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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: 1585082 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-07-01
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 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: LEVOTHYROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thyroid disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100988084

Write-up: Pregnancy loss <20 weeks gestation; This is a spontaneous report from a contactable consumer downloaded from the RA. The regulatory authority number is FR-AFSSAPS-NY20213001. This consumer reported information for both mother and fetus. This is the maternal report. A 23-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in the left arm on 30Apr2021 (Batch/Lot Number: ET6956) as dose 2, single for COVID-19 immunisation. Medical history included an unspecified thyroid disorder. Concomitant medication included levothyroxine sodium (LEVOTHYROX) strength: 25 ug, tablet, lot number: unknown; taken for thyroid disorder, start and stop date were not reported. On 01Jul2021, the patient experienced pregnancy loss <20 weeks gestation. The event was further described as: 11May2021, ovulation period. 21May2021, diagnosis of pregnancy. 01Jul2021, announces that the heart of the embryo has stopped. Miscarriage at 2 months of pregnancy. In recovery. In conclusion a 23-year-old woman, vaccinated before conception, who presents a miscarriage less than 20 weeks gestation (approximately 9 weeks), 63 days after the second injection of the COMIRNATY vaccine (batch ET6956). In recovery. The patient was recovering from the event. The case was considered serious, medically significant by the regulatory authority. NB: Accountability without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Reporter comment: 23-year-old woman, vaccinated before conception, who presents a miscarriage less than 20 weeks gestation (approximately 9 weeks), 63 days after the second injection of the COMIRNATY vaccine (lot ET6956). In recovery. No follow-up attempts possible. No further information expected.; Reporter''s Comments: 23-year-old woman, vaccinated before conception, who presents a miscarriage less than 20 weeks gestation (approximately 9 weeks), 63 days after the second injection of the COMIRNATY vaccine (lot ET6956). In recovery.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202100987903 fetal/maternal case


VAERS ID: 1589422 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-07-01
   Days after vaccination:43
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 spontaneous, Gastroenteritis, 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), Noninfectious diarrhoea (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101006146

Write-up: gastroenteritis; miscarriage; Maternal exposure during pregnancy; Early miscarriage; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041930473940-AKVKJ. Safety Report Unique Identifier GB-MHRA-ADR 25756260. A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ET8885), via an unspecified route of administration on 19May2021 (Age of vaccination: Unknown) as DOSE 1, SINGLE for covid-19 immunization. Medical history included suppressed lactation, abortion spontaneous, pregnancy, pregnancy as Patient no longer pregnant at the time of reporting. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. 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). Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation. On 01Jul2021 the patient experienced early miscarriage. On an unspecified date the patient experienced gastroenteritis, miscarriage, maternal exposure during pregnancy. The patient was advised to log this by the vaccination center, but she did has a miscarriage. she had the vaccine when she was only saying 1-2 weeks pregnant and did not know she was pregnant. The miscarriage happened at around 8 weeks, but she did not bleed etc. till 10 weeks. she knows something happened at 8 weeks because she had a private scan, and the fetus measurement was 8+3, she thinks. She knows miscarriage is common but was advised to report it. Her previous pregnancy was healthy. she did have gastroenteritis at the 8-week mark. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. The outcome of all events was unknown. Details of scans or investigations: the patient had a private early scan at 9+5 weeks which returned as a miscarriage at 8 weeks. When she had the vaccine she must only have been a week or two pregnant and had no idea. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593786 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   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 FE1573 / 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 INC202101010791

Write-up: Miscarriage; 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-00645356. A 33-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: FE1573) as dose 1, single (at the age of 33-years-old) for Covid-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient had no previous COVID-19 infection. The patient experienced maternal exposure during pregnancy on 01Jul2021, following the administration of the Covid-19 vaccine Pfizer injection, and had a miscarriage three days after, on 04Jul2021. The miscarriage occurred at a pregnancy duration of about 3.5 weeks. This was the first Covid vaccination, which took place at a pregnancy duration of about 3 weeks. The outcome of the events was unknown. Case Summary and Reporter''s Comments Text: BioNTech/Pfizer vaccine (Comirnaty): Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Miscarriage: Additional information about adverse drug reaction: Probably no connection to vaccine but would like to report this info. Other websites go further on pregnancy, as I do not lose the info. Confounding factors: COVID-19 vaccine exposure during pregnancy week: 3. COVID-19: Previous COVID-19 infection: No Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the HA criteria, the reaction was considered as serious by the regulatory authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1629737 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Chills, Extensive swelling of vaccinated limb, Fatigue, Headache, Human chorionic gonadotropin, Malaise, Myalgia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Blood test; Result Unstructured Data: Test Result:Normal, except for excessively low HCG levels; Comments: Normal, except for excessively lowHuman Chorionic Gonadotropin (HCG) levels at this stage of pregnancy; Test Date: 20210628; Test Name: HCG; Result Unstructured Data: Test Result:HCG rate problems
CDC Split Type: BEPFIZER INC202101021087

Write-up: Miscarriage; Injection site reaction; Headache; Shivering; Myalgia; Fatigue; Malaise; Extended swelling of the arm; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB regulatory authority number -FAMHP-DHH-N2021-103349 A 30-years-old female patient received first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 14Jun2021 (Batch/Lot Number: FA5833) as dose 1, single for covid-19 immunization. The patient''s medical history was not reported. Concomitant medication included paracetamol (PARACETAMOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced miscarriage, injection site reaction, headache, shivering, myalgia, fatigue, malaise, extended swelling of the arm all on 01Jul2021. The mother reported she was pregnant when she received BNT162B2. The pregnancy resulted in spontaneous abortion. It was reported that Conception of the baby at the end of May, Vaccine 14Jun. HCG rate problems noted from 28Jun and then during the various blood tests on 02Jul and 03Jul Bleeding from 01Jul. General practitioner visit 02July. Referral to the emergency room on 02Jul. Return to the emergency room on 03Jul for heavy bleeding and pelvic cramps. Miscarriage confirmed on 03Jul. The patient underwent lab tests and procedures which included blood test: normal, except for excessively low hcg levels on Jul2021 (Normal, except for excessively low Human Chorionic Gonadotropin (HCG) levels at this stage of pregnancy) and HCG (human chorionic gonadotropin): HCG rate problems on 28Jun2021. The outcome of all the events was recovered on 09Jul2021. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: No Evolution of the ADR: Recovered with sequelae Situations: Other: nothing special to report for this Examinations: Normal blood tests, except for the excessively low HCG level at this stage of the pregnancy


VAERS ID: 1638703 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Haemorrhage, Menstruation irregular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 4 weeks (on the 26th day 1st corona vaccine))
Allergies:
Diagnostic Lab Data: Test Name: Blood test for iron deficiency; Result Unstructured Data: Test Result:Values appeared to be relatively okay.
CDC Split Type: NLPFIZER INC202101045785

Write-up: period still isn''t back to the normal rhythm; Miscarriage; bled a little; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00659051. A 31-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 01Jul2021 at the age of 31-years-old (Batch/Lot Number: FE1573) as single dose for COVID-19 immunisation. Medical history included maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 4 weeks (on the 26th day 1st corona vaccine)). The patient''s concomitant medications were not reported. It was reported: "When I was 4 weeks pregnant I got the Covid vaccine. On the day of the Covid vaccine, I bled a little. Miscarriage started on 09Jul2021, lasted a week. My period still isn''t back to the normal rhythm. confounding factors COVID-19 vaccine exposure during pregnancy week: 4 weeks (on the 26th day 1st Covid vaccine) COVID19. Previous COVID-19 infection: No. Other diagnostic procedures: Blood test for iron deficiency because it lost a lot of blood. Values appeared to be relatively okay." The miscarriage occurred at a pregnancy duration of about 5 weeks. This was the first Covid vaccination, which took place at a pregnancy duration of about 4 weeks. The patient experienced miscarriage on 09Jul2021, bled a little on 01Jul2021, period still isn''t back to the normal rhythm on an unspecified date. The outcome of events was unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the HA criteria, the reaction (Miscarriage) was considered as serious by the regulatory authority. No follow-up attempts possible. No further information expected.


VAERS ID: 1669055 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101079619

Write-up: This is a spontaneous report from a contactable consumer (patient) downloaded from the Agency. A 31-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 28Jun2021 (Lot Number: FC5089) as dose 1, 0.3 ML single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Jul2021, the patient experienced miscarriage and abdominal cramps, vaccine exposure during pregnancy following administration of COVID-19 vaccine Pfizer injection for COVID-19 immunisation. The patient was vaccinated at a pregnancy duration of 6 weeks. Three days after the vaccination the patient experienced abdominal cramsp and a miscarriage occurred. No previous COVID-19 infection. The midwife indicated that several women with this problem had been put into practice after vaccination. The mother was 6 Weeks pregnant at the onset of the event. The outcome of the events was recovered on 01Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1671224 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004493 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: Gynaecological examination; Result Unstructured Data: Confirms missed abortion; Test Date: 20210723; Test Name: Ultrasound scan; Result Unstructured Data: Everything was normal
CDC Split Type: DKMODERNATX, INC.MOD20212

Write-up: Missed abortion in GA 10 +5/6, but first concluded in GA 13+4; Maternal exposure during pregnancy; This case was received via the regulatory authority (Reference number: DK-DKMA-ADR 25784395) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority prospective pregnancy case was reported by a physician and describes the occurrence of ABORTION MISSED (Missed abortion in GA 10 +5/6, but first concluded in GA 13+4) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004493) for COVID-19 immunisation. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In July 2021, the patient experienced ABORTION MISSED (Missed abortion in GA 10 +5/6, but first concluded in GA 13+4) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). At the time of the report, ABORTION MISSED (Missed abortion in GA 10 +5/6, but first concluded in GA 13+4) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, Ultrasound scan: normal (normal) Everything was normal. On 11-Aug-2021, Gynaecological examination: abnormal (abnormal) Confirms missed abortion. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Treatment information was not reported. Company Comment: This is a case of maternal exposure during pregnancy with associated Abortion missed for this 29-year old female. Very limited information regarding these events have been provided at this time. Further information regarding temporal association for the event abortion missed is necessary to assess causality.; Sender''s Comments: This is a case of maternal exposure during pregnancy with associated Abortion missed for this 29-year old female. Very limited information regarding these events have been provided at this time. Further information regarding temporal association for the event abortion missed is necessary to assess causality.


VAERS ID: 1709976 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-07-01
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191618

Write-up: Early miscarriage/miscarriage; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109100901041150-W52WV. Safety Report Unique Identifier GB-MHRA-ADR 25922619. A female patient (pregnant: yes) of an unspecified age received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot unknown), via an unspecified route of administration on 14May2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced miscarriage/early miscarriage after an embryo transfer (event reported as serious disability, medically significant) on 01Jul2021 (also reported as 17Jul2021). The patient underwent laboratory test which included Sars-cov-2 test: No negative covid-19 test on an unspecified date. The outcome of event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1710006 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Investigation, Physical examination, Scan, Ultrasound scan vagina, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; PRENATAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Live birth (First pregnancy in 2017 was successful)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: routine blood investigations; Result Unstructured Data: Test Result: unknown results; Test Date: 202108; Test Name: Speculum examination; Result Unstructured Data: Test Result: Fetal bradycardia; Test Date: 20210812; Test Name: checked; Result Unstructured Data: Test Result: It was threatened abortion at this stage with feta; Comments: It was threatened abortion at this stage with fetal bradycardia and small gestational week; Test Date: 202108; Test Name: Scan; Result Unstructured Data: Test Result: Fetal bradycardia; Test Date: 202108; Test Name: transvaginal ultrasound; Result Unstructured Data: Test Result: Fetal bradycardia.
CDC Split Type: GBPFIZER INC202101167537

Write-up: Miscarriage; Bleeding vaginal; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report from the Regulatory Authority. The Regulatory authority report number GB-MHRA-ADR 25847700. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW3143), via an unspecified route of administration on 09Jul2021 at single dose for COVID-19 immunisation. Medical history included Live birth from 2017 and unknown if ongoing (First pregnancy in 2017 was successful). Has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications included FOLIC ACID AND PRNATAL VITAMIN from 15Jul2021 to 18Aug2021. The patient experienced miscarriage on 18Aug2021, bleeding vaginal in Jul2021. It was reported that first bleeding start around 3 weeks post vaccination (end of Jul2021). It was streak of blood and only once. Then following next week (early Aug2021) it bled again. One episode. Two weeks later, on 12Aug2021 more bleeding occurred. Went to Emergency unit and get it checked. It was threatened abortion at this stage with fetal bradycardia and small gestational week. The bleeding continued for a week and resulted in misscarriage on 18Aug2021. Tissue of fetus was expelled. Waiting for scan on 26Aug2021 to determine either it''s completed or incomplete misscarriage. Patient has not tested positive for COVID-19 since having the vaccine. It was unsure if the medicine have an adverse effect on any aspect of the pregnancy. Details of previous pregnancies include Bleeding per vagina and following misscarriage. First pregnancy in 2017 was successful. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations included Fetal bradycardia in Aug2021. Relevant investigations or tests conducted provided as Speculum examination and transvaginal ultrasound Fetal bradycardia for both routine blood investigations unknown result, all in Aug2021. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected. Linked Report(s): GB-PFIZER INC-202101111607 Baby case.


VAERS ID: 1716967 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-07-01
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cold sores; Pregnancy (Patient no longer pregnant at the time of reporting.); Suspected COVID-19; Vitamin supplementation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168537

Write-up: cold sores; Maternal exposure during pregnancy; Early miscarriage; This is a spontaneous report from a contactable consumer (patient). This is the first of 2 report. The first report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109061115140900-UHIEO, Safety Report Unique Identifier (GB-MHRA-ADR 25899607). A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER1749) via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunisation. Medical history included oral herpes from an unknown date and unknown if ongoing, pregnancy from an unknown date and unknown if ongoing. Patient was no longer pregnant at the time of reporting, suspected COVID-19 from 01Apr2020, vitamin supplementation from an unknown date and unknown if ongoing. Concomitant medication(s) included folic acid taken for vitamin supplementation, start and stop date were not reported. No other medicines being taken Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The medicine has an adverse effect on any aspect of the pregnancy was reported as unsure. Patient was exposed to the medicine before pregnancy. Patient reported that she does not believe the miscarriage was related to the vaccine, but she reports it in case there was a trend. She believes it was simply a bad egg/sperm that didn''t develop properly. Regarding the cold sore, she was 39 and have never had a cold sore before and they say it was very rare to get a cold sore at this age if you haven''t already had one. She knows two other people who had the Pfizer vaccine and then developed cold sores. On 01Jul2021, the patient experienced early miscarriage and on an unspecified date she also experienced cold sores, maternal exposure during pregnancy. The clinical outcome of event early miscarriage was resolved on an unspecified date in 2021, while event cold sores was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101175473 Same patient/Drug/Reporter, different dose number and event


VAERS ID: 1720202 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101165608

Write-up: amniotic sac not further developed from sixth week of pregnancy; patient received dose 1 on 21Apr2021 and dose 2 on 01Jul2021; This is a spontaneous report from a non-contactable consumer, downloaded from the regulatory authority-WEB. The regulatory authority number is DE-PEI-CADR2021153653 with Sender''s Safety Report Unique Identifier: DE-PEI-202100154963. This is the first of two reports. This is a maternal report. A 28-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, strength: 0.3 mL), intramuscularly on 01Jul2021 at the age of 28 years old (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received bnt162b2 (COMIRNATY), on 21Apr2021 (Batch/Lot number and Expiration date were unknown) as dose 1, single for COVID-19 immunization and experienced exposure during pregnancy. The patient received dose 1 on 21Apr2021 and dose 2 on 01Jul2021. On 28Jul2021, the patient experienced pregnancy loss <20 weeks gestation, further reported as "amniotic sac not further developed from sixth week of pregnancy," which led to hospitalization on an unspecified date. The patient was pregnant while taking bnt162b2. The patient was 6 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The patient had recovered with sequelae from the event "amniotic sac not further developed from sixth week of pregnancy (pregnancy loss <20 weeks gestation)" on an unspecified date. Sender Comment: Are you or the person concerned known to have allergies? If yes, which? no. Information on risk factors or previous illnesses: No. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1760849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Menstruation irregular, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERELLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Contraception; Eczema; Miscarriage
Allergies:
Diagnostic Lab Data: Test Date: 20210920; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101252577

Write-up: miscarriage; Heavy periods; Prolonged periods; missed period; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109211643135030-CJ0XV. Safety Report Unique Identifier GB-MHRA-ADR 25975786. This is the first of 2 reports. This is a dose 1 report. An 18-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FE1510), via an unspecified route of administration on 07Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included miscarriage from Dec2020 to an unknown date (the patient had no periods from then until June 2021), eczema, asthma, and contraception. Concomitant medication(s) included CERELLE taken for contraception from 14Nov2020 to an unspecified stop date. Patient had not symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient had miscarriage. On an unspecified date in Jul2021, the patient experienced missed period, and on 22Aug2021, patient had heavy periods, prolonged periods. Had 1st dose in Jul2021 and had missed period but assumed it may be jab or pill. Came on period as normal on 22Aug2021. The patient had Physician visit for heavy periods and prolonged periods. The patient underwent lab tests and procedures which included SARS-CoV-2 test (No - Negative COVID-19 test) on 20Sep2021. Therapeutic measures taken for the events heavy periods and prolonged periods included Tranexamic Acid to reduce bleeding. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FE3380) via an unspecified route of administration on 01Sep2021 as dose 2, single for COVID-19 immunisation. The outcome of event missed period was recovered on 22Aug2021, and another events outcome was recovering. No follow-up attempts are needed. No further information is expected. Linked Report(s): GB-PFIZER INC-202101257790 Same patient,product,different event


VAERS ID: 1784552 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion, Myalgia, Pregnancy on oral contraceptive, Therapeutic product effect decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101233189

Write-up: Myalgia; I sincerely don''t know if the vaccine suppressed the effect of my pill (with antibiotics it seems to); Getting pregnant on the pill; send proof of the abortion if desired/ had to end the pregnancy and am still very sad about this; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00656983. Safety Report Unique Identifier NL-LRB-00688889 A 36-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FE1573, Expiry date: not reported) via an unspecified route of administration on 30Jun2021 as dose 1, single for covid-19 immunization; ethinylestradiol, levonorgestrel (MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL], tablet 30/150ug, Lot Number: Unknown; Expiry date: not reported), via an unspecified route of administration from 16Jul2021 to an unspecified date, at 1x per day 1 piece for contraception. The patient''s medical history and concomitant medications were not reported. Previously, patient had not COVID-19 infection. On Jul2021, 01 day after vaccination, the patient experienced Myalgia. Onset of latency of myalgia was 1 days after start. On an unspecified date on 2021, patient experienced getting pregnant on the pill, send proof of the abortion if desired/had to end the pregnancy and am still very sad about this, I sincerely don''t know if the vaccine suppressed the effect of my pill (with antibiotics it seems to). It was reported that, I can''t get this anywhere. That''s why I''m typing it here. I''m on the pill and I accidentally got pregnant while on the pill. I haven''t done anything different than normal. The only thing that has been different is the fact that I had a vaccination right before when my ovulation would theoretically take place. I had to end the pregnancy and am still very sad about this. I sincerely don''t know if the vaccine suppressed the effect of my pill (with antibiotics it seems to). But I find it a strange coincidence. I do take my second vaccination, but do not defy fate again and do not have sex in the days surrounding me vaccination. I can still send proof of the abortion if desired. Myalgia is treated with abortus. The patient received treatment for event Myalgia. The outcome of all events was unknown. No follow-up attempts are possible, no information is expected.


VAERS ID: 1795641 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-07-01
   Days after vaccination:112
Submitted: 0000-00-00
Entered: 2021-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pigmented naevus; Short sightedness; Vegan; Vegetarian
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101314264

Write-up: miscarriage/Spontaneous abortion; This is a spontaneous report from a contactable physician downloaded from the Agency -WEB, regulatory authority number CZ-CZSUKL-21010858. A 28-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 11Mar2021 (Lot Number: EP2166) as dose 1, single for COVID-19 immunization. Medical history included ongoing: vegan, vegetarian, pigmented naevus and short sightedness. There were no concomitant medications. The patient experienced spontaneous abortion (hospitalization, medically significant) in Jul2021 with outcome of recovered with sequelae. The patient had not known she was pregnant at the time of vaccination, and a miscarriage occurred at week 23. She was hospitalized, no revision of the uterine cavity was needed. Lactation stopped with medication. For elevation of inflammatory parameters, antibiotics were administrated. No follow-up attempts possible. No further information expected.


VAERS ID: 1796045 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Biopsy placenta, Blood test, Body mass index, Culture urine, Haemorrhage in pregnancy, Maternal exposure during pregnancy
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 2021; Test Name: Biopsy placenta; Result Unstructured Data: Test Result: Fetal placenta tissue for genetic examine -array CGH; Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result: TORCH test, no result; Test Name: Body mass index; Result Unstructured Data: Test Result:31; Test Date: 2021; Test Name: Culture urine; Result Unstructured Data: Test Result: No result.
CDC Split Type: DKPFIZER INC202101314312

Write-up: Maternal exposure during pregnancy, first trimester; Hemorrhage in 1. trimester of pregnancy. Starting for some days from 23Jul2021 and again in gestation age 14 week.; Spontaneous abortion in gestation age 15 week; This is a spontaneous report from a contactable Other Healthcare Professional downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0089108. This other healthcare professional reported information for both mother and fetus/baby. This is a maternal report. A 30-years-old female patient received bnt162b2 (COMIRNATY, Solution for Injection), dose 1 intramuscularly on 09Jul2021 (Lot Number: FE2090; Expiration Date: 31Oct2021) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced maternal exposure during pregnancy. On 23Jul2021, the patient had haemorrhage in 1st trimester of pregnancy. starting for some days from 23jul2021 and again in gestation age 14 week and in Jul2021, the patient had spontaneous abortion in gestation age 15 week. The mother reported she became pregnant while taking bnt162b2. The mother was 15 Weeks pregnant at the onset of the event. The patient underwent lab tests and procedures which included biopsy placenta showed foetal placenta tissue for genetic examine array CGH in 2021, blood test which was torch test with no result in 2021, body mass index was 31 on an unknown date and culture urine with no result in 2021. The patient had second dose on 06Aug2021 (Lot number: FC5029; Expiry date 31Oct2021). The stop date of the events abortion spontaneous and hemorrhage in pregnancy was on 25Sep2021. The outcome of all the events was recovered. Causality: The woman was vaccinated before known pregnancy. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1856453 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Inappropriate schedule of product administration
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: Maternal vaccine exposure (vaccine exposure during pregnancy week: 5)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101463400

Write-up: Missed abortion; Dose 1 on 27Jun2021 and Dose 2 on 01Jul2021; This is a spontaneous report from a contactable consumer or other non-health care professional downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number NL-LRB-00703920. This consumer or other non hcp reported information for both mother and fetus/baby. This is the maternal case. A 35-year-old pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Strength: 0.3 ml, Batch/Lot number was not reported) via an unspecified route of administration on 01Jul2021 as dose 2, 0.3 ml single for covid-19 immunization (reported as COVID-19 vaccination). Medical history included maternal vaccine exposure, vaccine exposure during pregnancy week: 5. The patient''s concomitant medications were not reported. Historical vaccine included BioNTech (Comirnaty, solution for injection, Strngth:0.3 ml) via unspecified route of administration, administered on 27Jun2021 as dose 1 single for COVID-19 immunization. On 09Jul2021 The embryo stopped growing (missed abortion) at a pregnancy duration of about 6 weeks, on an unspecified date vaccine exposure during pregnancy week: 5. The mother reported she became pregnant while taking bnt162b2. The mother was 5 Weeks pregnant at the onset of the event. Event missed abortion was medically significant. Drugs and latency: 1. covid-19 vaccine pfizer injection missed abortion: 8 days after start, maternal exposure during pregnancy: latency unknown. Outcome of the event missed abortion was unknown. Health authority Comment: Seriousness of Missed abortion was changed from death to other medically important condition. Reporter Comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 27Jun2021. Missed miscarriage: Additional information ADR: Just after the 2nd injection, the fetus has stopped growing. Confounding factors vaccine exposure during pregnancy week: 5. COVID19 Previous COVID-19 infection: No The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101478772 maternal/fetus case


VAERS ID: 1446053 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-05-03
Onset:2021-07-02
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

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

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

Write-up: Missed miscarriage. Expected due date 01/20/22. Fourth pregnancy. One termination, One live birth, two miscarriages. This is a second missed miscarriage in a row first one being in January 2021.


VAERS ID: 1449720 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-05-01
Onset:2021-07-02
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin, Intermenstrual bleeding, Progesterone
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? 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: B-12 500mcb d3 4000 iu liquid Slow release iron 50mg Pre natal with DHA Benedryl 50 mg Ambien 10mg - on occasion CoQ10 DHEA
Current Illness: None
Preexisting Conditions: None
Allergies: Penicillin, Ceclor, Sulfa
Diagnostic Lab Data: HcG and Progesterone
CDC Split Type:

Write-up: I had bleeding for my period 5 days earlier the month of my second vaccine. I subsequently got pregnant that month and miscarried at 5 weeks.


VAERS ID: 1461671 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-06-30
Onset:2021-07-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C21A / 1 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy, Haemoglobin, Haemorrhage in pregnancy, Human chorionic gonadotropin, Ultrasound antenatal screen, Uterine spasm
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Penicillin
Diagnostic Lab Data: OB US first trimester, 6-28-21 Obstetric panel, 6-28-21 SMA carrier screen, 6-28-21 Hemoglobinopathy evaluation, 6-28-21 OB US first trimester, 7-9-21 POCT hemoglobin 7-9-21 HCG quantitative panel 7-9-21
CDC Split Type:

Write-up: Pregnant at the time of vaccination, 8 weeks. Very first ever pregnancy, no history of miscarriage or abortion. Heartbeat detected via ultrasound 36 hours prior to shot on 6-28-21 at OBGYN appointment. Covid shot taken on Wednesday 7-1-21, Miscarriage occured on 7-3-21. Confirmed loss of pregnancy via ER visit due to bleeding and cramps from ultrasound. Please do more research for 1st trimester before clearing pregnant women as safe to take COVID-19 vaccination. Please add my information to any existing data regarding 1st trimester loss of pregnancy.


VAERS ID: 1656507 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-23
Onset:2021-07-02
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin, Ultrasound antenatal screen
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: Levothyroxine, prenatal vitamins
Current Illness: none
Preexisting Conditions: thyroid disease (levels under control and monitored by doctors)
Allergies: none
Diagnostic Lab Data: blood tests for pregnancy hormones and ultrasound
CDC Split Type:

Write-up: Miscarriage at 10 weeks


VAERS ID: 1468659 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-02
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Exposure during pregnancy; Miscarriage; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included No adverse event. On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria medically significant and congenital anomaly). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and EXPOSURE DURING PREGNANCY (Exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. No concomitant or treatment medication has been reported. This is a case of product exposure during pregnancy with an associated adverse event of spontaneous abortion in the mother. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This is a case of product exposure during pregnancy with an associated adverse event of spontaneous abortion in the mother. 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: 1506704 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021883054

Write-up: Intrauterine fetal death in the 31st + 6th week of pregnancy; This is a spontaneous report from a non-contactable consumer downloaded from the WEB (Regulatory Authority number DE-PEI-CADR2021130968, Safety Report Unique Identifier DE-PEI-202100128346). A 37 years old female patient received BNT162B2 (COMIRNATY; lot FD7958) on 25Jun2021, at single dose, for COVID-19 immunisation. Medical history included ongoing pregnancy. Concomitant medications were not reported. On 02Jul2021 the patient experienced intrauterine fetal death in the 31st + 6th week of pregnancy (abortion). Abortion outcome was reported as not resolved. Senders comments: the reporter was not the patient. Information on risk factors or previous illnesses. No known risk factors or previous illnesses. Sudden intrauterine fetal death in the 31st + 6th week of pregnancy. The pregnancy progress until then without complications. Otherwise no abnormalities were found in the fetus or the mother. Fetal autopsy result pending. Relatedness of drug to reaction(s)/event(s) D. Unclassifiable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1514167 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
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 INC2021895889

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the WEB, regulatory authority number is NL-LRB-00620240. A pregnant 26-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 1 via an unspecified route of administration on 30Jun2021 (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced miscarriage (other medically important condition), maternal exposure during pregnancy following administration of covid-19 vaccine Pfizer. The miscarriage happened on the 9th day after the vaccination (02Jul2021 as reported). Miscarriage is treated with Pain relief and follow-up anemia. The outcome of the events was unknown. No follow-up attempts are possible; information on lot and batch numbers cannot be obtained.


VAERS ID: 1520795 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-07-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-02
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? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: SCAN; Result Unstructured Data: Test Result:PREGNANT
CDC Split Type: GBPFIZER INC202100909254

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107161144236450-M6MB8, Safety Report Unique Identifier is GB-MHRA-ADR 25663011. A 22-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Jun2021 at the age of 22 years old (Batch/Lot Number: FA1027) as single dose for covid-19 immunization. Medical history included lactation decreased, pregnancy both from an unknown date. It was reported that patient was no longer pregnant at the time of reporting. Other medical history included vitamin supplementation from an unknown date. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concomitant medication included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. The patient experienced miscarriage on 02Jul2021. The events were reported as serious (medically significant). The patient reported that she miscarried within a week of having the vaccine. Patient has no previous pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included SARS-COV-2 test with No - Negative COVID-19 test result on an unknown date, patient had scans which revealed pregnant. The patient recovered from miscarriage on 16Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1533781 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-02
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (confirmed with positive test)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100948936

Write-up: had an (early) miscarriage; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB. The regulatory authority number is NL-LRB-00633090. A 41-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 14Jun2021 (Batch/Lot Number: FC3098) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 confirmed with positive test from 08Dec2020 to an unknown date. The patient''s concomitant medications were not reported. On 02Jul2021, 18 days after vaccination, the patient had an (early) miscarriage (other medically important condition). The miscarriage occurred at a pregnancy duration of about 4.5 weeks. This was the first COVID vaccination, which took place at a pregnancy duration of about 2 weeks (as reported). Confounding factors included COVID-19 vaccine exposure during pregnancy week: 2 and previous COVID-19 infection with little disease symptoms. The outcome of the event miscarriage was unknown. Sender Comment: "Since the nature of the reported reaction does imply seriousness according to one of the regulatory authority criteria, the reaction was considered as serious by the PRIVACY." Reporter comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. I had an (early) miscarriage. Additional information ADR: I had the miscarriage 2.5 weeks after the vaccination. Of course, it cannot be said that the vaccine is the cause of the miscarriage, but it cannot be ruled out either. confounding factors: COVID-19 vaccine exposure during pregnancy week: 2. Previous COVID-19 infection: disease symptoms: little No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. I had an (early) miscarriage. Additional information ADR: I had the miscarriage 2.5 weeks after the vaccination. Of course, it cannot be said that the vaccine is the cause of the miscarriage, but it cannot be ruled out either. confounding factors: COVID-19 vaccine exposure during pregnancy week: 2. Previous COVID-19 infection: disease symptoms: little


VAERS ID: 1625712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-02
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
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 INC202101016823

Write-up: Maternal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00646960. A 31-year-old female patient received bnt162b2 (COMIRNATY) strength: 0.3 ml, first single dose via an unspecified route of administration on 23Jun2021 (Batch/Lot Number: Unknown) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Previous COVID-19 infection was no. The patient was miscarriage (other medically important condition), maternal exposure during pregnancy following administration of covid-19 vaccin pfizer injection fluid. The miscarriage occurred at a pregnancy duration of about 8.5 weeks on 02Jul2021. This was the first Covid vaccination, which took place at a pregnancy duration of about 7 weeks. Sender''s comments: Since the nature of the reported reaction does imply seriousness according to one of the HA critera, the reaction was considered as serious by the regulatory authority. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.


VAERS ID: 1625821 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   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 FE6208 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101017144

Write-up: Late miscarriage; DRUG EXPOSURE DURING PREGNANCY; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-066318. A 33-year-old female patient received second dose of BNT162B2(COMIRNATY, Lot Number: FE6208), via an unspecified route of administration at the age of 33-year-old on 02Jul2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced drug exposure during pregnancy on 02Jul2021, late miscarriage on 20Jul2021. The events were serious for being medical significant. Reported suspected adverse reaction was miscarriage. The woman received her first vaccination dose week 19 of her pregnancy and had a symptom onset of abdominal pain 18 days after vaccination. Two days later, medical care was sought where an ongoing miscarriage was ascertained in the week of pregnancy 21 + 1. Course: Recovered with lasting damage. The case was considered a serious, important medical event. The outcome of events was recovered with sequelae. No follow-up attempts are needed. No further information expected.


VAERS ID: 1640887 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: Cow''s milk protein allergy ((Cow''s milk protein free diet)); Food allergy ((citrus allergy)); Penicillin allergy; Comments: Penicilline en citrus allergie Koemelkeiwit vrij dieet
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101090845

Write-up: Maternal Exposure During Pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer or other non-Healthcare Professional. This is the second of two reports. The first report is a report downloaded from the regulatory authority number BE-FAMHP-DHH-N2021-104121. A 28-years-old female patient received first dose of BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 02Jul2021 single dose for COVID-19 immunisation. Medical history included drug hypersensitivity, food allergy (citrus allergy), milk allergy (Cow''s milk protein free diet). Concomitant medications were not reported. on an unspecified date in 2021 the patient experienced miscarriage with outcome of unknown and maternal exposure during pregnancy since 02Jul2021 with outcome of 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) : BE-PFIZER INC-202101054441 same patient, different drug and event


VAERS ID: 1642091 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion, Abortion missed, Interchange of vaccine products, Maternal exposure timing unspecified, Off label use
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abortion missed
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101086256

Write-up: Abortion; Abortion; Interchange of vaccine products; Patient received bnt162b2 (COMIRNATY), dose 2 at the age of unknown, pregnant; Off-Label use; This is a spontaneous report from a contactable consumer or other non-HCP downloaded from the regulatory authority-WEB ES-AEMPS-964952. A 33-year-old female (pregnant) patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Jul2021 (Lot Number: FE3065) (at the age of unknown, pregnant) as dose 2 (initial pfizer dose), single for COVID-19 immunisation. Medical history included abortion missed in 11Dec2020. The patient''s concomitant medications were not reported. The patient previously received VAXZEVRIA on 24Mar2021 as Dose 1, batch number ABV8149, intramuscular, administration site-right for COVID-19 immunisation. The patient experienced abortion/ abortion missed (medically significant, life threatening) on 08Jul2021 with outcome of recovered. The mother reported she became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. No follow-up attempts possible. No further information expected. Reporter Comment: The patient was pregnant at the time of vaccination and did not receive the same vaccine, 2 doses administered. Additional information on ADRs: Abortion The patient has a history of missed abortion.; Reporter''s Comments: The patient was pregnant at the time of vaccination and did not receive the same vaccine, 2 doses administered. Additional information on ADRs: Abortion The patient has a history of missed abortion.


VAERS ID: 1667643 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D015A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion, Maternal exposure during pregnancy, Trisomy 18
SMQs:, Congenital, familial and genetic disorders (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? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101126767

Write-up: unborn child (11+4 pregnancy week) was diagnosed with trisomy 18.; unborn child (11+4 pregnancy week) was diagnosed with trisomy 18; Maternal Exposure During Pregnancy, first trimester; This is a spontaneous report from a non-contactable consumer or other non hcp reported information for both mother and fetus/baby. This is a Fetus report. The first report is a spontaneous report received from a consumer downloaded from the regulatory authority. The regulatory authority report number is DE-PEI-CADR2021162112 , Safety report unique identifier DE-PEI-202100167154 . A fetus patient of an unspecified gender received bnt162b2 (COMIRNATY), transplacental on 02Jul2021 (Batch/Lot Number: 1D015A) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 10Aug2021, the unborn child (11+4 pregnancy week) was diagnosed with trisomy 18. The mother have previously given birth to 4 healthy children, never from complications or genetic defects. The patient also experienced maternal exposure during pregnancy, first trimester on 02Jul2021. Trisomy 18 was considered to cause congenital anomaly. The outcome of the events was unknown. No follow-up attempts possible. No further information expected; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101079366 Maternal case


VAERS ID: 1671251 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion complete, 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: ESPFIZER INC202101086201

Write-up: Abortion complete; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer downloaded from regulatory authority WEB ES-AEMPS-976761. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 34-year-old pregnant female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Jul2021 (Batch/Lot Number: FE2090) as dose 1, single, then intramuscular on 28Jul2021 (Batch/Lot Number: FE7053) as dose 2, single for COVID-19 immunisation. Date of last menstrual period (LMP): Jul2021. The patient''s medical history and concomitant medications were not reported. The patient experienced abortion complete on 01Aug2021 and maternal exposure during pregnancy, first trimester on 02Jul2021. The mother reported she became pregnant while taking bnt162b2. The mother was pregnant with 1 baby. The pregnancy resulted in spontaneous abortion. The patient had no history of abortion. The first dose was given to her the same week she got pregnant. Heavy bleeding occurred from the second dose and it was diagnosed as complete abortion after 5 days. Therapeutic measures were taken as a result of abortion complete (psychological treatment). The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1676018 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Abortion spontaneous, Maternal exposure during pregnancy, Vaginal haemorrhage
SMQs:, 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: Medical History/Concurrent Conditions: Multiparous
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101088700

Write-up: Abortion spontaneous/ She fears the miscarriage is due to the covid vaccine.; Bloody vaginal discharge; Abdominal pain lower; Was at covid vaccination on 02Jul2021; This is a spontaneous report from a contactable healthcare professional downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20213993. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left arm (also reported as left upper arm) on 02Jul2021 (at the age of 30-year-old) (Batch/Lot Number: FE3065) as dose 1, single for covid-19 immunisation. Medical history included. No allergies. The patient was a generally healthy woman. The patient had no concomitant medications. She had no regular medication. On 21Jul2021, the patient at gestation week 6+ experienced bloody vaginal discharge, abdominal pain lower and abortion spontaneous. She feared that the miscarriage was due to the covid vaccine. She called the clinic on 22Jul2021 and reported that since yesterday there has been a lot of vaginal bleeding and lower abdominal pain and clots. It was reported that fertilization also matches this time. She stated that she does not dare to take the booster shot. Outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1737693 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-07-02
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101194801

Write-up: Miscarriage. Definitely not sure if affiliated; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB BE-FAMHP-DHH-N2021-106420. A 35-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Jun2021 (Batch/Lot Number: EW4811; also reported as EW4811 and FC2336, pending clarification) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 02Jul2021, the patient experienced miscarriage, definitely not sure if affiliated. Patient was pregnant at time of vaccination: 1st trimester. The mother was 1 Trimester pregnant at the onset of the event. The mother delivered the pregnancy on 02Jul2021. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. There was no treatment. The event was recovered on 02Jul2021 (as reported). Reporter''s comments: Treatment - No. Evolution of the ADR - Recovered. : 1 month ADR description - Miscarriage. Definitely not sure if affiliated.; Reporter''s Comments: Treatment - No. Evolution of the ADR - Recovered. : 1 month ADR description - Miscarriage. Definitely not sure if affiliated.


VAERS ID: 1738479 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-07-02
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101194906

Write-up: miscarriage/pregnancy loss <20 weeks gestation; shifted menstrual cycle/menses delayed; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PA20211293. A 41-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), intramuscular, administered in the left arm on 14May2021 (Lot Number: unknown) as dose 1, 0.3 ml single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient did not have a history of COVID-19. The patient reported a shifted menstrual cycle/menses delayed on an unknown date in 2021, after the 1st injection which resulted in a pregnancy then a miscarriage/pregnancy loss <20 weeks gestation on 02Jul2021. The pregnancy resulted in spontaneous abortion. The outcome of the event miscarriage/pregnancy loss <20 weeks gestation was recovered with sequelae on 02Jul2021 while the outcome of shifted menstrual cycle/menses delayed was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1750928 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal growth restriction, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Ultrasound scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (had asthma (As reported)); Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy (Had healthy pregnancy in 2011); Pregnancy (Had healthy pregnancies in 2011 and 2015.)
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: Intrauterine scan; Result Unstructured Data: Test Result:Intrauterine pregnancy of unknown viability
CDC Split Type: GBPFIZER INC202101224612

Write-up: miscarriage/ Early miscarriage; Started brown spotting; Dose 1: 07May2021; dose 2: 02Jul2021; Maternal exposure during pregnancy/ sack showed gestational age of 6-7 weeks.; intrauterine pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202109161213373470-8JLVD, Safety Report Unique Identifier GB-MHRA-ADR 25952401. A 40-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD5613) via an unspecified route of administration on 02Jul2021, as a single dose for COVID-19 immunisation. Medical history included asthma (also reported as: had asthma), pregnancy (Also reported as: patient no longer pregnant at the time of reporting), healthy pregnancies in 2011 and 2015. The patient not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient was not currently breastfeeding. Concomitant medications included folic acid (MANUFACTURER UNKNOWN) from an unknown date for folic acid supplementation and unknown if ongoing. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07May2021, as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced intrauterine growth restriction (also reported as intrauterine pregnancy), maternal exposure during pregnancy, first trimester. On 03Sep2021, the patient experienced early miscarriage/ miscarriage, spotting vaginal. The events intrauterine pregnancy, maternal exposure during pregnancy, miscarriage/ early miscarriage; were reported as serious for being medically significant and causing congenital anomaly. The clinical course was reported as follows: Started brown spotting 03/09/21 continuous for 13 days (ongoing at time of writing this). Missed miscarriage confirmed 15/09/21. Medical diagnosis: intrauterine pregnancy of unknown viability. Did the medicine have an adverse effect on any aspect of the pregnancy: Unsure details of previous pregnancies: Had healthy pregnancies in 2011 and 2015. COVID vaccine 2- 3 weeks before conception. Should be 9+5 weeks but sack showed gestational age of 6-7 weeks with no visible content. Patient was exposed to the medicine before pregnancy. On 15Sep2021, the patient underwent intrauterine scan and the result was intrauterine pregnancy of unknown viability. Since the vaccination, the patient had not tested positive for COVID-19. The clinical outcome of the event miscarriage/ early miscarriage was not resolved; while that of the event maternal exposure during pregnancy first trimester, intrauterine growth restriction (also reported as intrauterine pregnancy), spotting vaginal was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101263676 Mother/fetus case;GB-PFIZER INC-202101263674 Same pt, different events/doses


VAERS ID: 1763619 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Ageusia, Arthralgia, Body temperature, Fatigue, Headache, Malaise, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (at 22:00:00)
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: Pyrexia; Result Unstructured Data: Test Result:38.0 to 40.4 Centigrade; Test Date: 20201209; Test Name: SARS-CoV-2 test positive; Test Result: Positive ; Comments: at 22:00:00
CDC Split Type: NLPFIZER INC202100914030

Write-up: miscarriage; Loss of taste; Myalgia; Pyrexia; Generalized joint pain; Headache; Fatigue; Malaise; COVID-19 INTENSIVE MONITORING This is a non-interventional report from a contactable consumer downloaded from the Regulatory Agency (RA)-WEB, the regulatory authority number is NL-LRB-COVID-00625622. A 32-year-old female pregnant subject received bnt162b2 (COMIRNATY, Batch/Lot Number: FE1573, strength: 0.3 ml), via an unspecified route of administration on 02Jul2021 (at the age of 32-year-old) as single dose for COVID-19 immunization. Medical history included COVID-19 from 09Dec2020 at 22:00 to an unknown date. Previous COVID-19 infection had no disease symptoms. The subject''s concomitant medications were not reported. The subject experienced fatigue on 02Jul2021, malaise on 02Jul2021, myalgia on 03Jul2021, pyrexia on 03Jul2021, generalized joint pain on 03Jul2021, headache on 03Jul2021, loss of taste on 05Jul2021, miscarriage on 18Aug2021. Event of miscarriage was reported as serious (other medically important condition). The subject underwent lab tests and procedures which included SARS-CoV-2 test: positive on 09Dec2020 at 22:00:00, pyrexia: 38.0 to 40.4 centigrade on 03Jul2021. The outcome of events for headache was resolved on 04Jul2021, for loss of taste was recovering, of miscarriage was not resolved, for other events was resolved on 05Jul2021. Pyrexia impacted qualify of life very bad. Headache, fatigue, loss of taste, miscarriage impacted qualify of life very. Myalgia, generalized joint pain and malaise impacted qualify of life rather. No treatment was received for all events. The reporter''s assessment of the causal relationship of all events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow up attempts are needed. No further information is expected. Follow-up (20Sep2021): New information received from the same contactable consumer downloaded from the Regulatory Agency (RA)-WEB NL-LRB-COVID-00685665 includes: added new reference number, new serious event (miscarriage), clinical events information; updated outcome of loss of taste; case upgraded to serious. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the currently available information the possibility of causal association between the reported events, fatigue, malaise, myalgia, pyrexia, generalized joint pain, headache, loss of taste, and the suspect drug BNT162B2 cannot be ruled out. Conversely, the reported miscarriage is unlikely related to BNT162B2.


VAERS ID: 1845758 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion, Body temperature increased, Maternal exposure during pregnancy, Prenatal screening test, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: Antrnetal Examination; Result Unstructured Data: Patient was normal and 19 week pregnant.; Test Date: 20210908; Test Name: Antrnetal Examination; Result Unstructured Data: Fetus had no heartbeat
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Abortus; slightly higher body temperature; mild pain at the injection site; Maternal exposure during pregnancy; This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION (Abortus) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3004223-CDC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 06-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BODY TEMPERATURE INCREASED (slightly higher body temperature) and VACCINATION SITE PAIN (mild pain at the injection site). On 08-Sep-2021, the patient experienced ABORTION (Abortus) (seriousness criterion medically significant). The delivery occurred on 08-Sep-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On September 8, patient underwent Week 24 antenatal examination, and found that the fetus had no heartbeat. On 06-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. In August 2021, BODY TEMPERATURE INCREASED (slightly higher body temperature) and VACCINATION SITE PAIN (mild pain at the injection site) had resolved. At the time of the report, ABORTION (Abortus) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, Prenatal screening test: normal (normal) Patient was normal and 19 week pregnant.. On 08-Sep-2021, Prenatal screening test: fetus had no heartbeat (abnormal) Fetus had no heartbeat. No concomitant and treatment medication were provided Patient age was given as 24.2. Company comment: This case concerns a 24 year old female with no reported medical history , who experienced Serious , unexpected event of Spontaneous abortion which occurred 1 month 2 days after vaccination with the 2nd dose of mRNA-1273 (Moderna Covid 19 vaccine.). This was accompanied by other non-serious expected events of vaccination site pain and unexpected event of Body temperature increased which occurred on an unknown time after vaccination with the 2nd dose. Non-serious event of maternal exposure during pregnancy was also coded. The patient received the vaccine at 19 weeks AOG for dose 1 and for dose 2 at 24 weeks AOG, while Spontaneous Abortion occurred during the 30 weeks AOG. The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna Covid 19 vaccine ) is not affected by this report. Per medical reviewer''s assessment agree that event Spontaneous Abortion serious : Medically Significant.; Sender''s Comments: This case concerns a 24 year old female with no reported medical history , who experienced Serious , unexpected event of Spontaneous abortion which occurred 1 month 2 days after vaccination with the 2nd dose of mRNA-1273 (Moderna Covid 19 vaccine.). This was accompanied by other non-serious expected events of vaccination site pain and unexpected event of Body temperature increased which occurred on an unknown time after vaccination with the 2nd dose. Non-serious event of maternal exposure during pregnancy was also coded. The patient received the vaccine at 19 weeks AOG for dose 1 and for dose 2 at 24 weeks AOG, while Spontaneous Abortion occurred during the 30 weeks AOG. The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna Covid 19 vaccine ) is not affected by this report. Per medical reviewer''s assessment agree that event Spontaneous Abortion serious : Medically Significant.


VAERS ID: 1455745 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-04-26
Onset:2021-07-03
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / 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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarriage


VAERS ID: 1457035 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-15
Onset:2021-07-03
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 001321A / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound scan abnormal, Uterine dilation and curettage
SMQs:, 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)

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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Singlulair, Cymbalta, Imitrex, Flonase, Atrovent
Current Illness: Gluten, Milk, amytriptiline
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 7/7/21 - ultrasound 7/8/21 - D&C
CDC Split Type:

Write-up: Patient was pregnant but not known at at time of first shot. She then got the second vaccine and had a miscarriage diagnosed 7/7/21 at 8w6d


VAERS ID: 1499838 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-07-03
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-07-24
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? 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: maternal exposure during pregnancy; Miscarriage; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria medically significant and congenital anomaly). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. On 07-Jul-2021, ABORTION SPONTANEOUS (Miscarriage) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. This is a case of product exposure during pregnancy with associated AE of abortion spontaneous for this 35-year-old female. Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AE of abortion spontaneous for this 35-year-old female. Very limited information regarding this event has been provided at this time. No further follow-up information is expected.


VAERS ID: 1538118 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-07-03
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100954682

Write-up: Pregnancy loss <20 weeks gestation/ pregnancy which ended in a miscarriage after 8 weeks of amenorrhea; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. The Regulatory Authority report number is FR-AFSSAPS-LL20214958. A 31-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on 26May2021 (Batch/Lot number: J07BX03 and expiration date was not reported) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pregnancy loss <20 weeks gestation on 03Jul2021. It was reported that non-evolutionary pregnancy was observed 15 days after the 2nd injection, pregnancy which ended in a miscarriage after 8 weeks of amenorrhea on 03Jul2021. The outcome of the event was recovering.


VAERS ID: 1575225 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Abortion spontaneous, Arthralgia, Body temperature, Endocrine test, Hormone level abnormal, Inappropriate schedule of product administration, Malaise, Pain, Pain in extremity, Pelvic pain, Pyrexia, SARS-CoV-2 test, Ultrasound abdomen
SMQs:, 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), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Vitamin supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: temperature; Result Unstructured Data: Test Result:slight fever; Test Name: hormone levels; Result Unstructured Data: Test Result:weren''t rising enough; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: 5 internal intrauterine scans; Result Unstructured Data: Test Result:sac had increased; Test Name: 5 internal intrauterine scans; Result Unstructured Data: Test Result:the sac had grown; Comments: the sac had grown. But there was no sign of life inside; Test Name: 5 internal intrauterine scans; Result Unstructured Data: Test Result:very small sac in the uterus; Comments: found a very small sac in the uterus. But much smaller than it should be for 5 weeks; Test Name: 5 internal intrauterine scans; Result Unstructured Data: Test Result:can see a sac with no foetal pole or yolk present.; Test Name: 5 internal intrauterine scans; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202100977268

Write-up: generally unwell; pain/aches; miscarriage; hormone levels weren''t rising enough; in pain with pains shooting down her leg from her pelvis; Leg pain; Generalised joint pain/hips pains; Lower abdominal pain/pains on the side by the appendix; Slight fever/had a temperature; Dose 1 on 06Mar2021, dose 2 on 03Jul2021; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107301012054630-3YTOV. Safety Report Unique Identifier GB-MHRA-ADR 25731765. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Jul2021 (at the age of 30 years old) (Lot Number: FA1027) as single dose, for COVID-19 immunisation. Medical history included Lactation decreased, ongoing pregnancy, Vitamin supplementation. Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. Concomitant medication included folic acid taken for Folic acid supplementation. The patient previously received the first dose of BNT162B2 on 06Mar2021 (Lot Number: ET8885) for COVID-19 immunisation. The patient experienced generally unwell on an unspecified date, miscarriage on an unspecified date, pain on an unspecified date, generalised joint pain on 05Jul2021, leg pain on 05Jul2021, slight fever on 03Jul2021, lower abdominal pain on 04Jul2021. It was reported that: The patient had a temperature and felt generally unwell. On the Sunday, the hips pains and aches led to an A and E visit. They suspected ectopic pregnancy. The patient''s hormone levels weren''t rising enough. She had to go back every two days for monitoring. By the Wednesday, they said it would be ectopic or early miscarriage. She was still in pain with pains shooting down her leg from her pelvis and pains on the side by the appendix. By Friday, they decided to keep in for observations. She nearly had surgery for ectopic, but requested a scan. On the scan they found a very small sac in the uterus. But much smaller than it should be for 5 weeks. By the Monday, the pains subsided. She went back on Tuesday and the sac had increased. She had to go in 2 weeks. At this scan, the sac had grown. But there was no sign of life inside. This could easily be coincidental. But worth noting to you so that you can monitor any trends. But the pains she had seems to coincide with the vaccine which should be noted. This was the patient''s first pregnancy and it is highly likely that it would result in a miscarriage. Patient was exposed to the medicine first-trimester (1-12 weeks). On recent scans, they can see a sac with no foetal pole or yolk present. They believed it was now an early miscarriage. Her hormone levels were not rising as they should. She had the vaccine at 4 weeks and had been going in every 2 days since. Relevant investigations or tests conducted: 5 internal intrauterine scans. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of generally unwell, miscarriage and pain/aches was recovering; of Generalised joint pain/hips pains and leg pain was recovered on 13Jul2021; of Slight fever/had a temperature was recovered on 03Jul2021; of Lower abdominal pain/pains on the side by the appendix was recovered on 12Jul2021; of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1642237 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-07-03
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal exposure during pregnancy, Foetal movement disorder, Haemorrhage, SARS-CoV-2 test, Ultrasound foetal abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Various ultrasounds; Result Unstructured Data: Test Result:UNKNOWN
CDC Split Type: GBPFIZER INC202101047488

Write-up: severe blood loss; foetal movement; Foetal exposure during pregnancy; Early miscarriage/miscarriage; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108121649203830-3RCFB. Safety Report Unique Identifier: GB-MHRA-ADR 25790581. This consumer or other non hcp reported information for both mother and fetus. This is a maternal report. A 35-years-old female patient (mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22May2021 (Batch/Lot Number: ET8885) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included miscarriage and folic acid supplementation. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation. The patient experienced early miscarriage on 03Jul2021; severe blood loss, foetal movement and foetal exposure during pregnancy on an unspecified date. It was repoted that the patient had the first dose on the 22May2021, which was exactly 3 weeks before she "fell pregnant". Then she lost the baby at 6 weeks gestation. There was no heartbeat and no foetal movement. She had to be admitted to hospital for severe blood loss and they confirmed the miscarriage. The fetus was exposed to the medicine: first-trimester (1-12 weeks). The mother had the first dose 3 weeks before conception and embryo stopped developing at 6 weeks. Patient was exposed to the medicine first-trimester (1-12 weeks). The events have caused hospitalization to the patient. The pregnancy resulted in spontaneous abortion. The fetal outcome is neonatal death. The patient underwent lab tests and procedures which included various ultrasounds with unknown results and COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of the event miscarriage was recovering; while unknown for the rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702579 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101125767

Write-up: vaccination during 6th week of pregnancy; I was pregnant and started bleeding after 2 hours; My fetus is not healthy and I am expecting a miscarriage.; The miscarriage occurred at a pregnancy duration of about 6 weeks.; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB (regulatory authority number NL-LRB-00673254). A 39 years old female patient received BNT162B2 (COMIRNATY) on 03Jul2021, at the age of 39 years, as the first single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received vaccination during 6th week of pregnancy. The patient was pregnant and started bleeding after 2 hours. Her fetus was not healthy and she was expecting a miscarriage. The miscarriage occurred at a pregnancy duration of about 6 weeks. It was also reported that the patient was unsure whether this had really happened. The case was reported serious as medically significant. Events outcome was unknown. Additional information: her fetus was not healthy and she was expecting a miscarriage. It was of course not certain that this was due to the vaccine, but it was very coincidental that she had bleeding that day. BSN available: yes. Reporter comment: Past drug therapy Pfizer vaccine (COMIRNATY): no. COVID-19 vaccine exposure during pregnancy week: 6. Previous COVID-19 infection: No. Diagnostic procedures: no. Sender Comment: Seriousness of miscarriage was changed from Congenital anomaly / birth defect to other medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Past drug therapy Pfizer vaccine (COMIRNATY): no. COVID-19 vaccine exposure during pregnancy week: 6. Previous COVID-19 infection: No. Diagnostic procedures: no.


VAERS ID: 1454586 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-25
Onset:2021-07-04
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2613 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: VAGINAL BLEEDING MISCARRIAGE O20.9 - Vaginal bleeding in pregnancy, first trimester


VAERS ID: 1526098 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-01
Onset:2021-07-04
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009C21A / 2 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Ultrasound scan, Uterine dilation and curettage
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: Prenatal vitamin, iron, calcium, vitamin D supplements
Current Illness: N/A
Preexisting Conditions: Mild asthma
Allergies: Milk allergy
Diagnostic Lab Data: Ultrasounds (multiple), Urgent Care and subsequent Emergency Room visit, D&C procedure
CDC Split Type:

Write-up: Miscarriage, I became pregnant soon after the vaccine and miscarried 2 months later.


VAERS ID: 1495867 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-07-04
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:health a baby and heartbeat; Comments: 7 week scan health a baby and heartbeat; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:stopped growing, no heartbeat; Comments: by 10 weeks baby stopped growing, no heartbeat. physical miscarriage
CDC Split Type: GBPFIZER INC2021854306

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107042334576040-BKZRY, Safety Report Unique Identifier GB-MHRA-ADR 25593298. This consumer reported information for both mother and fetus. This is a maternal report. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included lactation decreased. 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, start and stop date were not reported. On 04Jul2021, the patient experienced miscarriage. The patient accepted the vaccine at 5 weeks pregnancy as told pros outweighs the risk. All seemed fine with the pregnancy however baby stopped growing at 8 weeks, this was discovered at the 10 week scan. At 7 week scan, healthy baby and a heartbeat, by 10 weeks baby stopped growing, no heartbeat. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jul2021. The outcome of the event was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1510536 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-07-04
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0195 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion, Ultrasound scan, Ultrasound scan vagina
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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:Absence of fetal heartbeat; Test Name: transvaginal ultrasound; Result Unstructured Data: Test Result:fetal hydrops
CDC Split Type: BRPFIZER INC2021893449

Write-up: abortion; This is a spontaneous report from a contactable pharmacist (patient) via regulatory authority. This pharmacist reported information for both mother and fetus. This is the maternal report. A 36-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, lot number: Ew0195), dose 1 via an unspecified route of administration, administered in Arm Right on 19May2021 07:30 (received at the age of 35-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The COVID-19 vaccine was administered at a Public Health Center. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient medical history and concomitant medications were not reported. The patient previously took Profenid and experienced allergic condition; the patient presented allergic condition when receiving intravenous Profenid. The patient was pregnant at the time of vaccination. Her last menstrual period date was on 23Apr2021. Expected delivery date was 23Jan2022. It was reported that the patient experienced abortion on 04Jul2021 09:30. Absence of fetal heartbeat elucidated by ultrasound at 10 weeks and 2 days of gestation, due to non-evolving pregnancy, gestational age 9 weeks and 6 days with transvaginal ultrasound showing fetal hydrops. The patient chose to continue with surgical intervention (Manual intrauterine aspiration) for material retention and cytogenetic analysis. The adverse event resulted into a Doctor or other healthcare professional office/clinic visit / Emergency room/department or urgent care / Hospitalization. The patient was hospitalized for 2 days, from 04Jul2021 to an unspecified date. Therapeutic measures were received for the adverse event which included surgical intervention (Manual intrauterine aspiration). Outcome of the event was reported as resolved on an unspecified date.; Sender''s Comments: Based on available information and the drug temporal relationship, the causality between the event "abortion" and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1511334 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100949716

Write-up: Heart stopped shortly after vaccination; received BNT162B2 (COMIRNATY) dose 1 transplacental; 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 downloaded from the Regulatory Authority NL-LRB-00616253. A fetus received BNT162B2 (COMIRNATY) dose 1 transplacental on 04Jul2021 (Batch/Lot Number: FE1573) as dose 1, single for covid-19 immunisation when patient mother had pregnant duration of 7 weeks and 3 days. The patient medical history and concomitant medications were not reported. The patient heart stopped shortly after vaccination on 06Jul2021 with fatal outcome. The patient 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) : NL-PFIZER INC-2021895854 mother/child case; Reported Cause(s) of Death: Heart stopped shortly after vaccination; received BNT162B2 (COMIRNATY) dose 1 transplacental


VAERS ID: 1529951 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 17Feb2022)
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20200630; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: scans; Result Unstructured Data: Test Result:Miscarriage; Comments: at week 10
CDC Split Type: GBPFIZER INC202100934256

Write-up: Miscarriage; SARS-CoV-2 infection; This is a solicited report received from a contactable consumer from the Regulatory Agency. Regulatory authority report number GB-MHRA-YCVM- 202106301517180920-XV7CK, Safety Report Unique Identifier GB-MHRA-ADR 25686669. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Jun2021 (Batch/Lot Number: FD5613) as dose 1, single for COVID-19 vaccination. Medical history included ongoing pregnancy (Estimated due date: 17Feb2022) and folic acid supplementation. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Patient last menstrual period date on 06May2020. Concomitant medication(s) included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced miscarriage on 19Jul2021 with outcome of not recovered, sars-cov-2 infection on 04Jul2021 with outcome of recovering. Patient does think vaccination had an adverse effect on the pregnancy. Patient had Miscarriage 3 weeks after vaccine. Patient was exposed to the vaccine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included No - Negative COVID-19 test on 30Jun2020 and Details of scans or investigations: Miscarriage at week 10. 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 the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1549884 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-07-04
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100975450

Write-up: Miscarriage; Hives; 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-202107300616000320-S8Q4B, Safety Report Unique Identifier GB-MHRA-ADR 25730921. A 39-year-old pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number unknown), via an unspecified route of administration on 15Jun2021 as single dose for COVID-19 immunisation. Patient was exposed to vaccine during first-trimester (1-12 weeks) of pregnancy. Medical history included abortion spontaneous on an unknown date. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. On 04Jul2021, patient experienced hives; on 12Jul2021, patient experienced miscarriage. The miscarriage was considered as serious-medically significant, hives non-serious. Outcome of event miscarriage was recovered on 14Jul2021, hives recovered on 09Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1590524 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-04
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101015830

Write-up: Abortion spontaneous; Abdominal pain; This is a spontaneous report from a contactable nurse. Regulatory authority report number is AEFI-A-007245. A 39-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 01Jul2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced abortion spontaneous and abdominal pain on 04Jul2021 (also reported as two days after second dose). It was reported that the patient experienced miscarriage in early pregnancy two days (as reported) after second dose of vaccine. The reporter assessed all events as serious (medically significant). 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: 1695078 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Late miscarriage; Maternal exposure during pregnancy; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25896293) on 05-Sep-2021 and was forwarded to Moderna on 05-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Late miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 22-Aug-2021, the patient experienced ABORTION SPONTANEOUS (Late miscarriage) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized on sometime in August 2021 due to ABORTION SPONTANEOUS. The delivery occurred on 22-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 04-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 28-Aug-2021, ABORTION SPONTANEOUS (Late miscarriage) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported . Treatment information was not provided. Patient has not tested positive for COVID-19 since having the vaccine. This is a case of maternal exposure during pregnancy with an associated AE for this unknown age female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This is a case of maternal exposure during pregnancy with an associated AE for this unknown age female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1783839 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214001 / 1 - / OT

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

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: Migraine; Psoriasis of scalp
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Ultrasound scan; Result Unstructured Data: In gestation week 6: Normal; Test Date: 20210918; Test Name: Ultrasound scan; Result Unstructured Data: In gestation week 12+2: Missed abortion confirmed
CDC Split Type: DKMODERNATX, INC.MOD20213

Write-up: Missed abortion estimated to have happened around gestation week 7-8; Spotting menstrual. Increasing spotting menstrual during pregnancy two weeks before missed abortion was confirmed with ultrasound; Maternal exposure during pregnancy, first trimester; This case was received via Regulatory authority(Reference number: DK-DKMA-WBS-0088717) on 07-Oct-2021 and was forwarded to Moderna on 07-Oct-2021. This regulatory authority prospective pregnancy case was reported by a physician and describes the occurrence of ABORTION MISSED (Missed abortion estimated to have happened around gestation week 7-8), INTERMENSTRUAL BLEEDING (Spotting menstrual. Increasing spotting menstrual during pregnancy two weeks before missed abortion was confirmed with ultrasound) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, first trimester) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3004493 and 214001) for COVID-19 immunisation. Concurrent medical conditions included Migraine and Psoriasis of scalp. On 04-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Aug-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 04-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, first trimester) (seriousness criterion medically significant). On 07-Aug-2021, the patient experienced INTERMENSTRUAL BLEEDING (Spotting menstrual. Increasing spotting menstrual during pregnancy two weeks before missed abortion was confirmed with ultrasound) (seriousness criterion medically significant). On 08-Aug-2021, the patient experienced ABORTION MISSED (Missed abortion estimated to have happened around gestation week 7-8) (seriousness criterion medically significant). On 04-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, first trimester) had resolved. At the time of the report, ABORTION MISSED (Missed abortion estimated to have happened around gestation week 7-8) and INTERMENSTRUAL BLEEDING (Spotting menstrual. Increasing spotting menstrual during pregnancy two weeks before missed abortion was confirmed with ultrasound) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: normal (normal) In gestation week 6: Normal. On 18-Sep-2021, Ultrasound scan: abnormal (abnormal) In gestation week 12+2: Missed abortion confirmed. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. This case concerns a 34-year-old, female patient with no relevant medical history, who experienced maternal exposure during pregnancy (first trimester) and the serious (medically significant) unexpected events of Abortion missed and Intermenstrual bleeding. The patient received the both doses of vaccine during first trimester. Intermenstrual bleeding and abortion missed occurred approximately 6 and 7 days after the second dose mRNA-1273 (Spikevax). The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced maternal exposure during pregnancy (first trimester) and the serious (medically significant) unexpected events of Abortion missed and Intermenstrual bleeding. The patient received the both doses of vaccine during first trimester. Intermenstrual bleeding and abortion missed occurred approximately 6 and 7 days after the second dose mRNA-1273 (Spikevax). The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1459858 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-07
Onset:2021-07-05
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017C21A / 1 RA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Rocephin
Diagnostic Lab Data: Pregnancy confirmed by OBGYN on 6/15/21. Miscarriage confirmed by doctor on 7/5/21.
CDC Split Type:

Write-up: Miscarriage of pregnancy - conception occurred around the time of first dose. Shot given 5/7/21, miscarriage occurred 7/5/21.


VAERS ID: 1540378 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-06-14
Onset:2021-07-05
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053C21A / 1 RA / 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? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: NK
Preexisting Conditions: IV drug use recovery
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported during second dose that she miscarried at 4 months pregnant. Patient reported receiving another vaccination as well, not given at our facility. She did not blame the vaccine, but thought it was worth mentioning. Other vaccine not reported to IMPACTSISS, vaccine likely to be Tdap booster.


VAERS ID: 1722630 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-03-26
Onset:2021-07-05
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -
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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: miscarriage


VAERS ID: 1775822 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-13
Onset:2021-07-05
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Menstruation delayed, Ovulation delayed, Rash, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Vitamin D3, apple cidar vinegar gummies
Current Illness: None
Preexisting Conditions: Hypothyroidism, obesity
Allergies: none
Diagnostic Lab Data: I underwent HcG blood tests every 48 hours from July 1 - 7 and 2 ultrasounds on July 1 and July 5 to determine whether I was either 1) in early pregnancy 2) ectopic pregnancy or 3) miscarriage. The u/s were both unable to determine a viable pregnancy or a ectopic pregnancy . A miscarriage was not diagnosed until on or around July 7th after lab results showed a decline in my HcG levels.
CDC Split Type:

Write-up: Following my 1sst dose of Moderna I developed a rash, that began on my hip but slowly traveled up my back. However following my 2nd dose I experienced a delay in my menstrual cycle in June 2021 which cause a late ovulation and a subsequent miscarriage.


VAERS ID: 1511322 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Malaise, 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy 7 week and 3 days)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021895854

Write-up: Miscarriage; Reaction at or around the injection site: pain; Fatigue; Malaise; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00616253. This consumer reported information for both mother and fetus. This is a mother report. A 30-year-old female patient received BNT162B2 (COMIRNATY) dose 1 via an unspecified route of administration on 04Jul2021 (Lot Number: FE1573) as dose 1, single for covid-19 immunisation. Medical history included COVID-19 vaccine exposure during pregnancy 7 week and 3 days. The patient''s concomitant medications were not reported. This was the first Covid vaccination, which took place at a pregnancy duration of 7 weeks and 3 days. The miscarriage occurred at a pregnancy duration of 7 weeks and 5 days. Miscarriage occurred 2 days after start on 06Jul2021. Malaise, fatigue and injection site pain occurred 1 day after start on 05Jul2021. The patient is recovering from fatigue, recovered from injection site pain, recovered from malaise, outcome of event miscarriage was unknown. No previous COVID-19 infection. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202100949716 mother/child case


VAERS ID: 1625716 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:Unknown
CDC Split Type: NLPFIZER INC202101016879

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00651681. This consumer reported information for the mother. This is a maternal report. A 28-year-old (4 week-pregnant) female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Jul2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no previous COVID-19 infection. On 05Jul2021, the pregnancy resulted in spontaneous abortion. Outcome of the event was unknown. The patient had ultrasound on unknown date with unknown results. Health Authority 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 are possible, information on batch number cannot be obtained.


VAERS ID: 1664555 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-07-05
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Oligomenorrhoea, Pregnancy test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOL; LEVAXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Name: Pregnancy test; Test Result: Negative ; Comments: The next menstrual cycle after the miscarriage
CDC Split Type: ISPFIZER INC202101079621

Write-up: Longer menstrual cycle; Two days after the miscarriage the patient started with heavy vaginal bleeding; Miscarriage; This is a spontaneous report from a contactable consumer or other non hcp (patient) downloaded from the regulatory authority, regulatory authority number IS-IMA-4327. This consumer or other non hcp reported information for mother. This is a retrospective maternal report. A 32-years-old pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number-unknown), via an unspecified route of administration on 03Jun2021 as dose 2, single for covid-19 immunization. The patient previously received BNT162B2 (COMIRNATY, Solution for injection, Lot number-unknown), via an unspecified route of administration on 28Apr2021 as dose 1, single for covid-19 immunization. Medical history included hypothyroidism from an unknown date. Concomitant medications included omeprazole (OMEPRAZOL) taken for an unspecified indication, from an unknown start date (daily for many years), levothyroxine sodium (LEVAXIN) taken for an unspecified indication, from an unknown start date (daily for many years). On 05Jul2021, the patient had a miscarriage. At that time patient estimates that she was approx. 4 weeks pregnant. On 07Jul2021, two days after the miscarriage the patient started with heavy vaginal bleeding. The mother reported she became pregnant while taking BNT162B2. The pregnancy resulted in spontaneous abortion. The foetal outcome is intrauterine death. On 04Aug2021, the patient again started with menstrual cycle which was approx. 2 weeks later than usual. On an unknown date, before the next menstrual cycle after miscarriage the patient took 2 pregnancy tests and results for both were negative. The event spontaneous abortion assessed as medically significant. The outcome of the events was reported as unknown. No follow up attempts possible. No further information is expected. Lot/batch number was not provided and unable to obtain.


VAERS ID: 1667757 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-05
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5436 / 1 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? 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: ESPFIZER INC202101079632

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-974892. A 32-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 22Jun2021 (Batch/Lot Number: FC5436) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had vaccine exposure during pregnancy (as reported) then had abortion spontaneous on 05Jul2021. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738956 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-07-05
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101224936

Write-up: Early miscarriage; Miscarriage at 5 weeks; Weeks/asthenia; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109160817115020-OBS4D, Safety Report Unique Identifier GB-MHRA-ADR 25950638. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW4109), via an unspecified route of administration on 24May2021, as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date in 2021, the patient experienced miscarriage at 5 weeks, and was weak. On 05Jul2021, the patient experienced early miscarriage. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative, on an unspecified date in 2021. The reporter considered the events as serious (medically significant). The outcome of events miscarriage and weak was unknown and early miscarriage was resolved on 05Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841728 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-07-05
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Antinuclear antibody, Antiphospholipid antibodies, Beta-2 glycoprotein antibody, Blood test, Cardiolipin antibody, Coagulation test, Culture cervix, Culture urine, Cytomegalovirus test, Herpes simplex, Parvovirus B19 test, Pregnancy test, Rubella, Toxoplasma serology
SMQs:, Termination of pregnancy and risk of abortion (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ANA; Result Unstructured Data: Test Result:Normal; Test Name: ENA; Result Unstructured Data: Test Result:Normal; Test Name: lupus anticoagulant test; Result Unstructured Data: Test Result:Normal; Test Name: Beta2glycoprotein1; Result Unstructured Data: Test Result:Normal; Test Name: Blood test; Result Unstructured Data: Test Result:Normal; Comments: Coagulation test, toxoplasma, rubella, cytomegalovirus, Herpes simplex, Parvo B19, lupus anticoagulant test, ANA, ENA, cardiolipin antibdoy test, Beta2glycoprotein1. All tests were normal.; Test Name: cardiolipin antibody; Result Unstructured Data: Test Result:Normal; Test Name: Coagulation test; Result Unstructured Data: Test Result:Normal; Test Name: Cervical culture; Result Unstructured Data: Test Result:Normal; Test Name: Urine culture; Result Unstructured Data: Test Result:Normal; Test Name: cytomegalovirus; Result Unstructured Data: Test Result:Normal; Test Name: Herpes simplex; Result Unstructured Data: Test Result:Normal; Test Name: Parvo B19; Result Unstructured Data: Test Result:Normal; Test Date: 20210424; Test Name: Pregnancy test; Test Result: Positive ; Test Name: Rubella; Result Unstructured Data: Test Result:Normal; Test Name: Toxoplasma; Result Unstructured Data: Test Result:Normal
CDC Split Type: ISPFIZER INC202101415253

Write-up: Miscarriage; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number IS-IMA-4982. This physician reported information for both mother and fetus. This is a maternal report. A 33-years-old female pregnant patient received bnt162b2 (COMIRNATY, solution for injection) via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunization. No underlying diseases are reported. No concomitant medication is reported. The mother reported she became pregnant while taking bnt162b2. The mother was 13 Weeks pregnant at the onset of the event. The mother was pregnant with 2 baby(s). The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient experienced miscarriage (medically significant, congenital anomaly) on 05Jul2021. The patient took a pregnancy test on 24Apr2021 that was positive (11 days after ovulation). MC/DA twin pregnancy was confirmed but she had a miscarriage in week 13+5 days on 05Jul2021. Examination has not shown an obvious explanation for the miscarriage, a certain suspicion of TAPS which was not possible to confirm. Further tests done to investigate the cause of miscarriage were all normal. On an unspecified date the patient underwent lab tests and procedures which included Urine culture, Cervical culture, Blood test, Coagulation test, toxoplasma, rubella, cytomegalovirus, Herpes simplex, Parvo B19, lupus anticoagulant test, ANA, ENA, cardiolipin antibody test, Beta2glycoprotein1. All tests were normal. The outcome of event was recovered with sequelae. No follow up attempts possible. No further information is expected. Lot/batch number was not provided and unable to obtain.; Sender''s Comments: Linked Report(s) : IS-PFIZER INC-202101434819 mother/ baby cases


VAERS ID: 1487447 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-05-14
Onset:2021-07-06
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 2 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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

Write-up: I received first dose of Pfizer vaccine on 4/12/2021 and second dose of Pfizer vaccine on 5/14/2021. At the time of first dose, I was not pregnant but we were actively trying to become pregnant. At time of second vaccine, I was pregnant (possibly 1-2 weeks along). I did not know I was pregnant. At my regular first check up on July 6, 2021, I went in to confirm pregnancy with my OGBYN. An ultrasound confirmed I had a blighted ovum, which is a type of miscarriage that the body does not recognize on its own. I did have a surgery to end to miscarriage since my body did not do it naturally. I wanted to report this happening in case it was significant since the timeframes of receiving vaccine and pregnancy were very close together. I know tests on the safety of this vaccine have been very limited and wanted to offer my experience in case it is relevant. Thank you,


VAERS ID: 1709168 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-10
Onset:2021-07-06
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Asthenia, Fatigue, Pain in extremity, Ultrasound scan, Vomiting
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy. Started to bleed after your Covid shot no blood prior to Covid shot more fatigue during pregnancy. Had miscarriage after 8 weeks.
Preexisting Conditions:
Allergies: None
Diagnostic Lab Data: Sonogram July 16, 2021
CDC Split Type:

Write-up: Miscarriage one week after shot pain in left arm consistent for three days weakness fatigue vomiting


VAERS ID: 1768697 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-01
Onset:2021-07-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Muscle spasms, Ultrasound scan vagina, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), 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: Prenatal Vitamins.
Current Illness: No.
Preexisting Conditions: Fibromyalgia.
Allergies: Bactrim; Carafate; Wellbutrin; Dairy.
Diagnostic Lab Data: At least four all together of ultrasounds, 1st one: Did a transvaginal ultrasound, but I was less than 4 weeks pregnant so she couldn''t see anything (may have had 5 of them). Ultrasounds performed at physician''s office.
CDC Split Type: vsafe

Write-up: I may have started bleeding on July 5th because I called and then went to the Gyn on July 6th. I was having bleeding a lot. It stopped and then I went back again for the other transvaginal ultrasound and they said it wasn''t developing and then they said come back again and there was no heartbeat and then they said come back again 8/13 it was a miscarriage and on the 21st of Aug they gave me pills to clear everything out and 8/25 said it was all clear. Pregnancy history: 1st pregnancy; estimated due date 3/10/2022. I am still having cramping but it is probably the uterus resetting, the doctor says it can take awhile. Urgent care visits, 2 visits, had to go because of cramping.


VAERS ID: 1497636 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-07-06
   Days after vaccination:17
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, Haemorrhage, Maternal exposure during pregnancy, Pregnancy test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: Pregnancy test; Test Result: Positive ; Result Unstructured Data: 2 positive tests but very heavy bleeding including clots and spotting
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Bleeding; Maternal exposure during pregnancy; Miscarriage; This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) and ABORTION SPONTANEOUS (Miscarriage) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Pregnancy. Previously administered products included for an unreported indication: FOLIC ACID. Concurrent medical conditions included Miscarriage. On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, HAEMORRHAGE (Bleeding) was resolving, ABORTION SPONTANEOUS (Miscarriage) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: positve (Positive) 2 positive tests but very heavy bleeding including clots and spotting. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient took pregnancy tests and was positive. Experienced very heavy bleeding for 6 days. Tests was showing positive but intermittent bleeding. Patient did not take folic acid supplement during pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). Treatment information was not provided.; Sender''s Comments: This is a case of product exposure during pregnancy which resulted in Spontaneous Abortion, for this 32 years old female. Very limited information has been provided at this time.


VAERS ID: 1530320 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-06
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: NLPFIZER INC202100940051

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the WEB. The Regulatory Authority report number is NL-LRB-00631825. A 34-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 03Jul2021 (Batch/Lot number and expiration date were not reported) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has no previous COVID-19 infection. No diagnostic procedures. The patient experienced maternal exposure during pregnancy on an unspecified date and miscarriage on 06Jul2021. The miscarriage occurred at a pregnancy duration of about 8.5 weeks. This was the first Covid vaccination, which took place at a pregnancy duration of about 8 weeks. The outcome of the events 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1576945 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-06
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Fatigue, Lymphadenopathy, Malaise, Maternal exposure during pregnancy, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Dyspnoea; Eczema; Stomach discomfort
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Malaise; Lymphadenopathy cervical; Generalized joint pain; Myalgia; Fatigue; This case was received via regulatory authority (Reference number: 00639772) on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS in a 30-year-old female patient who received mRNA-1273 (batch no. 3003186) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Eczema, Dyspnoea and Stomach discomfort. Concurrent medical conditions included Allergy. On 01-Jun-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Jul-2021, the patient experienced MALAISE and FATIGUE. On an unknown date, the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant), MATERNAL EXPOSURE DURING PREGNANCY , MALAISE (Malaise), LYMPHADENOPATHY (Lymphadenopathy cervical), ARTHRALGIA (Generalized joint pain), MYALGIA (Myalgia) and FATIGUE (Fatigue). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS , MALAISE (Malaise), LYMPHADENOPATHY (Lymphadenopathy cervical), ARTHRALGIA (Generalized joint pain), MYALGIA (Myalgia) and FATIGUE (Fatigue) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY , MALAISE and FATIGUE had resolved. No concomitant medication were reported. No treatment information was reported. Company Comment: This is a case of maternal exposure during pregnancy with abortion spontaneous for this 30-year-old female.Patient will not be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of these other events, a causal relationship cannot be excluded.; Sender''s Comments: This is a case of maternal exposure during pregnancy with abortion spontaneous for this 30-year-old female.Patient will not be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of these other events, a causal relationship cannot be excluded.


VAERS ID: 1664922 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Test Result: Positive
CDC Split Type: NLPFIZER INC202101056257

Write-up: Menstrual problems: After first stress it took 37 days to get going. Seemed to be miscarriage, pregnancy test was positive.; clots; Menstrual problems: After first stress it took 37 days to get going. Seemed to be miscarriage, pregnancy test was positive.; clots; Vaccination during pregnancy; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00651665. A 42 years female patient received 1st dose of BNT162B2 (COMIRNATY, lot# FE7010), at the age of 42 years old, on 06Jul2021 at single dose for COVID-19 immunisation. Medical history was maternal vaccine exposure (unspecific). Normally fairly regular cycle. No Previous COVID-19 infection. No diagnostic procedures. Concomitant drug was not reported. Patient experienced with miscarriage (other medically important condition) and late period on 06Jul2021 (also reported as 1 day after start) following administration of covid-19 vaccine pfizer injection fluid with outcome was recovered on 29Jul2021 and maternal exposure during pregnancy. The patient had a delayed menstruation and had a positive pregnancy test. She then had a vaginal bleeding which was a suspected miscarriage. The pregnancy duration is unknown and is asked in a follow-up email. Treatment: Late period is treated with went to a doctor for clots and miscarriage is treated withwent to a doctor for clots. The patient recovered from late period and miscarriage, the outcome of maternal exposure during pregnancy is unknown. The clinical course was reported as follows: after first stress took 37 days to get going. Seemed like a miscarriage, pregnancy test was positive, clots. No follow-up activities possible. No further information expected.


VAERS ID: 1665057 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101056492

Write-up: 10 days delayed menstruation or miscarriage; 10 days delayed menstruation or miscarriage; different bleeding; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority. A 34-year-old female patient received 1st dose of BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 06Jul2021 (at the age of 34-year-old) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The menstruation should have come on the day of the vaccine (06Jul2021), but came instead 10 days later, and were in a different shape. Unclear if it was a miscarriage or delayed different menstruation (bleeding). The case was considered as serious, important medical event by the regulatory authority. 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: 1676967 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002615 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Foetal death, Maternal exposure during pregnancy, Mean cell haemoglobin, Mean cell volume, Physical examination, Red blood cell count, SARS-CoV-2 test, Ultrasound antenatal screen, Unresponsive to stimuli, Vaccination complication, White blood cell count
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Anemia; Gestational diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: Mean cell haemoglobin; Result Unstructured Data: 21.3 pg; Test Date: 20210719; Test Name: Mean cell volume; Result Unstructured Data: 69.2 fL; Test Date: 20210719; Test Name: Physical examination; Test Result: Inconclusive ; Result Unstructured Data: cervical dilation 1cm, 70% thick, One contraction in 3-4 minutes.; Test Date: 20210719; Test Name: Red blood cell count; Result Unstructured Data: 5.36 x 10e6/UL; Test Date: 20210719; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210719; Test Name: Ultrasound antenatal screen; Result Unstructured Data: Pregnancy 39 5/7 weeks with IUFD; Test Date: 20210719; Test Name: White blood cell count; Result Unstructured Data: 14.22 x 1000/UL
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Fetal death in utero; Abdominal pain; unresponsive; Vaccine exposure during pregnancy; unwell; This regulatory authority retrospective pregnancy case was reported by a pharmacist and describes the occurrence of FOETAL DEATH (Fetal death in utero), ABDOMINAL PAIN (Abdominal pain) and UNRESPONSIVE TO STIMULI (unresponsive) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002615) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anemia and Gestational diabetes. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. The patient''s last menstrual period was on an unknown date and the estimated date of delivery was 11-Jul-2021. On 06-Jul-2021, the patient experienced UNRESPONSIVE TO STIMULI (unresponsive) (seriousness criterion medically significant), MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and VACCINATION COMPLICATION (unwell). On 10-Jul-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion hospitalization prolonged). On 19-Jul-2021, the patient experienced FOETAL DEATH (Fetal death in utero) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 21-Jul-2021 due to ABDOMINAL PAIN and FOETAL DEATH. The delivery occurred on an unknown date, which was reported as Unknown. On 06-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, FOETAL DEATH (Fetal death in utero), ABDOMINAL PAIN (Abdominal pain), UNRESPONSIVE TO STIMULI (unresponsive) and VACCINATION COMPLICATION (unwell) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2021, Mean cell haemoglobin: low (Low) 21.3 pg. On 19-Jul-2021, Mean cell volume: low (Low) 69.2 fL. On 19-Jul-2021, Physical examination: cervical dilation 1cm (Inconclusive) cervical dilation 1cm, 70% thick, One contraction in 3-4 minutes.. On 19-Jul-2021, Red blood cell count: normal (normal) 5.36 x 10e6/UL. On 19-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. On 19-Jul-2021, Ultrasound antenatal screen: abnormal (abnormal) Pregnancy 39 5/7 weeks with IUFD. On 19-Jul-2021, White blood cell count: high (High) 14.22 x 1000/UL. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Gestation period at exposure was 37.5 weeks. Patient was vaccinated after assessment by a home medical practitioner. On 09-Jul-2021, Obstetric examination was performed and results were normal and did not tend to induce childbirth. On 21-Jul-2021 around 18:00 hours, she experienced obstetrics pain and was hospitalized with abdominal pain, cervical dilation 1cm, 70% thick, one contraction in 3-4 minutes. On 16-Jul-2021, Birth check-Up information reports The amniocentesis of the fetus is normal (46,XX) and all were normal. No relevant concomitant medications were reported. No treatment information was provided. Company Comment : This is a case of product exposure during pregnancy with associated foetal death and abdominal pain for this 25-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 patient?s concurrent condition of anemia and gestational diabetes could be confounding factors for the events.; Sender''s Comments: This is a case of product exposure during pregnancy with associated foetal death and abdominal pain for this 25-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 patient?s concurrent condition of anemia and gestational diabetes could be confounding factors for the events.


VAERS ID: 1690964 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-13
   Days after onset: 38
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: 20210812; Test Name: Ultrasound; Result Unstructured Data: Test Result:Heartbeat visible
CDC Split Type: NLPFIZER INC202101182998

Write-up: Heart of the embryo stopped beating; First vaccination took place at a pregnancy duration of about 1 week; second vaccination on sixth week of pregnancy; This is a spontaneous report from a contactable consumer (patient''s mother). This is the third of three reports. The first report downloaded from the Regulatory Authority. Regulatory Authority Report Number: NL-LRB-00672883. This consumer reported events for the mother and the fetus. This is the fetus report. A 24-year-old mother received BNT162B2 (COMIRNATY; Strength: 0.3 mL, Lot Numbers were not reported), via unspecified routes of administration, on 06Jul2021, as dose 1, 0.3 mL, single, and then on 10Aug2021, as dose 2, 0.3 mL, single, for COVID-19 immunization. The mother''s medical history and concomitant medications were not reported. On 06Jul2021, the fetus of an unspecified gender experienced maternal exposure during pregnancy via transplacental route of administration. The first vaccination took place at a pregnancy duration of about 1 week. On 10Aug2021, the mother had her second vaccination (sixth week of pregnancy) and now two weeks later unfortunately the baby has no heartbeat and she ended up having a miscarriage. 2 days after the second vaccination (12Aug2021), there was a heartbeat visible at the ultrasound. The day after the ultrasound (13Aug2021), the mother started bleeding, which was still present at the moment of the report. On Friday (13Aug2021), the mother started losing blood after seeing a heartbeat on 12Aug2021. So far blood loss. On 13Aug2021, the heart of the embryo stopped beating and a miscarriage has occurred. The miscarriage occurred at a pregnancy duration of about 6 weeks. The outcome of the events was fatal. The patient died on 13Aug2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101125594 Maternal report; Reported Cause(s) of Death: Heart of the embryo stopped beating; First vaccination took place at a pregnancy duration of about 1 week; second vaccination on sixth week of pregnancy


VAERS ID: 1701455 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-06
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage, Pain, Pregnancy test, Urine analysis
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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Folic acid supplementation; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Result Unstructured Data: Test Result:positive; Test Name: Urine Test; Result Unstructured Data: Test Result:miscarriage
CDC Split Type: GBPFIZER INC202101138124

Write-up: pain; heavy bleeding; 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 [GB-MHRA-WEBCOVID-202108312327565170-WETNR], Safety Report Unique Identifier [GB-MHRA-ADR 25877544]. A 28-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jun2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included pregnancy, depression and vitamin supplementation, all from an unknown date. Concomitant medications included citalopram taken for depression from 12Jan2020 to an unspecified stop date; folic acid taken for Folic acid supplementation, start and stop date were not reported. The patient experienced early miscarriage on 06Jul2021; and pain and heavy bleeding on an unspecified date. The patient underwent lab tests and procedures which included urine test: miscarriage and positive pregnancy test, both on an unknown date. The outcome of the events was unknown. Patient no longer pregnant at the time of reporting. The clinical course was reported as follows: Patient had her first vaccine the day she felt implantation happening and lost the baby the week after a positive pregnancy test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. It was reported that the medicine has an adverse effect on any aspect of the pregnancy. She had her first vaccine one hour after she felt implantation of the pregnancy and she lost the baby at 5 weeks so she was unsure if it was linked. Details of previous pregnancies: No other pregnancies. Patient was exposed to the medicine first-trimester (1-12 weeks). She went to the diagnostics unit after 4 days of pain and heavy bleeding where it confirmed the loss with a urine test. Additional information: 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 possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1705746 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-06
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during breast feeding, Maternal exposure during pregnancy, Pregnancy test, 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
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: faint positive; Result Unstructured Data: Test Result:Faint positive; Comments: Faint positive; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101152974

Write-up: Maternal exposure during pregnancy; Maternal exposure during breast feeding; Miscarriage; This is a spontaneous report from a contactable consumer . This is the first of 2 report. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109031536235060-9PCVF.Safety Report Unique Identifier GB-MHRA-ADR 25893165. A 32-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: Fd8813), dose 2 via an unspecified route of administration on 08Jul2021 as DOSE 2, SINGLE, dose 1 (Batch/Lot Number: Fc8289) via an unspecified route of administration on 17Jun2021 as DOSE 1 ,SINGLE for COVID-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing Patient no longer pregnant at the time of reporting, ongoing breast feeding. Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. On 06Jul2021 the patient experienced miscarriage which was medically significant maternal exposure during pregnancy and maternal exposure during breast feeding on an unspecified date. Patient not had symptoms associated with COVID-19. Pregnancy adverse effects details: The patient stated that 1st dose the day she was ovulating. She had a chemical pregnancy. Period came 5 days late and she had a faint positive for 5 days, she had her 2nd jab 3 weeks later, conceived again next cycle which was 5 days delayed ovulation. No Heartbeat detected 8 weeks. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. pregnancy test: faint positive on an unspecified date Faint positive. The clinical outcome of the events were unknown. No follow-up attempts are possible ,No further information is expected; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101162016 Baby case


VAERS ID: 1738155 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
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, Pain in extremity
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Miscarriage; Vaccine exposure during pregnancy; Brachialgia; This case was received via regulatory authority (Reference number: FI-FIMEA-20214157) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage), MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN IN EXTREMITY (Brachialgia) in a 32-year-old female patient who received mRNA-1273 (Spikevax) for an unknown indication. Concomitant products included CETIRIZINE HYDROCHLORIDE (HEINIX) for Allergy. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant), MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Brachialgia) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. Miscarriage. On 06-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and PAIN IN EXTREMITY (Brachialgia) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. treatment to the events not reported. This case concerns a 32-year-old female patient with no relevant medical, who experienced the unexpected events of abortion spontaneous, pain in extremity and maternal exposure during pregnancy. The events occurred on the same day after first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose.The benefit-risk relationship of Spikevax is not affected by this report. Coding, seriousness, and dates of events were captured as per Regulatory Authority assessment provided in Source Document.; Sender''s Comments: This case concerns a 32-year-old female patient with no relevant medical, who experienced the unexpected events of abortion spontaneous, pain in extremity and maternal exposure during pregnancy. The events occurred on the same day after first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose.The benefit-risk relationship of Spikevax is not affected by this report. Coding, seriousness, and dates of events were captured as per Regulatory Authority assessment provided in Source Document.


VAERS ID: 1807176 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-07-06
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Injection site pain, Malaise, Maternal exposure during pregnancy, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Miscarriage. The babies'' (twins) heart was not beating at an August 5th check up (10 weeks along). They stopped growing at 6.5 weeks; Feeling unwell; Nausea; Muscle pain; Reaction at or around the injection site: pain; Vaccination during 5th week of pregnancy; This case was received (Reference number: NL-LRB-00690981) on 12-Oct-2021 and was forwarded to Moderna on 12-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage. The babies'' (twins) heart was not beating at an August 5th check up (10 weeks along). They stopped growing at 6.5 weeks) in a 41-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. no medical history was reported. On 08-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. The patient''s last menstrual period was on 30-May-2021 and the estimated date of delivery was 06-Mar-2022. On 06-Jul-2021, the patient experienced MALAISE (Feeling unwell), NAUSEA (Nausea), MYALGIA (Muscle pain), INJECTION SITE PAIN (Reaction at or around the injection site: pain) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during 5th week of pregnancy). On 20-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage. The babies'' (twins) heart was not beating at an August 5th check up (10 weeks along). They stopped growing at 6.5 weeks) (seriousness criterion medically significant). The patient received mRNA-1273 (Spikevax) beginning around the fifth week of the pregnancy. The delivery occurred on 20-Jul-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 06-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during 5th week of pregnancy) had resolved. On 07-Jul-2021, MALAISE (Feeling unwell), NAUSEA (Nausea) and MYALGIA (Muscle pain) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage. The babies'' (twins) heart was not beating at an August 5th check up (10 weeks along). They stopped growing at 6.5 weeks) and INJECTION SITE PAIN (Reaction at or around the injection site: pain) outcome was unknown. Relevant concomitant medications were not reported. Treatment information was not provided. It was reported that vaccine exposure during pregnancy week, First vaccination a when she was ovulated. First day of her last period was 30-May-2021, Patient had her first vaccination on 8-Jun-2021. Her cycle was 26 days, and now it''s different, longer. This case concerns a 41-year-old, female patient with no disclosed medical history, who experienced the unexpected events of maternal exposure during pregnancy and abortion spontaneous and other non-serious events of malaise, nausea, myalgia and injection site pain. The patient received the second dose of vaccine at 5 weeks of gestation. Spontaneous abortion occurred approximately 14 days after the second dose of Spikevax. The patient''s age remains as a confounding factor to event abortion spontaneous. The benefit-risk relationship of Spikevax is not affected by this report. Authority report structured field indicates that spontaneous abortion occurred 14 days after second dose, while narrative states that the babies'' heart stopped beating approximately 1 month after second dose, dates captured were from RA structured field. Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Significant Translation received.; Reporter''s Comments: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS critera, the reaction was considered as serious by the .; Sender''s Comments: This case concerns a 41-year-old, female patient with no disclosed medical history, who experienced the unexpected events of maternal exposure during pregnancy and abortion spontaneous and other non-serious events of malaise, nausea, myalgia and injection site pain. The patient received the second dose of vaccine at 5 weeks of gestation. Spontaneous abortion occurred approximately 14 days after the second dose of Spikevax. The patient''s age remains as a confounding factor to event abortion spontaneous. The benefit-risk relationship of Spikevax is not affected by this report. Authority report structured field indicates that spontaneous abortion occurred 14 days after second dose, while narrative states that the babies'' heart stopped beating approximately 1 month after second dose, dates captured were from RA structured field.


VAERS ID: 1866284 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Maternal exposure during pregnancy, Premature delivery
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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Polycystic ovarian syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101461943

Write-up: Death fetal; Premature delivery; Maternal exposure during pregnancy, second trimester/ 1st vaccination at 18 weeks; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number FR-AFSSAPS-PC20215030. A 33-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 06Jul2021 (Batch/Lot Number: FE1573) as DOSE 1, SINGLE administered in the arm left for covid-19 immunisation. Medical history included Polycystic ovary syndrome from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was reported that pregnancy in progress: start of pregnancy 18Mar2021 (also reported date of last menstruation: 18Mar2021, due date 23Dec2021, Primiparous, Pregnancy achieved by MAP, No history of miscarriage). 1st vaccination at 18 weeks of amenorrhoea, 06Jul2021. 2nd vaccination (lot: FF4213, intramuscular) at 21 weeks of amenorrhoea + 2 days on 29Jul2021. At DAY 6 of the 2nd dose (04Aug2021), contractions occur; water broke; visit to gynaecological emergency room. Cervix completely open. Delivery in 2 hours of a live baby when the cord was cut also reported as Premature delivery and Death fetal). The outcome of the events was not recovered.


VAERS ID: 1454526 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-06-14
Onset:2021-07-07
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016C21A / 1 RA / SC

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin, Ultrasound pelvis
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: Multivitamin Probiotic Vitamin B
Current Illness: None
Preexisting Conditions: Eczema
Allergies: Hydrocodone-Tylenol
Diagnostic Lab Data: pelvic ultrasound and bHCG to confirm diagnosis
CDC Split Type:

Write-up: Patient was newly pregnant when she received her first Covid vaccine. Was later diagnosed with a missed miscarriage


VAERS ID: 1492898 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

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

Life Threatening? Yes
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage; At the time of the shot she was 7 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) in a 39-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. No Medical History information was reported. On 07-Jul-2021, 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 07-Jul-2021, the patient experienced EXPOSURE DURING PREGNANCY (At the time of the shot she was 7 weeks pregnant). On 08-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) (seriousness criteria medically significant, life threatening and congenital anomaly). On 07-Jul-2021, EXPOSURE DURING PREGNANCY (At the time of the shot she was 7 weeks pregnant) had resolved. On 09-Jul-2021, ABORTION SPONTANEOUS (Next day 8July2021 she started spotting/Then the day after 9July2021, she started bleeding more/she had a miscarriage) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. The laboratory exams performed to further understand the event included were ultrasound a week prior to the shot to show the babies heart rate. Treatment medication use information was not provided by reporter.; Sender''s Comments: This case concerns a 39-year-old female patient gravida 1 who received mRNA-1273 at 7 weeks of pregnancy and experienced spotting one day post vaccination and spontaneous abortion 2 days post vaccination. Last menstrual period and estimated date of delivery were not provided. Spontaneous abortion show temporal association with product use and a causal relationship cannot be excluded. The event of exposure during pregnancy is assessed not applicable


VAERS ID: 1592596 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-07
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Ectopic pregnancy, Fallopian tube disorder, Haemoperitoneum
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101055072

Write-up: Fallopian tube disorder; Hemoperitoneum; Miscarriage; Tubal pregnancy; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB FI-FIMEA-20213861. A 22 years old female patient received BNT162B2 (COMIRNATY, batch/lot: FE2296) on an unspecific date at single dose for COVID-19 immunisation. Medical history and concomitant drug were not reported. Patient experienced Fallopian tube disorder, Hemoperitoneum, Miscarriage, Tubal pregnancy and Salpingectomy (as reported) from 07Jul2021 with outcome was recovering. All events were serious as life-threatening. The clinical course was reported as follows: I had a miscarriage in the fallopian tube and my fallopian tube had to be cut off because of that and the miscarriage led to damage to the fallopian tube and caused accumulation of blood in the abdomen. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592744 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-07
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1248 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101010302

Write-up: Pregnancy loss <20 weeks gestation; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-TO20216199. A 24-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in Arm Left on 25Jun2021 (Batch/Lot Number: FE1248) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced spontaneous miscarriage at 4.5 months of pregnancy on 07Jul2021. The outcome of the event was recovered with sequel. No follow-up attempts possible. No further information expected.


VAERS ID: 1634095 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-07-07
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, 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? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Miscarriage
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: miscarriage; Result Unstructured Data: Test Result:miscarriage; Comments: Baby stopped growing at 6 weeks, miscarriage physically occurred at 9 weeks. Vaccine was given in week 1 of pregnancy; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: 3x ultrasound; Result Unstructured Data: Test Result:unknown; Comments: 7w 6d, 9w 0d and 9w 5d
CDC Split Type: GBPFIZER INC202101040855

Write-up: miscarriage; Maternal exposure during pregnancy; Early miscarriage; This is a spontaneous report from a contactable consumer or other non HCP received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108111122593500-6GAA7. [Safety Report Unique Identifier: GB-MHRA-ADR 25783947] A 33-years-old female patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot number: ET8885, expiry date: not reported) dose 1 via an unspecified route of administration on 26May2021 as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased, ongoing miscarriage (Scan at 7w 6d showed baby as being 6w 1d with no heartbeat. Miscarriage occurred naturally at 9w 0d, with all products of conception confirmed as having passed by 9w 5d), Pregnancy (Patient no longer pregnant at the time of reporting), folic acid supplementation. Concomitant medication included folic acid taken for folic acid supplementation start and stop date were not reported. On an unspecified date, the patient experienced miscarriage, maternal exposure during pregnancy. on 07Jul2021, the patient experienced early miscarriage. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. it was reported that vaccine taken in first week of pregnancy, before conception. Missed miscarriage occurred. Scan at 7w 6d showed baby as being 6w 1d with no heartbeat. Miscarriage occurred naturally at 9w 0d, with all products of conception confirmed as having passed by 9w 5d. 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 had an adverse effect on any aspect of the pregnancy. First pregnancy of the patient. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient patient underwent lab tests and procedures which include miscarriage Baby stopped growing at 6 weeks, miscarriage physically occurred at 9 weeks. Vaccine was given in week 1 of pregnancy on 20Jul2021. Vaccine was given in week 1 of pregnancy, sars-cov-2 test: negative on an unspecified date: negative, ultrasound scan: unknown on an unspecified date 7w 6d, 9w 0d and 9w 5d. The outcome of event early miscarriage was recovered on 03Aug2021. The outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1656828 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-07
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101055611

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, the regulatory authority number is FI-FIMEA-20213923. This consumer reported information for both mother and baby. This is a maternal report. A 44-year-old pregnant female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: unknown), via an unspecified route of administration on 11Jun2021 as single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced abortion spontaneous on 07Jul2021, the event was serious per hospitalization. The pregnant female reported she became pregnant while taking bnt162b2. The female was 1 Trimester pregnant at the onset of the event. After receiving the Pfizer vaccine, she had a miscarriage between weeks 8-9. She was generally healthy. This happened two weeks after the vaccination. The outcome of event was resolved on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1714563 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214001 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DITEBOOSTER; ZOPICLONE ORION; AIROMIR [SALBUTAMOL SULFATE]; AVONEX; SERTRALIN ORION; SERETIDE DISKUS [FLUTICASONE PROPIONATE;SALMETEROL XINAFOATE]; IBUPROFEN TEVA; PARACETAMOL ORIFARM
Current Illness: Asthma; Depression; Insomnia; Multiple sclerosis; Sleep difficult
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: Human chorionic gonadotropin; Test Result: Positive ; Result Unstructured Data: 3U/L (enzyme unit per litre); Test Date: 20210817; Test Name: Scan; Result Unstructured Data: Apontan abortion confirmed
CDC Split Type: DKMODERNATX, INC.MOD20213

Write-up: Abortion spontaneous, with severe bleeding and labour like pain in lower back and abdomen; ''Maternal exposure during pregnancy, first trimester''; This case was received via Agency (Reference number: 25816401) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Abortion spontaneous, with severe bleeding and labour like pain in lower back and abdomen) and MATERNAL EXPOSURE DURING PREGNANCY (''Maternal exposure during pregnancy, first trimester'') in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3004959 and 214001) for COVID-19 immunisation. Concurrent medical conditions included Multiple sclerosis, Asthma, Depression, Sleep difficult and Insomnia. Concomitant products included IBUPROFEN (IBUPROFEN TEVA) and PARACETAMOL (PARACETAMOL ORIFARM) for Adverse drug reaction, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SERETIDE DISKUS [FLUTICASONE PROPIONATE;SALMETEROL XINAFOATE]) for Asthma, SALBUTAMOL SULFATE (AIROMIR [SALBUTAMOL SULFATE]) for Bronchospasm, SERTRALINE HYDROCHLORIDE (SERTRALIN ORION) for Depression, INTERFERON BETA-1A (AVONEX) for Multiple sclerosis, DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (DITEBOOSTER) from 29-Jul-2021 to an unknown date for Revaccination, ZOPICLONE (ZOPICLONE ORION) for Sleep difficult. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Aug-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 07-Jul-2021, after starting mRNA-1273 (Spikevax), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (''Maternal exposure during pregnancy, first trimester'') (seriousness criterion medically significant). On 13-Aug-2021, the patient experienced ABORTION SPONTANEOUS (Abortion spontaneous, with severe bleeding and labour like pain in lower back and abdomen) (seriousness criterion medically significant). The delivery occurred on 13-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 07-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (''Maternal exposure during pregnancy, first trimester'') had resolved. At the time of the report, ABORTION SPONTANEOUS (Abortion spontaneous, with severe bleeding and labour like pain in lower back and abdomen) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Human chorionic gonadotropin: 3 (Positive) 3U/L (enzyme unit per litre). On 17-Aug-2021, Scan: abnormal (abnormal) Apontan abortion confirmed. No treatment medications were provided On 19-Aug-2021 Blood test was scheduled, results were not provided This case concerns a 35-year-old female patient with a history of Multiple sclerosis, Depression and asthma, who experienced the serious unexpected event Abortion spontaneous on first trimester of pregnancy. The event occurred approximately 37 days after the first dose and 3- days after the most recent dose (second dose) of mRNA-1273 Moderna vaccine. The medical history of Multiple sclerosis, use of multiples concomitant medications, could be a potential confounder/co-suspects. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Translation received on 15-sep-21 and included significant information, Added additional information about the concomitant drug Ibuprofen Teva.; Sender''s Comments: This case concerns a 35-year-old female patient with a history of Multiple sclerosis, Depression and asthma, who experienced the serious unexpected event Abortion spontaneous on first trimester of pregnancy. The event occurred approximately 37 days after the first dose and 3- days after the most recent dose (second dose) of mRNA-1273 Moderna vaccine. The medical history of Multiple sclerosis, use of multiples concomitant medications, could be a potential confounder/co-suspects. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.


VAERS ID: 1845035 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Abortion spontaneous, Amenorrhoea, Fatigue, Headache, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101415014

Write-up: Miscarriage; Menstrual problems; intestinal complaints; Headache; Nausea; Fatigue; pain; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number NL-LRB-00689577. A 25-year-old female pregnant patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 07Jul2021 (at the age of 25-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previous COVID-19 infection was none. The patient previously received first dose of BNT162B2 (COMIRNATY, Batch/Lot number was not reported) on 01Jun2021 at 0.3 ml, single for COVID-19 immunisation. The patient experienced miscarriage on 31Jul2021, nausea, fatigue, headache on 07Jul2021, menstrual problems on 08Jul2021, intestinal complaints on 08Jul2021, pain in 2021. The mother reported this side effect was constantly present, menstruation failing. Upset intestines causing her stomach to swell and she was often unable to go to the toilet. The pain she experienced was also not very mild. She stated they lost their child (miscarriage) after she had her second injection on 07Jul2021. The outcome of the event headache was recovering, of the events Miscarriage and pain was unknown, of the other events was not recovered. Reporter''s comments: BioNTech/Pfizer vaccine (Comirnaty); Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 01Jun2021. Menstrual/intestinal troubles (Additional information ADR: This side effect is constantly present, menstruation failing. Upset intestines causing my stomach to swell and I am often unable to go to the toilet. The pain I experience is also not very mild). Miscarriage (Additional information ADR: We lost our child after I had my second injection on 07Jul2021). COVID19: Previous COVID-19 infection: No Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the agency critera, the reaction was considered as serious by the Centre. The lot number for BNT162b2 was not provided and will be requested during follow up. ; Reporter''s Comments: ~~~


VAERS ID: 1847911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-07-07
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (vaccine exposure during pregnancy week: +/- 3)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101462277

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Regulatory Agency (RA)-WEB:NL-LRB-00701368. This consumer or other non hcp reported information for both mother and fetus/baby. This is a maternal report. A 24-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: Unknown, Expiration date: not reported) via an unspecified route of administration on 20Jun2021as dose 2, single for covid-19 immunization. No Previous COVID-19 infection reported. Medical history included maternal exposure timing unspecified from an unknown date and unknown if ongoing vaccine exposure during pregnancy week: +/- 3. Historical vaccine included first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: Unknown, Expiration date: not reported), via an unspecified route of administration 15May2021 as dose 1, single for COVID-19 immunization experienced No adverse event. The patient''s concomitant medications were not reported. On 07Jul2021, patient experienced miscarriage which was medically significant. The mother reported she became pregnant while taking bnt162b2. The mother was 3 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. It was reported that the miscarriage occurred at a pregnancy duration of about 5,5 weeks. This was the second Covid vaccination, which took place at a pregnancy duration of about 3 weeks, miscarriage started after 17 days. The outcome of events was unknown. Reporter Comment: Since the nature of the reported reaction does imply seriousness according to one of the Agency critera, the reaction was considered as serious by the center The reporter (health authority) considered the event as serious (medically significant). No follow-up attempts are possible, information on batch number cannot be obtained.


VAERS ID: 1520637 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-07-08
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vaginal delivery (1 vaginal delivery in 2018)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100926956

Write-up: Pregnancy loss <20 weeks gestation; Maternal exposure during pregnancy - first trimester; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-LY20217769. This physician reported information for both mother and fetus/baby. This is a maternal report. A 33-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FA5831), first dose via intramuscular on 19May2021, as a single for COVID-19 immunisation. Medical history included delivery from 2018 to an unknown date 1 vaginal delivery in 2018. The patient''s concomitant medications were not reported. It was reported that date of last period was on 27Apr2021. On 08Jul2021, the patient experienced pregnancy loss <20 weeks gestation, maternal exposure during pregnancy - first trimester. On 08Jul2021, pregnancy stopped at 10 weeks amenorrhea + 2 days aspiration and curettage. The mother reported she became pregnant while taking bnt162b2. The mother was 10 Weeks pregnant at the onset of the event. The mother was due to deliver on 01Feb2022. Therapeutic measures were taken as a result of pregnancy loss <20 weeks gestation (abortion spontaneous); Aspiration and curettage. The outcome of the events was reported as not resolved. No follow-up attempts are possible, no further information is expected. Information about batch number has been obtained


VAERS ID: 1548817 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-07-08
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Chlamydia test, Cytomegalovirus test, Hepatitis A virus test, Hepatitis B virus test, Hepatitis C virus test, Herpes simplex, Histology, Pregnancy test, Rubella antibody test, Toxoplasmosis, Treponema test, Ultrasound scan, Varicella virus test
SMQs:, Termination of pregnancy and risk of abortion (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood group A; Chlamydia test positive; Herpes simplex type I; Herpes simplex type II; Rubella; Varicella
Allergies:
Diagnostic Lab Data: Test Name: chlamydia IgA; Test Result: Negative ; Test Name: chlamydia IgG; Test Result: Positive ; Test Name: cytomegalovirus; Test Result: Negative ; Test Name: HAV; Test Result: Negative ; Test Name: HBV; Test Result: Negative ; Test Name: HCV; Test Result: Negative ; Test Name: herpes simplex virus type I; Test Result: Positive ; Test Name: herpes simplex virus type II; Test Result: Positive ; Test Date: 20210518; Test Name: histology; Result Unstructured Data: Test Result:compatible with a non-progressive pregnancy; Comments: macroscopic description: In formalin, 35cc of membrano-villous samples, presence of villi. Partially included, A1, A2 microscopic description: The material consists in part of deciduous necrosis and hemorrhagic disease with some fibrin removal and infiltration by numerous trophoblast cells, reflecting the site of implantation. There are also areas of placental villi. They are of relatively regular contours, a little edematous, rarely dropsy, or fibrosis, without image of cisterns or trophoblastic inclusion. They surround themselves with a trophoblastic population without hyperplasia or atypia. No argument for molar pathology.; Test Date: 20210518; Test Name: pregnancy test; Test Result: Positive ; Comments: 5 6/7 week of pregnancy, usual contact at 12 6/7 - fetus without CA, LCC 10,2 cm; Test Name: rubella; Test Result: Positive ; Test Name: toxoplasmosis test; Test Result: Negative ; Test Name: lues; Test Result: Negative ; Test Date: 20210518; Test Name: Echographic; Result Unstructured Data: Test Result:gestational sac; Comments: gestational sac corresponding to amenorrhoea; Test Name: varicella; Test Result: Positive
CDC Split Type: CHPFIZER INC2021566447

Write-up: Spontaneous miscarriage; This is a spontaneous report from a contactable physician. A 38-year-old pregnant female patient received the first dose of BNT162B2 (COMIRNATY; lot number: ER7449), via intramuscular on 29Apr2021 (at the age of 38-years-old) at dose 1, single in the left arm for COVID-19 immunisation. Medical history included blood group ARh+, chlamydia IgG positive, herpes simplex virus type I, herpes simplex virus type II, rubella, and varicella. The patient has no family medical history relevant to the adverse event. The patient was pregnant at the time of vaccination. No specific relevant test for thromboembolic events with thrombocytopenia. Concomitant medication included folic acid tablet for prevention of spina bifida taken from 23Oct2020 to 05Jul2021. The patient experienced maternal exposure during pregnancy, first trimester on 29Apr2021. The patient had her first Pfizer vaccine on 29Apr2021. Last menstrual period was on 07Apr2021. Today (18May2021), the patient came for the first check-up in pregnancy at 5 + 6/7 week. Echographically, there is a gestational sac corresponding to amenorrhoea on 18May2021. They asked what should be done with the second vaccine, and if it can wait until the second trimester of pregnancy. They asked when it is allowed, or if there are other provisions. The mother was due to deliver on 12Jan2022. Upon follow-up information received on 30Jul2021, it was reported that on 08Jul2021, the patient experienced spontaneous miscarriage and underwent curettage aspiration. The patient had not used recreational drug during pregnancy, has not drank alcohol during pregnancy, and the patient did not use illicid drugs during pregnancy. The patient has no previous pregnancy and had not received treatment for infertility. Histological diagnosis includes uterine cavity, aspiration curettage, product of conception. Paternal information includes: no drugs taken by the father of the child during the mother''s (patient) pregnancy. The father smoked at 10-15 a day during the mother''s pregnancy. The father did not drink alcohol and did not use illicit drugs during the mother''s pregnancy. The patient underwent lab tests which includes: On an unspecified date (reported under relevant history), chlamydia IgA: negative, chlamydia IgG: positive, cytomegalovirus: negative, HAV: negative, HBV: negative, HCV: negative, herpes simplex virus type I: positive, herpes simplex virus type II: positive, rubella: positive, lues: negative, toxoplasmosis test: negative, varicella: positive; On 18May2021, histology: compatible with a non-progressive pregnancy (macroscopic description: In formalin, 35cc of membrano-villous samples, presence of villi. Partially included, A1, A2. Microscopic description: The material consists in part of deciduous necrosis and hemorrhagic disease with some fibrin removal and infiltration by numerous trophoblast cells, reflecting the site of implantation. There are also areas of placental villi. They are of relatively regular contours, a little edematous, rarely dropsy, or fibrosis, without image of cisterns or trophoblastic inclusion. They surround themselves with a trophoblastic population without hyperplasia or atypia. No argument for molar pathology.), pregnancy test: positive (5 6/7 week of pregnancy, usual contact at 12 6/7 - fetus without CA, LCC 10,2 cm), Echographic: gestational sac corresponding to amenorrhoea. Outcome of the event was unknown. Information on the batch/lot number has been requested. Follow-up (30Jul2021): New information received includes: patient details (age, age at vaccination, pregnancy information), lab data, concomitant medication, suspect drug details (route of administration, lot number, anatomical location), reaction data (new event (Miscarriage of pregnancy), deleted event Maternal exposure during pregnancy, first trimester), and clinical course details. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of spontaneous abortion. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1550033 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-08
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:The pregnancy and SPONTANEOUS ABORTION was confirm; Comments: The pregnancy and SPONTANEOUS ABORTION was confirmed by blood tests by the general physician.
CDC Split Type: NOPFIZER INC202100967138

Write-up: spontaneous abortion when she was about 7 weeks pregnant; This is a spontaneous report from a contactable consumer downloaded from the WEB NO-NOMAADVRE-PASRAPP-2021-Uq4zw5, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00037719. A 31-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left arm on 02Jul2021 12:00 (Batch/Lot Number: Unknown) as single for COVID-19 immunisation. Medical history included abstains from alcohol from an unknown date and unknown if ongoing, non-smoker from an unknown date and unknown if ongoing. No allergies, no special diet. The patient''s concomitant medications were not reported. On 05Jul2021, the patient developed spontaneous abortion when she was about 7 weeks pregnant. She has no other known risk factors as alcohol, caffein, stress, etc. The reactions/case was considered to be spontaneous abortion: serious due to other serious (important medical events). Spontaneous abortion stop date was reported as 08Jul2021 (delivery date/termination date). The pregnancy and spontaneous abortion was confirmed by blood tests on an unspecified date by the general physician. No follow up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Contact with healthcare professionals: Physician. The patient has no allergies, no special diets. The spontaneous abortion happened when she was about 7 weeks pregnant. She has no other known risk factors as alcohol, caffeine, stress, etc. The pregnancy and spontaneous abortion was confirmed by blood tests by the general physician.


VAERS ID: 1623233 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-07-08
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101016540

Write-up: Spontaneous abortion; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number CZ-CZSUKL-21008944. A 43-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on 27May2021 (Lot Number: FA4598) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient''s last menstrual period was on 20May2021. The patient experienced spontaneous abortion on 08Jul2021 but was also reported as reactions began on day 43. The health authority assessed the event as serious due to hospitalization. The outcome of the event was recovered on unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1665178 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Activated partial thromboplastin time, Body temperature, C-reactive protein increased, Diarrhoea, Foetal death, Pyrexia, White blood cell count
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: APTT; Result Unstructured Data: 37.7; Test Date: 20210708; Test Name: Body temperature; Result Unstructured Data: fever; Test Date: 20210708; Test Name: crp; Result Unstructured Data: 0.278; Test Date: 20210708; Test Name: wbc; Result Unstructured Data: 26800; Test Date: 20210709; Test Name: wbc; Result Unstructured Data: 33800
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: fetus death; Abdominal Pain; diarrhea; pyrexia; This regulatory authority retrospective pregnancy case was reported by a pharmacist and describes the occurrence of FOETAL DEATH (fetus death), ABDOMINAL PAIN (Abdominal Pain), DIARRHOEA (diarrhea) and PYREXIA (pyrexia) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jul-2021, the patient experienced FOETAL DEATH (fetus death) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal Pain) (seriousness criterion medically significant), DIARRHOEA (diarrhea) (seriousness criterion medically significant) and PYREXIA (pyrexia) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Stillbirth NOS. fetal heart stopped beating after a slow heartbeat, so the patient was given an induction of labor. At the time of the report, FOETAL DEATH (fetus death), ABDOMINAL PAIN (Abdominal Pain), DIARRHOEA (diarrhea) and PYREXIA (pyrexia) outcome was unknown. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Body temperature: 38.8 (High) fever. On 08-Jul-2021, C-reactive protein increased (Unknown-<0.5): 0.278. On 08-Jul-2021, White blood cell count: 26800 (abnormal) 26800. On 09-Jul-2021, Activated partial thromboplastin time (24-35): 37.7 (abnormal) 37.7. On 09-Jul-2021, White blood cell count: 33800 (abnormal) 33800. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had medical history of test tube baby. No history of allergies No concomitant and treatment information was provided. The patient first went to a nearby clinic for medical treatment at 3:00 p.m., and had no fever at that time and the fetus in her womb was found to still have a heartbeat. At about 5:00 p.m., the patient suffered from an aggravated abdominal pain with a fever (38.8?C), and went to our hospital for treatment, where the fetal heart stopped beating after a slow heartbeat, so the patient was given an induction of labor. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1679627 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-08
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Abortion spontaneous, Blood test, Gynaecological examination, Human chorionic gonadotropin, Ultrasound scan
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parity 1 (patient is in good health and good shape)
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: Blood test; Result Unstructured Data: Test Result:confirms Consummated abortion; Test Date: 20210712; Test Name: Gynaecological examination; Result Unstructured Data: Test Result:confirms Consummated abortion; Test Date: 20210706; Test Name: Human chorionic gonadotropin; Result Unstructured Data: Test Result:Low value; Test Date: 20210708; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:confirms missed abortion
CDC Split Type: DKPFIZER INC202101095385

Write-up: As a consequence of missed abortion the patient experienced the following consequence spontaneous abortion on 11Jul2021.; Missed abortion in week 9; This is a spontaneous report from a contactable other healthcare professional (midwife- patient) downloaded from the regulatory authority-WEB. This is a report received from the regulatory authority. Regulatory authority report number DK-DKMA-WBS-0082707 with Safety Report Unique Identifier DK-DKMA-ADR 25755091. A 31-years-old female patient received first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 25Jun2021 (Batch/Lot Number: EW6126; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. The patient''s medical history included has a healthy daughter and concomitant medications. The patient has no concomitant medications. On 08Jul2021, 13 days after the first vaccination, the patient developed missed abortion. As a consequence of missed abortion, the patient experienced the following consequence spontaneous abortion on 11Jul2021. The mother reported she became pregnant while taking bnt162b2. The events were reported as serious (medically significant). The mother was 9 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. No treatment due to the ADRs was reported and/or (Medical procedure) was performed. The fetal outcome is intrauterine death. There is not reported any other health issues. The patient is in good health and good shape. No previous history of spontaneous or provoked abortions. Has a healthy daughter from 2020, uncomplicated pregnancy and childbirth. The patient underwent lab tests and procedures which included blood test that confirms consummated abortion on 12Jul2021, gynaecological examination that confirms consummated abortion on 12Jul2021, human chorionic gonadotropin with low value on 06Jul2021 and ultrasound scan that confirms missed abortion on 08Jul2021. The patient recovered from the events on 11Jul2021. No follow up attempts possible. No further information is expected.


VAERS ID: 1769851 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-08
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Delivery; Miscarriage of pregnancy
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:pregnancy hormones had decreased and fetus died; Test Date: 20210708; Test Name: Prenatal screening test; Result Unstructured Data: Test Result:the gynecologist couldn''t see clearly
CDC Split Type: ISPFIZER INC202101278885

Write-up: Absence of menstruation; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number IS-IMA-4840. The consumer reported information for both mother and fetus, this is mother''s report. A 33-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 30Jun2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. Medical history included Miscarriage of pregnancy in 2012. The patient was healthy and has a child born on 2015. There were no concomitant medications. The patient previously received bnt162b2, dose 1 on 02Jun2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. The patient experienced miscarriage of pregnancy on 08Jul2021 and absence of menstruation on an unspecified date. Clinical course details: patient discovered she was pregnant on 14Jun2021 and had an appointment in prenatal screening on 08Jul2021, then 8 weeks pregnant. In the screening the gynecologist couldn''t see clearly so she was sent for a blood test. The results from the blood test showed her pregnancy hormones had decreased and that the fetus had died. She waited for 2 weeks for the uterus to evacuate naturally which did not happen. Therefore, she got medicine to help with passing the pregnancy tissue. Since then she hasn''t menstruated. Therapeutic measures were taken as the result of the event miscarriage of pregnancy. The outcome of the event miscarriage of pregnancy was recovered with sequelae, of absence of menstruation was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : IS-PFIZER INC-202101316293 mother/ baby cases


VAERS ID: 1796043 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1433 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, Maternal exposure during pregnancy, Pregnancy test, Ultrasound antenatal screen
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Pregnancy test; Test Result: Negative ; Comments: Negative before vaccination; Test Date: 202107; Test Name: Pregnancy test; Test Result: Positive ; Comments: Positive a few days after vaccination; Test Date: 20210915; Test Name: Fetal nuchal translucency ultrasound; Result Unstructured Data: Test Result:Missed abortion. Fetus approx. 7 weeks old
CDC Split Type: DKPFIZER INC202101312885

Write-up: Abortion missed; Postive pregnancy test a few days after vaccination. approx. week 7 end of july. Last menstruation 08jun2021.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number DK-DKMA-WBS-0089014. This physician reported information for both mother and fetus/baby. This is a maternal report. A 29-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 08Jul2021 (Batch/Lot Number: FC1433, Expiration date: 31Oct2021) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient was described as otherwise healthy and well. The patient''s concomitant medications were not reported. On 08Jul2021, the patient experienced maternal exposure during pregnancy, positive pregnancy test a few days after vaccination, approximately week 7 end of July. Patient''s last menstruation 08Jun2021. Gestation period at time of exposure (number) : 0 weeks. The mother reported she became pregnant while taking bnt162b2. The mother was 7 Weeks pregnant at the onset of the event. The mother was due to deliver on 15Mar2022. On 15Sep2021, 69 days after the first injection, the missed abortion was discovered. The Adverse Drug Reaction were by the physician reported as resulting in congenital abnormality. The patient underwent lab tests and procedures which included: pregnancy test in Jul2021 showed negative, before vaccination; pregnancy test in Jul2021 showed positive a few days after vaccination, fetal nuchal translucency ultrasound on 15sep2021 showed missed abortion. Fetus approximately 7 weeks old. No treatment or medical procedures due to the ADR was reported. The clinical outcome of reported event missed abortion was not recovered.; Sender''s Comments: Linked Report(s) : DK-PFIZER INC-202101358450 foetus case


VAERS ID: 1478012 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-10
Onset:2021-07-09
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Positive UPT on 23 June 2021
CDC Split Type:

Write-up: G3P2002 now G3P2012 - Pregnancy, confirmed by UPT at 4 weeks gestation. Spontaneous miscarriage at 6 weeks 5 days. Of note, first covid vaccine was with Pfizer in late April


VAERS ID: 1532604 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-07-09
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abortion; Cesarean section (cesarean section for expired); Miscarriage; Vaginal delivery
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: first trimester follow-up ultrasound; Result Unstructured Data: Test Result:nothing to report; Comments: First trimester ultrasound performed at 16 weeks of amenorrhea; Test Date: 20210607; Test Name: ultrasound; Result Unstructured Data: Test Result:perceived heart sounds; Test Date: 20210709; Test Name: ultrasound; Result Unstructured Data: Test Result:lack of heart sounds; Comments: at 21 weeks + 2 days of amenorrhea
CDC Split Type: FRPFIZER INC202100948931

Write-up: Foetal death in utero; This is a spontaneous report from a contactable other health professional downloaded from the regulatory authority-WEB. The regulatory authority number is FR-AFSSAPS-TS20213117. A 32-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), intramuscular, on 04Jun2021 (Batch/Lot Number unknown), as dose 1, single, for COVID-19 immunisation. The patient was pregnant at the time of vaccination. Medical history included abortion in 2008, vaginal delivery in 2013, miscarriage in 2014, caesarean section in 2015 ("cesarean section for expired" as reported). The patient''s concomitant medications were not reported. On 09Jul2021, 1 month and 5 days after the vaccination (also reported as "Time Interval between Beginning of Drug Administration and Start of Reaction/Event: 36 Days"), the patient experienced foetal death in utero. On 04Jun2021, first trimester follow-up ultrasound was performed at 16 weeks of amenorrhea with nothing to report. On the same day, 04Jun2021, the patient received the first vaccination of COMIRNATY. On 07Jun2021, the patient had ultrasound examination with perceived heart sounds. On 09Jul2021, at 21 weeks + 2 days of amenorrhea, the female patient consulted for lack of recording of heart sounds by the liberal midwife. Diagnosis of fetal death in utero with termination of pregnancy presumed at 16 weeks of amenorrhea was made (no additional information on this subject). In total, fetal death in utero was observed at 21 weeks of amenorrhea with termination of pregnancy which would be suspected at 16 weeks of amenorrhea, term at which the first dose of COMIRNATY was performed in a female patient with a history of miscarriage. The date of LMP was 19Feb2021. The mother was 20 weeks pregnant at the onset of the event. The mother was due to deliver on 26Nov2021. The mother underwent elective termination. The fetal outcome is intrauterine death. The event resulted to hospitalization. The outcome of the event was recovered/resolved with sequel. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1579175 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-07-09
   Days after vaccination:66
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: ultrasound uterus; Result Unstructured Data: Test Result:fetus with a normal heart rate, normal pregnancy; Comments: size corresponding to pregnancy week 6+3.; Test Date: 20210708; Test Name: ultrasound uterus; Result Unstructured Data: Test Result:the fetus size was found to correspond to less we; Comments: the fetus size was found to correspond to less weeks than it should, since it was supposed to be 11 + 2, and there was no more heart rate. Miscarriage.
CDC Split Type: FIPFIZER INC202100990126

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Agency-WEB FI-FIMEA-20213693. A 27-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 04May2021 (Batch/Lot Number: UNKNOWN) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced miscarriage (abortion spontaneous) (hosp) on 09Jul2021 with outcome of unknown. The mother reported she received her first covid vaccine on 04May2021. On 05Jun2021 in the ultrasound of the uterus a fetus with a normal heart rate, normal pregnancy, size corresponding to pregnancy week 6 + 3. In the ultrasound on 08Jul2021, the fetus size was found to correspond to less weeks (8 + 5) than it should, since it was supposed to be 11 + 2, and there was no more heart rate. Miscarriage. The leak began spontaneously on 09Jul2021. The patient had to the hospital for vacuum aspiration because of a heavy leak. The patient had no underlying illnesses or allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1624759 (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: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Body mass index
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: Asthma; Ex-smoker; Foetal death (autopsy not performed)
Allergies:
Diagnostic Lab Data: Test Name: body mass index; Result Unstructured Data: Test Result:26.18
CDC Split Type: FRPFIZER INC202101016576

Write-up: Late miscarriage; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-CN20212564. A 34-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 06Jul2021 (Batch/Lot Number: Unknown) as single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, fetal death in utero at 40 weeks of amenorrhea on 30Jun2020 (autopsy not performed) and ex-tobacco user from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced late miscarriage on 09Jul2021 with outcome of not recovered. The event was also reported as occurrence on Day + 3 of vaccination of a spontaneous miscarriage at 19 weeks of amenorrhea. Discovery on 30Jul2021 of a fetal death estimated 3 weeks earlier. The patient was 22 weeks amenorrhea on 02Aug2021. The patient has no hormonal or morphological abnormality. No diabetes, high blood pressure, thyroid disorders during pregnancy. No drug intake during pregnancy. Tobacco stopped at 8 weeks of amenorrhea, no alcohol, no drugs. No obesity (body mass index at 26.18). No performance of an amniocentesis. No infectious cause found. Post-vaccine adverse reactions: unknown. An autopsy is in progress. No follow-up attempts possible. No further information expected.


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