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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: 1638700 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-09
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-27
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 INC202101038830

Write-up: Had a miscarriage 8 days after the first vaccination; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00657608. A 30-year-old female patient received the first dose of bnt162b2 (COMIRNATY; Batch/Lot Number: FE1573) via an unspecified route of administration on 01Jul2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was reported that the first dose of bnt162b2 took place at a pregnancy duration of about 6 weeks. On 09Jul2021, patient had a miscarriage 8 days after the first vaccination and was 7 weeks pregnant at the time. The event was reported as serious, medically significant. Outcome of event was unknown. Sender Comment: Since the nature of (some of) the reported reactions does imply seriousness according to one of the HA critera, the report was considered as serious by the regulatory authority. No follow-up attempts possible. No further information expected.


VAERS ID: 1671998 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Dysmenorrhoea
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 INC202101079692

Write-up: Severe menstrual cramps/a lot of cramps; Miscarriage; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00667446. A 23-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Jul2021 (lot number and expiry date: unknown) as dose 1, single, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had no history of COVID-19. The patient experienced miscarriage on 09Jul2021 and severe menstrual cramps on 13Aug2021. The clinical course was reported as follows: The mother reported she became pregnant while taking bnt162b2. 4 days after the vaccination, the patient had an early miscarriage after 3.5 weeks of pregnancy. The pregnancy resulted in spontaneous abortion. More than a month after vaccination, her menstruation was different than usual, she had a lot of cramps (severe menstrual cramps). Outcome of the events was unknown. Reporter''s Comments Text: BioNTech/Pfizer vaccin (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Sender''s Comment: Since the nature of the reported reaction does imply seriousness according to one of the regulatory authority criteria, the reaction (miscarriage) was considered as serious by the regulatory authority. For event: Abortion spontaneous end date 13Aug2021 has been reported. No follow-up attempts are possible. Information about lot/batch cannot be obtained. No further information is expected.


VAERS ID: 1484431 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2021-07-09
Onset:2021-07-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Rhesus antigen, Somatotropin stimulation test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal Vitamin
Current Illness: Sore throat on/around the last weekend of June 2021
Preexisting Conditions: Migraines and bits of depression
Allergies: Sulfur
Diagnostic Lab Data: Yes, I just do not have them with me at the moment. Hormone test RH Test
CDC Split Type: vsafe

Write-up: Well I had no other symptoms, no fever no day after problems like people say they have. I started spotting blood vaginally and by night time I was full blown bleeding. And to note, this is my 7th miscarriage in three years, it may not be shot related it may be just me. I had an appointment with my DR due to my history of miscarriages and I went in on Monday. My date was delivery was to be February 22 2022.


VAERS ID: 1506454 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Dysuria, Feeling hot, Malaise, Nausea, Panic reaction, Premature separation of placenta, Stillbirth, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Drug exposure during pregnancy; DVT (Family history of DVT. Father had 3 DVT''s post trauma); Scoliosis (scoliosis of the spine); Trauma
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021894115

Write-up: bleed from her vagina; she felt the need to pass urine but felt unable to do so; She was getting hot; wanting to vomit; quite panicked; baby was subsequently stillborn; back pain; feeling unwell; Abruptio placentae; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107130914052200-P0ESV, Safety Report Unique Identifier GB-MHRA-ADR 25638930. This other hcp reported information for both mother and fetus. This is a maternal report. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 10Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included exposure during pregnancy, back pain, scoliosis (scoliosis of the spine) and trauma. The patient had family history of DVT: Father had 3 DVT''s post trauma. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient was 25 weeks pregnant. The patient experienced back pain on an unspecified date, feeling unwell on an unspecified date, abruptio placentae on 10Jul2021, bleed from her vagina on an unspecified date, she felt the need to pass urine but felt unable to do so on an unspecified date, she was getting hot on an unspecified date, wanting to vomit on an unspecified date, quite panicked on an unspecified date. The clinical course was as follows: the patient was 25 weeks pregnant with her first baby. Low risk pregnancy. She had her second COVID vaccination on the 10Jul2021. The patient rang the pregnancy advice line from the vaccination center as she felt the need to pass urine but felt unable to do so. She was getting hot and wanting to vomit, feeling unwell and quite panicked. The previous day (09Jul2021) she was experiencing back pain. She attended maternity triage where she began to bleed from her vagina. A fetal heart was present on admission. The patient continued to bleed heavily and was later diagnosed with placental abruption and unfortunately there was no fetal heart detected and the baby was subsequently stillborn. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible blood clots or low platelet counts. Abruptio placentae was resolved, the outcome of the other events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021903036 Baby case


VAERS ID: 1525525 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-07-10
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9093 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Pregnancy at time of vaccination: yes; Result Unstructured Data: Test Result:Pregnancy at time of vaccination: yes
CDC Split Type: CAPFIZER INC202100941550

Write-up: Missed miscarriage - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is a maternal report. A 37-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 16Jun2021 17:15 (Batch/Lot Number: FA9093) as single dose, dose 1 via an unspecified route of administration, administered in Arm Right on 09May202117:30 (Batch/Lot Number: EW0193) as single dose for covid-19 immunisation at the age of 37-year-old. The patient medical history and concomitant medications were not reported. The patient experienced missed miscarriage (as reported) - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks on 10Jul2021 18:15 with outcome of recovering. The patient was hospitalized from 10Jul2021 to 11Jul2021. The mother reported she became pregnant while taking bnt162b2. The mother was 11 Weeks pregnant at the onset of the event. The mother was due to deliver on 27Jan2022. The pregnancy resulted in spontaneous abortion. The fetal outcome is neonatal death. The patient underwent lab tests and procedures which included pregnancy test: pregnancy at time of vaccination on unspecified date. Therapeutic measures were taken as result of the event. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department visit or urgent care. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, the patient hasn''t been tested for COVID-19. ; Sender''s Comments: Linked Report(s) : CA-PFIZER INC-202100991812 baby case


VAERS ID: 1546638 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-07-10
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? 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: Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:miscarried; Comments: at estimated 8 weeks
CDC Split Type: GBPFIZER INC202100975254

Write-up: Maternal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107291928211310-ESPZZ, Safety Report Unique Identifier GB-MHRA-ADR 25729433. A 30-years-old pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiry date was not reported) on 26Jun2021 as dose 1, single for COVID-19 immunization. Medical history included Miscarriage, Pregnancy with not ongoing: Patient no longer pregnant at the time of reporting. Concomitant medication(s) included folic acid (FOLIC ACID) taken for Folic acid supplementation as 400 ug. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not currently breastfeeding. The mother reported that, she became pregnant while taking BNT162B2. The mother was 1 Trimester pregnant at the onset of the event. The patient was unsure for the medicine have an adverse effect on any aspect of the pregnancy. She has had two previous healthy pregnancies with no complications and no previous history or miscarriage. Patient was exposed to the medicine first-trimester (1-12 weeks). On an unspecified date, the patient experienced maternal exposure during pregnancy; Miscarriage on 10Jul2021. All events were reported as medically significant and congenital anomaly. The patient underwent lab tests and procedures, which included scan: miscarried on an unspecified date, at estimated 8 weeks. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. 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.


VAERS ID: 1590314 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (disease symptoms: quite)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100996476

Write-up: a lot of abdominal pain; Miscarriage after about 6 weeks pregnant; Muscle pain; Not feeling well; This is a spontaneous report from contactable consumer or other non hcp downloaded from the Regulatory Authority NL-LRB-00643842. A 36-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 06Jul2021 (Lot Number: FE7010) as dose 1, single for covid-19 immunisation. Medical history included suspected covid-19 from 10Mar2020 to an unknown date (disease symptoms: quite). Concomitant medication(s) included beclometasone dipropionate, formoterol fumarate (FOSTER) taken for an unspecified indication, start and stop date were not reported. The patient experienced miscarriage after about 6 weeks pregnant on 24Jul2021 with outcome of unknown, muscle pain on 24Jul2021 with outcome of recovering, not feeling well on 10Jul2021 with outcome of recovering, abdominal pain on unknown date with outcome of unknown. The mother reported she became pregnant while taking bnt162b2. The mother was 4 Weeks pregnant at the onset of the event. The miscarriage occurred at a pregnancy duration of about 6 weeks. This was the first Covid vaccination, which took place at a pregnancy duration of about 3,5 weeks. Clinical course as reported: I was finally pregnant after 9 months, after vaccination a lot of abdominal pain now lost fruit after about 6 weeks pregnant. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the 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: Additional information ADR: I was finally pregnant after 9 months, after vaccination a lot of abdominal pain now lost fruit after about 6 weeks pregnant confounding factors: COVID-19 vaccine exposure during pregnancy week: COVID-19: Previous COVID-19 infection: disease symptoms: quite


VAERS ID: 1657979 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
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: TWMODERNATX, INC.MOD20213

Write-up: Fetus died in utero; Receiving the Moderna vaccine on 07/10/2021; This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of FETAL DEATH (Fetus died in utero) and MATERNAL EXPOSURE DURING PREGNANCY (Receiving the Moderna vaccine on 07/10/2021) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Receiving the Moderna vaccine on 07/10/2021) (seriousness criterion medically significant). On 21-Jul-2021, the patient experienced FETAL DEATH (Fetus died in utero) (seriousness criterion medically significant). The delivery occurred on 20-Jul-2021, which was reported as Intrauterine death. For fetus 1, The outcome was reported as Stillbirth NOS. On 10-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Receiving the Moderna vaccine on 07/10/2021) had resolved. At the time of the report, FETAL DEATH (Fetus died in utero) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. On 10/Jul/2021, the patient took Moderna vaccine. After receiving the Moderna vaccine the patient''s water suddenly broke on 20/Jul/2021 and she was admitted to Clinic. On 20/Jul/2021, the fetus died in utero and labor was induced. The patient was currently recovering in Clinic. She had suffered greatly both physically and mentally and was still unable to discuss the matter (miscarriage). Treatment medication were not reported. This is a case of product exposure during pregnancy for this30 years female, with the associated adverse event of fetal death in utero. No further information is available for this case .; Sender''s Comments: This is a case of product exposure during pregnancy for this30 years female, with the associated adverse event of fetal death in utero. No further information is available for this case .


VAERS ID: 1667092 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-07-10
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0193 / 1 RA / -

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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101132622

Write-up: Missed miscarriage - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is a maternal report. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 09May2021 17:30 (Lot Number: EW0193) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Last menstrual period date: 22Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 10Jul2021 18:15, the patient experienced missed miscarriage - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks with outcome of recovering. The event was assessed as serious (medically significant). The patient was hospitalized from 10Jul2021 to 11Jul2021. The mother reported she became pregnant while taking bnt162b2. The mother was 11 weeks pregnant at the onset of the event. The mother was pregnant with 1 baby. The mother was due to deliver on 27Jan2022. The fetal outcome is neonatal death. Therapeutic measures were taken as the result of the event. The event resulted into doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Linked Report(s) : CA-PFIZER INC-202100991812 Baby case


VAERS ID: 1676841 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101089414

Write-up: COVID-19 vaccine exposure during pregnancy week: 11; Missed abortion; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is NL-LRB-00669298. A 34-year-old female patient who was 11 weeks pregnant, received BNT162B2 (COMIRNATY; solution for injection; strength: 0.3 ml; lot number: FE7010), via an unspecified route of administration on 10Jul2021 (at the age of 34-years-old) as dose number unknown, 0.3 ml single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had no history of previous COVID-19 infection. On 10Jul2021, the patient experienced COVID-19 vaccine exposure during pregnancy week: 11 and missed abortion. It was reported that possibly there has been a missed abortion because of the vaccination. When looking back, it seemed to have occurred around the same time as the vaccination. It was unclear whether this report concerned the first or second vaccination. Diagnostic procedures were not performed. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1736222 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-10
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: BRJNJFOC20210941765

Write-up: SPONTANEOUS ABORTION; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was gravida 1, para 0, abortion 1. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency one total, administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-JUL-2021, the patient experienced vaccine exposure during pregnancy. The date of the patient''s last menstrual period and expected delivery date were not reported. On 01-AUG-2021, the pregnancy resulted in a spontaneous abortion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine exposure during pregnancy and spontaneous abortion was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210941765-COVID-19 VACCINE AD26.COV2.S-spontaneous abortion. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210941765-COVID-19 VACCINE AD26.COV2.S-vaccine exposure during pregnancy . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1751164 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-07-10
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (two live births)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226792

Write-up: one miscarriage; Bleeding menstrual heavy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109181552073240-OYV1I, and Safety Report Unique Identifier is GB-MHRA-ADR 25964898. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18May2021 (lot/batch number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included pregnancy from an unknown date (two live births). Unsure if patient has had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation. The patient experienced one miscarriage on an unspecified date with outcome of unknown, and bleeding menstrual heavy on 10Jul2021 with outcome of recovered with sequelae. The events were reported as serious with seriousness criteria of hospitalization and other medically important condition. The patient underwent lab test which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. Additional information: Patient had a very heavy menstrual bleeding following the vaccine. She was unknowingly pregnant. She was admitted to A&E. She was told to report this to yellow card. Patient has not tested positive for COVID-19 since having the vaccine. It was unsure if the medicine had an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient had two live births (previous pregnancies), and one miscarriage. Patient no longer pregnant at the time of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1755204 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-07-10
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Human chorionic gonadotropin, Ultrasound antenatal screen
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: Blood beta human chorionic gonadotropin; Result Unstructured Data: Test Result:16681; Test Date: 20210709; Test Name: Blood beta human chorionic gonadotropin; Result Unstructured Data: Test Result:49037; Test Date: 20210712; Test Name: Blood beta human chorionic gonadotropin; Result Unstructured Data: Test Result:60149; Test Date: 20210710; Test Name: Ultrasound pregnancy; Result Unstructured Data: Test Result:visible gestational sac, a visible fetal pole; Comments: a visible gestational sac, a visible fetal pole, a visible yolk sac and absence of fetal cardiac function.
CDC Split Type: GRPFIZER INC202101229058

Write-up: Missed abortion; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number: GR-GREOF-20216858. A 29-year-old female patient received bnt162b2 (COMIRNATY) (batch/lot number: unknown), second dose intramuscular on 10Jun2021 as dose 2, single, and first dose intramuscular on 20May2021 as dose 1, single; both for COVID-19 immunisation. The patient does not have a medical history of diseases. The patient did not deliver a baby before. She did not have another pregnancy in the past. Last menstruation was on 15May2021. Concomitant medications were not reported. The patient experienced missed abortion on 10Jul2021 with outcome of recovered. The event was reported as serious, other medically important condition. The mother was 8 Weeks pregnant at the onset of the event. The mother was due to deliver on 19Feb2022. Blood beta human chorionic gonadotrophin on 01Jul2021: 16681, on 09Jul2021: 49037, and on 12Jul2021: 60149. The patient suffered a missed abortion on 10Jul2021. From the ultrasound pregnancy on 10Jul2021, it was found that there was a visible gestational sac, a visible fetal pole, a visible yolk sac and absence of fetal cardiac function. The patient underwent a therapeutic evacuation of the uterus. The fetal outcome was intrauterine death. No follow-up attempts are possible; batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1863034 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-10
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Echocardiogram, Menstruation irregular
SMQs:, Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: REMSIMA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (vaccine exposure during pregnancy week: In retrospect in the early stages)
Allergies:
Diagnostic Lab Data: Test Name: Echo; Result Unstructured Data: Test Result:Unknown results; Comments: Echo after miscarriage
CDC Split Type: NLPFIZER INC202101462061

Write-up: Menstrual complaints; Miscarriage around 5 weeks; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00702456. This is one of two reports, for 2nd dose of Comirnaty A 29-year-old pregnant female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Jun2021 (Batch/Lot Number: FC5089) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included maternal vaccine exposure (vaccine exposure during pregnancy week: In retrospect in the early stages). Concomitant medication included infliximab (REMSIMA) for unspecified indication, start and stop date unknown. The patient received the first dose of COMIRNATY on 19May2021 for Covid-19 immunisation and had diarrhea. The patient experienced miscarriage around 5 weeks on 10Jul2021 and menstrual complaints on 07Aug2021. The mother was 5 weeks pregnant at the onset of the event. The miscarriage occurred at a pregnancy duration of about 5 weeks. This was the second Covid vaccination, which took place at a pregnancy duration of about 3 weeks. The first Covid vaccination took place before pregnancy. The mother reported she became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. Since the vaccination and miscarriage her menstruation has changed. Instead of 4 to 5 days with build-up and decrease roughly a week menstruating whereby the bleeding always stops in the meantime before it really gets going. The patient underwent lab tests and procedures which included echocardiogram: unknown results (Echo after miscarriage) on unknown date. The outcome of the event miscarriage around 5 weeks was unknown and not recovered from menstrual complaints. The patient has no previous Covid-19 infection. No follow-up attempts possible. No further information expected. Information about batch/lot already obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101476928 same patient, different dose


VAERS ID: 1541070 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-01-08
Onset:2021-07-11
   Days after vaccination:184
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin, zinc
Current Illness:
Preexisting Conditions: Raynauds syndrome
Allergies: Gluten
Diagnostic Lab Data: Ultrasound and hcg blood tests to confirm loss.
CDC Split Type:

Write-up: Miscarriage, became pregnant after receiving the vaccine. Final dose on February, pregnant in May, loss of pregnancy in July.


VAERS ID: 1524025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-07-11
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-08-03
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, 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: Asthma; Pregnancy (first pregnancy)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: scan; Result Unstructured Data: Test Result:initial 6 weeks pregnant
CDC Split Type: GBPFIZER INC202100928783

Write-up: Early miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107201654351390-3PM2J, and Safety Report Unique Identifier is GB-MHRA-ADR 25681782. A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Apr2021 (batch/lot number not reported) as dose 2, single for COVID-19 immunisation. Medical history included asthma, and pregnancy from an unknown date and unknown if ongoing (first pregnancy). Unsure if patient has had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation. Patient has not tested positive for COVID-19 since having the vaccine. Patient was exposed to the medicine before pregnancy. The details of previous pregnancies: first pregnancy. It was also reported that patient has ongoing pregnancy. Details of scans or investigations: initial 6 weeks pregnant on scan. The patient experienced early miscarriage on 11Jul2021 with outcome of recovering (as reported). The event ''early miscarriage'' was considered serious (hospitalization and medically significant). The patient underwent lab test which included COVID-19 virus test: No-Negative COVID-19 test on an unspecified date. No follow-up attempts are possible; information about batch/lot number cannot be obtained.


VAERS ID: 1585277 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-11
Submitted: 0000-00-00
Entered: 2021-08-19
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: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100990831

Write-up: Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number GB-MHRA-WEBCOVID-202107271422330850-DUEFR, Safety Report Unique Identifier GB-MHRA-ADR 25714711. A 37-year-old female patient received first dose of 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 pregnancy from an unknown date and unknown if ongoing. No other medications or medical complications. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced miscarriage of pregnancy on 11Jul2021. Patient fell pregnant in the same menstrual cycle as she received the first dose of the vaccine. This was her third pregnancy and she has not experienced a miscarriage before. She appreciated it may not be related but she was reporting to help in identifying possible connections. She since received her second dose of the vaccine. The event was reported as medically significant. The outcome of the event was recovering. No follow-up attempts are needed, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1592641 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Anaemia, Blood pressure measurement, Body temperature, C-reactive protein, Foetal death, Gynaecological examination, Hyperleukocytosis, Investigation, Physical examination, Pyrexia, SARS-CoV-2 test, Tachycardia, Ultrasound abdomen, Ultrasound foetal, Ultrasound uterus, White blood cell count
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Malignancy related conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cervical conisation (conization in 2017 for CIN3. Height of the conization: 1.5 cm.); Constipation chronic; Endometriosis (Right uterine torus nodule); Irritable bowel syndrome; Premature placental detachment (which subsequently resolved)
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: blood pressure; Result Unstructured Data: Test Result:108/66; Test Date: 20210711; Test Name: Body temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Test Date: 20210711; Test Name: C-reactive protein; Result Unstructured Data: Test Result:170 mg/l; Comments: Inflammatory syndrome; Test Date: 20210715; Test Name: C-reactive protein; Result Unstructured Data: Test Result:107 mg/l; Test Date: 20210717; Test Name: Vaginal touch; Result Unstructured Data: Test Result:1 finger wide cervix; Test Date: 20210711; Test Name: infectious assessment; Test Result: Negative ; Test Date: 20210711; Test Name: Abdominal examination; Result Unstructured Data: Test Result:Bloated abdomen, sensitive; Comments: hypochondrium, flank and left iliac fossa.; Test Date: 20210715; Test Name: Clinical examination; Result Unstructured Data: Test Result:Pelvic pain, with radiation; Comments: due to an endometriosis nodule that has grown since the beginning of the pregnancy. For the past 3 weeks, patient with minor pain attributed to ligament pain.; Test Date: 20210711; Test Name: Covid-19 test; Test Result: Negative ; Test Date: 20210711; Test Name: Abdominal ultrasound; Result Unstructured Data: Test Result:confirmed the appearance of the; Comments: gallbladder but without intrahepatic bile duct dilatations. Diagnosis of biliary colic after meals, not explaining the inflammatory syndrome. Gallbladder increased in size with polyp, posterior lithiasis but thin walls.; Test Date: 20210714; Test Name: Abdominal ultrasound; Result Unstructured Data: Test Result:Absence of digestive pathologies, in; Comments: particular diverticulitis.; Test Date: 20210711; Test Name: Ultrasound; Result Unstructured Data: Test Result:Fetus of variable presentation; Comments: fetal weight of 340g 15th percentile, good vitality. Normal amount of fluid, non-low inserted anterior placenta without placental abruption or hematoma (confirmed by another ultrasound). Suprapubic cervical measurement: 32mm, and 20mm endovaginally (difficult visualization), no maternal pyelocalyceal dilatation; Test Date: 20210715; Test Name: Cervical ultrasound; Result Unstructured Data: Test Result:Cervix at 22 mm stable.; Test Date: 20210716; Test Name: Cervical ultrasound; Result Unstructured Data: Test Result:Short but stable cervix; Test Date: 20210717; Test Name: Cervical ultrasound; Result Unstructured Data: Test Result:Clear cervical modification, significant; Comments: funneling with a water sac reaching the external orifice.; Test Date: 20210711; Test Name: Monitoring; Result Unstructured Data: Test Result:No uterine contractions; Test Date: 20210715; Test Name: white blood cells; Result Unstructured Data: Test Result:ok
CDC Split Type: FRPFIZER INC202101010594

Write-up: Foetal death; Late miscarriage; diffuse abdominal pain sometimes in the right hypochondrium (after meals), pain radiating to the pelvis and sacrum with sometimes pain in the left flank.; fever at 38.6C; hyperleukocytosis; tachycardia; mild anaemia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB WEB FR-AFSSAPS-CF20212205. A 35-year-old female patient received BNT162B2 (COMIRNATY; lot number: FE2707) intramuscular, administered in Arm Left on 08Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included irritable bowel syndrome, constipation chronic, cervical conization (conization in 2017 for CIN3. Height of the conization: 1.5 cm), endometriosis (Right uterine torus nodule), placental abruption in early pregnancy on 07Mar2021 (which subsequently resolved). The patient''s concomitant medications were not reported. The patient previously took pyostacine and experienced allergies. The patient experienced foetal death and late miscarriage on 18Jul2021. On 11Jul2021 patient experienced diffuse abdominal pain sometimes in the right hypochondrium (after meals), pain radiating to the pelvis and sacrum with sometimes pain in the left flank. Tachycardia, mild anaemia, hyperleukocytosis and fever at 38.6C on 11Jul2021. On 11Jul2021: Hospitalization in 20 weeks for fever at 38.6C, diffuse abdominal pain sometimes in the right hypochondrium (after meals), pain radiating to the pelvis and sacrum with sometimes pain in the left flank. Inflammatory syndrome with C-reactive protein 170, tachycardia, mild anaemia, hyperleukocytosis, blood pressure 108/66. No functional urinary signs, metrorrhagia or loss of amniotic fluid, no abdominal trauma. Negative infectious assessment. Long, closed posterior cervix of firm consistency. Monitoring: No uterine contractions. Abdominal examination: Bloated abdomen, sensitive hypochondrium, flank and left iliac fossa. Ultrasound: Fetus of variable presentation, fetal weight of 340g 15th percentile, good vitality. Normal amount of fluid, non-low inserted anterior placenta without placental abruption or hematoma (confirmed by another ultrasound). Suprapubic cervical measurement: 32mm, and 20mm endovaginally (difficult visualization), no maternal pyelocalyceal dilatation. Gallbladder increased in size with polyp, posterior lithiasis but thin walls. Abdominal ultrasound confirmed the appearance of the gallbladder but without intrahepatic bile duct dilatations. Diagnosis of biliary colic after meals, not explaining the inflammatory syndrome. Thickening in the right uterine torus which may correspond to a 25 mm endometriosis nodule (Medical history). Probabilistic treatment with AMOXICILLIN, analgesic treatment: PARACETAMOL, TRIMEBUTINE, and laxative MOVICOL. Covid-19 test: tested negative on 11Jul2021. On 12Jul2021: Apyrexie. On 14Jul2021: Reappearance of abdominal pain in the left iliac fossa =$g abdominal ultrasound: Absence of digestive pathologies, in particular diverticulitis. INDOCID suppository treatment, does not relieve the patient. On 15Jul2021: Follow-up assessment: Inflammatory syndrome improved, white blood cells OK, C-reactive protein 107 mg/L. Cervical ultrasound: Cervix at 22 mm stable. Clinical examination: Pelvic pain, with radiation due to an endometriosis nodule that has grown since the beginning of the pregnancy. For the past 3 weeks, patient with minor pain attributed to ligament pain. On 16Jul2021: Ultrasound: Short but stable cervix. Discharge from hospital due to improvement in inflammatory syndrome and pain. Rest and time off work and back at the end of next week for a cervical ultrasound. Treatment: PROGESTERONE 200mg, intravaginal ovule in the presence of a short cervix and a medical history of conization, to prevent preterm delivery, and to alleviate pain from the endometriosis nodule. On 17Jul2021: Return for labour at 20 weeks + 6 days. Abdominal pain with contractions during the night and expulsion of a clot in the early afternoon. Ultrasound: Clear cervical modification, significant funneling with a water sac reaching the external orifice. Vaginal touch: 1 finger wide cervix. Agreement with the couple: Attempted tocolysis with TRACTOCILE. On 18Jul2021: Ineffective treatment, as premature delivery with labour 6 hours later =$g expulsion of a breech fetus at 21 weeks of age. 150ml of waste. Waiting for the analysis (bacterial and anatomical pathology) of the placenta. Ongoing medical care. Consultation, hospitalization. Complete dossier. The mother reported she became pregnant while taking bnt162b2. The mother was 20 Weeks pregnant at the onset of the event. The mother delivered the pregnancy on 18Jul2021 via vaginal delivery. The baby was delivered premature. The fetal outcome is neonatal death. Therapeutic measures were taken as a result of diffuse abdominal pain sometimes in the right hypochondrium (after meals), pain radiating to the pelvis and sacrum with sometimes pain in the left flank, tachycardia, mild anaemia, hyperleukocytosis and fever. Outcome of the events foetal death and late miscarriage was recovered with sequelae while unknown for the other events. No follow-up attempts possible. No further information expected.


VAERS ID: 1634613 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-11
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-26
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, Ultrasound uterus
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Disease risk factor
Allergies:
Diagnostic Lab Data: Test Date: 20200926; Test Name: SARS-CoV-2 test positive; Test Result: Positive ; Test Name: Ultrasound examination uterus; Result Unstructured Data: Test Result:results unknown
CDC Split Type: NLPFIZER INC202101026139

Write-up: Miscarriage; This is a spontaneous report from a contactable Consumer or other non HCP downloaded from the regulatory authority-WEB NL-LRB-00653210. A 30-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: Unknown), Dose 1 via an unspecified route of administration on 30Jun2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19 from 26Sep2020 to an unknown date and disease risk factor from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient received bnt162b2 on 30Jun2021 while she was 4 weeks pregnant. The patient experienced miscarriage on 11Jul2021 (medically significant) when the patient was 5.5 - 6 weeks pregnant. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 26Sep2020, and ultrasound uterus: results unknown. The outcome of the event, miscarriage was unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty). Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no. BSN available: yes, confounding factors . COVID-19 vaccine exposure during pregnancy week: 4. COVID19. Previous COVID-19 infection: disease symptoms: quite. Other diagnostic procedures: Ultrasound examination uterus


VAERS ID: 1638706 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-07-11
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101045695

Write-up: After I was vaccinated I had a spontaneous miscarriage on July 11.; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB NL-LRB-00659372. A 38-year-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 24Jun2021 as single dose for COVID-19 immunization. Medical history included COVID-19 vaccine exposure during pregnancy week 10, Suspected COVID-19 from 20Mar2020. Concomitant medications were not reported. The patient stated "After I was vaccinated I had a spontaneous miscarriage on July 11 (11Jul2021)." The miscarriage occurred at a pregnancy duration of about 12.5 weeks. This was the first Covid vaccination, which took place at a pregnancy duration of about 10 weeks. The outcome of the event was unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1672001 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101086709

Write-up: Miscarriage/ The miscarriage occurred at a pregnancy duration of about 7 weeks; COVID-19 vaccine exposure during pregnancy week: 3; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number [NL-LRB-00668389]. A 35-year-old pregnant female patient received bnt162b2 (COMIRNATY, Lot Number: FE7010), dose 1 via an unspecified route of administration on 11Jul2021 (at the age of 35-year-old) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced miscarriage on 11Aug2021 which occurred at a pregnancy duration of about 7 weeks. This was after the first Covid vaccination which took place at a pregnancy duration of about 3 weeks (COVID-19 vaccine exposure during pregnancy week: 3/Maternal exposure during pregnancy, first trimester on 11Jul2021). The mother was 3 Weeks pregnant at the onset of the event. The outcome of the events was unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the HA critera, the reaction (miskraam) was considered as serious by the regulatory authority. Reporter''s Comments Text: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no confounding factors: COVID-19 vaccine exposure during pregnancy week: 3 Previous COVID-19 infection: No No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no confounding factors: COVID-19 vaccine exposure during pregnancy week: 3 Previous COVID-19 infection: No


VAERS ID: 1710471 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Diarrhoea, Headache, Myalgia, SARS-CoV-2 test positive, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Previous COVID-19 infection symptoms: quite)
Allergies:
Diagnostic Lab Data: Test Date: 20201130; Test Name: corona, confirmed with test; Test Result: Positive ; Test Name: ultrasound; Result Unstructured Data: Test Result:pregnant with twins; Comments: stopped growing early in the pregnancy
CDC Split Type: NLPFIZER INC202101150040

Write-up: Miscarriage; Headache; Myalgia; little abdominal pain; Diarrhoea; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00674456. This is a maternal report. A 26-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 10Jul2021 (Lot Number: unknown) as dose 1, 0.3 mL single for COVID-19 immunisation. Medical history included COVID-19 from 30Nov2020 to an unknown date. Previous COVID-19 infection symptoms: quite. The patient''s concomitant medications were not reported. On 11Jul2021 (1 day after the vaccination), patient experienced little abdominal pain, diarrhoea, headache and myalgia.On 23Aug2021 (1 month 13 days after the vaccination) miscarriage. The miscarriage occurred at a pregnancy duration of about 8 weeks (as reported). This was after the first Covid vaccination which took place at a pregnancy duration of about 2 weeks. The reporter had an ultrasound at week 8 of pregnancy. She found out she was pregnant with twins, but they stopped growing early in the pregnancy. Vaccination took place around conception or during the first days of pregnancy. The reporter didn''t know she was pregnant at the time and would not have taken the vaccine if she had known. Patient said that she miscarried because her twins stopped growing early, and thinks the reason is the vaccine. The mother reported she became pregnant while taking bnt162b2. The mother was 8 Weeks pregnant at the onset of the event. The mother was pregnant with 2 babies (twins). The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The outcome of the event '' Miscarriage'' was unknown, for headache and myalgia was recovered on 14Jul2021, for little abdominal pain and diarrhea was recovered on 16Jul2021. No follow-up attempts are possible, information on batch number cannot be obtained.


VAERS ID: 1724527 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-07-11
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-09-23
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: GBPFIZER INC202101176157

Write-up: Pregnancy loss; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109071153367230-HWN4C, Safety Report Unique Identifier GB-MHRA-ADR 25906283. A 31-year-old patient of an unspecified gender received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, 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 was not reported. The patient''s concomitant medications were not reported. The patient experienced pregnancy loss (abortion spontaneous) on 11Jul2021. The event was reported as medically significant. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient received second dose on 01Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. The outcome of event was recovered with sequelae in 2021. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1470304 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-15
Onset:2021-07-12
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0169 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EEW0179 / 2 LA / IM

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

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

Write-up: Patient had a miscarriage.


VAERS ID: 1474200 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-05-28
Onset:2021-07-12
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK AR / SYR

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

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

Write-up: My period started May 28 and my second vaccine was May 29. I found out I was pregnant June 27 and had a miscarriage on July 12. Not sure if this is related but my OB wanted me to report it.


VAERS ID: 1745262 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-04-21
Onset:2021-07-12
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Muscle spasms, Ovulation disorder, Pregnancy, Pregnancy test positive, Ultrasound scan vagina, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pre-natal vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: N/A
Diagnostic Lab Data: July 12, HCG test to confirm pregnancy level at 2,667 mIU/mL . July 14 2,905 mIU/mL. July 29 5,022 mIU/mL (prior to passing of fetus)
CDC Split Type:

Write-up: After second shot ovulation tests showed I did not ovulate in the months of April (month of shot). Month after, ovulation hit peak but did not see "high fertility" as expected. On June 28th I had a positive pregnancy test. July 12 cramping and bleeding began HCG test performed to confirm pregnancy. On July 14 test repeated, HCG did not double as expected. July 15 transvaginal ultrasound performed, confirmed fetus in gestational sac, and heartbeat subchorionic hemorrhage identified. Repeat ultrasound on Jul 23, heart beat heard, hemorrhage grown larger. Additional ultrasound on Jul 26, still a heart beat hemorrhage had grown more. On July 29 severe cramping and bleeding began and a spontaneous abortion occurred and pregnancy was lost. July 30 ultrasound confirmed no fetus.


VAERS ID: 1517046 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-07-12
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916340

Write-up: Miscarriage; YELLOW CARD VACCINE MONITOR This is a solicited report from a contactable HCP. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-YCVM-202107181146530380-Safety Report Unique Identifier GB-MHRA-ADR 25669667. A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 24Jun2021 (Batch/Lot Number: EW3143) 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 on 12Jul2021. The mother reported she became pregnant while taking bnt162b2. The mother was 4 Weeks pregnant at the onset of the event. The mother was due to deliver on 12Mar2022. Patient was not enrolled in clinical trial Details of scans or investigations: Miscarriage. The outcome of event was reported as recovered. The reporter''s assessment of the causal relationship of the reported 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 possible. No further information is expected.; Sender''s Comments: The Company cannot completely exclude the possible causality between the reported miscarriage and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1579642 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
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? 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: FRMODERNATX, INC.MOD20212

Write-up: Death intrauterine; Maternal exposure during pregnancy; This case was received via Medicines Agency (Reference number: 20212950) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This regulatory authority prospective pregnancy case was reported by a pharmacist and describes the occurrence of FOETAL DEATH (Death intrauterine) in a 35-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 12-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. The patient''s last menstrual period was on 17-Dec-2020 and the estimated date of delivery was 23-Sep-2021. On 12-Jul-2021, after starting mRNA-1273 (Spikevax), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 28-Jul-2021, the patient experienced FOETAL DEATH (Death intrauterine) (seriousness criteria hospitalization and medically significant). The patient received mRNA-1273 (Spikevax) beginning around the twenty-ninth week of the pregnancy. The delivery occurred on 28-Jul-2021, which was reported as Intrauterine death. For foetus 1, The outcome was reported as Intrauterine Fetal Death. On 12-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, FOETAL DEATH (Death intrauterine) had resolved with sequelae. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No Treatment medication reported. Company comment: This is a case of maternal exposure during pregnancy with associated adverse event of foetal death. Very limited information regarding this event has been provided at this time. 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.; Reporter''s Comments: Treatment:; Sender''s Comments: This is a case of maternal exposure during pregnancy with associated adverse event of foetal death. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1590804 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-07-12
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Miscarriage; Vaccine exposure before pregnancy; This case was received via Regulatory Authority (Reference number: 20213797) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) in a 37-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 31-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria hospitalization and medically significant) and MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) (seriousness criterion hospitalization). At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant product was reported. No treatment information was reported. Company Comment : This is a case of Product exposure before pregnancy with associated AE of Spontaneous Abortion for this 37-year-old female. No further information is expected as there is no contact information for further monitoring.; Sender''s Comments: This is a case of Product exposure before pregnancy with associated AE of Spontaneous Abortion for this 37-year-old female. No further information is expected as there is no contact information for further monitoring.


VAERS ID: 1593788 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101010858

Write-up: COVID-19 vaccine exposure during pregnancy week: 6; Miscarriage; This is a spontaneous report from a contactable consumer (patient) downloaded from the Agency. Regulatory authority number NL-LRB-00645820. A 30-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 10Jul2021 (Lot Number: FE7010) as dose 1, single for COVID-19 immunisation. Medical history included maternal vaccine exposure from unspecified date. The patient''s concomitant medications were not reported. The patient experienced miscarriage 2 days after start on 12Jul2021 and COVID-19 vaccine exposure during pregnancy week: 6. It was reported that Saturday patient got her vaccination and Monday she had a miscarriage. At a pregnancy of 6 weeks. No previous COVID-19 infection. The outcome of miscarriage was unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the critera, the reaction was considered as serious by the Pharmacovigilance Centre Lareb. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1630765 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003604 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion missed, Chills, Malaise, Maternal exposure during pregnancy, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), 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: Disease risk factor
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 3)
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: corona, bevestigd met test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: COVID-19 vaccine exposure during pregnancy week 3; ; This case was received (Reference number: 00660952) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION MISSED in a 41-year-old female patient who received mRNA-1273 (batch no. 3003604) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19 on 21-Jan-2021 and Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 3). Concurrent medical conditions included Disease risk factor. On 12-Jul-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 12-Jul-2021, the patient experienced MALAISE, MYALGIA and CHILLS. On 24-Jul-2021, the patient experienced ABORTION MISSED (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (COVID-19 vaccine exposure during pregnancy week 3). On 14-Jul-2021, MYALGIA had resolved. On 15-Jul-2021, MALAISE and CHILLS had resolved. At the time of the report, ABORTION MISSED and MATERNAL EXPOSURE DURING PREGNANCY (COVID-19 vaccine exposure during pregnancy week 3) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Company Comment : This is a case of product exposure during pregnancy with associated missed abortion. Very limited information regarding this event has been provided at this time. No further information is expected. Company causality for missed Abortion, malaise, myalgia and chills is assessed as possible, while company causality for Maternal exposure during pregnancy is not applicable.; Sender''s Comments: This is a case of product exposure during pregnancy with associated missed abortion. Very limited information regarding this event has been provided at this time. No further information is expected. Company causality for missed Abortion, malaise, myalgia and chills is assessed as possible, while company causality for Maternal exposure during pregnancy is not applicable.


VAERS ID: 1634135 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-07-12
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

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

Life Threatening? No
Birth Defect? 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:
Allergies:
Diagnostic Lab Data: Test Name: scans; Result Unstructured Data: Test Result:silent miscarriage; Test Name: investigations; Result Unstructured Data: Test Result:silent miscarriage
CDC Split Type: GBPFIZER INC202101040870

Write-up: Maternal Exposure During Pregnancy, first trimester; 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-202108111710354570-K1MCA. Safety Report Unique Identifier is GB-MHRA-ADR 25785600. A 37-year-old pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23May2021 (lot number: EY5456) as single dose for COVID-19 immunisation. Medical history included was not reported. 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 taken for folic acid supplementation. The patient experienced maternal exposure during pregnancy on an unspecified date and miscarriage on 12Jul2021. Case narrative: Did the medicine have an adverse effect on any aspect of the pregnancy: Unsure. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: silent 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 recovered from miscarriage on an unspecified date in 2021. Case reported as medically significant by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1637561 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-07-12
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101045317

Write-up: first dose on 04May2021, second dose on 19Jun2021; After Covid vaccination on 04May2021: Spontaneous abortion on 12Jul2021 with severe blood loss; After Covid vaccination on 04May2021: Spontaneous abortion on 12Jul2021 with severe blood loss; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, company number DE-PEI-202100161504. A 31-years-old female patient received second dose of bnt162b2 (COMIRNATY), dose 2 intramuscular on 19Jun2021 (Batch/Lot Number: FC3095) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: EX8679), on 04May2021 intramuscular for covid-19 immunisation and experienced Maternal Exposure during pregnancy. The patient experienced after covid vaccination on 04May2021: spontaneous abortion on 12Jul2021 with severe blood loss on 12Jul2021. Outcome of event was not recovered. Case is reported as serious medically significant. Sender comments: Gmoidity (not known at the time of vaccination) Spontaneous abortion, profuse bleeding, Relatedness of drug to reaction(s)/event(s) Source of assessment: HA Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101094888 same patient, different vaccine doses


VAERS ID: 1701411 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Inappropriate schedule of product administration, SARS-CoV-2 test, Scan
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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20210811; Test Name: Scan; Result Unstructured Data: Test Result:confirmed miscarriage (empty gestational sac) at 9; Comments: confirmed miscarriage (empty gestational sac) at 9 weeks
CDC Split Type: GBPFIZER INC202101138086

Write-up: Early miscarriage; First dose of BNT162B2 received on 15May2021/second dose on 12Jul202; 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-202108310856581280-4ATDZ], Safety Report Unique Identifier [GB-MHRA-ADR 25872683]. A 32-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 12Jul2021 (Lot Number: FD5613), at the age of 32-year-old, as dose 2, single for COVID-19 immunisation. Medical history included pregnancy and Folic acid supplementation, both on an unknown date. The patient previously took first dose of BNT162B2 on 15May2021 (lot number: EW4109) for COVID-19 immunization. Concomitant medications included folic acid taken for Folic acid supplementation, start and stop date were not reported. The patient experienced early miscarriage on 11Aug2021 and inappropriate schedule of vaccine administered on 12Jul2021. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date and Scan confirmed miscarriage (empty gestational sac) at 9 weeks on 11Aug2021. The outcome of the event ''early miscarriage'' was recovering Patient no longer pregnant at the time of reporting. The clinical course was reported as follows: Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. It was unsure if the medicine has an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). Scan confirmed miscarriage (empty gestational sac) at 9 weeks. Additional information: Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724197 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion missed, Maternal exposure during pregnancy, Ultrasound scan vagina, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210830; Test Name: Transvaginal ultrasound scan; Result Unstructured Data: Test Result:Missed abortion corresponding to gestation age 5+6
CDC Split Type: DKPFIZER INC202101174531

Write-up: Slight abdominal pain (slightly similar to menstruation); Missed abortion; Slight brownish bleeding approximately a week ago (calculated from reporting date, 30Aug2021), increased two days ago and this morning. Dark red mucus, no clots or tissue.; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number DK-DKMA-WBS-0086996. This physician reported information for both mother and fetus/baby. This is a maternal report. A 30-year-old female pregnant patient received first dose of bnt162b2 (COMIRNATY), intramuscularly on 12Jul2021 (Batch/Lot Number: FD0932) as single dose, second dose intramuscularly on 06Aug2021 (Batch/Lot Number: FD4555) as single dose for covid-19 immunisation. The patient was pregnant and LMP was 28Jun2021. There is no known concurrent conditions or medical history. There is no information regarding concomitant or past medication. The mother reported she became pregnant while taking bnt162b2. The mother was 2 weeks pregnant at the onset of the event. The mother was due to deliver on 04Apr2022. Patient experienced maternal exposure during pregnancy, first trimester. On 08Aug2021 (gestation week 5+6), two days after the second vaccination, the patient experienced missed abortion. In august 2021, the patient experienced slight brownish bleeding approximately a week ago (calculated from reporting date, 30Aug2021), increased two days ago and this morning. Dark red mucus, no clots or tissue. On 30Aug2021, 24 days after the second vaccination, the patient experienced slight abdominal pain (slightly similar to menstruation). The patient underwent lab tests and procedures which included ultrasound scan vagina showed missed abortion corresponding to gestation age 5+6 on 30Aug2021. The fetus did not have any congenital anomaly/birth defect. No treatment or medical procedure due to the ADRs was reported. The outcome of event missed abortion was not recovered, of event "maternal exposure during pregnancy, first trimester" was recovered, of events abdominal pain and "slight brownish bleeding approximately a week ago (calculated from reporting date, 30Aug2021), increased two days ago and this morning. Dark red mucus, no clots or tissue" was unknow. The ADRs were by the Agency assessed medically significant due to Abortion missed (PT) being on the IME list. The physician comments that the pregnancy was achieved through natural conception and that the pregnancy was whished. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1728889 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Headache
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: Grossesse au moment de la vaccination: Date de naissance trimestre.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101180239

Write-up: Miscarriage; Headache; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is BE-FAMHP-DHH-N2021-106158. A 31-year-old pregnant female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Jul2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Pregnancy at time of vaccination was reported as "Date of birth trimester". On 12Jul2021, the patient experienced miscarriage and headache. The patient did not receive treatment for the events. The patient has not recovered from the events. Reporter''s commnets: Treatment No Evolution of the ADR - No improvement ADR description - Miscarriage No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment No Evolution of the ADR - No improvement ADR description - Miscarriage


VAERS ID: 1863030 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-12
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-11-12
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 INC202101463367

Write-up: Miscarriage in July at 6 weeks of pregnancy/In Sep2021, she had another miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number is NL-LRB-00700583. A 30-year-old pregnant female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 25Jun2021 (Batch/Lot Number: Unknown) as dose 1, single and via an unspecified route of administration on Aug2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has no previous COVID-19 infection. The first COVID vaccination, took place at a pregnancy duration of about 4 weeks. Miscarriage on 12Jul2021 at 6 weeks of pregnancy. The patient got pregnant again and had the second COVID vaccination in Aug2021. In Sep2021, she had another miscarriage at a pregnancy duration of about 6 weeks. Outcome of event was unknown. The reporter assessed the event as serious, medically significant. Sender''s comments Since the nature of the reported reaction does imply seriousness according to one of the CIOMS critera, the reaction (miskraam) was considered as serious by the Pharmacovigilance Centre Lareb. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS critera, the reaction (miskraam) was considered as serious by the Pharmacovigilance Centre Lareb.


VAERS ID: 1521697 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
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 INC202100915829

Write-up: Miscarriage at 5 weeks of pregnancy; This is a spontaneous report from a contactable consumer downloaded from the WEB, regulatory authority number NL-LRB-00623041. A 30-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 06Jul2021 (Batch/Lot Number: Unknown) 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 at 5 weeks of pregnancy on 13Jul2021 (7 days after start). This was the first COVID vaccination which took place at a pregnancy duration of about 4 weeks. The outcome of the event was unknown. This report was assessed as serious - other medically important condition. Reporter Comment: BioNTech/Pfizer vaccine (Comirnaty) - Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Citizen service number available: yes. confounding factors - COVID-19 vaccine exposure during pregnancy week: 4. COVID19 - Previous COVID-19 infection: No. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS critera, the reaction (Miscarriage) was considered as serious by the . No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) - Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Citizen service number available: yes. confounding factors - COVID-19 vaccine exposure during pregnancy week: 4. COVID19 - Previous COVID-19 infection: No.


VAERS ID: 1532862 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Haemorrhage, Human chorionic gonadotropin, Illness, Scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Unknown result; Test Name: HCG hormone; Result Unstructured Data: Test Result:continued to drop over the following weekend; Test Date: 20210713; Test Name: HCG hormone; Result Unstructured Data: Test Result:high; Test Name: Scan; Result Unstructured Data: Test Result:Confirmed miscarriage. Baby stopped growing
CDC Split Type: GBPFIZER INC202100943253

Write-up: bleeding; Miscarriage; sickness; 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-202107231055479350-7M1IF. Safety Report GB-MHRA-ADR 25698091. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (Lot Number: FE1510) as single dose (at age of 31-years-old) for COVID-19 immunisation. Medical history included miscarriage, pregnancy, pregnancy (patient no longer pregnant at the time of reporting, as reported). Not on any medication (as reported). Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medication included folic acid (FOLIC ACID) taken for vitamin supplementation. On 13Jul2021 patient experienced sickness and on 14Jul2021 she experienced bleeding and miscarriage. Events considered serious as per hospitalization, medically significant, congenital anomaly. It was reported that her pregnancy was absolutely fine with no issues. The morning of her second vaccine patient had even started with morning sickness and human chorionic gonadotropin (HCG) hormone was high. The day after (less than 24hours after) having her second vaccine patient started with stomach pains and spotting which was the start of her miscarriage. (Patient was not pregnant when she had her first vaccine). Patient ended up at the emergency doctors on the 15Jul2021 as the bleeding increased and then the really pregnancy unit on the 16Jul2021 whereby they could see the baby sac. Her HCG levels continued to drop over the following weekend and she had now miscarried fully. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. It was reported that the medicine had an adverse effect on an aspect of the pregnancy, pregnancy adverse effects details was miscarriage. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations performed on unknown date Confirmed miscarriage. Baby stopped growing. Patient underwent Scans and blood tests. Patient was recovering from the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1547127 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood pressure fluctuation, Body temperature, C-reactive protein increased, Pregnancy test positive, Pyrexia, SARS-CoV-2 test, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (broad), Cardiomyopathy (broad), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (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: AMOXICILLIN TRIHYDRATE;CLAVULANIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:39.8 Centigrade; Test Date: 20210714; Test Name: inflammation values high; Result Unstructured Data: Test Result:high; Test Date: 20210712; Test Name: positive pregnancy test; Test Result: Positive ; Test Name: Covid test; Test Result: Negative ; Test Date: 20210714; Test Name: white blood cell count high; Result Unstructured Data: Test Result:high
CDC Split Type: NLPFIZER INC202100960308

Write-up: high fever of 39.8 degrees; blood pressure fluctuation/My blood pressure also shot up in all directions.; white blood cells were also high; Miscarriage; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB. The regulatory authority number is NL-LRB-00632760 and Safety Report Unique Identifier is NL-LRB-00637105. A 28-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 10Jul2021 (Batch/Lot Number: FE7010) as dose 1, single for COVID-19 immunisation. The patient was pregnant at time of vaccination. Medical history included suspected COVID-19 from 09Mar2021 to an unknown date and disease risk factor. Concomitant medication included amoxicillin trihydrate;clavulanic acid tablet 500/125mg taken for an unspecified indication, start and stop date were not reported. The patient had no past drug therapy BioNTech/Pfizer vaccine and had no previous COVID-19 infection and disease symptoms. The patient experienced miscarriage 3 days after start on 13Jul2021 (other medically important condition) and had high fever of 39.8 degrees and blood pressure fluctuation 4 days after start on 14Jul2021, following administration of COVID-19 vaccine. The patient was recovering from blood pressure fluctuation and fever. The miscarriage occurred 1 day after the patient found out she was pregnant, with a pregnancy duration of about 4 weeks. This was the first COVID vaccination, which took place 2 days before the patient found out she was pregnant. The outcome of the events fever and blood pressure fluctuation was recovering, while for miscarriage and white blood cell count high was unknown. Sender''s comments: Since the nature of the reported reaction does imply seriousness according to one of the a regulatory authority criteria, the reaction miscarriage was considered as serious by a research authority Reporter''s Comments: Had vaccination on Saturday 10Jul2021. Monday 12Jul2021, a positive pregnancy test. Tuesday evening 13Jul2021, loss of clear blood. Wednesday morning and Thursday morning 14Jul2021 and 15Jul2021, the rest came down. Thursday evening, a high fever of 39.8 degrees. The doctors at the birth centre could not quite tell where this came from. Also, the values of my blood were not good. Inflammation values were raised, and the white blood cells were also high. My blood pressure also shot up in all directions. Covid test, this was negative. They gave me an antibiotic course for home. Other: diagnostic procedures: Measurements of vital functions temperature and blood pressure abnormalities; blood tests abnormalities found; vaginal examination smear not yet known. Upon follow-up on 23Jul2021, had a positive pregnancy test on 12Jul2021. I think I was expecting between 3 and 4 weeks when it unfortunately went wrong. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Upon follow-up on 23Jul2021, had a positive pregnancy test on 12Jul2021. I think I was expecting between 3 and 4 weeks when it unfortunately went wrong.


VAERS ID: 1589022 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety attack; Condyloma; Delivery; Depressive disorder; Detachment retinal; Eczema eyelids; Metrorrhagia; Miscarriage; Tightness of jaw muscles; Vaginal cyst
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Miscarriage; Maternal exposure during pregnancy; This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 41-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Condyloma, Delivery, Depressive disorder, Anxiety attack, Detachment retinal, Miscarriage, Eczema eyelids, Vaginal cyst, Metrorrhagia and Tightness of jaw muscles. On 13-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient''s last menstrual period was on 13-May-2021 and the estimated date of delivery was 17-Feb-2022. On 13-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 16-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (COVID 19 Vaccine Moderna) beginning around the tenth week of the pregnancy. The delivery occurred on 16-Jul-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) was resolving and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information was provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-NT20212994. Company comment: This is a case of product exposure during pregnancy with associated AE of abortion spontaneous for this 41-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. Patients past medical history, specially previous miscarriage, and age are co suspects for the event.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AE of abortion spontaneous for this 41-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. Patients past medical history, specially previous miscarriage, and age are co suspects for the event.


VAERS ID: 1654346 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-07-13
   Days after vaccination:96
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101067521

Write-up: FOETAL DEATH; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 80383], license party for Comirnaty. A pregnant female patient of an unspecified age received bnt162b2 (COMIRNATY; Lot number was not reported), on 17Mar2021 (first dose) and on 08Apr2021 (second dose) each time at single doses for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The pregnant patient has been vaccinated with bnt162b2 on 17Mar2021 and on 08Apr2021 and has been diagnosed with fetal death on 13Jul2021. She was in the 18th week of gestation. Outcome was reported as unknown.; Sender''s Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of event foetal death cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1665188 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-13
   Days after vaccination:0
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 induced, Foetal heart rate, Maternal exposure during pregnancy, Stillbirth
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Uterine fibroids
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: Foetal heart rate; Result Unstructured Data: absent
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: terminate the pregnancy.; no fetal heart sounds no fetal movement; Vaccination exposure during pregnancy; This regulatory authority prospective pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION INDUCED (terminate the pregnancy.) and STILLBIRTH (no fetal heart sounds no fetal movement) in a 37-year-old female patient (gravida 1) 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 Uterine fibroids. On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On 13-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccination exposure during pregnancy). On 22-Jul-2021, the patient experienced STILLBIRTH (no fetal heart sounds no fetal movement) (seriousness criterion medically significant). On 23-Jul-2021, the patient experienced ABORTION INDUCED (terminate the pregnancy.) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Still birth. For foetus 1, The outcome was reported as Stillbirth w Congenital Anomaly. On 13-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccination exposure during pregnancy) had resolved. At the time of the report, ABORTION INDUCED (terminate the pregnancy.) outcome was unknown and STILLBIRTH (no fetal heart sounds no fetal movement) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2021, Foetal heart rate: absent (abnormal) absent. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details was reported. No treatment medication details was reported. This is a RA report of maternal exposure during pregnancy and the serious unlisted events Stillbirth and Induced abortion that occurred 10 days after receiving the first dose of the product. Based on temporal association a causal relationship cannot be excluded. As per age (37 years) and previous uterine pathology, the pregnancy was a high-risk-pregnancy. Neither body mass index (relevant for assessing pregnancy risk) nor concomitant medications were provided.; Sender''s Comments: This is a RA report of maternal exposure during pregnancy and the serious unlisted events Stillbirth and Induced abortion that occurred 10 days after receiving the first dose of the product. Based on temporal association a causal relationship cannot be excluded. As per age (37 years) and previos uterine pathology, the pregnancy was a high-risk-pregnancy. Neither body mass index (relevant for assessing pregnancy risk) nor concomitant medications were provided.


VAERS ID: 1679776 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-07-13
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101086525

Write-up: Abortion spontaneous/ Miscarriage; hemorrhage; This is a spontaneous report from a contactable consumer downloaded from The Regulatory Authority-WEB. The Regulatory Authority report number is FI-FIMEA-20213981. A 31-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in right arm on 17Jun2021 (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 abortion spontaneous/ miscarriage with limited hemorrhage on 13Jul2021. The event required emergency room treatment on 15Jul2021. It was the first pregnancy and gestation week 11. The outcome of the events was recovering. The events were assessed as serious (medically significant). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1760744 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-13
   Days after vaccination:0
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: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (She was no longer pregnant at the time of reporting; has 1 other health pregnancy, 9.5 years ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 2021; Test Name: scans or investigations; Result Unstructured Data: Test Result:The baby was shown to have stopped growing around; Comments: The baby was shown to have stopped growing around 6-7 weeks
CDC Split Type: GBPFIZER INC202101242917

Write-up: Maternal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number: GB-MHRA-WEBCOVID-202109201055024500-EQQ1I, Safety Report Unique Identifier: GB-MHRA-ADR 25967704. A 45-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 13Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included pregnancy (patient no longer pregnant at the time of reporting, patient has 1 other health pregnancy, 9.5 years ago). Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation. The patient experienced maternal exposure during pregnancy on 13Jul2021. Patient was exposed to the medicine at first-trimester (1-12 weeks). The patient suspected that thee vaccine may have impacted the growth of the baby after she had the 2nd dose of the vaccination. She had miscarriage of the baby on an unspecified date in 2021 (reported as 23Aug2021 also reported as 01Sep2021). Details of scans or investigations on an unspecified date in 2021: The baby was shown to have stopped growing around 6-7 weeks, she miscarried at approximately 10-11weeks. The events were considered serious due to hospitalization (date/s unspecified) and congenital anomaly (as reported). No further investigation was undertaken at the time. No other relevant investigations or tests conducted. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 28Aug2021. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1651636 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-14
Onset:2021-07-14
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0148 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Acute lymphocytic leukaemia, Biopsy bone marrow abnormal, Blood test, Chemotherapy, Exposure during pregnancy, Labour induction, Lymphadenopathy, Pain in extremity, White blood cell count increased
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Neuroleptic malignant syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Malignant lymphomas (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamins, DHA, Calcium
Current Illness:
Preexisting Conditions: Minor hearing loss, moderate depression (better then), hypothyroidism (cured then)
Allergies:
Diagnostic Lab Data: Bone Marrow Biopsy, 7/27/2021, B-cell Acute Lymphoblastic leukemia/Lymphoma with t(4;11)(q21;q23) KMT2A-Rearranged
CDC Split Type:

Write-up: Pregnant 18 weeks when having the second does (6/14/2021). Arm was hurt and sore for the next 2 days. A week later, a big lymph node showed up behind my right ear (size a little bigger than half a marble). In another week, another showed up behind my left ear, and more poped out (around 10 ) all around my neck and behind my head. I went for a blood check at 7/13/2021, and got the result the next day showing 26 times more than normal white blood counts. Went to the ER that night, and got initial diagnosis of leukimea/blood cancer. I was admitted into the cancer ward in the next two days, and stayed for 3 weeks. in the first week, I had a bone marrow biopsy done and got confirmed that I got B-cell Acute Lymphoblastic Luekemia. I started receiving chemo therapy right away. 3 weeks later I was released from the hospital at 7/29/2021. That weekend, My baby died when he was 25 weeks. I had to return to the hospital and had a induction at 8/3/2021.


VAERS ID: 1657701 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Foetal death, Ultrasound foetal
SMQs:, 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: Medical History/Concurrent Conditions: Maternal exposure during pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Fetal ultrasound; Result Unstructured Data: Normal Fetal ultrasound indicated normal fetal heartbeat.; Test Date: 20210715; Test Name: Fetal ultrasound; Result Unstructured Data: Abnormal Fetal ultrasound indicated: no fetal heartbeat.
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Fetal demise; This regulatory authority case was reported by a physician and describes the occurrence of FOETAL DEATH (Fetal demise) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600-CDC) , while the mother received the product for COVID-19 vaccination. The patient''s past medical history included Maternal exposure during pregnancy. On 14-Jul-2021, the mother 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 14-Jul-2021, the patient was diagnosed with FOETAL DEATH (Fetal demise) (seriousness criteria death and medically significant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Intrauterine Fetal Death. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Ultrasound foetal: normal (normal) Normal Fetal ultrasound indicated normal fetal heartbeat.. On 15-Jul-2021, Ultrasound foetal: abnormal (abnormal) Abnormal Fetal ultrasound indicated: no fetal heartbeat.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported . Treatment information was not provided. Patient reported that the hospital was going to perform a fetal autopsy and labor induction will be performed on the patient the next day (07/16). The case is still pending confirmation on whether a fetal autopsy will be performed. Company Comment: This is a case of maternal exposure during breastfeeding with associated adverse event of foetal death. 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 maternal exposure during breastfeeding with associated adverse event of foetal death. 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: 1780020 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
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, Inappropriate schedule of product administration, Maternal exposure before pregnancy, Pregnancy test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: pregnancy test; Test Result: Positive
CDC Split Type: FIPFIZER INC202101278474

Write-up: Miscarriage; Positive pregnancy test 2 weeks after the vaccination; second dose injected on 14Jul2021 (8 weeks after the first dose); This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority number FI-FIMEA-20215015. A 28-year-old pregnant female patient received the second dose of BNT162b2 (COMIRNATY), intramuscular, administered in left arm on 14Jul2021 (Batch/Lot Number: UNKNOWN) (at the age of 28 years old) as single dose for Covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The first dose of BNT162b2 (COMIRNATY) was administered on an unknown date for Covid-19 immunisation. The patient''s concomitant medications were not reported. The second dose was injected on 14Jul2021. On 28Jul2021, the patient had a positive pregnancy test 2 weeks after the vaccination. Then on 18Aug2021, the patient experienced miscarriage. The mother reported she became pregnant after taking BNT162b2. The pregnancy resulted in spontaneous abortion. Outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1799706 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Haemorrhage, Maternal exposure during pregnancy, Pain in extremity, SARS-CoV-2 test, 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), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Breast feeding; Folic acid supplementation; Pregnancy (Estimated due date: 22Mar2022).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test; Test Name: Scan; Result Unstructured Data: Test Result: smaller gestational sac.
CDC Split Type: GBPFIZER INC202100992382

Write-up: suspected miscarriage; bleeding; Maternal exposure during pregnancy; Painful arm; Fatigue; This is a solicited report from a contactable Consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-YCVM-202108021656440150-7JKAD, Safety Report Unique Identifier GB-MHRA-ADR 25742257. A 37-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection), dose 2 via an unspecified route of administration on 14Jul2021 (age at the time of vaccination was 37-year-old) (Batch/Lot Number: FD8813) as DOSE 2, SINGLE for covid-19 immunization. Medical history included ongoing pregnancy Estimated due date: 22Mar2022, ongoing breast feeding, Folic acid supplementation ongoing. Concomitant medication included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as for covid-19 immunization. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The mother reported she became pregnant while taking bnt162b2. On an unspecified date, the patient experienced maternal exposure during pregnancy. The mother delivered the pregnancy on 22Mar2022. On 14Jul2021 patient had fatigue. On 15Jul2021, patient had painful arm. Further reported as patient had currently bleeding, suspected miscarriage. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Jul2021 No - Negative COVID-19 test, scan: smaller gestational sac on an unspecified date. The details of scans or investigations: Scan due to bleeding at 6.5 weeks shown to be smaller gestational sac than expected 4.5 to 5 week size, concerns reliability - repeat scan to be performed 11Aug2021. The outcome of Fatigue and Painful arm was recovered on 17Jul2021. The outcome of currently bleeding, suspected miscarriage was unknown. 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 possible. No further information is expected.; Sender''s Comments: Based on available information and the drug temporal relationship, the causality between the events "abortion spontaneous, hemorrhage, pain in extremity, fatigue, Maternal exposure during pregnancy" and the suspect drug "BNT162B2" cannot be completely excluded.


VAERS ID: 1526181 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-30
Onset:2021-07-15
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 005C21A / 2 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pantoprazole - heartburn; Topical stuff for psoriasis
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: Ultrasound prior and an Ultrasound after - both at MGH
CDC Split Type: vsafe

Write-up: July 15 I started bleeding; July 19 - when the miscarriage happened. Pregnancy - 1 live birth pregnancy - 2nd miscarriage. - (three pregnancies altogether). Estimated due date - February 2nd, 2022


VAERS ID: 1719484 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-02-09
Onset:2021-07-15
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 028L20A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Coagulation time, In vitro fertilisation, Karyotype analysis, Pregnancy
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro; birth control
Current Illness:
Preexisting Conditions: depression and anxiety
Allergies: azithromycin
Diagnostic Lab Data: August 2021- karyotype testing; genetic testing of fetal tissue; blood clotting disorder testing; autoimmune disorder testing; thyroid panel; diabetes panel
CDC Split Type:

Write-up: I began the IVF process after receiving both COVID-1 vaccines. I got pregnant through IVF in May 2021 and had a miscarriage in July 2021. My doctors have not been able to determine why the miscarriage happened.


VAERS ID: 1491047 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

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

Write-up: Miscarriage 3 days after vaccine (1st trimester loss)


VAERS ID: 1549848 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-15
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, COVID-19, Drug ineffective, Polymerase chain reaction, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Termination of pregnancy and risk of abortion (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Test Result: Positive ; Test Name: PCR; Result Unstructured Data: Test Result:unknown result; Test Name: lateral flow; Result Unstructured Data: Test Result:unknown result
CDC Split Type: GBPFIZER INC202100941682

Write-up: Miscarriage; SARS-CoV-2 infection; SARS-CoV-2 infection; 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-202107230035359310-KUAGC. Safety Report Unique Identifier GB-MHRA-ADR 25696091. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jun2021 as dose 2, single for COVID-19 immunisation. Medical history included pregnancy, suspected COVID-19 from 15Jul2021 to 17Jul2021, and folic acid supplementation. Historical vaccine included BNT162B2 on 28Apr2021 for COVID-19 immunisation. Concomitant medications included folic acid taken for folic acid supplementation. The patient experienced SARS-COV-2 infection on 15Jul2021 and miscarriage on an unknown date. Lost the pregnancy around the time of the vaccine. The events were considered were medically significant. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included SARS-COV-2 test: positive COVID-19 test on 15Jul2021, lateral flow and polymerase chain reaction (PCR) both on an unknown date. The patient recovered from the event SARS-COV-2 infection on an unknown date and outcome of miscarriage is unknown. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1554833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-15
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Pregnant (3 weeks)
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Pregnancy test; Test Result: Positive
CDC Split Type: NOPFIZER INC202100973286

Write-up: Spontaneous abortion week 5; This is a spontaneous report from a non-contactable consumer downloaded from the WEB NO-NOMAADVRE-PASRAPP-2021-Uxprq1. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 33-year-old pregnant female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), intramuscular, administered in arm left on 02Jul2021 09:28 as dose 1, single for COVID-19 immunisation. Medical history included pregnancy (3 weeks) from an unknown date. The patient''s concomitant medications were not reported. The patient reported to have been 3 weeks pregnant at the time of the vaccination, and that she took a positive test four days later. The patient experienced spontaneous abortion week 5 on 15Jul2021. The reactions/case was considered to be serious due to [Other Serious (Important Medical Events)]. The mother reported she became pregnant while taking bnt162b2. The mother was 5 Weeks pregnant at the onset of the event. The patient underwent lab tests and procedures which included pregnancy test: positive on 06Jul2021. The outcome of the event was recovered with sequelae. Reporter Comment: Contact with healthcare professionals: Physician. The patient reports to have been 3 weeks pregnant at the time of the vaccination, and that she took a positive test four days later. The SPONTANEOUS ABORTION happened in week 5. Sender Comment: Upgraded to Serious due to (Other Serious (Important Medical Events)). Did not provide a causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Contact with healthcare professionals: Physician. The patient reports to have been 3 weeks pregnant at the time of the vaccination, and that she took a positive test four days later. The SPONTANEOUS ABORTION happened in week 5.


VAERS ID: 1585986 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-07-15
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 1 LA / OT

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Spontaneous abortion (previously had 4 spontaneous abortions in the absence of a known pathology, after natural conception)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood chemistry; Result Unstructured Data: Test Result:no results provided
CDC Split Type: ITPFIZER INC202100996156

Write-up: Spontaneous abortion; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB: -MINISAL02-763725. A 38-years-old pregnant female patient received bnt162b2 (COMIRNATY, solution for injection, lot Number: FC5089, Expiration Date: 31Oct2021), via an intramuscular route of administration, administered in Left Deltoid on 21Jun2021 at 14:33 as dose 1, 0.3 ML single for covid-19 immunization. Medical history included abortion spontaneous (the patient was having previously had 4 spontaneous abortions in the absence of a known pathology and after natural conception). The patient''s concomitant medications were not reported. On 15Jul2021, the patient had spontaneous abortion and visited to Emergency Room. The event was considered as serious (Congenital Anomaly) by health authority. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included blood chemistry report in 2021: no results provided. The outcome of all the events was unknown. Sender Comment: Suspected adverse reaction after first vaccine administration. The patient reports having previously had 4 spontaneous abortions in the absence of a known pathology and after natural conception. Attached Emergency Room and blood chemistry report. Reporter comment: none. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589036 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-07-15
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal death, 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? Yes
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: 20210716; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210703; Test Name: Ultrasound; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210715; Test Name: Ultrasound; Result Unstructured Data: Test Result:Cardiac arrest of the fetus; Comments: Cardiac arrest of the fetus at 10 weeks of pregnancy
CDC Split Type: FRPFIZER INC202101003844

Write-up: received the 1st injection of the COMIRNATY vaccine although she was pregnant; Fetal death in utero; Pregnancy loss <20 weeks gestation; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-NY20213108. The consumer reported events for both mother and fetus. This is the mother case. A 34-year-old female patient received BNT162B2 (COMIRNATY), via intramuscular route administered in left arm on 12May2021 (Batch/Lot Number: EX7389) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had no history of COVID-19. The patient did not know she was pregnant but had a pregnancy plan. She received the 1st injection of COMIRNATY vaccine while she was a few days pregnant without knowing it. Date of last menstrual period was on 26Apr2021. On 03Jul2021, follow-up ultrasound showed no abnormality. On 15Jul2021, 53 Days after the beginning of drug administration, the patient developed Loss of pregnancy < 20 weeks of gestation (10 weeks)/ fetal death in utero which constituted a congenital anomaly / birth defect. On 15Jul2021, new ultrasound showed cardiac arrest of the fetus at 10 weeks of pregnancy. Patient had hospitalization for curettage. Patient recovered in Jul2021. SARS-COV 2 test negative on 16Jul2021. Note: Imputability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. Therapie 1985; 40: 111-8.; Reporter''s comments: Death of the fetus in utero and miscarriage <20 weeks gestation (10 weeks) in a 34-year-old woman who received the 1st injection of the COMIRNATY vaccine (lot EX7389) although she was pregnant for a few days without knowing it. Patient recovered.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101046535 Foetus case


VAERS ID: 1589104 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-15
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4342 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WYSTAMM; FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101003949

Write-up: Spontaneous abortion / Miscarriage at 6 weeks of pregnancy; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-ST20212951. A pregnant 32-year-old female patient received the second dose of BNT162b2 (COMIRNATY), intramuscular, administered in left arm on 14Jun2021 (Batch/Lot Number: FD4342) at 0.3mL single dose for Covid-19 immunisation. The patient medical history was not reported. Concomitant medications included rupatadine fumarate (WYSTAMM, strength: 10mg) taken for an unspecified indication, start and stop date were not reported; folic acid, strength: 0.4mg taken for an unspecified indication, start and stop date were not reported. The patient experienced spontaneous abortion/miscarriage at 6 weeks of pregnancy on 15Jul2021. Clear egg, awaiting further information. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. Outcome of the events was recovered with sequelae on 15Jul2021. The regulatory authority assessed the events as medically significant. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1589195 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-15
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? 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; Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: Pregnancy; Result Unstructured Data: Test Result:I found out I was pregnant; Comments: Suffered from a complete miscarriage; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998273

Write-up: Early miscarriage/miscarriage; 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-202108031127078600-JV2UD, Safety Report Unique Identifier GB-MHRA-ADR 25746037. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Jun2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included miscarriage, lactation decreased, 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. Concomitant medications included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient experienced early miscarriage/miscarriage on 15Jul2021 with outcome of not recovered, and maternal exposure during pregnancy on an unspecified date with outcome of unknown. The patient underwent lab test which included Covid-19 virus test: No- Negative COVID-19 test on an unspecified date, pregnancy test: found out she was pregnant on 09Jul2021 suffered from a complete miscarriage. The event was assessed as serious and congenital anomaly by regulatory authority. The clinical course was reported as follows: "I received the vaccine on the 25Jun2021 when I did not know I was pregnant. I found out I was pregnant on the 09Jul2021 and I then suffered from a miscarriage which has been confirmed on the 02Aug2021." Patient has not tested positive for COVID-19 since having the vaccine. Did the medicine have an adverse effect on any aspect of the pregnancy: Unsure. Details of previous pregnancies: This was my first pregnancy. I had received the vaccine before I knew I was pregnant and have subsequently suffered a miscarriage. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Suffered from a complete miscarriage No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1625415 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Menstruation delayed, Muscle spasms, SARS-CoV-2 test
SMQs:, Dystonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (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 ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: cramping; Maternal exposure during pregnancy; Late period; Miscarriage; This case was received via a regulatory authority (Reference number: 25801348) on 15-Aug-2021 and was forwarded to Moderna on 15-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage), MUSCLE SPASMS (cramping), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MENSTRUATION DELAYED (Late period) in a 34-year-old female patient (gravida 1) who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. The patient''s past medical history included Pregnancy (Patient no longer pregnant at the time of reporting.). 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 15-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On 10-Aug-2021, the patient experienced MENSTRUATION DELAYED (Late period) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCLE SPASMS (cramping) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). The delivery occurred on 15-Jul-2021, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 15 th July patient had miscarriage. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) had resolved with sequelae, MUSCLE SPASMS (cramping) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown and MENSTRUATION DELAYED (Late period) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided . No treatment information was reported. Patient was exposed to the medicine first trimester 1- 12 weeks. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This is a case of product exposure during pregnancy with associated AE for this 34-year-old female.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This is a case of product exposure during pregnancy with associated AE for this 34-year-old female.


VAERS ID: 1633300 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous complete, Fatigue, Headache, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma; COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101026066

Write-up: Abortion spontaneous complete; Fever; Tiredness; Headache; Abdominal pain; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority WEB ES-AEMPS-953589. A 35-year-old female patient received second dose of BNT162B2 (COMIRNATY) intramuscular in left arm 0.3 mL single for COVID-19 immunisation on 14Jul2021. Medical history included COVID-19, allergic asthma. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) on 22Jun2021. The patient experienced abortion spontaneous complete (medically significant) on 17Jul2021 with outcome of recovering; fever, tiredness, headache, abdominal pain, all on 15Jul2021 with outcome of unknown. The mother reported she became pregnant while taking BNT162B2. The pregnancy resulted in spontaneous abortion. On 15Jul2021, the patient had fever, very tired, headaches but mainly the pain in belly in the area of the reproductive system. It was not a normal pain and after just over 24 hours the patient had the beginning of the abortion. The lot number for BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1664609 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-07-15
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101067122

Write-up: Abortion; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-770535. This physician reported information for both mother and fetus. This is the maternal report. A pregnant 43-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: FA8016), intramuscular, on 03Jun2021, as dose 1, 0.3 mL, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was unaware of her pregnancy at the time of vaccination. On 15Jul2021, the patient experienced abortion in the ninth week of pregnancy with revision of the uterine cavity. The patient was 9-weeks pregnant at the onset of the event. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101117992 Same patient and product; different event and dose


VAERS ID: 1668373 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-15
   Days after vaccination:20
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 spontaneous, SARS-CoV-2 test, Ultrasound abdomen
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test; Test Name: Ultrasound; Result Unstructured Data: Test Result:Normal; Comments: Normal; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown; Comments: no foetus developed.
CDC Split Type: GBPFIZER INC202101111552

Write-up: Early miscarriage; 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-202108251526371560-DLJCA.Safety Report Unique Identifier GB-MHRA-ADR 25847767. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Jun2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included lactation decreased and suspected covid-19 from 11Apr2021 to 19Apr2021. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for pregnancy and as folic acid supplementation from 01Mar2021 to 19Jul2021. The patient experienced early miscarriage on 15Jul2021 with outcome of recovered on 10Aug2021. It was reported that the patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations revealed ultrasound at 6 weeks of pregnancy, normal. Ultrasound at 8 weeks pregnant, no foetus developed. The patient underwent lab tests and procedures on 13Apr2021 which included positive COVID-19 test. The patient received BNT162B2 dose 2 via an unspecified route of administration on 30JUL2021 (Batch/Lot Number:Unknown) as Dose 2 for COVID-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1686763 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101114986

Write-up: early spontaneous miscarriage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number is FR-AFSSAPS-CN20212731. A 31-year-old pregnant female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administered in left arm on 12Jul2021 (Batch/Lot Number: FE3065) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has no history of COVID-19 and PCR testing. On 15Jul2021, 3 days after vaccination, the patient experienced early spontaneous miscarriage at 5 weeks of amenorrhea. Patient was referred to the gynecological emergency department for medical management. Outcome of event was recovering. The reporter assessed the event as serious, medically significant.


VAERS ID: 1698191 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-07-15
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK RA / -

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: FIPFIZER INC202101125497

Write-up: Miscarriage at seven weeks pregnant; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20214179. A 43-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Right on 20May2021 (Batch/Lot Number: UNKNOWN) as single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced "Miscarriage at seven weeks pregnant" (medically significant) on 15Jul2021 with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1701003 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-15
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Chills, 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: NATALBEN PLUS
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:no heartbeat at 01 weeks amenorrhea; Test Date: 2021; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:haematoma; Comments: at 7 weeks of pregnancy. A haematoma was found; Test Date: 2021; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:embryo did not develop, no heartbeat; Comments: Ultrasound at 10 weeks of pregnancy which showed the embryo did not develop properly at all, no heartbeat.
CDC Split Type: BEPFIZER INC202101142575

Write-up: Shivering; Miscarriage; This is a spontaneous report from a contactable consumer or other non-health care professional downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-105780. Spontaneous COVID-19 report received by the regulatory authorities on 25Aug2021. A 32-years-old female pregnant patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch no not reported / Lot Number: FC2336; expiration date: Unknown) via unknown route of administration on 25Jun2021 as dose 1, single for covid-19 immunization. The patient medical history was reported as none and concurrent medications included Ascorbic acid, biotin, Docosahexaenoic acid, Folic acid, Iodine, Iron, Nicotinamide, Pantothenic acid, Pyridoxine hydrochloride, Riboflavin, Selenium, Vitamin B1 NOS, Vitamin B12 NOS, Vitamin D NOS, Zinc [NATALBEN PLUS] (food supplement), taken for unspecified indication from an unknown date and unknown if ongoing. Patient was into First trimester of pregnancy at the time of vaccination. On 15Jul2021, patient reported of Shivering and Miscarriage. Patient did not list long-term adverse reactions and the miscarriage started almost 3 weeks later after the first dose of the vaccine. Unspecified treatment was received in response to the events. On unknown dates in 2021, the patient underwent lab tests and procedures which included ultrasound at 01 week with result of no heartbeat and amenorrhea, 7 weeks of pregnancy which showed a haematoma and ultrasound at 10 weeks of pregnancy which showed the embryo did not develop properly at all, no heartbeat. The outcome of the events was recovering. Health Authority Comment: Treatment as Yes (not specified). Evolution of the ADR: In the process of improvement. Situations reported as Other: Lack of research on the safety of messenger ribonucleic acid vaccines against COVID-19 in humans. Examinations reported as Ultrasound at 7 weeks of pregnancy. A haematoma was found. Ultrasound at 10 weeks of pregnancy which showed the embryo did not develop properly at all, no heartbeat.; Sender''s Comments: Linked Report(s) : BE-PFIZER INC-202101193285 mother/foetus case


VAERS ID: 1746486 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-05
   Days after onset: 52
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: 20210905; Test Name: Foetal heart rate; Result Unstructured Data: Test Result:stopped
CDC Split Type: FRPFIZER INC202101210953

Write-up: my baby''s heart suddenly stopped without reason one and a half month after the injection whereas there was no anomaly; my baby''s heart suddenly stopped without reason one and a half month after the injection whereas there was no anomaly; 2 weeks pregnant at the time of injection; This is a spontaneous report from a contactable consumer (patient''s mother) received via COVID-19 adverse event self-reporting solution. This is a fetus report. A fetus patient of an unspecified gender exposed to BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot Number: unknown), via transplacental route which was administered to her mother in her left arm on 15Jul2021 as dose number unknown, single for COVID-19 immunisation for her mother. The patient''s medical history and concomitant medication was not reported. The patient was 2 weeks fetus. The patient''s mother was a 32-year-old female. The mother was 2 weeks pregnant at the time of injection on 15Jul2021. Pregnancy was normal. Then the mother reported that her baby''s heart suddenly stopped without reason one and a half month after the injection, whereas there was no anomaly. It was not reported if an autopsy was performed. No follow up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: 2 weeks pregnant at the time of injection; heart suddenly stopped without reason one and a half month after the injection whereas there was no anomaly


VAERS ID: 1569094 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-04-20
Onset:2021-07-16
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft, buspar, multivitamin, probiotic
Current Illness: N/a
Preexisting Conditions: N/a
Allergies: Seasonal allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was 3 weeks pregnant at the time of the 2nd moderna shot. Due date was set for 1/9/22. Discovered I was miscarrying at 15 weeks (7/16/21). Contact from the V-safe program reached out and suggested I submit a report.


VAERS ID: 1496401 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during breast feeding, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal exposures via breast milk (narrow), Termination of pregnancy and risk of abortion (narrow), 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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200518; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during breast feeding; Miscarriage; Maternal exposure during pregnancy; This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Breast feeding since an unknown date. Concomitant products included FOLIC ACID for Folic acid supplementation, PARACETAMOL for Pain. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 16-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. On 16-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 19-Jul-2021, ABORTION SPONTANEOUS (Miscarriage) was resolving. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2020, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. Patient reports that she was 4.5 weeks pregnant when she received the 2nd vaccine and miscarried 2 days later. No treatment information was provided. Company Comment: This is a case of product exposure during pregnancy with associated AE of Spontaneous Abortion for this 39-year-old female. There is very limited information regarding the reported maternal exposure during breast feeding as there is inability to confirm breastfeeding while pregnant. No further information is expected. This case was linked to MOD-2021-263018 (Parent-Child Link). See case MOD-2021-263018 for details regarding the child case.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AE of Spontaneous Abortion for this 39-year-old female. There is very limited information regarding the reported maternal exposure during breast feeding as there is inability to confirm breastfeeding while pregnant. No further information is expected.


VAERS ID: 1584749 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous complete, Headache, Pyrexia, Vaginal haemorrhage, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100991136

Write-up: Bleeding vaginal; Vomited; Headache; Low grade fever; Abortion spontaneous complete; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-956021. A 37-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 13Jul2021 (Batch/Lot Number: FF3318) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included penicillin allergy and macrolide allergy. The patient''s concomitant medications were not reported. Historical vaccine included COMIRNATY dose 1 (lot number: FC5436) via intramuscular route on 22Jun2021 for COVID-19 immunisation. The patient was pregnant at the time of vaccination. The patient experienced vomiting, headache, low grade fever and and abortion spontaneous complete on 16Jul2021 with outcome of recovering; bleeding vaginal on 18Jul2021 with outcome of recovering. Further ADR description stated that the patient experienced abortion spontaneous two days after the administration of the second dose of the Pfizer vaccine being 8 weeks pregnant and with a perfect check up two days before the administration of the vaccine. The same day of the vaccine (as reported) she started with descents of fever, vomiting and a very bad headache. And 36 hours later the bleeding that ended up in an abortion spontaneous complete and its corresponding curettage. The patient reported that she became pregnant while taking bnt162b2. The patient was 8 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585012 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-07-16
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100990330

Write-up: Early miscarriage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LY20218522. A 43-year-old pregnant female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 09Jun2021 (Batch/Lot Number: FC3143) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY, lot AX7389) on 01May2021 at Arm Left for COVID-19 immunization and experienced maternal exposure during pregnancy. The patient''s last menstrual period was on 15Apr2021. On 16Jul2021, the patient experienced early miscarriage requiring aspiration. Age of gestation at exposure was 7 weeks. The mother was 13 weeks pregnant at the onset of the event (also reported as 11 weeks of amenorrhea). The mother was due to deliver on 20Jan2022. The pregnancy resulted in spontaneous abortion. The outcome of the event was recovered with sequel.


VAERS ID: 1589616 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-07-16
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-08-20
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
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101040696

Write-up: Miscarriage/Missed miscarriage; This is a spontaneous report from a contactable other HCP. This is a report received from the Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202108112216401540-RQHOR], Safety Report Unique Identifier [GB-MHRA-ADR 25787123]. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28May2021 (Lot Number: ET8885) as dose 1, single for COVID-19 Immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced Miscarriage/Missed miscarriage on 16Jul2021. The event was assessed as serious (fatal and Congenital anomaly). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 04Aug2021. The patient died on 16Jul2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: Missed miscarriage of child confirmed on 16th July. Festus had stopped growing some weeks earlier. She was likely in week 1-2 of pregnancy at the time of being vaccinated. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Miscarriage/Missed miscarriage


VAERS ID: 1593559 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion, 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: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Echography; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101016631

Write-up: Internal abortion found at 7 gestational week; Internal abortion found at 7 gestational week; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-767325. This pharmacist reported information for both mother and fetus/baby. This is a maternal report. A 32-years-old pregnant female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: FF4213), dose 2 intramuscular, administered in Deltoid Left on 16Jul2021 11:30 (7 weeks pregnant at the time of vaccination) as 0.3ml single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included folic acid taken for an unspecified indication from 01Nov2019 to an unspecified stop date. The patient previously received COMIRNATY as first dose on 11Jun2021(Lot number: FC3098) for COVID-19 immunization and did not experience any adverse events. On 30Jul2021, the patient experienced internal abortion found at 7 gestational weeks occurred 14 days after second dose. sequelae: waiting for evaluation of medical intervention and or surgery. The patient underwent lab tests and procedures which included ultrasound scan: unknown results on 30Jul2021. The outcome of the events was unknown. Sender comment: Adverse drug reactions received by the regulatory authority on 03Aug2021: asked the reporter to change the profile Privacy to Privacy batch and expiry date saline solution not available; vaccine reconstruction time not available. No follow-up attempts are possible. No further information expected.


VAERS ID: 1625715 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENLAFAXINE
Current Illness: Pregnancy; Sarcoidosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101016967

Write-up: Miscarriage; Vaginal bleeding; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00650860. A 43-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: FF0688) (at the age of 43-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing sarcoidosis, ongoing pregnancy. Concomitant medication included venlafaxine controlled-release capsule taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included first dose of BNT162B2 (COMIRNATY) on 11Jun2021 for COVID-19 immunisation and with no adverse reaction. Previous COVID-19 infection was No. The patient experienced miscarriage on 29Jul2021 (reported as 2 weeks after start Covid-19 vaccine Pfizer injection), maternal exposure during on 16Jul2021, vaginal bleeding on 17Jul2021 (reported as 1 days after start Covid-19 vaccine Pfizer injection and duration reported as 2 weeks). The miscarriage occurred at a pregnancy duration of about 4 weeks. Bled for 2 weeks and eventually had a miscarriage. Probably got pregnant right before the 2nd vaccination. This was the second Covid vaccination, which took place at a pregnancy duration of about 2 weeks. The first vaccination took place before pregnancy. The outcome of event vaginal bleeding was recovered on 29Jul2021, of the other event was unknown. The event miscarriage was reported as serious due to other medically important condition. Sender comment: Since the nature of (some of) the reported reactions does imply seriousness according to the health authority criteria, the report was considered as serious by the regulatory authority. No follow-up attempts are possible. No further information expected.


VAERS ID: 1659756 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

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: ESPFIZER INC202101061707

Write-up: Spontaneous abortion; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-967560. A 33-year-old pregnant female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 15Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has no history of COVID-19. Historical vaccination included bnt162b2 (COMIRNATY) given on 24Jun2021 administered in left arm as dose 1, single for COVID-19 immunisation and experienced no adverse effect. The patient experienced spontaneous abortion on 16Jul2021 with outcome of unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1688375 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-16
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, 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: NLPFIZER INC202101115176

Write-up: Vaccination during ..week of pregnancy; Pregnancy terminated prematurely, miscarriage as result. Pregnancy still unknown at time of vaccination; This is a spontaneous report from a contactable consumer or other non-health care professional downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00670243. A 25-year-old pregnant female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FE1573), dose 1 via an unspecified route of administration on 30Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient did not have previous COVID-19 infection. The patient had vaccination during week of pregnancy and on 16Jul2021, 16 days after administration of covid-19 vaccine, the patient experienced pregnancy terminated prematurely, miscarriage as result. Pregnancy still unknown at time of vaccination. The gestation period at the time of vaccination and at the time of the miscarriage was not reported. This was the first vaccination. The clinical outcome of the events was unknown. Health Authority comments: BioNTech/Pfizer Vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no, confounding factors, COVID-19 vaccine exposure during pregnancy week: COVID19. Previous COVID-19 infection: No. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1736168 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-07-16
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / UN

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal malformation, Inappropriate schedule of product administration, Labour induction, Uterine dilation and curettage
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Elemama, prenatal vitamins
Current Illness: None
Preexisting Conditions: None that I am aware of
Allergies: None that I am aware of
Diagnostic Lab Data: Medical induction/labour/birth/D&C on July 21, 2021.
CDC Split Type:

Write-up: This was my first pregnancy. I got my first dose of Pfizer when I was 6 weeks and some days along, and my second dose at 13 weeks and some days. My baby''s heart did not develop properly and I lost him at 16 weeks and some days. Hypoplastic left heart syndrome was the official diagnosis I got for him. There may of course be no connection to the vaccine, but I feel a responsibility to contribute to the data so this can be studied more at the very least.


VAERS ID: 1826908 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-16
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: echo; Result Unstructured Data: Test Result:embryonic demise; Comments: on 16Jul2021 the foetus was no longer alive
CDC Split Type: NLPFIZER INC202101379476

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00678503. This is a maternal report. A 35-year-old female patient received bnt162b2 (COMIRNATY, solution for injection) via an unspecified route of administration on 23Jun2021 (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. On 16Jul2021, the patient miscarried. The patient had an echo at 29Jul2021 on which became clear that embryonic demise had occurred on 16Jul2021. The mother reported she became pregnant while taking bnt162b2. The pregnancy duration at time of the miscarriage and the COVID vaccination is unknown. The pregnancy resulted in spontaneous abortion. The outcome of the event was unknown. Sender''s comments: Since the nature of the reported reaction does imply seriousness according to one of the company critera, the reaction (miscarriage) was considered as serious by the Centre. Case Summary and Reporter''s Comments Text: Date or period COVID-19 VACCIN PFIZER used: 23Jun2021 I have miscarried. Additional information ADR: I had an ultrasound on 29Jul2021 when they could see that on 16Jul2021 the foetus was no longer alive No follow-up attempts are possible, information on batch/lot number cannot be obtained. No further information expected.; Reporter''s Comments: Date or period COVID-19 VACCIN PFIZER used: 23Jun2021 I have miscarried. Additional information ADR: I had an ultrasound on 29Jul2021 when they could see that on 16Jul2021 the foetus was no longer alive


VAERS ID: 1587265 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-01
Onset:2021-07-17
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / UN

Administered by: School       Purchased by: ?
Symptoms: Angiogram, Angiogram normal, Caesarean section, Chorioretinopathy, Computerised tomogram head normal, Exposure during pregnancy, Magnetic resonance imaging spinal normal, Magnetic resonance imaging thoracic normal, Plasmapheresis, Platelet count decreased, Platelet transfusion, Premature delivery, Premature separation of placenta, Third trimester pregnancy, Thrombotic thrombocytopenic purpura
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, arterial (narrow), Retinal disorders (narrow), Renovascular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: prenatal vitamin
Current Illness: none.
Preexisting Conditions: none.
Allergies: none.
Diagnostic Lab Data: Platelets down to nadir of 9,000. MRI of lumbar spine - negative. MRI of thoracic spine - negative. CT brain and CT angiogram - negative.
CDC Split Type:

Write-up: thrombotic thrombocytopenic purpura leading to a placental abruption, emergency c-section at 35 weeks of pregnancy. birth weight was 4lb 4.1oz. Pt received several units of platelets, several days of plasmapheresis. Diagnosed with central serous retinopathy.


VAERS ID: 1579689 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / OT

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

Life Threatening? No
Birth Defect? 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: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Scan; Result Unstructured Data: Test Result:showed the baby died just days after receiving the; Comments: vaccine just after 8 weeks.
CDC Split Type: GBPFIZER INC202101019814

Write-up: Baby died; Patient was exposed to the medicine first-trimester (1-12 weeks).; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and fetus. This is a fetus 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 patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 transplacental on 17Jul2021 (Lot Number: FE1510) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included folic acid taken for vitamin supplementation. Baby died days after 2nd vaccine dose just over 8 weeks gestation (baby had not been conceived before first dose). Patient was exposed to the medicine first-trimester (1-12 weeks). Scan just before 12 weeks showed the baby died just days after receiving the vaccine just after 8 weeks. The baby died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101012902 case for mother; Reported Cause(s) of Death: Patient was exposed to the medicine first-trimester (1-12 weeks); baby died


VAERS ID: 1589613 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Maternal exposure during pregnancy, Scan, 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: 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: scan; Result Unstructured Data: Test Result:Missed Pregnancy (7weeks3 days) found out at 11 we; Comments: Missed Pregnancy (7weeks3 days) found out at 11 weeks pregnant; Test Name: ultrasound scan; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101040994

Write-up: Missed abortion; and I had my 2nd vaccine at 7 weeks pregnant.; 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-202108111935192920-WV8ZL. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: FF3319) as single dose for covid-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing. Patient no longer pregnant at the time of reporting. Concomitant medication(s) included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient experienced missed abortion on 17Jul2021. 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 ultrasound scan: unknown results, scan: Missed Pregnancy (7weeks3 days) found out at 11 weeks pregnant. I had the second vaccination at 7 weeks pregnant. The embryo stopped developing at 7 weeks 3 days and had a missed abortion which I only found out in a scan at 11 weeks. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Pregnancy adverse effects details: missed miscarriage. Details of previous pregnancies: Other normal pregnancies. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Missed Pregnancy (7weeks3 days) found out at 11 weeks pregnant and I had my 2nd vaccine at 7 weeks pregnant. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Outcome was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1590444 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-17
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / 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: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202100996275

Write-up: SPONTANEOUS ABORTION; This is a spontaneous report from a non-contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-PASRAPP-2021-Uxpejd. A 32-year-old female patient (pregnant) received bnt162b2 (COMIRNATY), first dose intramuscular, administered in arm right on 30Jun2021 07:30 (pregnant at time of vaccination) (batch/lot number was unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included folic acid. The patient developed spontaneous abortion in gestation week 9 (on 17Jul2021). The patient did not know that she was pregnant at the time of dose No. 1 of the vaccine (suspect). The event spontaneous abortion was serious due to other serious (important medical events). The event outcome was recovered in 2021. Reporter''s comments: Contact with healthcare professionals: Other health care professional. The patient did not know that she was pregnant at the time of dose No. 1 of the vaccine (suspect). The SPONTANEOUS ABORTION happened in gestation week 9. Sender Comment: Upgraded to Serious due to SPONTANEOUS ABORTION: Important Medical Events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Contact with healthcare professionals: Other health care professional. The patient did not know that she was pregnant at the time of dose No. 1 of the vaccine (suspect). The SPONTANEOUS ABORTION happened in gestation week 9.


VAERS ID: 1656759 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma; Head pain; Menstruation normal (Last menstruation date); Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101054873

Write-up: maternal exposure during pregnancy; Abortion complete; Bleeding vaginal; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, Regulatory authority number: ES-AEMPS-967563. A 30-years-old pregnant female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 16Jul2021 (Batch/Lot Number: FF0900) as dose 2, single for Covid-19 immunisation. Medical history included normal menstruation from 18May2021 to an unknown date (last menstruation date), head pain, allergic asthma and pregnancy from May2021 to an unknown date. The patient had not had Covid-19. Concomitant medication included paracetamol (PARACETAMOL) taken for head pain, start and stop date were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 intramuscular on 25Jun2021 (Batch/Lot Number: unknown) as dose 1, single for Covid-19 immunisation. The patient experienced maternal exposure during pregnancy, vaginal bleeding and had a complete abortion on 17Jul2021. The mother reported she became pregnant while taking bnt162b2. The mother was 8 weeks pregnant at the onset of the event and was due to deliver on 22Feb2022. The patient had approximately 10 weeks of gestation and the midwife encouraged her to get the vaccine. Now after all, she has received a lot of information about how the recommendation for vaccination is after the 20 weeks of gestation. Therapeutic measures were taken as a result of the events maternal exposure during pregnancy, vaginal bleeding and complete abortion which included Paracetamol and vaginal tablets. The events resolved on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1668169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-07-17
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 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? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210810; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 2021; Test Name: Scans; Result Unstructured Data: Test Result:no development of baby since 6 weeks; Comments: at 10 weeks
CDC Split Type: GBPFIZER INC202101056927

Write-up: Early miscarriage; 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-202108152055357210-6VJDN, safety report unique identifier is GB-MHRA-ADR 25802102. A pregnant 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jun2021 (Lot Number: FA1027) as single dose for COVID-19 immunisation. Medical history included lactation decreased, miscarriage, and pregnancy (Patient no longer pregnant at the time of reporting). Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date for COVID-19 immunisation. Patient was exposed to the medicine first-trimester (1-12 weeks). Scans at 10 weeks on unspecified date in 2021 revealed no development of baby since 6 weeks resulting in missed miscarriage. The patient experienced early miscarriage on 17Jul2021 with outcome of recovered on 01Aug2021. The event was considered serious due to medically significant and led to congenital anomaly. No previous history of issues with pregnancies prior to having vaccine and two healthy children. The patient had negative COVID-19 virus test on 10Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1697659 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-07-17
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nicotine dependence
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101129816

Write-up: Abortion in the 9th week of pregnancy; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100176531. This is the 1st of two reports considering second dose administered. A 21-years-old pregnant female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 24Jun2021 (Lot Number: FD7958) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included nicotine. The patient''s concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 intramuscular on 25May2021 (LOT: 1D014A 03046) for COVID-19 immunisation at 3th week of pregnancy. The patient experienced abortion in the 9th week of pregnancy on 17Jul2021. Result of assessment (source: HA) unclassifiable. The outcome of the event was recovered in 2021. Sender''s comment: Vaccination with Comirnaty in the 3rd and 7th week of pregnancy. Special features: nicotine.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101188266 same patient, different events, different dose


VAERS ID: 1702923 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004498 / UNK - / OT

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

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

Write-up: Maternal exposure during pregnancy; This case was received via a regulatory authority (Reference number: PT-INFARMED-R202108-1941) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of PREMATURE DELIVERY and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004498) for COVID-19 vaccination. Previously administered products included for an unreported indication: NATALBEN PLUS (Natalben). On 17-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On 17-Jul-2021, after starting mRNA-1273 (Spikevax), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criteria hospitalization, disability and medically significant). On 18-Jul-2021, the patient experienced PREMATURE DELIVERY (seriousness criteria hospitalization, disability and medically significant). The delivery occurred on 18-Jul-2021, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. On 17-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 19-Jul-2021, PREMATURE DELIVERY had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medical information was reported. No treatment information was reported. Company Comment: This is a case of maternal exposure during pregnancy and premature delivery for this 29-year old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up received on 01-SEP-2021, event outcome was updated.; Sender''s Comments: This is a case of maternal exposure during pregnancy and premature delivery for this 29-year old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.


VAERS ID: 1724393 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-17
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nettle rash; Pregnancy (3 times Pregnant and 2 given birth 2 times (G3P2); 3 gestations,2 deliveries (G3P2) vaginal delivery); Toxoplasmosis; Vaginal delivery (3 times Pregnant and 2 given birth 2 times (G3P2); 3 gestations,2 deliveries (G3P2) vaginal delivery)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101155986

Write-up: amenorrhea; Miscarriage; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number FR-AFSSAPS-RN20212659. A 38-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administered in the left arm on 22Jun2021 (Batch/Lot Number: FD0168) as dose 2, single for COVID-19 immunisation. The patient was then pregnant, in the first trimester. The patient had no medical history of COVID-19. The patient was not tested for COVID-19. Medical history included nettle rash from an unknown date, toxoplasmosis from an unknown date to an unknown date, and 3 times pregnant and 2 given birth 2 times (G3P2) (3 gestations, 2 deliveries (G3P2) vaginal delivery). The patient''s concomitant medications were not reported. The patient experienced miscarriage on 17Jul2021 and experienced amenorrhea on 17Aug2021, both reported as serious (hospitalization). The events were described as on 17Jul2021, she had a spontaneous miscarriage, the patient was then 10 weeks to amenorrhea. The patient reported she reported she became pregnant while taking BNT162B2 and that she was 1 Trimester pregnant at the onset of the event (as reported). The outcome of miscarriage was recovered with sequelae, while the outcome of amenorrhea was unknown. The physician also reported "Subject to other elements of investigations which could be carried out as part of legal or amicable compensation procedures". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746662 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Dysmenorrhoea, Inappropriate schedule of product administration
SMQs:, 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: Medical History/Concurrent Conditions: Endometriosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101225464

Write-up: miscarriage; Painful periods; First dose of BNT162B2 received on 19May2021/second dose on 17Jul2021; 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-202109160952513370-BFCKU], Safety Report Unique Identifier [GB-MHRA-ADR 25951376]. This is the first of two reports; the report for the second dose of BNT162B2. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Lot Number: FD5613), at the age of 39-year-old, as dose 2, single for COVID-19 immunisation. Medical history included endometriosis from 2012 and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 19May2021 (batch EN4109) for COVID-19 immunisation and experienced periods have been especially painful.The patient experienced miscarriage and painful periods on 16Aug2021; and inappropriate schedule of vaccine administered on 17Jul2021. The outcome of the event ''miscarriage'' was unknown and event ''painful periods'' was not recovered. The clinical course was reported as follows: Possible miscarriage on 16Aug2021 but would have only been 4/5 weeks pregnant. Periods have been especially painful since her first dose of Pfizer on 19May2021 (batch EN4109). She also has endometriosis and the pain has increased since both doses. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional information: Endometriosis - confirmed in 2012. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. No follow up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101239124 Same patient/drug, different dose/event


VAERS ID: 1789646 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-07-17
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 0)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20213

Write-up: Miscarriage; vaccination during pregnancy; Inappropriate schedule of vaccine administered; This case was received (Reference number: NL-LRB-00665777) on 08-Oct-2021 and was forwarded to Moderna on 08-Oct-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003659) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 0). On 29-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-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 17-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccination during pregnancy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On 17-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccination during pregnancy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) outcome was unknown. No concamitant medications were provided by reporter. No treatment was provided. COVID-19 vaccine exposure during pregnancy week: 0 Company Comment: This case concerns a 39 year-old, female patient with no relevant medical history, with maternal exposure during pregnancy, who experienced the serious unexpected event of Abortion spontaneous. The event occurred approximately 10 days after the second dose of Moderna COVID-19 vaccine and 2 months 1 day after the first dose. The rechallenge was not applicable due to the nature of the event. Inappropriate schedule of product administration was considered as an additional event. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Translation received on 13-oct-21 which contains NNI.; Reporter''s Comments: Since the nature of the reported reaction does imply seriousness according to one of the critera, the reaction was considered as serious; Sender''s Comments: This case concerns a 39 year-old, female patient with no relevant medical history, with maternal exposure during pregnancy, who experienced the serious unexpected event of Abortion spontaneous. The event occurred approximately 10 days after the second dose of Moderna COVID-19 vaccine and 2 months 1 day after the first dose. The rechallenge was not applicable due to the nature of the event. Inappropriate schedule of product administration was considered as an additional event. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1802345 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion induced, Antiphospholipid antibodies, Antithrombin III, Beta-2 glycoprotein antibody, Beta-2 glycoprotein antibody positive, Blood homocysteine, Body temperature, C-reactive protein, C-reactive protein increased, Cardiolipin antibody, Cerebral thrombosis, Cerebral venous thrombosis, Coma scale, Computerised tomogram, Ear pain, Factor II mutation, Factor V Leiden mutation, Haemoglobin, Headache, Human chorionic gonadotropin, Hyperleukocytosis, Magnetic resonance imaging head, Maternal exposure during pregnancy, Musculoskeletal stiffness, Neck pain, Neurological examination, Otitis media chronic, Pain, Photophobia, Platelet count, Platelet count decreased, Protein C, Protein S, Protein S decreased, Pyrexia, Strabismus, Subarachnoid haemorrhage, Ultrasound scan, VIth nerve paralysis, Vision blurred, White blood cell count
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Malignancy related conditions (narrow), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Ocular motility disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune 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? Yes, 22 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Miscarriage; Thrombocytopenia (immunological thrombocytopenia in 2020 treated with corticoids); Tonsillectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: antiphospholipids; Test Result: Positive ; Comments: (weak) positivity of antiphospholipids (anticardiolipin and anti-beta 2Gp1) leads to the suspicion of SAPL; Test Date: 20210729; Test Name: antithrombin; Test Result: 112 %; Test Date: 20210729; Test Name: anti-beta2GP1 immunoglobulin G antibody; Result Unstructured Data: Test Result:12; Comments: Unit: U/mL; Test Date: 20210729; Test Name: Homocysteine; Result Unstructured Data: Test Result:12.3 umol/l; Test Date: 20210729; Test Name: temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Test Date: 20210729; Test Name: anti-cardiolipin IgG antibody; Result Unstructured Data: Test Result:27; Comments: Unit: U/mL; Test Date: 20210729; Test Name: Glasgow; Result Unstructured Data: Test Result:15; Test Date: 20210729; Test Name: Cerebral CT scan; Result Unstructured Data: Test Result:in favor of a subarachnoid hemorrhage; Comments: discrete thickening of the right mastoid cells compatible with mastoiditis; Test Date: 20210729; Test Name: C-reactive protein; Result Unstructured Data: Test Result:145 mg/l; Test Date: 20210729; Test Name: factors II and V Leiden; Result Unstructured Data: Test Result:No mutation; Test Date: 20210729; Test Name: factors II and V Leiden; Result Unstructured Data: Test Result:No mutation; Test Date: 20210729; Test Name: hemoglobin; Result Unstructured Data: Test Result:13 g/dl; Test Date: 20210729; Test Name: Beta HCG; Result Unstructured Data: Test Result:74434 IU/l; Comments: confirmation of pregnancy by ultrasound; Test Date: 20210729; Test Name: Brain Magnetic Resonance Imaging; Result Unstructured Data: Test Result:bilateral diffuse cerebral hrombophlebitis; Comments: associated with ischemic remodeling probably of venous origin of the posteroinferior part of the left parietal lobe, without intraparenchymal hemorrhagic remodeling; Test Date: 20210729; Test Name: Neurological examination; Result Unstructured Data: Test Result:conscious patient; Comments: no deficit nor motor nor sensitive, BBK-, deep tendon reflex plus bilateral and symmetrical, convergent strabismus, visual blur, no balance disorder, no diplopia; Test Date: 20210729; Test Name: platelets; Result Unstructured Data: Test Result:101 x10 9/l; Test Date: 20210729; Test Name: Protein C; Test Result: 106 %; Test Date: 20210729; Test Name: Protein S; Test Result: 32 %; Comments: decreased to 32%; Test Date: 20210729; Test Name: ultrasound; Result Unstructured Data: Test Result:pregnancy; Test Date: 20210729; Test Name: hyperleukocytosis; Result Unstructured Data: Test Result:19.7 x10 9/l
CDC Split Type: FRPFIZER INC202101313490

Write-up: Termination of pregnancy; hyperleukocytosis at 19.7 G/L; subarachnoid hemorrhage; persistent pain; Cerebral thrombosis; cerebral thrombophlebitis/thrombophlebitis; temperature was at 37.9; neck stiffness; photophobia; convergent strabismus; visual blur; C-reactive protein at 145mg/L; platelets at 101 G/L; Protein S decreased to 32% (N: 58.6-126); anti-beta2GP1 immunoglobulin G antibody at 12 U/mL (<10); right serous otitis; otalgia; neck pain; headache/persistent headache; VI paralysis, predominantly on the right; Maternal exposure during pregnancy; This is a spontaneous report from a contactable physician (patient) downloaded from the RA, regulatory authority number FR-AFSSAPS-BS20211793. A 24-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in arm left on 17Jul2021 (Lot Number: FE2296) as dose 2, single (at the age of 24 years old) for COVID-19 immunisation. Medical history included appendectomy, tonsillectomy, immunological thrombocytopenia in 2020 treated with corticoids, miscarriage in 2020. Medication reported as none, no contraception. No medical history of COVID-19 and had not been tested. The patient''s concomitant medications were not reported. On Day 8, on 25Jul2021: presence of otalgia, neck pain, headache. On Day 12, on 29Jul2021, she was hospitalized for persistent pain. Upon admission: temperature was at 37.9, neck stiffness, photophobia, persistent headache, cardiopulmonary examination without any particularity. Neurological examination: conscious patient, Score 15, no deficit nor motor nor sensitive, bilateral below knee (BBK) -, deep tendon reflex plus bilateral and symmetrical, convergent strabismus, visual blur, no balance disorder, no diplopia. Biological examination included hyperleukocytosis at 19.7 G/L (also reported as x10 9/l), C-reactive protein at 145mg/L, hemoglobin at 13g/dL, platelets at 101 G/L (also reported as x10 9/l). Beta HCG at 74434 IU/L (confirmation of pregnancy by ultrasound). Cerebral CT scan in favor of a subarachnoid hemorrhage, discrete thickening of the right mastoid cells compatible with mastoiditis. Brain Magnetic Resonance Imaging performed: bilateral diffuse cerebral thrombophlebitis, associated with ischemic remodeling probably of venous origin of the posteroinferior part of the left parietal lobe, without intraparenchymal hemorrhagic remodeling. It was also reported that the patient experienced cerebral thrombosis on 29Jul2021. Ongoing medical care included curative anticoagulation, neurological monitoring, thrombophilia workup and gynecological follow-up for management of an incidental pregnancy and ENT workup for suspected mastoiditis. Thrombophilia test: antithrombin 112% (N: 79-119.8), Protein C at 106% (N: 70-140), Protein S decreased to 32% (N: 58.6-126), Homocysteine at 12.3 umol/l (N: 3.7-13.9), anti-cardiolipin IgG antibody at 27U/mL (<40), anti-beta2GP1 immunoglobulin G antibody at 12 U/mL (<10). No mutation of factors II and V Leiden. No identifiable paroxysmal nocturnal hemoglobinuria clone. The thrombophilia workup was partially interpretable because of the presence of thrombophlebitis and pregnancy, to be checked on a new sample at a distance. Nevertheless, the (weak) positivity of antiphospholipids (anticardiolipin and anti-beta 2Gp1) leads to the suspicion of SAPL, to be checked at a distance. ENT opinion: no clear sign of mastoiditis, but doubt about a right serous otitis probably in progress. Favorable outcome of ENT disorders after antibiotic treatment. Termination of pregnancy on 17Aug2021 due to the patient''s refusal to continue the pregnancy. Further reported favorable outcome until the end of her hospitalization, persistent visual blur on VI paralysis, predominantly on the right (from unspecified date in 2021). Discharged from hospital on 20Aug2021. In summary: thrombophlebitis discovered at Day12 of a Dose2 of COMIRNATY in a pregnant patient (fortuitous discovery) with a doubt on a SAPL. The patient was 7 Weeks pregnant at the onset of the event. Reported that the patient was due to deliver on 12Mar2022. The outcome of visual blur and VI paralysis, predominantly on the right was not recovered while the outcome of the other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1518036 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Idaho  
Vaccinated:2021-07-06
Onset:2021-07-18
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO198 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnant
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100922731

Write-up: Spontaneous miscarriage with no previous history of miscarriages.; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 25-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: ewo198) via an unspecified route of administration, administered in arm left on 06Jul2021 at 16:30 pm as dose 1, single dose for covid-19 immunization (at the age of 25-years-old). Medical history included pregnancy from an unknown date. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. It was reported that on 06Jul2021 the pregnant female patient received first dose of vaccine and on 18Jul2021 at 14:00 pm she had spontaneous miscarriage with no previous history of miscarriages. The mother was 4 weeks pregnant at the onset of the event. The mother was due to deliver on 28Mar2022. Patient had not received any treatment for the event. The outcome of the event was reported as recovering. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1797729 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-04-19
Onset:2021-07-18
   Days after vaccination:90
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood test normal, Cervical dilatation, Exposure during pregnancy, Premature delivery, Premature labour
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamins, prescription folic acid 1mg, stool softener
Current Illness: n/a
Preexisting Conditions: Rheumatoid arthritis
Allergies: N/a
Diagnostic Lab Data: Blood work - normal - 7/19/2021
CDC Split Type: vsafe

Write-up: Overnight Sunday into Monday (July 18/19 2021) I started having contractions and it lasted overnight. I went to the hospital around 7AM and was 2CM dilated and 100% effaced upon arrival. I was admitted and had her at 2:48PM on the 19th Of July this year. She was born at 33weeks and 2 days, she was 7 weeks premature. Other than that, everything was fine, she was just early and did not have any complications or medical conditions at all. Pregnancy history is uneventful, I was not on any restrictions at all. My Due date was to be Sept 22 of 2021. It was a pretty uneventful pregnancy up until the premature labor. Her birth weight was 4.8 pounds.


VAERS ID: 1526986 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
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, Ultrasound scan vagina, Urine analysis
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; NASONEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic sinusitis; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210720; Test Name: Vaginal U/S; Result Unstructured Data: Test Result:confirmed the probability of miscarriage as there; Comments: confirmed the probability of miscarriage as there was no fetus seen; Test Date: 20210720; Test Name: urine test; Test Result: Positive
CDC Split Type: GBPFIZER INC202100934334

Write-up: Early miscarriage; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202107212245044910-TCJZI. Safety Report Unique Identifier is GB-MHRA-ADR 25689709. This is the maternal report. A 25-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 17Jul2021 as dose 2, single for COVID-19 immunization. Medical history included lactation decreased, and chronic sinusitis. Patient had no previous pregnancy. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Historical vaccine included first dose on BNT162B2, received on 19Jun2021 for COVID-19 immunization. Concomitant medications included folic acid taken for folic acid supplementation; and mometasone furoate (NASONEX) taken for chronic sinusitis. The patient experienced early miscarriage on 18Jul2021. The event was reported as serious per congenital anomaly/birth defect. The clinical course was reported as follows: The patient had her 1st dose on 19Jun2021 and the 2nd on 17Jul2021. She was 5 weeks pregnant when she had her second dose, this meant that she had her 1st dose 1 week before conception. On 18Jul2021 on 24 hours, patient started to bleed. Therefore, she called 111 and they got her a U/S appointment on Tuesday 20Jul2021. There, they confirmed the probability of miscarriage as there was no fetus seen, despite positive urine test. She told the midwives about her concerns regarding the vaccine and they agreed that its worth to mention this on the report. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. They were unsure if the medicine had an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient was no longer pregnant at the time of reporting. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The patient had only 1 scan (Vaginal U/S) when the bleeding started 2 days after her 2nd dose. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 10Jun2021; urine test: positive and Vaginal U/S: confirmed the probability of miscarriage as there was no fetus seen, both on 20Jul2021. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1592955 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-07-18
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-20
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: Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:Miscarriage
CDC Split Type: GBPFIZER INC202101012707

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-202108051813563660-13RHD, Safety Report Unique Identifier GB-MHRA-ADR 25761307. A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Jun2021 (Lot number was not reported) as first dose, single for COVID-19 immunisation. Medical history included miscarriage and pregnancy (patient no longer pregnant at the time of reporting). Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medication included folic acid for folic acid supplementation. The patient experienced miscarriage on 18Jul2021 with outcome of not recovered. The patient was unsure if the medicine had an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine throughout the pregnancy. 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 scan on unspecified date which showed miscarriage. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1629642 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-18
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101026272

Write-up: Pregnancy loss $g20 weeks/ Late miscarriage at 21 weeks pregnant + 1 day; spontaneous miscarriage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-ST20213014. A 33-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 08Jul2021 (Batch/Lot Number: FE1573) as dose 1, 0.3 ml, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced Late miscarriage at 21 weeks pregnant + 1 day (spontaneous rupture of membranes during labor, clear amniotic fluid; male baby 405 g with early neonatal death) on 18Jul2021. Pregnancy loss $g20 weeks. 10 days after the vaccination of a spontaneous miscarriage. The mother was 21 Weeks pregnant at the onset of the event. The mother was pregnant with 1 baby. The mother was due to deliver on 29Nov2021. The baby weighed 405grams. No autopsy request made by the parents. Patient was hospitalized. Outcome of events was recovered on 19Jul2021 No follow-up attempts are possible. No further information is expected.


VAERS ID: 1664153 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-07-18
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, 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: AMOXICILLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ear infection; 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 INC202101069486

Write-up: Maternal exposure during pregnancy; Miscarriage; 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-202108171559107740-3AFWJ, Safety Report Unique Identifier (GB-MHRA-ADR 25811830). A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW4109), via an unspecified route of administration on 19May2021 as dose 1, single for COVID-19 immunization. Medical history included ear infection (Was on antibiotics for ear infection), pregnancy (Patient was no longer pregnant at the time of reporting). Had previous successful pregnancy. Patient had no symptoms associated with COVID-19. Concomitant medication(s) included amoxicillin (AMOXICILLIN) taken for ear infection. The patient had experienced maternal exposure during pregnancy on an unspecified date. On 18Jul2021, the patient had miscarriage. Pregnancy adverse effects details included miscarried. Patient was exposed to the medicine first-trimester (1-12 weeks). The events seriousness was assessed as medically significant. Patient was not enrolled in clinical trial. The medicine had an adverse effect on an aspect of the pregnancy. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No- Negative COVID-19 test) on an unspecified date. The outcome of the events maternal exposure during pregnancy was unknown and miscarriage was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1822551 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-07-18
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: KARDEGIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Endometriosis ablation (Resection of an endometriosis nodule); Pre-eclampsia (at 39 weeks of amenorrhea); Pregnancy (complicated by preeclampsia vaginal birth with instrumental extraction)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101370021

Write-up: injection site pain/ pain in the arm; Early miscarriage; This is a spontaneous report from a contactable consumer and physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-SE20212570. A 41-year-old female patient received BNT162B2 (COMIRNATY), intramuscular (IM), administered in arm left on 25May2021 (Batch/Lot Number: FC3558) as dose 2, single for COVID-19 immunisation. Medical history included 1st pregnancy in 2016 complicated by preeclampsia at 39 weeks of amenorrhea (vaginal birth with instrumental extraction, female child 3110g, APGAR 8-10-10), endometriosis ablation from 2010 (Resection of an endometriosis nodule). Person was not at risk of developing a severe form of COVID-19, did not had COVID-19 and has not been tested. Concomitant medication(s) included acetylsalicylate lysine (KARDEGIC) taken for pre-eclampsia prevention, start and stop date were not reported. The patient previously received first dose of COMIRNATY (Batch/Lot Number: ET6956) IM administered in arm left on 27Apr2021. On 18Jul2021 (D54), the patient had early miscarriage in the first trimester. Last menstrual period (LMP) date was unknown, "DDG a priori" on 28May2021 or 29May2021 (3 to 4 days after COMIRNATY dose 2, dates not specified on the retrieved gynecology report). Patient tolerated the vaccine well, with no side effects except pain in the arm for a few days (injection site pain) on an unspecified date. The mother reported she became pregnant while taking bnt162b2 - a few days after this 2nd injection (around 28-29May2021). But she had a miscarriage a few weeks later, at 7NT around 18Jul2021. The mother was 7 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Evolution: Outpatient curettage on 27Jul2021. Exit treatment: paracetamol and ketoprofen. Conclusion: Early miscarriage at 7 amenorhea weeks (AW) or 7 weeks of pregnancy) following the 2nd injection of COMIRNATY performed 3 to 4 days before conception in a 41-year-old G2P1 patient with a history of endometriosis and pre-eclampsia. Outcome of event early miscarriage was recovered with sequelae on 27Jul2021, while pain in the arm was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1744493 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-05-28
Onset:2021-07-19
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004C21A / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal death, Haemorrhage, Uterine dilation and curettage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: prenatals
Current Illness: suffered a miscarrige after the second dose of the vaccine on 7/19/2021
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: D &C conducted on July 22 at 7am after loosing my child.
CDC Split Type:

Write-up: I had no history of miscarriage, my baby was developing strong and healthy at the 7 1/2 week scan my baby was perfect everything was fine... until I received the second dose. once the second dose was given I was fine for a week then I heavily bled. went to the hospital in which they said my baby passed. I''m linking it to me receiving the vaccine same with everyone I talk to says its from the vaccine since i took every single precaution as an expecting mother to make sure my baby would be healthy. July 19th is the date I found ou t of the miscarriage.


VAERS ID: 1554828 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-19
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Pregnancy test; Test Result: Positive
CDC Split Type: NLPFIZER INC202100973349

Write-up: Spontaneous miscarriage; This is a spontaneous report from a contactable consumer downloaded from the WEB (Regulatory Authority Number: NL-LRB-00638699). A 26-year-old pregnant female patient received BNT162B2 (COMIRNATY; solution for injection), via an unspecified route of administration on 02Jul2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient has no previous COVID-19 infection. On 06Jul2021, the patient had a positive pregnancy test on hand. The patient was already pregnant for about 3 weeks at the time of vaccination on 02Jul2021. On 19Jul2021 (about 5.5 weeks of pregnancy), the patient had a spontaneous miscarriage. 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: 1565992 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-07-19
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? Yes
Birth Defect? Yes
Died? Yes
   Date died: 2021-07-24
   Days after onset: 5
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: Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101005881

Write-up: Maternal exposure during pregnancy; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority. Regulatory authority report number (GB-MHRA-WEBCOVID-202108042255110690-DRTHG). Safety Report Unique Identifier (GB-MHRA-ADR 25756910). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pregnancy, Lactation decreased, Pregnancy (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(s) included folic acid taken for Folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy (death, hospitalization, medically significant, life threatening, congenital anomaly) on an unspecified date, miscarriage of pregnancy (death, hospitalization, medically significant, life threatening, congenital anomaly) on 19Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: yes - positive covid-19 test on an unknown date. The outcome of events were fatal. It was not reported if an autopsy was performed. Patient died on 24-JUL-2021. 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: Yes Pregnancy adverse effects details: 18 week miscarriage. Details of previous pregnancies: All 4 live birth no problems. Patient was exposed to the medicine Before pregnancy. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: miscarriage of pregnancy; Maternal exposure during pregnancy


VAERS ID: 1584993 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-07-19
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6884 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: beta HCG; Result Unstructured Data: Test Result:22 to 37 MiU/mL
CDC Split Type: FRPFIZER INC202100990316

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable consumer downloaded from the Agency WEB, regulatory authority number FR-AFSSAPS-LM20212035. A 34-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 03Jun2021 (Batch/Lot Number: FC6884) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced abortion spontaneous on 19Jul2021 with outcome of recovered with sequelae. The mother reported she became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. Further ADR description stated that the pregnancy was detected on 07Jul2021, betaHCG concentration remained very low, 22 to 37 MiU/mL over 10 days a spontaneous miscarriage at Day 47 after injection. Female patient declared a spontaneous miscarriage at Day 47 (D47), incompatible chronological criterion for the Regulatory Authority. No follow-up attempts are possible. No further information is expected.


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