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

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

Government Disclaimer on use of this data



Case Details (Sorted by Onset Date)

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VAERS ID: 1584067 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100989332

Write-up: Strong pulling in the abdomen, miscarriage; This is a spontaneous report from a non-contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021100135. Sender''s Safety Report Unique Identifier: DE-PEI-202100093560. A 23-year-old female patient received bnt162b2 (COMIRNATY, strength: 0.3 mL), via an unspecified route of administration on 28May2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient experienced strong pulling in the abdomen, miscarriage (hospitalization) on 02Jun2021. The mother was 6 Months pregnant at the onset of the event. She had no previous illnesses. She had lost her child. The outcome of the event was not recovered. Result of assessment (source: HA) unclassifiable. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no. Information on risk factors or previous illnesses: I have no previous illnesses / I have lost my child No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1374744 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: New York  
Vaccinated:2021-03-30
Onset:2021-06-03
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8733 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, 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? 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: Unknown - answered none to screening question on 3/30/2021 (first shot Pfizer) and again on second dose 5/16/2021.
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: Unknown - answered no to screening question both vaccination dates
Diagnostic Lab Data: None Known
CDC Split Type:

Write-up: Patient received a two dose series of Pfizer /BioNTech vaccine. First dose March 30 , 2021 and second dose May 16, 2021. She answered no to all questions including no to pregnancy at both occurrences. There were no requests at either times for a medical evaluator to answer additional questions. The patient returned to the vaccination POD on June 3rd, 2021 claiming that she had a miscarriage some time after the second dose. She requested information about the POD but did not offer any other information. She requested that we advise people that this happened to her and that she has already alerted the local news agencies and CDC.


VAERS ID: 1421534 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-17
Onset:2021-06-03
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin, Progesterone, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vaccinated at 4-5 weeks pregnant. At 8-9 weeks, found that fetus had stopped growing and no heartbeat developed. Two ultrasounds were performed at 1 week apart, and both times, fetus measured 6 weeks 5 days with no heartbeat. Secondary yolk
Current Illness: None
Preexisting Conditions: Interstitial cystitis Chronic flexor and patellar tendonitis Major depressive disorder Anxiety disorder Migraine
Allergies: Olives/olive oil (anaphylaxis) Tetracycline class antibiotics (anaphylaxis) Nitrile (skin rash)
Diagnostic Lab Data: 6/1 Blood draw for Progesterone and HCG; levels low 6/3 diagnostic ultrasound 6/10 diagnostic ultrasound 6/22 blood draw for Progesterone and HCG
CDC Split Type:

Write-up: History: live births in 2008 and 2017. Abortion in 2016 using misoprostol. Miscarriage 12/20 at 6-7 wks. Received dose 2 around 4-5 weeks of pregnancy. At 6 wk 5 days, growth of growth of fetus stopped, as determined by ultrasound at what should have been 9 weeks (6/3). No heartbeat was ever detected. Yolk sac was determined to be enlarged and thin-walled, and blood tests showed a low progesterone level. Started daily Rx progesterone but on 6/5, spotting occurred and RX was discontinued. Spotting continued for one week on and off, with no heavier bleeding. Second ultrasound on 6/10 showed no change. On 6/13, miscarriage of gestational sac and fetal tissue occurred. Bleeding continued for about one week.


VAERS ID: 1513895 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-20
Onset:2021-06-03
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion induced, Exposure during pregnancy, Hydrops foetalis, Parvovirus B19 test negative, Toxoplasma serology negative, Treponema test, Ultrasound antenatal screen abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal Vitamins Vitamin D
Current Illness: Runny nose and cough 3-4 days before vaccination
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Negative TORCH titers (including Parvo B19) and Treponema Pallidum Normal NIPT
CDC Split Type:

Write-up: EDC 9/8/21 Fetus developed severe hydrops after COVID vaccination Patient had normal anatomy scan on 4/21/21 at 20 weeks Patient had COVID vaccine on 5/21/21 Patient had a repeat US on 6/3 at 26+1 weeks which showed severe hydrops Patient terminated pregnancy - birth weight unavailable


VAERS ID: 1411635 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Maternal exposure during pregnancy, SARS-CoV-2 test, Stillbirth
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: 2021-06-04
   Days after onset: 1
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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Placental histology; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021671682

Write-up: Stillbirth; Maternal exposure during pregnancy; This is a spontaneous report received from a contactable Other Health Professional from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106072030392800-ZLHTG, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25433570. This other health care professional reported information for both mother and fetus. This is a maternal report. A 41-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown) dose 1, via an unspecified route of administration on 03Jun2021 as 1st dose single dose for covid-19 immunization. Medical history included suppressed lactation. Patient was pregnant at the time of vaccination. The patient has not had symptoms associated with COVID-19 and had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient was not currently breastfeeding. The patient report was not related to possible blood clots or low platelet counts. Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation. On an unknown date the patient underwent lab tests and procedures which included Placental histology which result was unknown and COVID-19 virus test which result was negative. It was reported that on 03Jun2021 patient received the first dose of vaccine while she was pregnant and was exposed to the vaccine in her third trimester (29-40 weeks) and on 04Jun2021 the pregnancy resulted in stillbirth. The seriousness criteria were reported as death and medically significant. Death date was reported on 04Jun2021 and it was unknown if an autopsy was performed. The outcome of the event maternal exposure during pregnancy was unknown and outcome was fatal for the event of stillbirth. No follow-up attempts are possible, information on batch number and expiry date cannot be obtained.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : GB-PFIZER INC-2021676820 mother/foetus case; Reported Cause(s) of Death: Stillbirth


VAERS ID: 1415590 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH E003143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Back pain, Maternal exposure during pregnancy, Muscle spasms, Primigravida, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dystonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), 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: ELLESTE-SOLO; FOLIC ACID; PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CY; UTROGESTAN
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021657922

Write-up: miscarriage; first pregnancy; Early miscarriage; Vaginal bleeding; Cramps; Low back ache; 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-20210605192632, Safety Report Unique Identifier GB-MHRA-ADR 25426369. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E003143)via an unspecified route of administration at single dose on 03Jun2021 at the age of 36 years old for COVID-19 immunisation. Medical history included miscarriage, lactation decreased, ongoing pregnancy. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medications included estradiol (ELLESTE-SOLO) taken for IVF support from 19Apr2021; folic acid (Manufacturer unknown) taken for folic acid supplementation at 400 ug; ascorbic acid, betacarotene, biotin, calcium pantothenate, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, magnesium, nicotinamide, phytomenadione, pyridoxine hydrochloride, riboflavin, selenium, thiamine mononitrate, tocopheryl acid succinate, zinc (PREGNACARE ORIGINAL) taken for pregnancy vitamins from 22May2021; progesterone (UTROGESTAN) taken for IVF support from 06May2021. The patient experienced miscarriage on an unspecified date, early miscarriage on 05Jun2021, first pregnancy on an unspecified date, maternal exposure during pregnancy on 03Jun2021, vaginal bleeding on 04Jun2021, cramps on 04Jun2021, low back ache on 04Jun2021. The events were serious as medically significant. The clinical course was reported as follows: The day after the first dose of vaccine was administered the patient started having cramps in her low abdomen, ache in the low back, and brown vaginal spotting. The day after the patient had a more intensive, red, bleeding. The patient was 7 weeks pregnant, and the patient was suspecting that the vaccine might have caused this bleeding/aches and potentially miscarriage(?). The patient was yet to confirm if she has had a miscarriage (it is Saturday evening and the patient was unable to get hold of anyone on the phone or via email). The patient was first pregnancy via IVF. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab test included COVID-19 virus test: Negative(No - Negative COVID-19 test) on 04Jun2021. The outcome of the events first pregnancy, miscarriage was recovering, of the event Maternal exposure during pregnancy was unknown, of the events Vaginal bleeding, Cramps, Low back ache, Early miscarriage was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1419050 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-03
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.Normal pregnancy 3 years prior)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 Test.; Test Name: Ultrasound vaginal; Result Unstructured Data: Test Result:showed the fetus stopped growing at 6 weeks and h; Comments: showed the fetus stopped growing at 6 weeks and had no heartbeat.
CDC Split Type: GBPFIZER INC2021671750

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106072200355830-WOQZF. Safety Report Unique Identifier - GB-MHRA-ADR 25434203 . This reporter reported for mother and fetus. This is the maternal case. A 38-years-old female patient received First Dose Of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20May2021 (Lot Number: ew4109) As Single Dose For Covid-19 immunisation Medical history included lactation Decreased , pregnancy (Patient no longer pregnant at the time of reporting;Normal pregnancy 3 years prior) , vitamin supplementation Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not currently breastfeeding .Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. The patient experienced maternal miscarriage (abortion spontaneous) (medically significant) on 03Jun2021 with outcome of recovering. The patient underwent lab tests and procedures which included Sars-Cov-2 test: negative on No - Negative Covid-19 Test , ultrasound uterus: unknown results on unknown date.Additional Information : Patient has not tested positive for COVID-19 since having the Vaccine.The clinical course was : Miscarriage at 6 weeks, around 5 days post vaccine.Patient was exposed to the medicine first-trimester (1-12 weeks).Vaginal ultrasound at 8 weeks showed the fetus stopped growing at 6 weeks and had no heartbeat. No follow-up attempts are possible. No further information Is Expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021676922 fetus Case


VAERS ID: 1486443 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002542 / UNK - / 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANAFRANIL
Current Illness: Migraine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Miscarriage; vaccine exposure during pregnancy; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 31-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002542) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product CLOMIPRAMINE HYDROCHLORIDE (ANAFRANIL) for Migraine. Concurrent medical conditions included Migraine. On 03-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 milliliter. On an unknown date, the patient started CLOMIPRAMINE HYDROCHLORIDE (ANAFRANIL) (Oral) 10 milligram once a day. The patient''s last menstrual period was on 15-Apr-2021 and the estimated date of delivery was 20-Jan-2022. On 03-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 07-Jun-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (COVID 19 Vaccine Moderna) beginning around the seventh week of the pregnancy and CLOMIPRAMINE HYDROCHLORIDE (ANAFRANIL) during pregnancy. On 03-Jun-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. On 09-Jun-2021, ABORTION SPONTANEOUS (Miscarriage) had resolved. There was no concomitant medication reported. There was no treatment medication reported. Historical drug information included, anafra. Sender''s case number FR-AFSSAPS-PA20211154. Company comment: This is a case of product exposure during pregnancy with associated Abortion spontaneous for this 31-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded for Abortion spontaneous, very limited information regarding the event has been provided at this time. No further information is expected at this time due to from Regulatory Authority.; Sender''s Comments: This is a case of product exposure during pregnancy with associated Abortion spontaneous for this 31-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded for Abortion spontaneous, very limited information regarding the event has been provided at this time. No further information is expected at this time due to from Regulatory Authority


VAERS ID: 1498993 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021857802

Write-up: vaginal expulsion; Foetal death in utero; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-2021084126. A 38-year-old pregnant female patient received bnt162b2 (COMIRNATY, Lot Number: FC1526), intramuscular on 03Jun2021 as dose 1, single for COVID-19 immunization. Medical history included pregnancy from an unknown date. The patient''s concomitant medications were not reported. On 03Jun2021 on the day of vaccination, the patient had vaginal expulsion and fetal death in utero at 14 weeks of gestation. The mother was due to deliver on 02Dec2021 based on the last menstrual period date of 25Feb2021. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient was hospitalized because of the events. The outcome of the events was recovered with sequel. No follow-up attempts possible. No further information expected.


VAERS ID: 1506710 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Maternal exposure timing unspecified
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: DEPFIZER INC2021890779

Write-up: baby died after 2nd vaccination; vaccinated during pregnancy; This is a spontaneous report from a contactable consumer (patient). This is the second of three reports. The first report is a report is received by Pfizer from Biontech (manufacturer control number: 73312), license party for Comirnaty. This consumer reported information for both mother (two doses) and fetus. This is the maternal report of the second dose. Only this case and fetus case are serious. A female patient of unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 03Jun2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient previously received bnt162b2 (COMIRNATY), dose 1 on an unspecified date as single dose for covid-19 immunisation during pregnancy. It was reported that the patient was vaccinated during pregnancy and 2 days after the 2nd dose, on 05Jun2021, the fetus died. Outcome of the event was unknown. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021892004 same patient, same drug, different events under separate doses.;DE-PFIZER INC-2021892163 baby case


VAERS ID: 1579253 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-06-03
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA J07BX03 / UNK - / -

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

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

Write-up: This case received via the regulatory authority (reference number: LY20218445) on Aug 6, 2021 and forwarded to Moderna on Aug 6, 2021. This regulatory authority retrospective pregnancy case reported by a pharmacist, describes the occurrence of spontaneous abortion (pregnancy loss <20 weeks gestation) and maternal exposure during pregnancy in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# J07BX03) for COVID-19 immunization. No medical history reported. On May 4, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. The patient''s last menstrual period was Apr 1, 2021 and the estimated date of delivery was Jan 6, 2022. On Jun 3, 2021, the patient experienced spontaneous abortion/pregnancy loss <20 weeks gestation (medically significant). On an unknown date, patient experienced maternal exposure during pregnancy) (seriousness criterion medically significant). The patient received mRNA-1273 (COVID 19 Vaccine Moderna) beginning around the fourth week of the pregnancy. The delivery occurred on an unknown date, reported as abortion (NOS). For fetus 1, the outcome reported as spontaneous abortion (NOS). At the time of the report, spontaneous abortion (pregnancy loss <20 weeks gestation) resolved with sequelae; and maternal exposure during pregnancy resolved. The reporter did not provide any causality assessments, concomitant medications or treatment information. Sender''s comments: This is a case of product exposure during pregnancy with associated spontaneous abortion. Very limited information regarding this event provided at this time. No further information expected. Company causality for spontaneous abortion assessed as possible; while company causality for maternal exposure during pregnancy: not applicable.


VAERS ID: 1579309 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-06-03
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984549

Write-up: Miscarriage of pregnancy; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer or other non hcp received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011309402640-3OFMJ. Safety Report Unique Identifier GB-MHRA-ADR 25738048. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced miscarriage of pregnancy on 03Jun2021 with outcome of recovering (as reported). The event was assessed as serious (medically significant and resulted to congenital anomaly). Lab data includes COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1751041 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-03
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Placenta praevia, SARS-CoV-2 test, Scan, Stillbirth
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: Pfizer, Inc. EUA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic; COVID-19 (Unsure when symptoms stopped); Gluten intolerance; Irritable bowel syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20201206; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test; Test Name: scan; Result Unstructured Data: Test Result:all scans healthy
CDC Split Type: GBPFIZER INC202101226522

Write-up: Stillbirth; Placenta was low; 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-202109171657420210-TS4EU) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25960230).This consumer reported information for both mother and fetus. This is the maternal report. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19May2021 (Batch/Lot Number: ET8885) as Dose 1, Single for COVID-19 immunization. Medical history included irritable bowel syndrome, asthmatic and gluten intolerant, all from an unknown date and unknown if ongoing, suspected COVID-19 from 06Dec2020 and unsure when symptoms stopped (patient tested Yes - Positive COVID-19 test in a COVID-19 virus test on 06Dec2020). Patient was 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 stillbirth on 03Jun2021. The clinical course was reported as follows: First pregnancy, no concerns, all scans healthy. Child was exposed to the medicine during the second-trimester (13-28 weeks). Everything was normal and on track until 28 weeks. Placenta was low but not dangerously in 2021. Second scan was due to happen at 32 weeks. There were no details of developmental milestones. A Post Mortem on the child was performed. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1375791 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-03
Onset:2021-06-04
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
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: Positive pregnancy test 5/8/2021
CDC Split Type:

Write-up: Did not know we were pregnant, received vaccine. Got positive pregnancy test a few days later and miscarried the next month at 8 weeks with baby measuring 6 weeks. Have no history of miscarriage and two full term healthy babies prior to this. Unknown if related for sure, but this is the only change and timing seems important to report as possibly correlated.


VAERS ID: 1392992 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-12
Onset:2021-06-04
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Amniorrhoea, Blood test, Epidural injection, Exposure during pregnancy, Induced labour, Laboratory test abnormal, Premature delivery, Premature labour
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: I was taking prenatal vitamins, clindamycin and a topical betamethasone.
Current Illness: I did not have any other illnesses.
Preexisting Conditions: I do not have any chronic or long-standing health conditions.
Allergies: I do not have any allergies.
Diagnostic Lab Data: I had blood work drawn and my amniotic fluid checked. I had an epidural and everything else that comes along with giving birth.
CDC Split Type: vsafe

Write-up: On 06/04 I woke up and I had a lot of water leakage and I let it go throughout the day a little longer. I called the OBGYN and I went in and had it checked around 4:00PM. There were several tests that were run. I was leaking amniotic fluid. I had to go into labor that day. The pregnancy was considered pre-term because I wasn''t due until 07/15. On 06/05, my baby was born at 5lb, 5oz. After I was told I had to go into labor, I was induced. I received a cervix softener and than I was given Pitocin. I was induced at 10PM on 06/04 and I delivered at 12PM on 06/05. I was in labor for 14 hours. Right now my baby is in the NICU and she will hopefully be coming home 06/13. If she does come home on 06/13, she will have been in the NICU for 8 days. I was given penicillin and betamethasone, which is supposed to help with the development of the babies lungs. All of her tests have come back normal. The only issue was with her bilirubin levels.


VAERS ID: 1407189 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-05-27
Onset:2021-06-04
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Abdominal pain, Blood glucose abnormal, Chest pain, Dizziness, Exposure during pregnancy, Headache, Peripheral swelling, Protein urine present, Stillbirth
SMQs:, Acute renal failure (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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? No
Previous Vaccinations:
Other Medications: Prenatal vitimen, Operazole, cepalexin,Tyelenol,
Current Illness: Hep c Hypertension Asthma UTI Bladder infection
Preexisting Conditions: Kidney stones UTI Hep c
Allergies: Sulfa, bactrim, gentmuzine, tramodol
Diagnostic Lab Data: 3 HR glucose test
CDC Split Type:

Write-up: Positive glucose test Protein in urine Swollen feet and hands Headaches Abdominal pain Dizziness Chest pain Baby was 3lbs 2.9 oz 29 weeks pregnant baby stillbirth Positive glucose test 6/4 6/7 3hour glucose test 2hr was high protein in urine


VAERS ID: 1412849 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-05-28
Onset:2021-06-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Muscle spasms, Pain in extremity, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: prenatal vitamins; low dose aspirin
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: June 4th - ultrasounds; glucose tests; blood tests; etc June 15th - ultrasounds; glucose test; blood tests; rogam tests (my blood was compatible with baby''s)
CDC Split Type: vsafe

Write-up: I just had my second shot yesterday morning. For the first dose, I didn''t have any of the typical side effects other than sore arm. On June 4th, I started having vaginal bleeding. I called the on call triage and the bleeding was significant enough to go to ER. Was there and almost had a DNC at that point because the doctor felt the bleeding was so significant. But there was a wait in ER, had an ultrasound, by that time bleeding slowed down and I went home with the caveat that if the bleeding returned to go to ER again. The doctor''s were saying that a miscarriage was going to happen....so we were taking it day by day. 10 days later, I started bleeding again and then I miscarried on Tuesday of this week. I started cramping at 1;:00 in the morning and felt the water break and then started bleeding heavily again at 03:00 in morning. Follow up with OB''s on June 7th. And I went to ER and once we got there and they checked the ultrasound and they couldn''t see the baby any more and they had me go in to a D&E. Pregnancy - 3rd pregnancy - one live birth (my son); the first pregnancy was an elective abortion; Estimated date of delivery was going to be December 1 (I was 15 weeks)


VAERS ID: 1498261 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-04-20
Onset:2021-06-04
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Full blood count normal, Pregnancy, Pregnancy test positive, Progesterone decreased, Ultrasound foetal abnormal, Uterine dilation and curettage
SMQs:, Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Post Natal Multivitamin
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: June 4, 2021 - serum pregnancy test - positive July 12, 2021 - ultrasound - a single gestational sac CRL not seen, not consistent with LMP, cardiac activity absent July 12, 2021 - Progesterone - 10.87 July 19, 2021 - CBC - normal July 22, 2021 - Suction DNC with anesthesia - July 23, 2021 - tissue exam - final diagnosis
CDC Split Type: vsafe

Write-up: Well so on June 4th 2021 I got a positive pregnancy test via blood in the Hospital. On July 12th I would have been 9.5 weeks pregnant. I went to a regular ultrasound appointment and there was an early miscarriage. On July 22, I had a DNC procedure due to the early/silent miscarriage.


VAERS ID: 1549009 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-13
Onset:2021-06-04
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

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

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

Write-up: Miscarriage; bleeding started on May 28 and was confirmed on June 1


VAERS ID: 1641057 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-04-10
Onset:2021-06-04
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 AR / IM

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: Calcium, vitamin D, prenatal
Current Illness: No
Preexisting Conditions: No
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2nd miscarriage. July 4th. (First miscarriage prior to first dose of moderna vaccine). Periods completely normal following vaccination.


VAERS ID: 1471567 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-06-04
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 0
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: Test Date: 20210602; Test Name: progesterone; Result Unstructured Data: Test Result:16,7 nmol/L
CDC Split Type: EEPFIZER INC2021881381

Write-up: pregnancy at that time was 4 weeks, at the time of abortion (04.06) - 7 + 2; the fetal heart stopped; foetal death; This is a spontaneous report from a non-contactable consumer reported information for both mother and fetus. This is a fetus report. The mother report was downloaded from the regulatory authority-WEB report number RO-NMA-2021-SP37643. A fetus patient of unspecified age and gender received the second dose of BNT162B2 (COMIRNATY), transplacental on 07May2021 (Lot number EW6126) as 0.3 ml single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient mother medical history included endometriosis from 2020 and not ongoing, pregnancy normal from 2021 and not ongoing. Patient mother received the second dose of BNT162B2, intramuscular on an unspecified date as 0.3 ml single dose for covid-19 immunisation. Patient experienced foetal death on 04Jun2021. On 10May2021, the patient mother discovered that she was pregnant. On 04Jun2021, the pregnancy terminated spontaneously. Eventually, the fetal heart stopped and the pregnancy interrupted. On 02Jun2021, the patient mother went emergency department due to bleeding. Progesterone analysis was performed - 16,7 nmol/l. Gepretix (progesterone) 1 capsule orally three times a day was prescribed. The size of the pregnancy at that time was 4 weeks, at the time of abortion (04.06) - 7 + 2. Outcome of events were fatal. Patient died on 04Jun2021. It was not reported if an autopsy was performed. Sender Comment: Serious report due to miscarriage (medically significant). The initial side effects are known, the causal link is considered possible. Previous gynecological problems (endometriosis) may have contributed to the termination of the pregnancy. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : EE-PFIZER INC-2021804367 same product, reporter/ different patient (mother''s case); Reported Cause(s) of Death: foetal death; pregnancy; the fetal heart stopped


VAERS ID: 1478706 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-06-04
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Karyotype analysis
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: VITAMINE D; ASAFLOW; FOLIUMZUUR
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Analyzes of the karyotype of the fetus; Result Unstructured Data: Test Result:in progress
CDC Split Type: BEPFIZER INC2021824245

Write-up: Miscarriage at 10 weeks pregnant. Cardiac activity stopped observed on 04Jul2021. Curettage.; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB, regulatory authority number BE-FAMHP-DHH-N2021-97258. A 34-year-old female patient received the first dose of BNT162B2 (COMIRNATY; solution for injection; Lot #: EW6126) via an unspecified route of administration on 12May2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included colecalciferol (VITAMINE D), acetylsalicylic acid (ASAFLOW) and folic acid (FOLIUMZUUR), all taken for unspecified indications on unspecified dates. On 04Jun2021, the patient experienced miscarriage at 10 weeks pregnant. Cardiac activity stopped observed on 04Jul2021. The event was serious for hospitalization. The action taken in response to the event for concomitant medications colecalciferol, acetylsalicylic acid and folic acid was reported as unknown. The clinical outcome of the event was recovered/resolved with sequel on 04Jun2021. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - Yes Evolution of the ADR - Healing with sequelae Examinations - Analyzes of the karyotype of the fetus are in progress. ADR description - Miscarriage at 10 weeks pregnant. Cardiac activity stopped observed on 06/04.


VAERS ID: 1498931 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-06-04
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / UNK LA / -

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021865075

Write-up: Abortion spontaneous/Miscarriage; Abortion spontaneous/Miscarriage; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory authority, regulatory authority number FI-FIMEA-20211867. A 26-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: EW4815, expiry date not reported), via an unspecified route of administration, administered in left arm on 21Apr2021 as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced abortion spontaneous also reported as miscarriage on 04Jun2021. The patient was hospitalized on an unknown date. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1507698 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-04
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021883149

Write-up: 22Apr2021 as single dose for COVID-19 immunisation. The patient experienced maternal vaccine exposure on 04Jun2021 with outcome of recovering, missfall on 04Jun2021 with outcome of recovering, hemorrhaging and later miscarriage on an unspecified date in 2021 with outcome of unknown. The patient received BNT162B2 dose 2 and the next day was hemorrhaging and a few days later miscarriage. Suspected side effect was observed on 04Jun2021. The observer had reported the exact time of dose 1, but there was no information regarding dose 2. The case was considered as serious, important medical event. Follow-up attempt are not possible. No expected further information.


VAERS ID: 1547063 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Lymphadenitis, Maternal exposure during pregnancy, Pain
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTPFIZER INC202100973440

Write-up: pregnancy does not develop, Uterine aspiration was applied.; she was 6 weeks pregnant; Tiredness; arm pain; Lymphadenitis; This is a spontaneous report from a contactable consumer or other non hcp downloaded from a regulatory authority-WEB, regulatory authority number LT-SMCA-4216. A 31-years-old pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 03Jun2021 (Batch/Lot number: not provided) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 04Jun2021, the patient experienced tiredness, arm pain and lymphadenitis. On 08Jul2021, the patient experienced pregnancy did not develop, uterine aspiration was applied. The patient reported that she became pregnant while taking bnt162b2. The patient received the vaccine without knowing that she was pregnant. On 23Jun2021, she was 6 weeks pregnant, but on 08Jul2021 found that pregnancy did not develop. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. For abortion spontaneous, uterine aspiration was applied. The outcome of fatigue, pain and lymphadenitis was recovered on 06Jun2021 while remaining events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1708196 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Maternal exposure during pregnancy, Premature delivery, Tic, Vaccination site pain
SMQs:, Supraventricular tachyarrhythmias (narrow), Dyskinesia (broad), Dystonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101193865

Write-up: Atrial fibrillation; Early onset of delivery; Tics in right eye; Puncture site pain; Exposure During Pregnancy, second trimester; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number is CZ-CZSUKL-21010217. A 41-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 04Jun2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing pregnancy. The patient''s concomitant medications were not reported. The patient experienced atrial fibrillation (atrial fibrillation) (hospitalization, medically significant, life threatening) on 29Jun2021 with outcome of recovered with sequelae on 01Jul2021, early onset of delivery (premature delivery) (hospitalization, medically significant) on 26Jun2021 with outcome of not recovered, puncture site pain (puncture site pain) (non-serious) on 05Jun2021 with outcome of recovered on 06Jun2021, tics in right eye (tic) (non-serious) on 10Jun2021 with outcome of not recovered, exposure during pregnancy, second trimester (exposure during pregnancy) (non-serious) on 04Jun2021 with outcome of unknown. The mother reported she became pregnant while taking bnt162b2. The mother was 25 Weeks pregnant at the onset of the event. Therapeutic measures were taken as a result of atrial fibrillation (atrial fibrillation), early onset of delivery (premature delivery), puncture site pain (puncture site pain), tics in right eye (tic). Additional information: Preterm labor was stopped by the administration of magnesium. However, further uterine stiffening still came irregularly, the condition was subsequently defined as a high-risk pregnancy. The patient was vaccinated with Comirnaty vaccine at 25th week of pregnancy. As of the day of this report, the patient was 25 weeks pregnant. The reporter does not wish to contact her general practitioner.


VAERS ID: 1385542 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-16
Onset:2021-06-05
   Days after vaccination:109
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BNT162B2 / 1 LA / -

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? 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 @ 8 weeks gestation


VAERS ID: 1422003 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-05
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   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: FOSTAIR; MONTELUKAST
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (in very early pregnancy); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test in very early pregnancy
CDC Split Type: GBPFIZER INC2021671284

Write-up: Pregnancy loss; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is [GB-MHRA-WEBCOVID-202106071636271310-HWKUJ]. Safety Report Unique Identifier GB-MHRA-ADR 25432035. A 31-year-old female patient received her first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19May2021 (Lot Number: ET8885) as dose 1, single for COVID-19 immunisation. Medical history included suppressed lactation and COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included beclometasone dipropionate, formoterol fumarate (FOSTAIR) and montelukast; both taken for asthma, start and stop date were not reported. Patient was not enrolled in clinical trial and was not breastfeeding. Patient was COVID positive in very early pregnancy. Patient was exposed to the medicine Second-trimester (13-28 weeks). Patient has not had symptoms associated with COVID-19. On 05Jun2021, patient was found to have Intrauterine death at her 28 week scan by antenatal staff. The mother was 28 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Patient has not tested positive for COVID-19 since having the vaccine. Physician was unsure if the vaccine had an adverse effect on any aspect of the pregnancy. The report did not relate event to possible blood clots or low platelet counts. Relevant investigations or tests conducted was reported as awaiting PM. The patient died on 05Jun2021. It was unknown if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pregnancy loss


VAERS ID: 1461569 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-06-05
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Amniotic cavity infection, Antibody test, Blood pressure measurement, Body temperature, C-reactive protein increased, Coagulation test, Foetal death, HIV test, HTLV-1 test, HTLV-2 test, Haemoglobin, Heart rate, Hepatitis B virus test, Hepatitis C virus test, Histology, Investigation, Maternal exposure during pregnancy, Microbiology test, Platelet count increased, Ultrasound scan, White blood cell disorder
SMQs:, Haematopoietic leukopenia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: In vitro fertilization
Allergies:
Diagnostic Lab Data: Test Name: anti-beta 2 GPI antibodies; Result Unstructured Data: Test Result:negative; Test Name: Anti-erythrocytic antibodies; Result Unstructured Data: Test Result:negative; Test Date: 20210606; Test Name: Blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 20210606; Test Name: Body temperature; Result Unstructured Data: Test Result:normal; Test Name: coagulation assessment; Result Unstructured Data: Test Result:normal; Test Name: CRP; Result Unstructured Data: Test Result:27 mg/l; Test Name: hemoglobin; Result Unstructured Data: Test Result:9.7 g/dl; Test Date: 20210606; Test Name: heart rate; Result Unstructured Data: Test Result:Normal; Test Name: Hepatitis B; Result Unstructured Data: Test Result:serology negative; Test Name: Hepatitis C; Result Unstructured Data: Test Result:serology negative; Test Name: anatomopathological examination; Result Unstructured Data: Test Result:no abnormality on fetopathological examination; Comments: of the deceased twin; Test Name: Pathological examinations of the 2 placentas; Result Unstructured Data: Test Result:presence of stage 2 chorioamnionitis; Comments: with stage 3 funniculitis for the deceased twin, less intense chorioamnionitis without funniculitis for the other twin; Test Name: HIV; Result Unstructured Data: Test Result:serology negative; Test Name: HTLV 1; Result Unstructured Data: Test Result:serology negative; Test Name: HTLV 2; Result Unstructured Data: Test Result:serology negative; Test Name: Anti-cardiolipid; Result Unstructured Data: Test Result:negative; Test Name: Foetopathological examination; Result Unstructured Data: Test Result:normal; Comments: male fetus, macerated, without apparent or visceral malformation detected, no dysmorphia of the face or extremities; Test Name: Bacteriology on the placenta; Result Unstructured Data: Test Result:rare leukocytes, direct negative examination; Comments: sterile culture; Test Name: Platelets; Result Unstructured Data: Test Result:254 g/l; Test Name: USG; Result Unstructured Data: Test Result:normal; Test Date: 20210521; Test Name: USG; Result Unstructured Data: Test Result:normal; Comments: 10% weight discrepancy between the 2 fetuses, which is not an anomaly in the context of twin pregnancy; Test Date: 20210606; Test Name: USG; Result Unstructured Data: Test Result:fetal death in utero of one of the 2 twins; Test Name: leukocytes; Result Unstructured Data: Test Result:10 g/l
CDC Split Type: FRPFIZER INC2021770452

Write-up: Foetal death in utero; Maternal Exposure During Pregnancy, third trimester ; Miscarriage; Chorioamnionitis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB [FR-AFSSAPS-TS20212485], Safety Report Unique Identifier [FR-AFSSAPS-2021078733]. A 38-year-old pregnant female patient received bnt162b2 (COMIRNATY), intramuscular on 21May2021 (Lot number: unknown) as dose 1, single for COVID-19 immunization. Medical history included in vitro fertilization. The patient''s concomitant medications were not reported. The patient previously took magnesium. The patient experienced foetal death in utero (hospitalization on unspecified date) on 06Jun2021, and miscarriage on 05Jun2021; both events resulted in emergency room visit. This mother reported her last menstrual period was on 08Nov2020 (as reported). The mother reported she became pregnant while taking bnt162b2 (Maternal Exposure During Pregnancy, third trimester). The mother was 28 weeks pregnant at the onset of the event. Course of events as follows: The patient who started a pregnancy on 22Nov2020 by in vitro fertilization (as reported). Twin chorionic, bi-amniotic twin pregnancy. Normal clinical and ultrasound course on unspecified date. Last ultrasound on 21May2021: normal. 10% weight discrepancy between the 2 fetuses, which is not an anomaly in the context of twin pregnancy. Last obstetric consultation (27May2021) normal. Emergency consultation on Saturday 05Jun2021 in the evening (D15 post-vaccine) for premature rupture of the membranes, spontaneous, without associated sign: frank rupture, clear liquid, no fever, no contraction, no other symptom. On ultrasound on 06Jun2021, fetal death in utero of one of the 2 twins (dating back several days, because signs of maceration and anamnios), good vitality of the other twin. The mother had not noticed any particular symptoms and felt her babies moving (difficulty assessing due to twin pregnancy?) On 06Jun2021, Normal blood pressure and heart rate, no fever (normal body temperature), no proteinuria. Start of amoxicillin (will not be not continued after birth). A few hours after admission, onset of contractions. Birth by cesarean on 06Jun2021 at 9:11 a.m., under cover of 2 g of cefazoline, of the first baby, alive, male, weighing 1.34 kg with normal pH then 1 minute later of the second baby, deceased, weighing 1.16 kg, with clear signs of maceration. Obstetricians noted that each child''s umbilical cords were very large and very swollen. For the living baby, however, the fluid was clear and no other peculiarities were observed. Baby hospitalized for prematurity, no infectious problem. Bacteriology on the placenta: rare leukocytes, direct negative examination, sterile culture. Biological assessment in the mother on unspecified date: CRP at 27 mg/L, normal coagulation assessment, hemoglobin 9.7 g/dL, platelets 254 G/L, leukocytes 10 G/L (but pregnancy). Sterile ECBU and vaginal sample. Hepatitis B, C, HIV, HTLV 1 and 2 serology negative, parvovirus and toxoplasmosis in favor of an old infection. Anti-cardiolipid and anti-beta 2 GPI antibodies negative. Anti-erythrocytic antibodies negative. Foetopathological examination: normal (male fetus, macerated, without apparent or visceral malformation detected, no dysmorphia of the face or extremities). No malformative cause identified likely to explain this MFIU. Pathological examinations of the 2 placentas: histological appearance in accordance with the term, presence of stage 2 chorioamnionitis with stage 3 funniculitis for the deceased twin, less intense chorioamnionitis without funniculitis for the other twin. In total, fetal death in utero of one of 2 twins in a twin chorionic, bi-amniotic twin pregnancy, discovered at 30 weeks on D15 of a first dose of Comirnaty, after premature rupture of the frank membranes of clear liquid, without fever or contraction. Aspect of maceration of the deceased twin suggesting a death dating back several days. Premature delivery in the following hours by Caesarean section of a live male child hospitalized for prematurity and of the deceased child. Chorioamnionitis for the 2 twins (stage 2 with stage 3 funniculitis for the deceased twin, less intense for the other) on anatomopathological examination of the placentas, no abnormality on fetopathological examination of the deceased twin. The outcome of the event foetal death in utero was resolved with sequel and the outcome of the remaining events was unknown. No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1506712 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-05
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   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: DEPFIZER INC2021892163

Write-up: exposure during pregnancy; baby died after 2nd vaccination; This is a spontaneous report from a contactable consumer (parent). This consumer reported information for both mother and fetus, this is the fetus report. The first dose of mother case is received by Pfizer from Biontech (manufacturer control number: 73312]), license party for Comirnaty. An unspecified age female mother received bnt162b2 (COMIRNATY), dose 1 on an unspecified date (Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as DOSE 1, SINGLE, via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The Fetus experienced exposure during pregnancy on an unspecified date, baby died after 2nd vaccination on 05Jun2021. The Fetus died on 05Jun2021. It was not reported if an autopsy was performed. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up. ; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021892004 mother case first dose;DE-PFIZER INC-2021890779 mother case second dose; Reported Cause(s) of Death: baby died after 2nd vaccination; exposure during pregnancy


VAERS ID: 1672003 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-06-05
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Echocardiogram
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: Echo; Result Unstructured Data: Test Result:unknown result
CDC Split Type: NLPFIZER INC202101086713

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00668957. A 38-year-old pregnant female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 23May2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced miscarriage on 05Jun2021 following administration of covid-19 vaccin pfizer injection solution. The outcome of event was unknown. The miscarriage occurred at a pregnancy duration of about 4 weeks. This happened after the first vaccination, which took place at a pregnancy duration of about 2 weeks. The reporter was in the early days of her pregnancy when she received her 1st dose of vaccine. After a week or two she found out that the embryo stopped growing and the miscarriage was induced. Therapeutic measures were taken as a result of event. Reporter''s Comments: Medication therapy in the past BioNTech/Pfizer vaccine (Comirnaty): no Miscarriage: Information HA other or disabling information: I have had a miscarriage. Additional information ADR: I was in the early days of my pregnancy when I received my 1st dose of vaccine. After about two weeks. I found out that the embryo had stopped growing. influencing factors: COVID-19 vaccine exposure during pregnancy week: Between 1 - 2 weeks Previous COVID-19 infection: None diagnostic procedures: Echo No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Medication therapy in the past BioNTech/Pfizer vaccine (Comirnaty): no Miscarriage: I have had a miscarriage. Additional info ADR: I was in early days of my pregnancy when I received my 1st dose of vaccine. After about 2 weeks. I found out that the embryo had stopped growing. influencing factors: COVID-19 vaccine exposure during pregnancy week: Between 1 - 2 weeks Previous COVID-19 infection: None diagnostic procedures: Echo


VAERS ID: 1676195 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Formication, Magnetic resonance imaging head, Maternal exposure timing unspecified, Paraesthesia, Post abortion haemorrhage, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: MRI brain; Result Unstructured Data: Test Result:unknown result; Test Date: 20210803; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101088841

Write-up: miscarriage is still not over at this time, bleeding persists; Abortion spontaneous/ miscarriage; Formication; tingling in the left foot/ tingling in all 4 limbs; The patient was pregnant at the time of vaccination; This is a spontaneous report from a contactable consumer or other non-hcp downloaded from the regulatory authority-WEB; the Regulatory Authority number is FR-AFSSAPS-ST20213143. A 37-year-old female patient received the first dose of BNT162B2 (COMIRNATY) intramuscular, administered in the arm on 05Jun2021 (batch/lot number: FD0785) at 37 years old as DOSE 1, 0.3 mL SINGLE for COVID-19 immunization. The patient had no medical history of COVID-19 infection. Concomitant medications were not reported. The patient was pregnant at the time of vaccination. One (1) minute after the Dose 1 injection, the patient experienced tingling in the left foot. Then the next day (06Jun2021) tingling in all 4 limbs. It was also reported that the patient experienced formication on 05Jun2021 and had abortion spontaneous reported as miscarriage on 25Jul2021. The patient was hospitalized for the event abortion spontaneous/ miscarriage. The miscarriage is still not over at this time (as reported), bleeding persists. Further information is awaited. The patient underwent lab tests and procedures which included the first brain magnetic resonance imaging in June 2021, results were unknown; the second will be done again in Sep2021. The patient tested negative for COVID-19 virus test on 03Aug2021. The patient was recovering from the event formication; and has not recovered from the events "abortion spontaneous/ miscarriage" and "miscarriage is still not over at this time, bleeding persists." Outcome of the rest of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1742229 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Amenorrhoea, Inappropriate schedule of product administration
SMQs:, Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101221116

Write-up: they lost their baby; stopped menstruating; Dose 2: 05Jun2021; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 86874, license party for Comirnaty]. A contactable consumer reported that a pregnant female patient of unspecified age received the second dose of BNT162b2 (COMIRNATY, Lot: Unknown) via an unspecified route on 05Jun2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot: Unknown) via unspecified route on 24Apr2021 as a single dose for COVID-19 immunization. The consumer called on behalf of his girlfriend, who was vaccinated with two doses of Comirnaty and has since then stopped menstruating. It was also reported they lost their baby. The outcome of the events was unknown. The lot/batch number for the vaccine, BNT162b2 (COMIRNATY), was not provided and will be requested during follow-up.


VAERS ID: 1766720 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: Fetal heart rate; Result Unstructured Data: Test Result:lack of fetal heart rate
CDC Split Type: PLPFIZER INC202101256816

Write-up: Lack of fetal heart rate, miscarriage of pregnancy (7th week); Maternal Exposure During Pregnancy, first trimester; Mild pain of the arm; This is a spontaneous report from a contactable Physician downloaded from the Regulatory Agency (RA)-WEB, authority number PL-URPL-3-1035-2021. This is first of two reports. This physician reported information for both mother and foetus/baby. This is a maternal report. A 40-years-old pregnant female patient received BNT162b2 (Comirnaty, Solution for injection, Batch/Lot number: FD0932 and Expiration date: 14Jun2021) via intramuscular route of administration on 05Jun2021 at 09:56 hours as dose 1, 0.3 mL single (at the age of 40-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. : The patient was 7 weeks pregnant. On 05Jun2021, a post-vaccination reaction occurred after vaccination, patient experienced minor shoulder pain after vaccination, no fever, no weakness, no rash. Patient was functioning normally, as per usual. On 22Jun2021 at 17:40 hours, patient attended a follow-up appointment with a gynecologist. Patient was found to have no fetal heartbeat and a miscarriage. The reporter classified the Adverse Vaccine Reaction as severe. Agency classified the report as severe (other medically significant). The outcome of the event was unknown. Health Authority Comment: Shoulder Pain is an expected side effect described in the SmPC. Fetal Abortion is an unexpected adverse reaction to Comirnaty that is not reported in the SmPC. There are no data in the current scientific literature to support a correlation between administration of Comirnaty and induction of miscarriage. There is a temporal relationship between the administration of the vaccine and the occurrence of adverse reactions. The reporter classified the adverse reaction as serious. The agency classified the report as severe (other medically significant) for this reason and because of the nature of the adverse reaction (miscarriage). No follow-up attempts possible. No further information expected.


VAERS ID: 1777779 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Asthenia, Ultrasound scan
SMQs:, Guillain-Barre syndrome (broad), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pollen allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: ultrasound; Result Unstructured Data: Test Result:cardiac activity; Test Date: 20210715; Test Name: ultrasound; Result Unstructured Data: Test Result:no evolution of the pregnancy and no cardiac...; Comments: no evolution of the pregnancy and no cardiac activity
CDC Split Type: FRPFIZER INC202101273739

Write-up: Pregnancy termination/ no evolution of the pregnancy; asthenia; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number FR-AFSSAPS-ST20213499. This pharmacist reported information for both mother and fetus, this is a case for 2nd dose of Comirnaty for mother. A 38-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Jun2021 (Batch/Lot Number: Unknown) as 0.3 ml single for COVID-19 immunization. Medical history included ongoing Pollen allergy, migraine from an unknown date and unknown if ongoing. No previous COVID experience. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 intramuscular on 30Apr2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization and experienced asthenia. The patient presented asthenia the day after D2 (05Jun2021). The patient was aware of her current pregnancy 1 week after the 2nd injection. First (1st) estimated pregnancy onset 25May2021. Initial ultrasound with real cardiac activity. On 15Jul2021 new ultrasound: no evolution of the pregnancy and no cardiac activity. Termination of pregnancy at 7 weeks of gestation (in 2021). Unfortunately incomplete (medical termination of pregnancy) followed by aspiration. The mother reported she became pregnant while taking bnt162b2. The mother was 7 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included ultrasound scan: cardiac activity on 2021, ultrasound scan: no evolution of the pregnancy and no cardiac activity on 15Jul2021. Therapeutic measures were taken as a result of pregnancy termination/ no evolution of the pregnancy. The outcome of the event pregnancy termination/ no evolution of the pregnancy was recovered with sequelae while for event asthenia was unknown. The event pregnancy termination/ no evolution of the pregnancy was considered as serious (hospitalization). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101304602 foetus case


VAERS ID: 1505645 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-27
Onset:2021-06-06
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0170 / 2 AR / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0151 / 1 AR / SYR

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec
Current Illness: None
Preexisting Conditions:
Allergies: None
Diagnostic Lab Data: Blood work, ultrasounds on 6/9, bloodwork 6/11, to confirm miscarriage and again on 6/16. & 6/24 to show pregnancy was fully gone.
CDC Split Type:

Write-up: I became pregnant following my second covid vaccine shot and suffered a miscarriage and lost the pregnancy at 6 weeks in June


VAERS ID: 1449843 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-06
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021761556

Write-up: This is a spontaneous report from a contactable other healthcare professional, via the regulatory authority (report number: 571009). A 37-year-old female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date for COVID-19 immunisation. The patient experienced spontaneous abortion on Jun 6, 2021 (onset latency: 67 days); outcome of recovered with sequelae. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1473672 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-06
   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 EW3143 / 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? 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: Pregnancy (Estimated due date: 16Jan2022)
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210620; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 202106; Test Name: scans; Result Unstructured Data: Test Result:early foetal demise at 12-week scan
CDC Split Type: GBPFIZER INC2021813936

Write-up: Early miscarriage; Maternal exposure during pregnancy; This is a solicited report from the RA from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202106291838394530-U87FD, Safety Report Unique Identifier: GB-MHRA-ADR 25564128. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Jun2021 (Lot Number: EW3143) at the age of 30-year-old as single dose for COVID-19 vaccination. Medical history included ongoing pregnancy (estimated due date: 16Jan2022), folic acid supplementation. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on 06Jun2021, early miscarriage on 28Jun2021. The events were reported as serious (hospitalization). Patient thought she lost her baby because of the COVID vaccine. Baby''s heart stopped same week as vaccine, 7.5 weeks. The patient underwent lab tests and procedures which included covid-19 virus test: no - negative covid-19 test on 20Jun2021 and scans: early foetal demise at 12-week scan in Jun2021. Outcome of events was not recovered. The reporter''s assessment of the causal relationship of the events with bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on available information and a temporal association, the causal association between the events and the suspect drug BT162B2 is assessed as possibly related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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: 1720868 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Complication of pregnancy, Feeling abnormal, Investigation, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (2 normal pregnancy and healthy children. Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: scans; Result Unstructured Data: Test Result:Swelling on back of baby. No heart beat at 12 week; Comments: Swelling on back of baby. No heart beat at 12 weeks.; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191667

Write-up: Miscarriage/ miscarriage of pregnancy/ pregnancy loss/ late miscarriage; Pregnancy disorder; Blurred vision; Spaced out; 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-202109111910234780-7ANFA, Safety Report Unique Identifier number is (GB-MHRA-ADR 25928649). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31May2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included folic acid supplementation and 2 normal pregnancy from an unknown date and unknown if ongoing, 2 previous pregnancies all fine. No problems. Until patient had the covid vaccine which she was fully blaming. 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 miscarriage/ miscarriage of pregnancy/ pregnancy loss/ late miscarriage, and pregnancy disorder on 10Sep2021, blurred vision on 09Jun2021, spaced out on 06Jun2021. The patient underwent lab tests and procedures which included covid-19 virus test: negative on an unknown date (No - Negative COVID-19 test). Patient caught pregnant within 2 weeks of her first vacation which ended in a missed miscarriage where her baby stopped growing and no heart beat at 13.4 weeks. She has had 2 normal pregnancy and healthy children and can not think of any other reason why this has happened other than accepting to have the first dose of the vaccine. Stated that "IT IS NOT SAFE FOR PREGNANT WOMENT OR WOMEN WHO ARE TRYING TO CONVINCE". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The medicine had an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine Second-trimester (13-28 weeks). Details of scans or investigations: Swelling on back of baby. No heart beat at 12 weeks. Relevant investigations or tests conducted: "Post mortem awaiting". The events were reported as serious due to hospitalization on an unknown date, medically significant, and life threatening. The outcome of blurred vision, spaced out, and pregnancy disorder was not recovered, while the rest of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1751143 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4103 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Anovulatory cycle, COVID-19, Drug ineffective, Interchange of vaccine products, Maternal exposure during pregnancy, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad), Medication errors (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101226929

Write-up: drug ineffective; SARS-CoV-2 infection; Maternal exposure during pregnancy; Miscarriage; Anovulation; ongoing breast feeding / first dose: COVID-19 VACCINE ASTRAZENECA, second dose: BNT162B2; ongoing breast feeding; first dose: COVID-19 VACCINE ASTRAZENECA, second dose: BNT162B2; This is a spontaneous report from a contactable consumer. This consumer reported for both mother and child. This is the mother report. This report was received from the Regulatory Agency (RA). The regulatory authority report number: GB-MHRA-WEBCOVID-202109181157529800-K1648, Safety Report Unique Identifier: GB-MHRA-ADR 25964633. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jun2021 (Lot Number: EW4103) as DOSE 2 (INITIAL PFIZER DOSE), SINGLE for COVID-19 immunisation. Medical history included ongoing breast feeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously took COVID-19 VACCINE ASTRAZENECA, via an unspecified route of administration on 19Mar2021 (Lot Number: 4120Z002) as DOSE 1, SINGLE for COVID-19 immunisation and experienced irregular periods and prolonged periods from 09Apr2021 and recovered with sequelae on 31Jul2021. The patient experienced maternal exposure during pregnancy on 06Jun2021, miscarriage and anovulation on 27Aug2021, and SARS-CoV-2 infection on 05Sep2021. The events were considered serious: medically significant and congenital anomaly (as reported). The patient underwent lab tests and procedures which included COVID-19 virus test: Yes - Positive COVID-19 test on 05Sep2021. The patient recovered from maternal exposure during pregnancy, miscarriage, and SARS-CoV-2 infection on an unspecified date in 2021. The outcome of anovulation was not recovered. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101234677 Baby Case


VAERS ID: 1383404 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-01-28
Onset:2021-06-07
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0301L20A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 03L20A / 2 LA / IM

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

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

Write-up: I became pregnant mid April 2021 after 3 uncomplicated pregnancies and suffered a miscarriage at approximately 10 weeks.


VAERS ID: 1388044 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-04-14
Onset:2021-06-07
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: No other comorbidities
CDC Split Type:

Write-up: Baby born at 35 weeks rather than full term.


VAERS ID: 1421029 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-29
Onset:2021-06-07
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Subchorionic haemorrhage, Ultrasound antenatal screen, Uterine dilation and curettage
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pre-natals
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 2 Ultrasounds and D&C
CDC Split Type:

Write-up: I had a very normal, healthy pregnancy and delivery.This is my second pregnancy that went into a miscarriage. The fetus stopped growth at 6w5days right around the time of my second dose of vaccine. I was initially detected with subchorionic hemorrhages, the fetal growth stopped around 6w5days. There was initial heart beat on the first ultrasound on 7th June but the later ultrasound on 18th June had a deceased fetus of 6w5days. It was a miscarriage and had to undergo D&C on June 22


VAERS ID: 1454459 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-05-06
Onset:2021-06-07
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 2 RA / SYR

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin
Current Illness: COVID-19 positive but didn?t know it at time of vaccination
Preexisting Conditions: None
Allergies: Penicillin
Diagnostic Lab Data: 7/4/21 transvaginal ultrasound and normal ultrasound
CDC Split Type:

Write-up: Miscarriage of baby confirmed in ER on 7/4/21. Fetus age based on ultrasound imagining estimated at 6weeks old at time of death. Estimated due date was 1/24/2022. Conception date estimated 5/3/21. Pregnancy at week 10 at time of miscarriage.


VAERS ID: 1628525 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-05-22
Onset:2021-06-07
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal death, Foetal growth restriction, Full blood count, Human chorionic gonadotropin abnormal, Pathology test, Ultrasound foetal abnormal, Uterine dilation and curettage
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: Amoxcillian
Diagnostic Lab Data: hcg beta, cbc, d&c between 06/07/21 and 07/01/21. The pathology from the fetal tissue showed no chromosomal or structural cause for miscarriage.
CDC Split Type:

Write-up: Shortly after getting the vaccine, my hcg beta labs (pregnancy) started to not increase like they should. I had an ultrasound on 06/11/21 showing a 6w5d fetus with a heartbeat of 129 bpm. I had another ultrasound on 06/29/21 that showed the fetus was no longer alive and had stopped growing at 7w6d. I was diagnosed with a missed miscarriage and had a d&c to remove the tissue on 07/01/21.


VAERS ID: 1456830 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to nuts (Relevant past drug history: Nuts allergy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021782397

Write-up: Spontaneous abortion was confirmed on 2021-06-22 by a gynecologist. At the time of reporting, the bleeding was not resolved.; I experienced vaginal bleeding.; This is a spontaneous report from a non-contactable consumer (patient). A 27-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included nuts allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included folic acid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jun2021, the patient experienced vaginal bleeding. Spontaneous abortion was confirmed on 22Jun2021 by a gynecologist. At the time of reporting, the bleeding was not resolved. The outcome of spontaneous abortion was unknown. The mother was 5 weeks pregnant at the onset of the event. The mother was due to deliver on 26Jan2022. The adverse event result in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. Information about lot/batch cannot be obtained.


VAERS ID: 1491295 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-06-07
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021848082

Write-up: Early miscarriage; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021083953. A 32-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 13May2021 (Batch/Lot Number: FA5831), dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 07Jun2021, day 25 of the first dose, the patient had an early miscarriage in the 1st trimester of pregnancy. The patient had a gynecologist consultation but it did not involve any surgical or drug treatment. The outcome of the event was recovered. The pregnancy resulted in spontaneous abortion. The fetal outcome is neonatal death. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1714579 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: D & C; Lactation decreased; Miscarriage
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: Ultrasound scan; Test Result: Inconclusive ; Result Unstructured Data: Transvaginal ultrasound-results unknown
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Miscarriage; Menstrual cycle abnormal; This case was initially received via Regulatory Authority (Reference number: GB-MHRA-ADR 25576495) on 02-Jul-2021. The most recent information was received on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) and MENSTRUAL DISORDER (Menstrual cycle abnormal) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased, Miscarriage in February 2020, Miscarriage in March 2021, D & C in May 2020, D & C in September 2020 and D & C in March 2021. On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced MENSTRUAL DISORDER (Menstrual cycle abnormal) (seriousness criterion medically significant). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and MENSTRUAL DISORDER (Menstrual cycle abnormal) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Ultrasound scan: inconclusive (Inconclusive) Transvaginal ultrasound-results unknown. No treatment medication was provided. No concomitant medication was provided Patient reported that she was due for her periods when she took vaccination, and did not get her periods. Patient consulted fertility specialist. Laboratory data of the patient included, blood hormone tests, with results not specified. This case concerns a 31-year-old, female patient with a medical history of previous miscarriage, intentional abortions and decreased lactation who experienced the unexpected events of menstrual disorder and abortion spontaneous. Menstrual disorder occurred on the same date as the first dose of mRNA-1273 and the abortion spontaneous occurred on an unspecified date. The medical history of miscarriage remains a confounder.The benefit-risk relationship of drug x in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow Up information was received on 12-Sep-2021 contains significant information, action taken of the drug , dose text , indication for use , lab data updated.


VAERS ID: 1381752 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-06-01
Onset:2021-06-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 2 LA / IM

Administered by: Other       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? 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, progesterone, estrogen.
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Scheduled DNC procedure and subsequent testing to follow.
CDC Split Type:

Write-up: I was 5 weeks pregnant for my first shot and 8.5 weeks pregnant for my second. I found out I was pregnant with twins the week after my first shot at 6 weeks pregnant, but on the day of my second shot, a prenatal ultrasound found no fetal heartbeats in either fetus and determined pregnancy loss.


VAERS ID: 1385852 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-08
Onset:2021-06-08
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 AR / IM

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

Life Threatening? No
Birth Defect? 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: synthroid, prenatal vitamins
Current Illness: none
Preexisting Conditions: hypothyroid
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: patient was found to have miscarriage on 6/8/21. Received dose 2 of vaccine at 3 weeks 5 days gestation


VAERS ID: 1458466 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-30
Onset:2021-06-08
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0258 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Abortion spontaneous, Blood test, Exposure during pregnancy, Foetal death, Haemorrhage, Near death experience, Prenatal screening test, Ultrasound foetal abnormal, Uterine dilation and curettage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Fluoxetine Zyrtec Montelukast
Current Illness: None
Preexisting Conditions: None
Allergies: Penicillin, Amoxicillin, Keflex Peanuts, treenuts, sesame, soy, cucumber
Diagnostic Lab Data: May 13, 2021: Prenatal genetic blood testing Results: Normal/healthy May 27, 2021: Prenatal genetic ultrasound screening Results: Normal/healthy June 24, 2021: Blood work up/ultrasound Result: fetus deceased, miscarriage
CDC Split Type:

Write-up: Pregnancy history: 3 full term LIVE pregnancies No previous miscarriages Due date was December 7th, 2021 Genetic/chromosomal blood testing was performed at 10 weeks and 2 days gestation on May 13, 2021: confirmed gender was male and everything was normal and healthy. Ultrasounds were performed both at 9 weeks gestation and at 13 weeks gestation (genetic/chromosomal screening) and everything was normal and healthy. On June 24th (16 weeks 3 days): was seen in ER due to upper abdominal pain. Was diagnosed with a miscarriage that occurred around 14 weeks gestation. Procesure (D&E) to remove fetus took place June 29, 2021. I lost over 3 pounds of blood and almost died following procedure.


VAERS ID: 1483954 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-16
Onset:2021-06-08
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Delivery, Exposure during pregnancy, Haemorrhage, Stillbirth, Thrombosis, Ultrasound antenatal screen
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (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: none
Current Illness: unknown
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: 30 year old female pregnant with EDC 12/12/21. Prenatal lab work detected no chromosomal anomalies. Pt had 3 prior uncomplicated term pregnancies. Pt began bleeding at 12.3 weeks pregnant and went to hospital. Pt passing copious amounts of blood clots. Fetus with heartbeat detected on ultrasound prior to spontaneous vaginal delivery of deceased male fetus.


VAERS ID: 1505681 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-06-04
Onset:2021-06-08
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

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

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

Write-up: Miscarriage; No heartbeat observed at 10 week checkup on 6/8/21


VAERS ID: 1679290 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-03
Onset:2021-06-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Bacterial infection, Biopsy placenta, Cervical dilatation, Exposure during pregnancy, Heavy menstrual bleeding, Premature delivery, Retained placenta or membranes, Twin pregnancy, Uterine contractions during pregnancy, Uterine dilation and curettage, Vaginal haemorrhage, White blood cell count increased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Progesterone suppository, 1.5 baby aspirins, prenatal multi vitamin, EFA supplement, zyrtec as needed, rhinocort as needed, tylenol as needed.
Current Illness: n/a
Preexisting Conditions: Prone to headaches and migraines
Allergies: Lactose intolerant, sensitive to walnuts, seasonal allergies (trees, grass, dander, etc)
Diagnostic Lab Data: The placenta pathology later indicated that there was a bacterial infection starting in Baby B''s placenta. When they drew my blood on June 8th my white blood cell count was high, which they said suggested the infection was starting to enter my bloodstream.
CDC Split Type:

Write-up: I was 19wks 5 days pregnant with twins when I started bleeding on June 8th in the morning. I''d been having Braxton Hicks/mild contractions starting on Saturday 6/5, two days after the vaccine. Around 5p on June 8th a gush of blood and a clot came out of my vagina, so I went to the ER. My cervix was closed and long when I got to the hospital but while I was there, maybe around 9p or 9:30p, my cervix dilated and they brought me Labor and Delivery. I gave birth on June 9th around 1am came about 30mins later. Both twins were born alive and appeared otherwise healthy but they died after birth as they were only measuring 20wks gestation. Their 40wk due date would have been October 28th, 2021. I gave birth to a son on July 21, 2020 at 22wks gestation after a placenta abruption. I had a miscarriage at 8wks on January 20th, 2020. I gave birth to a healthy daughter at 36wks 6wks gestation on 10/28/2018. Then on August 1st 2021, I started bleeding heavily and went to the ER. They found tissue stuck in my uterus so I had a D&C done. Pathology later confirmed that it had been products of conception still stuck in my uterus, so presumably placenta tissue.


VAERS ID: 1858782 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-01-09
Onset:2021-06-08
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011L20A / 1 RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 029L20A / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: FIRST TRIMESTER MISCARRIAGE CONFIRMED POST VACCINE BY ULTRASOUND AND BETA HCG. Patient is recovering from physical and emotional trauma. Will continue to follow.
CDC Split Type:

Write-up: LMP 3/28/21 miscarriage in first trimester post vaccine


VAERS ID: 1432637 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-06-08
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Maternal exposure during pregnancy; Miscarriage; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 35-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002537) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jun-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, ABORTION SPONTANEOUS (Miscarriage) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Concomitant product use was not provided by the reporter. Patient reported COVID-19 vaccine exposure during pregnancy week 0. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. This is a case of product exposure during pregnancy and abortion for this 35-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; Sender''s Comments: This is a case of product exposure during pregnancy and abortion for this 35-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded


VAERS ID: 1461505 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-10
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: CYCLOGEST; ESTRADOT
Current Illness:
Preexisting Conditions: Comments: No medical history provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20212

Write-up: Miscarriage; Vaccine exposure during pregnancy; This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 39-year-old female patient (gravida 1) who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history provided. Concomitant products included PROGESTERONE (CYCLOGEST) from 18-May-2021 to an unknown date and ESTRADIOL (ESTRADOT) from 06-May-2021 to an unknown date for an unknown indication. On 08-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) (seriousness criterion medically significant). On 11-Jun-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred on 11-Jun-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Treatment information was not provided. Company Comment: This is a case of product exposure during pregnancy with associated AE of Spontaneous abortion for this 39-year-old female. No further information is expected.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AE of Spontaneous abortion for this 39-year-old female. No further information is expected.


VAERS ID: 1462441 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-06-08
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-07-11
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID; IBUPROFEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Penicillin allergy; Period pains (Indication of IBUPROFEN and PARACETAMOL); Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: scans; Result Unstructured Data: Test Result:miscarriage; Comments: Pregnancy of unknown location at 6 weeks followed by miscarriage
CDC Split Type: GBPFIZER INC2021784459

Write-up: Maternal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106241100597240-BV8TN. Safety Report Unique Identifier GB-MHRA-ADR 25533766. This consumer reported information for both mother and fetus/baby. This is a mother report. A 35-years-old female (pregnant and not currently breastfeeding) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW4109), via an unspecified route of administration on 14May2021 as first dose, single for COVID-19 immunization. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. The patient was unsure, medicine have an adverse effect on any aspect of the pregnancy. Medical history included pregnancy (Patient no longer pregnant at the time of reporting), folic acid supplementation, dysmenorrhoea (Indication of IBUPROFEN and PARACETAMOL). Patient was allergic to penicillin. Concomitant medication(s) included folic acid, 400 ug taken for vitamin supplementation; ibuprofen taken for dysmenorrhoea; paracetamol taken for dysmenorrhoea. It was reported that on an unspecified date, the patient experienced maternal exposure during pregnancy, On 08Jun2021, the patient experienced miscarriage. The mother reported she became pregnant while taking bnt162b2. Patient was exposed to the medicine first-trimester (1-12 weeks). On unspecified date, the patient underwent lab tests and procedures which included scan: Miscarriage, pregnancy of unknown location at 6 weeks followed by miscarriage. Patient had not tested positive for COVID-19 since having the vaccine. It was unsure if the medicine had an adverse effect on any aspect of the pregnancy. No particular suspicion about a link however reporting in case it helps a pattern emerge. The outcome of event for maternal exposure during pregnancy was unknown and miscarriage was not recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021815143 For baby case;GB-PFIZER INC-2021815143 For mother case


VAERS ID: 1517795 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-08
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Premature delivery, Premature labour
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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021898914

Write-up: delivery 5 weeks prior to estimated birth; one week after the vaccine the labour started to initiate; mother was 33 Weeks pregnant at the onset of the event. The mother was due to deliver on 16Jul2021.; This is a spontaneous report from a contactable consumer reporting about herself. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 28-years-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot No: EX8680), via an unspecified route of administration, administered in Arm Right on 31May2021 16:00 (at the age of 28-year-old)as 1stdose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced delivery 5 weeks prior to estimated birth, one week after the vaccine the labor started to initiate on 08Jun2021 (at 12:00). The patient was hospitalized for delivery 5 weeks prior to estimated birth (premature delivery) for 7 days. The patient was hospitalized for one week after the vaccine the labor started to initiate (premature labor) for 7 days. The mother reported she became pregnant while taking BNT162b2.The mother was 33 Weeks pregnant at the onset of the event. The mother was due to deliver on 16Jul2021. The mother delivered the pregnancy on 12Jun2021. The baby was delivered premature. Therapeutic measures were taken as a result of delivery 5 weeks prior to estimated birth, one week after the vaccine the labor started to initiate. The event required visit to physician office/Emergency room. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.Outcome of the events was resolved.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-2021899332 Mother/fetus case


VAERS ID: 1521702 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-06-08
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Extensive swelling of vaccinated limb
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100921555

Write-up: Miscarriage; Extensive swelling of vaccinated limb; This is a spontaneous report from a contactable consumer (patient) downloaded from the WEB NL-LRB-00623493. A 28-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03May2021 (Lot number was not reported) as 0.3ml single for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced miscarriage and extensive swelling of vaccinated limb on unknown date. The patient hospitalized due to event miscarriage. The patient was vaccinated at a pregnancy duration of 26 weeks. Approximately 1 month later, the fetus got no heart rate anymore. Miscarriage seems clear enough explained. The outcome of events was unknown. The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1527937 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-06-08
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Foetal exposure during pregnancy, Foetal heart rate 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? Yes
   Date died: 2021-06-08
   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: NLPFIZER INC202100956326

Write-up: Covid-19 vaccine exposure during pregnancy week 26 weeks; Miscarriage; approximately 1 month later the foetus got no heart rate anymore; This is a spontaneous report splitted from master case, which was received from a contactable consumer (parent) or other non hcp downloaded from the Regulatory Authority . This consumer or other non hcp reported information for both mother and foetus/baby. This is the second of two reports. This is a foetus report. A foetus patient of an unspecified gender received BNT162b2 (COMIRNATY, solution for injection, Lot Number: Unknown), via transplacental route on 03May2021 as dose number unknown, 0.3ml single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 08Jun2021, the patient''s mother experienced miscarriage, the patient''s mother was vaccinated at a pregnancy duration of 26 weeks, approximately 1 month later, the foetus got no heart rate anymore, covid-19 vaccine exposure during pregnancy week: 26 weeks. The patient died due to miscarriage on 08Jun2021, and autopsy details was unknown.; Reported Cause(s) of Death: Approximately 1 month later, the fetus got no heart rate anymore; Miscarriage


VAERS ID: 1585077 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-08
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002184 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cholestasis of pregnancy, Maternal exposure during pregnancy, Premature delivery, SARS-CoV-2 test
SMQs:, Pregnancy-related hepatic disorders (narrow), Biliary tract disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201218; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Premature delivery; Cholestasis of pregnancy; maternal exposure during pregnancy; This case was received via Agency (Reference number: NT20213114) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority prospective pregnancy case was reported by a physician and describes the occurrence of CHOLESTASIS OF PREGNANCY (Cholestasis of pregnancy) and PREMATURE DELIVERY (Premature delivery) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3002184) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jun-2021, the patient experienced CHOLESTASIS OF PREGNANCY (Cholestasis of pregnancy) (seriousness criteria hospitalization and medically significant). On 26-Jun-2021, the patient experienced PREMATURE DELIVERY (Premature delivery) (seriousness criterion hospitalization). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). At the time of the report, CHOLESTASIS OF PREGNANCY (Cholestasis of pregnancy) and PREMATURE DELIVERY (Premature delivery) had resolved and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Intramuscular) was unknown. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. No concomitant product use was provided by the reporter. No treatment medication was provided. Company comment: This is a case of product exposure during pregnancy with associated AEs for this 35-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AEs for this 35-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1642656 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Body temperature, Chills, Fatigue, Fibrin D dimer, Headache, Malaise, Maternal exposure before pregnancy, Myalgia, Nausea, Petechiae, Platelet count, Pregnancy test, Pyrexia, Thrombocytopenia, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor; Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 1); Suspected COVID-19 (disease symptoms: quite)
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Test Name: fibrin d dimer; Result Unstructured Data: Test Result:normal; Test Date: 20210713; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:241 x10 9/l; Test Date: 20210701; Test Name: pregnancy test; Test Result: Positive
CDC Split Type: NLPFIZER INC202101062355

Write-up: Vaccination just before conception (1 week of pregnancy); Early miscarriage (5 weeks after last period) on 02Jul; had vaccination 08Jun; Thrombocytopenia after 1st and 2nd vaccination (09Jun); Generalized joint pain; Myalgia; Reaction at or around the injection site: redness; Inflammatory reaction at the reaction site: redness, warmth, pain; Reaction at or around the injection site: pain; Fever: 38 to 40.5 degrees Celsius; Reaction at or around the injection site: itching; Cold shivers; Reaction at or around the injection site: heat; Red spots (point bleeds) on entire body including fingertips. E.g. worse after measuring blood pressure; Nausea; Headache; Fatigue; Not feeling well; This is a spontaneous report from a contactable consumer or other non healthcare professional downloaded from the RA, regulatory authority number NL-LRB-00657538. This consumer or other non healthcare professional reported information for both mother and fetus/baby. This is a maternal report. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 08Jun2021 (Batch/Lot Number: FC3143) as Dose 2, single for covid-19 immunisation. Medical history included disease risk factor from an unknown date, suspected covid-19 from 18Feb2020 to an unknown date disease symptoms: quite, maternal exposure timing unspecified from an unknown date (COVID-19 vaccine exposure during pregnancy week: 1). The patient''s concomitant medications were not reported. Historical vaccination included first dose of Comirnaty on 04May2021 for covid-19 immunization for which the patient experienced fever, petechia, thrombocytopenia, and feeling unwell. Historical vaccination also included flu vaccine on an unspecified date. The patient experienced early miscarriage (5 weeks after last period) on 02jul; had vaccination 08jun on 02Jul2021 with outcome of unknown, thrombocytopenia after 1st and 2nd vaccination (09jun) on 09Jun2021 with outcome of unknown, generalized joint pain on 09Jun2021 with outcome of recovered on 10Jun2021, myalgia on 09Jun2021 with outcome of recovered on 10Jun2021, reaction at or around the injection site: redness on 09Jun2021 with outcome of recovered on 10Jul2021, not feeling well on 08Jun2021 with outcome of recovered on 11Jun2021, inflammatory reaction at the reaction site: redness, warmth, pain on 09Jun2021 with outcome of recovered on 10Jul2021, fatigue on 08Jun2021 with outcome of recovered on 12Jun2021, reaction at or around the injection site: pain on 09Jun2021 with outcome of recovered on 10Jul2021, fever: 38 to 40.5 degrees celsius on 09Jun2021 with outcome of recovered on 10Jun2021, reaction at or around the injection site: itching on 09Jun2021 with outcome of recovered on 10Jul2021, cold shivers on 09Jun2021 with outcome of recovered on 10Jun2021, reaction at or around the injection site: heat on 09Jun2021 with outcome of recovered on 10Jul2021, red spots (point bleeds) on entire body including fingertips. e.g. worse after measuring blood pressure on 09Jun2021 with outcome of recovered on 09Jun2021, nausea on 09Jun2021 with outcome of recovered on 17Jun2021, headache on 09Jun2021 with outcome of recovered on 10Jun2021, vaccination just before conception (1 week of pregnancy) on an unspecified date with outcome of unknown. The mother reported she became pregnant while taking bnt162b2. The mother was 5 Weeks pregnant at the onset of the event. The mother was pregnant with 1 baby(s). The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included body temperature: 38 to 40.5 centigrade on 09Jun2021, fibrin d dimer: normal on n unspecified date, platelet count: 241 x10 9/l on 13Jul2021, pregnancy test: positive on 01Jul2021. Chills is treated with Paracetamol 1g every 6h. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Summary of reporter comment: information about 1st dose, current ADRs, medical history, previous COVID-19 infection and diagnostic procedures; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101096417 1st/2nd dose;NL-PFIZER INC-202101062298 Pfizer


VAERS ID: 1760846 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-08
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation delayed, Taste disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Taste and smell disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Menorrhagia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101252706

Write-up: Late period; Chemical pregnancy; Heavy periods; Miscarriage; Menorrhagia; Last period was horrifically painful; This is a spontaneous report from a contactable consumer (patient) or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109210922562770-LNKAI, Safety Report Unique Identifier GB-MHRA-ADR 25973437. A 43-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Er1741, Expiration date was not reported), via an unspecified route of administration on 20May2021 as dose 2, single for covid-19 immunization. Medical history included menorrhagia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date in 2021, the patient experienced chemical pregnancy, heavy periods, miscarriage, menorrhagia, last period was horrifically painful and on 08Jun2021 patient had late period. She only had 3 periods since having her second COVID (Pfizer) jab in May 2021. She had no period for 35 days, 37 days and then the last cycle was 46 days. This last period was horrifically painful. She suffers from very heavy periods anyway and this was by far the worst. Completely debilitating for 4 days. She had menorrhagia and usually have a very regular 26-27-day cycle. She also had a chemical pregnancy 2 weeks before her second jab so she was not sure if that would also have had an effect on her cycle. Something feels very off, and she put it down to the miscarriage, but having read about the thousands of other women she thought it could be from the jab. She went to the doctor on 27Aug21 who said everything looked normal but would send me for an ultrasound. She was still waiting for the letter to book an appointment nearly a month later. The reporter considered the events as serious (medically significant). The outcome of events chemical pregnancy, heavy periods, miscarriage, menorrhagia was resolved on an unspecified date in 2021, outcome of event late period was not recovered, and outcome of event last period was horrifically painful was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1486837 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-21
Onset:2021-06-09
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarriage


VAERS ID: 1760449 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-05-02
Onset:2021-06-09
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Caesarean section, Exposure during pregnancy, Hypertension, Pre-eclampsia, Premature delivery, Protein urine
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Proteinuria (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: Prenatal vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: Amoxicillin
Diagnostic Lab Data: High blood pressure - 6/9/21 Protein in urine - 6/9/21
CDC Split Type:

Write-up: At 34 weeks, 4 days pregnant I was diagnosed with preeclampsia. As a result I had to deliver early at 34 weeks, 5 days via emergency csection. My son was born 5 weeks and 2 days early at 4 pounds, 8 ounces on 6/10/21.


VAERS ID: 1448671 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-06-09
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Abortion spontaneous, Heavy menstrual bleeding, Maternal exposure during pregnancy, Pregnancy test, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), 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; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: Pregnancy test; Test Result: Positive ; Result Unstructured Data: On day 9 of bleeding pregnancy test that came out strong positive.; Test Name: Pregnancy test; Test Result: Negative ; Result Unstructured Data: On day 10 bleeding stopped, pregnancy test was negative.; Test Date: 20210611; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Miscarriage; Maternal exposure during pregnancy; stomach cramps; Bleeding menstrual heavy; This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 38-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 and Lactation decreased. Concomitant products included FOLIC ACID for an unknown indication. On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Bleeding menstrual heavy). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and ABDOMINAL PAIN UPPER (stomach cramps). On 20-Jun-2021, HEAVY MENSTRUAL BLEEDING (Bleeding menstrual heavy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and ABDOMINAL PAIN UPPER (stomach cramps) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Pregnancy test: positive (Positive) On day 9 of bleeding pregnancy test that came out strong positive. and negative (Negative) On day 10 bleeding stopped, pregnancy test was negative.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. After the covid vaccine patient had periods five days later. On 9th day of bleeding pregnancy test shows positive and on 10th bleeding stopped and on pregnancy test it shows negative. Patient was pregnant previously via IVA and miscarriage occurred within 12 weeks with no bleeding. Treatment information was not provided. Based on current available information and the temporal association between product use and the start date of the events the company believes a causal relationship is unlikely.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the events the company believes a causal relationship is unlikely.


VAERS ID: 1457785 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-09
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Drug allergy; Elective abortion (3 abortions when she was between 17 and 20 years old); Pregnancy (a 6-year-old child)
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: blood test; Result Unstructured Data: Test Result:confirmed pregnancy; Test Date: 20210607; Test Name: pregnancy test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021758642

Write-up: Abortion spontaneous/early miscarriage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is FR-AFSSAPS-2021076425 with Safety Report Unique Identifier FR-AFSSAPS-2021077197. A 39-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), intramuscular, administered in the left arm, on 05Jun2021 (Batch/Lot Number: FC3143), as dose 1, 0.3 ml single, for COVID-19 immunisation. The patient was pregnant at the time of vaccination. Gestation period at exposure was 4 weeks. Medical history included drug allergy from an unknown date, COVID-19 in Mar2020, elective abortion (3 abortions when she was between 17 and 20 years old) on an unknown date, and pregnancy carried to term (6-year-old child) on an unknown date. The patient''s concomitant medications were not reported. The patient experienced abortion spontaneous/early miscarriage on 09Jun2021 (at the 5th amenorrhea week, did not know she was pregnant at the time of vaccination). The patient was 5 weeks pregnant at the onset of the event. The patient desired pregnancy and did not speak to the vaccinating doctor. The patient was due to deliver on 08Feb2022. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests which included pregnancy test: positive and blood test: confirmed pregnancy both on 07Jun2021 (discovery of the pregnancy on 07Jun2021: pregnancy test + and confirmation by blood test). The outcome of the event was recovered with sequel. The health authority assessed the event as serious (medically significant). No follow-up attempts possible. No further information expected.


VAERS ID: 1464925 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 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: GBPFIZER INC2021787273

Write-up: miscarriage/ Pregnancy loss; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is [GB-MHRA-WEBCOVID-202106250921322240-SCSMF], Safety Report Unique Identifier [GB-MHRA-ADR 25542187]. A 30-year-old female patient received first does of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Lot Number: EW3143) via unspecified route single dose for COVID-19 immunisation on 06Jun2021. Medical history included pregnancy. Patient was no longer pregnant at the time of reporting. Concomitant medication included folic acid for vitamin supplementation. The patient experienced miscarriage/ pregnancy loss on 09Jun2021 with outcome of unknown. This was patient first miscarriage, 2 healthy pregnancies prior to this one. Patient was exposed to the vaccine in first trimester (1-12 weeks). No follow-up required. No further information is expected.


VAERS ID: 1755043 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Cytokine test, Granuloma annulare, 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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: Blood cytokine test; Result Unstructured Data: Test Result:IL-10s were at 60; Comments: Cytokines and the IL-10s were at 60 when they should be no more than 30 max; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226966

Write-up: miscarriage; Blood cytokine test; Granuloma annulare; This is a spontaneous report from a contactable consumer received from the regulatory authority report number GB-MHRA-WEBCOVID-202109182308042600-IAGSW, Safety Report Unique Identifier GB-MHRA-ADR 25965270. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported), via an unspecified route of administration at single dose on 08Jun2021 for COVID-19 immunization. Medical history included endometriosis from an unknown date, pregnancy from an unknown date (Patient no longer pregnant at the time of reporting), and Folic acid supplementation from an unknown date. Concomitant medication included folic acid (FOLIC ACID) taken for Folic acid supplementation, start and stop date were not reported. The patient experienced miscarriage on an unspecified date with outcome of unknown, granuloma annulare on 09Jun2021 with outcome of not recovered, and of Blood cytokine test on 09Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included cytokine test: il-10s were at 60 when they should be no more than 30 max on an unspecified date, and sars-cov-2 test: negative on an unspecified date. Details were reported as follows: Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. She is having IVF. She had the first vaccine two weeks ahead of her embryo transfer. A day after the vaccine a granuloma annular appeared on her foot (diagnosed by dr). She then miscarried. She had a blood test to test her Cytokines and the IL-10s were at 60 when they should be no more than 30 max. Doctor was of the opinion this level of cytokines could be the cause of my miscarriage as he had never seen such a high score. He also said that as she reacted with an granuloma annular this was likely the reason for my test results. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1392838 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-24
Onset:2021-06-10
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: Synthroid 75 mcg Cytomel 10 mcg
Current Illness: None
Preexisting Conditions: Hashimotos
Allergies: Amoxicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarriage at 6 werks


VAERS ID: 1397052 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-02-19
Onset:2021-06-10
   Days after vaccination:111
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9266 / 2 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ritual prenatal vitamins
Current Illness: NA
Preexisting Conditions: Obesity
Allergies: Latex, codeine, clindamycin, lactose, peanut
Diagnostic Lab Data: Ultrasound 06/09/21 Labs to check progesterone approx. every week to 2 weeks
CDC Split Type:

Write-up: LMP: 01/11/21 EDD: 11/14/21 Fetal demise at 14 weeks 5 days (by ultrasound) Delivery: 06/10/21 Birthweight: 1oz Low progesterone through out pregnancy, progesterone supplements were prescribed


VAERS ID: 1412832 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-13
Onset:2021-06-10
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 035021A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound scan vagina
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: pre-natal vitamins, benadryl (50 mg)
Current Illness: Cold
Preexisting Conditions: Sjogren''s syndrom, POTS/dysautonomia
Allergies: None
Diagnostic Lab Data: transvaginal ultrasound diagnosed the miscarriage.
CDC Split Type:

Write-up: I have no reason to think this was caused by the vaccine but a lady from the CDC that called me asked me to file a report. I found out less than a week after my second vaccine dose that I was pregnant. At the time of the vaccine I was probably 3.5 weeks pregnant, but I didn''t know yet. At my first pre-natal appointment, on 6/17/2021 I found out that I was having a miscarriage. The fetus had stopped growing about a week earlier at 7.5 weeks (around 6/10/2021) and had no heartbeat. There''s no known cause for the miscarriage and I have not yet actually passed the fetus, so I''m still in the process of miscarrying. It was a missed miscarriage.


VAERS ID: 1686250 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-19
Onset:2021-06-10
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

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

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

Write-up: Miscarriage. Menstrual cycle has yet to resume.


VAERS ID: 1711699 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-25
Onset:2021-06-10
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER 1143165 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Pain, Pregnancy test, Pregnancy test urine, Ultrasound biliary tract
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: HUMAN CHORIONIC GONADOTROPIN; SINGULAIR; LATUDA; WELLBUTRIN; METOPROLOL; PROGESTERONE; OVIDREL [CHORIONIC GONADOTROPHIN]; LETROZOLE; VITAMIN D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Asthma; Bipolar disorder; Blood pressure high; Liposuction; Non-tobacco user; Obesity; Polycystic ovarian syndrome; Psoriatic arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: PREGNANCY TEST BY BLOOD; Test Result: Positive ; Test Date: 20210601; Test Name: HOME PREGNANCY TEST; Test Result: Positive ; Test Date: 202104; Test Name: GALL BLADDER ULTRASOUND; Result Unstructured Data: Test Result:Gall bladder stones were seen; Comments: Gall bladder stones were seen
CDC Split Type: USPFIZER INC202101151757

Write-up: Miscarriage; Pain/soreness; This is a solicited report based on the information received by Pfizer (manufacturer control number: 21K-163-4056010-00). A contactable consumer (patient) reported that a pregnant 32-year-old female patient received bnt162b2 (BNT162B2), dose 1 via intramuscular on 25May2021 (Lot Number: EW0183; Expiration Date: Aug2021) (at the age of 32-year-old) as single dose for covid-19 immunisation and adalimumab (HUMIRA, Solution for injection in pre-filled syringe), via subcutaneous from an unspecified date to 2021 (Lot Number: 1143165), at 40 mg, weekly for plaque psoriasis, psoriatic arthritis. The patient had a relevant medical history of weight loss surgery from 25Sep2019, polycystic ovary syndrome, obesity, Psoriatic arthritis, Asthma, high blood pressure and Bipolar. The patient was Alcohol use and Non-tobacco user. The family medical history of high blood pressure on maternal side, family medical history of endometrial cancer on maternal side and family medical history of diabetes on maternal side. Concomitant medications included human chorionic gonadotropin taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for asthma, start and stop date were not reported; lurasidone hydrochloride (LATUDA) taken for bipolar, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for bipolar, start and stop date were not reported; metoprolol taken for high blood pressure, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported; chorionic gonadotrophin (OVIDREL) taken for an unspecified indication, start and stop date were not reported; letrozole taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for supplementation therapy, start and stop date were not reported. The patient had other concomitant therapy of Prenatal Multivitamins. The patient previously took ciprofloxacin (CIPRO) and experienced itchiness, ciprofloxacin lactate (CIPRODEX) and experienced ear itchiness, hydrocodone bitartrate; paracetamol (VICODIN) and experienced hallucination and paranoia, naloxone hydrochloride (NARCAN) and experienced hallucination and paranoia. The patient previously took adalimumab (HUMIRA), via subcutaneous from Nov2020 (Batch/Lot Number: 1143165) to 2021, at 40 mg, weekly for plaque psoriasis, psoriatic arthritis and experienced Gallbladder stone in Apr2021 and Weight gain in 2020. In 2021, the patient experienced soreness. On an unknown date, the patient experienced maternal exposure during pregnancy. On 10Jun2021, the patient experienced miscarriage. BNT162b2 was also considered suspect. On 01Jun2021, the pregnancy was confirmed via home pregnancy test and pregnancy test by blood. Last menstrual period (LMP) was 03May2021. It was her first pregnancy after starting on HUMIRA. The fetus was exposed to maternal use of HUMIRA in utero. The estimated date of delivery (EDD) was 07Feb2022. On 10Jun2021, the fetus died. She was off of HUMIRA for three weeks when she had the miscarriage because of a recent gall bladder surgery as of 02Sep2021. The alternative etiology of the reporter for miscarriage was COVID 19 vaccine. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 25May2021, she received first dose COVID-19 Vaccine manufactured by Pfizer. In Jun2021, she received second dose COVID-19 Vaccine manufactured by Pfizer via intramuscular. The patient underwent lab tests and procedures which included pregnancy test by blood: positive on 01Jun2021, home pregnancy test: positive on 01Jun2021, gall bladder ultrasound: gall bladder stones were seen in Apr2021. The action taken in response to the events for adalimumab was Post-Therapy and therapy ongoing from 10Jun2021, at 40 mg, weekly. The outcome of the event pain/soreness was recovered in 2021, the outcome of the event Miscarriage was unknown. The reporter''s causality for the event(s) of miscarriage with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter''s causality for the event(s) of gall bladder surgery and maternal exposure during pregnancy was not provided. AbbVie''s opinion is that there is no reasonable possibility that the events of miscarriage, gall bladder surgery and maternal exposure during pregnancy are related to HUMIRA(ADALIMUMAB). The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal association, the reported event Abortion spontaneous and Pain is possibly related to BNT162B2.


VAERS ID: 1457990 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-10
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Parity (1x child at 39+1); Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Test Result: Positive ; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021773659

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number -MHRA-WEBCOVID-202106211529225020-5SLPZ. Safety Report Unique Identifier -MHRA-ADR 25511954. A 35-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot# ET8885, via an unspecified route of administration on 03Jun2021 as single dose for COVID-19 immunisation. Medical history included suppressed lactation, pregnancy, and "1x child at 39+1". Concomitant medication included folic acid taken for vitamin supplementation. The patient was 8 weeks pregnant at the onset of the event. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient experienced miscarriage on 10Jun2021. 10 days after a positive pregnancy test she started bleeding heavily again. She was unsure whether this was a period, still part of the miscarriage but "the dates don''t add up". The patient underwent lab tests and procedures which included pregnancy test: positive, sars-cov-2 test: negative. The outcome of the event was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1459378 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-06-10
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNK / 1 - / OT

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

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

Write-up: This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter once a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Jun-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant). The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. On 11-Jun-2021, ABORTION SPONTANEOUS had resolved with sequelae. No concomitant medication provided. No treatment information mentioned. Action taken with mRNA-1273 in response to the event was not applicable. Company comment: Very limited information regarding this event has been provided at this time. Further information regarding LMP, medical history and concomitant medications are required for further assessment.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information regarding LMP, medical history and concomitant medications are required for further assessment.


VAERS ID: 1485587 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Miscarriage; Exposure during Pregnancy; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Jun-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during Pregnancy). On 01-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria hospitalization and medically significant). The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Unknown. On 10-Jun-2021, EXPOSURE DURING PREGNANCY (Exposure during Pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. This report refers to a case of Maternal exposure to mRNA -1273 during pregnancy with reported Serious Adverse event. There is very limited information regarding this event that has been provided at this time. No further information is expected at this time.; Sender''s Comments: This report refers to a case of Maternal exposure to mRNA -1273 during pregnancy with reported Serious Adverse event. There is very limited information regarding this event that has been provided at this time. No further information is expected at this time.


VAERS ID: 1499412 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-10
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERAZETTE [DESOGESTREL]; FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: UPT; Test Result: Positive
CDC Split Type: GBPFIZER INC2021869446

Write-up: Maternal exposure during pregnancy, Miscarriage / passing clots/ heavy bleed; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107071400021180-I529E, Safety Report Unique Identifier is GB-MHRA-ADR 25616012. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW3143), dose 1, via an unspecified route of administration on 05Jun2021 at single dose for COVID-19 immunisation. Medical history included pregnancy (not ongoing, patient no longer pregnant at the time of reporting), contraception. Unsure if patient had had symptoms associated with COVID-19. The patient had not had a COVID-19 test. Unsure if patient was enrolled in clinical trial. The patient was not currently breastfeeding. Concomitant medication(s) included desogestrel (CERAZETTE [DESOGESTREL]) was taken for contraception from 01Oct2020 to 06May2021; folic acid (FOLIC ACID) was taken for an unspecified indication, start and stop date were not reported. The last date of menstrual period was 01May2021. The patient was not aware that she was pregnant (unplanned pregnancy) and had the vaccine on 05Jun2021. The patient was exposed to the vaccine during first-trimester (1-12 weeks). Then on 10Jun2021, she had passing clots/ heavy bleed. Pregnancy test (Urine Pregnancy Test, UPT) showed positive (unspecified date in Jun2021). The patient had miscarriage on 10Jun2021. The patient was not taking folic acid supplement during pregnancy. The outcome of miscarriage was reported as "recovered" with stop date of 15Jun2021. Patient had not tested positive for COVID-19 since having the vaccine. The reporter considered the vaccine had an adverse effect on the pregnancy - miscarriage. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1499585 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2245 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Headache, Heavy menstrual bleeding, Hypothyroidism, Intermenstrual bleeding, Menstruation delayed, Muscle spasms, SARS-CoV-2 test, Somnolence
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypothyroidism (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021869856

Write-up: cramping; underactive thyroid; when suffered an early miscarriage; heavier than usual; falling asleep at 7pm; headache; so tired; bizarre spotting; Delayed period; Fatigue; This is a spontaneous report from a contactable other-Health Care Professional. This is a report received from the Regulatory Agency (RA). The Regulatory authority report number is (GB-MHRA-WEBCOVID-202107081013321110-XYZAG) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25618384). A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW2245) via an unspecified route of administration on 10Jun2021 as a dose 1, single for COVID-19 immunization. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. The patient''s medical history included suppressed lactation and abortion spontaneous (from an unknown date and unknown if ongoing). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced cramping a underactive thyroid, when suffered an early miscarriage, heavier than usual, headache, so tired and falling asleep at 7pm. On 10Jun2021, she developed fatigue. On 19Jun2021, she had delayed period. On 29Jun2021, she found bizarre spotting. The patient stated that her periods are never delayed and it was always at 28 days. The only time she ever had a period that was delayed such as this, was when she suffered an early miscarriage (She was not currently sexually active so this was not a possibility). She was not stressed about Covid or about taking the vaccine. She took her vaccine after ovulation (chart cycles) and her luteal phase was 14 days. She was due to have a period on the 19Jun but it did not arrive, nor did I have any cramping to indicate its imminence. She then started to have bizarre spotting on the 29Jun of very dark, almost black blood. When her period arrived it was very slow to begin and very dark for several days. It was no heavier than usual, nor did it last longer than usual (7days). Her concern was the delay to her period. I know my body very well and this was worrying for me. Her second reaction was incredible fatigue since having the jab. She felt asleep at 7pm with her children and having headaches (She don''t typically suffer with these). She found it difficult to do her job as a parent due to being so tired. She was not deficient in iron or have an underactive thyroid. The outcome of the event delayed period was recovered on 30Jun2021. The outcome of the events cramping and underactive thyroid was recovering. The outcome of the event fatigue was not recovered. The outcome of the events when suffered an early miscarriage, bizarre spotting, heavier than usual, headache, so tired and falling asleep at 7pm was unknown. No follow-up attempts are possible; No further information expected.


VAERS ID: 1517007 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8289 / 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: 2021-07-19
   Days after onset: 39
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FLUOXETINE; FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Folic acid supplementation; Pregnancy (2 previous successful pregnancies carried to full term)
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:all fine
CDC Split Type: GBPFIZER INC202100934473

Write-up: Late miscarriage; Maternal exposure during pregnancy; 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-202107211054152390-AX5K3, Safety Report Unique Identifier GB-MHRA-ADR 25685292. A 40-year-old female pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine), dose 1 via an unspecified route of administration on 10Jun2021 (Lot Number: Fc8289) at the age of 40-year-old as single dose for COVID-19 immunisation. Medical history included pregnancy (2 previous successful pregnancies carried to full term), anxiety, folic acid supplementation. Scans were completed for this pregnancy prior to vaccine where all fine. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medications included fluoxetine taken for anxiety; folic acid taken for folic acid supplementation. The patient experienced late miscarriage on 19Jul2021, maternal exposure during pregnancy 10Jun2021. Patient was exposed to the medicine second-trimester (13-28 weeks). The case was reported as serious due to hospitalization, disability, medically significant, and death. The patient underwent lab tests and procedures which included COVID-19 virus test: negative covid-19 test on an unspecified date. The patient died on 19Jul2021. It was not reported if an autopsy was performed. Outcome of events was fatal. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: Maternal exposure during pregnancy; Late miscarriage


VAERS ID: 1524215 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

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

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

Write-up: miscarriage; Irregular periods; This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (miscarriage) and MENSTRUATION IRREGULAR (Irregular periods) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased, Anxiety and Miscarriage. Previously administered products included for an unreported indication: PROPRANOLOL. On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced MENSTRUATION IRREGULAR (Irregular periods) (seriousness criterion disability). On an unknown date, the patient experienced ABORTION SPONTANEOUS (miscarriage) (seriousness criteria disability and medically significant). At the time of the report, ABORTION SPONTANEOUS (miscarriage) and MENSTRUATION IRREGULAR (Irregular periods) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient stated that she was tracking her periods for 2 years after having 2 miscarriages and trying for a baby. Her cycle had been very regular throughout that time, quickly returning after each miscarriage and had not been disrupted by stress . 2 days after the jab she bled for 2 days a week after her period. This month she had bled 5 days before her period is due. After knowing her body well she now had no idea of her cycle and when is best to try conceive . No concomitant medication was reported. Treatment history 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 events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1676016 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Inappropriate schedule of product administration, 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 (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 normal
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101086569

Write-up: miscarriage at week 10 of pregnancy; Patient was pregnant at the time of vaccination of the second dose; first dose was administered on 11Mar2021 and the second dose was on 10Jun2021; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20213986. A 35-year-old female patient received the second dose of bnt162b2 (COMIRNATY; Batch/Lot Number: FC3098) intramuscularly on 10Jun2021 as dose 2, single for COVID-19 immunisation. Medical history included 3 normal pregnancies without issues. Patient was pregnant at the time of vaccination of the second dose. There were no concomitant medications. Historical vaccine includes first dose of bnt162b2 (COMIRNATY; Batch/Lot Number: ET1831) on 11Mar2021 for COVID-19 immunization. The patient experienced miscarriage at week 10 of pregnancy on 22Jun2021. It was also reported that first dose was administered on 11Mar2021 and the second dose was on 10Jun2021. Outcome of event recovered on an unspecified date. No follow-up attempts possible. No further information expected.


VAERS ID: 1780182 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-06-10
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101290530

Write-up: Early miscarriage; This is a spontaneous report from a contactable Pharmacist downloaded from the Regulatory Agency (RA)-WEB FR-AFSSAPS-MA20213680. This is a maternal report. A 30-year-old pregnant female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: ET6956), via an intramuscular route of administration on 04May2021 as dose 1, single (at the age of 30-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that, the patient was pregnant while taking bnt162b2. She was 31 days pregnant at the onset of the event. The patient was due to deliver on 14Feb2022. On 10Jun2021, after vaccination, the patient experienced early miscarriage. The pregnancy resulted in spontaneous abortion. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1420740 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-02-24
Onset:2021-06-11
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 001A21A / 2 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004M20A / 1 RA / -

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

Life Threatening? No
Birth Defect? 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: Multivitamin 1 tablet daily
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Fetal ultrasound on 6/11/21 diagnosed the missed miscarriage - fetus measured 10 weeks and there was no fetal heartbeat. Dilatation and Curettage 6/16/21, performed under general anesthesia at a local hospital.
CDC Split Type:

Write-up: I received the Moderna COVID19 vaccines on 1/22/21 and 2/24/21. I became pregnant shortly after my 2nd COVID19 vaccine. At 12 weeks pregnant, I found out that I had a Missed Miscarriage, and had to undergo a Dilatation and Curettage procedure.


VAERS ID: 1429845 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-05-19
Onset:2021-06-11
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6208 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Ultrasound foetal, Uterine dilation and evacuation
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pre natal vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: June 2nd (NIPT ultrasound and blood work) where pregnancy confirmed as viable, strong heartbeat and no abnormalities detected. No trisomy or downs. This was the last ultrasound before we learned on June 11th (at a regular doctors visit) that the baby died. Went to the hospital on June 14th for a D&E surgery.
CDC Split Type:

Write-up: Received 2nd dose at end of first trimester. Had healthy pregnancy with weekly scans. Strong growth and heart rate. No abnormalities detected during ultrasound on June 2nd (when I was 13.5 weeks pregnant). NIPT showed no abnormalities and they considered viable pregnancy. 2 1/2 weeks after vaccine, I went for routine doctor visit and baby had no heart beat. I STRONGLY believe this was the result of the Covid vaccine.


VAERS ID: 1438266 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-20
Onset:2021-06-11
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: I did not know I had conceived. I found out I was pregnant on 5/12/2021. Taking Nothing at time of vac
Current Illness: Na
Preexisting Conditions:
Allergies: Na
Diagnostic Lab Data:
CDC Split Type:

Write-up: Saw heart was 89 bpm on june 4. On june 11 heart was seen on u/s to have stopped. Still waiting on miscarriage to happen naturally and it has not.


VAERS ID: 1474511 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-06-09
Onset:2021-06-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 2 LA / SYR

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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness:
Preexisting Conditions:
Allergies: N/A
Diagnostic Lab Data: As stated first ultrasound on July 6th showed the fetus stopped growing at 5 weeks 6 days. Confirmed miscarriage on July 15th.
CDC Split Type:

Write-up: At the time of the vaccine I was 5 weeks 4 days pregnant. It was discovered at my first ultrasound at 8 weeks 3 days on July 6th that the baby had stopped growing at 5 weeks 6 days two days after the second vaccine. I officially miscarried naturally 5 days later. This was my first first pregnancy.


VAERS ID: 1474574 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-10
Onset:2021-06-11
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Haemorrhage in pregnancy, Polymenorrhoea, Pregnancy, Pregnancy test positive, Ultrasound scan abnormal, Vacuum aspiration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), 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: prenatal vitamins
Current Illness:
Preexisting Conditions: PCOS
Allergies: tetracyclines
Diagnostic Lab Data: initial ultrasound was 5/27/21 doctor''s appointment was 6/1/21 blood was drawn on 6/1/21 and 6/3/21 doctor''s appointment on 6/4/21 second ultrasound on 6/11/21 doctor''s appointment on 6/11/21 MVA hospital procedure on 6/11/21 doctor''s appointment on 6/28/21
CDC Split Type:

Write-up: The second Pfizer shot caused me to have a second period in the month of April. The period occurred around the time of ovulation for me (4/17/21). We were trying to conceive at the time. We managed to become pregnant that month despite the confusion with two periods and not knowing if my ovulation schedule would change. I had a positive pregnancy test on 5/7/21. By 5/20/21 I started bleeding. I had a hospital removal procedure (MVA) completed on 6/11/21 due to a miscarriage during this pregnancy.


VAERS ID: 1487021 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-04-17
Onset:2021-06-11
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0161 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal growth restriction, Foetal heart rate abnormal, Rhesus antigen negative, Ultrasound foetal abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin
Current Illness: I did not know I was pregnant until a week after getting the vaccine
Preexisting Conditions: None
Allergies: Amoxicillin
Diagnostic Lab Data: Ultrasound- shot RhoGAM Rh factor- negative
CDC Split Type: vsafe

Write-up: I had the first dose before I found out I was pregnant. I continued with the pregnancy and I went for the first ultrasound. I had to start coming in weekly. The following week I should have been at 7 weeks but the baby was only 6 weeks 5 days and had a heartbeat by then. The next week the baby did not grow and did not have a heartbeat. The following Monday they prescribed a medication for forced my body to eject the fetus. I had an allergic reaction to that medication. I continued bleeding for 11 days which was supposed to be 3 days. At that time it was all clear. We do not know if I would be able to conceive again. I had a shot of RhoGAM because I have an RH factor. Pregnancy- one birth one miscarriage, my daughter is 2 years old with no complications. Estimated date was 01/21/2022. I did not know I was pregnant until a week after getting the vaccine and the nurse advised me not to take the second dose.


VAERS ID: 1537797 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-08
Onset:2021-06-11
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017C21A / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion missed, Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin normal, Pregnancy test positive, Ultrasound antenatal screen abnormal, Ultrasound antenatal screen normal, 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: None
Diagnostic Lab Data: I had to have a D&C procedure on 7/21/21 under general anesthesia to remove the baby since my body did not naturally miscarry when the baby stopped growing 5 weeks earlier.
CDC Split Type:

Write-up: I received my 2nd dose of the Covid vaccine on 5/8/21. I had a positive pregnancy test on 5/14/21, I had an ultrasound performed at 7 weeks and baby was growing appropriately and a heart beat was detected. My HCG levels were monitored periodically until 9 weeks and were within normal limits. I went in for an ultrasound at 13 weeks and was told I had a missed miscarriage and the baby stopped growing at 8 weeks. My due date was supposed to be 1/21/22.


VAERS ID: 1586627 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-06
Onset:2021-06-11
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 023C21A / 2 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030B21A / 1 LA / SYR

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

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

Write-up: Miscarriage. Projected date of delivery: 1/20/22 Pregnancy history: 3 pregnancies previously, resulting in 3 live births


VAERS ID: 1431940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021692783

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106120727254080-ABT1T. Safety Report Unique Identifier GB-MHRA-ADR 25464605. A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: Not known) as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medication included folic acid taken for vitamin supplementation, start and stop date were not reported. Patient was exposed to the medicine at first-trimester (1-12 weeks). The patient had a miscarriage on 11Jun2021 with an outcome of recovering. The event was assessed as medically significant. The patient was no longer pregnant at the time of reporting. Patient has not tested positive for COVID-19 since having the vaccine. The patient was unsure if the medicine have an adverse effect on any aspect of the pregnancy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1448113 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-11
   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 ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, 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? 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: GBPFIZER INC2021736361

Write-up: Miscarriage; received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jun2021/ received covid-19 vaccine (COVID-19 VACCINE ASTRAZENECA) on 13Mar2021; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106172143332380-ARNWI, and Safety Report Unique Identifier GB-MHRA-ADR 25495615. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jun2021 (batch/lot number: ET8885) as dose 1, single for COVID-19 immunisation; and covid-19 vaccine (COVID-19 VACCINE ASTRAZENECA), via an unspecified route of administration on 13Mar2021 (batch/lot number: 41202001) as dose 1 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. Concomitant medication included folic acid taken for vitamin supplementation. The patient experienced miscarriage on 13Jun2021 with outcome of recovering (as reported). The event ''miscarriage'' was assessed as serious, other medically important condition by the regulatory authority. Patient has not tested positive for COVID-19 since having the vaccine. 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). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1480140 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-11
   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 FC3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hemoglobin low
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021804420

Write-up: Miscarriage; Headache; Fatigue; muscle pain; Abdominal pain; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the WEB NL-LRB-00592485. A 44-year-old female patient received the first dose of BNT162b2 (COMIRNATY, strength 0.3ml, lot number FC3143) via unspecified route of administration on 11Jun2021, at patient age of 44-year-old, as single dose for COVID-19 immunisation. The patient medical history included hemoglobin low. The patient had no previous COVID-19 infection. The patient concomitant medications were not reported. On 11Jun2021, the patient experienced abdominal pain, fatigue, myalgia. On 12Jun2021, the patient experienced headache. On 18Jun2021, the patient experienced miscarriage (other medically important condition). The miscarriage occurred at a pregnancy duration of about 5 weeks. This was the first COVID vaccination, which took place at a pregnancy duration of about 4 weeks. When patient came home she had abdominal pain, after 3 days it moved more in stomach so she ate food so it calmed down but after 6 weeks on 18Jun2021 when she woke up there was a drop of blood in a pelwis, at 8 o''clock then there was a blood already looked like menstruation. On 19Jun2021, in her right side where polyps were diagnosed by the doctor, hurt a lot and later there was a large mass of blood in the shower. On 21Jun2021, the blood stopped. On 13Jun2021, the patient''s 2 boys smell the bad smell but she did not smell, it lasted 1 week. Confounding factors: COVID-19 vaccine exposure during pregnancy week: 4weeks. Confounding factors: hemoglobin is low. Abdominal pain is treated with hot compress, fatigue is treated with sleep, headache is treated with sleep and myalgia is treated with cold compress / exercise. The patient has not recovered from abdominal pain, has not recovered from fatigue, has not recovered from headache, has not recovered from myalgia, the outcome of maternal exposure during pregnancy is unknown and the outcome of miscarriage is unknown. Sender''s comments: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS criteria, the reaction (miscarriage) was considered as serious. No follow-up attempts possible. No further information expected.


VAERS ID: 1541941 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
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: CLOBETASOL 0.05%
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100967024

Write-up: Miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer or other non hcp (patient) downloaded from the Agency Regulatory Authority, regulatory authority number NL-LRB-00636473. A 33-years-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 11Jun2021, as single dose for COVID-19 immunisation and second dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FF0688 and expiry date was not reported), via an unspecified route of administration, on 17Jul2021, as single dose, 0.3 ML, for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medication included clobetasol propionate (CLOBETASOL 0.05%) taken for an unspecified indication from 01Jan2015 to an unspecified stop date. patient did not diagnosed with covid-19 prior to vaccination. The patient did not undergo any other diagnostic procedures. This was the second Covid vaccination, which took place at a pregnancy duration of about 6 weeks. The first Covid vaccination took place before pregnancy. On 11Jun2021, the patient experienced maternal exposure during pregnancy. On 20Jul2021, 3 days after vaccination, the patient had miscarriage at a pregnancy duration of 6+3 weeks. Outcome of the events was unknown. Sender comment: Seriousness of miscarriage was changed from death to other medically important condition. No follow up attempts are possible. No further information is expected.


VAERS ID: 1668128 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Back pain, Blood loss anaemia, Haemorrhage, Headache, Maternal exposure during pregnancy, Pain, Peripheral swelling, Scan
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:Baby stopped crowing; Comments: Stayed in hospital for a week, lost baby, had operation
CDC Split Type: GBPFIZER INC202101049577

Write-up: pain; Maternal exposure during pregnancy; Miscarriage; Exposed to the medicine first-trimester (1-12 weeks).; Blood loss anemia; Bleeding; Back ache; General body pain; Swollen arm; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108141331295380-NL5WR and Safety Report Unique Identifier GB-MHRA-ADR 25800520. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: not reported) via an unspecified route of administration on 11Jun2021 (at age of 33-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included pregnancy (patient no longer pregnant at the time of reporting) and folic acid supplementation from on unknown date and unknown if ongoing. Unsure if patient has had symptoms associated with COVID-19 and 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 included folic acid taken for folic acid supplementation, start and stop date were not reported. On an unspecified date, the patient experienced pain, maternal exposure during pregnancy, miscarriage and exposed to the medicine first-trimester (1-12 weeks). On 11Jun2021, headache. On 12Jun2021, back ache, general body pain and swollen arm. On 24Jun2021, bleeding and blood loss anemia. The patient underwent lab tests and procedures which included scan: baby stopped crowing (Stayed in hospital for a week, lost baby, had operation) on an unspecified date. Therapeutic measures were taken as a result of pain, maternal exposure during pregnancy, headache, back ache, general body pain, swollen arm, bleeding, blood loss anemia, miscarriage, exposed to the medicine first-trimester (1-12 weeks) with lot of pain killer''s. The medicine did had an adverse effect on the pregnancy (Miscarriage). The outcome of pain, swollen arm was recovered on unspecified date in 2021 and bleeding was recovered on 20Jul2021. The outcome of back ache, general body pain and blood loss anemia was not recovered. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1743317 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-06-11
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Human chorionic gonadotropin, Ultrasound antenatal screen
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: Disease risk factor
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Ultrasound and blood tests that showed that the fe; Comments: Ultrasound and blood tests that showed that the fetus had completely dissolved all of a sudden.; Test Name: pergnancy hormone; Result Unstructured Data: Test Result:low; Comments: And the pregnancy hormone was low.; Test Name: ultrasound; Result Unstructured Data: Test Result:Ultrasound and blood tests that showed that the fe; Comments: Ultrasound and blood tests that showed that the fetus had completely dissolved all of a sudden.
CDC Split Type: NLPFIZER INC202101263065

Write-up: Miscarriage at 9 weeks of pregnancy; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00686194. A 34-year-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 11Feb2021, as single dose (Lot Number: EJ6788) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included disease risk factor. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, solution for injection 0,3ml), via an unspecified route of administration on 21Jan2021, as single dose (Batch/Lot Number was unknown) for covid-19 immunisation. The patient previous had no COVID-19 infection. The patient experienced miscarriage at 9 weeks of pregnancy 4 months after second dose on 11Jun2021. The patient stated at a check-up at 8 weeks, everything was fine and a week later the entire fetus, including the amniotic sac, had completely dissolved. This without having had blood loss or anything like that. Uterus was again in a normal state as if there had never been a fetus in it. The patient underwent lab tests and procedures which included Ultrasound and blood tests that showed that the fetus had completely dissolved all of a sudden. And the pregnancy hormone was low. The outcome of event was unknown. The case was reported as serious due to Medically Significant condition. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS critera, the reaction (miscarriage) was considered as serious by the regulatory authority. reporter''s comments: Past drug therapy BioNTech Pfizer vaccine (Comirnaty) was yes. Date was 21Jan2021. Miscarriage at 9 weeks of pregnancy. Additional information ADR: At a check-up at 8 weeks, everything was fine and a week later the entire fetus, including the amniotic sac, had completely dissolved. This without having had blood loss or anything like that. Uterus was again in a normal state as if there had never been a fetus in it. No Previous COVID-19 infection. diagnostic procedures: Ultrasound and blood tests that showed that the fetus had completely dissolved all of a sudden. And the pregnancy hormone was low. No follow-up attempts possible. No further information expected. ; Reporter''s Comments: Summary of reporter''s comments: Past drug therapy was BioNTech Pfizer vaccine (Comirnaty). Additional information on ADR and lab data are available. No previous COVID-19 infection.


VAERS ID: 1838530 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-11
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Maternal vaccine exposure (vaccine exposure during pregnancy week: 3)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20211100006

Write-up: MATERNAL EXPOSURE DURING PREGNANCY; MISCARRIAGE; This spontaneous pregnancy report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, NL-LRB-00703265] on 29-Oct-2021 concerned a 34 year old female patient of unspecified race and ethnicity. The patient''s weight was 59 kilograms, and height was 172 centimeters. The patient''s concurrent conditions included: maternal vaccine exposure. The patient was pregnant at the time of vaccination. The gestation period was 3 reported weeks. The patient was gravida 1. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C10-02 expiry: unknown) 0.5 ml, 1 dosage forms, frequency time 1 total was administered on 20-MAY-2021 for covid-19 immunisation. No concomitant medications were reported. On 11-JUN-2021, the patient had miscarriage. On an unspecified date, the patient experienced maternal exposure during pregnancy. The date of the patient''s last menstrual period were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the maternal exposure during pregnancy and miscarriage was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS critera, the reaction was considered as serious by a regulatory authority.


VAERS ID: 1438823 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CODEINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Haemorrhage; Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210612; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021765478

Write-up: Miscarriage; haemorrhage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106221658436270-JF7ZJ, and Safety Report Unique Identifier GB-MHRA-ADR 25521076. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jun2021 (lot number: Ew3143) as dose 1, single for COVID-19 immunisation. Medical history included miscarriage from an unknown date and unknown if ongoing, haemorrhage from an unknown date and unknown if ongoing, pregnancy from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. Concomitant medication included codeine. The patient experienced haemorrhage on 12Jun2021 with outcome of recovering, and miscarriage on 14Jun2021 with outcome of recovered with sequelae (as reported). The events were assessed as serious- life threatening and hospitalization. The patient underwent lab test which included COVID-19 virus test: No - Negative COVID-19 test on 12Jun2021. Additional information: Patient had Covid jab, started bleeding next morning (12Jun2021), had been perfectly normal pregnancy, miscarriage on the Monday (14Jun2021). Had a haemorrhage. Patient has not tested positive for COVID-19 since having the vaccine. Patient was exposed to the medicine throughout pregnancy, however patient was no longer pregnant at the time of reporting. No follow-up attempts are possible. No further information is expected.


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