 6 weeks). At the time of the reporting event outcome was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1527200 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   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: pregnancy scans; Result Unstructured Data: Test Result:embreo stopped growing; Comments: 2 weeks after vaccination
CDC Split Type: GBPFIZER INC202100962151

Write-up: vaginal bleeding; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107271445109040-AIR2K. Safety Report Unique Identifier (GB-MHRA-ADR 25714872). A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jun2021 (Batch/Lot number was not reported) single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced vaginal bleeding on an unspecified date, miscarriage of pregnancy on 24Jun2021. One week post Covid-19 Pfizer vaccination, vaginal bleeding occurred, and based on pregnancy scans, the embreo stopped growing 2 weeks after vaccination subsequently causing a missed miscarriage. Outcome of vaginal bleeding was resolved. The patient died on 24Jun2021 due to miscarriage of pregnancy. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: miscarriage of pregnancy


VAERS ID: 1533779 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-07
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 INC202100948916

Write-up: Early miscarriage possible due to vaccine. Not sure it''s because of that. But miscarriage 7 days after injection; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00632996. A 32-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: Unknown), via an unspecified route of administration, on 17Jun2021, as dose 1, single for COVID-19 immunisation. Medical history included maternal vaccine exposure. The patient''s concomitant medications were not reported. The patient has no previous COVID-19 infection. On 24Jun2021, it was reported that the patient experienced early miscarriage possible due to the vaccine and it was not sure if it''s because of that. COVID-19 vaccine exposure during pregnancy week was 4 weeks. Additional information: 7 days after injection miscarriage (5 weeks) so it can also be natural but a few days later. The miscarriage occurred at a pregnancy duration of about 5 weeks. This was the first Covid vaccination, which took place at a pregnancy duration of about 4 weeks. The outcome of the events was unknown. Sender''s comment: cince the nature of the reported reaction did imply seriousness according to one of the regulatory authority critera, the reaction was considered as serious by the regulatory authority. Reporter''s comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Early miscarriage possible due to vaccine: Not sure it''s because of that. But 7 days after injection miscarriage. Additional information ADR: 7 days after miscarriage injection (5 weeks) so can also be natural. But a few days later. COVID-19 vaccine exposure during pregnancy week: 4 weeks. Previous COVID-19 infection: No No follow-up is possible, information about batch number cannot be obtained; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Early miscarriage possible due to vaccine: Not sure it''s because of that. But 7 days after injection miscarriage. Additional information ADR: 7 days after miscarriage injection (5 weeks) so can also be natural. But a few days later. COVID-19 vaccine exposure during pregnancy week: 4 weeks. Previous COVID-19 infection: No


VAERS ID: 1579940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Ultrasound scan vagina
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: LETROZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (disease symptoms: quite)
Allergies:
Diagnostic Lab Data: Test Name: Internal ultrasound; Result Unstructured Data: Test Result:confirmed miscarriage
CDC Split Type: NLPFIZER INC202100990678

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB NL-LRB-00644217. A 36-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 22Jun2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation . Medical history included suspected covid-19 from 02Mar2020 to an unknown date disease symptoms: quite. Concomitant medication(s) included letrozole (LETROZOLE) taken for an unspecified indication, start and stop date were not reported. The patient experienced miscarriage (medically significant) on 24Jun2021 with outcome of unknown. It was reported the patient was six weeks pregnant when received bnt162b2. The mother was 6 +2Weeks pregnant when the miscarriage occurred. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The patient underwent lab tests and procedures which included ultrasound scan vagina: confirmed miscarriage. No follow-up attempts possible. No further information expected. Information about lot/batch# cannot be obtain.


VAERS ID: 1586081 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage in pregnancy, Impaired quality of life, Maternal exposure timing unspecified
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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 INC202101003978

Write-up: Not knowing I was pregnant, I ran the vaccine. After about a month, I started bleeding and had a miscarriage; Not knowing I was pregnant, I ran the vaccine. After about a month, I started bleeding and had a miscarriage; Not knowing I was pregnant, I ran the vaccine. After about a month, I started bleeding and had a miscarriage; Impact on quality of life was 7/10; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority number IT-MINISAL02-765352. A 29-year-old female pregnant patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FE2296), via intramuscular route in left arm (left shoulder) on 24Jun2021 as Dose1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 24Jun2021, the patient reported that, she was not knowing that she was pregnant, she ran the vaccine. On 16Jul2021 (after about a month), she started bleeding and had a miscarriage occurred without hospitalization. On an unknown date in 2021, the patient''s impact on quality of life was 7/10. The outcome of the events miscarriage was recovered on 19Jul2021 and the outcome of other events unknown. Health authority comments: Contacted patient for missing lot, date of vaccination and any emergency room reports. No follow-up attempts possible. No further information expected.


VAERS ID: 1686294 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-06-24
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy multiple (3 previous, intact, uncomplicated pregnancies, no abortion, abrasion/interruption)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101114454

Write-up: Early miscarriage; 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-202100174709. This is a maternal report. A 41-year-old female patient (mother) received bnt162b2 (COMIRNATY), intramuscular on 14May2021 (at the age of 41 years) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included 3 previous, intact, uncomplicated pregnancies, no abortion, abrasion/interruption. The patient''s concomitant medications were not reported. The patient previously took DOSE 1 of COMIRNATY on 23Apr2021 for COVID-19 immunzation. The patient experienced early miscarriage on 24Jun2021. The event was assessed as serious (medically significant). It was reported that the patient had vaccination after her last fertilisation period on 08May2021, so that vaccination mathematically falls into the implantation period. The pregnancy resulted in spontaneous abortion. The outcome of the event was not recovered. Relatedness of the drug to the event Early miscarriage were reported as D: unclassifiable by the regulatory authority. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1702584 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Body temperature, Chills, Fatigue, Injection site erythema, Injection site haematoma, Injection site inflammation, Injection site pain, Injection site warmth, Malaise, Maternal exposure during pregnancy, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIUMZUUR ACTAVIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 1.5)
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: Body temperature; Result Unstructured Data:
CDC Split Type: NLMODERNATX, INC.MOD20213

Write-up: ; This case was initially received (Reference number: NL-LRB-00674185) on 04-Sep-2021. The most recent information was received on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS in a 32-year-old female patient who received mRNA-1273 (batch no. 3004224) 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: 1.5). Concomitant products included FOLIC ACID (FOLIUMZUUR ACTAVIS) for an unknown indication. On 24-Jun-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Jun-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. On 29-Jul-2021, the patient experienced INJECTION SITE WARMTH, INJECTION SITE HAEMATOMA, INJECTION SITE INFLAMMATION, MALAISE, MYALGIA, INJECTION SITE ERYTHEMA, CHILLS, PYREXIA, NAUSEA, FATIGUE and INJECTION SITE PAIN. On 30-Jul-2021, the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant). The delivery occurred on 05-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 24-Jun-2021, MATERNAL EXPOSURE DURING PREGNANCY had resolved. On 31-Jul-2021, MALAISE, MYALGIA, CHILLS, PYREXIA and NAUSEA had resolved. On 01-Aug-2021, FATIGUE had resolved. On 03-Aug-2021, INJECTION SITE WARMTH, INJECTION SITE HAEMATOMA, INJECTION SITE INFLAMMATION, INJECTION SITE ERYTHEMA and INJECTION SITE PAIN had resolved. At the time of the report, ABORTION SPONTANEOUS outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, Body temperature: 38 to 40.5 (High). Treatment medication was not provided Company Comment: This report refers to a case of maternal exposure during pregnancy for mRNA-1273 with associated AEs reported as abortion spontaneous, myalgia, injection site warmth, injection site erythema, injection site hematoma, injection site inflammation, chills, malaise, pyrexia, nausea, fatigue, and injection site pain. Considering current available information and plausible temporal relationship, causal role cannot be excluded and therefore, causality is assessed as possibly related. Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Significant follow-up 06-SEP-2021: pregnancy details updated, concomitant drug detail added.; Sender''s Comments: This report refers to a case of maternal exposure during pregnancy for mRNA-1273 with associated AEs reported as abortion spontaneous, myalgia, injection site warmth, injection site erythema, injection site hematoma, injection site inflammation, chills, malaise, pyrexia, nausea, fatigue, and injection site pain. Considering current available information and plausible temporal relationship, causal role cannot be excluded and therefore, causality is assessed as possibly related.


VAERS ID: 1723724 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Limb discomfort, Nausea, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101166100

Write-up: Spotting vaginal; Miscarriage; Nausea; Fatigue; Limb discomfort; This is a spontaneous report received from a non-contactable consumer downloaded from the Regulatory Agency (RA)-WEB. The regulatory authority report number is DE-PEI-CADR2021137993. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100135959. A 31-year-old female patient received BNT162B2 (COMIRNATY) via unspecified route single dose for COVID-19 immunisation on 23Jun2021. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced fatigue on 24Jun2021 with outcome of recovering; limb discomfort on 24Jun2021 with outcome of unknown; spotting vaginal and miscarriage on 09Jul2021 with outcome of not recovered; nausea on 24Jun2021 with outcome of recovered; all hospitalization. The mother reported she became pregnant while taking BNT162B2. The mother was 1 months pregnant at the onset of the event. Relatedness of BNT162B2 to all events was reported as unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1484475 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-04-07
Onset:2021-06-25
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None.
Current Illness: None.
Preexisting Conditions: None.
Allergies: None.
Diagnostic Lab Data: Ultrasound June 10, 2021 Ultrasound June 25, 2021 D&C June 30, 2021
CDC Split Type:

Write-up: Miscarriage. First day of last menstrual cycle was March 30, 2021. Pregnancy was confirmed through home test on May 7, 2021 and with doctor on May 10th, 2021. The doctor referred me to OBGYN and first appointment was on June 9th, 2021. Expected delivery date was January 4, 2022. The first ultrasound occurred on June 10th, 2021. This ultrasound showed concerns of development as I was measuring 6 weeks and should have been at 10 weeks based on the previous dates. A follow-up ultrasound occurred on June 25th and confirmed the baby was not viable. My body was not recognizing the miscarriage and therefore had to go in for a D&C on June 30, 2021.


VAERS ID: 1671888 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-02-06
Onset:2021-06-25
   Days after vaccination:139
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage, Ultrasound scan abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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? 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: Ultrasound, bleeding 06/26/21. Conception 5/15/21
CDC Split Type:

Write-up: Miscarriage


VAERS ID: 1492644 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 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 INC2021843536

Write-up: Patient was pregnant still early but 25Jun2021 miscarriage underway; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00602837. A 40-year-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 17Jun2021 (Lot Number: FC3098) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was pregnant still early but 25Jun2021 miscarriage underway. The miscarriage occurred at a pregnancy duration of about 5.5 weeks (1 trimester). This was the first covid vaccination, which took place at a pregnancy duration of about 4 weeks. The patient previous was no COVID-19 infection. The outcome of the event was unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the HA critera, the reaction was considered as serious by the regulatory authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1498701 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-25
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage, Human chorionic gonadotropin, Maternal exposure during pregnancy
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: Drug intolerance (Aspirin intolerance); Factor V Leiden heterozygote (Thrombosis risk factor V Leiden heterozygous); First trimester pregnancy (pregnant without knowing it)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: beta-hCG-Wert; Result Unstructured Data: Test Result:consistently optimal
CDC Split Type: ATPFIZER INC2021865175

Write-up: At the time of the 1st vaccination (Pfizer) patient was pregnant without knowing it.; Miscarriage, Natural Departure, Natural finish, Abortion spontaneous; Haemorrhage; This is a spontaneous report from a contactable consumer (patient) downloaded from the WEB, regulatory authority number AT-BASGAGES-2021-34267. This serious spontaneous report was received from a consumer and concerns a female patient. This consumer reported information for both mother and baby. This is a maternal report. A 36-year-old female patient received bnt162b2 (COMIRNATY), via intramuscular on 02Jun2021 (Batch/Lot Number: FC2473) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s weight was not reported, and height was not reported.The patient''s medical history and concurrent conditions included drug intolerance (continuing), factor V Leiden heterozygote (continuing), first trimester pregnancy (continuing). The patient''s concomitant medications were not reported. At the time of the 1st vaccination (Pfizer) patient was pregnant without knowing it. Early pregnancy, approx. 3/4. Week. In the 5th week the pregnancy was confirmed, but it did not develop accordingly and ended in a miscarriage. 1st vaccination on 02Jun2021, no heartbeat of the baby when checked on 24Jun2021, bleeding (haemorrhage) from 25Jun2021, yolk sac and fruit cavity had developed well, unfortunately the fetus did not. The beta-hCG value was consistently optimal, normal pregnancy symptoms (nausea, vomiting, tiredness) were present. Natural finish today, 28Jun2021. The patient reported she became pregnant while taking bnt162b2. The patient was 1 Trimester pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The outcome of event haemorrhage was not recovered, of other events was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202100932663 mother/ foetus case


VAERS ID: 1506818 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Malaise, Premature separation of placenta
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021882981

Write-up: placental detachment; General malaise; dead fetus.; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number ES-AEMPS-933665. A 42-years-old female patient received BNT162B2 (Comirnaty, solution for injection, lot number: FD8274) on 24Jun2021 at single dose via an unspecified route of administration on arm left for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. At time of vaccination on 24Jun2021 patient was pregnant at 29+2 weeks. On 02Jul2021 patient was admitted due to placental detachment with a dead fetus. It was reported that she had been with a general malaise since the next day after vaccination. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1514923 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Cytomegalovirus test, Fatigue, Headache, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (with symptoms (loss of smell, fatigue, flu-like condition).); Cytomegalovirus infection (with symptoms, confirmed); Pregnancy (my child is almost 2 years old)
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: cytomegalovirus viral load; Result Unstructured Data: Test Result:60; Test Date: 202010; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: BEPFIZER INC2021905478

Write-up: Joint pain; Fatigue; Headache; Muscle aches; miscarriage (8 weeks of amenorrhea); This is a spontaneous report from a contactable consumer (patient) downloaded from the WEB, regulatory authority number BE-FAMHP-DHH-N2021-99737. A 37-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 04Jun2021 (Lot Number: FC2336) as Dose 1, single for covid-19 immunisation. Medical history included Cytomegalovirus with symptoms confirmed on 13Mar2021. As of 21May2021, cytomegalovirus viral load was 60. Covid positive in Oct2020 with symptoms (loss of smell, fatigue, flu-like condition). Previous pregnancy, patient''s child is almost 2 years old. The patient''s concomitant medications were not reported. The patient experienced joint pain (life threatening) on 25Jun2021 with outcome of recovered, fatigue (life threatening) on 25Jun2021 with outcome of recovered, headache (life threatening) on 25Jun2021 with outcome of recovered, muscle aches (life threatening) on 25Jun2021 with outcome of recovered, miscarriage (8 weeks of amenorrhea) (life threatening) on 25Jun2021 with outcome of recovered. It should be noted that exactly 4 weeks after vaccination, patient had a miscarriage (8 weeks of amenorrhea). The vaccination carries a major risk on the fetus for which patient was not alerted. Patient''s previous pregnancy had not presented any problem (her child is almost 2 years old), and she had never had a miscarriage before this one. Date of her last period before miscarriage was 26Apr2021. Miscarriage reported by gynecologist was 25Jun2021, 4 weeks after the first injection. Treatment was no. Evolution of the ADR was healing with sequelae. The outcome of events was recovered in 2021. Reporter comment: Treatment - No. Evolution of the ADR - Healing with sequelae. Situations - Other: The vaccination carries a major risk on the fetus for which I was not alerted. My previous pregnancy had not presented any problem (my child is almost 2 years old), and I had never had a miscarriage before this one. Date of my last period before miscarriage: 26Apr2021 Miscarriage reported by gynecologist: 25Jun2021, ie 4 weeks after the first injection on 04Jun2021.; Reporter''s Comments: Treatment - No Evolution of the ADR - Healing with sequelae Situations - Other: The vaccination carries a major risk on the fetus for which I was not alerted. My previous pregnancy had not presented any problem (my child is almost 2 years old), and I had never had a miscarriage before this one. Date of my last period before miscarriage: 26Apr2021 Miscarriage reported by gynecologist: 25June2021, ie 4 weeks after the first injection on 04Jun2021.


VAERS ID: 1540178 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100963563

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health professional via the regulatory authority). Regulatory authority report number is 588931. A 36-years-old pregnant female patient received bnt162b2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 22Jun2021 as dose number unknown, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 25Jun2021, 3 days after vaccination, the patient had abortion spontaneous. The pregnancy resulted in spontaneous abortion. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1573550 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-25
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100990372

Write-up: Aborted pregnancy; This is a spontaneous report from a contactable other health care professional downloaded from the WEB, regulatory authority number FR-AFSSAPS-NT20212975. A 44-year-old pregnant female patient received first dose of BNT162B2 (COMIRNATY), intramuscularly in right arm on 08Jun2021, as single dose (Lot Number: FC3143) for covid-19 immunisation. The patient was pregnant at the time of vaccine. Last menstrual period date was Apr2021. Gestation period was 8 weeks when the reaction occurred. The patient medical history and concomitant medications were not reported. It was not stated if patient had got COVID-19. It was not stated if the patient had PRC test. The patient experienced aborted pregnancy on 25Jun2021. It was reported that the patient pregnancy terminated at 8 weeks amenorrhea on 25Jun2021. The patient was managed with hospital in Jun2021. The treatment was not stated. The outcome was unknown. The event was assessesd serious due to medically significant condition. Imputability without prejudice to the elements of investigation which could be carried out within the framework of legal procedure.


VAERS ID: 1585190 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6997 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Ultrasound; Result Unstructured Data: Test Result:visible pregnancy sac
CDC Split Type: FRPFIZER INC202100988446

Write-up: spontaneous miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-TO20215791. A 33-years-old pregnant female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 04Jun2021 (Batch/Lot Number: FC6997) as dose 1, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 25Jun2021, while in her first trimester of her pregnancy, the patient experienced spontaneous miscarriage. The mother was in her 1st trimester of pregnancy at exposure. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included ultrasound scan: visible pregnancy sac on an unspecified date. The outcome of the event was recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1636300 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 66759P1234 (P;F / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Abortion spontaneous, Musculoskeletal stiffness, Vaccination site reaction
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Termination of pregnancy and risk of abortion (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101045205

Write-up: At week 12.5: missed abortion, fetus did not evolve beyond that 7.5 weeks....; At the moment (day afterwards) but slight side effect of a stiff arm; Miscarriage: 7.5 weeks pregnant; Injection site reaction; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-103829. A 37-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 24Jun2021 (Batch/Lot Number: 66759P1234 (P;FE2090)) as dose 1, single for covid-19 immunisation. The patient was pregnant at the time of vaccination: 1st trimester. The patient''s medical history and concomitant medications were not reported. On 25Jun2021, the patient experienced at week 12.5: missed abortion, fetus did not evolve beyond that 7.5 weeks, at the moment (day afterwards) but slight side effect of a stiff arm, miscarriage: 7.5 weeks pregnant, injection site reaction. Outcome of the events was unknown. Reporter''s comments: Treatment - Unknown. Evolution of the ADR - Situations - Other: Perhaps a possible consequence of the vaccination during that early period of pregnancy? ADR description - At the moment (day after) but slight side effect of a stiff arm. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Unknown. Evolution of the ADR - Situations - Other: Perhaps a possible consequence of the vaccination during that early period of pregnancy? ADR description - At the moment (day after) but slight side effect of a stiff arm.


VAERS ID: 1697920 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-25
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101195749

Write-up: Abortion at 8 weeks of pregnancy; This is a spontaneous report from a non-contactable consumer. This case is the 2nd of 2 reports. The first report was downloaded from the regulatory authority-WEB [Regulatory Authority number DE-PEI-202100175732]. A 34-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY), intramuscular on 07Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient was pregnant (8 weeks gestation) and was pregnant at time of vaccination. The patient''s concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (COMIRNATY) on 28Apr2021 for COVID-19 immunisation and experienced menoxenia. The patient experienced abortion at 8 weeks of pregnancy (caused hospitalization, medically significant) on 25Jun2021 with outcome of unknown. Result of Assessment: Comirnaty/ event(s):/ Abortion: D. Unclassifiable. 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) : DE-PFIZER INC-202101131164 Same patient/drug, different dose/events


VAERS ID: 1751025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-25
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Off label use, Product use issue, Ultrasound scan
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)

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
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:empty gestational sac; Comments: Empty gestational sac. The size of the sac was 3mm.
CDC Split Type: GBPFIZER INC202101226923

Write-up: Miscarriage; Maternal exposure during pregnancy, baby stopped to develop exactly when she got the vaccine, with 4 to 5 weeks pregnant; Maternal exposure during breast feeding; Maternal exposure during breast feeding; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109171449466310-7PL6I. Safety Report Unique Identifier GB-MHRA-ADR 25959653. This consumer reported information for both mother (herself) and baby. This is a maternal report. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jun2021 as single dose for COVID-19 immunisation. Medical history included pregnancy (no longer pregnant at the time of reporting), ongoing breast feeding, and headache. She has not had symptoms associated with COVID-19, not had a COVID-19 test, and was not enrolled in clinical trial. Concomitant medications included folic acid taken for folic acid supplementation and paracetamol taken for headache from 10Aug2021 to 10Aug2021. The patient experienced maternal exposure during pregnancy and maternal exposure during breast feeding 25Jun2021; and miscarriage on an unspecified date. Events were reported as serious by health authority (hospitalization). Case narrative: Patient has not tested positive for COVID-19 since having the vaccine. The medicine had an adverse effect on aspect/s of the pregnancy. Pregnancy adverse effects details: With 11 weeks, she was submitted to a scan, where they could see an empty gestational sac. The size of the sac was 3mm. So, they understood that the baby stopped to develop exactly when she got the vaccine, with 4 to 5 weeks pregnant. She was exposed to the medicine first-trimester (1-12 weeks). The outcome of miscarriage was recovering. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101235937 Baby case


VAERS ID: 1859895 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Menstruation irregular
SMQs:, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101462442

Write-up: Miscarriage after vaccination; Menstruation irregular; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB NL-LRB-00702145 received via regulatory authority. A 29 year old female patient received the first dose of bnt162b2 (COMIRNATY; Batch/Lot Number: unknown) on 25Jun2021 (at the age of 29-year-old) as single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history and concomitant drugs were unknown. Within 1 day on 25Jun2021 the patient experienced menstruation irregular. After the first Covid vaccination was received, the patient became pregnant. 3 months after the vaccination miscarriage occurred on 24Sep2021. The miscarriage occurred at a pregnancy duration of about 7 weeks. Miscarriage was considered medically important condition. The patient has not recovered from menstruation irregular. Sender Comment: Seriousness of miscarriage was changed from ''death'' to ''other medically important condition''. No follow-up attempts are possible, information on batch number cannot be obtained.


VAERS ID: 1438459 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-06-26
Onset:2021-06-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017C21A / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Blood test, Chills, Exposure during pregnancy, Headache, Muscle spasms, Myalgia, Pyrexia, Ultrasound scan, Vaginal haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins, D3 vitamin, B12 vitamin
Current Illness:
Preexisting Conditions: hEDS, Atrial septal defect (repaired three years ago), raynaud''s syndrome
Allergies: Zithromax, kiwi, monistat, triple antibiotic
Diagnostic Lab Data: Ultrasound, exam and blood work 6/26/21 Blood work 6/31/21
CDC Split Type:

Write-up: I was pregnant at the time of my first and second dose of the vaccine. My estimated due date was February 15th 2022. A half hour after my second dose I had a little bit of spotting and moderate to severe cramping. This was dismissed as gas pains. Later that night I went to the bathroom to find a substantial amount of blood in my underwear at which point I called a nurse line and was directed to go to the ER. They gave an ultrasound and ran blood work. Miscarriage was strongly suspected but not totally confirmed. I was also running a low fever and experiencing severe chills, muscle and joint pain and a severe headache. I was sent home and told to follow up with my doctor for more blood work to confirm the miscarriage. I continued to get severe cramping, bleeding and loss of uterine tissue vaginally. On Monday I saw my doctor had blood work and confirmed the miscarriage. I am still bleeding today.


VAERS ID: 1483046 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Montana  
Vaccinated:2021-06-15
Onset:2021-06-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Exposure to COVID-19 (Verbatim: exposure to COVID but tested negative Exposure to COVID-19); Pneumonia (Verbatim: pneumonia)
Allergies:
Diagnostic Lab Data: Test Name: blood type; Result Unstructured Data: Test Result:O negative; Test Date: 20201031; Test Name: Covid-19; Test Result: Negative
CDC Split Type: USPFIZER INC2021801653

Write-up: miscarried her baby; This is a spontaneous report from a contactable other HCP. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jun2021 (Batch/Lot number was not reported) at age of 33-year-old as DOSE NUMBER UNKNOWN, SINGLE for prevention of COVID. Medical history included the patient had exposure to COVID before but she tested negative, this occurred 31Oct2020. She also has history of pneumonia, on 31Dec2020. Obstetrical History: Number of previous pregnancies None that the caller is aware of. The patient''s concomitant medications were not reported. The patient became pregnant while taking bnt162b2. The due date was on 25Feb2022. The patient miscarried her baby on 26Jun2021. First Day of Last Menstrual Period was unknown. Caller said the patient thought she was right around 8 weeks when she called her on 16Jun2021 so by the callers calculations it would have been right around 21May2021 (as reported). She confirmed patient did not know but the date was provided by the callers calculation. Risk factors for adverse pregnancy outcomes including environmental or occupational exposures, e.g. hypertension, diabetes, etc. Family history of congenital abnormality/genetic diseases, consanguinity (or any family relation or lineage) between parents (specify degree): None. It was noted in the emergency room note that she had been trying to conceive for 15 years with her spouse, so she was having trouble getting pregnant. Caller was calling from a clinic about the Pfizer COVID vaccine. She has a patient who got the COVID vaccine 15Jun2021 and the patient miscarried her baby on 26Jun2021. She was looking for a place that was taking repots on stuff like that she did not feel that it was really a VAERS report. Dose: She did not have any record of the administration of her having it, she got it in a completely different town. The patient did not smoke during this pregnancy. The patient did not drink alcohol during this pregnancy. The patient did not use illicit drugs during this pregnancy. Caller added the patients blood type was O negative. She saw that Pfizer may be looking at information regarding blood type. Outcome of pregnancy was spontaneous abortion/miscarriage on 26Jun2021. No investigation assessment. The outcome of event was unknown. Seriousness: Caller stated this event was serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Miscarriages/spontaneous abortion occurred 11 days after the vaccination with BNT 162B2. Given that the patient with her spouse had trouble getting pregnancy for many years, the event more likely is associated with their underlying contributory factors. More information including genetic, immunological and endocrine workups are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1514899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Autopsy, Investigation, Vaginal 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Pregnancy at the time of vaccination: 2nd trimester)
Allergies:
Diagnostic Lab Data: Test Name: Autopsy; Result Unstructured Data: Test Result:in progress; Comments: Autopsy of the fetus in progress; Test Name: echo; Result Unstructured Data: Test Result:a good evolution of the fetus
CDC Split Type: BEPFIZER INC2021905519

Write-up: vaginal blood loss; Miscarriage between 24 and 48 hours after the injection; This is a spontaneous report from a contactable consumer (patient) downloaded from the WEB, regulatory authority number BE-FAMHP-DHH-N2021-100918. A 35-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: FE2083), dose 1 via an unspecified route of administration on 25Jun2021 (at an unspecified age) as dose 1, single for COVID-19 immunisation. The patient medical history included none, pregnancy at the time of vaccination: 2nd trimester. No concomitant drug. The patient experienced miscarriage between 24 and 48 hours after the injection (medically significant) on 26Jun2021, vaginal blood loss (medically significant) on 04Jul2021. The events resulted in emergency room visit. Therapeutic measures were taken as a result of events vaginal blood loss and miscarriage. The outcome of the events was recovered on an unspecified date. Reporter comment: Treatment received. Evolution of the adverse drug reaction (ADR) was Healing. Examinations: Autopsy of the fetus in progress. ADR description: Miscarriage between 24 and 48 hours after the injection. Vaccine carried out on 25Jun2021. On 05Jul2021, the fetus'' heart no longer beats at 16 + 6 weeks of amenorrhea (for about a good week) although it was an uncomplicated pregnancy with a good evolution of the fetus between each echo. Emergency consultation on 05Jul2021 following blood loss. The date of the vaccine strangely coincides with the stop of her baby''s heart. Time Link Information (ADR): Vaccine on 26Jun2021 (as reported). Blood loss the night from 04Jul2021 to 05Jul2021. Gynecological consultation in the emergency room on 05Jul2021. According to reports, the baby''s heart has stopped for a good week. Which brings them back to something close to the date of the vaccine. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Summary of Reporter Comment: Treatment received. Evolution of the adverse drug reaction (ADR) was Healing. Examinations: Autopsy of the fetus in progress. ADR description and Time Link Information (ADR) provided.


VAERS ID: 1514902 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / 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: Delivery (1 completed pregnancy); Miscarriage (history of miscarriage)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021898019

Write-up: miscarriage at 8-9 weeks; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-99283. A 41-year-old female patient received first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 15Jun2021 (Batch/Lot Number: fa5833) as Dose 1, single for covid-19 immunization. Medical history included miscarriage from an unknown date (history of miscarriage) and delivery from an unknown date (1 completed pregnancy). The patient''s concomitant medications were not reported. The patient experienced miscarriage at 8-9 weeks on 26Jun2021. The mother reported she became pregnant while taking BNT162B2. The pregnancy resulted in spontaneous abortion. Outcome of the event was not recovered. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - No Evolution of the ADR - Aggravation Examinations - in progress, reassuring assessment ADR description - miscarriage at 8-9 weeks, 26Jun2021


VAERS ID: 1516091 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1439 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Asthenia, Back pain, Blood pressure measurement, Gynaecological examination, Heart rate, Human chorionic gonadotropin, Intermenstrual bleeding, Maternal exposure during pregnancy, Physical examination, Ultrasound pelvis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cesarean section (fetal asphyxia)
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 20210630; Test Name: Speculum; Result Unstructured Data: Test Result:vulva unremarkable, no visible lesion; Comments: speculum: low abundance metrorrhagia; Test Date: 20210630; Test Name: Heart rate; Result Unstructured Data: Test Result:normal; Test Date: 20210630; Test Name: Beta-human chorionic gonadotropin level assay; Result Unstructured Data: Test Result:22 uiU/L; Test Date: 20210702; Test Name: Beta-human chorionic gonadotropin level assay; Result Unstructured Data: Test Result:5 uiU/L; Test Date: 20210630; Test Name: Clinical examination; Result Unstructured Data: Test Result:painless, yielding abdomen, no palpated mass; Test Date: 20210630; Test Name: Pelvic Ultrasound; Result Unstructured Data: Test Result:anteflected uterus, endometrium at 9.40mm; Comments: right and left ovary seen. Douglas'' cul de sac is free, no mass in the latero-uterine area
CDC Split Type: FRPFIZER INC2021905396

Write-up: Miscarriage; back pain; metrorrhagia; asthenia; Maternal Exposure During Pregnancy, first trimester; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB, regulatory authority number FR-AFSSAPS-2021088163. This is a maternal report. A 32-year-old female patient received bnt162b2 (COMIRNATY COVID-19 vaccine, solution for injection, batch/Lot Number: FC1439), via intramuscular, administrated on arm right on 26Jun2021 (age at vaccination 32-year-old) as dose 2, 0.3 mL single for covid-19 immunisation. Medical history included cesarean section for fetal asphyxia. The patient had no history of miscarriages. The patient had no medical history for Covid-19. Previously, the patient received first dose of BNT162b2 (COMIRNATY, solution for injection, batch/Lot Number: not provided), via an unspecified route of administration on an unknown date as single for COVID-19 immunisation. The patient''s concomitant medications were not reported. The mother was 4 weeks pregnant at the onset of the event. Last menstrual date was 28May2021. The mother reported she became pregnant while taking bnt162b2. On 30Jun2021, the patient experienced back pain, metrorrhagia, asthenia. On 02Jul2021, the patient experienced miscarriage. On 30Jun2021, the patient lab tests included blood pressure measurement was normal, gynaecological examination was vulva unremarkable, no visible lesion, speculum: low abundance metrorrhagia, heart rate was normal, beta-human chorionic gonadotropin level assay was 22 uiu/l, clinical examination was painless, yielding abdomen, no palpated mass and pelvic ultrasound was anteflected uterus, endometrium at 9.40mm right and left ovary seen. Douglas'' cul de sac is free, no mass in the latero-uterine area. On 02Jul2021, the patient lab test included beta-human chorionic gonadotropin level assay was 5 uiu/l. No treatment medication was received for the adverse events. The outcome of the event miscarriage was resolved on an unknown date. The outcome for other events were unknown. The mother was due to deliver on 04Mar2022. The patient confirms the case as medical confirmed.


VAERS ID: 1520315 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-26
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Physical examination, Ultrasound antenatal screen
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210626; Test Name: Examination; Result Unstructured Data: Test Result:throat smooth, closed, in the back vault a..; Comments: ..spoonful of dark blood.; Test Date: 20210626; Test Name: Ultrasound antenatal screen; Result Unstructured Data: Test Result:1 fetus, cardiac action present...; Comments: ...Crown-rump length 12.3 mm / 7 + 3 /, without periovular hematoma
CDC Split Type: CZPFIZER INC202100920590

Write-up: miscarriage; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number CZ-CZSUKL-21008187. A 40-years-old pregnant female patient received first dose of BNT162B2 (COMIRNATY), via intramuscular on 24May2021 (Batch/Lot Number: FA4598) as single dose for COVID-19 immunization. Medical history reported as allergy insignificant and without impaired immunity. There were no concomitant medications. On 26Jun2021, the patient had a miscarriage after 1st dose of COMIRNATY. At the time of vaccination, she was approximately 4 weeks pregnant, and did not know about pregnancy on the day of the vaccination. On 26Jun2021 a miscarriage took place. On 26Jun2021, she came to gynecology for a single bleeding that day about 2 hours ago for no apparent reason, the patient felt pain in the lower abdomen as in menses. On examination: throat smooth, closed, in the back vault a spoonful of dark blood. Ultrasound showed: 1 fetus, cardiac action present, Crown-rump length 12.3 mm / 7 + 3 /, without periovular hematoma. Conclusion: abortus imminens, in agreement with the patient chooses a conservative procedure at home, prescribed Exacyl and Utrogestan. Check-up at the attending gynecologist. She received the 2nd dose of COMIRNATY on 05Jul2021. Outcome of the event was recovered on 26Jun2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1530314 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100939972

Write-up: Miscarriage/miscarriage has not started yet/Missed abortion; Vaccination during 8th week of pregnancy; This is a spontaneous report from a contactable consumer downloaded from the WEB NL-LRB-00628349. A 27-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Jun2021 (Batch/Lot Number: FC5089) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced miscarriage on 30Jun2021 and vaccination during 8th week of pregnancy on 26Jun2021. The miscarriage occurred at a pregnancy duration of about 8.5 weeks. This was the first Covid vaccination, which took place at a pregnancy duration of about 8 weeks. A few days after vaccination, the heart stopped beating. The patient was then about 8.5 weeks pregnant. The miscarriage has "not started yet" (2 weeks later). The patient thinks it''s a coincidence but wanted to report it anyway. The events were assessed as medically significant. The outcome of the events was unknown. Reporter comment: BioNTech/Pfizer vaccine (Comirnaty) - Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no - Missed abortion - Additional information ADR: A few days after vaccination the heart stopped beating. I was then about 8.5 weeks pregnant. The miscarriage has not started yet (2 weeks later). I think it''s a coincidence, but wanted to report it anyway. - confounding factors - COVID-19 vaccine exposure during pregnancy week: 8 -COVID-19 - Previous COVID-19 infection: No; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) - Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no - Missed abortion - Additional information ADR: A few days after vaccination the heart stopped beating. I was then about 8.5 weeks pregnant. The miscarriage has not started yet (2 weeks later). I think it''s a coincidence, but wanted to report it anyway. - confounding factors - COVID-19 vaccine exposure during pregnancy week: 8 -COVID-19 - Previous COVID-19 infection: No


VAERS ID: 1634614 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Echocardiogram, Myalgia, SARS-CoV-2 test, Vaccination site bruising, Vaccination site erythema, Vaccination site haematoma, Vaccination site inflammation, Vaccination site pain, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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; Fruit allergy (allergy: Kiwi)
Allergies:
Diagnostic Lab Data: Test Name: Echo; Result Unstructured Data: Test Result:unknown results; Test Date: 20210101; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC202101026099

Write-up: Reaction at or around the injection site: redness; Reaction at or around the injection site: warmth; Inflammatory reaction at the reaction site: redness, warmth, pain; Reaction at or around the injection site: bruising; Injection site haematoma; Reaction at or around the injection site: pain; Miscarriage; Muscle pain; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB regulatory authority number NL-LRB-00654463. This is first of two reports. This consumer reported information for both mother and fetus/baby. This is a mother report. A 32-year-old female patient received first dose of BNT162B2 (COMIRNATY) via unspecified route 0.3 mL, single for COVID-19 immunisation on 26Jun2021 at 32-year-old. Medical history included COVID-19 from 01Jan2021, allergy: Kiwi. The patient''s concomitant medications were not reported. The patient experienced miscarriage (medically significant) on 26Jun2021 with outcome of unknown, muscle on 26Jun2021 with outcome of recovered, inflammatory reaction at the reaction site: redness, warmth, pain on 27Jun2021 with outcome of recovered, injection site haematoma on 27Jun2021 with outcome of recovered, reaction at or around the injection site: redness, warmth, bruising, pain, on 27Jun2021 with outcome of recovered. The miscarriage occurred at a pregnancy duration of about 4 weeks, on the same day as the first COVID vaccination. Miscarriage was treated with abortion. Lab test included Echo''s with unknown results; corona confirmed with test on 01Jan2021. Sender''s Comment: Since the nature of the reported reaction does imply seriousness according to one of the HA critera, the reaction (miscarriage) was considered as serious by the regulatory authority. Sender''s Diagnosis: Injection site inflammation Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no Redness or Swelling Extensive swelling of vaccinated limb: no miscarriage Additional information ADR: The embryo stopped growing around 4 weeks, exactly when I was vaccinated confounding factors confounding factors, allergy: Kiwi COVID-19 vaccine exposure during pregnancy week: 4 weeks COVID19 Previous COVID-19 infection: disease symptoms: little Other diagnostic procedures: Echo''s No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no Redness or Swelling Extensive swelling of vaccinated limb: no miscarriage Additional information ADR: The embryo stopped growing around 4 weeks, exactly when I was vaccinated confounding factors confounding factors, allergy: Kiwi COVID-19 vaccine exposure during pregnancy week: 4 weeks COVID19 Previous COVID-19 infection: disease symptoms: little Other diagnostic procedures: Echo''s; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101074329 same reporter/drug/dose, different patient/events


VAERS ID: 1637674 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-26
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C011A / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038778

Write-up: Miscarriage 2 weeks after vaccination (abortion); This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority. The regulatory authority number is DE-PEI-CADR2021126731, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100123398. A 35-year-old female pregnant patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 12Jun2021 (Batch/Lot Number: 1C011A) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history included ongoing pregnancy. The patient''s concomitant medications were not reported. The patient experienced miscarriage 2 weeks after vaccination (abortion) on 26Jun2021 and caused hospitalization on unspecified date in 2021. The mother was 1 Month pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The outcome of the event was recovered with sequelae on 02Jul2021. Sender Comment: Normal miscarriage with bleeding. Relatedness of drug to reaction/event from HA was D. Unclassifiable. No follow-up attempts possible. No further information expected.


VAERS ID: 1664125 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Investigation, 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: 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: Tests conducted on the placenta; Result Unstructured Data: Test Result:no chromosome abnormalities present; Comments: Tests conducted on the placenta showed no chromosome abnormalities present; Test Date: 20210718; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101069621

Write-up: Maternal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer received from The Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108171248408420-B4IHN, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25810493. A 34-years-old pregnant female patient received first dose of BNT162N2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: FA1027), via an unspecified route of administration on 22Jun2021 as single dose for COVID-19 immunization. The patient''s medical history included decreased lactation, pregnancy (the patient no longer pregnant at the time of reporting), vitamin supplementation from an unknown date and unknown if ongoing. The patient''s concomitant medications included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient not had symptoms associated with COVID-19. The patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 26Jun2021, four days after having the vaccine the patient had a spontaneous miscarriage at 13 weeks and 4 days pregnant. Unsure medicine had an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine Second-trimester (13-28 weeks). On an unspecified date, the patient had maternal exposure during pregnancy. Events were consider as medically significant. The patient underwent lab tests and procedures which included investigation: no chromosome abnormalities present on tests conducted on the placenta showed no chromosome abnormalities present , sars-cov-2 test: negative on 18Jul2021 No - Negative COVID-19 test. The outcome of event miscarriage was resolved while maternal exposure during pregnancy was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1686914 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-26
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: FRPFIZER INC202101108010

Write-up: spontaneous miscarriage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-PC20213053. This physician reported information for both mother and fetus/baby. This is the fetus/baby report. A 36-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: FA8016), via intramuscular, administered in left arm, on 24May2021 as dose 1, single for COVID-19 immunisation. Medical history was reported as none. The patient''s concomitant medications were not reported. The patient has no history of COVID-19. The patient''s date of last period was on 25Apr2021, and she was at 4 weeks of gestation when she took the vaccine. On 26Jun2021, it was reported that the patient experienced spontaneous miscarriage (medically significant) without history, with hypotrophic embryo. The patient was taking medication for a voluntary termination of pregnancy. The outcome of the event was recovered on 10Jul2021. The event was considered serious (medically significant) by the regulatory authority.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101152931 Baby case


VAERS ID: 1724530 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-26
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Menstruation delayed, Menstruation irregular, Pregnancy test, 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), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: pregnancy test; Result Unstructured Data: Test Result:positive clear blue pregnancy test with 3+ weeks; Test Date: 20210826; Test Name: pregnancy test; Result Unstructured Data: Test Result:clear blue pregnancy test is positive but now show; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210812; Test Name: scan; Result Unstructured Data: Test Result:confirms yolk sac; Comments: and concluded that my dates were off based on last period date so advised to return 2 weeks later for another scan; Test Date: 20210825; Test Name: scan; Result Unstructured Data: Test Result:scan showed no progress as could not find feral po; Test Date: 20210904; Test Name: scan; Result Unstructured Data: Test Result:scan confirmed complete miscarriage
CDC Split Type: GBPFIZER INC202101176232

Write-up: miscarriage; Maternal exposure during pregnancy; Irregular period; Early miscarriage; Late period; This is a spontaneous report from a contactable consumer or other non HCP. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202109071225469390-VXJNN, Safety Report Unique Identifier GB-MHRA-ADR 25906532. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot number: EW3143, Expiration date was not reported), dose 1 via an unspecified route of administration on 17Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included pregnancy (Patient no longer pregnant at the time of reporting). The patient has not had symptoms associated with COVID-19. The patient is not currently breastfeeding. Concomitant medication included folic acid taken for an unspecified indication, start and stop date were not reported. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The medicine had an adverse effect on any aspect of the pregnancy. The patient did not take folic acid supplement during pregnancy. The patient was exposed to the medicine Before pregnancy. On an unspecified date patient experienced miscarriage, irregular period and maternal exposure during pregnancy. on 04Aug2021, patient had early miscarriage. on 26Jun2021 patient had late period. The patient underwent lab tests and procedures which included sars-cov-2 test was no - negative COVID-19 test on unspecified date, scan confirms yolk sac on 12Aug2021 (and concluded that my dates were off based on last period date so advised to return 2 weeks later for another scan), the scan showed no progress as could not find feral po on 25Aug2021, the scan confirmed complete miscarriage on 04Sep2021, pregnancy test was positive clear blue pregnancy test with 3+ weeks on 05Aug2021, pregnancy test was clear blue pregnancy test is positive but now show on 26Aug2021. The outcome of the events miscarriage was not recovered, outcome of event early miscarriage was recovering, outcome of events irregular period, maternal exposure during pregnancy, late period was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1440620 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-18
Onset:2021-06-27
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046B21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Back pain, Blood potassium decreased, Blood test, Ultrasound scan abnormal, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin Probiotic Vitamin B complex Azelastine nasal spray Ambien - PRN
Current Illness: Left breast lesion- not concerning per PCP
Preexisting Conditions: Raynaud''s Mild renal insufficiency
Allergies: Erythromycin - GI Upset
Diagnostic Lab Data: Ultrasound performed: No intrauterine gestation. Findings concerning for incomplete miscarriage with gestational sac within the vagina and absent fetal heart tone. ABO/RH: B- Labs: evaluated and unremarkable except for low potassium (3.0)
CDC Split Type:

Write-up: Patient was 15w0d G1P0 presented to Emergency Room on 6/28/21 with complaint of mid abdominal pain and low back pain for several hours. Noted some vaginal spotting which occurred the night prior to ER and continued. Ultrasound performed. Confirmed Spontaneous abortion. blood type of B-, patient received dose of RhoGam. Labs: evaluated and unremarkable except for low potassium (3.0) Removal of products of conception at ER.


VAERS ID: 1538518 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100956847

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107260939388690-IXJEA. Safety Report Unique Identifier GB-MHRA-ADR 25705653. A 23-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Jun2021 for COVID-19 immunisation. Medical history included suppressed lactation, abortion spontaneous, pregnancy, pregnancy. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously took folic acid. The patient experienced miscarriage on 27Jun2021. The patient had negative COVID-19 test on 16Jul2021. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient had vaccine on 24Jun2021 and had found out the day previously that she was expecting. She explained this to the doctor inside and he said there was no evidence (due to how fast the vaccine was developed) that it caused harm to the female reproductive organs or how it affected those in 1st trimester. By the 27th the patient was experiencing excruciatingly painful cramps and excessively heavy bleeding. She was taken to hospital via ambulance where she was admitted and told she had a miscarriage. Patient did not take folic acid supplement during pregnancy. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of miscarriage was resolved with sequelae. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1457874 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-04-01
Onset:2021-06-28
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Subchorionic haematoma, Ultrasound antenatal screen
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

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

Write-up: I got pregnant less than 1 month after the vaccine. Since conception I had a Subchorionic Hemotomia. The hemotomia did not get smaller as pregnancy progressed and ended in a missed miscarriage at 10.5 weeks


VAERS ID: 1474458 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Delaware  
Vaccinated:2021-04-02
Onset:2021-06-28
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage in pregnancy, Maternal exposure before pregnancy, Pregnancy
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)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prentatal vitamin Vitamin D Calcium / magnesium Zinc Zyrtec (generic)
Current Illness: N/a
Preexisting Conditions:
Allergies: Amoxicillin, Percocet, zoloft
Diagnostic Lab Data: Fetus was sent for pathology on 7/8. I am unaware if this has been completed as of 7/15.
CDC Split Type:

Write-up: I became pregnant shortly after receiving the vaccine. I spotted the entire pregnancy and bleeding increased during the week of 6/28. Bleeding became alarming over the holiday weekend. OB ordered an ultrasound and it was scheduled for 7/9. I went to OB triage on 7/8 around 4:30 pm. I delivered (miscarriage) on 7/8/2021 at 11 weeks 6 days gestation. Bleeding has greatly reduced since 7/8.


VAERS ID: 1501455 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-13
Onset:2021-06-28
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 2 LA / SYR

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

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

Write-up: Shortly after receiving COVID vaccine, I got pregnant. I suffered a miscarriage on Jun 28th 2021. I was approximately 7 weeks pregnant. The date of my last period before pregnancy was May 11, 2021.


VAERS ID: 1509640 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-05-19
Onset:2021-06-28
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022B21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test normal, Exposure during pregnancy, Stillbirth
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: Standard Prenatal vitamin
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: My pregnancy ended in stillbirth on June 30, 2021. I was 34 weeks pregnant. My doctor confirmed no heartbeat on June 28, 2021. The estimated date of delivery was August 11, 2021. This was considered a low-risk pregnancy. There is no cause found for the still birth after multiple blood tests and during delivery.


VAERS ID: 1475820 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Myalgia, SARS-CoV-2 test, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (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: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021810163

Write-up: details of previous pregnancies : took the vaccine at 15 weeks; Muscle ache; Drowsiness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106281817034260-ZB8VF Safety Report Unique Identifier GB-MHRA-ADR 25556649. A 31-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE),via an unspecified route of administration on 28Jun2021 (Lot number was not reported) as single dose for COVID-19 immunization .Medical history included lactation decreased, ongoing pregnancy and vitamin supplementation all from an unknown date. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medication included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. The patient experienced details of previous pregnancies: took the vaccine at 15 weeks (miscarriage) on an unspecified date, muscle ache and drowsiness both on 28Jun2021. The events were reported as non-serious. The clinical course was reported as follows: the mother reported she became pregnant while taking BNT162B2. The mother was in her (Gestation period at exposure) of pregnancy at exposure. The mother was 2 Trimester pregnant at the onset of the event. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test on an unknown date. Patient was recovering from muscle ache and drowsiness while outcome of the other events was unknown. No follow-up attempts are possible, Information about batch number cannot be obtained.


VAERS ID: 1590321 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Fatigue, Malaise, Maternal exposure during pregnancy, Vaccination site bruising
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? 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: NLPFIZER INC202100990681

Write-up: cramps in her abdomen; Miscarriage; Fatigue; Malaise; Maternal exposure during pregnancy, vaccinated at 5 weeks; Reaction at or around the injection site: bruising; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB NL-LRB-00645411. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 28Jun2021 (Batch/Lot Number: FE1573) as Dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had miscarriage (29Jun2021), malaise (29Jun2021), fatigue (29Jun2021), injection site haematoma (28Jun2021). The miscarriage occurred at a pregnancy duration of about 5+2 weeks. Exactly 48 hours after administration patient got cramps in her abdomen. The outcome of the event Miscarriage and Maternal exposure during pregnancy, first trimester was unknown, other events was recovered. No Previous COVID-19 infection. Patient received the vaccine at 5 weeks pregnancy. No follow-up attempts possible. No further information expected.


VAERS ID: 1667800 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 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: Depression; Fibromyalgia; Migraine with aura
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101055061

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20213865. A 33-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FD4555), via an unspecified route of administration on 21Jun2021 as dose 1, single for COVID-19 immunization. Medical history included migraine with aura, fibromyalgia and depression, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced miscarriage on 28Jun2021. It was reported that the patient received the Biontech-Pfizer Comirnaty vaccine on 21Jun2021 without being aware that she was pregnant. She had a miscarriage on 28Jun2021. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1807180 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Malaise, 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? 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: Ultrasound; Result Unstructured Data: Test Result:the foetus had stopped growing; Comments: the foetus had stopped growing at exactly 4 weeks, which was the day I received the first corona vaccine.
CDC Split Type: NLPFIZER INC202101339695

Write-up: I was 4 weeks pregnant and miscarried; Not feeling well; Fatigue; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority number is NL-LRB-00694174. A 39-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 28Jun2021 (Lot Number: FC5089) (at the age of 39-year-old) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 28Jun2021, the patient experienced not feeling well and fatigue. On the same day, she was 4 weeks pregnant and miscarried. The event miscarriage was reportedly assessed as serious: medically significant. No past drug therapy with COMIRNATY. It was also reported on COVID-19 vaccine Pfizer injection and latency: miscarriage: 1 day after start (as reported); fatigue: 4 weeks after start (as reported), malaise: 1 day after start (as reported), and maternal exposure during pregnancy: latency unknown (as reported). Additional information on ADRs: on the ultrasound in the hospital (unspecified date), it was shown and measured that the foetus had stopped growing at exactly 4 weeks, which was the day she received the first corona vaccine. Confounding factors - vaccine exposure during pregnancy week: 4. COVID19 Previous COVID-19 infection: no. Other diagnostic procedures: no. The outcome of the events not feeling well and fatigue was recovered on 13Aug2021 and miscarriage was unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS critera, the reaction (miskraam) was considered as serious by the regulatory authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1475867 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-04-18
Onset:2021-06-29
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 045A21A / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Condition aggravated, Haemorrhage, Human chorionic gonadotropin increased, Illness, Menstruation normal, Pregnancy, Pyrexia, Thyroid function test normal, Ultrasound antenatal screen abnormal, Vaccination complication
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tumour markers (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), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Moderna, vaccine 1 had "covid arm"-- alternate arm was used for vaccine 2 and still resulted in slightly less worse version of "
Other Medications: methimazole 5mg, pristiq 25mg
Current Illness: none
Preexisting Conditions: graves disease
Allergies: erythromycin
Diagnostic Lab Data: May 14- labs results showed thyroid was optimal and hCg betas were good May 19- lab results showed thyroid was optimal and hCg betas were doubling May 28- u/s done and confirmed 5w2d in gestation June 14- u/s done and confirmed 6w gestation with good fetal HR, labs results showed thyroid optimal June 28- bleeding started June 29- passing tissue and naturally miscarrying June 30- confirmed miscarriage via u/s
CDC Split Type:

Write-up: I had an extremely high fever and illness that started 24hrs after the second vaccine that lasted up to 4 days. I was running 104F fever for 2 days that OTC medicine would not break the fever. On 04/20/21 I had my LMP while severely sick. I found out I was pregnant on 05/13/21 and had a miscarriage at around 10 weeks on 06/29/2021. I have 2 prior children with no history of miscarriage or fertility issues and was seen routinely and early on in my care. I wanted to report this in case anyone is studying these kinds of events and would want the information.


VAERS ID: 1666786 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-02-22
Onset:2021-06-29
   Days after vaccination:127
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Amniotic fluid volume decreased, Cytogenetic analysis normal, 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? 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: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: Ultrasound (20 week), genetic testing, micro oridon (everything normal, no syndromes)
CDC Split Type: vsafe

Write-up: Pregnancy Information: Normal pregnancy until 20 week ultrasound on June 29th, found that there was no amniotic fluid, although there had been fluid previously. Lost the pregnancy.


VAERS ID: 1495845 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-29
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Back pain, Dysmenorrhoea, Heavy menstrual bleeding, Pregnancy test, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage
Allergies:
Diagnostic Lab Data: Test Name: pregnancy tests; Result Unstructured Data: Test Result:negative; Test Date: 20210701; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021853643

Write-up: miscarriage; Menstrual cramp; Menstrual flooding; Severe back ache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107031156048910-91MRU. A 29-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: Not known) via an unspecified route of administration on 20Jun2021 at a dose 1, single for Covid-19 immunisation. Medical history included miscarriage and lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced miscarriage (as reported) on an unspecified date with outcome of unknown, menstrual cramp, menstrual flooding, and severe back ache on 29Jun2021 with outcome of not recovered. The patient underwent lab test which included Covid-19 virus test: no - negative covid-19 test, on 01Jul2021. The events were assessed as serious per disability by regulatory authority. The clinical course was reported as follows: Extreme heavy bleeding and lots of clots, severe back ache, extreme menstrual cramps. Have done multiple pregnancy tests in case of miscarriage but all negative 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: 1529663 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-06-29
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: scan; Result Unstructured Data: Test Result:normal pregnancy; Comments: at 6th week; Test Name: scan; Result Unstructured Data: Test Result:miscarriage; Comments: 4 days after the second dose of Pfizer, in week 8
CDC Split Type: GBPFIZER INC202100941537

Write-up: miscarriage; Foetal exposure during pregnancy; Miscarriage of pregnancy; 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-202107221204188600-GCMVO. This consumer or other non hcp reported information for both mother and fetus/baby. This is a {enter maternal or fetus/baby} report.A female patient of an unspecified age received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FA1027), via an unspecified route of administration on 22May2021 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 25Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included pregnancy. The patient''s concomitant medications were not reported.The patient experienced miscarriage on an unspecified date, miscarriage of pregnancy on 29Jun2021, foetal exposure during pregnancy (foetal exposure during pregnancy) on an unspecified date.The mother reported she became pregnant while taking bnt162b2.The mother was due to deliver on 29Jun2021.The pregnancy resulted in spontaneous abortion.The fetal outcome is intrauterine death.The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on scan: normal pregnancy on at 6th week , scan: miscarriage on 4 days after the second dose of Pfizer, in week 8. The events were assessed as serious. The outcome of event for miscarriage was recovered on unknown date.Outcome of event for Miscarriage of pregnancy was Recovered/Resolved with Sequel on 11Jul2021.Outcome of event for Foetal exposure during pregnancy was unknown on unknown date. No follow-up attempts are possible. No further information is expected.waaa


VAERS ID: 1589000 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-06-29
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XYZALL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Hemoptysis
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: ultrasound; Result Unstructured Data: Test Result:normal; Comments: 6mm embryo which distorts the date of conception, which should bring it normally to 8 or 9mm
CDC Split Type: FRPFIZER INC202101004147

Write-up: spontaneous miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LY20217843. A 38-year-old pregnant female patient received bnt162b2 (COMIRNATY), intramuscular on 16May2021 (Batch/Lot Number: J07BX03) as dose 1, single for COVID-19 immunization. Medical history included allergic rhinitis and postpartum hemoptysis from an unknown date. Concomitant medication included levocetirizine dihydrochloride (XYZALL) taken for an unspecified indication, start and stop date were not reported. On 29Jun2021, it was reported that the patient experienced spontaneous miscarriage at 11 weeks of amenorrhoea. The patient''s last menstrual period was on 11Apr2021. The patient was 11 weeks pregnant at the onset of the event and 5 weeks pregnant at exposure. The mother was due to deliver on 16Jan2022. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included ultrasound scan in 2021: normal: 6mm embryo which distorts the date of conception, which should bring it normally to 8 or 9mm. The outcome of the event was recovered with sequel.


VAERS ID: 1657408 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-29
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: GRPFIZER INC202101073287

Write-up: Miscarriage in the second month of pregnancy; Maternal Exposure During Pregnancy, first trimester; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number GR-GREOF-20215509. A 31-years-old pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: Unknown), via an intramuscular route of administration on 13Jun2021 as dose 1 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient exposed to vaccine during pregnancy, first trimester in 2021 and experienced miscarriage in the second month of pregnancy on 29Jun2021. The patient was unaware of her pregnancy, was vaccinated against COVID-19 with the first dose of the vaccine Comirnaty on 13Jun2021. 16 days later, on 29Jun2021 she had a miscarriage during the second month of her pregnancy. The event miscarriage in the second month of pregnancy considered as medically significant. The outcome of the event miscarriage in the second month of pregnancy was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1769224 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Eye irritation, Foetal death, Pregnancy test, Uterine contractions abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Noninfectious diarrhoea (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: ISOVORIN [CALCIUM LEVOFOLINATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma late onset; Lipoedema; Psoriasis
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: pregnancy test; Result Unstructured Data: Test Result:positive
CDC Split Type: ESPFIZER INC202101262694

Write-up: foetal death; uterine contractions; Eye irritation; Diarrhea; Abdominal pain; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number ES-AEMPS-1006616. A 41-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Right on 29Jun2021 (Lot Number: not reported), at the age of 41 years old, as first dose, single for covid-19 immunisation. Medical history included asthma late onset, psoriasis, lipoedema. Concomitant medication included calcium levofolinate (ISOVORIN [CALCIUM LEVOFOLINATE]) taken for pregnancy from 20Sep2020 to 11Aug2021. The patient also took prednisone (PREDNISONA CINFA) 5 mg TABLETS EFG, 30 tablets for pregnancy on 05Jul2021; and tinzaparin sodium (INNOHEP) 4,500 IU ANTI-XA / 0.45 ML INJECTABLE SOLUTION IN SYRINGES, 10 pre-filled syringes with 0.45 ml of solution taken for pregnancy from 05Jul2021 to 11Aug2021. The patient previously took calcifediol (HIDROFEROL) 0.266 mg ORAL SOLUTION, 10 drinkable ampoules of 1.5 ml for pregnancy from 10Oct2020 to 10Jun2021. On 29Jun2021, the patient experienced abdominal pain. On 31Jul2021, the patient experienced eye irritation. On 10Jul2021, the patient experienced diarrhea. On unspecified date, the patient experienced uterine contractions. On unspecified date, foetal death was reported. The mother reported she became pregnant while taking bnt162b2. "The abdominal pain was a very intense ascending pain, with uterine contractions. I notified my family doctor of the symptoms and she did not give them importance, she associated them with premenstrual pain. After not getting my period and continuing with those painful contractions for a week, I took a pregnancy test and it came back positive. I went to the ER (emergency room) because of the intensity of the pain and fear that something was wrong. The emergency gynecologist assessed an ectopic pregnancy, due to the intensity and location of the pain, which was negative. It was a normal pregnancy with very intense contraction pains that lasted for four weeks. In the emergency department, no importance was given to showing up just the day I received the vaccine. The control of a normal pregnancy was followed. In week 10 the embryo''s heart stopped beating and I was admitted for expulsion." Events abdominal pain and uterine contractions required physician office visit and emergency room visit. The patient underwent lab tests and procedures which included pregnancy test: positive on unspecified date in 2021. Therapeutic measures were taken as a result of eye irritation which included Soothing ophthalmic solution. Outcome of the events foetal death and eye irritation was not recovered. Outcome of the event abdominal pain was recovered on 18Jul2021; event diarrhea was recovered on 12Jul2021. Outcome of the event uterine contractions was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1443199 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-05-25
Onset:2021-06-30
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death, Foetal hypokinesia, Headache, Induced labour
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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Subjective: 33-year-old G4 P3 @36w5d presents for admission due to fetal demise diagnosed in clinic earlier today. Her pregnancy is complicated by hypothyroid, obesity, h/o LTCS with subsequent VBAC x 2, h/o GDM with normal screen this pregnancy, h/o preeclampsia in prior prgnancy, COVID this pregnancy. PNC with doctor. Patient called the office this morning noting lack of fetal movement. She believes she felt baby last night but is unsure. Possibly the last time was this weekend. She denies contractions, vaginal bleeding, LOF, fever, chills. Has mild HA now but that just started since being admitted. BP in office 160/94. Now normal.


VAERS ID: 1464663 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-01-02
Onset:2021-06-30
   Days after vaccination:179
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 043L20A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012A21A / 2 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: cetirizine 10mg
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data:
CDC Split Type:

Write-up: MISCARRIAGE AT 7 WEEKS 5 DAYS GESTASTIONAL AGE, 1 PREVIOUS HEALTY PREGNACY IN 7/17/2019, NO PREVIOUS HISTORY OF MISCARRIAGE


VAERS ID: 1485032 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-04-20
Onset:2021-06-30
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Caesarean section, Cardiac dysfunction, Cleft palate, Cleft uvula, Exposure during pregnancy, Heart rate decreased, Premature delivery
SMQs:, Cardiac failure (broad), Arrhythmia related investigations, signs and symptoms (broad), Congenital, familial and genetic disorders (narrow), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

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

Write-up: Baby delivered via emergency C Section at 32 weeks 5 days. Showing low heart rhythms and function. Born needing oxygen. Also born with cleft soft palette and bifurcated uvula.


VAERS ID: 1476207 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-30
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, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021822024

Write-up: Maternal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose1,single for covid-19 immunisation. Medical history included suppressed lactation , abortion spontaneous, pregnancy, pregnancy, patient no longer pregnant at the time of reporting, vitamin supplementation. Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. The patient previously took progesterone, aspirine. Also taking 75mg aspirin and 800mg progesterone daily for pregnancy . The patient experienced miscarriage (abortion spontaneous) (medically significant) on 30Jun2021 with outcome of unknown , maternal exposure during pregnancy (maternal exposure during pregnancy) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: No - Negative COVID-19 test. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was exposed to the medicine first-trimester (1-12 weeks). No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1504767 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021874597

Write-up: MISSFALL; This is a spontaneous report from a contactable nurse downloaded from the regulatory authority-WEB SE-MPA-2021-057294. A 29-year-old pregnant female patient received BNT162B2 (COMIRNATY), 2nd dose via an unspecified route of administration on 30Jun2021 (Lot Number: FD6840, expiration date not provided) at age of 29 years old as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced missfall (Miscarriage of pregnancy) (disability) on 30Jun2021. The mother reported she became pregnant while taking BNT162B2. The mother was 8 Weeks pregnant at the onset of the event. The outcome of the event was recovered with sequel on an unspecified date. Clinical course: Report from a nurse regarding a 29-year-old woman. Reported suspected vaccine was Comirnaty second dose (Covid-19 vaccines). Reported suspected adverse reaction was miscarriage. The nurse describes that the woman was pregnant in week 8. The same night that the woman received her second dose of vaccine, she had a miscarriage. Course: Recovered with lasting damage. The case was assessed as a serious, permanent physical impairment. No follow-up attempts possible. No further information expected.


VAERS ID: 1523765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Foetal death
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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UVEDOSE; SPASFON [PHLOROGLUCINOL]; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Convulsions generalized (at age 12); Early miscarriage (4.5 amenorrhea week); Head injury (at age 12); Ligament pain; Non-smoker; Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100932134

Write-up: Foetal death in utero; This is a spontaneous report from a contactable physician downloaded from the WEB, Regulatory authority report number FR-AFSSAPS-SE20211841. A pregnant 27-year-old female patient (mother) received BNT162B2 (COMIRNATY), intramuscular on 25May2021 (Lot Number: FC0081, unknown expiration) as dose 1, single; and via an unspecified route of administration on 29Jun2021 (Lot Number: FD0168, unknown expiration) as dose 2, single for COVID-19 immunisation. Medical history included generalized seizure secondary to head trauma in Mar2007 (at age 12), early spontaneous miscarriage in Sep2020 (4.5 amenorrhea week), pregnancies 2 deliveries 1, and ligament pain. Family medical history included arterial hypertension (mother) and cardiomyopathy (father). The patient has no toxic habits: tobacco 0, alcohol 0, other toxicants: 0. Concomitant medications included colecalciferol (UVEDOSE) from May2021 to an unspecified stop date; phloroglucinol (SPASFON) for ligament pain; and paracetamol for ligament pain. Declaration was confirmed medically, transmitted as part of the COVAC pregnancy study and documented to the Gynecology-Obstetrics department that took care of the patient. Patient''s date of last period was on 07Oct2020. Pregnancy start date: 21Oct2020. Planned date of birth: 14Jul2021. Course of pregnancy without particularity: On 30Jun2021 (one day following dose 2; 36 days following dose 1), the patient at 38 amenorrhea weeks, consulted in the gynecological emergency room for decrease in active fetal movements (time since which the patient noticed the decrease in active fetal movements is unknown). During monitoring: no audible heartbeats. On ultrasound control, there was absence of active fetal movements, no visible heartbeats. Announcement of foetal death in utero, information on the continuation of the care given to the couple. Decision of immediate management with initiation by dinoprostone (PROPESS). On 01Jul2021 at 18:40, the patient had vaginal birth of a female child born lifeless (Birth weight: 2940 g). Appearance of maceration of the fetus, no apparent malformation. Autopsy requested, in progress. No information regarding the appearance of the placenta. Conclusion: fetal death in utero discovered at 38 amenorrhea weeks, on day 1 of dose 2 and on day 36 of dose 1 of COMIRNATY, in a 27-year-old woman with a history of early spontaneous miscarriage but not belonging to a population at high fetal risk. Aspect of maceration of the fetus suggesting a death dating back several days. No apparent malformation. Awaiting fetal autopsy results. The patient (mother) recovered from the event with sequelae. The event was assessed as serious (hospitalization). Note: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible; information about batch number was already obtained.


VAERS ID: 1555702 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, 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? 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: IRON; FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: Pregnancy test; Test Result: Positive
CDC Split Type: NOPFIZER INC202100973208

Write-up: SPONTANEOUS ABORTION; Exposure during pregnancy, first trimester; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority number NO-NOMAADVRE-PASRAPP-2021-U1qa9y. This. This is a maternal report. A 33-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left on 30Jun2021 09:55 (Batch/Lot number was not reported) (at age 33-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included non-smoker. Concomitant medications included iron and folic acid ; all taken for an unspecified indication, start and stop date were not reported.On 10Jul2021, the patient developed spontaneous abortion and experienced exposure during pregnancy, first trimester on 30Jun2021. Outcome was recovering/resolving. The reactions/case was considered to be Serious due to (Other Serious (Important Medical Events)). The patient reported to have no allergies, never experienced spontaneous abortion before and being healthy. Outcome of the event of spontaneous abortion was recovering. Reporter Comment: The vaccination was 3 days before expected menstruation and before positive test. The patient reports to have no allergies, never experienced SPONTANEOUS ABROTION before and being healthy. 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)). The Regional Pharmacovigilance Center did not provide a causality assessment. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: The vaccination was 3 days before expected menstruation and before positive test. The patient reports to have no allergies, never experienced SPONTANEOUS ABROTION before and being healthy.


VAERS ID: 1630763 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad)

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: NLPFIZER INC202101017606

Write-up: This is a spontaneous report from a contactable consumer or other downloaded from the Agency A 33-year-old female patient received first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 29Jun2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunization. Medical history and concomitant medications were not reported. The patient experienced miscarriage on 15Jul2021, covid-19 vaccine exposure during pregnancy week: 3 on an unspecified date and muscle pain on 30Jun2021. This report concerns a female aged 33 years, with miscarriage (other medically important condition), myalgia, maternal exposure during pregnancy following administration of covid-19 vaccine pfizer injectable solution. The patient recovered from myalgia. The miscarriage occurred at a pregnancy duration of about 5,5 weeks. This was the first Covid vaccination, which took place at a pregnancy duration of about 3 weeks. Outcome of the events miscarriage on 15Jul2021 and covid-19 vaccine exposure during pregnancy week: 3 was unknown. Outcome of the event muscle pain on 30Jun2021 was recovered on 02Jul2021. No follow-up attempts are possible, information on batch number cannot be obtained.


VAERS ID: 1633844 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1439 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood grouping, Foetal death, Haemoglobin, Haemoglobin decreased, Inappropriate schedule of product administration, Rubella, Rubivirus test positive, Toxoplasmosis, Weight
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow), Opportunistic infections (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: Pre-eclampsia (at the end of 38 weeks of pregnancy + 6 days, induction for pre-eclampsia, girl weighing 2990g); Rh-positive; Vaginal delivery (at the end of 38 weeks of pregnancy + 6 days, induction for pre-eclampsia, girl weighing 2990g); Vaginal delivery (40 week of pregnancy + 2 days, boy weighing 3520g)
Allergies:
Diagnostic Lab Data: Test Name: blood group; Result Unstructured Data: Test Result:B Rh +; Test Date: 20210701; Test Name: hemoglobin; Result Unstructured Data: Test Result:11.5 g/dl; Test Name: rubella; Test Result: Positive ; Test Name: toxopasmosis; Test Result: Negative ; Test Date: 20210607; Test Name: weight; Test Result: 72 kg
CDC Split Type: FRPFIZER INC202101026507

Write-up: Fetal death in utero; rubella positive (+); Hb(hemoglobin) on D1 (01Jul2021) was 11.5 g / dl; Injection date: 18May2021 for D1 and 30Jun2021 for D2; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB FR-AFSSAPS-NT20213188. A pregnant 38-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in right arm on 30Jun2021 (Batch/Lot Number: FC1439) as DOSE 2, SINGLE for COVID-19 immunisation. Relevant medical history includes in 2015: vaginal delivery at the end of 38 weeks of pregnancy + 6 days, induction for pre-eclampsia, girl weighing 2990g; then in 2019: vaginal delivery 40 week of pregnancy + 2 days, boy weighing 3520g. No other significant medical and surgical history. Date of LMP was 24Sep2020. Date of presumed start of pregnancy was on 08Oct2020. Pregnancy without complications. No sign of preeclampsia during check-ups with the obstetrician. Patient was Group B Rh +. The patient''s concomitant medications were not reported. Patient historically received the first dose of COMIRNATY (batch/lot FA7082), intramuscular at the left arm on 18May2021 for COVID-19 immunisation and experienced maternal exposure during pregnancy. Patient had injection dates 18May2021 for D1 and 30Jun2021 for D2. Patient had Hb(hemoglobin) on D1 (01Jul2021) was 11.5 g / dl. Diagnosis of fetal death in utero on D(day)3 (03Jul2021) of the second dose of COMIRNATY at the end of 40 week of pregnancy + 2 days, patient in labor. Vaginal delivery of a male child weighing 3460 g, stillborn. The pregnancy resulted in still birth. The fetal outcome is intrauterine death. The patient was hospitalized on an unspecified date in 2021. Uncomplicated post-operative course. Apyretic patient, normotensive. No pain. Soft painless abdomen, tonic uterine globe under umbilical. Physiological lochia. DOSTINEX given, no breast pain. Patient underwent lab tests and procedures that includes Toxoplasmosis negative(-) and rubella positive (+) on an unspecified date, 72 kg on 07Jun2021. Evolution was recovered with sequelae. Contraception desired by OPTIMIZETTE to start 4 weeks after childbirth. To be followed for assessment of fetal death in utero, placental and fetal anatomopathology. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1638732 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   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 FD5996 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101041964

Write-up: Miscarriage; This is a spontaneous report from a contactable healthcare professional. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300097949. A pregnant 23-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on 30Jun2021 (Lot Number: FD5996, unknown expiration; at the age of 23 years old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced miscarriage on 30Jun2021 at 10:00. The patient recovered from the event in 2021. No follow-up attempts are possible; information about batch number was already obtained.


VAERS ID: 1664938 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Uterine spasm, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101056277

Write-up: severe cramps in uterus; Miscarriage; maternal exposure during pregnancy; bleeding; This is a spontaneous report from a contactable consumer or other non-HCP downloaded from the regulatory authority-WEB NL-LRB-00660542. A 32-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: FE1573) on 29Jun2021 at single dose for COVID-19 immunisation. The patient had no previous COVID-19 infection. The patient was pregnant at time of the second vaccination. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown) on 25May2021 at single dose for COVID-19 immunisation and the first vaccination took place before pregnancy. The patient experienced miscarriage and maternal exposure during pregnancy on 01Jul2021 (2 days after the vaccination). Stop date for events was reported as 01Jul2021 (Duration was also reported as 6 days). The miscarriage occurred at a pregnancy duration of about 5 weeks. This was 2 days after the second vaccination. The first vaccination took place before pregnancy. There was bleeding on 30Jun2021 (1 day after the second vaccination). The bleeding increased in combination with severe cramps in uterus. A miscarriage in the fifth week of pregnancy was a fact. At the time of the first vaccination, there was no pregnancy. This side effect therefore occurred once. There was no evidence of pregnancy until the second vaccination (COVID-19 vaccine exposure during pregnancy week was also reported as not yet). Seriousness criteria for event miscarriage was reported as medically significant. The outcome of events was unknown. Sender''s comment: Since the nature of the reported reaction implied seriousness according to one of the HA critera, the reaction (miscarriage) was considered as serious by the regulatory authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1664946 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:the fetus was found not to have a beating heart
CDC Split Type: NLPFIZER INC202101073274

Write-up: Suspicion of miscarriage; COVID-19 vaccine exposure during pregnancy week: 4; This is a first of two spontaneous reports (for mother) received from a contactable consumer (patient) downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00666642. This serious spontaneous report from a consumer or other non-health professional concerns a female aged 30 years. A 30-year-old (pregnant) female patient with 4 weeks of gestation period received a dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection), via unspecified date, administered on 30Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Jul2021, at 8 weeks of gestation, in the ultrasound, the foetus was found not to have a beating heart. The patient experienced a miscarriage following administration of covid-19 vaccine. Maternal exposure during pregnancy is treated with Medication to induce miscarriage and miscarriage was treated with Medication to induce miscarriage. Patient was not suspecting the miscarriage due to vaccine administration, but she wants to report the event. Since the nature of the reported reaction does imply seriousness according to one of the HA criteria, the reaction (suspected miscarriage) was considered as serious by the regulatory authority. The patient lab data includes Ultrasound abdomen on an unspecified date which showed the foetus was found not to have a beating heart. The outcome of the event Suspicion of miscarriage was recovered on 27Jul2021 and COVID-19 vaccine exposure during pregnancy week: 4 was recovered on 30Jun2021. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Summary of Reporter comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no Suspicion of miscarriage: Additional information ADR: I was 4 weeks pregnant during the 1st injection. Confounding factors: COVID-19 vaccine exposure during pregnancy week: 4 Previous COVID-19 infection: No; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101125979 fetus/mother case


VAERS ID: 1676318 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Maternal exposure during pregnancy, Pain in extremity, Pregnancy, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BEMFOLA; CYCLOGEST; DOMPERIDONE; FERROUS GLUCONATE; FOLIC ACID; GONADOTROPHIN CHORIONIC; MENOPUR; MERIOFERT; METHYLPHENIDATE; OVITRELLE; PARACETAMOL; TRAMADOL; VITAMIN D 3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Attention deficit hyperactivity disorder; Fertility increased; Fever; Lactation decreased; Migraine; Pregnancy (Patient no longer pregnant at the time of reporting.); Suspected COVID-19; Vitamin supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210819; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101092834

Write-up: Maternal exposure during pregnancy; pregnancy; Miscarriage; Fever; Exhaustion; Painful arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108201919016150-BQT40,Safety Report Unique Identifier GB-MHRA-ADR 25830996. This consumer reported information for mother. This is a maternal report. A 42-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection)on 30Jun2021 (Lot Number: FA1027) as dose 2, single for COVID-19 immunisation . Medical history included suppressed lactation, pregnancy , pyrexia , pregnancy Patient no longer pregnant at the time of reporting , suspected covid-19 from 31Jan2020 to 15Mar2021, fertility increased , migraine , vitamin supplementation , attention deficit hyperactivity disorder . Concomitant medication(s) included follitropin alfa (BEMFOLA) taken for fertility increased from 01Jul2021 to 05Jul2021; progesterone (CYCLOGEST) taken for pregnancy from 08Jun2021 to 20Aug2021; domperidone (DOMPERIDONE) taken for migraine from 01Jan2013 to 25Jun2021; ferrous gluconate (FERROUS GLUCONATE) taken for pregnancy from 01Dec2020 to an unspecified stop date; folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported; chorionic gonadotrophin (GONADOTROPHIN CHORIONIC) taken for fertility increased from 06Jan2021 to 06Jul2021; menotrophin (MENOPUR) taken for fertility increased from 08Dec2020 to 28Jun2021; menotrophin (MERIOFERT) taken for fertility increased from 29Jun2021 to 30Jun2021; methylphenidate (METHYLPHENIDATE) taken for attention deficit hyperactivity disorder from 01Jan2011 to an unspecified stop date; choriogonadotropin alfa (OVITRELLE) taken for fertility increased from 07Jun2021 to 07Jun2021; paracetamol (PARACETAMOL) taken for migraine from 01Jan2013 to an unspecified stop date; tramadol (TRAMADOL) taken for migraine from 01Jan2013 to an unspecified stop date; colecalciferol (VITAMIN D 3) taken for pregnancy from 28Jun2021 to an unspecified stop date. The patient received the historic vaccine BNT162B2 (Lot No-EW4109) for COVID-19 immunisation on 14 May 2021. Patient is not enrolled in clinical trial. The patient experienced pregnancy, maternal exposure during pregnancy on an unspecified date; painful arm on 30Jun2021; fever, exhaustion on 01Jul2021; miscarriage on 19Aug2021. The mother reported she became pregnant while taking bnt162b2. The patient had second Pfizer vaccine at the very beginning of the pregnancy and had first scan and the baby has no heartbeat. The baby was the correct size for 8 weeks pregnant, so the heart had only stopped in the last day or so. She woke with a fever around 4am she thinks it was the night after the vaccine (around 36 hours after I had the vaccine), she quickly took paracetamol, went back to sleep, and the fever was gone in the morning. Obviously any fever is worrying during pregnancy as it can cause brain damage etc, so possibly even that fever has caused this miscarriage.she is due to have a surgical abortion/evacuation next. Patient has not tested positive for COVID-19 since having the vaccine. the patient had Covid symptoms from 31Jan2020, a week of cold-like symptoms, then a 6 day high fever followed by a week of an intermittent fever, exhausted for a further three weeks then she thought she recovered. and then the pneumonia started. She was still very sick until the middle of 2020. She have been exhaused ever since, better able to do daily tasks since around March or so, but still very tired. This pregnancy was the result of IUI, using donor sperm, no known fertility issues.Patient was exposed to the medicine Throughout pregnancy. Ultrasound today (8 weeks + 2 days pregnant) showed no heartbeat, I have to have a surgical abortion/evacuation next week. Most of the medications listed above are used to time fertility treatment (IUI - Intrauterine Insemination) so that insemination occurs on exactly the right day. There wasn''t an option for ''fertility treatment'' or ''intrauterine insemination'', so I selected ''female fertility increase'' as it was the closest option. she was not actually infertile, I''m just using a sperm donor. Patient is not currently breastfeeding. The outcome of event pyrexia, Painful arm, Exhaustion was recovered; pregnancy is recovering; Miscarriage was not recovered. No follow up attempts are possible. No further information is expected.


VAERS ID: 1758541 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-30
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101239438

Write-up: Miscarriage, no embryo development; Miscarriage, no embryo development; This is a spontaneous report from a non-contactable consumer downloaded from the Agency WEB [DE-PEI-CADR2021156741], Safety Report Unique Identifier [DE-PEI-202100158868]. A 35-year-old female patient received BNT162B2 (COMIRNATY, Strength 0.3 ml) at single dose on 29May2021 for COVID-19 immunisation. Medical history, concurrent conditions and concomitant medications were not reported. Patient had no known allergies. Information on risk factors or previous illnesses was no, previously had 2 healthy children. On 30Jun2021, the patient experienced miscarriage and fatigue, described as miscarriage, no embryo development. The outcome of events was resolved with sequelae. This report was serious - hospitalization. Event assessment: Fatigue/RA: B Miscarriage/RA: D No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1859748 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-30
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC202101463459

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer or other non hcp (the patient). This is the first of two reports. The first report is a report received from the Regulatory Authority-WEB, regulatory authority number IS-IMA-5048. The consumer reported information for both mother and fetus. This is maternal case. This consumer or other non hcp reported information for both mother and fetus/baby. A 26-year-old pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown) via an unspecified route of administration on 09Jun2021 as DOSE 1, SINGLE for covid-19 immunization. The patient''s medical history included pregnancy (patient no longer pregnant at the time of reporting). Concomitant medications were not reported. The patient experienced miscarriage on 30Jun2021. The mother reported she became pregnant while taking bnt162b2. The mother was at 2 weeks plus 6 days of gestation (pregnant) at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. Outcome of event was recovered with sequelae on an unspecified date in 2021. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : IS-PFIZER INC-202101511115 fetus case


VAERS ID: 1510081 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-04-13
Onset:2021-07-01
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Chromosome analysis normal, Exposure during pregnancy, Foetal death, Ultrasound antenatal screen abnormal, Uterine dilation and curettage
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamins, Vitamin C
Current Illness: none
Preexisting Conditions: Asthma
Allergies: Seafood and shellfish and latex
Diagnostic Lab Data: Ultrasound confirming the baby was deceased and had cysts on the brain and back of the neck was performed on 7/6/2021. Chromosomal testing was preformed on myself, my husband, and the baby on 7/8/2021. A D&C was performed to remove the baby on 7/9/2021.
CDC Split Type:

Write-up: At the time of the second shot I found out I was pregnant that morning (4 weeks along). The estimated due date was January 12, 2022. The baby had a strong heartbeat at 7 weeks and at 8 1/2 weeks. However at 13 weeks had passed away due to cysts on the brain and back of the neck. Chromosome testing was done and the baby, my husband, and myself all came back without any chromosome issues. I had a miscarriage at 13 weeks after having both doses of the COVID 19 vaccine in the early month of my pregnancy.


VAERS ID: 1540824 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-05-06
Onset:2021-07-01
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0161 / 2 AR / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion induced, Computerised tomogram normal, Laparoscopic surgery, Pregnancy, Pregnancy test urine positive, Salpingectomy, Ultrasound scan vagina, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Uterine and fallopian tube malignant tumours (broad)

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: None
Current Illness: The week of the second dose I had a cold and a fever
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Vaginal ultrasound- pregnant, Urine test- pregnant, CT scan- normal
CDC Split Type: vsafe

Write-up: I went into the ER at the end of June because of vaginal bleeding and they found out I was pregnant but the pregnancy was at an unknown location so they did a surgery, a laparoscopic surgery. That resulted in pregnancy removal and fallopian tube removal. Before the surgery they did a urine test and vaginal ultrasound. I went to the ER again because of bad breathing post surgery so they did a CT scan. They prescribed me hydrocodone and Ibuprofen.


VAERS ID: 1743453 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210941603

Write-up: VACCINE EXPOSURE DURING PREGNANCY; MISCARRIED; This spontaneous pregnancy report received from a parent via a company representative concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient''s past medical history included: clotting. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine exposure during pregnancy. Reporter stated that, the report showed that the fetus stopped developing at five weeks. On an unspecified date in JUL-2021, the patient miscarried at ten weeks and the pregnancy resulted in a spontaneous abortion. The date of the patient''s last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy on JUL-2021, and the outcome of miscarried was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210941603-COVID-19 VACCINE AD26.COV2.S-miscarried. 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) 20210941603-COVID-19 VACCINE AD26.COV2.S-vaccine exposure during pregnancy . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1752848 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Guam  
Vaccinated:2020-12-29
Onset:2021-07-01
   Days after vaccination:184
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EH9899 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0140 / 2 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Abortion spontaneous, Emotional distress, Human chorionic gonadotropin, Maternal exposure before pregnancy, Ultrasound foetal abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Depression (excl suicide and self injury) (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: Fish oil, Via D3, Orthotricyclin-20
Current Illness: None
Preexisting Conditions: None
Allergies: Zofran
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. Bled heavily, did not need D&C.
CDC Split Type:

Write-up: Miscarriage / heavy bleeding, 07/2021 LMP, 08/12/2021


VAERS ID: 1754765 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-04-10
Onset:2021-07-01
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 LA / IM

Administered by: Other       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: Miscarriage, 07/2021


VAERS ID: 1538328 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Dizziness, Inappropriate schedule of product administration, SARS-CoV-2 test, Scan
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYCLOGEST; ESTRIOL; FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; In vitro fertilization (2nd attempt, successful in 2018, Taking estridiol and cyclogest.); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210311; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test; Test Name: viability scan; Result Unstructured Data: Test Result:slow heartbeat and measuring small (6w1d); Comments: Viability scan showed slow heartbeat and measuring small (6w1d) at 7-8 weeks
CDC Split Type: GBPFIZER INC202100949967

Write-up: Pregnancy failed and physical miscarriage happened at 9 weeks; First dose on 14May2021/ Second dose on 18Jul2021; Dizziness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107251013069950-7IBLF and Safety Report Unique Identifier GB-MHRA-ADR 25703793. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 18Jul2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased, Folic acid supplementation, details of previous pregnancies: IVF pregnancy (2nd attempt, successful in 2018), taking estridiol and cyclogest. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included progesterone (CYCLOGEST) taken for pregnancy from 30May2021 to 16Jul2021; estriol taken for pregnancy from 30May2021 to 16Jul2021; folic acid taken for folic acid supplementation, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 14May2021 for COVID-19 immunization. The patient experienced dizziness in Jul2021. Patient was no longer pregnant at the time of reporting. Patient was exposed to the medicine before pregnancy. Details of scans or investigations: Viability scan showed slow heartbeat and measuring small (6w1d) at 7-8 weeks. Pregnancy failed and physical miscarriage happened at 9 weeks. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 11Mar2021 Yes - Positive COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of dizziness was not recovered, of other events was unknown. Serious criteria for the case was reported as medical significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100960745 Same Patient, Different (Dose/Event)


VAERS ID: 1547376 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Asthenia, Human chorionic gonadotropin
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: HCG; Result Unstructured Data: Test Result:180; Test Date: 20210728; Test Name: HCG; Result Unstructured Data: Test Result:160
CDC Split Type: TRPFIZER INC202100973140

Write-up: Briefly became pregnant between the 2 vaccines, resulting in miscarriage; My wife and I shot 2 doses of the Biontech vaccine on July 16, and after the vaccine, especially my wife became very weak and rested at home for about 4 days.; This is a spontaneous report from a contactable consumer (reporting for his wife). This is a report based on information received by Pfizer (manufacturer control number 76807), license party for BNT162B2. A female patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 16Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY, solution for injection) on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunisation. The patient briefly became pregnant between the 2 vaccines, resulting in miscarriage on 28Jul2021. The reporter stated that his wife and him shot 2 doses of Biontech on 16Jul2021 (as reported) and after the vaccine, especially his wife became very weak (on Jul2021) and rested at home for about 4 days. They learned that his wife was pregnant 2 days ago (27Jul2021). Her hcg value was 180 on 27Jul2021. After 1 day (28Jul2021), bleeding occurred again, and miscarriage occurred. Hcg level dropped to around 160 on 28Jul2021. Briefly, she conceived in the middle of 2 rebellions and ended in miscarriage (as reported). This was why the reporting was writing about the side effects and results of the vaccine. It was reported that the inquiry involved a report of exposure during pregnancy. Nature of Pregnancy: miscarriage (as reported). The outcome of the events was unknown. Information on the batch/lot number has been requested.


VAERS ID: 1557931 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Maternal exposure during pregnancy, Stillbirth
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (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: DEPFIZER INC202100982260

Write-up: She was in the 37th week of pregnancy at the time of second vaccination; was vaccinated twice with Comirnaty: on 02Jul2021 and on 20Jul2021; She was during the 2nd vaccination in the 37th week of pregnancy and after that she had a stillbirth; This is a spontaneous report forma a consumer (patient''s husband) based on information received by Pfizer from Biontech, license party for Comirnaty [manufacturer control number: 76999]. A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 02Jul2021 (at an unspecified age of vaccination) (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on 20Jul2021 (at an unspecified age of vaccination) (Batch/Lot Number: FD7958) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she had a stillbirth after the 2nd vaccination in the 37th week of pregnancy(medically significant) in Jul2021 date with outcome of fatal, was vaccinated twice with COMIRNATY on 02Jul2021 and on 20Jul2021 in the 37th week of pregnancy at the time of second vaccination (non-serious) on 02Jul2021 with outcome of unknown. The mother was 37 weeks pregnant at the onset of the event stillbirth. The mother was pregnant with 1 baby. The pregnancy resulted in still birth. The fetal outcome was neonatal death. The course of events was as follows: The patient was vaccinated twice with Comirnaty: on 02Jul2021 and on 20Jul2021. She was in the 37th week of pregnancy at the time of second vaccination and after that she had a stillbirth in Jul2021. The caller wanted exact explanation how this is possible, because before the 2nd dose there were no indications that something was wrong with the pregnancy.


VAERS ID: 1579160 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal pain, Abortion incomplete, Blood count, Headache, Human chorionic gonadotropin, Intermenstrual bleeding, Lymphadenopathy, Physical examination, Ultrasound scan, Ultrasound scan vagina, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UTROGESTAN; ESTRADERM MATRIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Huntington''s chorea; Insomnia; Stress at work
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: blood count; Result Unstructured Data: Test Result:unbeatable; Test Date: 20210703; Test Name: HCG; Result Unstructured Data: Test Result:unbeatable; Test Date: 20210704; Test Name: physical examination; Result Unstructured Data: Test Result:GGC (Good general condition) presented; Comments: active vaginal bleeding, soft and depressible abdomen, painful in hypogastrium on palpation, without defense or peritoneal reaction; Test Date: 20210702; Test Name: ultrasounds; Result Unstructured Data: Test Result:a smooth implantation/good implantation; Test Date: 20210703; Test Name: ultrasounds; Result Unstructured Data: Test Result:unbeatable; Test Date: 20210704; Test Name: Transvaginal ECHO; Result Unstructured Data: Test Result:probable relation to incomplete abortion; Comments: in weeks 5-6 of pregnancy
CDC Split Type: ESPFIZER INC202100996761

Write-up: Lymphadenopathy axillary/feeling of bulging in the armpits; Incomplete abortion; Bleeding vaginal; Headache; abdominal discomfort; abdominal pain; metrorrhagia//abundant bleeding, bright red color.; This is a spontaneous report from a contactable consumer reporting for a family member downloaded from the WEB, regulatory authority number ES-AEMPS-957556. A 43-year-old pregnant female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 30Jun2021 (Batch/Lot Number: FE3065) as dose 2, single for COVID-19 immunisation. Medical history included huntington''s chorea, insomnia, anxiety and stressful work. Concomitant medications included progesterone (UTROGESTAN) from Jun2021 and ongoing, and estradiol (ESTRADERM MATRIX) from Jun2021, both taken for in vitro fertilisation. The patient previously took BNT162B2 (COMIRNATY), via an unspecified route of administration administered in right arm on 09Jun2021 (Batch/Lot Number: FA4632) as dose 1, single for COVID-19 immunisation. The patient experienced incomplete abortion on 03Jul2021, bleeding vaginal on 01Jul2021, headache on 01Jul2021, lymphadenopathy axillary on 03Jul2021, abdominal discomfort on 01Jul2021. The events were considered serious due to hospitalization and medically significant. Clinical course was reported as follows: In the process of "in vitro" fertilization, with a significant reduction in physical activity to facilitate the implantation that was carried out on June 14 (having put the first dose of Pfizer on June 9). Evolution "unbeatable" according to the words of the gynecologist in all reviews (reviewing both ultrasounds and blood count and / or HCG hormone values). Second dose of Pfizer on 30June. At 24 hours, abdominal discomfort, mild dark blood spotted, quite a headache (but no fever), and feeling of bulging in the armpits (the latter we are not sure if it was also just at 24h, everything else if). It should be noted that until that moment the patient had had very good feelings of pregnancy and zero problems. Review with gynecologist 2July: ultrasound still sees a smooth implantation and was expected day 9 to do the first ultrasound in which to see the heartbeat. The gynecologist thought that the staining could be normal. Next day the spots continued intermittently and the abdominal discomfort, and next wakes up with a lot of bleeding. On 04Jul2021, in emergencies: with ultrasound 48 h ago that reflected good implantation, which consulted for abdominal pain and metrorrhagia of 12 h of evolution, of abundant bleeding, bright red color. On physical examination, GGC (Good general condition) presented, with active vaginal bleeding, soft and depressible abdomen, painful in hypogastrium on palpation, without defense or peritoneal reaction. Transvaginal ECO: Findings in probable relation to incomplete abortion in weeks 5-6 of pregnancy. Heavy bleeding about 10 more days. Currently in gynecology reviews for possible curettage. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.


Result pages: prev   1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=18&PERPAGE=100&ESORT=ONSET-DATE&SYMPTOMS[]=Aborted_pregnancy_%2810000209%29&SYMPTOMS[]=Abortion_%2810000210%29&SYMPTOMS[]=Abortion_complete_%2810061614%29&SYMPTOMS[]=Abortion_early_%2810052846%29&SYMPTOMS[]=Abortion_incomplete_%2810000217%29&SYMPTOMS[]=Abortion_induced_%2810000220%29&SYMPTOMS[]=Abortion_late_%2810052847%29&SYMPTOMS[]=Abortion_missed_%2810000230%29&SYMPTOMS[]=Abortion_of_ectopic_pregnancy_%2810066266%29&SYMPTOMS[]=Abortion_spontaneous_%2810000234%29&SYMPTOMS[]=Abortion_spontaneous_complete_%2810061616%29&SYMPTOMS[]=Abortion_spontaneous_incomplete_%2810061617%29&SYMPTOMS[]=Foetal_cardiac_arrest_%2810084280%29&SYMPTOMS[]=Foetal_death_%2810055690%29&SYMPTOMS[]=Premature_baby_death_%2810076700%29&SYMPTOMS[]=Premature_delivery_%2810036595%29&SYMPTOMS[]=Stillbirth_%2810042062%29&VAX=COVID19


Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166