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

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

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Case Details (Sorted by Onset Date)

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VAERS ID: 1822403 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-04-27
Onset:2021-05-18
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8162 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Chromosome analysis normal, Condition aggravated, Foetal heart rate abnormal, Pregnancy, Pregnancy test positive, Thyroid function test normal, 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), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: fluvoxamine ER 2, 100mg daily
Current Illness: None
Preexisting Conditions: OCD
Allergies: None
Diagnostic Lab Data: See above
CDC Split Type:

Write-up: March 28, 2019 - 1st pregnancy, live birth, c-section, 5lbs 6oz, 42 weeks March 7, 2021 - 2nd pregnancy, miscarriage, approx 7 weeks March 30, 2021 - first dose of COVID vaccine April 27, 2021 - 2nd dose of COVID vaccine May 7, 2021 - positive pregnancy test May 26, 2021 - 3rd pregnancy, miscarriage, approx 5 weeks, thyroid blood test normal August 27, 2021 - 4th pregnancy, positive test September 22, 2021 - prenatal visit, ultrasound & heartbeat October 6, 2021 - prenatal visit, ultrasound with no heartbeat October 7, 2021 - D&C approx 10 weeks, chromosomal analysis normal


VAERS ID: 1379091 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2245 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021575383

Write-up: Early miscarriage/miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202105191939233480-VM06U, Safety Report Unique Identifier GB-MHRA-ADR 25324045. This consumer reported information for both mother and baby. This is the maternal report. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ew2245), via an unspecified route of administration on 15May2021 as 1st dose, single dose for COVID-19 immunization. Medical history included folic acid supplementation and pregnancy (patient no longer pregnant at the time of reporting), both from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced early miscarriage/miscarriage on 18May2021 and was hospitalized on an unspecified date. It was reported that the patient experienced possible cause of miscarriage/miscarried 3 days after vaccine. The reporter assessed the event as serious (hospitalization). Patient has not tested positive for COVID-19 since having the vaccine. It was unsure if the medicine caused an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included COVID-19 virus test: negative (no/negative COVID-19 test) on an unspecified date. The outcome of the event was recovered on 19May2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1396970 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Dizziness, Maternal exposure during pregnancy, Scan
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:miscarried; Test Name: scans; Result Unstructured Data: Test Result:miscarried
CDC Split Type: GBPFIZER INC2021628716

Write-up: light headed/dizzy; Miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-APPCOVID-202105300817237180-JXZKD. Safety Report Unique Identifier GB-MHRA-ADR 25387885. A 37-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 37-years-old, via an unspecified route of administration on 18May2021 (Lot Number: EW4109) as single dose for covid-19 immunisation. Medical history included abortion spontaneous on Feb2021, pregnancy (Patient no longer pregnant at the time of reporting), Folic acid supplementation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for Folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on 18May2021 with outcome of unknown, miscarriage on 24May2021 with outcome of recovering, light headed/dizzy on an unspecified date with outcome of unknown. HA seriousness assessment: Other medically important condition. Clinical course as follows: patient felt light headed/dizzy for a couple of days after injection. Then 6 days after the injection she began to miscarry her baby, she was treated by the hospital who confirmed via scans and blood tests that she had miscarried. She was not totally blaming the vaccine as she understand miscarriages can just happen however she was very concerned it had happened only six days after having vaccine so felt should report it. Patient has not tested positive for COVID-19 since having the vaccine. Unsure the medicine have an adverse effect on any aspect of the pregnancy. Details of previous pregnancies: Child born May 2020, miscarriage Feb 2021, now another miscarriage May2021. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: 7 weeks pregnant confirmed miscarriage at hospital. had Covid vaccine at 6 weeks 1 day pregnant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1479176 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-18
   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 FA 7082 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DAFLON
Current Illness: Twin pregnancy (Biamniotic bichorial twin pregnancy)
Preexisting Conditions: Medical History/Concurrent Conditions: Assisted fertilisation (in vitro fertilization (IVF))
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: Ultrasound; Result Unstructured Data: Test Result:good vitality of the 2 nd twin; Comments: good vitality of the 2 nd twin
CDC Split Type: FRPFIZER INC2021824423

Write-up: Single fetal death in twin pregnancy; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-2021081285. A 39-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 18May2021 (Lot Number: FA 7082) (at age of 39-year-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing Biamniotic bichorial twin pregnancy, assisted fertilisation from an unknown date, in vitro fertilization (IVF). Concomitant medication included diosmin (DAFLON) taken for an unspecified indication from 01Mar2021 to an unspecified stop date. The patient experienced maternal exposure during pregnancy, first trimester (medically significant) on 18May2021 with outcome of unknown, single fetal death in twin pregnancy (medically significant) on 25May2021 with outcome of unknown. The patient pregnancy obtained by IVF (Date of last menstruation on 10Feb2021 and date of start of pregnancy on 24Feb2021). The mother reported she became pregnant while taking bnt162b2. The mother was pregnant with 2 babys. Diagnosis on 25May2021: early fetal death in utero of a twin (pregnancy stopped in one of the twins at 14 weeks of amenorrhea and around 6 days). Ultrasound made on 14Jun2021 showing good vitality of the 2 nd twin. Amniocentesis proposed on the remaining fetus but the couple does not wish, because no morphological abnormality. Placenta analysis expected at birth. Time Interval between Beginning of Drug Administration and Start of Event Single fetal death in twin pregnancy was 8 days. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1703076 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Pregnancy of unknown location, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
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: LEVAXIN
Current Illness: Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Depressed mood (Provera)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101125738

Write-up: Miscarriage; PUL (PREGNANCY WITH UNKNOWN LOCALISATION); ITCHING AT THE VACCINATION SITE; REDNESS AT THE VACCINATION SITE; PAIN AT THE VACCINATION SITE; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-063878. A 35-years-old pregnant female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration at age of 35 years on 18May2021 (Lot Number: EX8680) as single dose for covid-19 immunisation. Medical history included depressed mood and not ongoing (with Provera), ongoing hypothyroidism. Concomitant medication included levothyroxine sodium (LEVAXIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took Provera and experienced depressed mood. The patient experienced itching at the vaccination site on 19May2021, pain at the vaccination site on 18May2021, redness at the vaccination site on 19May2021, miscarriage on 28Jun2021, PUL (pregnancy with unknown location) on 28Jun2021. The woman was vaccinated with the second dose of Comirnaty in week 1 of pregnancy and the suspected adverse reaction (miscarriage/ PUL) was detected in week 6 of pregnancy. Course was recovered but itching at the vaccination site, redness at the vaccination site and pain at the vaccination site, duration 8-10 days. Recovered with lasting symptoms of miscarriage /PUL (pregnancy with unknown location). Case assessed as serious, important medical event by the Medical Products Agency. The outcome of events Pregnancy of unknown location and Miscarriage was recovered/resolved with sequel on 12Jul2021, of itching at the vaccination site and pain at the vaccination site was recovered on 28May2021, redness at the vaccination site was recovered on 27May2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1773327 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001946 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: SEMODERNATX, INC.MOD20213

Write-up: VAGINAL BL?DNING; MATERNAL EXPOSURE DURING PREGNANCY; MISSFALL; This regulatory authority retrospective pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (MISSFALL), VAGINAL HAEMORRHAGE (VAGINAL BL?DNING) and MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3001946) for COVID-19 vaccination. No Medical History information was reported. On 18-May-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-May-2021, the patient experienced ABORTION SPONTANEOUS (MISSFALL) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) (seriousness criterion medically significant). On 19-May-2021, the patient experienced VAGINAL HAEMORRHAGE (VAGINAL BL?DNING) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 18-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) had resolved. At the time of the report, ABORTION SPONTANEOUS (MISSFALL) and VAGINAL HAEMORRHAGE (VAGINAL BL?DNING) had resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported. This case concerns a -32year-old, female patient with no relevant medical history, who experienced the serious unexpected events of maternal exposure during pregnancy, abortion spontaneous and vaginal hemorrhage. The patient received the second dose of vaccine at 6 weeks of gestation. Spontaneous abortion occurred on the same day after the second dose of Spikevax while vaginal hemorrhage occurred 1 day after the second dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Translated document received on 04-Oct-2021 contains no new information; Sender''s Comments: This case concerns a -32year-old, female patient with no relevant medical history, who experienced the serious unexpected events of maternal exposure during pregnancy, abortion spontaneous and vaginal hemorrhage. The patient received the second dose of vaccine at 6 weeks of gestation. Spontaneous abortion occurred on the same day after the second dose of Spikevax while vaginal hemorrhage occurred 1 day after the second dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1336963 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-04-16
Onset:2021-05-19
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal Vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: 5/20/21 Pelvic USG 5/20/21 QHCG
CDC Split Type:

Write-up: Patient is a G2P1, received her second Pfizer vaccine on 4/16/21. She began having bleeding on 5/19/21 and had a completed AB confirmed on USG 5/20/21. She was 6 4/7 weeks at the time of her miscarriage.


VAERS ID: 1341092 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-18
Onset:2021-05-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Miscarriage in first trimester of pregnancy day after receiving vaccine.


VAERS ID: 1350892 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-03-26
Onset:2021-05-19
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: prenatal vitamins
Current Illness: NA
Preexisting Conditions:
Allergies: allergic to gluten
Diagnostic Lab Data: ultrasound, HCG quantitative bloodwork
CDC Split Type:

Write-up: I was pregnant when I got my second shot (due date (1/2/2022). I subsequently had a pregnancy loss that started on 5/19/2021.


VAERS ID: 1361171 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: California  
Vaccinated:2021-05-06
Onset:2021-05-19
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025C21A / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal heart rate abnormal, 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? Yes
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Two ultrasounds.
CDC Split Type:

Write-up: I was 6 week pregnant at the time of my second vacine dose. My 8 week ultrasound found that the baby was probably 6 weeks and they couldn?t find a hear beat. The miscarriage was confirmed on the 28 of May.


VAERS ID: 1387039 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-05-16
Onset:2021-05-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarried at 6 weeks


VAERS ID: 1389195 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2021-04-22
Onset:2021-05-19
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

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

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

Write-up: Miscarriage discovered on 05/19/21


VAERS ID: 1401418 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021627759

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority number is NL-LRB-00555240. A 33-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 19May2021 (Batch/Lot Number: FA7082) (at the age of 33-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient was pregnant at time of vaccination. The patient''s medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (COMIRNATY) on 23Apr2021 with no adverse reaction but had maternal vaccine exposure. The patient had a miscarriage (other medically important condition), on the same day she had her COVID-19 vaccine. The miscarriage occurred at a pregnancy duration of 6 to 7 weeks. This was the second covid vaccination. The outcome of the event miscarriage was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1418385 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Depressed level of consciousness, Uterine hypertonus, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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: FIPFIZER INC2021662398

Write-up: Miscarriage/ complete miscarriage; decrease in consciousness; Heavy vaginal bleeding and contractions; Heavy vaginal bleeding and contractions; This is a spontaneous report from a contactable consumer, downloaded from the WEB. The regulatory authority number is FI-FIMEA-20212901. This is a maternal report. A 40-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 17May2021 (Batch/Lot number and Expiration date were unknown) dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 19May2021, the patient experienced miscarriage, which was considered serious, medically significant. It was further reported that the patient was pregnant at the time of COVID-19 vaccination (11 + 6, unit not provided). Heavy vaginal bleeding and contractions began in the evening of 19May2021. From the beginning of the night (19May2021 to 20May2021), there was a decrease in consciousness caused by bleeding and the outcoming of the placenta. In the morning of 20May2021, the outcoming of the fetal membranes and the fetus/embryo was reported. Gynecologist visited on 20May2021 and noted a complete miscarriage, for which a doctor''s diagnosis and a medical certificate were issued. The patient was pregnant while taking bnt162b2. The patient delivered the pregnancy on 19May2021. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The patient was not recovered from the event "miscarriage," while the outcome of the rest of the events was unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1418732 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting)
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: scan; Test Result: Inconclusive ; Comments: but assumed miscarriage at around 8 weeks
CDC Split Type: GBPFIZER INC2021655320

Write-up: Early miscarriage/miscarriage; Maternal exposure during pregnancy/Received Pfizer 1st dose on 19May2021 at around 6 weeks pregnant/Patient was exposed to the medicine first-trimester (1-12 weeks); This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106031114447150-XC89K, Safety Report Unique Identifier: GB-MHRA-ADR 25411774. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19May2021 (lot number: EW4109) at 1st dose, single for COVID-19 immunisation. Medical history included miscarriage, pregnancy from an unknown date to an unknown date (patient no longer pregnant at the time of reporting), and folic acid supplementation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation. The patient experienced miscarriage and maternal exposure during pregnancy on an unspecified date; and early miscarriage on 02Jun2021. Clinical course reported: received Pfizer 1st dose on 19May2021 at around 6 weeks pregnant. Began bleeding on 02Jun2021 and suspected miscarriage with inconclusive scan to be repeated on 15June2021 for confirmation. Unsure if the medicine had an adverse effect on any aspect of the pregnancy. Previous pregnancies: miscarriage occurred 14 days after first Pfizer dose. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: inconclusive scan but assumed miscarriage at around 8 weeks. Relevant investigations or tests conducted: inconclusive scan on 02Jun2021 to be repeated on 15Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event early miscarriage/miscarriage was recovering. Regulatory authority assessed the events as serious resulted in congenital anomaly (as reported) and for being medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1441296 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-05-19
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenoid vegetations; Early miscarriage; Functional bowel syndrome; Hematometra; Metrorrhagia
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Miscarriage; This regulatory authority prospective pregnancy case was reported by a physician and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 29-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Functional bowel syndrome, Early miscarriage, Adenoid vegetations, Metrorrhagia and Hematometra. On 25-Mar-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 19-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Miscarriage) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was not provided. Treatment information was provided. 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. However patient?s medical history of early miscarriage could be a confounder. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021075668; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However patient?s medical history of early miscarriage could be a confounder.


VAERS ID: 1452583 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Off label use, Product use issue
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (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: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy (Carried previous pregnancy to term. Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021747014

Write-up: Early miscarriage; Maternal exposure during breast feeding; Maternal exposure during breast feeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106202117591320-YEHYQ , Safety Report Unique Identifier GB-MHRA-ADR 25506717. This consumer reported information for both mother and fetus/baby.This is a the maternal report. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19May2021 (at the age of 42 years old) (Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included miscarriage, pregnancy and carried previous pregnancy to term in 2018, patient is no longer pregnant at the time of reporting, ongoing breast feeding, folic acid supplementation from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken for vitamin folic acid supplementation, start and stop date were not reported. The patient experienced early miscarriage on 12Jun2021, and maternal exposure during breast feeding on 19May2021. The mother reported she became pregnant while taking BNT162B2. The mother was 1 Trimester pregnant at the onset of the event. Early miscarriage. She did not want to attribute this specifically to the Pfizer vaccine, but she does want to flag that the miscarriage occurred in her 7th week of pregnancy three weeks after receiving the vaccine. She is sharing this information for the purposes of data gathering. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if the medicine have an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). No relevant investigations or tests conducted. The outcome of early miscarriage was recovered on 15Jun2021. No follow-up attempts are possible, information about Batch/Lot Number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021754367 Baby case


VAERS ID: 1480611 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EV8680 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Interchange of vaccine products, 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), Medication errors (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: SEPFIZER INC2021824547

Write-up: miscarriage in pregnancy week 6; Maternal exposure during pregnancy, 4 weeks; Interchange of vaccine products; This is a spontaneous report from a contactable consumer downloaded from the WEB SE-MPA-2021-052423. A 30-year-old female pregnant patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 19May2021 (at the age of 30 years old) (Batch/Lot Number: EV8680) as single dose for COVID-19 immunisation; received the first dose of covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA) via an unspecified route of administration on 03Mar2021 (Lot Number: ABV5441) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced miscarriage in pregnancy week 6 (medically significant) on 31May2021, maternal exposure during pregnancy 4 weeks on 19May2021, interchange of vaccine products on 19May2021. The mother was 4 weeks pregnant at the onset of the event. The outcome of the event Interchange of vaccine products was unknown, of the other events was recovered on 06Jun2021. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : SE-MPA-2021-013808 AstraZeneca


VAERS ID: 1504639 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-19
   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 FA7082 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Headache, Malaise, Maternal exposure during pregnancy, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site pruritus
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: TRAMADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021874145

Write-up: Fatigue; Miscarriage; Headache; Not feeling well; Inflammatory reaction at the reaction site: redness, pain; Reaction at or around the injection site: redness; Reaction at or around the injection site: pain; Reaction at or around the injection site: itching; vaccination during 8th week of pregnancy; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00613479. A 37-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: FA7082), via an unspecified route of administration, on 19May2021 (at the age of 37 years old) as dose 1, single for COVID-19 immunisation. The patient''s medical history included maternal vaccine exposure. Concomitant medication included tramadol taken for an unspecified indication, start and stop date were not reported. The patient has no previous COVID-19 infection. On 19May2021, it was reported that the patient experienced injection site erythema (reported as redness), pain, pruritus (reported as itching), inflammation (reported as redness and pain), and maternal exposure during pregnancy following the administration of COVID-19 vaccine. The patient had no extensive swelling of the vaccinated limb. On 20May2021, the patient experienced headache and malaise (not feeling well); and, on 21May2021, 2 days after the vaccination and gestational age of 8.5 weeks (as reported), the patient had a miscarriage (medically significant) and fatigue. Headache was treated with Tramadol. The outcome of the event fatigue was recovering; for the event headache was recovered on 28May2021; for the events not feeling well was recovered on 22May2021; for the events injection site erythema, pain, pruritus, inflammation was recovered on 25May2021, while for the other events was unknown. Sender''s comment: Since the nature of the reported reaction did imply seriousness according to one of the regulatory authority criteria, the reaction miscarriage was considered as serious by the regulatory authority. Sender''s Diagnosis: Injection site inflammation. Reporter''s comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Redness or Swelling Extensive swelling of vaccinated limb: no. Miscarriage: Additional information Adverse Drug Reaction: had a miscarriage 2 days after vaccination, gestational age of 8.5 weeks. confounding factors: COVID-19 vaccine exposure during pregnancy week: 8. COVID-19: Previous COVID-19 infection: No; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Redness or Swelling Extensive swelling of vaccinated limb: no. Miscarriage: Additional information Adverse Drug Reaction: had a miscarriage 2 days after vaccination, gestational age of 8.5 weeks. confounding factors: COVID-19 vaccine exposure during pregnancy week: 8. COVID-19: Previous COVID-19 infection: No


VAERS ID: 1343763 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-12
Onset:2021-05-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016C21A / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin, Pathology 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: None known
Current Illness: None known
Preexisting Conditions: None known
Allergies: Ampicillin, Penicillins class
Diagnostic Lab Data: HCG, surgical pathology of POC.
CDC Split Type:

Write-up: Miscarriage 5/20/2021


VAERS ID: 1365711 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: D.C.  
Vaccinated:2021-04-20
Onset:2021-05-20
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017B21A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 043B21A / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal death, Ultrasound foetal, Ultrasound foetal abnormal, Uterine dilation and curettage
SMQs:, 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: Anti-histamines PIO (progesterone in oil) shots Estrace
Current Illness: None
Preexisting Conditions: None
Allergies: Shellfish, apples, pollen
Diagnostic Lab Data:
CDC Split Type:

Write-up: Missed miscarriage. Was 4 weeks pregnant at time of second shot. Estimated delivery date of Dec 26, 2021. Heartbeat at 6 week ultrasound (May 7th). No heartbeat at 8 week ultrasound (May 20th). Pregnancy through IVF - frozen embroyo transfer on April 9th. Had D&C on May 24th.


VAERS ID: 1401471 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-06
Onset:2021-05-20
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Antiphospholipid antibodies negative, Blood thyroid stimulating hormone normal, Cardiolipin antibody, Cytomegalovirus test negative, Cytomegalovirus test positive, Exposure during pregnancy, Foetal death, Gestational diabetes, Glycosylated haemoglobin normal, Kleihauer-Betke test negative, Labour induction, Parvovirus B19 test, Pregnancy, Pregnancy with advanced maternal age, Prenatal screening test, Russell's viper venom time, SARS-CoV-2 test negative, Stillbirth, Toxicologic test normal, Toxoplasma serology
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamins, miralax, loratadine, anusol rectal cream, flonase, hydroxyprogesterone caproate weekly IM injections
Current Illness: Pregnancy
Preexisting Conditions: none known
Allergies: none
Diagnostic Lab Data: Lab work up for IUFD 5/21/21: anticardiolipin IgG < 14, dRVVT screen 38, lupus anticoag screen neg, A1c 5.5, TSH 2.20 Kleihauer betke negative CMV IgG positive, IgM negative Parvovirus B19 IgG positive, IgM negative Toxoplasma IgG positive, IgM negative COVID RT PCR negative Urine tox negative Placental path: Specimen is received in formalin labeled with patient name and medical record Number, placenta. Specimen consists of a 404 g single disc placenta measuring 18 by 14 x 3.5 cm. Three-vessel umbilical cord inserts into placenta eccentrically(fragmented) measuring 42 long and 1.4 cm in diameter. Fetal membranes attach to placenta along the edge and are thin and transparent. Fetal surface shows normal vascular distribution. Maternal surface shows intact cotyledons. Sectioning of placenta shows red-purple spongy parenchyma. No hematoma identified. Representative sections submitted in 3 blocks. PATHOLOGIC DIAGNOSIS: PLACENTA, REMOVAL: - THIRD TRIMESTER PLACENTA WITH EDEMA(404G). - THREE-VESSELED UMBILICAL CORD. - FOCAL ACUTE CHORIONITIS.
CDC Split Type:

Write-up: 40yo G7P3215 pregnant with EDD 7/28/21. Patient had h/o preterm delivery x2 and was receiving Makena (hydroxyprogesterone caproate) weekly IM injections, last dose 5/13/21. Pregnancy was complicated by AMA, had low risk NIPT, 2nd tri state screen, and normal level 2 anatomy ultrasound. She was diagnosed with GDM A1 5/14/21. Patient seen 4/29/21 at 27w with normal pregnancy. Next visit 5/20/21 was diagnosed with IUFD as no heart tones noted. She was not clear on last time fetal movement felt, but thought that demise occurred in the week prior to visit. Received Pfizer COVID vaccinations 4/8/21 and 5/6/21. She had induction of labor and delivered stillborn infant on 5/21/21 with birth weight 1305g. Gross examination was unremarkable as was work up - will include below in item 19.


VAERS ID: 1457438 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-05
Onset:2021-05-20
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER 8737 / 2 LA / IM

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarriage


VAERS ID: 1694062 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-11
Onset:2021-05-20
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Brain stem auditory evoked response, Caesarean section, Exposure during pregnancy, Gestational hypertension, Premature delivery
SMQs:, Hypertension (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin c, vitamin D3, prenatal multivitamin, DHA, singulair, Claritin, xyrem
Current Illness:
Preexisting Conditions: Asthma
Allergies: Amoxicillin
Diagnostic Lab Data: ABR June 28
CDC Split Type:

Write-up: LMP 8/22/2020, EDD 5/29/2021 Vaccinated March 11 and April 1. Isolated prenatal hypertension developed at 36 weeks Early c section due to isolated prenatal hypertension Baby born with unilateral auditory neuropathy


VAERS ID: 1379124 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-20
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Live birth (age 3 and 5); Miscarriage
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021582349

Write-up: Maternal exposure during pregnancy; Early miscarriage; This is a spontaneous report from a contactable physician received from Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202105200926272810-5AL8L Safety Report Unique Identifier GB-MHRA-ADR 25327118. A 39-year-old female patient (1 trimester pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ET8885), via an unspecified route of administration on 14May2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. Medical history included ongoing pregnancy, folic acid supplementation, 2 live births (age 3 and 5), miscarriage in 2020. Concomitant medications included folic acid taken for folic acid supplementation. The patient experienced early miscarriage on 20May2021, maternal exposure during pregnancy. Events were assessed as serious with criteria of Other medically important condition. Additional information: Patient pregnant PV bleeding started today 6 days after first vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Details of previous pregnancies: 2 live births age 3 and 5 1 miscarriage last year (2020). Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: PV bleeding this morning at 11+ weeks patient had Pfizer first dose on 14May2021. Regarding whether the report relates to possible blood clots or low platelet counts, the answer was "No". Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1380384 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-20
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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? 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: Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Test Result: Negative
CDC Split Type: MXPFIZER INC2021581267

Write-up: abortion; This is a spontaneous report from a contactable Other Health Professional (patient) via a Pfizer sponsored program Corporate Web Site, A 30-year-old female pregnant patient received bnt162b2, via an unspecified route of administration on 29Apr2021 (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. The patient''s medical history included didn''t smoke. Concomitant medications were not reported. The patient experienced abortion on 20May2021 with outcome of unknown. The mother reported she was almost 2 weeks pregnant while taking bnt162b2. Clinical course: before applying the vaccine on 29Apr2021, the patient took a blood pregnancy test which came out negative, so she decided apply it to her, but it turned out that she was almost 2 weeks pregnant, today she found out that she had an abortion. She thought they should carry out more studies and not say that it was 100% safe for this type of population. She was a healthy person so having this abortion seemed somehow incredulous, she didn''t smoke, she did not drink, she did not have diabetes or Hypertension and she was 30 years old with a son almost 2 years old.; Sender''s Comments: Based on chronological connection to the vaccine a causal relationship between event abortion and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1400771 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001945 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   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:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Fetal death; This regulatory authority case was reported by a physician and describes the occurrence of FOETAL DEATH (Fetal death) in a 22-week-old male infant exposed to mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001945) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): Concurrent medical conditions included Vaccine exposure during pregnancy. No Medical History information was reported. On 09-May-2021, the mother received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-May-2021, the infant was diagnosed with FOETAL DEATH (Fetal death) (seriousness criteria death and medically significant). The infant died on 20-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intra-uterine), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 (COVID 19 Vaccine Moderna) in response to the event was not applicable. Company Comment : Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. No further information is available for this case Sender''s (Case) Safety Report Unique Identifier : FR-AFSSAPS-2021061999; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. No further information is available for this case; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1416595 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA T3J051V / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Erythema, Exposure during pregnancy, Feeling hot, Pain in extremity, Peripheral swelling, Pruritus, Vaccination site pain, Vaccination site swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Miscarriage; Vaccination site pain; Localised erythema; Localised feeling of warmth; Vaccine exposure during pregnancy; Localised pruritus; Vaccination site swelling; Pain in arm; Swelling arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage), VACCINATION SITE PAIN (Vaccination site pain), ERYTHEMA (Localised erythema), FEELING HOT (Localised feeling of warmth), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PRURITUS (Localised pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), PAIN IN EXTREMITY (Pain in arm) and PERIPHERAL SWELLING (Swelling arm) in a 34-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. T3J051V) for COVID-19 vaccination. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SALMEX) for Asthma, CROMOGLICATE SODIUM (LECROLYN) for Pollen allergy. On 19-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant), VACCINATION SITE PAIN (Vaccination site pain) (seriousness criterion medically significant), ERYTHEMA (Localised erythema) (seriousness criterion medically significant), FEELING HOT (Localised feeling of warmth) (seriousness criterion medically significant), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) (seriousness criterion medically significant), PRURITUS (Localised pruritus) (seriousness criterion medically significant), VACCINATION SITE SWELLING (Vaccination site swelling) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant). The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. Miscarriage. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), VACCINATION SITE PAIN (Vaccination site pain), ERYTHEMA (Localised erythema), FEELING HOT (Localised feeling of warmth), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PRURITUS (Localised pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), PAIN IN EXTREMITY (Pain in arm) and PERIPHERAL SWELLING (Swelling arm) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. No Treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, these events appear to be non-serious. Also, this is a case of product exposure during pregnancy with abortion spontaneous.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, these events appear to be non-serious. Also, this is a case of product exposure during pregnancy with abortion spontaneous.


VAERS ID: 1438786 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? 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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: scan; Result Unstructured Data: Test Result:baby has no heart beat; Comments: Went for scan at 13 weeks and baby has no heart beat
CDC Split Type: GBPFIZER INC2021747460

Write-up: Miscarriage of pregnancy; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106202014123080-OIWE1, Safety Report Unique Identifier GB-MHRA-ADR 25506595. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via an unspecified route of administration on 20May2021 as dose 1, single for Covid-19 immunisation. Medical history included pregnancy (no longer pregnant at the time of reporting), vitamin supplementation. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medication included folic acid for vitamin supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy first-trimester (1-12 weeks) on 20May2021. She informed that she had a scan and baby had no heartbeat and she miscarried that day, 24May2021. The event was reported as serious medically significant, life threatening. The outcome of the event was recovered on 07Jun2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1539154 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Body temperature, Headache, Heavy menstrual bleeding, Malaise, Menstrual disorder, Myalgia, Nausea, Pain, Pyrexia, SARS-CoV-2 test, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contrast media allergy; COVID-19 (7 weeks pregnant at the time I got corona; disease symptoms: quite); Maternal vaccine exposure
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: body temperature; Result Unstructured Data: Test Result:Fever; Comments: not measured; Test Date: 20210329; Test Name: corona, confirmed by test; Test Result: Positive ; Test Name: ultrasound; Result Unstructured Data: Test Result:unknown result
CDC Split Type: NLPFIZER INC202100949096

Write-up: very sick/ill; a lot of pain; Menstruation abnormal; Heavy menstruation/has had period since 28Jun2021; Miscarriage; Myalgia; Fever: not measured; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB. The regulatory authority number is NL-LRB-00634371 and additional identifier NL-LRB-00640177. A 38-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 20May2021 (Batch/lot number: FA7082), at age 38 years old, as dose 1, single, for COVID-19 immunisation. The patient was pregnant at the time of vaccination. Gestation period at exposure was 14 weeks (also reported as 14.5 weeks). Relevant medical history included COVID-19 infection from 29Mar2021, not reported if ongoing or not (the patient was 7 weeks pregnant at the time she got corona; disease symptoms: quite; there were more severe symptoms, comparable to a severe flu and/or shortness of breath, but could stay at home); maternal vaccine exposure (as reported) and allergy to contrast media, both from unknown dates, not reported if ongoing or not. Concomitant medications were not reported. On 20May2021, 15 minutes after the vaccination, the patient experienced nausea. On the same day, 1 hour after the vaccination, the patient had headache. On the same day, on 20May2021 (also reported as 1 day after start), the patient had "fever: not measured". On 21May2021, 1 day after the vaccination, the patient experienced myalgia. On 01Jun2021, 12 days after the vaccination, the patient experienced miscarriage. The patient was 16 weeks pregnant at the onset of the event miscarriage. The pregnancy resulted in spontaneous abortion. On 28Jun2021, 1 month and 8 days after the vaccination, the patient experienced heavy menstruation and menstruation abnormal. On an unspecified date, the patient was very sick/ill and was in a lot of pain. The patient has had her period since 28Jun2021. She was still in a lot of pain. She previously had a stable cycle of 26 days. The patient was being treated by a gynecologist. Treatment for the events menstruation abnormal and heavy menstruation included PRIMOLUT. The patient underwent a diagnostic procedure which was ultrasound on an unspecified date with unknown results. The patient tested positive to COVID-19 (corona, confirmed by test) on 29Mar2021. Confounding factors were reported as allergy to contrast media and previous COVID-19 infection. The outcome of the events miscarriage and very sick/ill was unknown. The patient recovered from fever, headache, and myalgia on 22May2021, and from nausea on 21Jul2021. The outcome of menstruation abnormal, heavy menstruation/has had period since 28Jun2021, and a lot of pain was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1546365 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Off label use, Product use issue, Scan
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Mood change; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:Missed miscarriage; Comments: missed miscarriage initially diagnosed from a scan at 9 weeks, embryo measuring 6.5 weeks at the time/Missed miscarriage identified at 9 weeks
CDC Split Type: GBPFIZER INC202100957155

Write-up: Early miscarriage/ Miscarriage; Maternal exposure during breast feeding; Maternal exposure during breast feeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number [GB-MHRA-WEBCOVID-202107261359363560-QQLAR], Safety Report Unique Identifier [GB-MHRA-ADR 25707829]. This is the maternal report. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot Number: EW4109), via an unspecified route of administration on 20May2021 (at the age of 36 years old) (Lot Number: EW4109) as dose 1, single for COVID-19 immunisation. Medical history included mood change, miscarriage from an unknown date and unknown if ongoing, pregnancy (One previous healthy pregnancy) from n unknown date patient no longer pregnant at the time of reporting, ongoing breast feeding, and folic acid supplementation from an unknown date and unknown if ongoing. No pre-existing medical conditions, not taking any medications. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced early miscarriage on 16Jul2021 with outcome of recovered and maternal exposure during breast feeding on 20May2021. The events was reported as serious causing congenital anomaly. Vaccine received 20th May; conception around 28th May; missed miscarriage initially diagnosed from a scan at 9 weeks, embryo measuring 6.5 weeks at the time. The patient underwent lab tests and procedures which included scan: missed miscarriage initially diagnosed from a scan at 9 weeks, embryo measuring 6.5 weeks at the time/Missed miscarriage identified at 9 weeks on an unknown date. Details of scans or investigations: Missed miscarriage identified at 9 weeks. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. It was unsure if the medicine have an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). The outcome of early miscarriage was recovered on an unknown date. No follow up attempts are possible. No further information is expected.


VAERS ID: 1676849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-20
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYRIMOZ [ADALIMUMAB]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankylosing spondylitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101089260

Write-up: Spontaneous abortion week 6; This is a spontaneous report from a non-contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-PASRAPP-2021-Uxz5q1. A 30-year-old female patient received bnt162b2 (COMIRNATY), intramuscular administered in left arm on 29Apr2021 11:20 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included ankylosing spondylitis. Concomitant medication included adalimumab (HYRIMOZ [ADALIMUMAB]) taken for ankylosing spondylitis from Feb2021 to 06May2021. On 20May2021, the patient experienced spontaneous abortion week 6. The patient discovered pregnancy shortly after vaccination. The pregnancy resulted in spontaneous abortion. The event was considered to be serious due to other serious (important medical event). On unspecified date, the patient recovered from the event. Reporter comment: Contact with healthcare professionals: Physician. The patient discovered pregnancy shortly after vaccination. Health Authority Comment: Upgraded to Serious due to EARLY MISCARRIAG: Important Medical Events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Contact with healthcare professionals: Physician. The patient discovered pregnancy shortly after vaccination.


VAERS ID: 1347826 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-20
Onset:2021-05-21
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Mango Shellfish
Diagnostic Lab Data: Pelvic ultrasound 5/21/21
CDC Split Type:

Write-up: 24 year old female with last menstrual period 3/26/21, received Pfizer mRNA COVID vaccine on 4/20/21. she had yet to take a pregnancy test. She received her 2nd vaccine on 5/18/21. Ultrasound was done on 5/21 when patient was expected to be 8 weeks pregnant, showing pregnancy loss.


VAERS ID: 1365501 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-05-18
Onset:2021-05-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / UNK RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / UNK RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Blood test normal, Exposure during pregnancy, Laboratory test normal, Mobility decreased, Premature delivery, Premature labour, Pyrexia, Retained placenta or membranes, Thrombosis, Ultrasound antenatal screen normal, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NO
Current Illness: NO
Preexisting Conditions: NO
Allergies: NO
Diagnostic Lab Data: Genetic Testing, Ultrasound and Blood Work come up Normal/Low Risk-05/15/2021
CDC Split Type:

Write-up: on Tuesday 05/18/2021 i take my 2th dose of Vaccine and on 05/19/2021 at around 2100 pm i start to develop high fever at 103-104 with abdominal cramps, same way i was on the 05/20/2021 and on Friday morning 05/21/2021 i start bleeding with large clots and wasn''t able to get from the bed, and around noon my waters broke following with a lot of blood and clots,i had to deliver my baby girl at home at 15 weeks, 911 was called, because the placenta didn''t come out, so i was rushed to the ER Baby was Delivered at 13:30pm on 05/21/2021


VAERS ID: 1368536 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: California  
Vaccinated:2021-02-09
Onset:2021-05-21
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, Dizziness, Laboratory test, Ultrasound foetal
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), 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: Hydroxychloroquine, magnesium, prenatal vitamins
Current Illness: None
Preexisting Conditions: Arthritis and chronic constipation
Allergies: Naproxen, alcohol wipes, bentoperoxide
Diagnostic Lab Data: Ultrasounds Lab work
CDC Split Type: vsafe

Write-up: 03/04/2021 I had my last period. Then I had the second dose and a month later I knew I was pregnant and then I had a missed miscarriage. They gave me misoprostol and misoprostol. After the missed miscarriage I was dizzy because I lost blood.


VAERS ID: 1385395 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-15
Onset:2021-05-21
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033C21A / 2 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Blood test, Dizziness, Exposure during pregnancy, Syncope, Ultrasound antenatal screen abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (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), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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: Supplements I was taking were prenatal vitamin and vitamin d and DHS supplements.
Current Illness: None
Preexisting Conditions: None
Allergies: I am allergy to Sulfa antibiotic.
Diagnostic Lab Data: The did blood work and a ultra sound.
CDC Split Type: vsafe

Write-up: I was having light headeness and fainting. I also was having abdominal pain.I end up having a miscarriage at 8 weeks.


VAERS ID: 1414115 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-01-07
Onset:2021-05-21
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal heart rate abnormal, Ultrasound scan abnormal, Uterine dilation and curettage
SMQs:, Malignancy related therapeutic and diagnostic procedures (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
Current Illness:
Preexisting Conditions: none
Allergies: nkda
Diagnostic Lab Data: Ultrasound 5/21 and 6/9
CDC Split Type:

Write-up: Patient became pregnant in April 2021. At 8 week ultrasound on May 21, 2021, displaying signs of early miscarriage. Repeat ultrasound June 9, 2021 displayed no fetal cardiac activity. D&C procedure completed June 14, 2021.


VAERS ID: 1431535 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-04-14
Onset:2021-05-21
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 UN / IM

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

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

Write-up: Unaware of pregnancy status when she got her vaccine on 4/14 on 5/21 she had a miscarriage at 7-9 weeks of pregnancy.


VAERS ID: 1490635 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-12
Onset:2021-05-21
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test abnormal, Exposure during pregnancy, Maternal exposure during pregnancy, Pre-eclampsia, Premature delivery
SMQs:, Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: None
Preexisting Conditions: Prediabetic
Allergies: None
Diagnostic Lab Data: Preeclampsia bloodwork done at the hospital
CDC Split Type:

Write-up: Was 32+2 weeks pregnant at first dose. Developed preeclampsia after vaccination and 2 weeks later delivered baby at 34+4 due to severe preeclampsia. Due date was July 5th. First vaccine was May 12th. Preeclampsia diagnosis on May 21st. Delivered baby on May 28th due to severe features of preeclampsia.


VAERS ID: 1658988 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-05-18
Onset:2021-05-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Culture urine negative, Exposure during pregnancy, Foetal macrosomia, Haemorrhage, Leukocytosis, Malaise, Muscle spasms, Nausea, Pelvic discomfort, Perineal injury, Premature delivery, Premature labour, Toxicologic test normal, Umbilical cord blood pH, Uterine contractions during pregnancy, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

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

Write-up: a 33/F s/p NSVD viable male neonate at 28w4d after spontaneous onset of preterm labor. Pregnancy history of TAB in 2015. GYN history of ?LEEP for HPV+ many years ago, 09/24/19 pap NIL, HPV-. Current pregnancy course complicated by fetal macrosomia at 97th %ile on 20w3d US, first trimester A1c was WNL and BMI was 24. Otherwise uncomplicated pregnancy with routine prenatal care, negative Progenity NIPT and AFP screening. Patient did receive Moderna COVID19 immunization at 28w0d on 05/18/21 per personal wishes after informed consent of risks and benefits. On 05/20/21 and 05/21/21 she played some gentle softball, which she normally does once weekly. During these games she does not run. On the second day she went home early to rest because she wasn''t feeling well, starting having pelvic cramping and back pain around 2100 that evening. Symptoms progressed overnight, by 0400 on 05/22/21 she was still having cramping with some bleeding (unclear if vaginal or hematuria) and nausea/vomiting. She called the on-call physician and was advised to present to L&D immediately for evaluation. By the time she arrived on L&D, her contractions were very strong. As she was giving her admission urine sample she felt a fetal presenting part and called for help. Liveborn male neonate 1540 grams was delivered at 0741 on 05/22/21 with APGARs of 8 at one minute and 9 at five minutes. Had a small hemostatic periclitoral laceration that did not require repair and EBL 50mL. Placenta was delivered intact spontaneously with 3VC. Urine toxicology screening negative. Cord blood pH 7.33 arterial, 7.39 venous. Urine culture negative. Initial leukocytosis to 20.82 on 05/22/21 has completely resolved to 10.59. Patient''s postpartum course was uncomplicated, and she was discharged home within a couple days. She did receive her second Moderna dose on 06/15/21. Patient''s son was cared for in the NICU with brief intubation on first day of life (received surfactant), then progressed to CPAP and subsequently nasal cannula oxygen. Diagnosed with respiratory distress syndrome, apnea-bradycardia of prematurity, and a grade 1 R germinal matrix hemorrhage. Received a short course of phototherapy for hyperbilirubinemia. Passed car seat challenge and hearing screen. Circumcision performed 07/16/21. Received all routine immunizations through 2 months of age while in the NICU. He was discharged home on nasal cannula oxygen on 07/21/21 at postmenstrual age of 37w1d at 3268 grams. He has been breastfeeding, growing, and developing normally and was able to discontinue oxygen supplementation on 08/31/21.


VAERS ID: 1666272 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-02-01
Onset:2021-05-21
   Days after vaccination:109
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Infertility female, Menstrual disorder
SMQs:, Termination of pregnancy and risk of abortion (narrow), Fertility disorders (narrow), Sexual dysfunction (broad)

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

Write-up: Since the vaccine I have had 2 miscarriages and have been suffering with secondary infertility. I also have noticed changes in my menstrual cycle and am worried that the vaccine has affected my ability to get pregnant and carry to term. I of course do not know if it is related to the vaccine or just coincidental, but my health and fertility issues have me very concerned. I hope that more studies are done to look into this issue.


VAERS ID: 1666585 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-05-15
Onset:2021-05-21
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 1 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Amniotic fluid volume increased, Blood test, Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Foetal hypokinesia, Induced labour, Pathology test, Umbilical cord abnormality, Umbilical cord thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Protonix, ducolax stool softener and prenatal vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: Keflex
Diagnostic Lab Data: There was a pathology study done on the cord and placenta post delivery (May 26 or 27) I also have had bloodwork done to test for clotting disorders August 23, 2021.
CDC Split Type:

Write-up: I was 30 weeks and 3 days pregnant when I got the first Pfizer Covid vaccine. I stopped feeling my baby move that day. He had been VERY active until then. On May 21, 2021 I could not find his heartbeat with my at home monitor. On May 24, 2021 it was confirmed at my doctors office that there was no heartbeat. I delivered him on May 26, 2021 at 3:22pm after being induced. He weighed 4 pounds and was 17 1/2 inches long. I was told there was a stricture in one of the blood vessels in the cord and a blood clot. My due date was July 21, 2021. Other complications during the pregnancy: He had Down?s syndrome and a condition called Duodenal atresia. Because of the duodenal atresia I had slightly higher than normal amniotic fluid.


VAERS ID: 1404635 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-05-21
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021639312

Write-up: Abortion early; The patient experienced abortion early (medically significant) on 21May2021. Early miscarriage after first dose Pfizer vaccine; This is a spontaneous report received from a contactable physician downloaded from the European Medicine Agency (EMA) EudraVigilance-WEB. The regulatory authority report number is IT-MINISAL02-735893. A 33 years old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm right (right shoulder) on 16Apr2021 15:18 (Lot Number: EX0893; Expiration Date: 31Jul2021) at age of 33 years old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced abortion early (medically significant) on 21May2021. Early miscarriage after first dose Pfizer vaccine (pregnancy not known at time of administration). The patient became pregnant while taking bnt162b2. The mother was 8 weeks pregnant at the onset of the event. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1418519 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-21
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021662365

Write-up: Miscarriage; This is a spontaneous report from a contactable physician downloaded from the WEB FR-AFSSAPS-2021063280. A 34-year-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 14May2021 (Batch/Lot Number: FA5829) as DOSE 2, SINGLE for COVID-19 immunisation. Patient was pregnant at time of vaccination. The patient medical history and concomitant medications were not reported. Patient previously received BNT162B2 (COMIRNATY), on Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. Patient was not considered at risk. Patient has not had COVID. Patient was not tested. 1 week after the vaccine (21May2021), the patient has an early spontaneous miscarriage in the 1st trimester. The fetal outcome is intrauterine death. The reporter assessed the event as medically significant. The outcome of patient''s event was not recovered. NB: 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. No further information is expected.


VAERS ID: 1447748 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, 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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Mood change; Pregnancy (Patient no longer pregnant at the time of reporting/Have had a healthy pregnancy in the past.)
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: pregnancy test; Test Result: Positive ; Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: scans or investigations; Result Unstructured Data: Test Result:Confirmed miscarriage
CDC Split Type: GBPFIZER INC2021736165

Write-up: Miscarriage; The patient was just 1 week pregnant when had the vaccine (first-trimester ); This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106101208451380-2FTOI, Safety Report Unique Identifier GB-MHRA-ADR 25493814. A 37-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21May2021 (Lot Number: Ey5456) as single dose for COVID-19 immunisation. The patient was not currently breastfeeding. Medical history included mood altered, suppressed lactation, pregnancy (patient no longer pregnant at the time of reporting/ have had a healthy pregnancy in the past). Concomitant medication included folic acid at 400 ug taken for folic acid supplementation. The patient was just 1 week pregnant when had the vaccine on 21May2021 and experienced miscarriage on 03Jun2021 with outcome of unknown. The event was serious, medically significant. The patient underwent lab tests and procedures which included pregnancy test: positive on 28May2021, COVID-19 virus test: negative on an unspecified date and scan: confirmed miscarriage on an unspecified date. The clinical course was reported as follows: had first vaccine on the 21May2021. Had a positive pregnancy test on the 28May2021. Miscarried on the 03Jun2021. No proof that this was related however I would have been just 1 week pregnant when I had my vaccine. Did the medicine have an adverse effect on any aspect of the pregnancy: unsure. Details of previous pregnancies: have had a healthy pregnancy in the past this was the 2nd time I was pregnant. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: confirmed miscarriage. Additional information: the patient has not had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1452094 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Premature delivery, Retroplacental haematoma, Ultrasound foetal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: ultrasound; Result Unstructured Data: Test Result:at 31 WA + 6 days without identified placental abn; Comments: at 31 WA + 6 days without identified placental abnormality
CDC Split Type: FRPFIZER INC2021752015

Write-up: Retroplacental haematoma; Early onset of delivery; Maternal exposure during pregnancy, third trimester; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-2021074528. A 30-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: FC3558), intramuscular, administered in right arm on 21May2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had maternal exposure during pregnancy, third trimester on 21May2021. Five (5) days later (26May2021), at 35 weeks of amenorrhea, the patient had a premature delivery following a retroplacental haematoma which caused hospitalization. The mother was 35 weeks pregnant at the onset of the event. (beginning or pregnancy was 03Oct2020). The mother was pregnant with 1 baby. The mother delivered the pregnancy on 26May2021. The baby was delivered premature. The patient underwent lab tests and procedures which included ultrasound: at 31 wa + 6 days without identified placental abnormality on 30Apr2021. The outcome of the events was recovered. Time interval between beginning of drug administration and start of reaction / event was 6 days. Time interval between last dose of drug and start of reaction / event was 6 days. The reaction did not recur on readministration (no rechallenge was done, recurrence was not applicable). No follow-up attempts are possible. No further information is expected; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021830854 fetus case


VAERS ID: 1452251 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021830854

Write-up: Early onset of delivery; Maternal exposure during pregnancy, third trimester; This is a spontaneous report from a contactable physician created basing on the mother case from AER # 2021752015 (report downloaded from the Regulatory agency-WEB FR-AFSSAPS-2021074528). This physician reported information for both mother and fetus/baby. This is a fetus report. A fetus patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 2 transplacental, on 21May2021 (Lot Number: FC3558) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced maternal exposure during pregnancy, third trimester on 21May2021 and early onset of delivery on 26May2021 with outcome of recovered. Event was serious as hospitalization. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021752015 mother and fetus cases


VAERS ID: 1485856 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / 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: FOLIUMZUUR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS in a 28-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Disease risk factor. Concomitant products included FOLIC ACID (FOLIUMZUUR) for an unknown indication. On 21-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 ml. Last menstrual period and estimated date of delivery were not provided. On 21-May-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 an unknown date. For neonate 1, The outcome was reported as Unknown. At the time of the report, ABORTION SPONTANEOUS and MATERNAL EXPOSURE DURING PREGNANCY 3e week van de outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Seriousness for miscarriage was changed from congenital anomaly / birth defect to other medically important condition. The treatment was not received. 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. This case was linked to MOD-2021-258698 (Parent-Child Link). See case MOD-2021-258698 for details regarding the child case.; 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: 1496098 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-21
   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 - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test; Comments: Inconclusive test
CDC Split Type: GBPFIZER INC2021863708

Write-up: Early miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107061026534790-APOIK. Safety Report Unique Identifier GB-MHRA-ADR 25602511. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21May2021 at 25-year-old as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Lactation decreased, clinical trial participant. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient was pregnant from an unknown date and no longer pregnant at the time of reporting. Patient was exposed to the medicine first-trimester (1-12 weeks) and experienced miscarriage. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced medical significant maternal exposure during pregnancy on 21May2021, medically significant early miscarriage on 23May2021. The patient underwent lab tests and procedures which included inconclusive COVID-19 virus test. Outcome of the event early miscarriage was recovered, of other event was unknown. No follow-up attempts are needed, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1516869 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; LEVOTHYROXINE SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Hypothyroidism; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908772

Write-up: Maternal exposure during pregnancy/Patient was exposed to the medicine first-trimester (1-12 weeks).; Periods have been irregular and lighter since; 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-202107171636305370-33M4E, Safety Report Unique Identifier GB-MHRA-ADR 25668977. This case is pertinent for first dose. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 18May2021 as dose 1, single for COVID-19 immunisation. The patients medical history included pregnancy (Patient no longer pregnant at the time of reporting), vitamin supplementation, hypothyroidism (from an unknown date and unknown if ongoing). Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medication(s) included 400 ug of folic acid (FOLIC ACID) taken for vitamin supplementation, (start and stop date were not reported); levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for hypothyroidism (from 01Apr2013 to an unspecified stop date). On an unspecified date, the patient experienced maternal exposure during pregnancy and Periods have been irregular and lighter since. On 21May2021, the patient experienced early miscarriage. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient stated that she had a healthy 8 year-old with normal pregnancy. It had taken 7 months to get pregnant and then lost 5 days after the vaccine. The outcome of the events, maternal exposure during pregnancy and Periods have been irregular and lighter since was unknown. The outcome of the event early miscarriage was recovered on 22May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100921581 Second dose


VAERS ID: 1554638 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-21
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, 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 Date: 20210729; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977172

Write-up: Miscarriage; Menstrual flooding; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107301557110130-4D8VT. Safety Report Unique Identifier GB-MHRA-ADR 25733969. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose (dose number unknown) for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 21May2021 experienced menstrual flooding. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 29Jul2021 No - Negative COVID-19 test. On 30Jul2021 the patient experienced miscarriage. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1642191 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-05-21
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: investigation; Result Unstructured Data: Test Result:No infections or reason for miscarriage; Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Patient has not tested positive for COVID-19 since having the vaccine; Test Date: 2021; Test Name: emergency scan; Result Unstructured Data: Test Result:no heartbeat, pregnancy lost; Comments: 11 week emergency scan; Test Date: 2021; Test Name: internal scan; Result Unstructured Data: Test Result:heartbeat found; Comments: 6 weeks internal scan
CDC Split Type: GBPFIZER INC202101040924

Write-up: 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 is GB-MHRA-WEBCOVID-202108111823439790-O8VTQ, Safety Report Unique Identifier GB-MHRA-ADR 25785933. A pregnant 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Feb2021 (Lot Number: ER1741) as single dose for COVID-19 immunisation. Medical history included miscarriage, lactation decreased, and pregnancy from unspecified date and no longer ongoing (Patient no longer pregnant at the time of reporting). Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation. The patient was given second whilst in early stages of pregnancy, was told no known risks because not enough research done. Pregnancy stopped progressing approximately 2 weeks after vaccine. The patient experienced early miscarriage on 21May2021. Symptoms of miscarriage didn''t occur until 4 weeks later and then foetus was delivered with intervention on 26Jun2021 (pending clarification). Patient was exposed to the medicine during first-trimester (1-12 weeks). Details of scans or investigations on unspecified date in 2021: 6 weeks internal scan, heartbeat found. 11 week emergency scan, no heartbeat, pregnancy lost. No infections or reason for miscarriage was found after investigation. It was unsure whether the medicine has an adverse effect on any aspect of the pregnancy. The patient had negative COVID-19 virus test on unspecified date in 2021 (reported as patient has not tested positive for COVID-19 since having the vaccine). The outcome of the event was recovered on 21Jun2021. The event was considered serious, medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1356101 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-05-03
Onset:2021-05-22
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Citalopram 10mg Prenatal vitamin Iron 28 mg
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: First pregnancy Weeks of brown bleeding prior to miscarriage Due 12/17/21 Miscarriage 05/22/21 at 1pm


VAERS ID: 1359722 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-03
Onset:2021-05-22
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002C21A / 1 LA / IM

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

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

Write-up: Patient reports being 6 weeks pregnant (estimated Due 12/27/21) at time of vaccination. She has been previously been pregnant 3 times with no prior miscarriages or complications. Patient reports finding out about miscarriage on 5/22 during office visit and completed miscarriage on 5/25. Patient experienced mild fever and chills approximately 6 hours after vaccine which was controlled by acetaminophen and resolved by the following morning 5/4.


VAERS ID: 1441768 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-05-22
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; DHA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (2 pregnancies with excellent course)
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: common laboratory tests; Result Unstructured Data: Test Result:normal
CDC Split Type: ITPFIZER INC2021686612

Write-up: Abortion at the 8th week of gestation 52 days after the administration of the first dose of Comirnaty.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-739455. A 35-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: ER9470; Expiration Date: 31Jul2021), via intramuscular route of administration on 31Mar2021 as single dose for covid-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing 2 pregnancies with excellent course. Concomitant medication(s) included folic acid taken for an unspecified indication from Mar2021 to an unspecified stop date and the Multicentrum Materna supplement with DHA. Mother was reported on 22May2021 had spontaneous abortion at the 8th week of gestation in a 35-year-old patient. clinical history no previous pathologies: anamnesis 2 pregnancies with excellent course, no concomitant pathology, denies exposure to x-rays, alcohol, tobacco and drug use in general with the exception of sporadic use of paracetamol, only reports a start of intake, about 10 days before vaccination following an ascertained diagnosis of pregnancy, of folic acid and the Multicentrum Materna supplement with DHA. on gynecological advice, common laboratory tests were performed at the beginning of pregnancy and all results were normal. The outcome for the event was reported as unknown. Reporter comment: The patient (doctor in a care facility) told me about the abortion event that took place on 22May and the previous vaccination against Covid19 which took place on 31Mar. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The patient (doctor in a care facility) told me about the abortion event that took place on 22May and the previous vaccination against Covid19 which took place on 31Mar


VAERS ID: 1453343 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210517; Test Name: ultrasound; Result Unstructured Data: Test Result:everything fine including a beating hea; Test Date: 20210522; Test Name: ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210529; Test Name: ultrasound; Result Unstructured Data: Test Result:no heart activity
CDC Split Type: NLPFIZER INC2021730367

Write-up: ultrasound showed no heart activity; vaccinated at a pregnancy duration of 7 weeks; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number NL-LRB-00563615. This physician reported information for both mother and foetus/baby. This is a maternal report. A 41-years-old female patient received BNT162B2 (COMIRNATY, Lot number- FA7082), via an unspecified route of administration on 22May2021 (at the age of 41-year-old) as dose number unknown, single for covid-19 immunization. Medical history and concomitant medications were not reported. No Previous COVID-19 infection was reported. The patient experienced lifeless pregnancy. On 17May2021 had an ultrasound where everything turned out fine including a beating heart. On 22May2021 had vaccination during pregnancy and on 29May2021 ultrasound showed no heart activity (abortion spontaneous). The mother reported she became pregnant while taking bnt162b2. The mother was 7 Weeks pregnant at the onset of the event. The outcome of the events was reported as unknown at the time of report. No follow-up attempts possible. No further information expected.


VAERS ID: 1456744 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-22
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Chills, Fatigue, Headache, Malaise, Maternal exposure during pregnancy, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONCERTA
Current Illness: Disease risk factor; Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 3)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Fever; Result Unstructured Data: not measured; Comments: Fever: not measured
CDC Split Type: NLJNJFOC20210708119

Write-up: VACCINATION DURING THE 3RD WEEK OF PREGNANCY; MISCARRIAGE; FEELING UNWELL; JOINT PAIN; COLD CHILLS; FATIGUE; HEADACHE; NAUSEA; MUSCLE PAIN; FEVER: NOT MEASURED; This spontaneous pregnancy report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00597175] concerned a 26 year old female of unspecified race and ethnicity. The patient''s weight was 70 kilograms, and height was 168 centimeters. The patient''s concurrent conditions included disease risk factor and maternal vaccine exposure. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, 01 total, administered on 22-MAY-2021 for covid-19 immunization. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included from MAR-2018 to 01-JAN-2021 methylphenidate hydrochloride (Concerta) 18 milligram, 4 per week, for an unknown indication. On 22-MAY-2021, the patient experienced feeling unwell, joint pain, cold chills, fatigue, headache, nausea, muscle pain, fever: not measured. On 26-JUN-2021, the patient had miscarriage. On an unspecified date, the patient experienced vaccination during the 3rd week of pregnancy. Laboratory data (dates unspecified) included: Fever (NR: not provided) not measured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling unwell, fatigue, and fever: not measured on 29-MAY-2021, joint pain, and muscle pain on 24-MAY-2021, cold chills, headache on 23-MAY-2021, and nausea on 27-MAY-2021, and the outcome of miscarriage and vaccination during the 3rd week of pregnancy was not reported.. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210708119- Covid-19 vaccine ad26.cov2.s-Miscarriage. 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). V0:20210708119- Covid-19 vaccine - Vaccination during the 3rd week of 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 V0:20210708119- Covid-19 vaccine - Feeling Unwell, Joint Pain, Cold Chills, Fatigue, Headache, Nausea, Muscle pain, Fever: Not measured.. This event(s) is labeled per RSI and is therefore considered potentially related


VAERS ID: 1475238 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage (2 x miscarriage at 6 weeks in the past)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021778830

Write-up: Miscarriage; A 40-years-old pregnant female patient received bnt162b2; This is a spontaneous report from a contactable physician downloaded from regulatory authority number BE-FAMHP-DHH-N2021-95535. A 40-years-old pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW6126) via an unspecified route of administration on 22May2021 (was pregnant at the time of vaccination 1st trimester) as dose 1, single for COVID-19 immunization. Medical history included had 2 miscarriage at 6 weeks in the past. Concomitant medication included paracetamol. On 24May2021, the patient experienced miscarriage of pregnancy, had curettage gynecologist estimates dead fetus in around 24/5. It was unknown if treatment received for the event. It was reported that no improvement in evolution of the event. The outcome of the event miscarriage was not recovered and rest event was unknown. Situations - Other: probably no relationship with vaccine, but need to report this, in circle of friends still such cases. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - Unknown Evolution of the ADR - No Improvement Situations - Other: probably no relationship with vaccine, but need to report this, in circle of friends still such cases Examinations - patient also had 2 x miscarriage at 6 weeks in the past ADR description - miscarriage


VAERS ID: 1480219 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UTROGESTAN VAGINAL
Current Illness: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 4+3)
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Miskraam; Maternal exposure during pregnancy; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miskraam) in a 41-year-old female patient (gravida 1) who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 on 27-Feb-2020. Concurrent medical conditions included Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 4+3). Concomitant products included PROGESTERONE (UTROGESTAN VAGINAL) for an unknown indication. On 22-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On 22-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 30-May-2021, the patient experienced ABORTION SPONTANEOUS (Miskraam) (seriousness criterion medically significant). On 05-Jun-2021, ABORTION SPONTANEOUS (Miskraam) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. No treatment information was provided. 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. Regulatory Authority received translation, additional information does not change company comment. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Translated received on 01-JUL-2021 does not contain any new information On 09-Jul-2021: Batch number was added.; 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. Regulatory Authority received translation, additional information does not change company comment.


VAERS ID: 1520916 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Malaise, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Scan; Result Unstructured Data: Test Result:Had a scan a few days later which showed an early; Comments: Had a scan a few days later which showed an early miscarriage
CDC Split Type: GBPFIZER INC202100922947

Write-up: Early miscarriage; feeling sick; 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-202107190823464480-0OJHE, Safety Report Unique Identifier is GB-MHRA-ADR 25671022. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Not known), via an unspecified route of administration on 21May2021 at DOSE 1, SINGLE for COVID-19 immunisation. Medical history included abortion spontaneous and pregnancy. No other illnesses or regular medication. Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced feeling sick in 2021 with outcome of recovered on 22May2021, early miscarriage on 22May2021 with outcome of recovered with sequelae. The patient was pregnant while taking BNT162B2. The patient was 7 weeks pregnant at the onset of the event. Vaccine on Friday 21May2021 when approximately 7 weeks pregnant. Had been feeling sick from pregnancy, this stopped on Saturday 22May2021. Had a scan a few days later which showed an early miscarriage. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date (No - Negative COVID-19 test). This is a serious report received with serious criteria hospitalization, medically significant and congenital anomaly form MHRA. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1524631 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-22
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 5.5)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: SARS-CoV-2 test positive; Result Unstructured Data: Positive
CDC Split Type: NLJNJFOC20210764223

Write-up: VACCINATION DURING 5.5 WEEK OF PREGNANCY; MISCARRIAGE; This spontaneous pregnancy report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00636489] concerned a 31 year old female of unknown race and ethnicity. The patient''s weight was 88 kilograms, and height was 174 centimeters. The patient''s past medical history included covid-19, and concurrent conditions included maternal vaccine exposure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) 1 dosage forms, 0.5 ml, 1 total, administered on 20-APR-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 24-JAN-2021, the patient tested positive for SARS-CoV-2 test. The patient was vaccinated during 5.5 week of pregnancy. On 22-MAY-2021, the patient experienced miscarriage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination during 5.5 week of pregnancy and miscarriage was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0. 20210764223 -Covid-19 vaccine ad26.cov2.s- Miscarriage and vaccination during 5.5 week of pregnancy . These events are considered unassessable. The events 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 events.


VAERS ID: 1333195 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-19
Onset:2021-05-23
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0151 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8730 / 1 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain lower, Antiphospholipid antibodies negative, Beta-2 glycoprotein antibody negative, Blood thyroid stimulating hormone normal, Cardiolipin antibody negative, Chromosome analysis normal, Cytomegalovirus test negative, Cytomegalovirus test positive, Exposure during pregnancy, Foetal death, Foetal placental thrombosis, Glycosylated haemoglobin normal, Haematocrit decreased, Parvovirus B19 test negative, Platelet count normal, Toxoplasma serology negative, Treponema test negative, White blood cell count increased
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: No known drug allergies
Diagnostic Lab Data: 4/24/21: Placenta weighed <10th centile with evidence of 1.8cm subchorionic clot. 4/24 /21: cytogenetic testing (SNP microarray): normal male 4/24/21: CMV IgM neg, IgG pos. Toxo IgG/IgM neg, Parvo IgG/IgM neg. A1C 5.3, TSH 4.8, Trep NR. Lupus Anticoagulant Neg, B2GP-1 IgG/IgM Neg. Anticardiolipin IgG/IgM neg. 4/23/21 Admit WBC 12.5 HCT 36 PLT 168.
CDC Split Type:

Write-up: Patient is a 34 yo now G3P2011 (EDC 5/7/21) who presented at 4/23/21 for routine prenatal visit with 38w0d fetal demise noted after 24-48hrs of low abdominal cramping. Male fetus weighing 3820gm (approximately 80th centile) without obvious dysmorphic features. The couple declined autopsy.


VAERS ID: 1444094 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-23
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, Pelvic pain, Ultrasound pelvis
SMQs:, Termination of pregnancy and risk of abortion (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: urinary bHCG; Test Result: Positive ; Test Date: 20210523; Test Name: Pelvic ultrasound; Result Unstructured Data: Test Result:an anteverted anteflexed uterus of usual size 6x3; Comments: an anteverted anteflexed uterus of usual size 6x3 cm, an endometrium thickened to 16 mm with absence of intrauterine gestational sac and absence of peritoneal effusion
CDC Split Type: FRPFIZER INC2021729456

Write-up: This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB FR-AFSSAPS-2021063598. This consumer or other non hcp reported information for both mother and fetus/baby. This is a maternal report. A 34-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 05May2021 (Batch/Lot Number: EX6537) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included folic acid taken for an unspecified indication, start and stop date were not reported. The patient experienced miscarriage on 23May2021 with outcome of not recovered , pelvic pain on 23May2021 with outcome of unknown. The mother reported she became pregnant while taking bnt162b2. The mother was 3 Weeks pregnant at the onset of the event. The mother was due to deliver on 02Feb2022. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient underwent lab tests and procedures which included human chorionic gonadotropin: positive on 19May2021, ultrasound pelvis: an anteverted anteflexed uterus of usual size 6x3 on 23May2021 an anteverted anteflexed uterus of usual size 6x3 cm, an endometrium thickened to 16 mm with absence of intrauterine gestational sac and absence of peritoneal effusion. Therapeutic measures were taken as a result of pelvic pain. The clinical course was reported as follows: Patient declaration: 34-year-old patient with a LMP on 28Apr2021 and a positive urinary bHCG on 19May2021. Spontaneous miscarriage on 23May2021. She was vaccinated on 05May021 by COMIRNATY (batch: EX6537, D1, IM in the left arm). Appearance on 23May2021 of pelvic pain of the "tightness" type without irradiation and occurrence of metrorrhagia. The pelvic ultrasound of 23May2021 shows an anteverted anteflexed uterus of usual size 6x3 cm, an endometrium thickened to 16 mm with absence of intrauterine gestational sac and absence of peritoneal effusion. Taking analgesic for pelvic pain.


VAERS ID: 1448644 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Early miscarriage; Maternal exposure during pregnancy; This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Early miscarriage) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Pregnancy (Patient no longer pregnant at the time of reporting.). Concomitant products included FOLIC ACID for Folic acid supplementation. On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 27-May-2021, the patient experienced ABORTION SPONTANEOUS (Early miscarriage) (seriousness criterion medically significant). On 23-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 31-May-2021, ABORTION SPONTANEOUS (Early miscarriage) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. The patient was unsure on the exposure to the medicine first-trimester (1-12 weeks). No treatment information was provided by the reporter. This is a case of product exposure during pregnancy with associated event Abortion spontaneous. Very limited information regarding this event has been provided at this time. No further information is expected. Company causality for Abortion spontaneous is assessed as possible, while company causality for Maternal exposure during pregnancy is not applicable.; Sender''s Comments: This is a case of product exposure during pregnancy with associated event Abortion spontaneous. Very limited information regarding this event has been provided at this time. No further information is expected. Company causality for Abortion spontaneous is assessed as possible, while company causality for Maternal exposure during pregnancy is not applicable.


VAERS ID: 1455421 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-23
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: ultrasound antenatal; Result Unstructured Data: Test Result:pregnancy termination dated approximately 23May202; Comments: pregnancy termination dated approximately 23May2021
CDC Split Type: FRPFIZER INC2021759223

Write-up: Early miscarriage/pregnancy termination; This is a spontaneous report from a contactable consumer (patient) downloaded from a regulatory authority-WEB FR-AFSSAPS-BX20215747. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04May2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. First dose received on an unknown date. Medical history included miscarriage from 01Mar2021 to 01Mar2021. The patient''s concomitant medications were not reported. The patient experienced early miscarriage/pregnancy termination on 23May2021. Date of last menstruation 01Apr2021, estimated date of pregnancy start 20Apr2021. On 03Jun2021, during the dating ultrasound, pregnancy termination dated approximately 23May2021. The outcome of event was recovered (as reported). Imputation made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1585408 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-23
   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 BW4109 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood cholesterol, Off label use, Product use issue
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (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: ROSUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: High cholesterol; Miscarriage; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: cholesterol; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC202100992027

Write-up: Miscarriage; Without knowing that she was pregnant at the time, she had her first Pfizer vaccine on 23/05/2021. She was 4 weeks pregnant.; Without knowing that she was pregnant at the time, she had her first Pfizer vaccine on 23/05/2021. She was 4 weeks pregnant.; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021840301840-SBY43. Safety Report Unique Identifier is GB-MHRA-ADR 25742911 A pregnant female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 23May2021 (lot number: BW4109) as single dose for COVID-19 immunisation. Medical history included miscarriage, suspected COVID-19 from 10Dec2020 to an unknown date (unsure when symptoms stopped), and high cholesterol. She has not had a COVID-19 test and was not enrolled in clinical trial. Concomitant medication included rosuvastatin (ROSUVASTATIN) taken for blood cholesterol increased from an unspecified start date to 03Jun2021. The patient experienced miscarriage on 11Jun2021. Case narrative: Without knowing that she was pregnant at the time, she had her first Pfizer vaccine on 23/05/2021. She was 4 weeks pregnant. On 11/06/2021, she started to have bleedings and on 16/06/2021 she went to the hospital and they confirmed she had a miscarriage. Even though there was no evidence confirming that the miscarriage was a side effect, she wanted all women to be made aware that there is always a chance to be pregnant and they should get a pregnancy test before getting the COVID vaccine. Small things could change people''s life. She has not tested positive for COVID-19 since having the vaccine. The patient recovered from miscarriage on 22Jun2021. Case reported as medically significant by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1765758 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101255200

Write-up: During this ninth cycle, I first observed bloody and then brownish vaginal discharge until the 16th day, and again no changes were found during the gynaecological examination.; observed bloody and then brownish vaginal discharge; The monthly bleeding lasted 1-2 days more than norma; On the 25th day of the cycle, I again observed brownish bloating. On the 36th day of the cycle I had an abortion.; I received the 2nd vaccination on the 6th day of the menstrual cycle. The monthly bleeding lasted 1-2 days more than normal, observed little vaginal discharge until the 15th-16th day of the cycle.; This is a spontaneous report from a contactable consumer from the regulatory authority. Regulatory authority report number CH-SM-2021-20232. This is a maternal report. A 33-year-old female patient received BNT162B2 (COMIRNATY; Batch/Lot Number: ER7449), via an unspecified route of administration on 22May2021 (at the age of 33-yar-old) as dose 2, single for COVID-19 immunisation. Medical history included penicillin allergy. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY; Batch/Lot Number: EX7823), via an unspecified route of administration on 24Apr2021 (at the age of 33-yar-old) as dose 1, single for COVID-19 immunisation. The patient received the 2nd vaccination on the 6th day of the menstrual cycle. The monthly bleeding lasted 1-2 days more than normal, then until the 15th-16th day of the cycle the patient observed little vaginal discharge, brownish in colour on 23May2021. On the 25th day of the cycle, the patient again observed brownish bloating. On the 36th day of the cycle the patient had an abortion (30Jun2021). It was also reported that during the ninth cycle, the patient first observed bloody and then brownish vaginal discharge until the 16th day, and again no changes were found during the gynaecological examination. The mother reported she became pregnant after taking BNT162B2. The mother underwent elective termination. The outcome was unknown for abortion and recovered on an unknown date for rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1344635 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-05-24
Onset:2021-05-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Endometritis, Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Labour induction, Retained placenta operation, Second trimester pregnancy, Stillbirth, 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), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Wellbutrin XL 150mg
Current Illness: none
Preexisting Conditions: anxiety
Allergies: nkda
Diagnostic Lab Data: 04/21 - IUFD, 04/22 Induction of labor & delivery of stillborn daughter, 5/2/21 -dx with endometritis, placed on Augmentin and Flagyl x7 days, 5/4 retained placenta removal in office - doxycycline added for 5 days
CDC Split Type:

Write-up: I received my first Moderna 3 days prior to obtaining a positive pregnancy test. EDD: 09/21/2021. 2nd vaccine received at about 8 weeks of pregnancy. No medical history, two previous normal spontaneous vaginal deliveries, no diabetes, no HTN, no complications. Normal initial OB labs at 12 weeks, normal ultrasound for confirmation at 9wks and 3 days of gestation. At 18wks and 1 day during an ultrasound the baby was found to not have a heartbeat. At 18.2wks (on 04/22/21) I delivered my daughter stillborn without gross deformity. She weighed 5.2oz and was 7.5in long.


VAERS ID: 1365132 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-21
Onset:2021-05-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Dyspnoea, Exposure during pregnancy, Headache, Human chorionic gonadotropin decreased, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: pre natal vitamins
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Low HCG levels recorded on May 23 indicating threatened pregnancy; HCG levels decreased again by May 27
CDC Split Type:

Write-up: Heart racing, shortness of breath which leads to mild headache; noticed approximately Monday, May 24 Miscarriage symptoms began on Tuesday May 25th


VAERS ID: 1421769 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-15
Onset:2021-05-24
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Muscle spasms, Ultrasound antenatal screen, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid 4g Prenatal one a day
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: May 27, 2021: ultrasound Intrauterine gestational sac is too small to correspond to an estimated gestational age and contains a yolk sac but no definite fetal pole. The findings may represent an early intrauterine pregnancy or possibly an anembryonic pregnancy. C June 9, 2021: ultrasound 1. Previously seen intrauterine gestational sac is no longer identified. There is now small amount of complex fluid in the endometrial cavity, likely blood products and an ovoid heterogeneous structure with vascularity measuring 15 x 8 x 12 mm, likely retained products of conception. 2. Mild complex fluid in the pelvis, likely blood products.
CDC Split Type:

Write-up: Miscarriage: bleeding began May 24, 2021, ultrasound on May 27 showed small development/ only gestational sac and yolk, no fetal pole. Progressively heavier bleeding, mild cramping, expelled tissue. Ultrasound confirmed incomplete miscarriage June 9. Anembryonic pregnancy (blighted ovum). Continued bleeding mod-heavily. Took prescribed misoprostol (3 tablets vaginally) to help complete miscarriage on June 19 (limited effects). Took second dose (4 tablets vaginally) on June 22, limited effects. Continued bleeding until June 23, 2021 (lighter now, the rest is TBD). Est date of delivery: Jan 12, 2022 Second pregnancy (First child born 2017, healthy).


VAERS ID: 1452190 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-03-11
Onset:2021-05-24
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

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

Write-up: Miscarriage following 2nd dose


VAERS ID: 1498170 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-10
Onset:2021-05-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Body temperature increased, Exposure during pregnancy, Ultrasound antenatal screen abnormal, Ultrasound scan vagina
SMQs:, Neuroleptic malignant syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: low thyroid
Allergies: penicillin, avrothmycan, penuts
Diagnostic Lab Data: blood test physical test 2 ultra sound
CDC Split Type: vsafe

Write-up: A week after my second dose, my tempter was between 99.1 to 99.4 for seven days straight. My normal tempter is 97.9. I took Tylenol that did not help. On May 21st, I had a miscarriage, Went to the ER (Keizer Bellevue). They did the blood test, physical test, and 2 ultra sounds (external and internal). I come from a long line with a history of mom''s with zero history of miscarriages.


VAERS ID: 1533968 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-24
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: It was reported that this was twin pregnancy.
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: Ultrasound scan; Result Unstructured Data: Baby B was diagnosed as no longer having a heartbeat; Comments: Baby B was diagnosed as no longer having a heartbeat.
CDC Split Type: USJNJFOC20210754070

Write-up: SPONTANEOUS ABORTION; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a patient concerned a 36 year old female of unspecified race and ethnic origin. The patient was enrolled in a non-company sponsored study. The patient''s weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total administered on 24-MAY-2021 for prevention of covid-19 (covid-19 immunisation). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The date of the patient''s last menstrual period was 09-APR-2021 and expected delivery date was 14-JAN-2022. On 24-MAY-2021, the patient experienced maternal exposure during pregnancy. On 28-JUN-2021, the patient experienced spontaneous abortion. Laboratory data included: Ultrasound scan (NR: not provided) Baby B was diagnosed as no longer having a heartbeat. On 28-JUN-2021, the pregnancy resulted in a spontaneous abortion. Gestational age 6 weeks and 3 days. That was twin pregnancy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spontaneous abortion, and maternal exposure during pregnancy on 28-JUN-2021. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and spontaneous abortion, and maternal exposure during pregnancy as related. Company causality between covid-19 vaccine ad26.cov2.s, and spontaneous abortion, and maternal exposure during pregnancy was not related. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210803924. This case was reassessed as serious based on additional information received from patient on 30-JUL-2021, the following information was updated and incorporated into case narrative: Pregnancy (Gestation Period changed from 4 weeks to 6 weeks, outcome updated from ongoing/continuing to spontaneous abortion, EOP date, Expected Delivery Date); Event (spontaneous abortion), upgraded the seriousness of event maternal exposure during pregnancy, outcome of maternal exposure during pregnancy changed from unknown to recovered, lab (Ultrasound scan), Product (Indication changed from prophylactic vaccination to Prevention of Covid-19 (Covid-19 immunisation).; Sender''s Comments: V1: Follow up information received to previous non serious case updates, addition of serious event (spontaneous abortion), Pregnancy details (Gestation Period changed from 4 weeks to 6 weeks), Expected Delivery Date); upgraded the seriousness of event maternal exposure during pregnancy, laboratory data (Ultrasound scan), Product (Indication changed from prophylactic vaccination to Prevention of Covid-19 (Covid-19 immunization). 20210754070-covid-19 vaccine ad26.cov2.s-Spontaneous abortion. Follow-up received regarding Clinical Details. 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: UNDERLYING DISEASE 20210754070-covid-19 vaccine ad26.cov2.s-maternal exposure during pregnancy. Follow-up received regarding Clinical Details. 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: 1379898 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20211

Write-up: Maternal exposure during pregnancy; Early miscarriage; This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Early miscarriage) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased, Lactation decreased and Pregnancy (Patient no longer pregnant at the time of reporting.). Concomitant products included FOLIC ACID for Folic acid supplementation. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced ABORTION SPONTANEOUS (Early miscarriage) (seriousness criteria medically significant and congenital anomaly). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, ABORTION SPONTANEOUS (Early miscarriage) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Patient miscarried at 9 weeks and 3 days. Patient has not had symptoms associated with COVID-19 Treatment medications was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This is a case of product exposure during pregnancy with associated AE for this 36-year-old female.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This is a case of product exposure during pregnancy with associated AE for this 36-year-old female.


VAERS ID: 1389636 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Dizziness, Fatigue, Maternal exposure during pregnancy, Nausea, Pain in extremity, Somnolence
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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), Hypoglycaemia (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: CYCLIZINE; FOLIC ACID; PARACETAMOL
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage (2 miscarriages, 6 weeks before this one); Nausea; Pregnancy with advanced maternal age
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021606889

Write-up: miscarriages; groggy; nausea; tiredness; Maternal exposure during pregnancy; sore arm; Belly ache; Dizzy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202105250837423560-DREDO, Safety Report Unique Identifier GB-MHRA-ADR 25355319. A 39-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing pregnancy, nausea, folic acid supplementation from an unknown date and unknown if ongoing, pregnancy with advanced maternal age, 2 miscarriages at 6 weeks before this one. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient Had the jab at 12 weeks and 5 days. Concomitant medications included cyclizine taken for nausea from 15Apr2021, folic acid taken for vitamin supplementation, paracetamol taken for pregnancy with advanced maternal age from 31Mar2021. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced miscarriages on an unspecified date, groggy on an unspecified date, nausea on an unspecified date, tiredness on an unspecified date, maternal exposure during pregnancy on an unspecified date, belly ache on 24May2021, dizzy on 24May2021. It was reported the following: ''About 24 hours after the jab I started feeling dizzy and had to lie down to finish work. Nausea got worse in the evening although I managed to go for a 30min walk. Spent most of the evening lying down. I have just woken up after a night of an aching lower belly so I am worried the jab has affected my pregnancy. Head feels groggy, am partially congested but the congestion is improving as I am awake. I cannot work today. Arm is less sore than the previous day''. The outcome of belly ache, dizzy was not recovered. The outcome of maternal exposure during pregnancy, pain in arm was unknown. The outcome of the other events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1393580 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Maternal exposure during pregnancy, Pain in extremity, 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), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage
Allergies:
Diagnostic Lab Data: Test Date: 20210516; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20211

Write-up: Miscarriage happened 5 days after vaccination.; Maternal exposure during pregnancy; Painful arm; Fatigue; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage happened 5 days after vaccination.) in a 37-year-old female patient (gravida 2) who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Miscarriage. Concomitant products included FOLIC ACID for Folic acid supplementation. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. The patient''s last menstrual period was on 15-Mar-2021 and the estimated date of delivery was 20-Dec-2021. On 24-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), PAIN IN EXTREMITY (Painful arm) and FATIGUE (Fatigue). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage happened 5 days after vaccination.) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna CoviD-19 Vaccine) beginning around the tenth week of the pregnancy. On 24-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 26-May-2021, FATIGUE (Fatigue) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage happened 5 days after vaccination.) had resolved and PAIN IN EXTREMITY (Painful arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. On unknown date at 6 weeks scan test was done and result indicated: Subchorionic bleeding At 8 weeks and 4 day scan test was done and indicated Subchorionic hematoma. Heartbeat seen at that scan. Treatment information was not reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Added new event abortion spontaneous. On 08-Jun-2021: No new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1438779 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Folic acid supplementation; Lactation decreased; Miscarriage; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201223; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021747052

Write-up: Early miscarriage/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-202106201244167670-GVPAH, Safety Report Unique Identifier GB-MHRA-ADR 25505862. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 18May2021 as dose 1, single for COVID-19 immunization. Medical history included miscarriage, lactation decreased, folic acid supplementation, all from an unknown date and unknown if ongoing; suspected COVID-19 from 22Dec2020 to 26Dec2020 and COVID-19 from 23Dec2020 to an unknown date. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Patient no longer pregnant at the time of reporting. Concomitant medications included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced early miscarriage/miscarriage on 24May2021. It was unsure if the medicine had an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). It was reported that the patient experienced miscarriage started 6 days after vaccine given. The pregnancy resulted in spontaneous abortion. The reporter assessed the event as serious (life-threatening). 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: positive (yes - positive COVID-19 test) on 23Dec2020. The outcome of the event was not recovered. No follow-up attempts are possible; information about batch/lot number cannot be obtained.


VAERS ID: 1495954 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FT8885 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (one other child with no complications during pregnancy, and no other miscarriages)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021859836

Write-up: Early miscarriage; This is a spontaneous report from a contactable consumer (patient). This is a report received from a regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202107051228256910-2RVVV, Safety Report Unique Identifier is GB-MHRA-ADR 25595410. A pregnant 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FT8885), via an unspecified route of administration on 19May2021 as dose 1, single for COVID-19 immunization. Medical history included pregnancy. There were no concomitant medications. The patient was fit and healthy, with no medical issues or medication. Patient has not had symptoms associated with COVID-19, has not had a COVID-19 test, was not enrolled in clinical trial, and was not currently breastfeeding. The patient experienced early miscarriage on 24May2021. The event was reported as non-serious. The clinical course was reported as follows: The patient was 4.5 weeks pregnant when she had her first dose of the vaccination, and then miscarried 4 days later. She had one other child with no complications during pregnancy, and no other miscarriages. Patient was exposed to the vaccine first trimester (1-12 weeks). It was reported that it was too early for a scan. Patient has not tested positive for COVID-19 since having the vaccine. They were unsure if the medicine had an adverse effect on any aspect of the pregnancy. Patient did not take folic acid supplement during pregnancy. Patient was no longer pregnant at the time of reporting. The mother was 4 weeks (reported as 4.5 weeks) pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The outcome of the event was recovered on 25May2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1499146 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-24
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Ultrasound uterus
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: blood test; Result Unstructured Data: Test Result:normal; Test Name: ultrasound; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021865198

Write-up: Miscarriage; This is a spontaneous report received from a contactable consumer downloaded from the WEB, regulatory authority number FR-AFSSAPS-PA20211101. Safety Report Unique Identifier: FR-AFSSAPS-2021087982. A 28-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 15May2021 (Batch/Lot Number: Unknown) as 0.3 ml single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced miscarriage on 24May2021 with outcome of recovered with sequelae. The mother reported she became pregnant while taking BNT162B2. The mother was 5 weeks pregnant at the onset of the event. The mother was due to deliver on 21Jan2022. Last Period Date: 16Apr2021. No medical or obstetrical history. No treatment during pregnancy. Pregnancy monitored, normal blood tests and ultrasound. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1633707 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-24
   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 EY7015 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blindness, Ophthalmological examination
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: ophthalmologist examination; Result Unstructured Data: Test Result:unknown result
CDC Split Type: FIPFIZER INC202101026650

Write-up: Miscarriage; vision in her left eye went completely dark; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20213842. A 38-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 24May2021, (Lot Number: EY7015) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 24May2021, the same night of vaccination, the vision in her left eye went completely dark. No headache. The patient was examined in the emergency room, underwent ophthalmologist examination; an ophthalmologist also checked her eyes. The next day, the patient''s vision returned to normal. Later, the patient also found out that she was pregnant when she was vaccinated, and the pregnancy ended in a miscarriage. The patient received her first dose of the COVID-19 vaccine while she was five weeks pregnant. The miscarriage happened in Jul2021 (week 12 (11+0)). The patient stated she suspect the vaccine affected the pregnancy. The events were assessed as medically significant. The outcome of the event vision in her left eye went completely dark was recovered; the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected. Batch/Lot number has been obtained.


VAERS ID: 1368498 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-05-05
Onset:2021-05-25
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025B21A / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Nausea, Pain, Pain in extremity, Ultrasound scan
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: NAUSAU SORENESS OF ARM AND BODY ACHES Miscarriage (due date unknown)


VAERS ID: 1375991 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-29
Onset:2021-05-25
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 008C21A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021C21A / 2 RA / SYR

Administered by: Military       Purchased by: ?
Symptoms: Exposure during pregnancy, Premature separation of placenta, Stillbirth
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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Levothyroxine, prenatal, omeprazole, turmeric, iron, fish oil
Current Illness:
Preexisting Conditions: Lower back, disk degeneration and hernia
Allergies: N/a
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pregnancy still birth, 34 weeks, 3 days. Baby delivered at 5 lbs 3.8 ounces, 18 inches. Placental abruption


VAERS ID: 1402228 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Vermont  
Vaccinated:2021-03-26
Onset:2021-05-25
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ERE727 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Amniotic fluid volume decreased, Blood test, Exposure during pregnancy, Inappropriate schedule of product administration, Pain in extremity, Stillbirth
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pre-natal vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Autopsy of the baby Blood tests of both parents
CDC Split Type:

Write-up: *COVID-19 Vaccine dose #2 was given on 4/16/21 **TDAP booster was given on 3/10/21 I had no side effects after any of the vaccinations. I had a bit of a sore arm after the TDAP and the first COVID-19 vaccination but that was it. I didn''t even have a sore arm really at all after the second COVID-19 shot. I did have a bandaid mark that lingered for a few days after the second COVID-19 shot but that was it. I was 30 weeks and 6 days pregnant during the first COVID-19 shot. I felt the baby kicking normally after that and had normal follow up appointments after that too. My entire pregnancy was completely normal (this was my first pregnancy) with no complications or issues. I felt great throughout the entire pregnancy and was active biking, working out, walking, etc. I would consider myself a very healthy and active person and I followed all of the pregnancy "guidelines" in terms of what to eat, what not to eat, etc. The adverse event here is the fact that my baby was stillborn at 39 weeks and 4 days. The appointment with the doctor the week before was totally normal too. What the doctor *thinks* happened is that my amniotic fluid somehow disappeared in the final few days before going into labor (they don''t know where it went - my water did not break prior to the delivery of the baby) and the lack of fluid caused the baby to pass meconium. The high level of meconium surrounding her and the amount of time she was exposed to it seem to have degraded the umbilical cord, affecting her oxygen flow. By the time I went into labor, she may have already been dead, though I did not know it. When I got to the hospital in labor, there was already no heartbeat. Baby delivery date: 5/26/21 Weight: 6 lbs 9 oz Length: 21 in The mystery here is why was there suddenly a lack of fluid and why did that cause her to pass so much meconium? The doctors do not know and there does not seem to be a way to share this information with other doctors or facilities to gain a better understanding.


VAERS ID: 1431297 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-05-23
Onset:2021-05-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Caesarean section, Cervical dilatation, Cervix disorder, Condition aggravated, Exposure during pregnancy, Haemorrhage in pregnancy, Premature delivery, Premature separation of placenta, Ultrasound scan normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamin D (1000iu) Prenatal Vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was 34 weeks pregnant and I woke up in the middle of the night to what I thought was my water breaking, but was large amounts of blood. After going to the hospital they determined that my placenta had an abruption, and I was 1cm dilated. My abruption created a clot about 7cm. I was kept in the hospital for about a week. Things stabilized so I was sent home. Around week 19 of my pregnancy- I had this same thing happen, a placenta abrupted that caused two clots about 5 cm. But after 8 weeks, I had passed both clots and was cleared from my doctor. During this time I was put on pelvic rest. After my first COVID-19 vaccine (May2) - I noticed my bleeding had picked up some. Enough to need a liner, but not large amounts like week 19. After an ultrasound appointment- they didn?t see any new clots and just said I had a sensitive cervix. Again still on pelvic rest, taking it easy. It was unclear why the bleeding had started up, and the only new thing was the COVID-19 vaccine I ended up delivering my baby at 35 weeks via a c-section. I don?t have any other history of bleeding issues or clots.


VAERS ID: 1467230 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-01-08
Onset:2021-05-25
   Days after vaccination:137
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0142 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage in pregnancy, Muscle spasms, Ultrasound abdomen, Uterine dilation and curettage
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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin - 500 mg twice a day; Levothyroxine - 0.88 mg once a day; Lexapro- 10 mg once daily; Zyrtec - 10 mg once daily; inhaler - Wixela - use it twice a day
Current Illness: no
Preexisting Conditions: PCOS; allergies; hypothyroidism; asthma
Allergies: sulfa drugs
Diagnostic Lab Data: Ultrasound -hospital
CDC Split Type: vsafe

Write-up: Bleeding and cramping; I was pregnant and the ultrasound showed it was a miscarriage and so they had to do a DNC - OUT PATIENT PROCEDURE. . May 25th


VAERS ID: 1383281 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
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: GBMODERNATX, INC.MOD20211

Write-up: Miscarriage; Maternal exposure during pregnancy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-May-2021 and was forwarded to Moderna on 31-May-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Pregnancy (Patient no longer pregnant at the time of reporting.). Concomitant products included FOLIC ACID for Folic acid supplementation. On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 29-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On 25-May-2021, EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 30-May-2021, ABORTION SPONTANEOUS (Miscarriage) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication were provided. No concomitant medication were provided.Patient was exposed to the medicine first-trimester (1-12 weeks). This is a case of product exposure during pregnancy with reported associated AE of spontaneous abortion for this 32-year-old female.; Sender''s Comments: This is a case of product exposure during pregnancy with reported associated AE of spontaneous abortion for this 32-year-old female.


VAERS ID: 1471993 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-05-25
   Days after vaccination:45
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, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021775771

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-APPCOVID-20210623114837, Safety Report Unique Identifier GB-MHRA-ADR 25525004. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Apr2021 (Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing. Patient no longer pregnant at the time of reporting, folic acid supplementation from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced miscarriage on 25May2021. Unsure if the medicine have an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Miscarried between 6-7 weeks. The patient underwent lab tests and procedures which included covid-19 virus test: negative on 03Jun2021, No - Negative COVID-19 test. The outcome of the event was recovered on an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516511 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-30
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, Scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 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; Test Name: scans; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC2021906934

Write-up: Miscarriage; Bleed; 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-202107152006018810-HCZBS, safety report unique identifier is GB-MHRA-ADR 25659259. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22May2021 as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased, folic acid supplementation. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medication included folic acid taken folic acid supplementation, start and stop date were not reported. The patient experienced bleed on 25may2021, miscarriage on an unspecified date in Jun2021. The case was reported as serious per Congenital Anomaly (as reported). Events details: Patient was exposed to the medicine first-trimester (1-12 weeks). 3 days after her first vaccine she started to bleed. She had weekly scans to make sure the baby was okay. 4 weeks later (9 weeks pregnant) she miscarried. It was unsure if the medicine had an adverse effect on any aspect of the pregnancy. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of event miscarriage was resolved in 2021, outcome of event bleed was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1733015 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Inappropriate schedule of product administration, Maternal exposure before pregnancy, Maternal exposure during pregnancy, SARS-CoV-2 test, 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 (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Ultrasounds; Result Unstructured Data: Test Result:miscarriage; Test Date: 20210823; Test Name: Ultrasounds; Result Unstructured Data: Test Result:missed miscarriage
CDC Split Type: GBPFIZER INC202101196526

Write-up: Missed miscarriage confirmed on 23Aug2021; Maternal exposure during pregnancy, dose 2: 06Jul2021, LMP: 07Jun2021; dose 1 25May2021, LMP: 07Jun2021; Dose 1: 25May2021, Dose 2: 06Jul2021; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109122220442660-IXVT2. Safety Report Unique Identifier GB-MHRA-ADR 25929462. This consumer or other non health care professional reported information for both mother and fetus/baby. This is a mother report. A 33-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE): formulation: solution for injection; Batch/Lot number was not reported), second dose via an unspecified route of administration on 06Jul2021 as DOSE 2, SINGLE for COVID-19 immunization and first dose via an unspecified route of administration on 25May2021 (Batch/Lot number was not reported), ) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing (Patient no longer pregnant at the time of reporting), ongoing breast feeding, Folic acid supplementation from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation, (dose: 400ug) start and stop date were not reported. On 25May2021, patient experienced maternal exposure before pregnancy (hospitalization, medically significant, congenital anomaly). On 06Jul2021, maternal exposure during pregnancy, first trimester (hospitalization, medically significant, congenital anomaly) and inappropriate schedule of vaccine administered (non-serious). On 23Aug2021, the patient experienced missed abortion (medically significant, hospitalization from 24Aug2021 to unknown, congenital anomaly). The mother reported she became pregnant while taking bnt162b2. The mother was due to deliver on 14Mar2022. The mother underwent therapeutic abortion. First day of period 07Jun2021. Conceived around 26Jun2021. Spotting started on 29Jul2021. Pregnancy sac 1 did not develop past around 5 weeks. Pregnancy sac 2 had an embryo that stopped growing at around 7 weeks. Missed miscarriage confirmed on 23Aug2021. Surgical management of miscarriage on 24Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Did the medicine have an adverse effect on any aspect of the pregnancy: Unsure. Patient was exposed to the medicine Before pregnancy. Details of scans or investigations: Missed miscarriage. Ultrasounds to confirm miscarriage. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test, ultrasound scan: miscarriage on an unspecified date, ultrasound scan: missed miscarriage on 23Aug2021. The outcome of the event missed abortion was not recovered, outcome of the event Maternal exposure during pregnancy, first trimester, Maternal exposure before pregnancy, Inappropriate schedule of vaccine administered was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101210366 Baby case


VAERS ID: 1352520 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-05-06
Onset:2021-05-26
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamin, baby aspirin, Claritin, Tylenol
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None performed yet. Plan to go in tomorrow 5/27 for labor induction. Plan to run LaBa and testing then.
CDC Split Type:

Write-up: 14 weeks pregnant at town of vaccine. Due date 11/4/2021. Found out 5/26/2021 at 16 weeks 6 days that there was fetal demise. No heartbeat found on ultrasound. No other symptoms noted. No bleeding, spotting, or cramping. Fetus measured 16+ weeks on ultrasound. Last fetal heart tones heard on at home doppler on Monday 5/17 at 15 weeks 4 days.


VAERS ID: 1362298 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-16
Onset:2021-05-26
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin
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: Keflex
Diagnostic Lab Data: HCG doubled until 5/22, then declined.
CDC Split Type:

Write-up: Missed miscarriage. Ovulation 5/5/21, resulting in a miscarriage between 5-6 weeks.


VAERS ID: 1368076 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-11
Onset:2021-05-26
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 (1ST DOS / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Womens Multi-vitamin. Albuterol
Current Illness: none
Preexisting Conditions: Asthma
Allergies: none
Diagnostic Lab Data: I had a sonogram on May 5th and baby was fine and had a heart beat. I was scheduled for a typical 8 week appointment and again at 12 weeks. When I arrived on May 26th for my 8 week appointment; the sonographer could not find a heart beat. I was scheduled for a recheck in 7 days. There was still no heart beat this morning.
CDC Split Type:

Write-up: I was 4/5 days pregnant the day the first dose was administered. I was 21 days pregnant the day the second does was administered. I was supposed to be due December 31st, 2021. On my 8 week appointment check up; the OB discovered there was no longer a heartbeat they could find for baby. I subsequently went in for a recheck 1 week later ( today) to discover there was still no heartbeat for baby. I was diagnosed as having a misses miscarriage. I was given the same medication that patients receive when they want to have a medical abortion by choice. I will go back to the OB in 10 days to make sure that all of the pregnancy has vacated and the uterus is clear for a new pregnancy.


VAERS ID: 1371940 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-16
Onset:2021-05-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Laboratory 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? Yes
Birth Defect? No
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: Several weeks before the second dose that I received for the Pfizer vaccine I was not feeling well nauseous and I learned after taking a pregnancy test that it was because I was pregnant.
Preexisting Conditions: My fiance and I lost our child due to the Pfizer vaccine
Allergies: None
Diagnostic Lab Data: 5/26/2021 emergency room 5/28/2021 lab work Next month I have an appointment
CDC Split Type:

Write-up: I experienced a miscarriage a week after having the Pfizer to vaccine and I''m not being given much information from the vaccine facility they gave me a piece of paper with a phone number to vaers in this doesn''t even look like a phone number or a fax number to their facility


VAERS ID: 1656067 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-04-27
Onset:2021-05-26
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8736 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Behcet's syndrome, Condition aggravated, Exposure during pregnancy, Gait disturbance, Headache, Intermittent claudication, Uveitis
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vasculitis (narrow), Ocular infections (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (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: labetolol 300 mg twice daily, vitamin D3 5000 units daily, Valtrex 1000 mg twice daily, Zyrtec 10 mg up to twice daily as needed
Current Illness:
Preexisting Conditions: hypertension, history of recurrent uveitis in her right eye (last flare up in December 2020)
Allergies: penicillin, sulfa, capers
Diagnostic Lab Data:
CDC Split Type:

Write-up: After first vaccination on April 1st, patient was limping several days later (thought to be claudication by patient). After second vaccination on April 27th, patient was diagnosed on May 26th as having had a miscarriage. She subsequently developed uveitis in her left eye on May 26th. It did not respond to prednisolone eye drops and was treated with an extended course of prednisone. She had continual headaches for several weeks and was diagnosed with Behcet''s disease on August 12th.


VAERS ID: 1412125 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-05-26
   Days after vaccination:118
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LORAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psychiatric evaluation
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021653352

Write-up: Late spontaneous abortion at +22 weeks; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number PT-INFARMED-A202105-3003. A 30-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 intramuscular on 28Jan2021 (Lot Number: EJ6797) as second dose, 0.3 mL single for COVID-19 immunisation. The patient has her first dose of BNT162B2 on 06Jan2021 (lot: EJ6797) for COVID-19 immunisation. Medical history included psychiatric evaluation. Concomitant medications included lorazepam and natural micronized form of progesterone (GESTCARE) Gestation once a day. She has no history of illnesses during pregnancy and was followed by Psychiatry before becoming pregnant, taking only, occasionally, Lorazepam 2.5 mg 1/4. The patient is a nurse and was on her first pregnancy. The mother reported was pregnant while taking BNT162B2. The mother was 22 Weeks pregnant at the onset of the event. The mother was pregnant with 1 baby. The pregnancy resulted in spontaneous abortion. Patient presented with late spontaneous abortion at +22 weeks and exposure during pregnancy associated with the use of BNT162B2. The adverse drug reaction (ADR) appeared 4 months after the start of administration of the suspected drug on 26May2021 and was reported as serious, caused/prolonged hospitalization. There is no suspicion of drug interactions. Previous reactions to the same drug or to other drugs are not known. The outcome of the event was unknown. Reporter''s comment: Concomitant Medication-Gestacare pregnancy 1 x day Medication Error Occurred?-No Further information-The patient is a Nurse and is the first pregnancy. She has no history of illnesses during pregnancy and was followed by Psychiatry before becoming pregnant, taking only, occasionally, Lorazepam 2.5 mg 1/4. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Concomitant Medication-Gestacare pregnancy 1 x day Medication Error Occurred?-No Further information-The patient is a Nurse and is the first pregnancy. She has no history of illnesses during pregnancy and was followed by Psychiatry before becoming pregnant, taking only, occasionally, Lorazepam 2.5 mg 1/4.


VAERS ID: 1435596 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / UNK - / 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: Medical History/Concurrent Conditions: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 11)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Maternal exposure during pregnancy; This regulatory authority case was reported by a physician and describes the occurrence of ABORTION SPONTANEOUS.in a 31-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001941) 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: 11). On 26-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 02-Jun-2021, the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant). On 26-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. At the time of the report, ABORTION SPONTANEOUS outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was provided. This is a case of product exposure during pregnancy with associated event Abortion spontaneous. Very limited information regarding this event has been provided at this time. No further information is expected. Company causality for Abortion spontaneous is assessed as possible, while company causality for Maternal exposure during pregnancy is not applicable. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Added Vaccine Batch number.; Sender''s Comments: This is a case of product exposure during pregnancy with associated event Abortion spontaneous. Very limited information regarding this event has been provided at this time. No further information is expected. Company causality for Abortion spontaneous is assessed as possible, while company causality for Maternal exposure during pregnancy is not applicable.


VAERS ID: 1441726 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
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, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.); Vitamin supplementation
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:nothing wrong with her placenta or the baby; Comments: 12 week scan
CDC Split Type: GBPFIZER INC2021772466

Write-up: Maternal exposure during pregnancy; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106211836307990-I0TYG, Safety Report Unique Identifier GB-MHRA-ADR 25513969. A 41-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 26May2021 as dose1, single for COVID-19 immunisation. Medical history included suppressed lactation and pregnancy, patient no longer pregnant at the time of reporting, vitamin supplementation. Concomitant medication included folic acid taken for vitamin supplementation. The patient experienced maternal exposure during pregnancy, first-trimester (12 weeks) on 26May2021 and miscarriage of pregnancy on 26May2021. In detail, the patient stated that the heartbeat of her perfectly formed and perfectly healthy baby stopped the same time she had the vaccine. Pregnancy ended the day of vaccine. 12 week scans say there was nothing wrong with her placenta or the baby. Patient has not tested positive for COVID-19 since. The patient underwent lab tests and procedures which included SARS-COV-2 test: no-negative covid-19 test on an unknown date. As per health authority outcome of miscarriage was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Miscarriage


VAERS ID: 1462240 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: scans or investigations; Result Unstructured Data: Test Result:Miscarriage at 7 weeks
CDC Split Type: GBPFIZER INC2021772632

Write-up: Miscarriage; Maternal exposure during pregnancy/Patient was exposed to the medicine first-trimester (1-12 weeks); This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106211536520790-8LYA2, Safety Report Unique Identifier: GB-MHRA-ADR 25512023. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26May2021 (lot number: ET8885) at dose 1, single for COVID-19 immunisation. Medical history included miscarriage, pregnancy (patient no longer pregnant at the time of reporting), and folic acid supplementation. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation. The patient experienced maternal exposure during pregnancy (26May2021). The patient had miscarriage on 02Jun2021. Details of scans or investigations: miscarriage at 7 weeks. It was unsure if the medicine had an adverse effect on any aspect of the pregnancy. 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 04Jun2021. The outcome of the event miscarriage was recovered on 04Jun2021. Regulatory authority assessed the events as serious: hospitalization and medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1503880 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   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 - / 1 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (one previous pregnancy leading to live birth/ no longer pregnant at the time of reporting)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021871646

Write-up: Early miscarriage; received BNT162B2/ ongoing breast feeding; received BNT162B2/ ongoing 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-202107102110010290-NVAB6, Safety Report Unique Identifier GB-MHRA-ADR 25632575. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN), the first dose via an unspecified route of administration on 26May2021 as single dose for COVID-19 immunisation. Medical history included pregnancy from an unknown date and not ongoing (one previous pregnancy leading to live birth/ no longer pregnant at the time of reporting), folic acid supplementation and ongoing breast feeding. Patient had not had symptoms associated with COVID-19. Concomitant medications included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced early miscarriage on 05Jul2021 with outcome of not recovered. Narrative case summary: Patient was exposed to the medicine first-trimester (1-12 weeks). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The events were reported as serious due to congenital anomaly. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date (No - Negative COVID-19 test). No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1523847 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal exposure during pregnancy, Inappropriate schedule of product administration
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? Yes
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID; LABETALOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Miscarriage; Pregnancy; Suspected COVID-19 (Unsure when symptoms stopped); Vitamin supplementation; Comments: Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916680

Write-up: Late miscarriage; Foetal exposure during pregnancy; dose 2 via an unspecified route of administration on 26May2021; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from the Regulatory Agency (RA). The regulatory authority report number is -MHRA-WEBCOVID-202107181937155690-Y3DMO. A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW4109) via an unspecified route of administration on 26May2021 as single dose for COVID-19 immunisation and covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ), via an unspecified route of administration from 25Feb2021 (Lot Number: AB0012) to an unspecified date, at dose 1 for an unspecified indication. The patient medical history included abortion spontaneous, pregnancy both from an unknown date and unknown if ongoing, suspected covid-19 from 16Mar2020 to an unknown date, unsure when symptoms stopped, vitamin supplementation and hypertension. Concomitant medications included folic acid (FOLIC ACID) taken for vitamin supplementation and labetalol (LABETALOL) taken for hypertension, start and stop dates were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 25Feb2021 as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced late miscarriage and foetal exposure during pregnancy and dose 2 via an unspecified route of administration on 26May2021. Had a scan at 16 weeks and baby was fine. Had a 20-week scan and baby had passed away. She had to labour and birth the baby over the course of 3 days. Not sure if it was linked but this was the only pregnancy this has ever happened to her (had 8 healthy babies). Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Child was exposed to the medicine: first-trimester (1-12 weeks). Details of previous pregnancies included pregnancy was fine and healthy until 16 weeks when she had second dose . Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Miscarriage at 20 weeks. Suspect reactions included to please provide details of any relevant investigations or tests conducted: scans and lots of tests. Outcome was resolved with sequelae on 01Jul2021 for event late miscarriage and unknown for rest of the events. No follow-up attempts are possible. No further information is expected.


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