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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: 1496264 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test; Test Name: scans; Result Unstructured Data: Test Result:miscarriage; Comments: Details of scans or investigations: Vaccine given approx 3 or 4 weeks. Empty sac at 8 weeks measuring approx 5 weeks. Resulting in miscarriage
CDC Split Type: GBPFIZER INC2021864016

Write-up: miscarriage; This is a spontaneous study report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number [GB-MHRA-WEBCOVID-202107062252070270-2OUOS]. Safety Report Unique Identifier [GB-MHRA-ADR 25608270]. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot Number: EY5456) dose 1 via an unspecified route of administration on 26May2021 (Lot Number: EY5456) as single dose for COVID-19 immunisation. Medical history included suppressed lactation. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation, start and stop date were not reported. Patient was unable to confirm if the vaccine caused the miscarriage but still thought it best to report. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient was no longer pregnant at the time of reporting. Scans: vaccine given approximately 3 or 4 weeks. Empty sac at 8 weeks measuring approximately 5 weeks. Resulting in miscarriage. COVID-19 virus test was negative. This case was reported as serious with seriousness criteria: congenital anomaly. No follow up attempts are possible. No further information is expected.


VAERS ID: 1499580 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-24
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, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased; Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: ultrasound scan; Result Unstructured Data: Test Result:embryonic development; Comments: embryonic development had stopped
CDC Split Type: GBPFIZER INC2021869944

Write-up: Early miscarriage; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107080952422140-FOXU3. Safety Report Unique Identifier: GB-MHRA-ADR 25618135. A 31-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EW3143), dose 1 via an unspecified route of administration on 05Jun2021 as 1st dose, single for COVID-19 immunization (at the first trimester. Patient''s medical history included abortion spontaneous from an unknown date and unknown if ongoing, pregnancy from an unknown date and unknown if ongoing, lactation decreased from an unknown date and unknown if ongoing, ongoing pregnancy, vitamin supplementation from an unknown date and unknown if ongoing. Concomitant medications included folic acid taken for vitamin supplementation, start and stop date were not reported. Patient had no symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient was not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced maternal exposure during pregnancy, first trimester and early miscarriage on an unspecified date. Patient was exposed to the medicine first-trimester (1-12 weeks). Both the events were reported as medically significant. The patient underwent lab tests and procedures which included negative sars-cov-2 test on no-negative COVID-19 test and ultrasound scan in her 9th week of pregnancy which resulted embryonic development on embryonic development had stopped shortly after the first 6 weeks on an unspecified date. Patient did not know that if the vaccine was connected to her miscarriage. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1505139 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
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: CAPFIZER INC2021887843

Write-up: lost her baby due to miscarriage during her first trimester; This is a spontaneous report from a contactable physician. This is a maternal report. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The physician reported that he had a female patient on her first pregnancy, who had lost her baby due to miscarriage on an unspecified date, during her first trimester, 3 weeks after receiving her first dose of the covid vaccine. It was reported that the event took place after use of the product. The pregnancy resulted in spontaneous abortion. Outcome of event was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Miscarriage and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1507040 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021886320

Write-up: Miscarriage; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number [GB-MHRA-WEBCOVID-202107130727092340-6SKL0], Safety Report Unique Identifier [GB-MHRA-ADR 25638233]. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jun2021 (Batch/Lot Number: FA1027) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing and pregnancy from an unknown date and unknown if ongoing (Patient no longer pregnant at the time of reporting), Folic acid supplementation from an unknown date and unknown if ongoing. Concomitant medications included folic acid (FOLIC ACID) taken for Folic acid supplementation, start and stop date were not reported. The patient experienced Maternal exposure during pregnancy, first trimester and miscarriage on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. The outcome of the event ''maternal exposure during pregnancy, first trimester'' was unknown and event ''miscarriage'' was recovering. The clinical course was reported as follows: Patient had her COVID vaccine and didn''t know she was pregnant. She miscarried this pregnancy at weeks, only a week after her jab. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was exposed to the medicine first-trimester (1-12 weeks). Additional information: Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1509344 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0195 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac arrest, Hydrops foetalis, Maternal exposure during pregnancy, Ultrasound scan, Ultrasound scan vagina
SMQs:, Congenital and neonatal arrhythmias (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ultrasound (mother); Result Unstructured Data: Test Result:Absence of fetal heartbeat; Test Name: transvaginal ultrasound (mother); Result Unstructured Data: Test Result:fetal hydrops
CDC Split Type: BRPFIZER INC2021900344

Write-up: fetal hydrops; Absence of fetal heartbeat; Maternal exposure during pregnancy; This is a spontaneous report from a contactable pharmacist (patient''s mother) via COVAES. A fetus patient of an unspecified gender received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: EW0195, Expiration Date was not reported) via transplacental on 19May2021 07:30 as dose 1, single for COVID-19 immunisation at public health center. The patient medical history and concomitant medications were not reported. It was reported that, absence of fetal heartbeat elucidated by ultrasound at 10 weeks and 2 days of gestation, due to non-evolving pregnancy, gestational age 9 weeks and 6 days with transvaginal ultrasound showing fetal hydrops. The patient chose to continue with surgical intervention (Manual intrauterine aspiration) for material retention and cytogenetic analysis. The patient''s mother was hospitalized for fetal hydrops for 2 days, hospitalized for absence of fetal heartbeat from 04Jul2021 to an unknown date for 2 days. The patient (fetus) died on 04Jul2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included ultrasound scan: absence of fetal heartbeat on an unspecified date, ultrasound scan vagina: fetal hydrops on an unspecified date.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events : Maternal Exposure during pregnancy, hydrops fetalis, fetal cardiac arrest and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Hydrops fetalis


VAERS ID: 1517077 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021906186

Write-up: had the second jab and miscarried shortly after; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was previously taken first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Apr2021 for COVID-19 immunization and experienced "she was pregnant" (vaccine exposure during pregnancy). The patient had the second jab and miscarried shortly after on an unspecified date. 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) : GB-PFIZER INC-2021905861 same patient/drug, Different event/dose


VAERS ID: 1520899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), 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: PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased; Miscarriage (Before vaccination); Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916777

Write-up: miscarriages; Gasping; 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-202107182254080430-OBUHQ. Safety Report Unique Identifier: GB-MHRA-ADR 25670159. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in 2021 as dose 1, single for COVID-19 immunization. Medical history included pregnancy, miscarriage before vaccination, anxiety, and lactation decreased. Patient no longer pregnant at the time of reporting. Concomitant medication included propranolol taken for anxiety. The patient previously took folic acid. The patient experienced miscarriages and gasping in 2021. Additional information reported as follows: random gasping. During verbal conversation suddenly one gasp intermittently or less often at random times. No treatment received but GP informed. Also had two miscarriages 1 since first and other after the second vaccination. Patient did not take folic acid supplement during pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative COVID-19 test on an unknown date. The patient has not recovered from the event, gasping and outcome of miscarriage was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1522502 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
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: Exposure during pregnancy, Foetal death
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100924360

Write-up: Foetal death; Foetal death; This is a spontaneous report from a contactable healthcare professional via the regulatory authority report number is 584157. A 33-year-old pregnant female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced foetal death on an unspecified date. The fetal outcome was intrauterine death. Outcome of events for the patient was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1523795 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100929217

Write-up: A miscarriage; Received a first dose of the Comirnaty vaccine after which she became pregnant; This is a spontaneous report from a contactable physician via Medical Information. A female patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration in 2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The physician reported that she called for information regarding the vaccination of the second dose beyond the deadline. Indeed, her female patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY) then she became pregnant, but she had a miscarriage. Now she exceeded the 42 days since the first dose. The question of the physician was to know if it was possible to do the second dose after the 42 days or if she should redo another vaccination schedule. The clinical outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Spontaneous Abortion cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1524625 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Body temperature, Chills, Exposure during pregnancy, Extensive swelling of vaccinated limb, Fatigue, Headache, Hyperpyrexia, Inappropriate schedule of product administration, Malaise, Myalgia, Nausea, Vaccination site erythema, Vaccination site haematoma, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (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), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 26).
Allergies:
Diagnostic Lab Data: Test Date: 05/04/2021; Test Name: Body temperature; Result Unstructured Data: Test Result:40.5-42?C.
CDC Split Type: NLPFIZER INC202100919790

Write-up: This is a spontaneous report from a contactable consumer, downloaded via the regulatory authority (report number: NL-LRB-00624510). An adult female patient, of unspecified age, received the 2nd dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# unknown), intramuscularly, on Jul 13, 2021, single dose, for COVID-19 immunization. Medical history included maternal exposure/COVID-19 vaccine exposure during pregnancy week: 26 (timing unspecified from an unknown date and unknown if ongoing). Historical vaccine included the 1st dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# unknown), via an unspecified route of administration, on May 3, 2021, 0.3mL, single dose, for COVID-19 immunization. The patient''s concomitant medications were not reported. The patient did not test COVID-19 positive prior to vaccination. Reportedly (one hour after vaccination), patient experienced chills, headache, nausea, injection site erythema, injection site warmth, injection site pain, injection site pruritus, injection site swelling, injection site hematoma, injection site induration, extensive swelling of vaccinated limb and hyperpyrexia on an unspecified date. This was followed by malaise (three hours after vaccination), generalized joint pain, fatigue (24 hours after vaccination) and myalgia (48 hours after vaccination) on an unspecified date. The patient also experienced COVID-19 vaccine exposure during pregnancy and miscarriage. The patient underwent lab tests and procedures, which included body temperature: 40.5-42 centigrade on May 4, 2021. Outcome of the fatigue reported not recovered. Outcome of all the remaining events reported unknown. No follow-up attempts possible. No further information expected information about lot/batch number cannot be obtained.


VAERS ID: 1525283 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / 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: NYCOPLUS GRAVID; CETIRIZIN; FLUTIKASON
Current Illness: Asthma; Pollen allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20212

Write-up: Spontaneous abortion; This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS in a 36-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 immunisation. Concurrent medical conditions included Pollen allergy and Asthma. Concomitant products included FLUTIKASON for Asthma, CETIRIZINE for Pollen allergy, NYCOPLUS GRAVID for an unknown indication. On 07-Jun-2021 at 12:50 PM, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. The outcome was reported as Spontaneous Abortion. In June 2021, ABORTION SPONTANEOUS outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. No treatment information mentioned. Patient did not know she was pregnant at the time of the vaccination. Spontaneous abortion occurred between week 4 and 7+3. Company comment Very limited information regarding the events has been provided at this time. Further information has been requested. Sender''s Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.


VAERS ID: 1526979 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Scan; Result Unstructured Data: Test Result:Miscarriage
CDC Split Type: GBPFIZER INC202100934150

Write-up: Early miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107212208351700-RZEG2. Safety Report Unique Identifier is GB-MHRA-ADR 25689596. A 42-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 22May2021 as dose 1, single for COVID-19 immunization. Medical history included miscarriage and folic acid supplementation. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test, and not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation. The patient experienced early miscarriage on an unspecified date in 2021. The event was reported as non-serious. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient was no longer pregnant at the time of reporting. The pregnancy resulted in spontaneous abortion. They were unsure if the medicine had an adverse effect on any aspect of the pregnancy. The patient underwent lab tests and procedures which included scan: miscarriage on 2021. The outcome of the event early miscarriage was recovering. No follow-up attempts are possible; information about batch no cannot be obtained.


VAERS ID: 1532703 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100941499

Write-up: Miscarriage; This is a spontaneous report from a contactable other healthcare professional received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107220858126830-1DZGP. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EY5456, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 27May2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was not enrolled in clinical trial. The patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. On an unspecified date, the patient experienced miscarriage. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532859 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Ultrasound scan; Result Unstructured Data: Test Result:indicated missed miscarriage; Comments: Ultrasound scan at 12/40 indicated missed miscarriage which had occurred at 9/40
CDC Split Type: GBPFIZER INC202100942996

Write-up: Early miscarriage; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107231043215540-CEKTO, Safety Report GB-MHRA-ADR 25697986. A 30-year-old female patient received 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE), via an unspecified route of administration 04Jun2021, at dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-1. Not had a COVID-19 test. Patient is not currently breastfeeding. On an unspecified date, the patient experienced early miscarriage. According to the reporter, it was unsure if medicine have an adverse effect on any aspect of the pregnancy. Patient was no longer pregnant at the time of reporting. Details of previous pregnancies: Pfizer covid vaccine given 04Jun2021 at 8/40. 2nd dose given 23Jul2021 when no longer pregnant. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Ultrasound scan at 12/40 indicated missed miscarriage which had occurred at 9/40. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event early miscarriage was recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1532985 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100943148

Write-up: fell pregnant and had since miscarried; 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-202107232119586980-ONSAE. Safety Report Unique Identifier GB-MHRA-ADR 25702015. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via an unspecified route of administration, administered in arm left on 20Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included lactation decreased from an unknown date. Patient had not had symptoms associated with COVID-19. Patient was not pregnant (as reported). Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Case Narrative: Vaccine administered to left arm which was where contraceptive vaccine was also located. The patient believed the vaccine had caused her implant to no longer work as she fell pregnant and had since miscarried. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The event was reported as serious due to medically significant and congenital anomaly. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1533009 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy
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:missed miscarriage at 12 weeks; Comments: missed miscarriage at 12 weeks, heartbeat at 6 weeks but scan revealed stopped growing at 9 weeks.
CDC Split Type: GBPFIZER INC202100943428

Write-up: Miscarriage/missed miscarriage identified at 12 weeks 5 days; 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-202107240612074590-R5DPT, Safety Report Unique Identifier GB-MHRA-ADR 25702534. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27May2021 (Lot Number: ET8885) as single dose for COVID-19 immunisation. Medical history included ongoing pregnancy at the time of vaccination, lactation decreased, first pregnancy healthy in 2018. Concomitant medication included folic acid, taken for vitamin supplementation, start and stop date were not reported. Vaccine given at 5 weeks pregnant, missed miscarriage identified at 12 weeks 5 days, baby stopped growing at 8 weeks 4 days exactly 4 weeks after vaccine given. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans: missed miscarriage at 12 weeks, heartbeat at 6 weeks but scan revealed stopped growing at 9 weeks. This was 3 weeks following first vaccine. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. COVID-19 virus test: No - Negative COVID-19 test. This case was reported as serious with seriousness criteria-congenital anomaly/birth defect. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1539053 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / 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: LUPFIZER INC202100954708

Write-up: Miscarriage; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is LU-ALMPS-202102883. A 37-year-old pregnant female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number: FC2336) intramuscularly on 16Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced miscarriage while not knowing that she was pregnant at the first vaccination. Baby birth type was reported as spontaneous abortion. Patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number: FC5029) intramuscularly on 14Jul2021 at a dose of 1 DF as dose 2, single for COVID-19 immunization. Patient received a first vaccination (D1) by COMIRNATY (lot FC2336) on 16Jun2021. On 14Jul2021, the day of the second injection of COMIRNATY (lot FC5029), the lady reported having had a miscarriage, without knowing that she was pregnant at D1. Miscarriage occurred after a first vaccination with COMIRNATY (batch FC2336) in a 38-year-old woman who was unaware of her pregnancy at the time of vaccination. Second vaccination administered 4 weeks after Dose 1. The outcome of the event was resolved on an unspecified date in 2021. No follow-up attempts possible. No further information expected. Health Authority Comment included: 38-year-old woman who on 16Jun2021 received a first vaccination (D1) by COMIRNATY (lot FC2336). On 14Jul2021, the day of the second injection of COMIRNATY (lot FC5029), the lady reported having had a miscarriage, without knowing that she was pregnant at D1.


VAERS ID: 1546031 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-11
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: Medical History/Concurrent Conditions: Pregnancy multiple (2 successful pregnancies)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021462792

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient) based on information received by Pfizer from BioNTech (Manufacturer Control Number: 44635), license party for BNT162B2 (COMIRNATY). A female patient of an unspecified age received BNT162B2 (COMIRNATY; Lot Number was not reported), via an unspecified route of administration, in Feb2021 (non-pregnant at the time of vaccination), as dose 2, single, for COVID-19 immunization. The patient''s medical history included 2 successful pregnancies. The patient''s concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (COMIRNATY) in Jan2021 for COVID-19 immunization. The patient got the first and second BioNTech vaccinations in January and February. About 2 weeks after the second dose (2021), the patient must have become pregnant. On Friday (unspecified), the scraping takes place because unfortunately it was a miscarriage in 2021 after 2 successful pregnancies. Now the patient''s question was if the company is interested in the medical material for research purposes, whether the miscarriage might be vaccine related. The outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1547130 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200401; Test Name: corona; Result Unstructured Data: Test Result:Positive; Comments: corona, confirmed with test
CDC Split Type: NLPFIZER INC202100967093

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number NL-LRB-00637160. An adult female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 24Jun2021 (Batch/Lot Number: Unknown) as dose 1, 0.3 ml single for COVID-19 immunization. Medical history included COVID-19 from 01Apr2020 (previous COVID-19 infection, disease symptoms: little). The patient''s concomitant medications were not reported. The patient experienced miscarriage on an unspecified date 4 weeks following administration of covid-19 pfizer vaccine injection. The miscarriage occurred at a pregnancy duration of about 7 weeks. This was the first Covid vaccination, which took place at a pregnancy duration of about 3 weeks. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Apr2020 corona, confirmed with test. The outcome of the event was unknown. Sender comment: Case Summary: BioNTech/Pfizer vaccine (Comirnaty); Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no; miscarriage, at 7 weeks no heartbeat. Information PRIVACY or other or disabling information: miscarriage; Additional information ADR: 6 healthy kids, never miscarriage. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1573667 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: ; Maternal exposure during pregnancy; This case was received via Medicines Agency (Reference number: 101812) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS in a 40-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant), EMOTIONAL DISORDER and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS and EMOTIONAL DISORDER was resolving and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter. Reporter''s comment: Patient stated she had a miscarriage: side effects were physical and emotional. This is a case of Maternal exposure during pregnancy in a 40-year-old female with associated AEs. Causality for Maternal exposure during pregnancy is not applicable. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Translation received on 6 Aug 2021, reporter''s comments, event as reported by primary source were translated to English. Reporter''s comment added. Narrative updated accordingly.; Sender''s Comments: This is a case of Maternal exposure during pregnancy in a 40-year-old female with associated AEs. Causality for Maternal exposure during pregnancy is not applicable. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. .


VAERS ID: 1576040 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8819 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage, Inappropriate schedule of product administration, Maternal exposure during pregnancy, SARS-CoV-2 test, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: Ultrasound; Result Unstructured Data: Test Result:foetus had no heartbeat
CDC Split Type: GBPFIZER INC202100984393

Write-up: bleeding; Maternal exposure during pregnancy; Miscarriage; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. This is a report received from the Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108012045520550-STVTY, Safety Report Unique Identifier GB-MHRA-ADR 25738390. A 38-year-old female patient received second dose of BNT162B2 (BNT162B2) (Lot Number: FD8819), via an unspecified route of administration on 19Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing, pregnancy from an unknown date and unknown if ongoing, Patient no longer pregnant at the time of reporting, vitamin supplementation from an unknown date and unknown if ongoing. Concomitant medication included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. Patient has not had symptoms associated with COVID-1. Patient is not enrolled in clinical trial. Patient was not currently breastfeeding. The patient received historic vaccine of BNT162B2 (BNT162B2,lot no: ET8885), dose 1 on 17 May 2021. The patient experienced bleeding, maternal exposure during pregnancy, miscarriage, inappropriate schedule of vaccine administered on an unspecified date. The events were reported as serious hospitalization, congenital anomaly. Ultrasound on the day after 2nd dose showed that foetus had no heartbeat. Based on size of foetus, it was suspected to have stopped growing 2 weeks prior. Three days after 2nd dose, she naturally miscarried (labour/contractions, water broke then delivered the foetus and part of placenta at home, continued bleeding for several hours until gynaecologist at A&E removed the rest of the placenta). unsure whether the medicine have an adverse effect on any aspect of the pregnancy. Details of previous pregnancies: One previous healthy pregnancy, delivered in Feb2019, child is healthy and well. Patient was exposed to the medicine first-trimester (1-12 weeks). Pregnancy was planned, conceived by the 2nd month of trying. Was just 3-4 weeks pregnant at the time of first vaccine dose, miscarried during the week of 2nd vaccine dose (8 weeks after first dose). The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on unspecified date, ultrasound scan: foetus had no heartbeat on unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of event bleeding was recovered on an unknown date, miscarriage was not recovered, whereas the outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576345 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: Scan; Result Unstructured Data: Test Result:baby died; Comments: Scan just before 12 weeks showed the baby died just days after receiving the vaccine just after 8 weeks
CDC Split Type: GBPFIZER INC202101012902

Write-up: Early miscarriage; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and fetus. This is a mother report. The mother report is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108051925090980-SOJDR. Safety Report Unique Identifier GB-MHRA-ADR 25761509. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 17Jul2021 (Lot Number: FE1510) as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation, pregnancy (Patient no longer pregnant at the time of reporting, Previous pregnancy was low risk, straightforward pregnancy to term plus 13 healthy baby), vitamin supplementation. Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation. The patient previously received first dose of BNT162B2 for Covid-19 immunisation. Patient was exposed to the medicine first-trimester (1-12 weeks). Baby died days after 2nd vaccine dose just over 8 weeks gestation but the physical miscarriage did not happen for another 3 weeks (baby had not been conceived before first dose). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Unsure if the medicine have an adverse effect on any aspect of the pregnancy. Scan just before 12 weeks showed the baby died just days after receiving the vaccine just after 8 weeks. The patient underwent lab tests included Negative COVID-19 test. The outcome of event was not recovered. The report was considered as serious as caused/prolonged hospitalization from regulatory authority. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101019814 baby case


VAERS ID: 1577723 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Pain in extremity, Ultrasound uterus
SMQs:, 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 Name: Ultrasound; Result Unstructured Data: Test Result:Fetus died, already in a state of decomposition
CDC Split Type: BRPFIZER INC202100992568

Write-up: She lost the baby, he died inside her belly; Pain in her arm; This is a spontaneous report from a contactable consumer (patient''s mother). A 32-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient medical history included and concomitant medications were not reported. The patient, who was pregnant with her first child, was going to enter the ninth week, had the BNT162b2 vaccine and, after 4 days, she lost the baby, he died inside her belly, the patient only found out when she went for the ultrasound, there was no way to perform a biopsy, because the baby was already in a state of decomposition. It was not necessary to perform curettage. She said that the patient, in addition to this loss, had pain in her arm. The outcome of the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follo-wup.


VAERS ID: 1585014 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Delivery (1 delivery G2P1); Multiple pregnancy (two pregnancies G2P1); Smoker (5 cigarettes/a day)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100996691

Write-up: Miscarriage; This is a spontaneous report from a contactable other health professional (HCP) downloaded from the regulatory authority-WEB. The regulatory authority report number FR-AFSSAPS-LY20218568. This other HCP reported information for both mother and fetus/baby. This is a maternal report. A 36-year-old pregnant female patient received bnt162b2 (COMIRNATY, Batch/Lot Number not reported), intramuscular on 15Apr2021 as dose 1, single for COVID-19 immunisation. Medical history included tobacco user (5 cigarettes/a day), had two pregnancies G2P1 and 1 delivery G2P1, all on an unknown date. The patient''s concomitant medications were not reported. The patient experienced miscarriage at 9 weeks of ammenorhae (SA) on an unspecified date. This mother reported her last menstrual period was on 04Apr2021. The mother reported she became pregnant while taking bnt162b2. The mother was due to deliver on 09Jan2022. The pregnancy resulted in spontaneous abortion. The fetal outcome is neonatal death. Therapeutic measures were taken as a result of miscarriage (07May2021: treatment by folic acid, nicotine patch). The outcome of the event was recovered with sequelae on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593134 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Headache, Pain in extremity, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CEFRADINE; FOLIC ACID; LEVOTHYROXINE
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Hypothyroidism; Lactation decreased; Miscarriage (Details of previous pregnancies: Previous missed miscarriage at 13 weeks. Child born at 35 weeks in 2019.); UTI
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014776

Write-up: Miscarriage; Headache; Vomiting; Painful arm; Tired out; 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-202108061449302430-KHPAP, Safety Report Unique Identifier GB-MHRA-ADR 25765898. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8813), via an unspecified route of administration on 05Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation, abortion spontaneous [Details of previous pregnancies: Previous missed miscarriage at 13 weeks. Child born at 35 weeks in 2019], ongoing pregnancy, hypothyroidism, vitamin supplementation, urinary tract infection. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concomitant medication(s) included cefradine (Manufacturer unknown) taken for urinary tract infection, start and stop date were not reported; folic acid (Manufacturer unknown) taken for vitamin supplementation, start and stop date were not reported; levothyroxine (Manufacturer unknown) taken for hypothyroidism, start and stop date were not reported. The patient experienced miscarriage (abortion spontaneous) (medically significant) on an unspecified date with outcome of unknown, headache (headache) (medically significant) on an unspecified date with outcome of recovering, vomiting (vomiting) (medically significant) on an unspecified date with outcome of recovering, painful arm (pain in extremity) (medically significant) on an unspecified date with outcome of recovering, tired out (fatigue) (medically significant) on an unspecified date with outcome of recovering. The mother reported she became pregnant while taking BNT162B2. The mother was 3 Trimester pregnant at the onset of the event. Patient was exposed to the medicine Third-trimester (29-40 weeks). The patient underwent lab tests and procedures which included sars-cov-2 test: No Negative COVID-19 test. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593163 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014303

Write-up: Miscarriage; ongoing breast feeding; ongoing breast feeding; This is a spontaneous report from a contactable consumer. This is the first of two reports. The first report is a report downloaded from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108061845272790-Y4KLJ, Safety Report Unique Identifier GB-MHRA-ADR 25767384. This consumer reported for both mother & baby case. This case was mother case report. A 38-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included Folic acid supplementation. Patient has not had symptoms associated with COVID-19. Concomitant medications included folic acid at 400 mcg taken for Folic acid supplementation, start and stop date were not reported. The patient experienced miscarriage and ongoing breast feeding on an unspecified date. Pregnancy adverse effects details: Miscarriage after both 1st and 2nd dose of the vaccine. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient was no longer pregnant at the time of reporting. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date, No - Negative COVID-19 test. The outcome of miscarriage was recovered. Serious criteria for the case was reported as medical significant. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101022758 For baby case


VAERS ID: 1625720 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101060370

Write-up: Missed miscarriage discovered on 03Aug. At 8 weeks the heart stopped beating while I was 12 weeks pregnant. The exorcism has yet to take place.; Vaccination 3 months before pregnancy; fetal demise; This is a spontaneous report from a contactable consumer reported different events for different patients. This is second of two reports. This is the child case. The first report was downloaded from the Regulatory Authority-WEB [NL-LRB-00651922]. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via transplacental from a mother who received the dose 2 on 14Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient''s mother previously took dose 1 on 24Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fetal demise on an unspecified date, missed miscarriage discovered on 03aug2021 at 8 weeks the heart stopped beating while patient''s mother was 12 weeks pregnant and "the exorcism has yet to take place", vaccination 3 months before pregnancy. The patient died on an unspecified date. It was not reported if an autopsy was performed.Course of events: The patient''s mother missed abortion was discovered at a pregnancy duration of about 12 weeks. The fetal demise occurred at a pregnancy duration of about 8 weeks. Both Covid vaccinations took place a few months before pregnancy. It was found out that patient''s mother had a "missed miscarriage". At 8 weeks the heart stopped beating while patient''s mother was 12 weeks pregnant. The exorcism has yet to take place. Between 8 and 12 weeks. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101017609 mother/child case.; Reported Cause(s) of Death: Fetal heartbeat absent; fetal demise


VAERS ID: 1625853 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Hypogeusia, Hyposmia, Menstrual disorder, SARS-CoV-2 antibody test
SMQs:, Taste and smell disorders (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Fruit allergy; Spina bifida
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Covid-19 antibody test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: SEPFIZER INC202101016077

Write-up: Miscarriage; menstrual disorders; decreased smell and taste for 2-3 weeks; decreased smell and taste for 2-3 weeks; This is a spontaneous report from a contactable consumer (patient). A pregnant 39-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration in left arm on 03Jul2021 at 10:00 (Lot Number: FE6208, unknown expiration; at the age of 39 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19, spina bifida, and known allergies to stone fruits. Concomitant medications reported as none. The patient experienced miscarriage, menstrual disorders, and decreased smell and taste for 2-3 weeks in 2021 (also reported as 13Jun2021, pending clarification. Last menstrual period was on 05May2021. The mother was due to deliver on 22Feb2022. The pregnancy resulted in spontaneous abortion. The events resulted in doctor/other medical staff visits. The patient had not received any other vaccine within 4 weeks. Patient had been diagnosed with COVID-19 prior to vaccination and had been tested negative after the vaccination. The patient underwent lab tests and procedures which included COVID-19 antibody test: negative (nasal swab) on 30Jul2021. The patient did not receive treatment for the events. The patient was recovering from the events. Information on the lot/batch number has been requested.


VAERS ID: 1627836 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101026387

Write-up: Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority. Regulatory Authority Report Number: BE-FAMHP-DHH-N2021-103302. A 33-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 23Jun2021 (Lot Number: FE2090) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced miscarriage of pregnancy on an unspecified date with outcome of recovering. The mother reported she became pregnant while taking bnt162b2. Miscarriage week 10. Seriousness criteria reported as disability and medical significant. No treatment for miscarriage of pregnancy. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1630759 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101026160

Write-up: Miscarriage 6 week; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the regulatory authority-WEB NL-LRB-00653168. A 31 year old adult female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 09Jul2021 (Lot Number: FE1573) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced miscarriage 6 week (medically significant) on an unspecified date with outcome of unknown, Clinical course as reported: the miscarriage occurred at a pregnancy duration of about 6,5 weeks. This was the first Covid vaccination, which took place at a pregnancy duration of about 5 weeks. 10 days after start vaccination, miscarriage occurred. Reporter comment: BioNTech/Pfizer vaccine (Comirnaty) . Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no, Miscarriage (6 weeks). Additional information ADR: one and a half week after vaccination, confounding factors. COVID-19 vaccine exposure during pregnancy week: 5 weeks. COVID19. Previous COVID-19 infection: No. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the HA critera, the reaction (miscarriage) was considered as serious by the regulatory authority. No follow-up attempts possible. No further information expected. ; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) . Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no, Miscarriage (6 weeks). Additional information ADR: one and a half week after vaccination, confounding factors. COVID-19 vaccine exposure during pregnancy week: 5 weeks. COVID19. Previous COVID-19 infection: No.


VAERS ID: 1633919 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic Acid
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decreased lactation; pregnancy (patient was no longer pregnant).
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: No heartbeat and baby stopped growing at 6 week; Comments: Scan at 8.5 weeks suggesting no heartbeat. Baby stopped growing at 6 weeks.
CDC Split Type: GBPFIZER INC202101045787

Write-up: This is a spontaneous report from a contactable consumer, downloaded via the regulatory authority (GB-MHRA-WEBCOVID-202108081619068620-PWKZB; safety report unique identifier: GB-MHRA-ADR 25771551). A 28-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not known), via an unspecified route of administration, on an unspecified date, as dose number unknown, single dose, for COVID-19 immunisation. Medical history included decreased lactation from an unknown date and unknown if ongoing. Patient conceived in the mid of Jun 2021 and lost pregnancy. Concomitant medication(s) included folic acid for vitamin supplementation, start and stop date not reported. The patient had her last dose of vaccine in May 2021. Her husband had vaccination at the end of Jul 2021. The patient found she had a miscarriage on unknown date. Patient exposed to the medicine before pregnancy. The patient underwent lab tests and procedures, which included SARS-CoV-2 test: negative (No - Negative COVID-19 test) and scans. The scan at 8.5 weeks suggested no heartbeat. The baby stopped growing at 6 weeks. Patient has not tested positive for COVID-19 since the vaccination. Patient not enrolled in a clinical trial. Reportedly, the medicine had an adverse effect on any aspect of the pregnancy. The event reported serious (congenital anomaly/birth defect); with outcome of not recovered. No follow-up attempts possible. Information about lot number cannot be obtained. No further information expected.


VAERS ID: 1636014 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210609; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Abortion spontaneous; Maternal exposure during pregnancy; This case was received (Reference number: ADR 25811486) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Abortion spontaneous) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jul-2021, the patient received second 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 an unknown date, the patient experienced ABORTION SPONTANEOUS (Abortion spontaneous) (seriousness criteria hospitalization and medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Abortion spontaneous) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. Concomitant drug details not provided. Treatment details not provided One week after having the vaccine patient had a miscarriage at between 7-11 weeks pregnant. Company Comment: This is a case of product exposure during pregnancy with associated adverse event for this 37-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This is a case of product exposure during pregnancy with associated adverse event for this 37-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1657297 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Headache, Inappropriate schedule of product administration, Lethargy, Maternal exposure during pregnancy, SARS-CoV-2 test, Scan
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage; Pregnancy (The patient first pregnancy (previous pregnancies) was healthy to term); Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20210806; Test Name: SCAN; Result Unstructured Data: Test Result:No fetal heartbeat found; Comments: no fetal heartbeat found at 12 weeks scan
CDC Split Type: GBPFIZER INC202101075807

Write-up: headache; Maternal exposure during pregnancy; Miscarriage of pregnancy; Lethargy; inappropriate schedule of vaccine administered (first dose was administered on 17May2021 and second dose was administered on 01Jul2021); This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. This report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108181146037250-QNDLO and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25816793. A 39-year-old (pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC9001) via an unspecified route of administration on 01Jul2021 as dose 2, single and the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER9449) via an unspecified route of administration on 17May2021 as dose 1, single for COVID-19 immunisation. Medical history included abortion spontaneous from an unknown date and unknown if ongoing, pregnancy from an unknown date and unknown if ongoing, suppressed lactation from an unknown date and unknown if ongoing and pregnancy from an unknown date and unknown if ongoing, patient was no longer pregnant at the time of reporting. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Concomitant medications included folic acid was taken for vitamin supplementation, start and stop date were not reported and paracetamol was taken for toothache, start and stop date were not reported. On an unspecified date, the patient experienced headache, maternal exposure during pregnancy, miscarriage of pregnancy, lethargy and inappropriate schedule of vaccine administered (first dose was administered on 17May2021 and second dose was administered on 01Jul2021). Second vaccine administered at around the patient was 6 weeks pregnant. On 06Aug2021, 12 weeks dating scan, no fetal heartbeat found, estimated to have stopped developing around 10 days after vaccine. Reporter was unsure that the vaccine had an adverse effect on any aspect of the pregnancy. The patient first pregnancy (previous pregnancies) was healthy to term. Second pregnancy missed miscarriage. Patient was exposed to the medicine first-trimester (1 to 12 weeks). Estimated stopped developing around 7/8 weeks gestation. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on an unspecified date No - Negative COVID-19 test, scan: no fetal heartbeat found on 06Aug2021 no fetal heartbeat found at 12 weeks scan. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1659891 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Body mass index, Ultrasound foetal
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: Multiple meningioma; Obesity (BMI 44.9 kg / m?); Surgery
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:44.9 kg / m?; Test Date: 20210721; Test Name: Ultrasound; Result Unstructured Data: Test Result:estimated a term of around 6 weeks of amenorrhea; Comments: and which found an embryo without cardiac activity
CDC Split Type: FRPFIZER INC202101061873

Write-up: Early miscarriage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-NC20213492. This physician reported information for both mother and fetus. This is a maternal report. A 31-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on 03Jun2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history Obesity (BMI 44.9 kg / m?), and history of multiple operated meningiomas. The patient''s concomitant medications were not reported. The patient had vaccination against COVID-19 with the COMIRNATY vaccine: dose 1 (batch number unknown) on 03Jun2021, and dose 2 (batch no. FE7010) in the left arm on 15Jul2021. Clinical signs and chronology of events: patient with no particular gynaecological-obstetrics history and having discovered her pregnancy during the period between the two doses of the COMIRNATY vaccine. She performed an Ultrasound to check the dating of her pregnancy on 21Jul2021 which estimated a term of around 6 weeks of amenorrhea, and which found an embryo without cardiac activity. The patient''s gynaecologist was of the opinion that the pregnancy stopped (unspecified date) during the period between the two doses of the COMIRNATY vaccine. Conclusion: A 31-year-old female patient who had an early miscarriage (medically significant) within a timeframe compatible with her anti-COVID 19 vaccination with the COMIRNATY vaccine. The outcome of the event was recovered with sequelae. 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-202101102469 mother and fetus case


VAERS ID: 1661927 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

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

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

Write-up: Miscarriage; Pain; Heavy periods; Menstrual cramp; This case was received via RA (Reference number: GB-MHRA-ADR 25836822) on 24-Aug-2021 and was forwarded to Moderna on 24-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage), PAIN (Pain), HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Menstrual cramp) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Miscarriage. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant) and DYSMENORRHOEA (Menstrual cramp) (seriousness criterion medically significant). The patient was treated with CODEINE PHOSPHATE HEMIHYDRATE, PARACETAMOL (COCODAMOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), PAIN (Pain) and HEAVY MENSTRUAL BLEEDING (Heavy periods) was resolving and DYSMENORRHOEA (Menstrual cramp) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided. The patient had never in life had such painful cramping and heavy bleeding. The patient could not walk properly or sit down, was in so much pain. The patient experienced a period considerably heavier than had ever before. The patient had to empty menstrual cup 4 times in 24 hours because it was full and leaking. The patient usually only have to empty it each day twice, for hygiene purposes, not because its full! There were very large clots in period, which is not typical for the patient. The patient thought that she was experiencing a miscarriage (but tested negative) it was so much worse than she have experienced before. The patient Saw the GP for advice and been taking Cocodamol to help. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. 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. Events seriousness captured as per Regulatory Authority assessment in the Source Document. Event Miscarriage captured per SD from Regulatory Authority reporting and it differ from what is described on the narrative (The patient thought that she was experiencing a miscarriage but tested negative).; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness captured as per Regulatory Authority assessment in the Source Document. Event Miscarriage captured per SD from Regulatory Authority reporting and it differ from what is described on the narrative (The patient thought that she was experiencing a miscarriage but tested negative).


VAERS ID: 1671275 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed
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: ESPFIZER INC202101095051

Write-up: Fetus stopped growing at week 8/deferred abortion; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program COVID 19 Dedicated Call Center (Customer Service). A 44-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer reported that his partner is using by medical prescription cytotec as an abortive (the fetus stopped growing at week 8) to expel him. Had the first dose of the anti-covid. This Monday has an appointment to put the second dose and that same Monday should put a tablet of cytotec via vaginal. The reporter further reported that they have a deferred abortion. The doctor recommended him to remove Cytotec via vaginal. The patient has had a first cycle of 2 times four pills every day and the last time, the consumer think it was the last Sunday and now she has been prescribed Monday Thursday Monday Thursday and has started this morning with a single pill then this afternoon at a four o''clock scheduled the vaccine and the question is whether they are compatible or not. Therapeutic measures were taken as a result of the event which included treatment with Cytotec as an abortifacient to expel him (baby). The outcome of the event was unknown. The lot number for bnt162b2, was not provided and will be requested during follow up


VAERS ID: 1671298 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101086534

Write-up: Nausea; Vaccine exposure during pregnancy; Abortion spontaneous; Endometriosis related pain; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB FI-FIMEA-20213990. A 41 years old female patient received BNT162B2 (COMIRNATY) intramuscular on 22Jun2021 at single dose administered in the right upper arm for COVID-19 immunisation. Medical history and concomitant drug were not reported. patient experienced nausea, Vaccine exposure during pregnancy, Abortion spontaneous and Endometriosis related pain with outcome was not revovered. The pain in the endometriosis worsened considerably, also had a miscarriage at about 5+1 weeks of gestation, i.e., fertilization probably at the same time with the vaccine. Endometriosis pain + nausea were significantly more severe also in the post miscarriage cycle. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information expected.


VAERS ID: 1676879 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101096253

Write-up: Stillbirth/child would not be born (the child had died).; fever; weakness; This is a spontaneous report from a contactable consumer. This is the second of the two reports. Only this case is serious. A pregnant female patient of an unspecified age received bnt162b2 (COMIRNATY, lot unknown), via an unspecified route of administration on an unspecified date as dose 2, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had her dose 1 of bnt162b2 (lot unknown) on unspecified date and experienced weakened and fever. The reporter''s wife consulted a doctor about whether or not the patient should be admitted a second dose of vaccine. The doctor said the reporter''s wife should take a second dose of the vaccine. In 10 during the week of pregnancy, the reporter and his wife learned from the doctor that the child would not be born (the child had died, also reported as stillbirth). The patient also experienced weakened and had she a fever on unspecified date. The outcome of events was unknown. The following information on the lot number has been requested.


VAERS ID: 1679422 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-07
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 INC2021888544

Write-up: 6 weeks pregnant and a miscarriage at 9 weeks''; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient stated that patient have taken the 2 doses of the Pfizer COVID vaccine and just now found out that she was 6 weeks pregnant. She would have taken the second dose probably 1-2 days after conception or somewhere around there. She works in clinical research in another pharma company (1 of the big ones like Pfizer) and understand the need to collect sound data specially at times like now when they are eager to know as much as possible about the vaccine and in this case, in pregnancies. Upon follow up on 22Jul2021, it was reported that there was no adverse event (AE), had no symptoms or any untoward medical occurrences to warrant AE reporting and she was about 7 weeks pregnant. Upon follow up on 25Aug2021, it was reported that she had a miscarriage at 9 weeks. She believed this needs to be reported now. The outcome of event was unknown. Follow up (25Aug2021): New information from the same consumer included: Event "6 weeks pregnant" was updated to "6 weeks pregnant and a miscarriage at 9 weeks". Clinical course was updated. No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected.


VAERS ID: 1687092 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101097327

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-202108222031541240-NKKLN. Safety Report Unique Identifier GB-MHRA-ADR 25833817. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing and suspected COVID-19 unsure when symptoms started and unsure when symptoms stopped. Patient is not enrolled in clinical trial. Patient is not pregnant at the time of reporting. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced miscarriage on an unspecified date with outcome of recovered with sequelae on an unspecified date . he patient underwent lab tests and procedures which included Covid-19 virus test: Negative COVID-19 test on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The patient also received the dose 2 of BNT162B2 on unspecified date (Lot number was not reported) for COVID-19 immunisation. The event was assessed as serious, medically significant and congenital anomaly by regulatory authority. Additional information: Had TWO miscarriages between my 1st and 2nd dose of Pfizer. Relevant investigations or tests conducted: "Being referred to a recurrent miscarriage clinic." No follow-up attempts are possible; mention about lot/batch number cannot be obtained.


VAERS ID: 1690005 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Illness, Pyrexia, SARS-CoV-2 antibody test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Test Result: high number of antibodies.
CDC Split Type: DEPFIZER INC202101144523

Write-up: in the 6th SW she suffered an abortion; high fever; she was very sick; This is a spontaneous report based on information received by Pfizer from Biontech manufacturer control number 83041, license party for Comirnaty. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient''s concomitant medications were not reported. As reported the patient has been vaccinated against Corona since May. She had a side effect of a high fever and she was very sick. There were high levels of antibodies. In mid-July she was 4 weeks pregnant. The physician already said that the baby is developing very difficult. Today we got the news that the baby has not developed after 6 weeks. The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1697086 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101128070

Write-up: pregnant and had the vaccine and miscarried; This is a spontaneous report from a contactable consumer. A pregnant female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that she knew the patient who was pregnant and had the vaccine and miscarried. The pregnancy resulted in spontaneous abortion. The outcome of the event was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1697894 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Eye pain, Fatigue, Headache, Pain in extremity
SMQs:, Glaucoma (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101132630

Write-up: miscarriage; brutal headache; eye pain; exhaustion; pain in limb; This is a spontaneous report from a contactable consumer, reporting for herself. A 36-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Jul2021 (Batch/Lot Number: FE6975; Expiration Date: 31Aug2021) as DOSE NUMBER UNKNOWN, SINGLE (at the age of 36 years old) for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced miscarriage on an unspecified date with outcome of unknown, brutal headache on an unspecified date with outcome of unknown, eye pain on an unspecified date with outcome of unknown, exhaustion on an unspecified date with outcome of unknown, and pain in limb on an unspecified date with outcome of unknown. Adverse reaction description: 2.5 weeks of brutal head and eye pain, exhaustion, pain in the limbs and miscarriage because fetus was not intact due to vaccination. No follow-up attempts possible. No further information expected.


VAERS ID: 1698608 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Termination of pregnancy and risk of abortion (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101133975

Write-up: Pregnancy prematurely stopped; Urticaria; This is a spontaneous report received from a contactable physician. An adult female patient received bnt162b2 (COMIRNATY), dose 1 and dose 2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pregnancy prematurely stopped and urticaria. The patient''s pregnancy was prematurely stopped at month 2, she also presented with urticaria. There was no details regarding the beginning of pregnancy. According to the physician, urticaria was probably related to pregnancy and the pregnancy prematurely stopped at month 2 was not necessarily related to the vaccination. The outcome of the events was unknown. The lot number for bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event spontaneous abortion and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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..


VAERS ID: 1714766 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
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: Foetal death, Headache, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

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

Write-up: Her 6-month baby died inside her womb; headaches; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of FOETAL DEATH (Her 6-month baby died inside her womb) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced FOETAL DEATH (Her 6-month baby died inside her womb) (seriousness criterion medically significant), HEADACHE (headaches) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Still birth. For foetus 1, The outcome was reported as Stillbirth NOS. At the time of the report, FOETAL DEATH (Her 6-month baby died inside her womb) and HEADACHE (headaches) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient called to inform that her 6-month baby died inside her womb. He died after received the 2nd dose of the vaccine. Since her son''s passing, she has been getting these terrible headaches. Patient was angry at Moderna since this was her first baby. Doctors confirmed that the cause of death was the vaccine This case concerns female patient of unknown age with no relevant medical history, who experienced the unexpected events of vaccine exposure during pregnancy and foetal death (6 months pregnancy). The patient received the second dose of vaccine at an unknown period of gestation. Foetal death occurred at an unknown date after the second dose of Spikevax. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax in not affected by this report. Reporter did not allow further contact; Sender''s Comments: This case concerns female patient of unknown age with no relevant medical history, who experienced the unexpected events of vaccine exposure during pregnancy and foetal death (6 months pregnancy). The patient received the second dose of vaccine at an unknown period of gestation. Foetal death occurred at an unknown date after the second dose . The event was considered related to the product per the reporter''s assessment.


VAERS ID: 1716061 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

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

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

Write-up: miscarriage; Maternal exposure during pregnancy; Early miscarriage; This case was received (Reference number: GB-MHRA-ADR 25928047) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (miscarriage), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and ABORTION SPONTANEOUS (Early miscarriage) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Ectopic pregnancy. Concurrent medical conditions included Pregnancy. Concomitant products included FOLIC ACID for Folic acid supplementation. On 18-Aug-2021, the patient received second 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 an unknown date, the patient experienced ABORTION SPONTANEOUS (miscarriage) (seriousness criteria medically significant and congenital anomaly), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion congenital anomaly) and ABORTION SPONTANEOUS (Early miscarriage) (seriousness criteria medically significant and congenital anomaly). At the time of the report, ABORTION SPONTANEOUS (miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown and ABORTION SPONTANEOUS (Early miscarriage) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication reported. Lab data given Ultrasound with unknown results. On the 25th September patient was due to have a surgical management of miscarriage procedure. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Details of previous pregnancies: 3 and a half weeks after patient''s second Moderna jab, she had an early ultrasound due to a previous ectopic pregnancy a few years ago. No heartbeat was detected via the ultrasound and she was diagnosed with a delayed pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). Diagnosed with a delayed miscarriage. This case concerns a 34-year-old, female patient with relevant medical history of previous ectopic pregnancy, who experienced the unexpected events of maternal exposure during pregnancy and spontaneous abortion. The patient received the second dose of vaccine at around 1-12 weeks of gestation or during the first trimester. Date of spontaneous abortion was not given. The event was considered related to the product per the reporter''s assessment. The medical history of previous ectopic pregnancy remains a confounder. The benefit-risk relationship of Moderna CoviD-19 Vaccine in not affected by this report.; Sender''s Comments: This case concerns a 34-year-old, female patient with relevant medical history of previous ectopic pregnancy, who experienced the unexpected events of maternal exposure during pregnancy and spontaneous abortion. The patient received the second dose of vaccine at around 1-12 weeks of gestation or during the first trimester. Date of spontaneous abortion was not given. The event was considered related to the product per the reporter''s assessment. The medical history of previous ectopic pregnancy remains a confounder. The benefit-risk relationship of Moderna CoviD-19 Vaccine in not affected by this report.


VAERS ID: 1718521 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-21
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: GBPFIZER INC202101204814

Write-up: Miscarriage; This is a spontaneous report received from two contactable consumers (one of them is the patient) downloaded from the Regulatory Authority-WEB XI-EMA-DD-20210902-agrahari_P-131107. The husband of a 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient did not have the vaccine but the husband has had the Pfizer vaccine & within a few weeks of the second vaccine she fell pregnant & then miscarriaged on an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. The event was considered medically significant. Outcome of the event was unknown. Follow up (06Sep2021): New information downloaded from the Regulatory Authority-WEB includes: EMA WWID reported as XI-EMA-DD-20210902-agrahari_P-131107. Case 2021705171 was incorrectly submitted to E2B trading partners with the E2B Authority number GB-MHRA-WEBCOVID-202106101118539710-KWMZL of this case 202101204814. Case 2021705171 is considered invalid and corresponding information is re-entered under this new manufacturer report number 202101204814. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724389 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: Ultrasound; Result Unstructured Data: Test Result:- Consultation with a midwife with an ultrasound
CDC Split Type: FRPFIZER INC202101185932

Write-up: Pregnancy loss <20 weeks gestation; This is a spontaneous report from a contactable physician received via database, was notified by a doctor and downloaded from the Regulatory Agency (RA)-WEB FR-AFSSAPS-PV20212657. This physician reported information for both mother and fetus. This is a maternal report. A 4-decade-old (30-40 years) pregnant female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an intramuscular route of administration on an unspecified date as dose 1, 0.3 ml single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date in 2021, the patient experienced pregnancy loss <20 weeks gestation. It was further reported that 7 days after a first vaccination against COVID-19, onset of an early miscarriage at 5 weeks of amenorrhea. The mother reported she became pregnant while taking bnt162b2. The mother was 5 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. It was reported that patient never had miscarriage. The patient underwent lab tests and procedures which included ultrasound scan: - consultation with a midwife with an ultrasound on an unspecified date. The clinical outcome of the events was reported as recovering. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.


VAERS ID: 1726091 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion, 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: BRPFIZER INC202101182886

Write-up: two more cases of abortion in my city because of this vaccine; two more cases of abortion in my city because of this vaccine; This is a spontaneous report from a contactable consumer (unspecified relationship with patient) via Medical Information Team. This consumer reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age received BNT162B2 (COMIRNATY; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The consumer reported that there were two more cases of abortion in his/her city because of this vaccine. The outcome of the events 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) : BR-PFIZER INC-202101190479 same reporter, drug, and event; different patient.


VAERS ID: 1733157 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 04Feb2022 Was 3/4 weeks pregnant at first vaccine)
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201103; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 202107; Test Name: scan; Result Unstructured Data: Test Result:the baby had stopped developing at 5 or 6 weeks; Comments: 12 week scan
CDC Split Type: GBPFIZER INC202101251733

Write-up: missed miscarriage; This is the second of 2 reports, for the first dose. The first report is a a solicited report from a Monitor program from a contactable consumer (patient), received from a regulatory authority, regulatory authority report number is GB-MHRA-YCVM-202106021734434530-YAPSO, Safety Report Unique Identifier GB-MHRA-ADR 25706700. An adult (33 or 34 years old) pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 33 years old via an unspecified route of administration on 19May2021 (Lot Number: ET8885) as single dose for COVID-19 vaccination. Medical history included pregnancy from 27Apr2021 (last menstrual period) and ongoing Estimated due date as reported: 04Feb2022, Was 3/4 weeks pregnant at first vaccine); and Suspected COVID-19 from 01Nov2020 to an unknown date (Unsure when symptoms stopped); and Folic acid supplementation. Patient is not currently breastfeeding. Patient is 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 had Missed abortion, serious for other medically important condition. The patient was unaware she was pregnant when she had the first vaccine dose. She was 3/4 weeks pregnant at first (bnt162b2) vaccine. She was due to deliver on 04Feb2022. She found on her 12 week (assumed in Jul2021) scan that her baby had stopped developing at about 6 weeks and she had had a missed miscarriage. Details of scans or investigations: 12 weeks scan found the baby had stopped developing at 5 or 6 weeks. The patient also underwent COVID-19 virus test on 03Nov2020: negative (No - Negative COVID-19 test). She had no idea if this was related to the first vaccine dose or not. Patient was unsure if vaccination had an adverse effect on any aspect of the pregnancy. The outcome of the event Missed abortion was unknown. Patient has not tested positive for COVID-19 since having the vaccine. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information provided, there is no information to suggest a causal relationship between bnt162b2 vaccine and the reported event of Abortion missed. The first trimester is associated with the highest risk for miscarriage. Case will be reassessed upon receipt of additional information.


VAERS ID: 1738846 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211459

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109142037511830-IREPZ, Safety Report Unique Identifier GB-MHRA-ADR 25941239. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The patient medical history and concomitant medications were not reported. The patient previously received the dose 1 of BNT162B2 on an unspecified date (batch/lot number not reported) for COVID-19 immunisation.The patient experienced miscarriage on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included Covid-19 virus test: negative on unspecified date No - Negative COVID-19 test. The event was assessed as serious and medically significant by regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742015 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101206338

Write-up: I had a miscarriage after the first vaccine and after the second dose. Two separate pregnancies, both ended in tremendous loss. I was ENCOURAGED to get the shot while pregnant. Background info - I h; This is a spontaneous report received from a contactable Consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 28Jun2021 (at the age of 27-years-old) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient was pregnant at the time of vaccination. The patient had 2 children, both carried to full term. The patient reported that she experienced a miscarriage after the first vaccine and after the second dose on unspecified dates. She had two separate pregnancies, both ended in tremendous loss and she was encouraged to get the shot while pregnant. The events resulted in physician office visit and emergency room care. The patient did not receive any treatment for the event. The outcome of the event was recovered with sequalae.


VAERS ID: 1745779 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion, 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: BRPFIZER INC202101190479

Write-up: Abortion because of this vaccine; Abortion because of this vaccine; This is a spontaneous report from a contactable consumer via the Regulatory Authority. This consumer reported the same events for two patients. This is the second of two reports. A female patient of unspecified age received BNT162B2 (COMIRNATY; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The consumer reported that there were two more cases of abortion in his/her city because of this vaccine. The outcome of the events 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) : BR-PFIZER INC-202101182886 same reporter, drug, and event; different patient


VAERS ID: 1746001 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / 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? 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: DEPFIZER INC202101223991

Write-up: she has lost the child; Case 202101223991 and 202101224160 are duplicates. All subsequent follow-up information will be reported under 202101223991. This is a spontaneous report from a non-contactable consumer based on information received by Pfizer from Biontech [manufacturer control number: 87092, license party for Comirnaty. A female patient of an unspecified age received bnt162b2 (COMIRNATY; Lot Number: FA5833 and expiration date was not reported), via an unspecified route of administration on 05Jun2021 at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY; Lot Number: EX3510 and expiration date was not reported), via an unspecified route of administration on 23Apr2021 at dose 1, single for covid-19 immunization. After second dose of vaccination, patient noticed that she did not get her next two periods, it turned out that she was pregnant in July2021. Now she has lost the child her doctor said it could be related to the vaccination. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101224160 PFIZER INC


VAERS ID: 1746527 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.); Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190706

Write-up: Maternal exposure during pregnancy; Early miscarriage; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109091921216430-EOEZC; Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25919948. A 33-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing (Patient no longer pregnant at the time of reporting). The patient''s concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced maternal exposure during pregnancy and early miscarriage. The medicine had an adverse effect on any aspect of the pregnancy. Pregnancy adverse effects details reported as miscarriage after 2nd vaccine. Patient was exposed to the medicine first-trimester (1-12 weeks). The outcome of the event early miscarriage was recovered with sequelae. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746611 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: scan; Result Unstructured Data: Test Result:No heartbeat at 8 weeks 2 days; Comments: No heartbeat at 8 weeks 2 days but found out at 10 weeks
CDC Split Type: GBPFIZER INC202101224692

Write-up: Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109160758518780-QTFPN with Safety Report Unique Identifier of GB-MHRA-ADR 25950287. A 33-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration on 26Aug2021 as a single dose for COVID-19 immunisation. Medical history included pregnancy. The patient was not breast feeding at the time of report. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not enrolled in the clinical trial. Concomitant medications included folic acid at 400 ug for folic acid supplementation. It was reported that patient received second dose of bnt162b2 on 26Aug2021 and was pregnant at the time of vaccination, had maternal exposure of pregnancy in the first trimester (1-12 weeks). On an unknown date in 2021, the patient experienced miscarriage of pregnancy. Event was reported as serious for being medically significant. It was reported that medicine had an adverse effect on the pregnancy. On an unknown date in 2021, the patient underwent scan and the result was no heartbeat of the foetus at 8 weeks 2 days but found out at 10 weeks. The patient had not been tested positive for COVID-19 since the vaccination. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1747379 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? 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: PLPFIZER INC2021682500

Write-up: miscarriage; This is a spontaneous report from a contactable consumer (patient herself) forwarded by Medical information team. A female patient of an unspecified age received BNT162b2 (COMIRNATY, Solution for injection, Lot number- unknown) via an unspecified route of administration on 07May2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On 07May2021, she accepted the first dose of vaccination. She was pregnant which she found out after vaccination. She decided not to take the second dose. However, the pregnancy was stopped and the patient had a miscarriage. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. In view of the situation, the reporter took the second dose of COMIRNATY 07Jul2021. After the second dose of the vaccine, no adverse reactions occurred. The outcome of the event was unknown. Follow up (17Sep2021): New information from the same consumer (patient) includes: pregnancy information, event miscarriage added, event Maternal vaccine exposure deleted; and second dose vaccination details.


VAERS ID: 1751520 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, 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? 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 INC202101229191

Write-up: Miscarriage; the second vaccination took place during pregnancy; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB NL-LRB-00684090. This consumer or other non hcp reported information for both mother and fetus. This is a maternal report for the second dose. Two reports out of three are serious. This serious spontaneous report from a consumer or other non-health professional concerns about 31-years-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 03Aug2021, as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 22Jun2021, as single dose, 0.3ml, for COVID-19 immunisation and had maternal exposure before pregnancy. On an unspecified date the patient had miscarriage (3 days after start vaccination), maternal exposure during pregnancy following administration of covid-19 vaccine, and inappropriate schedule of vaccine administered. The first Covid vaccination took place before pregnancy and the patient was not pregnant at the time of the first vaccination, while the second vaccination took place during pregnancy. At the time of the second vaccination the patient was pregnant. According to the gyn''s calculations, a few days later the embryo stopped dividing. Miscarriage occurred last week at approx 10 weeks. The foetus stopped dividing at approx 6 weeks. The pregnancy duration at time of the second vaccination and the miscarriage were unknown. Outcome of the events was unknown. Sender''s comment: Since the nature of the reported reaction does imply seriousness according to one of the regulatory authority critera, the reaction was considered as serious by the regulatory authority. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101263453 The same patient, first dose, different events


VAERS ID: 1755017 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Dysmenorrhoea, 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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225238

Write-up: Early miscarriage/ miscarriage; Period pains; Irregular periods; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109160935497650-ZPRFR and Safety Report Unique Identifier is GB-MHRA-ADR 25951301. A 33-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: ew4109) as dose 1, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient previously took folic acid. On an unspecified date, the patient experienced early miscarriage/ miscarriage, period pains and irregular periods. The clinical course was reported as follows: The patient was pregnant (no longer pregnant at the time of the report) and had an early miscarriage after vaccine. Unknown if related. Also having irregular and painful periods now. Unsure if the vaccine has an adverse effect on any aspect of the pregnancy. Patient did not take folic acid supplement during pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient had COVID-19 Virus Test (Unknown date): No - Negative COVID-19 test. The outcome for the events early miscarriage/ miscarriage was unknown; outcome for the events period pains and irregular periods was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1758087 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Menstruation delayed, 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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226709

Write-up: Miscarriage; Late period; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109171958298350-4CXUV. Safety Report Unique Identifier GB-MHRA-ADR 25961077. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at dose 1, single for COVID-19 immunisation; and folic acid, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included pregnancy (Patient no longer pregnant at the time of reporting). Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced maternal exposure during pregnancy on an unspecified date with outcome of unknown, miscarriage on an unspecified date with outcome of recovered with sequelae, late period on an unspecified date with outcome of not recovered. The patient underwent lab tests which included Covid-19 virus test: negative No - Negative COVID-19 test on an unspecified date. The events were assessed as serious and medically significant by regulatory authority. Additional information: Did the medicine have an adverse effect on any aspect of the pregnancy: Yes. Pregnancy adverse effects details: Began to bleed the day after first dose. Patient did not take folic acid supplement during pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Miscarried the day after first dose. No follow-up at tempts are possible, information about Lot/Batch number cannot be obtained. No further information is expected.


VAERS ID: 1758410 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
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 INC202101243261

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 624478. A pregnant female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced abortion spontaneous on an unspecified date. The pregnancy resulted in spontaneous abortion. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1760052 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101263402

Write-up: spontaneous miscarriage; pregnant female patient received bnt162b2; This is as spontaneous report received from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-PS20212091. The same reporter reported events after both vaccine doses for the mother and the fetus. This is the first report for the second dose, for the mother. A 34-year-old pregnant female patient received bnt162b2 (COMIRNATY), intramuscular, administered in the left arm on 31Jul2021 (at the age of 34-years-old) (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunisation. Pregnancy information included 48 days gestation period. Medical history and concomitant medications were not reported. No history of COVID. On an unspecified date, the patient experienced spontaneous miscarriage. The event was described as follows: Report of a spontaneous miscarriage 13 days after the second injection of the Comirnaty vaccine. There is a strong coincidence between the date of the stop of growth of the embryo given by the doctor and the date of this second injection. The embryo stopped at 6 WA + 6 days. The patient recovered from spontaneous miscarriage on an unspecified date. Spontaneous miscarriage was considered serious, medically significant by the regulatory authority. "Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures" Official Bulletin No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101239544 Fetal case


VAERS ID: 1760094 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
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 INC202101243042

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other healthcare professional (HCP) received from the regulatory authority. The regulatory authority report number is 624105. This is a maternal report. A 36-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced abortion spontaneous on an unspecified date. The patient was pregnant at the time of vaccination. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1762579 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101243854

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health care professional via the Regulatory Authority (RA). Regulatory authority report number is 625999. A 27-years-old female pregnant patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number-not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Patient was pregnant at the time of vaccination. The patient medical history was not reported. The concomitant medications included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient experienced abortion spontaneous on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1762584 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Stillbirth
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 INC202101288744

Write-up: stillborn babe third trimester; This is a spontaneous report from a contactable nurse received via a sales representative. A female patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced stillborn babe third trimester on an unspecified date. 2nd dose Pfizer COVID vaccine 3 days before patient stopped feeling baby moving. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the reported information ,a causal relationship between the event Still Birth and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1763053 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101264950

Write-up: Pregnancy loss; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109231037235130-2X9WZ, Safety Report Unique Identifier GB-MHRA-ADR 25982714. A non-pregnant female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), via an unspecified route of administration on 11Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19.The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced pregnancy loss (abortion spontaneous). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.The outcome of pregnancy loss was resolved on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1763573 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210920; Test Name: ultrasound; Result Unstructured Data: Test Result:detected that the embryo had no signs of life and; Comments: I had an ultrasound for my pregnancy and they detected that the embryo had no signs of life and that its development was cut off in the 8th SDG, when it should have had 12 SDG
CDC Split Type: MXPFIZER INC202101280886

Write-up: had an ultrasound for my pregnancy and they detected that the embryo had no signs of life and that its development was cut off in the 8th week of gestation; This is a spontaneous report from a contactable consumer or other non hcp (patient) received from medical information team and reported information for both mother and fetus/baby. This is maternal report. A 33-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: unknown, expiry date: not reported) via an unspecified route of administration on 30Jul2021 as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: unknown, expiry date: not reported) via an unspecified route of administration on 07Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On an unspecified date, The patient had an ultrasound for pregnancy and they detected that the embryo had no signs of life and that its development was cut off in the eighth week of gestation. The patient was vaccinated with the first dose of the vaccine when was fourth weeks pregnant (sdg) (at that time, did not know that she was pregnant 30jul2021), and in the tenth week of gestation at sdg 10, the patient received the second dose. The mother was 4 Weeks pregnant at the onset of the event.The patient would like her case to be taken into account and can be informed when there are studies on the application of the vaccine and if it has negative effects on the product of a pregnancy and if it was possible that this was the reason that the patient pregnancy failed . As of today, they are following me up in my hospital to carry out the necessary studies and give an accurate diagnosis of situation.The patient underwent lab tests and procedures which included ultrasound scan: detected that the embryo had no signs of life and on 20Sep2021 I had an ultrasound for my pregnancy and they detected that the embryo had no signs of life and that its development was cut off in the 8th SDG, when it should have had 12 SDG.The outcome of the event was unknown. The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.


VAERS ID: 1769785 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210819; Test Name: pregnancy test; Test Result: Positive ; Test Name: scans; Result Unstructured Data: Test Result:Restricted growth, missed miscarriage; Test Name: ultrasound scan; Result Unstructured Data: Test Result:embryo with restricted growth (3mm); Comments: At week 7 of pregnancy
CDC Split Type: GBPFIZER INC202101294558

Write-up: Maternal exposure during pregnancy, exposed to the medicine first-trimester (1-12 weeks); non-viable pregnancy; Early miscarriage; i had the second dose of the vaccine 5 days before ovulation; no other medication; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109291142347970-IXTEG, Safety Report Unique Identifier GB-MHRA-ADR 26008867. This consumer reported information for both mother and fetus. This is a mother report. A 34-year-old pregnant female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 30Jul2021 as single dose for COVID-19 immunisation. Medical history included pregnancy and ongoing pregnancy. She has not had symptoms associated with COVID-19, not had a COVID-19 test, not currently breastfeeding, and not enrolled in clinical trial. Concomitant medication included folic acid for folic acid supplementation from Nov2020. The patient experienced maternal exposure during pregnancy, early miscarriage, ovulation pain (reported as i had the second dose of the vaccine 5 days before ovulation), and vaccination site erythema (reported as no other medication) on an unspecified date. Case narrative: She had the second dose of the vaccine 5 days before ovulation and 20 days before testing positive in a pregnancy test (19Aug2021). At week 7 of pregnancy, an ultrasound scan showed an embryo with restricted growth (3mm). She was diagnosed with a "non-viable pregnancy" at week 9. She has been taking folic acid since Nov2020. No other medication, alcohol or drugs. No other health issues were known. Unsure if medicine had an adverse effect on aspect/s of the pregnancy. She had one successful previous pregnancy before. She was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Restricted growth, missed miscarriage. She was no longer pregnant at the time of reporting. She has not tested positive for COVID-19 since having the vaccine. The patient was recovering from early miscarriage, while 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.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101315108 Fetus case


VAERS ID: 1772469 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:size of the embryo did not correspond with the con; Comments: 1st scan; Test Name: ultrasound; Result Unstructured Data: Test Result:heart sounds detected; Comments: 2nd scan; Test Date: 20210628; Test Name: ultrasound; Result Unstructured Data: Test Result:no heart activity; Comments: (10th week)
CDC Split Type: DEPFIZER INC202101274287

Write-up: spontaneous abortion; drug exposure during pregnancy; This is a spontaneous report from a contactable consumer reporting for herself. This consumer reported information for both mother and fetus. This is a maternal report. A 39 year old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 06May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE (at the age of 38 years old) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced spontaneous abortion on an unspecified date with outcome of unknown, and drug exposure during pregnancy on an unspecified date with outcome of unknown. The mother reported she became pregnant while taking bnt162b2. The mother was due to deliver on 21Jan2022. The fetal outcome is intrauterine death. The patient underwent lab tests and procedures which included ultrasound scan: size of the embryo did not correspond with the conception date (10 days later) on 1st scan, ultrasound scan: heart sounds detected on 2nd scan, and ultrasound scan: no heart activity on 28Jun2021 (10th week). Description was reported as follows: "My last menstruation was on 16Apr. In this cycle fertizilation had taken place (25/26 Apr). On 06May I received my 1st vaccination (without knowing that I was already pregnant). During the 1st ultrasound the size of the embryo did not correspond with the conception date (10 days later). During 2nd ultrasound heart sound were detected. In the 10th week, on 28Jun unfortunately no heart activity was detected, anymore so that on 01Jul a curettage was performed. I do not blame the vaccination but wanted to inform you about that". The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1777267 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101273560

Write-up: Miscarriage; Child dead; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number DE-PEI-CADR2021071257 with Safety Report Unique Identifier DE-PEI-202100064544. A 33-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 04May2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunization. Medical history included pregnancy from an unknown date. The patient''s concomitant medications were not reported. The patient experienced a miscarriage, child died on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The mother was 4 months pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. Outcome of the event was recovered with sequelae. The reporter''s causality assessment for drug Comirnaty with the event as per agency was D. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1779712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UTROGESTAN; Zumenon
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101282853

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 628662. A 34-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included progesterone (UTROGESTAN) and estradiol (ZUMENON) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced abortion spontaneous (medically significant). Outcome of the event was recovered with sequelae. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1783735 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? 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 INC202101300901

Write-up: Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109292149205510-PWX3D, Safety Report Unique Identifier is GB-MHRA-ADR 26014663 A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test Patient was not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient experienced miscarriage of pregnancy on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The mother was 1 trimester (1-12 weeks) pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Patient no longer pregnant at the time of reporting. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Unsure if medicine have an adverse effect on any aspect of the pregnancy. The outcome of event was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1785890 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0575 / 1 RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: BRPFIZER INC202101293084

Write-up: missed abortion; This is a spontaneous report from a contactable consumer (patient) received through Regulatory Authority portal. This is first of two reports pertained to first dose. A 40-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in arm right on an unspecified date (pending clarification) (Lot Number: EY0575; Expiration date: not reported) as dose 1, single for COVID-19 immunisation. The patient''s medical history was not reported. Last menstrual period on 25May2021. Concomitant medication included folic acid (FOLIC ACID; strength: 5 mg) taken for an unspecified indication, start and stop date were not reported (taken within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On the date of the first dose, she was 07 weeks pregnant. In tenth week (unspecified date; pending clarification), she suffered a missed abortion in which it was found that the fetus stopped developing at 07 weeks. It was not resulted of doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care/hospitalization/prolongation of existing hospitalization (vaccine received during existing hospitalization)/life threatening illness (immediate risk of death from the event)/disability or permanent damage/patient died/congenital anomaly or birth defect. No treatment was received for the said event. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 03Aug2021 which was negative. The outcome of the event missed abortion was unknown. Additional information has been requested.; Sender''s Comments: Linked Report(s) : BR-PFIZER INC-202101306542 same patient/product; different dose and event


VAERS ID: 1786158 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Headache, Hypoaesthesia, Hypoaesthesia eye, Malaise, Paralysis
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Corneal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Termination of pregnancy and risk of abortion (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101298515

Write-up: Hypoaesthesia/numbness of the whole hand and gradual numbness of the cheek up to the area of the eye, followed by numbness of the flank down to the hips; Hypoaesthesia/numbness of the whole hand and gradual numbness of the cheek up to the area of the eye, followed by numbness of the flank down to the hips; Fatigue; Headache; feeling unwell/malaise; Miscarriage/miscarriage of pregnancy; subsequent paralysis-type reaction; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (RA)-WEB, Regulatory authority report number FI-FIMEA-20215083. This is the first of two reports. This is for the first dose. A pregnant 41-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced hypoaesthesia, fatigue, headache, feeling unwell/malaise, and miscarriage on unspecified dates. The patient was not diagnosed. The event further described as numbness of the whole hand and gradual numbness of the cheek up to the area of the eye, followed by numbness of the flank down to the hips. There was also some symptom in the leg on the vaccination side. The reaction from the first vaccine was immediate and transient until the next day. At the time of the first vaccination, the patient was pregnant in the very first weeks without her knowledge. The patient later experienced a miscarriage of pregnancy in week 9. The patient does not know if there was a connection between the vaccination, the subsequent paralysis-type reaction and miscarriage. The patient is recovering from the events. The events were assessed as serious (medically significant). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : FI-PFIZER INC-202101304019 same patient/drug, similar events, different dose


VAERS ID: 1789672 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101365805

Write-up: spontaneous miscarriage; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00648844. A 35-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Jun2021 (Lot number unknown) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced maternal vaccine exposure on an unspecified date with outcome of unknown and spontaneous miscarriage on an unspecified date with outcome unknown. The mother was pregnant while taking bnt162b2. The mother was 2 weeks pregnant at the onset of the event of exposure. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1794481 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? 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: NLMODERNATX, INC.MOD20213

Write-up: The foetus died in the uterus at around week 20 (1.5 to 2 weeks after vaccination); Vaccination during the 18th week of pregnancy; This case was received (Reference number: NL-LRB-00687341) on 04-Oct-2021 and was forwarded to Moderna on 08-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of FOETAL DEATH (The foetus died in the uterus at around week 20 (1.5 to 2 weeks after vaccination)) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during the 18th week of pregnancy) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 3003659) for COVID-19 vaccination. No Medical History information was reported. On 16-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced FOETAL DEATH (The foetus died in the uterus at around week 20 (1.5 to 2 weeks after vaccination)) (seriousness criterion medically significant). an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during the 18th week of pregnancy) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Intrauterine death. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, FOETAL DEATH (The foetus died in the uterus at around week 20 (1.5 to 2 weeks after vaccination)) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during the 18th week of pregnancy) had resolved. No concomitant medication is provided No treatment medication is provided Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Translated document received on 08-OCT-2021 contains updated verbatim; Sender''s Comments: This case concerns a female of unknown age, with no relevant medical history, who experienced the unexpected event of MATERNAL EXPOSURE DURING PREGNANCY and the serious unexpected event of FOETAL DEATH. The patient received the second dose of Spikevax at 18 weeks of gestation. The date of the event foetal death is not reported. Rechallenge is not applicable since no additional dose will be administered. The benefit-risk relation of Spikevax is not affected by this report.


VAERS ID: 1798798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: AUPFIZER INC202101319394

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 636573. A 36-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced abortion spontaneous on an unspecified date. The outcome of the event was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1806577 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: investigations; Result Unstructured Data: Test Result:Miscarriage following vaccine; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: scans; Result Unstructured Data: Test Result:Miscarriage following vaccine
CDC Split Type: GBPFIZER INC202101334563

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-GB-MHRA-WEBCOVID-202109302143519760-BD42I. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Known) as dose 1, single for Covid-19 immunisation. Medical history included pregnancy from an unknown date (patient no longer pregnant at the time of reporting). Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on an unspecified date with outcome of unknown and miscarriage on an unspecified date with outcome of recovering. The mother reported she became pregnant while taking bnt162b2. The mother was 1 Trimester pregnant at the onset of the event. The patient underwent lab tests and procedures which included Covid-19 virus test: no - negative Covid-19 test on an unspecified date. Additional information: Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Did the medicine have an adverse effect on any aspect of the pregnancy: Unsure Details of previous pregnancies: Pregnancy was not known when vaccine was given. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Miscarriage following vaccine - while I don''t think the vaccine causes the miscarriage. It should be recorded. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1807184 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Ultrasounds; Result Unstructured Data: Test Result:1 or 2 weeks behind calculations
CDC Split Type: NLPFIZER INC202101339824

Write-up: fetus died at 9 weeks and 2 days gestation; maternal exposure before pregnancy; Delayed ovulation. According to the ultrasounds I was 1 to 2 weeks behind according to the calculations; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority number NL-LRB-00694840. An adult female patient received bnt162b2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 31May2021 as dose 1, single for covid-19 immunisation. The patient medical history suspected covid-19 from 26Sep2020. The patient''s concomitant medications were not reported. This concerns a female aged 26 years, with ovulation delayed, maternal exposure before pregnancy, miscarriage. The patient was vaccinated on 31May2021, period started on 29May2021. The patient have a cycle of 28 days, where the ovulation was calculated. She became pregnant in this month (Oct2021), after getting the vaccine. According to the ultrasounds, she was 1 or 2 weeks behind according to the calculations. The pregnancy was almost terminated because there was no foetus. On the day of termination they only saw the foetus with a beating heart. At 9 weeks and 2 days the heart stopped beating and she had to take pills to terminate the pregnancy. Her body did not clear up on its own. Afterwards she also had a curettage. The outcome of the events was unknown. No follow-up attempts possible. No further information expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1809627 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400780

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer. This is the report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202110162319541620-RT9X0, Safety Report Unique Identifier GB-MHRA-ADR 26085188. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient''s medical history and patient''s concomitant medications were not reported. The patient experienced miscarriage on an unspecified date. The event was assessed as serious (medically significant, life threatening). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of the event was not recovered. The clinical course was reported as follows: Miscarriage. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1817693 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? 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 INC202101360777

Write-up: Foetal death; Maternal exposure during pregnancy; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number is 640260. A 33-years-old pregnant female patient received bnt162b2 (COMIRNATY, solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient was pregnant at time of vaccination. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had maternal exposure during pregnancy and experienced foetal death. The fetal outcome is intrauterine death. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1817766 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Back pain, Dysuria
SMQs:, Retroperitoneal fibrosis (broad), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101361921

Write-up: Abortion spontaneous; Back pain; Dysuria; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 639898. A 31-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced abortion spontaneous on an unspecified date with outcome of recovered with sequelae, back pain on an unspecified date with outcome of recovered with sequelae, dysuria on an unspecified date with outcome of recovered with sequelae. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1819146 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-09
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion induced
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 INC202101373371

Write-up: the patient was not anymore pregnant at the time of reporting; This is a spontaneous report received from a contactable pharmacist from a Pfizer-sponsored program. A 30-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 09Aug2021, as dose 1, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was pregnant at the time of vaccination. It was reported that the patient was exposed to vaccine at the time of pregnancy and the patient was not anymore pregnant at the time of reporting and did not receive the second dose. The reporter would like to know if the patient should receive the second dose or if she had to restart the vaccinal scheme. The reporter would like to know the vaccination protocol with Corminaty when the patient has exceeded the deadline for the 2nd dose. The outcome of the event was recovered. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: The information available in this report is limited and the reported event abortion induced cannot be totally excluded/assessed. This case will be reassessed when 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.


VAERS ID: 1823226 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004955 / 2 - / OT

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

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

Write-up: Maternal exposure during pregnancy; Missed abortion; This case was received via Regulatory Agency (Reference number: SE-MPA-2021-087805) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION MISSED (Missed abortion) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004955) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced ABORTION MISSED (Missed abortion) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION MISSED (Missed abortion) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. No Concomitant Medication Reported. No Treatment Medication Reported This is a regulatory case concerning a 35-year-old, female patient with a no relevant medical history reported who experienced the unexpected events of maternal exposure during pregnancy (at week 6 of gestation period) and ABORTION MISSED at 13 weeks of gestation.The events occurred after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report. Event?s seriousness was assessed as per regulatory authority report. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Translation document received on 20 Oct 2021 include Dosage text; Sender''s Comments: This is a regulatory case concerning a 35-year-old, female patient with a no relevant medical history reported who experienced the unexpected events of maternal exposure during pregnancy (at week 6 of gestation period) and ABORTION MISSED at 13 weeks of gestation.The events occurred after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report. Event?s seriousness was assessed as per regulatory authority report.


VAERS ID: 1841696 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101492448

Write-up: Fetal Movements not felt; possible intrauterine death; This is a spontaneous report from a contactable physician. The first report is received from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 25639498, Safety Report Unique Identifier GB-MHRA-ADR 25639498.This physician reported information for both mother and fetus. This is a fetus report. A fetus patient of unspecified age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number not reported), via transplacental on 23Jun2021 at 0.3 ml single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications was not reported. The patient experienced fetal movements not felt and possible intrauterine death (medically significant, life threatening) on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021893948 Maternal case


VAERS ID: 1841869 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMYLMETACRESOL;DICHLOROBENZYL ALCOHOL; CODEINE; VALERIAAN; FOLIUMZUUR; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (the first pregnancy was ok (without vaccination).)
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:with no baby left and blood t; Comments: the first ultrasound with no baby left and blood traces
CDC Split Type: NLPFIZER INC202101414923

Write-up: Miscarriage; This is a spontaneous report from a consumer downloaded from the Agency WEB, regulatory authority number NL-LRB-00698988. A 35 years old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Aug2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient had received the first dose of bnt162b2 on 09Jul2021. The patient medical history was not reported. Concomitant medications included amylmethacresol/dichlorobenzylalcohol Suction tablet, codeine tablet 20mg; valeriana officinalis extract (VALERIAAN) root extract tablet 45mg; folic acid (FOLIUMZUUR) suspension oral 1mg/ml; multivitamin with vitamin d capsule and paracetamol capsule 500mg all taken for an unspecified indication. On an unknown date after the Covid vaccinations the patient got pregnant. The patient had miscarriage which occurred on the 7th week of pregnancy. Pregnancy due day was before 28May2022. The first ultrasound showed no baby left and blood traces. It was reported that the first pregnancy was ok (without vaccination). The event was considered medically important condition. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the RA critera, the reaction (miscarriage) was considered as serious by the Regulatory Authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1845869 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESTROFEM [ESTRADIOL]; UTROGESTRAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Polycystic ovarian syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101429534

Write-up: Pregnancy measuring behind at 7 - 8 weeks, resulted in early pregnancy loss; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported information for both mother and fetus. This is a maternal report. A 36-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Sep2021 (Lot number was not reported) (at the age of 36-years-old) as dose 1, single for covid-19 immunisation. Medical history included polycystic ovaries (PCOS). Concomitant medications within two weeks included estradiol (ESTROFEM); progesterone (UTROGESTRAN); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced allergy (known allergies). The patient did not receive any other vaccines within four weeks of vaccination. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. The patient had pregnancy measuring behind at 7 - 8 weeks, resulted in early pregnancy loss on an unspecified 2021. The gestational period was reported as 5 weeks. The mother was due to deliver on 20May2022. The pregnancy resulted in spontaneous abortion. The event resulted in doctor or other healthcare professional office/clinic visit, congenital anomaly or birth defect. Therapeutic measures taken as a result of event was D&C (Dilation and curettage). The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : AU-PFIZER INC-202101429557 foetus case


VAERS ID: 1847688 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101447700

Write-up: Miscarriage; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable other HCP. This is the second of 2 reports. The first report is a report received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202110231014383890-7HCAW. Safety Report Unique Identifier GB-MHRA-ADR 26113273. An adult female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included miscarriage. Concomitant medications were not reported. Historical vaccine included the first dose of bnt162b2 on 01Feb2021 for covid-19 immunisation. Patient was not pregnant. Patient was not currently breastfeeding. Patient had had 3 miscarriages this year 11 weeks, 5 weeks and 10 weeks, 2 were post covid vaccination. Patient had not had symptoms associated with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative: No - Negative COVID-19 test. Outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101429000 Same patient/vaccine, different dose and events


VAERS ID: 1855206 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: AUPFIZER INC202101453284

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 648724. A 30-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number unknown), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On unknown date, the patient had abortion spontaneous, medically significant. The outcome of the event was reported as recovered on unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1855226 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101458399

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable healthcare professional via Regulatory Authority. Regulatory authority report number is 649343. This healthcare professional reported information for both the mother and the baby. This is the mother case. A 31-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reaction reported as abortion spontaneous. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : AU-PFIZER INC-202101499997 baby case


VAERS ID: 1861702 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101483930

Write-up: miscarriages (someone she knows had one at 27 weeks); This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced miscarriage at 27 weeks. The mother reported she became pregnant while taking BNT162b2. The mother was 27 weeks pregnant at the onset of the event. The outcome of the event was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1864722 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Stillbirth
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 INC202101484725

Write-up: had a baby still born, she was vaccinated; This is a spontaneous report from a contactable consumer (patient''s friend) via Medical Information team. This is a maternal report. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient had a baby still born, she was vaccinated. The patient was pregnant while taking BNT162B2. The pregnancy resulted in still birth. The fetal outcome is intrauterine death. The outcome of the event was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1866479 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101548227

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202111082251105800-IVKCE, safety report unique identifier is GB-MHRA-ADR 26179287. A female patient of an unspecified age (pregnant) received BNT162B2 (COMIRNATY, batch/lot number and expiration date not provided), dose 2 via an unspecified route of administration on an unspecified date (not pregnant) 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. The patient experienced foetal exposure during pregnancy and miscarriage (death) on an unspecified date. The patient and child was exposed to the medicine before pregnancy. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The reporter did not relate the reaction to possible inflammation of the heart (myocarditis or pericarditis). Lab data included COVID-19 virus test was negative (No - Negative COVID-19 test) on an unknown date. The outcome of the event was fatal. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Miscarriage


VAERS ID: 1870566 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101506174

Write-up: miscarriage; This is a spontaneous report from a contactable consumer (reporting for friend''s wife). A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced miscarriage on an unspecified date 3 days after the vaccine. The wife was about 7 or 10 weeks pregnant. The husband did not believe that the miscarriage was related to the vaccine. His wife was fine. Outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1874174 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101506606

Write-up: Miscarriage; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced miscarriage. It was further stated by the reporter that there is a young woman (reported as women) who reported a miscarriage after getting the Pfizer covid vaccine. She noticed the studies show no relation with the covid vaccine. The reporter intent is to phone the patient and see if she is interested in following up with the manufacturer. She wanted to know if Pfizer is interested in doing a follow up with the patient, some manufacturers are interested in following up with pregnant woman that have been immunized. She confirmed that patient had a miscarriage after the Pfizer covid vaccine. She declined to complete a report and states it will be documented and she is aware that it is not a link with the covid vaccine and wants to give the patient additional information. The outcome of the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: based on the known safety profile of vaccine and the information available event miscarriage was considered unrelated to the suspect drug.


VAERS ID: 1877842 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002913 / 2 - / OT

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

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

Write-up: Miscarriage 2 weeks after the 2nd dose; Miscarriage 2 weeks after the 2nd dose; This case was received via the Regulatory Authority (Reference number: DE-PEI-202100112345) on 09-Nov-2021 and was forwarded to Moderna on 09-Nov-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage 2 weeks after the 2nd dose) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3002913) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Jun-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage 2 weeks after the 2nd dose) (seriousness criterion medically significant) and FATIGUE (Miscarriage 2 weeks after the 2nd dose). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Miscarriage 2 weeks after the 2nd dose) and FATIGUE (Miscarriage 2 weeks after the 2nd dose) had resolved with sequelae. No concomitant product provided by reporter. No treatment product provided by reporter Information on risk factors or previous illnesses / Factor V Leiden / On the day after vaccination, pregnancy in the 7th week of gestation was confirmed, which unfortunately ended in a miscarriage 2 weeks later. Company comment:This regulatory authority case concerns a 34-year-old female patient with Factor V Leiden as a concurrent medical condition who experienced serious unexpected event of abortion spontaneous. The patient was also pregnant during vaccination. The event occurred approximately two weeks after the second dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. Patient''s Factor V Leiden is possible confounder and alternative plausible explanation for occurrence of the event. The benefit-risk relationship of drug is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Document received on 11-NOV-21 included events verbatim term updated and pregnancy related information updated in sender''s comment.; Reporter''s Comments: Information on risk factors or previous illnesses / Factor V Leiden / On the day after vaccination, pregnancy in the 7th week of gestation was confirmed, which unfortunately ended in a miscarriage 2 weeks later.; Sender''s Comments: This regulatory authority case concerns a 34-year-old female patient with Factor V Leiden as a concurrent medical condition who experienced serious unexpected event of abortion spontaneous. The patient was also pregnant during vaccination. The event occurred approximately two weeks after the second dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. Patient''s Factor V Leiden is possible confounder and alternative plausible explanation for occurrence of the event. The benefit-risk relationship of drug is not affected by this report.


VAERS ID: 1883637 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROXOCOBALAMIN; PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CY
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101602915

Write-up: Foetal exposure during pregnancy; Foetal movements decreased; Intrauterine death; This is a spontaneous report from a contactable consumer. This is the second of 2 reports. The first report is a report received from the Regulatory Authority, regulatory authority report number GB-MHRA-TPP50285778C579748YC1624450738500 Safety Report Unique Identifier GB-MHRA-ADR 25567222. This physician reported information for both mother and fetus/baby. This is a fetus report. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), transplacental on 23Jun2021 (Batch/Lot number was not reported) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included hydroxocobalamin taken for an unspecified indication from 26Feb2020 to 26Feb2020; 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 an unspecified indication from 23Apr2021 to 23May2021. The patient experienced foetal exposure during pregnancy, foetal movements decreased and intrauterine death on an unspecified date. The events were assessed as serious (medically significant, life threatening that resulted to death). It was reported that Pregnant 25/40. Had 1st Pfizer Covid-19 vaccine 8/7 ago. Fetal Movements not felt 5/7, possible ARM type amniotic fluid leak 24 hours, no paravertebral block. Referred urgently to maternity ward today for scan possible intrauterine death. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021829300 Mother case; Reported Cause(s) of Death: Foetal exposure during pregnancy; Foetal movements decreased; Intrauterine death


VAERS ID: 1730068 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2012-08-14
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia, Fatigue, Maternal exposure during pregnancy, Myalgia, Night sweats, Pain, Pain in extremity, Pyrexia, Stillbirth, Uterine contractions abnormal, Vaccination complication
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Still birth; Fatigue (vaccine-related adverse reaction); Muscle pain (vaccine-related adverse reaction); Joint pain (vaccine-related adverse reaction); Abdominal pain (vaccine-related adverse reaction); Pain of limbs (vaccine-related adverse reaction); Vaccine-related adverse reaction; uterine contractions; night sweats; fever (vaccine-related adverse reaction); generalized aches; Maternal exposure during pregnancy; Muscle Pain (vaccine-related adverse reaction); This regulatory authority retrospective pregnancy case was reported by a health care professional and describes the occurrence of STILLBIRTH (Still birth), FATIGUE (Fatigue (vaccine-related adverse reaction)), UTERINE CONTRACTIONS ABNORMAL (uterine contractions), NIGHT SWEATS (night sweats), PYREXIA (fever (vaccine-related adverse reaction)), MYALGIA (Muscle pain (vaccine-related adverse reaction)), ARTHRALGIA (Joint pain (vaccine-related adverse reaction)), ABDOMINAL PAIN (Abdominal pain (vaccine-related adverse reaction)), PAIN (generalized aches), PAIN IN EXTREMITY (Pain of limbs (vaccine-related adverse reaction)), VACCINATION COMPLICATION (Vaccine-related adverse reaction) and MYALGIA (Muscle Pain (vaccine-related adverse reaction)) in a 37-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. No Medical History information was reported. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Aug-2012, the patient experienced MYALGIA (Muscle Pain (vaccine-related adverse reaction)) (seriousness criterion medically significant). On 12-Jul-2021, the patient experienced PAIN (generalized aches) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 14-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NIGHT SWEATS (night sweats) (seriousness criterion medically significant) and PYREXIA (fever (vaccine-related adverse reaction)) (seriousness criterion medically significant). On 16-Aug-2021, the patient experienced UTERINE CONTRACTIONS ABNORMAL (uterine contractions) (seriousness criterion medically significant). On 25-Aug-2021, the patient experienced STILLBIRTH (Still birth) (seriousness criteria death, hospitalization and medically significant). On 26-Aug-2021, the patient experienced FATIGUE (Fatigue (vaccine-related adverse reaction)) (seriousness criterion medically significant), MYALGIA (Muscle pain (vaccine-related adverse reaction)) (seriousness criterion medically significant), ARTHRALGIA (Joint pain (vaccine-related adverse reaction)) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain (vaccine-related adverse reaction)) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain of limbs (vaccine-related adverse reaction)) (seriousness criterion medically significant). 26-Aug-2021, the patient experienced VACCINATION COMPLICATION (Vaccine-related adverse reaction) (seriousness criterion medically significant). The delivery occurred on 25-Aug-2021, which was reported as Still birth. For foetus 1, She was 36 weeks and 3 days pregnant. The patient died on an unknown date. At the time of death, FATIGUE (Fatigue (vaccine-related adverse reaction)), UTERINE CONTRACTIONS ABNORMAL (uterine contractions), NIGHT SWEATS (night sweats), PYREXIA (fever (vaccine-related adverse reaction)), MYALGIA (Muscle pain (vaccine-related adverse reaction)), ARTHRALGIA (Joint pain (vaccine-related adverse reaction)), ABDOMINAL PAIN (Abdominal pain (vaccine-related adverse reaction)), PAIN (generalized aches), PAIN IN EXTREMITY (Pain of limbs (vaccine-related adverse reaction)), VACCINATION COMPLICATION (Vaccine-related adverse reaction) and MYALGIA (Muscle Pain (vaccine-related adverse reaction)) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. During the prenatal check-up, the patient and fetus were both normal and amniocenteswas showed that the fetus had a normal chromosome variant (Chromosome 15 satellite variation)The frequency of uterine contractions increased on 25august2021.She informed the physician of the decreased fetal movement and the fetal heartbeat was normal upon examination. Subsequently, decreased fetal movement persisted and the patient experienced uterine contractions. The frequency of uterine contractions increased on 25 august 2021 so the patient sought medical attention. Company Comment: This case concerns a 37-year-old, female subject, with no relevant medical history, who experienced the serious unexpected events of Fatigue, Uterine contractions abnormal, Night sweats, Pyrexia, Myalgia, Arthralgia, Abdominal pain, Pain, Pain in extremity, Maternal exposure during pregnancy, Stillbirth and vaccination complication. The patient received the first dose of vaccine at 36 weeks and 3 days of gestation a Maternal exposure during pregnancy. The occurrence of the event Stillbirth occurred 13 days after second dose of mRNA-1273 (COVID-19 Vaccine Moderna) and had a fatal outcome of the foetus. The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.; Sender''s Comments: This case concerns a 37-year-old, female subject, with no relevant medical history, who experienced the serious unexpected events of Fatigue, Uterine contractions abnormal, Night sweats, Pyrexia, Myalgia, Arthralgia, Abdominal pain, Pain, Pain in extremity, Maternal exposure during pregnancy, Stillbirth and vaccination complication. The patient received the first dose of vaccine at 36 weeks and 3 days of gestation a Maternal exposure during pregnancy. The occurrence of the event Stillbirth occurred 13 days after second dose of mRNA-1273 (COVID-19 Vaccine Moderna) and had a fatal outcome of the foetus. The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.


VAERS ID: 1664402 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2019-08-05
Submitted: 0000-00-00
Entered: 2021-09-02
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: PARACETAMOL
Current Illness: Headache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during pregnancy; Miscarriage; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 25837979) on 24-Aug-2021 and was forwarded to Moderna on 24-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 30-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. Concurrent medical conditions included Headache. Concomitant products included PARACETAMOL for Headache. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 05-Aug-2019, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 03-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The treatment information was not provided. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The treatment information was not provided.: As per first dose date was not provided, the schedule of product administration is unknown. Company Comment : This is a RA case of maternal exposure during pregnancy with associated adverse event of miscarriage after the second dose of the product, in a 30 years old person. No information regarding pregnancy was provided. Based on temporal association a causal relationship cannot be excluded. First dose date was not provided, thus, schedule of product administration is unknown.; Sender''s Comments: This is a RA case of maternal exposure during pregnancy with associated adverse event of miscarriage after the second dose of the product, in a 30 years old person. No information regarding pregnancy was provided. Based on temporal association a causal relationship cannot be excluded. First dose date was not provided, thus, schedule of product administration is unknown.


VAERS ID: 1510359 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-05-27
Onset:2020-05-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Miscarriage
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:Miscarriage
CDC Split Type: GBPFIZER INC2021870115

Write-up: Early 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-202107071307047180-ALIXE, Safety Report Unique Identifier GB-MHRA-ADR 25615902. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Formulation: Solution for injection; Lot number: not reported), dose 1 via an unspecified route of administration on 27May2020 as single dose for COVID-19 immunisation. Medical history included abortion spontaneous from an unknown date and ongoing, pregnancy from an unknown date and unknown if ongoing (Patient no longer pregnant at the time of reporting, pregnancy from 2008 to an unknown date, vitamin supplementation from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient 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 early miscarriage on 10Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included ultrasound scan: miscarriage on (unspecified date). The outcome of the event Early miscarriage was resolved on 10Jun2021 and for event maternal exposure during pregnancy, outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


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https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=2&PERPAGE=100&ESORT=ONSET-DATE&SYMPTOMS[]=Aborted_pregnancy_%2810000209%29&SYMPTOMS[]=Abortion_%2810000210%29&SYMPTOMS[]=Abortion_complete_%2810061614%29&SYMPTOMS[]=Abortion_early_%2810052846%29&SYMPTOMS[]=Abortion_incomplete_%2810000217%29&SYMPTOMS[]=Abortion_induced_%2810000220%29&SYMPTOMS[]=Abortion_late_%2810052847%29&SYMPTOMS[]=Abortion_missed_%2810000230%29&SYMPTOMS[]=Abortion_of_ectopic_pregnancy_%2810066266%29&SYMPTOMS[]=Abortion_spontaneous_%2810000234%29&SYMPTOMS[]=Abortion_spontaneous_complete_%2810061616%29&SYMPTOMS[]=Abortion_spontaneous_incomplete_%2810061617%29&SYMPTOMS[]=Foetal_cardiac_arrest_%2810084280%29&SYMPTOMS[]=Foetal_death_%2810055690%29&SYMPTOMS[]=Premature_baby_death_%2810076700%29&SYMPTOMS[]=Premature_delivery_%2810036595%29&SYMPTOMS[]=Stillbirth_%2810042062%29&VAX=COVID19


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