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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: 1642170 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-19
   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 FF0688 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Early onset of delivery (3 children. second (2nd) born very prematurely); Parity 3 (3 children. second (2nd) born very prematurely)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101055763

Write-up: 3 hours after Dose 1: delivery at 36 weeks; Early onset of delivery; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-TO20216615. This physician reported information for both mother and baby. This is the maternal report. A 31-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), administered via intramuscular route in right arm on 19Jul2021, at 31 years of age, (Batch/Lot Number: FF0688) as single dose for COVID-19 immunization. Medical history included 3 previous pregnancies and premature delivery on an unknown date of her second baby. The patient''s concomitant medications were not reported. It was reported that on 19Jul2021, 3 hours after the first vaccine dose, the mother experienced early onset of delivery at 36 weeks. The mother was 36 weeks pregnant of 1 baby at the onset of the event. The patient gave birth to a premature baby on 19Jul2021. The fetal outcome was perinatal complication: the baby was currently in intensive care for respiratory distress. At the time of the report the event had not resolved yet. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101091804 Baby case


VAERS ID: 1658456 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0586 / 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UTROGESTAN; IODARA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thrombophilia
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101063899

Write-up: lost her baby; This is a spontaneous report from a contactable consumer (patient). A pregnant 33-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration in left arm on 09Jul2021 (Lot Number: EY0586, unknown expiration; at the age of 33 years old) as dose 1, single for COVID-19 immunisation. Medical history included thrombophilia. Concomitant medications included progesterone (UTROGESTAN); potassium iodide (IODARA); and "Foli". The patient previously took dipyrone and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported that she received the vaccine on 09Jul2021 and lost her baby on 19Jul2021, the following week. The mother was 6 weeks pregnant at the onset of the event. The mother was due to deliver on 03Mar2022. Last menstrual date: 27May2021. The patent has no idea if it could have been due to the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit and hospitalization for 1 day. Curettage was done. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient is recovering from the event. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : BR-PFIZER INC-202101069025 baby case


VAERS ID: 1739838 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 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: SEPFIZER INC202101195689

Write-up: Miscarriage; MATERNAL EXPOSURE DURING PREGNANCY; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-082414. A 26-year-old female patient (pregnant; Gestation Period: 11 weeks) received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 19Jul2021 (Lot Number: FF0680) at the age of 26-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. About week 5 of pregnancy, the woman was vaccinated with dose 1. The woman did not know she was pregnant at the time of vaccination. On 05Sep2021, about 6 weeks after dose 1 vaccination miscarriage occurred, when the woman was at week 11 of prenancy. The outcome of events was recovering.


VAERS ID: 1816843 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-07-19
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Stillbirth, Ultrasound Doppler, 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: Medical History/Concurrent Conditions: Breast implant user; Miscarriage (treated with laser); Myopia (treated with laser)
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: Ultrasound Doppler; Result Unstructured Data: Test Result:particular seriousness of the clinical picture; Comments: new ultrasound doppler: weight 605 g (5?p), medullary cone was rather low seated (L3L4). No movement in the upper limbs with elbows and fingers in permanent flexion, and wrists in extension. Lower limbs with very reduced motility in permanent extension with an aspect of "ice axe" feet. No abnormal shape of the long bones. Amniotic fluid in normal quantity. Doppler normal. The rest of the morphology is unremarkable. Conclusion: particular seriousness of the clinical picture.; Test Date: 20210624; Test Name: 3D ultrasound; Result Unstructured Data: Test Result:lower limbs immobile; Comments: a 3D ultrasound was performed in a context of foetal hypokinesia: weight 554 g (33?p), immobile lower limbs, blocked in hip flexion, knee and foot in extension. Hands were also slighty mobile on each side of the cephalic pole with wrist in exntension and tensed fingers. The rest of the morphology is unremarkable; Test Date: 20210707; Test Name: amniotic fluid exploration; Result Unstructured Data: Test Result:105 mL of clear fluid. Good technical conditions; Comments: collection of amniotic fluid by non-placental transabdominal route: 105 mL of clear fluid. Good technical conditions. Cytogenetic research for ACPA (anti-cyclic citrullinated peptide autoantibodies), DNA conservation, SMN (Spinal muscular atrophy genes), DMPK (Myotonic Dystrophy Type 1) and 15q11q12 research (awaited).
CDC Split Type: LUPFIZER INC202101351047

Write-up: termination of pregnancy with premature delivery of a stillborn female child; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number LU-ALMPS-202103081. This consumer reported information for both mother and fetus. This is the maternal report. A 36-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot Number: FA5833), intramuscular on 08Jun2021 (36-year-old at time of vaccination) as single dose, the second dose of bnt162b2 (COMIRNATY, Lot Number: FC1433), intramuscular on 06Jul2021 as single dose for COVID-19 immunisation. Medical history included myopia (treated with laser), breast implant user, miscarriage in 2014 (treated with laser). The patient''s concomitant medications were not reported. The patient experienced maternal exposure during pregnancy, second trimester on 08Jun2021; experienced Termination of pregnancy - medical (hospitalization) on 19Jul2021 with outcome of recovered with sequel (as reported). Case narrative: Termination of pregnancy for fetal malformation. Obstetrical history: gravidity 2 Parity 0 with miscarriage in 2014. In 2021, new pregnancy started on 20Jan2021 with due date 20Oct2021. On 24Jun2021 (23+1 amenorrhea week), a 3D ultrasound was performed in a context of foetal hypokinesia: weight 554 g (33?p), immobile lower limbs, blocked in hip flexion, knee and foot in extension. Hands were also slighty mobile on each side of the cephalic pole with wrist in exntension and tensed fingers. The rest of the morphology is unremarkable. On 01Jul2021 (25+1 amenorrhea week), new ultrasound doppler: weight 605 g (5?p), medullary cone was rather low seated (L3L4). No movement in the upper limbs with elbows and fingers in permanent flexion, and wrists in extension. Lower limbs with very reduced motility in permanent extension with an aspect of "ice axe" feet. No abnormal shape of the long bones. Amniotic fluid in normal quantity. Doppler normal. The rest of the morphology is unremarkable. Conclusion: particular seriousness of the clinical picture. Indication for amniotic fluid exploration. On 07Jul2021 (26 amenorrhea week), collection of amniotic fluid by non-placental transabdominal route: 105 mL of clear fluid. Good technical conditions. Cytogenetic research for ACPA (anti-cyclic citrullinated peptide autoantibodies), DNA conservation, SMN (Spinal muscular atrophy genes), DMPK (Myotonic Dystrophy Type 1) and 15q11q12 research (awaited). On 19Jul2021, termination of pregnancy with premature delivery of a stillborn female child. An autopsy was performed. Assessment: "Comirnaty/Termination of pregnancy - medical/NCA: C1 S1 (I1 dubious) B1". No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : LU-PFIZER INC-202101351051 mother/foetus case: LU-ALMPS-202103054


VAERS ID: 1871920 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101516380

Write-up: MISCARRIAGE in week 7; menstrual disorder (menstruation and ovulation came earlier than expected); This is a spontaneous report from a contactable consumer or other non HCP. This is the second of two cases for the same patient and it refers to the first dose of Comirnaty. The first case is received from the Regulatory Authority, regulatory authority number SE-MPA-2021-083606. A 35-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot# FE6208) via an unspecified route of administration as a single dose on 12Jul2021 for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced menstrual disorder (menstruation and ovulation came earlier than expected) on 19Jul2021 with outcome of unknown, miscarriage in week 7 on 04Sep2021 with outcome of resolved on an unspecified date. During the last eight months before vaccination, the patient had had regular menstruation and ovulation. After the first dose of BNT162B2, menstruation and ovulation came just over a week prematurely. The woman still became pregnant about a week after the first dose of BNT162B2. The pregnancy ended with miscarriage in week 7. A few days after the miscarriage, the second dose of Comirnaty was given, and shortly thereafter, the woman developed mole pain in the lower abdomen. The pain lasted just over two weeks. The miscarriage had ended and there were no remnants left. The reporter stated that everything looked good gynecologically. The course of menstrual disorders was unknown. The case was considered a serious, important medical event. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-202101494978 Same reporter/patient/product, other dose/event(s)


VAERS ID: 1532033 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-05-01
Onset:2021-07-20
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 043B21A / 2 AR / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002B21A / 1 AR / SYR

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

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

Write-up: Misscarriage at approximately 8 weeks


VAERS ID: 1574015 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-03-23
Onset:2021-07-20
   Days after vaccination:119
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2613 / 1 RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Foetal hypokinesia, SARS-CoV-2 test negative, Stillbirth, Ultrasound foetal abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), 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? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatals
Current Illness:
Preexisting Conditions:
Allergies: Amoxicclyn
Diagnostic Lab Data: Covid Test Negative at the time of the event.
CDC Split Type:

Write-up: I was 27 weeks pregnant on July 20th 2021. I noticed the baby wasn''t moving inside. I went to my doctors office to see Dr. and that when he determined that there was not heart beat we did a ultra sound to confirm.MY DAUGHTER DIDNT MAKE IT. I had to then go to Hospital to deliver my baby. The process started on July 20th 2021 and I delivered my STILLBORN daughter on Thursday July 22nd. MY due Date was OCTOBER 17TH. the baby weighed 2 pounds and was 15 inches long.


VAERS ID: 1629424 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-20
   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 UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101026101

Write-up: Miscarriage; abdominal pain; bleeding; Maternal Exposure During Pregnancy, first trimester; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB FR-AFSSAPS-BX20217117. A 28-year-old female patient received 2nd dose of BNT162B2 (COMIRNATY) at single dose intramuscular on 20Jul2021 13:45 at 28-year-old for COVID-19 immunisation. Patient had no history of Covid (no test performed). No information on the date of the 1st dose. Patient was in 1st trimester of pregnancy (without further details, no information on date of start of pregnancy). Undesirable effect reported as miscarriage was 20Jul2021. The clinical course was reported as follows: Injection of the 2nd dose of Comirnaty at 1.45 p.m., then 2 hours later, onset of abdominal pain. 1 hour later, onset of bleeding. The next morning, spontaneous miscarriage occurred. Patient went to the emergency room. Outcome of miscarriage was resolved. Outcome of the other events was unknown.


VAERS ID: 1672168 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-07-20
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage in pregnancy, Incorrect route of product administration, Maternal exposure during pregnancy, Premature delivery, Uterine contractions during pregnancy
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Drug abuse and dependence (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Medication errors (narrow)

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

Write-up: Excessive Bleeding; Irregular contraction; The patient gave birth to a baby at on the afternoon of 21/07/2021; exposer During pregnency; Vaccine administered subcutaneously; This regulatory authority retrospective pregnancy case was reported by an other health care professional and describes the occurrence of HAEMORRHAGE IN PREGNANCY (Excessive Bleeding), UTERINE CONTRACTIONS DURING PREGNANCY (Irregular contraction) and PREMATURE DELIVERY (The patient gave birth to a baby at on the afternoon of 21/07/2021) in a 34-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. Co-suspect product included non-company product DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for an unknown indication. No Medical History information was reported. On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient received dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) (unknown route) at an unspecified dose. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to .5 milliliter. The patient''s last menstrual period was on an unknown date and the estimated date of delivery was 25-Aug-2021. On 20-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (exposer During pregnency) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subcutaneously). On 21-Jul-2021, the patient experienced HAEMORRHAGE IN PREGNANCY (Excessive Bleeding) (seriousness criteria hospitalization and medically significant), UTERINE CONTRACTIONS DURING PREGNANCY (Irregular contraction) (seriousness criteria hospitalization and medically significant) and PREMATURE DELIVERY (The patient gave birth to a baby at on the afternoon of 21/07/2021) (seriousness criteria hospitalization and medically significant). The delivery occurred on 21-Jul-2021, which was reported as Premature. For neonate 1, The outcome was reported as Delivered NOS. On 20-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (exposer During pregnency) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subcutaneously) had resolved. On 21-Jul-2021, HAEMORRHAGE IN PREGNANCY (Excessive Bleeding), UTERINE CONTRACTIONS DURING PREGNANCY (Irregular contraction) and PREMATURE DELIVERY (The patient gave birth to a baby at on the afternoon of 21/07/2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This is a case of maternal exposure during pregnancy and incorrect route of administration with associated uterine contractions during pregnancy, haemorrhage in pregnancy and premature delivery for this 34-year old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.; Sender''s Comments: This is a case of maternal exposure during pregnancy and incorrect route of administration with associated uterine contractions during pregnancy, haemorrhage in pregnancy and premature delivery for this 34-year old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.


VAERS ID: 1716662 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-20
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Abortion spontaneous, Haemorrhage in pregnancy, Human chorionic gonadotropin, Ultrasound scan
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; BION 3 [ASCORBIC ACID;BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LONGUM;BIOTIN;CALCIUM;CALCIUM PANTOTHE; MAGNESIUM + B6
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cervical conization; Ectopic pregnancy; Sleeve gastrectomy
Allergies:
Diagnostic Lab Data: Test Name: Beta HCG; Result Unstructured Data: Test Result:Not doubling every 48 hours iU; Test Date: 20210813; Test Name: Beta HCG; Test Result: 13670 [iU]; Comments: Still rising; Test Name: Ultrasound; Result Unstructured Data: Test Result:Miscarriage; Test Date: 20210722; Test Name: Ultrasound; Result Unstructured Data: Test Result:Gestational sac and a 7.4mm embryo visualised; Test Date: 20210730; Test Name: Ultrasound; Result Unstructured Data: Test Result:Nothing visible; Test Date: 20210806; Test Name: Ultrasound; Result Unstructured Data: Test Result:2mm spot appears; Test Date: 20210814; Test Name: Ultrasound; Result Unstructured Data: Test Result:Nothing visible
CDC Split Type: FRPFIZER INC202101155432

Write-up: Blood loss; Early miscarriage; Severe pain in the lower abdomen; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. This is a report received from Regulatory authority report number FR-AFSSAPS-NC20213867 with Safety Report Unique Identifier FR-AFSSAPS-NC20213867. A 37-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 03Jul2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included mini conization on Dec2009 and Dec2019, sleeve (gastrectomy) on Jan2018 and ectopic pregnancy on 01Jan2021. Concomitant medications included folic acid; ascorbic acid, bifidobacterium bifidum, bifidobacterium longum, biotin, calcium, calcium pantothenate, chromic chloride, colecalciferol, folic acid, iron, lactobacillus gasseri, magnesium, manganese, molybdenum, nicotinamide, phosphorus, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (BION 3) and magnesium oxide, pyridoxine hydrochloride (MAGNESIUM + B6) all taken for an unspecified indication, start and stop date were not reported. The patient previously received dose 1 of Comirnaty on unspecified date or Covid-19 immunization. On 20Jul2021, the patient experienced severe pain the lower abdomen, early miscarriage on 30Jul2021 and blood loss on 04Aug2021. The patient reported she became pregnant while taking bnt162b2. She was 2 weeks pregnant at the onset of the event and was due to deliver on 23Mar2022. The patient reported non-evolving pregnancy, early miscarriage at 7 weeks of amenorrhoea. Potential nidation on the day of the 2nd dose injection, 03Jul2021. Severe pain in the lower abdomen with onset 20Jul2021, lasting 44 hours. Gestational sac and a 7.4mm embryo visualised on 22Jul2021. The patient underwent lab tests and procedures which included: Beta HCG: not doubling every 48 hours on an unspecified date and 13670 IU (still rising) on 13Aug2021; Ultrasound scan: miscarriage on an unspecified date, gestational sac and a 7.4mm embryo visualised on 22Jul2021, nothing visible on 30Jul2021, 2mm spot appears on 06Aug2021 and nothing visible on 14Aug2021. It was reported that blood loss is moderately abundant on 04Aug2021 and loss of tissue in the blood with pain in the lower abdomen on 08Aug2021. Miscarriage confirmed by an ultrasound. Bleeding stopped on 10Aug2021. Curettage scheduled for 15Aug2021 at 7 h. The medical team had great difficulty determining the outcome of the pregnancy, and visibility on ultrasound was very complicated. Conclusion: early miscarriage at 7 weeks of amenorrhoea with uterine retention requiring a curettage. Vaccination at 2 weeks of amenorrhoea + 3 days. The events required emergency room visit without hospitalisation. The outcome of the events was recovered with sequelae. The lot number for bnt162b2, was not provided and will be requested during follow up.


VAERS ID: 1780596 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal growth restriction, Maternal exposure during pregnancy, SARS-CoV-2 test, 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), 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: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test; Test Name: Scan; Result Unstructured Data: Confirmed miscarriage; Test Date: 20210818; Test Name: Scan; Result Unstructured Data: Baby had stopped growing.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Vaginal bleeding; Foetal growth arrest; Miscarriage; Maternal exposure during pregnancy; This case was received via RA (Reference number: GB-MHRA-ADR 26030163) on 04-Oct-2021 and was forwarded to Moderna on 04-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage), VAGINAL HAEMORRHAGE (Vaginal bleeding) and FOETAL GROWTH RESTRICTION (Foetal growth arrest) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Pregnancy (Patient no longer pregnant at the time of reporting.). Concomitant products included FOLIC ACID for Folic acid supplementation. On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 07-Aug-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) (seriousness criterion medically significant). an unknown date, the patient experienced FOETAL GROWTH RESTRICTION (Foetal growth arrest) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 20-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and VAGINAL HAEMORRHAGE (Vaginal bleeding) outcome was unknown and FOETAL GROWTH RESTRICTION (Foetal growth arrest) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, Scan: baby had stopped growing (abnormal) Baby had stopped growing.. On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. On an unknown date, Scan: confirmed miscarriage (abnormal) Confirmed miscarriage. Patient was about 6 and a half weeks when getting the vaccine and about 8 and a half weeks baby stopped growing after patient had been bleeding. Patient had a scan on the 18-Aug-2021 saying baby was measuring 8 and half weeks and patient should have been about 10 nearly 11 a few days after this scan patient lost my baby at home confirmed by a follow up scan Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans include Baby stopped growing around 8 and a half weeks. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received contains laboratory data, additional events was added and action taken was updated.; Sender''s Comments: This maternal exposure during pregnancy case concerns a 28-year-old female patient with no reported relevant medical history, who experienced the unexpected serious events of Vaginal haemorrhage, Foetal growth restriction and Abortion spontaneous. The events occurred approximately 18 days after the first dose of Moderna CoviD-19 Vaccine administration. The rechallenge was unknown since information on the second dose was not provided. The benefit-risk relationship is not affected by this report.


VAERS ID: 1858921 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-20
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: Ultrasound; Result Unstructured Data: Test Result:nonviable; Comments: that her pregnancy was nonviable on 20Jul2021 Patient was approximately 12 weeks along but ultrasound showed she was 9 weeks gestation.
CDC Split Type: CAPFIZER INC202101505561

Write-up: her pregnancy was nonviable on 20Jul2021; This is a Spontaneous case received from a Contactable Nurse. A 41-years-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on 30Jun2021 as dose 1, single for COVID-19 immunization. Patient was pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced her pregnancy was nonviable on 20Jul2021. The patient underwent lab tests and procedures which included ultrasound abdomen that her pregnancy was nonviable on 20Jul2021. Patient was approximately 12 weeks along, but ultrasound showed she was 9 weeks gestation. Nurse was calling to see if there are any studies or tracking that the company is doing to follow up with patients if they''ve had a miscarriage after receiving the vaccine. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the reported information ,a causal relationship between the event Spontaneous abortion and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1863033 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-11-12
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 INC202101462068

Write-up: Miscarriage at 5.5 weeks; This is a spontaneous report from a contactable consumer (patient) downloaded from the Agency Regulatory Authority-WEB with regulatory authority report number NL-LRB-00702337 and safety report unique identifier NL-LRB-00703809. This is a maternal report. A 38-year-old female patient received the first dose of BNT162b2 (COMIRNATY, solution for injection, lot number/expiry date unknown), via an unspecified route of administration on 10Jul2021 as dose 1, 0.3 mL single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has no previous covid-19 infection. The patient experienced miscarriage at 5.5 weeks (medically significant) on 20Jul2021 with outcome of unknown. It was also reported that the patient had a maternal exposure during pregnancy following administration of covid-19 vaccine. The miscarriage occurred at a pregnancy duration of about 5.5 weeks. This was the first covid vaccination, which took place at a pregnancy duration of about 4 weeks (as reported) - further reported that the patient "got pregnant just after vaccination" and it turned out to be a miscarriage. The patient can''t say if this was due to the vaccination. Sender''s Comment: Since the nature of the reported reaction does imply seriousness according to one of the Regulatory Authority criteria, the reaction (miscarriage) was considered as serious by the Agency. Reporter''s Comment: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Miscarriage. Additional information ADR: Got pregnant just after vaccination. It turned out to be a miscarriage. Can''t say if this is due to the vaccination. I did get pregnant permanently after the 2nd vaccination. COVID19. Previous COVID-19 infection: No. Follow-up 25Oct2021 Follow-up received: Hello, here are my answers: 5 and a half weeks pregnant. Yes about 10 days. No follow-up attempts are possible; information on the batch/lot number cannot be obtained. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Miscarriage. Additional information ADR: Got pregnant just after vaccination. It turned out to be a miscarriage. Can''t say if this is due to the vaccination. I did get pregnant permanently after the 2nd vaccination. COVID19. Previous COVID-19 infection: No. Follow-up 25Oct2021 Follow-up received: Hello, here are my answers: 5 and a half weeks pregnant. Yes about 10 days.


VAERS ID: 1518114 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-19
Onset:2021-07-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 1 RA / -

Administered by: Other       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? 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 [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201111; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC202100941229

Write-up: I miscarried my healthy pregnancy two days after vaccination. I want to report this event for data collection and reporting purposes for future studies. I do not know if the vaccine caused the miscarr; I miscarried my healthy pregnancy two days after vaccination.; This is a spontaneous report from a contactable consumer(patient) reported for herself that: A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 19Jul2021 18:15 (Batch/Lot Number: EW0181) as DOSE 1, SINGLE for covid-19 immunization. The patient past Medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Nov2020. On 21Jul2021 at 11:45 PM, she miscarried her healthy pregnancy two days after vaccination. she wants to report this event for data collection and reporting purposes for future studies. she does not know if the vaccine caused the miscarriage. The events result in doctor or other healthcare professional office/clinic visit. No treatment was reported. Since the vaccination, the patient had been tested for COVID-19. The event outcome was resolving.


VAERS ID: 1534965 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-10
Onset:2021-07-21
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Computerised tomogram head, Exposure during pregnancy, Fall, Retained placenta operation
SMQs:, Accidents and injuries (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: Prilosec Krill Oil Zyrtec Prenatal vitamins
Current Illness: Acid reflux, IBS, Fatty Liver -non alcoholic
Preexisting Conditions: NA
Allergies: Penicillin
Diagnostic Lab Data: I was transported via ambulance to hospital. I was put under anesthesia to have the rest of the placenta taken out of me as there were still some parts left inside. I also had a CT scan done of my head as I had two falls during the miscarriage.
CDC Split Type:

Write-up: Miscarriage at 18 weeks.


VAERS ID: 1529452 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-07-21
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Amniotic fluid volume increased, Blood pressure measurement, Coagulopathy, Depressed mood, Foetal death, Hypertension, Karyotype analysis, Ultrasound scan
SMQs:, Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Depression (excl suicide and self injury) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210721; Test Name: karyotype exam; Result Unstructured Data: Test Result:unknown; Test Name: ultrasound; Result Unstructured Data: Test Result:her baby had hydrops fetalis/Anasarca; Test Name: blood pressure; Result Unstructured Data: Test Result:high
CDC Split Type: BRPFIZER INC202100951502

Write-up: baby stopped moving/ baby died; amniotic fluid significantly increased; high blood pressure; problem with blood clotting; deep sadness; This is a spontaneous report from a contactable consumer (patient''s mother). This consumer reported information for both mother and fetus. This is the maternal report. A female patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Jun2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The reporter (patient''s mother) reported that the patient was pregnant. A pregnancy that unfortunately ended at 30 weeks and 4 days, a pregnancy that until 26 weeks went perfectly, as expected, where mother and baby were in perfect health. Until, on 16Jun2021 she took the Pfizer vaccine, then a week later she started to have symptoms that she did not have before, until after a few days her baby stopped moving, so they ran to the hospital where an ultrasound was done which showed that her baby had hydrops fetalis/Anasarca. She was transferred to the hospital on an unspecified date, an excellent public hospital that is a reference in fetal medicine, there several exams were performed and all possible causes were discarded, leaving only the karyotype exam to be performed, which exam was collected in the material in the on 21Jul2021 when her baby died, that is: all tests that would identify genetic causes have already been done, and it is possible to discard all known causes, thus leaving only the vaccine as the cause of the problem. Even the patient, after taking the vaccine, had the aminiotic fluid significantly increased, high blood pressure and a problem with blood clotting on an unspecified date. Given the way everything happened and seeing all the indicators leaning towards the vaccine, losing the reporter''s granddaughter and fearing for the life of the patient, who went through serious health situations, and is in deep sadness, taking medications and undergoing medical follow-up, given everything that is happening, and as everything happened after she took the Pfizer vaccine, the reporter was contacting so that we can take the necessary measures such as help in the patient''s health treatment and also "do research to avoid that other people suffer what they are suffering from, because applying a vaccine without being sure of the effects it causes on pregnant women is negligence, and killing babies as was done to my granddaughter is murder! We are suffering a lot with all this that has been happening... I am eagerly awaiting an answer. I wait for an answer, I wait for a contact, I wait for an explanation". The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : BR-PFIZER INC-202100950671 fetal case


VAERS ID: 1576042 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; THYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Lactation decreased; Miscarriage; Pre-diabetes
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984388

Write-up: miscarriage; cramps; The first dose of the vaccine my period to be late; Prolonged periods; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108012051023560-U1ZND. A 37-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: FE1510), via an unspecified route of administration on 21Jul2021 (at an age of 37-years-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included suppressed lactation, abortion spontaneous, glucose tolerance impaired, hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for glucose tolerance impaired from 01Jan2021 to an unspecified stop date; levothyroxine sodium (THYROXINE) taken for hypothyroidism from 01May2004 to an unspecified stop date. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Previously patient received BNT162B2, via an unspecified route of administration on an unspecified date as DOSE 1 SINGLE for covid-19 immunization. On an unspecified date the patient experienced cramps, miscarriage, prolonged periods on 21Jul2021, the first dose of the vaccine the patient period to be late on an unspecified date. As soon as she revived the vaccine her period started over a week early. She had really bad cramps which don''t usually get. She was with at if had been pregnant would she have had a miscarriage? Her periods are regular and this was very unusual. The first dose of the vaccine her period to be late. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No-Negative COVID-19 test. The outcome of the event period to be late was unknown and where as other events were recovering. No follow-up attempts are possible; No further information expected.


VAERS ID: 1585150 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-21
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100988477

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority number is FR-AFSSAPS-RE20212044. A 36-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in left arm on 13Jul2021 (Batch/Lot Number: FE2707) as dose 1, single for COVID-19 immunisation. The patient was pregnant at time of vaccination. The patient''s weight was 75 kg and height was 169 cm. The patient''s medical history and concomitant medications were not reported. Date of last menstruation was not reported. Patient was not considered at risk for developing a severe form of COVID-19 disease, did not contract COVID-19, and did not perform COVID-19 testing. On 21Jul2021, there was occurrence of a miscarriage during the first trimester of pregnancy. The outcome of the event was recovered on 21Jul2021. Note: Subject to further investigations that may be carried out in the context of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1634704 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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 INC202101026730

Write-up: Death intrauterine; malaise; fever; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-066015. This physician reported information for both mother and fetus. This is a maternal report. A 33-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 21Jul2021 (Batch/Lot Number: FD9309) at the age of 33 years old as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The mother was pregnant when she took bnt162b2. The patient experienced common side effects in the form of fever and malaise on the same day (on 21Jul2021). Fetal movements also decreased and when she applied for it the day after the vaccination (on 22Jul2021), the patient experienced death intrauterine (important medical event) - intrauterine fetal death was found in week 24 + 2 of pregnancy. The mother was 24 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion (as reported). The fetal outcome is intrauterine death. Patient course was recovering/being resolved from death intrauterine. Outcome of other events was unknown. The case is considered a serious, important medical event. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-202101078012 mother and fetus case


VAERS ID: 1634752 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 1 - / OT

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

Life Threatening? 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 INC202101078012

Write-up: Death intrauterine; Exposure during pregnancy; Foetal hypokinesia; This is a spontaneous report from a contactable physician reporting information for both mother and fetus. This is fetus report. The mother report was downloaded from the -Regulatory Authority WEB SE-MPA-2021-066015. A fetus patient of an unspecified gender received first dose of BNT162b2 (COMIRNATY), transplacental on 21Jul2021 (Lot Number: FD9309) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that: the mother received first dose of vaccine (during pregnancy, second trimester), she experienced common side effects in the form of fever and malaise on the same day. Fetal movements also decreased (on 21Jul2021) and when she applied for it the day after the vaccination (on 22Jul2021), intrauterine fetal death was found in week 24 + 2 of pregnancy. Unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-202101026730 Mother and foetus Comirnaty case; Reported Cause(s) of Death: Death intrauterine; Foetal hypokinesia; Foetal hypokinesia


VAERS ID: 1665077 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-21
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, 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: TROMBYL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: ultrasound; Result Unstructured Data: Test Result:unremarkable
CDC Split Type: SEPFIZER INC202101056454

Write-up: missed miscarriage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-071957. A 29-year-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Jul2021 (Lot Number: FE6208) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (TROMBYL). On 21Jul2021, patient experienced missed miscarriage. The mother was 20 weeks pregnant at the onset of the event. Routine ultrasound from 21Jul2021 was unremarkable. On 27Jul2021 no fetal heart activity. Case assessed as serious, major medical event. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1676977 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: died in the abdomen during the 24 weeks of pregnancy and 6 days of pregnancy; Vaccine exposure during pregnancy; This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of FOETAL DEATH (died in the abdomen during the 24 weeks of pregnancy and 6 days of pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On 21-Jul-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 05-Aug-2021, the patient experienced FOETAL DEATH (died in the abdomen during the 24 weeks of pregnancy and 6 days of pregnancy) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Intrauterine death. For foetus 1, The outcome was reported as Unknown. At the time of the report, FOETAL DEATH (died in the abdomen during the 24 weeks of pregnancy and 6 days of pregnancy) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown. 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 product was not provided. Treatment medication was not reported. 2021/08/05 died in the abdomen during the 24 weeks of pregnancy This is a case of product exposure during pregnancy with associated AE of fetal death for this 37-year-old female. No further information is expected.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AE of fetal death for this 37-year-old female. No further information is expected.


VAERS ID: 1863032 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   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 UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101462283

Write-up: Miscarriage around 8.5 weeks; Reaction at or around the injection site: pain; This is a spontaneous report from a contactable consumer downloaded from the Agency -WEB, regulatory authority number NL-LRB-00701163. A 31-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 21Jul2021 (Batch/Lot Number: Unknown) at the age of 31 years old as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had no previous COVID-19 infection. The patient previously received first dose COMIRNATY on 14Jun2021. The patient had maternal exposure during pregnancy following administration of BNT162B2. The patient had miscarriage around 8.5 weeks (other medically important condition) on 23Aug2021 (also reported as 1 month after start). This was the second COVID vaccination, which took place at a pregnancy duration of about 4 weeks. The first COVID vaccination took place before pregnancy. The mother reported she became pregnant while taking BNT162B2. The miscarriage occurred at a pregnancy duration of about 8.5 weeks. The pregnancy resulted in spontaneous abortion. The patient experienced reaction at or around the injection site: pain on 21Jul2021 (also reported as 1 day after start). Outcome of reaction at or around the injection site: pain was recovered on 23Jul2021, while other event was unknown. Reporter Comment: BioNTech/Pfizer vaccin (Comirnaty), Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): yes Date: 14Jun2021. confounding factors, vaccine exposure during pregnancy week: 4. COVID19, Previous COVID-19 infection: No Sender Comment: Seriousness of miscarriage was changed from ''''death'''' 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: BioNTech/Pfizer vaccin (Comirnaty), Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): yes Date: 14Jun2021. confounding factors, vaccine exposure during pregnancy week: 4. COVID19, Previous COVID-19 infection: No


VAERS ID: 1878165 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-21
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: blood tests; Result Unstructured Data: Test Result:miscarriage confirmation; Test Date: 20210729; Test Name: ultrasound; Result Unstructured Data: Test Result:miscarriage confirmation
CDC Split Type: FRPFIZER INC202101491089

Write-up: Early miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-ST20214046. This is a maternal report. A 33-year-old pregnant (also at the time of vaccination) female patient received bnt162b2 (COMIRNATY), intramuscular on 06Jul2021 (Batch/Lot Number: Unknown) as dose 2, 0.3 ml, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient presented with early miscarriage on 21Jul2021 when she was 4 weeks gestation and 2 weeks pregnant. Confirmation of miscarriage was noted on 29Jul2021 by ultrasound and blood tests. The event was considered as serious (medically significant). The patient recovered from the event with sequalae on 21Jul2021. Note : A drug is substantially coded when the specialty name is not known. Accountability without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : -PFIZER INC-202101491093 same patient/drug/dose number, different events


VAERS ID: 1529952 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Pregnancy (Estimated due date- 26-MAR-2021)
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Spontaneous Abortion; General body pain; Fever; Maternal exposure during pregnancy; This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of PAIN (General body pain), PYREXIA (Fever) and ABORTION SPONTANEOUS (Spontaneous Abortion) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient has not had symptoms associated with COVID-19. Concurrent medical conditions included Pregnancy (Estimated due date- 26-MAR-2021). On 22-Jul-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. The patient''s last menstrual period was on 19-Jun-2021 and the estimated date of delivery was 26-Mar-2022. On 22-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 23-Jul-2021, the patient experienced PAIN (General body pain) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Spontaneous Abortion) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna CoviD-19 Vaccine) beginning around the fourth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 22-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 24-Jul-2021, PYREXIA (Fever) had resolved. On 25-Jul-2021, PAIN (General body pain) had resolved. At the time of the report, ABORTION SPONTANEOUS (Spontaneous Abortion) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID-19 Negative. Patient was exposed to the vaccine in the first trimester (1-12 weeks). Details of scan or investigation revealed miscarriage. No concomitant product was reported. Treatment information was not provided. Company comment: This is a case of Maternal exposure during pregnancy with associated AEs (Spontaneous abortion, pain,pyrexia ) for this 39-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. This being a report from a regulatory authority, there are no contact details, so no further information is expected.; Sender''s Comments: This is a case of Maternal exposure during pregnancy with associated AEs (Spontaneous abortion, pain,pyrexia ) for this 39-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. This being a report from a regulatory authority, there are no contact details, so no further information is expected.


VAERS ID: 1638705 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-07-22
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 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: Shellfish allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101038661

Write-up: COVID-19 vaccine exposure during pregnancy week: 3 weeks; Unfortunately I miscarried at 7 and a half weeks; This is a spontaneous report from a contactable consumer or other non healthcare professional downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00659350. This consumer or other non healthcare professional reported information for both mother and fetus/baby. This is a maternal report. A 34-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 19Jun2021 (Batch/Lot Number: FC3098) as Dose 1, single for covid-19 immunisation. Medical history included shrimp allergy from an unknown date. The patient''s concomitant medications were not reported. The patient miscarried at 7 and a half weeks on 22Jul2021 (reported as medically significant) with outcome of unknown, and had covid-19 vaccine exposure during pregnancy week: 3 weeks on an unspecified date with outcome of unknown. The mother reported she became pregnant while taking bnt162b2. The mother was 7 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. No follow-up attempts possible. No further information expected.


VAERS ID: 1660239 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-07-22
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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; Test Date: 20210722; Test Name: Scans or investigations; Result Unstructured Data: Test Result:Miscarriage 10 weeks
CDC Split Type: GBPFIZER INC202101075760

Write-up: Maternal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108181316122530-7Y098. This consumer or other non hcp reported information for both mother and fetus. This is a maternal exposure during pregnancy report. A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not known), dose 1 via an unspecified route of administration on 18Apr2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included pregnancy (patient no longer pregnant at the time of reporting). Concomitant medication included folic acid taken for vitamin supplementation, start and stop date were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On 22Jul2021, the patient experienced miscarriage. On unspecified date, the patient experienced maternal exposure during pregnancy. The mother reported she became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. Did the medicine have an adverse effect on any aspect of the pregnancy unsure. Patient was exposed to the medicine before pregnancy. Patient has not tested positive for COVID-19 since having the vaccine. The events were serious (congenital anomaly, medically significant). The patient underwent lab tests and procedures which included scans or investigations miscarriage 10 weeks on 22Jul2021 and covid-19 virus test no - negative on unspecified date. Outcome of the event miscarriage was recovering. Outcome of the event maternal exposure during pregnancy was unknown and resolving for miscarriage. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1669286 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-22
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Menstruation irregular, Pregnancy test, Unwanted pregnancy
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (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: SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: pregnancy test; Test Result: Positive
CDC Split Type: SEPFIZER INC202101055189

Write-up: miscarriage; unwanted pregnancy; menstrual disorder; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Agency WEB. The regulatory authority report number is SE-MPA-2021-068170. A 25-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 22Jun2021 (Lot Number: FD4555) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline from 14May2020 to an unspecified stop date. Patient experienced suspected adverse reactions menstrual disorders (irregular menstruation), unwanted pregnancy and miscarriage which occurred one month after vaccination, on 22Jul2021. The patient had a safe period without ovulation after the vaccination, she still became pregnant on 28Jun2021 or 29Jun2021, actually at the time when her menstrual period would have come after. Menstruation never occurred and on 30Jul2021, she had a miscarriage and had received a positive pregnancy test. Menstrual disorders contributed to unwanted pregnancy and later to miscarriage. The patient always had regular menstruation. Her last period began on 25May2021 and she would have her period around the 01July2021. Outcome of the events was not recovered. The case was considered as serious, important medical events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1669692 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-22
   Days after vaccination:0
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: Foetal death, Foetal monitoring, Maternal exposure during pregnancy, Premature labour, Premature separation of placenta
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: Test Date: 20210726; Test Name: Cardiotocography; Result Unstructured Data: normal fetal heart sound before birth.
CDC Split Type: DKMODERNATX, INC.MOD20212

Write-up: Dead fetus at birth; Frequent contractions, sings of labour; Possible placental abruption; Maternal exposure during pregnancy, second trimester; This case was received via a regulatory authority (Reference number: DK-DKMA-ADR 25714095) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of FOETAL DEATH (Dead fetus at birth), PREMATURE LABOUR (Frequent contractions, sings of labour), PREMATURE SEPARATION OF PLACENTA (Possible placental abruption) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, second trimester) in a 26-year-old female patient (gravida 1) who received mRNA-1273 (Spikevax) (batch no. 3004493) for COVID-19 vaccination. No Medical History information was reported. On 22-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. On 22-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, second trimester) (seriousness criterion medically significant). On 26-Jul-2021, the patient experienced FOETAL DEATH (Dead fetus at birth) (seriousness criterion medically significant), PREMATURE LABOUR (Frequent contractions, sings of labour) (seriousness criterion medically significant) and PREMATURE SEPARATION OF PLACENTA (Possible placental abruption) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. At the time of the report, FOETAL DEATH (Dead fetus at birth) had not resolved and PREMATURE LABOUR (Frequent contractions, sings of labour), PREMATURE SEPARATION OF PLACENTA (Possible placental abruption) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, second trimester) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2021, Foetal monitoring: normal (normal) normal fetal heart sound before birth.. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. On JUN-2021, the patient had an additional test performed that included a Chromosomal analysis, Histology (Histology test of placenta,) however, the result was not provided. No treatment information was provided. Company comment: This is a RA case of maternal exposure during pregnancy with associated serious adverse events including fetal death, 5 days after first product dose in a 26 years old woman whose medical history was not provided. Based on temporal association a causal relationship cannot be excluded.; Sender''s Comments: This is a RA case of maternal exposure during pregnancy with associated serious adverse events including fetal death, 5 days after first product dose in a 26 years old woman whose medical history was not provided. Based on temporal association a causal relationship cannot be excluded.


VAERS ID: 1675995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-22
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101086330

Write-up: Abortion missed; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB (Regulatory Authority report number: ES-AEMPS-976988). A 37-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: FE3065; Expiration date was not reported), intramuscular on 02Jul2021 as dose 1, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient did not have COVID-19. The patient was pregnant at the time of vaccination. On 22Jul2021, the patient had abortion missed. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1698440 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOMID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: Beta-HCG; Result Unstructured Data: Test Result:10; Test Date: 20210726; Test Name: Beta-HCG; Result Unstructured Data: Test Result:5; Comments: confirming early miscarriage
CDC Split Type: FRPFIZER INC202101131038

Write-up: Pregnancy loss <20 weeks gestation; miscarriage bleeding; exposure during pregnancy; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PA20211415. A 24-years-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 22Jul2021 (Lot Number: FE2083) as 0.3 mL, single for covid-19 immunisation. Medical history included miscarriage, not ongoing. Concomitant medications included clomifene citrate (CLOMID). The patient experienced pregnancy loss <20 weeks gestation on 24Jul2021, miscarriage bleeding on 24Jul2021, exposure during pregnancy on 22Jul2021. 24Jul2021: miscarriage bleeding, SOS doctor consultation, blood test on 24Jul2021 (Beta-HCG=10) and 26Jul2021 (Beta-HCG (beta human chorionic gonadotropin)=5) confirming early miscarriage (1 month pregnant). Case was reported as serious, medically significant. Outcome of pregnancy loss <20 weeks gestation was recovered with sequelae on 24Jul2021 and the other events were recovered with sequelae on unspecified date. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724691 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Headache, Malaise, 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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191489

Write-up: unwell; miscarriage; Early miscarriage; Headache; Exhaustion; 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-202109110755105230-OCPLQ. Safety Report Unique Identifier: GB-MHRA-ADR 25927634. A 36-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: FD8813; Expiration Date: unknown), dose 2 via an unspecified route of administration on 21Jul2021 as dose 2, single for COVID-19 immunisation. The patient took the historical BNT162B2 vaccine on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included pregnancy, Patient no longer pregnant at the time of reporting, vitamin supplementation. Concomitant medications included folic acid taken for vitamin supplementation. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. Patient was exposed to the medicine Before pregnancy. On an unspecified date, the patient experienced unwell, miscarriage; on 22Jul2021, the patient experienced headache, exhaustion; on 04Sep2021, the patient experienced early miscarriage. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 04Sep2021 No - Negative COVID-19 test. The clinical outcome of the events unwell, miscarriage was not resolved; headache was resolved on 08Aug2021; exhaustion was resolved on 24Aug2021; early miscarriage was resolved on 11Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1739044 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

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

Life Threatening? No
Birth Defect? 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: Pregnancy (Estimated due date: 20-MAR-2022)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Miscarriage; Maternal exposure during pregnancy; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 25954595) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pregnancy (Estimated due date: 20-MAR-2022). Concomitant products included FOLIC ACID for Folic acid supplementation. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. The patient''s last menstrual period was on 14-Jun-2021 and the estimated date of delivery was 21-Mar-2022. On 22-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 18-Aug-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna CoviD-19 Vaccine) beginning around the fifth week of the pregnancy. On 22-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative covid-19 (Negative) Negative COVID-19. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was exposed to the vaccine first-trimester (1-12 weeks). Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Treatment information was not provided. Company Comment: This case concerns a 29 year old female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure during pregnancy and spontaneous abortion. The patient received the first dose of vaccine at around 5 weeks of gestation. Spontaneous abortion occurred approximately 27 days after the first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 29 year old female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure during pregnancy and spontaneous abortion. The patient received the first dose of vaccine at around 5 weeks of gestation. Spontaneous abortion occurred approximately 27 days after the first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1742247 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Biopsy placenta, Blood culture, Blood test, C-reactive protein, Chromosomal analysis, Culture urine, Foetal death, Foetal monitoring, Maternal exposure during pregnancy, Placental disorder, Premature labour, Premature separation of placenta, White blood cell count
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: Non-smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Biopsy placenta; Result Unstructured Data: Acute inflammation stage 1; Test Name: Blood culture; Test Result: Inconclusive ; Result Unstructured Data: No blood culture has not been performed; Test Date: 20210726; Test Name: Blood test; Result Unstructured Data: Blood type: No antibodies; Test Name: Chromosomal analysis; Result Unstructured Data: normal; Test Date: 20210726; Test Name: C-reactive protein; Result Unstructured Data: 11 (usually for a pregnant woman); Test Date: 20210726; Test Name: Urine culture; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210726; Test Name: Cardiotocography; Result Unstructured Data: normal fetal heart sound before birth.; Test Date: 20210726; Test Name: Leukocyte count; Result Unstructured Data: 30.7 (elevated)
CDC Split Type: DKMODERNATX, INC.MOD20212

Write-up: Dead fetus at birth; Frequent contractions, sings of labour; Possible placental abruption; Possible placental abruption; Maternal exposure during pregnancy, second trimester; This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of FOETAL DEATH (Dead fetus at birth), PREMATURE LABOUR (Frequent contractions, sings of labour), PREMATURE SEPARATION OF PLACENTA (Possible placental abruption), PLACENTAL DISORDER (Possible placental abruption) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, second trimester) in a 26-year-old female patient (gravida 1) who received mRNA-1273 (batch no. 3004493) for COVID-19 vaccination. Concurrent medical conditions included Non-smoker. On 22-Jul-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, second trimester) (seriousness criterion medically significant). On 26-Jul-2021, the patient experienced FOETAL DEATH (Dead fetus at birth) (seriousness criterion medically significant), PREMATURE LABOUR (Frequent contractions, sings of labour) (seriousness criterion medically significant), PREMATURE SEPARATION OF PLACENTA (Possible placental abruption) (seriousness criterion medically significant) and PLACENTAL DISORDER (Possible placental abruption) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Still birth. For foetus 1, The outcome was reported as Stillbirth NOS. On 22-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, second trimester) had resolved. At the time of the report, FOETAL DEATH (Dead fetus at birth) had not resolved and PREMATURE LABOUR (Frequent contractions, sings of labour), PREMATURE SEPARATION OF PLACENTA (Possible placental abruption) and PLACENTAL DISORDER (Possible placental abruption) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2021, Biopsy placenta: abnormal (abnormal) Acute inflammation stage 1. On 26-Jul-2021, Blood test: normal (normal) Blood type: No antibodies. On 26-Jul-2021, C-reactive protein: 11 (High) 11 (usually for a pregnant woman). On 26-Jul-2021, Culture urine: negative (Negative) Negative. On 26-Jul-2021, Foetal monitoring: normal (normal) normal fetal heart sound before birth.. On 26-Jul-2021, White blood cell count: 30.7 (High) 30.7 (elevated). On an unknown date, Blood culture: not performed (Inconclusive) No blood culture has not been performed. On an unknown date, Chromosomal analysis: normal (normal) normal. The action taken with mRNA-1273 (Unknown) was unknown. For mRNA-1273 (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. On JUN-2021, the patient had an additional test performed that included a Chromosomal analysis, Histology (Histology test of placenta,) however, the result was not provided. No treatment information was provided. Company comment - This is a RA case of maternal exposure during pregnancy with associated serious adverse events including fetal death, 5 days after first product dose in a 26 years old woman whose medical history was not provided. Based on temporal association a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: significant information that include lab data added.; Sender''s Comments: This is a RA case of maternal exposure during pregnancy with associated serious adverse events including fetal death, 5 days after first product dose in a 26 years old woman whose medical history was not provided. Based on temporal association a causal relationship cannot be excluded.


VAERS ID: 1818550 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-07-22
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Acne, Anovulatory cycle, Hormone level abnormal, Maternal exposure before pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad), Sexual dysfunction (broad)

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

Write-up: Miscarriage July 22, acne worsened, hormones, 3 missed ovulation cycles.


VAERS ID: 1819772 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Human chorionic gonadotropin, Interchange of vaccine products, Maternal exposure before pregnancy, Menstruation delayed, Off label use, Pregnancy test, Vulvovaginal discomfort
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), Fertility disorders (broad), Medication errors (broad), Sexual dysfunction (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: EFEXOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data: Test Name: Multiple Human chorionic gonadotropin urine tests; Test Result: Negative ; Test Name: several pregnancy tests; Result Unstructured Data: Test Result:unknown result
CDC Split Type: NLPFIZER INC202101268653

Write-up: vaccination before pregnancy; miscarriage after 6 weeks; much heavier than normal clear blood loss; including vaginal irritation; Overdue by a week -- menstruation came a week later; Off label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer or other non-health professional downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number NL-LRB-00655540, Sender''s (Case) Safety Report Unique Identifier NL-LRB-00698369. A 33-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: FF0688), via an unspecified route of administration, on 22Jul2021 as (INITIAL PFIZER DOSE), single for COVID-19 immunization.The patient medical history included disease risk factor, The patients concomitant medications included venlafaxine hydrochloride (EFEXOR) Modified Release Capsule 150mg (lot number: unknown). The patient historical vaccine included AstraZeneca injection fluid with status migrainosus. This serious spontaneous report from a consumer or other non-health professional concerns a female aged 33 Years, with late period, heavy menstrual bleeding, vaginal irritation, miscarriage of pregnancy (other medically important condition), maternal exposure before pregnancy following administration of covid-19 vaccine pfizer injection fluid (action taken: not applicable) for covid 19 immunisation. The patient recovered from heavy menstrual bleeding, recovered from late period, recovered from vaginal irritation. The first and second Covid vaccinations took place before pregnancy. The miscarriage occurred at a pregnancy duration of about 6 weeks. Overdue by a week -- menstruation came a week later. Additional information added she was a week late, not pregnant, several pregnancy tests, now I have my period but much heavier blood loss than usual, including vaginal irritation. New information received on 12Oct2021 B/ If she do not use a pill, vaginal ring, hormonal shot or coil: What has changed about her 1st menstruation after the vaccination she have had: menstruation came 0-30 days later than expected. Menstruation was expected 4 days after vaccination and came 11 days after vaccination, How many menstrual cycles did it take until her periods were back to normal cycle was normal again, next time no cycle because pregnant after 6 weeks miscarriage, now menstruating again. The patient underwent laboratory tests Multiple Human chorionic gonadotropin urine tests, each negative, several pregnancy tests with unknown results.The outcome of events Heavy menstrual bleeding, vulvo vaginal discomfort, Menstruation delayed was recovered on 2021, off label use, Interchange of vaccine products, abortion spontaneous, Maternal exposure before pregnancy was unknown. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Yes, I developed migrainosus status, also reported to Date: 30Mar2021. Overdue by a week -- menstruation came a week later Additional information ADR: I was a week late, not pregnant, several pregnancy tests, now I have my period but much heavier blood loss than usual, including vaginal irritation Citizen''s service number available: yes. Previous COVID-19 infection: No


VAERS ID: 1501852 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-22
Onset:2021-07-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

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

Write-up: I got the Covid vaccine being 5 weeks pregnant and I went home and felt fine. On 7/23 the next day I experience a very high fever . But I felt fine otherwise . On 7/24, I began to have bleeding while I was urinating . I went to the ER that same day and I ended up having a miscarriage. I want to believe that the Covid vaccine was so strong on my body and I was so early in my pregnancy that my body was not able to hold out .


VAERS ID: 1519697 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-12
Onset:2021-07-23
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vyvanse 40 mg 1X daily Metformin 500mg 2X daily
Current Illness: No illnesses
Preexisting Conditions:
Allergies: Shellfish Tamiflu Bee stings
Diagnostic Lab Data: Miscarriage resulted
CDC Split Type:

Write-up: I had a miscarriage. I have had 3 previous pregnancies that have resulted in a live child. I was between 6 and 8 weeks pregnant and I had a miscarriage.


VAERS ID: 1641142 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-02-22
Onset:2021-07-23
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Abortion spontaneous complete, Blood test, First trimester pregnancy, Haemorrhage in pregnancy, Maternal exposure before pregnancy, Menstruation irregular, Pregnancy, Ultrasound antenatal screen abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prescription: Nexium 40 mg po qd, Allegra 180 mg po qd, Valtrex 1 gram po bid, Nasonex 1 nasal spray daily each nostril, Astelin 1 nasal spray each nostril daily OTC vitamins: MVI, magnesium, flax seed oil, vit D
Current Illness: No acute illnesses
Preexisting Conditions: Migraines, seasonal allergies, GERD
Allergies: Sulfa drugs
Diagnostic Lab Data: Ultrasounds on July 2, July 24, Aug 6. Blood tests were also done on July 2 and July 24.
CDC Split Type:

Write-up: I experienced menstrual irregularity starting the day after my 2nd dose (which is very uncommon for me); those irregular cycles continued for ~2-3 months after my 2nd dose. Then, after a more normal cycle, I got pregnant (LMP May 13, 2021), had a confirmed intrauterine pregnancy with heartbeat seen on July 2, and then experienced a miscarriage at 10 weeks gestation. I started bleeding on July 23, 2021, went to an ER (was traveling at the time) on July 24 where an ultrasound showed loss of heartbeat and small for gestational age. I then miscarried the baby spontaneously the night of July 24/morning July 25. After traveling back home, I was seen for follow up by Doctor D. (University Hospital) on Aug 6 when I had an ultrasound that confirmed the miscarriage was complete.


VAERS ID: 1689170 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-03-11
Onset:2021-07-23
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 2 - / SYR

Administered by: Other       Purchased by: ?
Symptoms: Blood test normal, Caesarean section, Exposure during pregnancy, HELLP syndrome, Hypertension, Oedema, Peripheral swelling, Platelet count decreased, Premature delivery, Protein urine present, Ultrasound foetal
SMQs:, Acute renal failure (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal, iron, aspirin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Genetic testing maternity 21- normal blood work- normal ultra sounds- normal
CDC Split Type: vsafe

Write-up: I did not know I was pregnant at the time I received the first dose. They sent me directly to OB triage on 07/18/2021. I got something called HELLP syndrome and I had extremely high blood pressure, my platelets dropped very low, I had protein in my urine. I was in the hospital for a couple of days because my baby was born at 26 weeks. I had to be put on magnesium sulfate. I had to have an emergency c- section. My blood pressure remains elevated 7 weeks postpartum and I still have swelling in my legs. I still remain on blood pressure medications. It is rare for symptoms to persist these long after delivery and I still have edema and high blood pressure. Pregnancy history- first baby, I was considered a high risk pregnancy, I had to go to the OB pretty often. I was supposed to be due at 35 weeks but my baby was born at 26. Otherwise it was pretty unremarkable, a lot of ultrasounds which were normal. My baby''s weight was 850 grams


VAERS ID: 1529831 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Diarrhoea, Intermenstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Miscarriage; Diarrhea; Spotting menstrual; This regulatory authority case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Miscarriage. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced INTERMENSTRUAL BLEEDING (Spotting menstrual). On 24-Jul-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On 25-Jul-2021, INTERMENSTRUAL BLEEDING (Spotting menstrual) had resolved. On 26-Jul-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment information was provided. Patient experienced very unusual spotting, no period pains and usually did not spot between periods, wasn''t due on. A bit worrying as she had a miscarriage a few months ago, and planning on trying again once she had second dose, so although it wasn''t painful, and she was concerned something might be wrong. She had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AEs (spontaneous abortion, Diarrhoea and intermenstrual bleeding) for this 38-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1538678 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Electrocardiogram, Facial paralysis, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Facial palsy (incident of facial palsy in Feb/ March 2021 with some ongoing mild numbness); Folic acid supplementation; Miscarriage (1 miscarriage 2017); Pregnancy (in 2018, Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:Unknown result; Test Name: ECG; Result Unstructured Data: Test Result:Unknown result; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976836

Write-up: Maternal exposure during pregnancy; facial palsy; facial droop; Facial palsy aggravated; Early miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107302129011470-SQLM6, Safety Report Unique Identifier GB-MHRA-ADR 25735950. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FD8813 and expiry date was not reported), via an unspecified route of administration, on 23Jul2021 (at age of 39-year-old), as a single dose for COVID-19 immunization. The patient was pregnant at the time of vaccination. Prior to vaccine had healthy pregnancy. The patient has not tested positive for COVID-19 since having the vaccine. The patient''s medical history included facial paralysis (incident of facial palsy in Feb/ March 2021 with some ongoing mild numbness) from an unknown date and unknown if ongoing, pregnancy (2018, patient no longer pregnant at the time of reporting) from an unknown date and unknown if ongoing, clinical trial participant from an unknown date and unknown if ongoing, folic acid supplementation from an unknown date and unknown if ongoing, and miscarriage (1 miscarriage 2017) from an unknown date and unknown if ongoing. The patient has not had symptoms associated with COVID-19. The patient was not currently breastfeeding. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. On 23Jul2021, the patient experienced facial palsy, facial droop (LHS within 5 min of vaccine about 3.30 pm), facial palsy aggravated, early miscarriage and maternal exposure during pregnancy. The patient took place at hospital walk in centre and supported to ED and went through triage system and under observation for c 5 hours until cleared. Subsequently signs of early miscarriage in evening, continued next day. The medicine had an adverse effect on any aspect of the pregnancy. Miscarriage started within 8 hours. The patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included blood test with unknown result, electrocardiogram with unknown result, and sars-cov-2 test: negative No - Negative COVID-19 test on an unspecified date. Outcome of the event Facial palsy aggravated was recovered with sequel on 23Jul2021, for the event maternal exposure during pregnancy was unknown, and for all other events, it was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585207 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214004 / 1 - / OT

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

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

Write-up: Pregnancy loss <20 weeks gestation; Vaccine exposure during pregnancy; This case was received via Medicines Agency (Reference number: FR-AFSSAPS-TO20216256) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of ABORTION SPONTANEOUS (Pregnancy loss <20 weeks gestation) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214004) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Pregnancy. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. The patient''s last menstrual period was on 21-May-2021 and the estimated date of delivery was 25-Feb-2022. On 23-Jul-2021, after starting mRNA-1273 (Spikevax), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 01-Aug-2021, the patient experienced ABORTION SPONTANEOUS (Pregnancy loss <20 weeks gestation) (seriousness criterion medically significant). The patient received mRNA-1273 (Spikevax) beginning around the ninth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 23-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 01-Aug-2021, ABORTION SPONTANEOUS (Pregnancy loss <20 weeks gestation) had resolved with sequelae. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.


VAERS ID: 1593124 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-07-23
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101014634

Write-up: Abortion; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108061338018170-QUQGI, Safety Report Unique Identifier GB-MHRA-ADR 25767662. A 29-year-old pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 08Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included folic acid taken at 5 mg as folic acid supplementation, start and stop date were not reported. The patient experienced abortion on 23Jul2021. It was reported that child was exposed to the medicine in first-trimester (1-12 weeks). Patient was exposed to the medicine in first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. The patient had not recovered from the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1654876 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac arrest, Maternal exposure during pregnancy, Ultrasound scan
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? 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 scan; Result Unstructured Data: Test Result:bad ultrasound after my 2nd vaccination
CDC Split Type: NLPFIZER INC202101099914

Write-up: Heart stopped beating; first Covid vaccination took place at a pregnancy duration of about 2 weeks, and the second Covid vaccination at 6w5 days pregnancy; This is a spontaneous report from a contactable consumer (patient). This is the third of three reports. The first report is a report downloaded from the Regulatory Authority-WEB NL-LRB-00661848. This consumer reported information for both mother and fetus. This is a fetus report. A fetus patient received second dose of bnt162b2 (COMIRNATY), via transplacental route on 23Jul2021 (Batch/Lot Number: Unknown) as Dose 2, single for covid-19 immunisation. The mother received first dose on 18Jun2021. The first Covid vaccination took place at a pregnancy duration of about 2 weeks, and the second Covid vaccination at 6w5 days pregnancy. In the week mother received the vaccine, the heart of the fetus stopped beating. Had a good ultrasound at 6w4 days and a bad ultrasound after 2nd vaccination. The miscarriage occurred at a pregnancy duration of about 7.5 weeks. The patient experienced heart arrest on 30Jul2021. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101055410 Maternal case; Reported Cause(s) of Death: Fetal cardiac arrest


VAERS ID: 1664945 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-23
   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 UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Body temperature, Fatigue, Malaise, Maternal exposure during pregnancy, Myalgia, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:Fever: not measured
CDC Split Type: NLPFIZER INC202101073312

Write-up: Early miscarriage; Fatigue; Reaction at the injection site: pain; Fever; Generalized joint pain; Myalgia; Malaise; Maternal exposure during pregnancy; This spontaneous report from a contactable consumer or other non-HCP reported different events for each dose of drug. This is the first of two reports. This is a spontaneous report received from the regulatory authority-WEB, regulatory authority number NL-LRB-00666392. This is case for 2nd dose. A 26-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number were not reported) dose 2 via unknown route of administration on 23Jul2021 (at the age of 26-years-old) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient past drug therapy included Comirnaty 1st dose, 0.3 ml, batch #unknown for COVID-19 immunization and the reaction was tired, temperature/feverish for 24 hours and sore muscles start and stop date on 18Jun2021. The patient had miscarriage (other medically important condition), generalized joint pain, myalgia, malaise, fatigue, injection site pain, fever, maternal exposure during pregnancy on 23Jul2021. The miscarriage took place at a pregnancy duration of 4 weeks. One week before, she was vaccinated. The patient underwent lab tests and procedures which included body temperature fever (not measured) on an unknown date. The outcome of the events generalized joint pain, fever, injection site pain, myalgia was recovered on 24Jul2021, malaise and fatigue were recovered on 25Jul2021, the outcome of maternal exposure during pregnancy and miscarriage was unknown. Health Authority Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): yes. ADRs. Temperature/feverish for 24 hours, sore muscles and tired. Date: 18Jun2021. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101124835 same patient, different dose


VAERS ID: 1716635 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Hypothyroidism; Obesity; Pregnant; Sleeve gastrectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101160539

Write-up: Miscarriage; occurrence of an early miscarriage in the first trimester of pregnancy; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LL20215957. A 29-years-old female patient received the second dose of bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in left arm on 23Jul2021 (Batch/Lot Number: FE7010) as single dose for covid-19 immunisation. Medical history included hypothyroidism, sleeve from 2017, obesity. Patient had no history of COVID, had not been tested. Patient was pregnant on 12Jun2021, Gestation 0, Parity 0. No risk factors for miscarriage. The patient''s concomitant medications were not reported. Historical vaccine included the first dose of bnt162b2 in Jun2021 as single dose for covid-19 immunisation. On 10Aug2021, the doctor reported the occurrence of an early miscarriage in the first trimester of pregnancy in the patient. Outcome of events were recovering.


VAERS ID: 1780572 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-07-23
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Scan, Stillbirth
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; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congenital central diabetes insipidus; COVID-19 (at early pregnancy (5 weeks).); Diabetes steroid-induced
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: Scans Or Investigations; Result Unstructured Data: Test Result:Normal
CDC Split Type: GBPFIZER INC202101300808

Write-up: Stillbirth; This is a spontaneous report from a contactable consumer, received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109301035169690-WZ0ZQ, Safety Report Unique Identifier is GB-MHRA-ADR 26015088. This consumer reported information for both mother and fetus/baby. This is a maternal report. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jun2021 (Batch/Lot Number: Not Known) as single dose for COVID-19 immunisation. Medical history included diabetes steroid-induced, congenital diabetes mellitus and COVID-19 at early pregnancy (5 weeks) all from an unknown date. Patient has not had symptoms associated with COVID-19. Concomitant medication included folic acid taken for vitamin supplementation, start and stop date were not reported; influenza vaccine taken for immunization, start and stop date were not reported. The patient experienced had a stillbirth on 23Jul2021. The pregnancy resulted in still birth. The fetal outcome is neonatal death. The patient reportedly took the vaccine during third trimester (32 weeks) and the fetus is exposed to the medicine during 29-40 weeks of gestation. The seriousness criteria of the events is medically significant. The patient underwent lab tests and procedures on unspecified dates, which included SARS-CoV-2 test with no - negative COVID-19 test result on an unknown date and details of scans and investigations was normal, details of developmental milestones was reported as yes. Patient has not tested positive for COVID-19 since having the vaccine and is not enrolled in clinical trial. The outcome stillbirth was recovered on an unspecified date. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101308915 Fetal Case


VAERS ID: 1809844 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-07-23
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XYZAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Normal birth (gave birth to first daughter; alive birth); Pregnancy (past pregnancy, Number of other children were 1)
Allergies:
Diagnostic Lab Data: Test Date: 20210626; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: JPPFIZER INC202101244275

Write-up: Spontaneous abortion; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 30Sep2021, this case now contains serious adverse reactions. Information processed together. GENERAL INVESTIGATION TARGETING THE VACCINES (HEALTH CARE PROVIDERS HCPS) WHO ARE VACCINATED IN EARLY POST-APPROVAL PHASE (FOLLOW-UP STUDY) This is a report from a Non-Interventional Source for Protocol C4591006 from two physicians, an other health professional, and a pharmacist (investigators) of the study. The subject was a 30-year-old female. On 15Mar2021 at 13:09 the subject received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EP2163, Expiration date 31May2021) in arm left as 0.3 mL, single for COVID-19 immunization at 29 years old; Suspected pregnancy, presence or absence of breastfeeding at second dose vaccination: No. Medical history included past pregnancy (Number of other children were 1), and on 22Mar2019 gave birth to first daughter. Concomitant medication included levocetirizine dihydrochloride (XYZAL, strength 5MG) taken for an unspecified indication, start and stop date were not reported. On 22Feb2021, the subject received the first dose of BNT162b2 (COMIRNATY, Lot# EP2163, Expiration date 31May2021) received in arm left as 0.3 mL, single for COVID-19 immunization at 29 years old; Presence or absence of complication (pre-vaccination questionnaire): No, Presence or absence of allergy: No, Presence or absence of complication (medical questionnaire): No, Presence or absence of medical history: No, Presence or absence of treatment drug which the subject is orally taking: Yes, Suspected pregnancy, presence or absence of breastfeeding at first dose vaccination: No. The subject had no adverse event after prior vaccination. The subject did not receive any other vaccines. It was reporter that the subject was pregnant during observation period. The subject was not breastfeeding during observation period. Serious adverse event had occurred. On 23Jul2021, the subject experienced spontaneous abortion, which was considered as serious for medically significant. The subject was 6 Weeks pregnant at the onset of the event. Last Menstrual Period was started on 09Jun2021. Estimated date of pregnancy was 23Jun2021. The subject was due to deliver on 16Mar2022. The pregnancy resulted in spontaneous abortion. Detailed pregnancy information was as follows; The subject did not smoke during this pregnancy. The subject did not drink alcohol during this pregnancy. The subject did not use illicit drugs during this pregnancy. Obstetrical history: Number of past pregnancies were 2 times. Number of other children were 1. The outcome of past 2 pregnancies were alive birth and spontaneous abortion as follows: On 22Mar2019, the subject gave birth to first daughter. On 23Jul2021, the subject experienced spontaneous abortion. The subject underwent COVID-19 antigen test on 26Jun2021 and the result was negative. The event spontaneous abortion did not required emergency room/physician office visit. The outcome of the event spontaneous abortion was unknown. There was no rational causality with study drug or concomitant drug to the event. The investigator assessed there was no reasonable possibility of causal relationship between the event and BNT162b2 or the concomitant medication. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: based on the known safety profile of vaccine and the information available the event was considered unrelated to the suspect drug.


VAERS ID: 1841276 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Balance disorder, Eye disorder, Headache, Hypoaesthesia, Internal haemorrhage, Muscular weakness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: EEPFIZER INC202101414929

Write-up: Miscarriage of pregnancy; Internal haemorrhage; Eye disorder; right hand is numb and weak (can''t hold a cup of coffee); Hypoaesthesia; Myalgia; Headache; Balance disorder; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number EE-SAM-538321100426. A 41-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 21Jul2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3 ML, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced miscarriage of pregnancy (abortion spontaneous) (medically significant) on 21Sep2021 with outcome of recovered on 21Sep2021, internal haemorrhage (medically significant) on 21Sep2021 with outcome of recovered on 21Sep2021, eye disorder (medically significant) on 23Jul2021 with outcome of not recovered, right hand is numb and weak (can''t hold a cup of coffee) (muscular weakness) (disability) on 23Jul2021 with outcome of not recovered, hypoaesthesia (disability) on 23Jul2021 with outcome of not recovered, myalgia, headache and balance disorder on 23Jul2021 with outcome of not recovered (stop date of 04Oct2021 was reported for the non-recovered events). The mother reported she became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. Treatment included paracetamol, and on 21Sep2021 the patient went to the emergency department of the hospital with great blood loss, blood transfusion, plasma, etc. were performed, right eye cells dead requires surgery. Sender Comment: Partly serious side effects, unlisted. The exact relationship with the vaccine and also the diagnosis (eye cells dead) remains unclear, more detailed data are needed. The relationship cannot be accurately assessed. No follow up attempts possible. No further information is expected. Lot/batch number was not provided and unable to obtain.


VAERS ID: 1585343 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Haemorrhage, Maternal exposure during pregnancy, SARS-CoV-2 test, Urinary tract infection
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased; Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100991898

Write-up: maternal exposure during pregnancy, first trimester; UTI; Miscarriage; bleeding; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number [GB-MHRA-WEBCOVID-202108021306002150-9Q2KE], Safety Report Unique Identifier [GB-MHRA-ADR 25741004].This consumer reported information for both mother and fetus. This is the maternal report. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jul2021 (Lot Number: FD8813) as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation, miscarriage, pregnancy and Folic acid supplementation, all on an unknown date. Concomitant medications included folic acid taken for Folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy, first trimester and urinary tract infection (UTI) on an unspecified date; bleeding on 24Jul2021; and miscarriage on 27Jul2021. The events were assessed as serious (hospitalization). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 16Jul2021 and blood test: unknown result on an unknown date. The outcome of the events ''miscarriage'' and ''UTI'' was recovering and outcome of the other events was unknown. Patient no longer pregnant at the time of reporting. The clinical course was reported as follows: Began bleeding 24th July. Miscarriage on 27th July. Patient has not tested positive for COVID-19 since having the vaccine. Patient was 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). Additional information: Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101006706 fetus


VAERS ID: 1638382 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-24
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8289-L719 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; LANSOPRAZOL; SERTRALINE
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Folic acid supplementation; Stomach ulcer
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101040658

Write-up: Miscarriage; This is a solicited report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202106111405526270-WQSTW. Safety Report Unique Identifier: GB-MHRA-ADR 25786867. A 30-year-old female patient received 1st dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, lot number: FC8289-L719),via an unspecified route of administration on 11Jun2021 as single dose for COVID-19 immunisation. Medical history included ongoing pregnancy, folic acid supplementation, stomach ulcer and depression from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concomitant medications included folic acid taken for folic acid supplementation, start and stop date were not reported; lansoprazol taken for stomach ulcer, start and stop date were not reported; sertraline taken for depression, start and stop date were not reported. The patient had maternal exposure during pregnancy. Patient was exposed to the vaccine first-trimester (1-12 weeks). The patient last menstrual period date was 16Apr2021 and estimated due date was 21Jan2022. The patient experienced miscarriage on 24Jul2021 with outcome of unknown. Patient does think vaccination had an adverse effect on the pregnancy. Pregnancy adverse effects details: Foetal heartbeat was fine but 2 weeks after vaccine the heartbeat stopped. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. 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 in the case report and a plausible temporal relationship, a possible causal relationship between the events abortion spontaneous and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1657607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Body temperature, Fatigue, Pyrexia, Ultrasound scan
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: At the implantation)
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: body temperature; Result Unstructured Data: Test Result:38-40.5 Centigrade; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:good ultrasound at 6w4 days; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:bad ultrasound after her 2nd vaccination
CDC Split Type: NLPFIZER INC202101055410

Write-up: Miscarriage; Fatigue; Fever: 38 to 40.5 degrees Celsius; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB NL-LRB-00661848. This is first of three reports. This consumer reported information for both mother and fetus. This is a maternal report. A 39-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Jul2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. Medical history included maternal vaccine exposure (covid-19 vaccine exposure during pregnancy week: at the implantation). The patient''s concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (COMIRNATY) for covid-19 immunisation on 18Jun2021 at 0.3 ml single dose and experienced maternal exposure during pregnancy, first trimester. The patient experienced miscarriage on 30Jul2021, fatigue on 24Jul2021, fever: 38 to 40.5 degrees Celsius on 24Jul2021. The event miscarriage was reported as serious (other medically important condition). Pyrexia was treated with paracetamol. Clinical course: The miscarriage occurred at a pregnancy duration of about 7.5 weeks. The first Covid vaccination took place at a pregnancy duration of about 2 weeks, and the second Covid vaccination at about 6.5 weeks. The patient was recovering from fatigue, recovered from fever on 25Jul2021. Outcome of miscarriage was unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the HA critera, the reaction (miscarriage) was considered as serious by the regulatory authority. Reporter comment: Additional information ADR: she had her 2nd vaccination at 6w5 pregnancy. In the week that she received the vaccine, the heart of the fetus stopped beating. Patient had a good ultrasound at 6w4 days and a bad ultrasound after her 2nd vaccination. Previous COVID-19 infection was no. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reporter''s Comments: Additional information ADR: she had her 2nd vaccination at 6w5 pregnancy. In the week that she received the vaccine, the heart of the fetus stopped beating. Patient had a good ultrasound at 6w4 days and a bad ultrasound after her 2nd vaccination. Previous COVID-19 infection was no.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101099913 same reporter/patient, different vaccine dose/events;NL-PFIZER INC-202101099914 fetus case


VAERS ID: 1667089 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-07-24
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0578 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:unknown results
CDC Split Type: CAPFIZER INC202101090623

Write-up: miscarriage; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EY0578), via an unspecified route of administration, administered in the left arm on 16Jun2021 (at the age of 29 years old) as dose 2, single for COVID-19 immunization. The patient''s medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included minerals NOS, vitamins NOS (PRENATAL VITAMINS) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0199), via an unspecified route of administration, administered in the right arm on 19May2021 (at the age of 28 years old) as dose 1, single for COVID-19 immunization. The patient experienced miscarriage on 24Jul2021 09:00. It was reported that the patient had a miscarriage on 24Jul2021 at 7 weeks + 5 days. It was identified that the miscarriage likely occurred several days or weeks prior to the bleeding starting. It was likely that the patient had the vaccine shot on or near the day of conception. While she had no hard proof that there was a link, she wanted to have it noted in case it becomes a trend. The event resulted on doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included care to confirm miscarriage including ultrasounds. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was reported as 20Aug2021. The outcome of the event was recovered on an unspecified date.


VAERS ID: 1746455 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214009 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Intermenstrual bleeding, 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: FRMODERNATX, INC.MOD20213

Write-up: Miscarriage; Metrorrhagia; Maternal exposure during pregnancy; This case was received via regulatory authority(Reference number: FR-AFSSAPS-RS20212836) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority retrospective pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214009) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-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 24-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 31-Jul-2021, the patient experienced INTERMENSTRUAL BLEEDING (Metrorrhagia). In August 2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 24-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) had resolved with sequelae and INTERMENSTRUAL BLEEDING (Metrorrhagia) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medication were provided Company Comment: This case concerns a 30-year-old female patient with no details on previous relevant medical history, who experienced the unexpected events of Maternal exposure during pregnancy, Metrorrhagia and Spontaneous abortion after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The patient received the first dose of vaccine at an unknown week of gestation. The onset of the event Metrorrhagia occurred 7 days after the first dose of Spikevax and Spontaneous abortion occurred later at an unspecified date. The benefit-risk relationship of Spikevax vaccine is not affected by this report; Sender''s Comments: This case concerns a 30-year-old female patient with no details on previous relevant medical history, who experienced the unexpected events of Maternal exposure during pregnancy, Metrorrhagia and Spontaneous abortion after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The patient received the first dose of vaccine at an unknown week of gestation. The onset of the event Metrorrhagia occurred 7 days after the first dose of Spikevax and Spontaneous abortion occurred later at an unspecified date. The benefit-risk relationship of Spikevax vaccine is not affected by this report


VAERS ID: 1875387 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-24
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Malaise, Maternal exposure before pregnancy, Nausea, Ovulation delayed, Pregnancy, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Fertility disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Maternal vaccine exposure
Allergies:
Diagnostic Lab Data: Test Date: 20201023; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive
CDC Split Type: NLJNJFOC20211128734

Write-up: MISCARRIAGE; MATERNAL EXPOSURE BEFORE PREGNANCY; PREGNANCY; OVULATION DELAYED; MENORRHAGIA; NAUSEA; MALAISE; This spontaneous pregnancy report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, NL-LRB-00708018] concerned a 30 year old female of unspecified race and ethnic origin. The patient''s weight was 75 kilograms, and height was 175 centimeters. The patient''s past medical history included: maternal vaccine exposure on an unspecified date and had covid-19 on 23-OCT-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry: unknown) 1 dosage forms, 1 total, 0.5 ml administered on 24-JUL-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced maternal exposure before pregnancy. During her pregnancy her ovulation delayed and had miscarriage on unspecified date. On 23-OCT-2020, Laboratory data included: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test showed positive result. On 24-JUL-2021, she had malaise and nausea. On 30-JUL-2021, she had menorrhagia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from malaise, menorrhagia, pregnancy, and ovulation delayed, and nausea on 25-JUL-2021, and the outcome of miscarriage and maternal exposure before pregnancy was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1554146 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-09
Onset:2021-07-25
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: pre-natal vitamins
Current Illness: none
Preexisting Conditions: PCOS
Allergies: pears
Diagnostic Lab Data: Multiple sonograms and blood tests
CDC Split Type:

Write-up: 2 consecutive miscarriages after covid vaccine. 2nd miscarriage requiring D&C


VAERS ID: 1663424 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Utah  
Vaccinated:2020-12-30
Onset:2021-07-25
   Days after vaccination:207
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Private       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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: Shellfish
Diagnostic Lab Data: On both diagnostic ultrasounds, no e/o fetal pole visible; sac noted. On second miscarriage, POC via D&C noted immature chorionic villi; HbA1C WNL, APLA Negative. Awaiting genetics on second miscarriage POC.
CDC Split Type:

Write-up: G2P2 prior to vaccination. Two prior uncomplicated pregnancies- both infants born at term by SVD without any complications; born 09/2019 and 01/2018. No prior history of miscarriage. Following injection, experienced a missed miscarriage at 12w5d despite normal genetic testing; then a second missed miscarriage at 10w3d.


VAERS ID: 1630894 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-25
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy; Rash (Previous side effect in the form of rash of Penicillin.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101017170

Write-up: Early miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number SE-MPA-2021-067630. A 38-year-old female patient received first dose of BNT162B2 (COMIRNATY) via unspecified route single dose for COVID-19 immunization on 01Jul2021. Medical history included previous side effect in the form of rash of Penicillin from 1984. The patient''s concomitant medications were not reported. The patient experienced early miscarriage (medically significant) on 25Jul2021 with outcome of unknown. The mother was 5 weeks pregnant at the onset of the event. According to the report, the woman became pregnant a few days after the vaccination and was thus in week 1 of pregnancy at the time of administered vaccine. The miscarriage occurred in week 5 of pregnancy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1784119 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-07-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004499 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion, 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: Abortion
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Maternal exposure during pregnancy; This case was initially received via regulatory authority (Reference number: IT-MINISAL02-792451) on 05-Oct-2021. The most recent information was received on 05-Oct-2021 and was forwarded to Moderna on 08-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of ABORTION in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004499) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Abortion in May 2021. On 25-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 25-Jul-2021, after starting mRNA-1273 (Spikevax), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 02-Aug-2021, the patient experienced ABORTION (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 02-AUG-2021 Patient had abortion. On 25-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medication were provided Company Comment: This case concerns a 32-year-old, female patient with past medical history of abortion in May 2021, who experienced the unexpected events of abortion and maternal exposure during pregnancy. The event of abortion occurred approximately 6 days after the first dose of Moderna COVID-19 Vaccine. It was reported that spontaneous abortion occurred. Last menstruation date and gestation age at time of abortion was unknown. The rechallenge is not applicable considering the nature of events. The patient''s medical history of abortion which occurred three month prior to reported events remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Translation document received on 08-OCT-2021. Sender comment and dose number updated.; Reporter''s Comments: THE PATIENT ALSO REPORTS HAVING HAD AN ABORTION IN MAY 2021.; Sender''s Comments: This case concerns a 32-year-old, female patient with past medical history of abortion in May 2021, who experienced the unexpected events of abortion and maternal exposure during pregnancy. The event of abortion occurred approximately 6 days after the first dose of Moderna COVID-19 Vaccine. It was reported that spontaneous abortion occurred. Last menstruation date and gestation age at time of abortion was unknown. The rechallenge is not applicable considering the nature of events. The patient''s medical history of abortion which occurred three month prior to reported events remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1789666 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-07-25
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure (Vaccine exposure during pregnancy week: 0)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101331299

Write-up: irregular menstruation 2 months later; Miscarriage after 2nd vaccination; This is a spontaneous report from a contactable consumer or other non-Healthcare Professional downloaded from the regulatory authority number NL-LRB-00690929. A 33-years-old female patient (patient was pregnant at the time of vaccination) received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 27Jun2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient''s medical history included maternal vaccine exposure. The patient did not have previous COVID-19 infection. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY, Solution for injection, Dose: 0.3 mL, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 23May2021 (age at vaccination was unknown) as dose 1, 0.3 ml single for COVID-19 immunization and had no adverse reaction. The vaccine exposure during pregnancy week was reported as 0. On 25Jul2021, 28 days after start, the patient had miscarriage (other medically important condition) following administration of COVID-19 Pfizer vaccine. On an unspecified date, 2 months after start, the patient experienced menstruation irregular following administration of COVID-19 Pfizer vaccine. The pregnancy duration at times of the vaccination and the miscarriage were unknown. No diagnostic procedures were done. The case was assessed as serious. The outcome of the events was unknown. Health Authority Comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: No Date: 23May2021 citizen service number available: yes confounding factors vaccine exposure during pregnancy week: 0 COVID19 Previous COVID-19 infection: No Other diagnostic procedures: No Sender comment: Seriousness of miscarriage was changed from "death" to "other medically important condition". No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1856530 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-07-25
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: vaccine exposure during pregnancy week: unknown; Miscarriage; This case was received via the RA (Reference number: NL-LRB-00703381) on 02-Nov-2021 and was forwarded to Moderna on 02-Nov-2021. This regulatory authority retrospective 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 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product MEBENDAZOLE tablet for Prophylaxis. The patient''s past medical history included Suspected COVID-19 on 24-Feb-2020 and Maternal vaccine exposure (vaccine exposure during pregnancy week: unknown). Concomitant products included SALMETEROL for an unknown indication. On 23-May-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Jun-2021, the patient started MEBENDAZOLE (unknown route) 100 milligram. Last menstrual period and estimated date of delivery were not provided. On 25-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy week: unknown). The delivery occurred on 25-Jul-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy week: unknown) outcome was unknown. No treatment medications received. Company Comment : This case concerns a 35-year-old female patient with no relevant medical history, who experienced Maternal exposure during pregnancy and the unexpected serious event of Spontaneous abortion. The event occurred approximately 2 months and 2 days after the Moderna COVID-19 Vaccine, dose number unknown. The patient received the dose of the vaccine at an unknown stage of gestation. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received on 02-Nov-2021 contains no newinformation On 02-Nov-2021: Translation received on 4-Nov-21 includes drug info and senders comment (Initial) On 02-Nov-2021: Translation received on 4-Nov-21 contains no new information (FU); Reporter''s Comments: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS criteria, the reaction (miscarriage) was considered as serious by the RA.; Sender''s Comments: This case concerns a 35-year-old female patient with no relevant medical history, who experienced Maternal exposure during pregnancy and the unexpected serious event of Spontaneous abortion. The event occurred approximately 2 months and 2 days after the Moderna COVID-19 Vaccine, dose number unknown. The patient received the dose of the vaccine at an unknown stage of gestation. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report


VAERS ID: 1752109 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-04-28
Onset:2021-07-26
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Bell's palsy
SMQs:, Hearing impairment (broad), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101227852

Write-up: I had a miscarriage at 4 months; Bell''s palsy; This is a Spontaneous report received from a contactable other HCP (patient). A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular on 28Apr2021 (Batch/Lot number was not reported) age at vaccination of 27-years-old, as single dose, for covid-19 immunisation. Medical history was none. No known allergies. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unspecified date in 2021 (Batch/Lot number was not reported), age at vaccination of 27-years-old, as single dose, for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced miscarriage at 4 months on 26Jul2021 and bell''s palsy on 26Jul2021; the events were serious as congenital anomaly. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included D&C (as reported), antiviral medicine and steroids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered with sequelae on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Miscarriage, Bell''s palsy and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1779476 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-04-13
Onset:2021-07-26
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 (2ND DOS / 2 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins, Vyvanse 10 mg (weaning off for conception), buproprion 300 mg
Current Illness:
Preexisting Conditions: ILVEN (skin disorder/birth defect)
Allergies:
Diagnostic Lab Data: 1.) Follow-up pathology revealed no chromosomal or cervical abnormalities
CDC Split Type:

Write-up: 1.) Had delayed ovulation in cycle immediately following vaccine (3 days late; typically have 28 day cycles); did not attempt to conceive this cycle 2.) Successfully Conceived during my 2nd cycle following my vaccine on June 8th (within 60 days of 2nd dose); due date was March 3rd, 2020. Healthy fetal heart beat was detected at 6 weeks 6 days and normal blood tests; experienced missed miscarriage on July 26th at 8 weeks 5 days (diagnosed via ultrasound on August 11th at 10 weeks 5 days); 3.) Follow-up pathology revealed no chromosomal or cervical abnormalities


VAERS ID: 1557964 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-07-26
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210726; Test Name: scan; Result Unstructured Data: Test Result:Miscarriage
CDC Split Type: GBPFIZER INC202100975484

Write-up: Early miscarriage/miscarriage; 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-202107291515257010-PMGEB, Safety Report Unique Identifier GB-MHRA-ADR 25727488. A 31-year-old female patient (pregnant: first trimester 1-12 weeks, not currently breastfeeding) received bnt162b2 (BNT162B2 also reported as COVID-19 MRNA VACCINE BIONTECH, lot EY5456), via an unspecified route of administration on 16Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included pregnancy (no longer pregnant at the time of reporting). Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medication included folic acid for vitamin supplementation. The patient experienced miscarriage/early miscarriage on 26Jul2021, reported as serious-medically significant, congenital anomaly. The patient further informed that this was her first miscarriage and she had one healthy pregnancy before miscarriage. She was unsure if the medicine had an adverse effect on any aspect of the pregnancy. The patient underwent laboratory test and procedure, which included: Blood test on unknown date: unknown results; scan 26Jul2021: Miscarriage. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575400 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976857

Write-up: Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107301356126020-VBYSU and Safety Report Unique Identifier is GB-MHRA-ADR 25733102. A 38-year-old female patient received 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot Number: FE1510), via an unspecified route of administration on 21Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history was folic acid supplementation. Concomitant medication included folic acid taken for folic acid supplementation. On 26Jul2021, the patient experienced miscarriage of pregnancy. It was reported that bleeding started approximately 1 week after vaccination. Full miscarriage 29Jul21. Pregnancy adverse effects details: miscarriage. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient no longer pregnant at the time of reporting. The case is serious (medically significant, congenital anomaly). The outcome of miscarriage of pregnancy was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593195 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   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 FE1510 / 2 - / -

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? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014480

Write-up: Miscarriage; dose 1 on 22-MAY-2021, dose 2 on 26-JUL-2021; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID 202108062050589520-ZWAUO, Safety Report Unique Identifier GB-MHRA-ADR 25768061. A 34-year-old female pregnant patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jul2021 at 34 years old (Lot Number: FE1510) as dose 2, single for COVID-19 immunization. Medical history included Miscarriage, pregnancy, Folic acid supplementation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medication included folic acid at 400 ug taken for Folic acid supplementation, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: EW4109) on 22May2021 for COVID-19 immunisation. The patient experienced miscarriage on 04Aug2021. Clinical course: I have had a miscarriage 10 days (as reported) after receiving my second vaccine. Patient no longer pregnant at the time of reporting. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of miscarriage was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1633876 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Inappropriate schedule of product administration
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (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: FRPFIZER INC202101072895

Write-up: Foetal death in utero; 1st dose of Comirnaty on 10Jun2021, 2nd dose on 26Jul2021; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-ST20213106. A 30-year-old pregnant female patient received BNT162B2 (COMIRNATY), 2nd dose intramuscularly on 26Jul2021 (Batch/Lot number and expiration date were not reported) at age of 30 years old as 0.3ml, a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (COMIRNATY, batch/lot number unknown) on 10Jun2021 at 0.3ml, a single dose for COVID-19 immunisation and experienced Maternal Exposure During Pregnancy, second trimester. The patient experienced ''foetal death in utero'' on 09Aug2021 with outcome of Recovered/Resolved with Sequel on an unknown date. The mother reported she became pregnant while taking bnt162b2. The mother was 33 Weeks pregnant at the onset of the event. The fetal outcome is intrauterine death. On Day 14 Fetal death in utero at 33 gestation week + 5 days on a first pregnancy with no particularity in evolution, pending further information. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1642055 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   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 FD0932 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: Blood test; Result Unstructured Data: Test Result: routine blood tests, no results provided
CDC Split Type: DKPFIZER INC202101054717

Write-up: Intrauterine death, affecting management of mother, antepartum.; Maternal exposure during pregnancy; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number DK-DKMA-WBS-0081295. Sender''s (Case) Safety Report Unique Identifier: DK-DKMA-ADR 25719935. A 29-year-old female patient received bnt162b2 (Pfizer), dose 1 intramuscular on 26Jul2021 (Batch/Lot Number: FD0932) as dose 1, single at 29-year-old female for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced maternal exposure during pregnancy on 26Jul2021. On 27Jul2021, intrauterine death affecting management of mother antepartum was reported. The outcome of intrauterine death was not recovered. The events were considered medically significant. The patient underwent lab tests and procedures which included blood test: routine blood tests, no results provided on 27Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1664328 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Inappropriate schedule of product administration, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (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: FOLIC ACID
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (two previous pregnancies); Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101092992

Write-up: Miscarriage; Patient was Breast feeding; Patient was Breast feeding; DOSE 1 on 26May2021; DOSE 2 on 26Jul2021; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108201821212560-AZUJN, Safety Report Unique Identifier GB-MHRA-ADR 25830930. A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jul2021 (Lot number was not reported), at the age of 37-year-old, as single dose for COVID-19 immunisation. Medical history included pregnancy (Patient no longer pregnant at the time of reporting), ongoing breast feeding and two previous pregnancies. No medical conditions, no other medication. Patient has not had symptoms associated with COVID-19. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient previously received first dose of BNT162B2 on 26May2021 for COVID-19 immunization. The patient experienced miscarriage on 17Aug2021 with outcome of recovered on 18Aug2021. The event was reported as serious for being life threatening, hospitalisation, and being medically significant. The patient was breast feeding while taking BNT162B2 is considered as off-label use and drug use in unapproved population. The patient received BNT162B2 dose 1 on 26May2021 and dose 2 on 26Jul2021 which is considered as the inappropriate schedule of vaccine administered. The patient reported that she miscarried at 11 weeks pregnant, but the fetus died in the womb sometime during her 8th week of pregnancy, and at the beginning of her 8th week of pregnancy she received her second COVID vaccination. It was most likely coincidence, but she was reporting it just in case there are others also and it''s worth investigating. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Did the medicine have an adverse effect on any aspect of the pregnancy: Unsure. Details of previous pregnancies: Two previous pregnancies all fine. No previous miscarriages. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient didn''t discuss with any medical practitioner. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101101601 Baby case


VAERS ID: 1667674 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004493 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210810; Test Name: Ultrasound abdomen; Result Unstructured Data: showed missed abortion
CDC Split Type: DKMODERNATX, INC.MOD20212

Write-up: Missed abortion; Maternal exposure during pregnancy, first trimester; This case was received via a regulatory authority (Reference number: DK-DKMA-ADR 25779907) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of ABORTION MISSED (Missed abortion) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, first trimester) in a 36-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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, first trimester) (seriousness criterion medically significant). In August 2021, the patient experienced ABORTION MISSED (Missed abortion) (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. On 26-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, first trimester) had resolved. On 10-Aug-2021, ABORTION MISSED (Missed abortion) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, Ultrasound abdomen: abnormal (abnormal) showed missed abortion. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications are provided, Treatment to the events not reported. Company Comment: This is a case of product exposure during pregnancy with associated abortion missed for this 36-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This is a case of product exposure during pregnancy with associated abortion missed for this 36-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1720591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, 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: Medical History/Concurrent Conditions: Ectopic pregnancy (treated naturally); Pregnancy (1 child)
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: BHCG; Result Unstructured Data: Test Result:147 IU/l; Test Date: 20210724; Test Name: BHCG; Result Unstructured Data: Test Result:148 IU/l; Test Date: 20210726; Test Name: BHCG; Result Unstructured Data: Test Result:152 IU/l; Comments: miscarriage in progress; Test Date: 20210729; Test Name: BHCG; Result Unstructured Data: Test Result:48 IU/l; Test Date: 20210805; Test Name: BHCG; Result Unstructured Data: Test Result:3 IU/l; Test Date: 20210719; Test Name: pregnancy test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101166573

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient) and an other healthcare professional downloaded from the regulatory authority-WEB FR-AFSSAPS-BR20213326. A 28-year-old female patient received the second dose of BNT162b2 (COMIRNATY; lot number: FF3318), intramuscularly in arm right on 21Jul2021 at dose 2, single for COVID-19 immunisation. Medical history included pregnancy, 1 child, and an ectopic pregnancy treated naturally. No other gynecological history. Concomitant medications were not reported. The patient experienced miscarriage on 26Jul2021. The event was reported as serious as important medical event. Clinical course was reported as follows: on 19Jul2021, positive pregnancy test. Date of last period: 20Jun2021. On 22Jul2021, BHCG positive 147 IU/l. On 24Jul2021, BHCG positive 148 IU/l. On 26Jul2021, miscarriage at about 5 amenorrhea weeks. Consultation at gynecological emergencies on 27Jul2021. BHCG 152 IU/l: miscarriage in progress. Blood test on 29Jul2021: BHCG 48 IU/l. Blood test on 05Aug2021: BHCG 3 IU/l. This was the 3rd pregnancy (1 child and an ectopic pregnancy treated naturally). The patient had recovered from the event. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1765988 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Vitiligo
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:pregnancy termination estimated at 7 weeks; Comments: pregnancy termination estimated at 7 weeks on ultrasound
CDC Split Type: FRPFIZER INC202101256639

Write-up: Early miscarriage; This is a spontaneous report from a contactable physician, first of two cases. This is a first report which has been downloaded from the regulatory authority-WEB [FR-AFSSAPS-LY202110240]. This physician reported information for both mother and fetus. This is a maternal report. A 34-years-old female patient received second dose of BNT162B2 (COMIRNATY) intramuscular, administered in Arm Right on 19Jul2021 (Batch/Lot Number: FE1573) as DOSE 2,SINGLE for covid-19 immunization. Medical history included vitiligo from an unknown date. The patient''s concomitant medications were not reported. The patient experienced early miscarriage on 26Jul2021. The mother was 10 Weeks pregnant at the onset of the event. The mother was due to deliver on 19Feb2022. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included ultrasound scan: pregnancy termination estimated at 7 weeks on an unspecified date (pregnancy termination estimated at 7 weeks on ultrasound). Outcome of the event was recovered on an unspecified date. The patient received Comirnaty as 1st dose, batch/lot number FD0785, anatomical location right arm, route of administration intramuscular on 11Jun2021 and experienced Maternal Exposure During Pregnancy, first trimester No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101269631 same patient/drug, different dose/events


VAERS ID: 1807201 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-26
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101323245

Write-up: SPONTANEOUS ABORTION; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority number NO-NOMAADVRE-PASRAPP-2021-U49wej. A 29-year-old female patient received bnt162b2 (COMIRNATY) dose 1 intramuscular in Arm Left on 07Jul2021 10:18 single dose for covid-19 immunisation. Medical history included pregnancy. The patient''s concomitant medications were not reported. The patient experienced spontaneous abortion (medically significant) on 26Jul2021 with outcome of unknown. The mother reported she became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. Reporter''s comments Contact with healthcare professionals: Physician. The patient reports PREGNANCY at the time of the VACCINATION. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Contact with healthcare professionals: Physician. The patient reports PREGNANCY at the time of the VACCINATION.


VAERS ID: 1834442 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (Betulaceae allergy); COVID-19; Vertigo
Allergies:
Diagnostic Lab Data: Test Name: beta-Chorionic Gonadotropin dosage; Result Unstructured Data: Test Result:unknown result; Test Name: ultrasound; Result Unstructured Data: Test Result:unknown result; Test Date: 20211004; Test Name: ultrasound; Result Unstructured Data: Test Result:Fetus without cardiac activity. Pregnancy stopped; Comments: Fetus without cardiac activity. Pregnancy stopped at 7 weeks of amenorrhea (09Sep21).
CDC Split Type: FRPFIZER INC202101384413

Write-up: Miscarriage; patient was 10 weeks pregnant; This is a spontaneous report from a contactable consumer (patient) and other healthcare professional downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-CF20212842. A 28-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), dose 1 intramuscular, administered in Arm Left on 26Jul2021 (at the age of 28years) as dose 1, single for Covid-19 immunization. Medical history included Covid-19 from 02Nov2020 to an unknown date, vertigo, and allergy (Betulaceae allergy). The patient''s concomitant medications were not reported. The patient experienced miscarriage on 04Oct2021. "Medical consultation, emergency room" on an unspecified date. The patient reported she became pregnant while taking bnt162b2. The patient was 10 weeks pregnant at the onset of the event. The patient was due to deliver on 27Apr2022. Consultation of the patient for an ultrasound check 04Oct21 at 10 amenorrhea weeks + 5 days =$g Fetus without cardiac activity. Pregnancy stopped at 7 weeks of amenorrhea (09Sep21); went to the hospital for further treatment." Emergency report: Entry 08Oct21: Pregnancy problem 1st trimester (bleeding, pain) 11 week of pregnancy, 1st ultrasound scheduled for next week. Presence of bleeding for 1 week, in small quantity, this day, more abundant bleeding since 3 pm, associated with pain in the lower abdomen. Eviction would appear to take place this afternoon. First pregnancy, 11 amenorrhea weeks. Metrorrhagia for a week. No pelvic pain, more and more bleeding, brown discharge. 48 hours after discharge beta- Chorionic Gonadotropin dosage, ultrasound. The outcome of event was recovered with sequel. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1861749 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Echo; Result Unstructured Data: Test Result:not provided
CDC Split Type: BEPFIZER INC202101461780

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer or other non healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-107845. A 41-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 26Jul2021 (Batch/Lot Number: FE9174) as DOSE 2, SINGLE (at the age of 41-years old) for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Historical vaccination included first dose of COVID-19 vaccine, MANUFACTURER UNKNOWN on an unspecified date for covid-19 immunization. The patient experienced miscarriage on 26Jul2021 with outcome of unknown. Pregnant at time of vaccination was 1st trimester. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient underwent lab tests and procedures which included ultrasound scan: results not provided on an unspecified date. It was unknown if treatment was received. It was reported that "Second dose administered I heard the baby heart beating perfectly normally on 23Jul2021. Three days later I had myself vaccinated and shortly after the vaccination the baby died". No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Unknown Evolution of the ADR - Deceased Examinations - Echo ADR description - Miscarriage


VAERS ID: 1866135 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1433 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202101490742

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DK-DKMA-WBS-0080275 and Safety Report Unique Identifier DK-DKMA-ADR 25705697. A 32-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FC1433; Expiration Date: 31Oct2021), dose 1 intramuscular on 15Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. There is no information regarding patient medical history or concurrent conditions. There is no information regarding concomitant medication and past medication. On 26Jul2021, the patient experienced abortion spontaneous. It was reported that on 26Jul2021, 11 days after first vaccination was given, the patient developed Abortion spontaneous. The ADRs were by the regulatory authority assessed medically significant due to Abortion spontaneous (Abortion spontaneous) being on the RA list. No treatment or medical procedure due to the ADRs was reported. On 12Aug2021 the patient was vaccinated with 2nd dose of Comirnaty (Batch number: FD4555) dosed 1DF for COVID-19 immunisation. There is no information regarding test results. The outcome of abortion spontaneous was not resolved. No follow-up attempts possible. No further information expected


VAERS ID: 1752831 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-05-04
Onset:2021-07-27
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038B21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 024C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage, Human chorionic gonadotropin, Ultrasound foetal abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: FIRST TRIMESTER MISCARRIAGE CONFIRMED POST VACCINE BY ULTRASOUND AND Beta HCG. Patient is recovering from physical and emotional trauma. Will continue to follow.
CDC Split Type:

Write-up: Miscarriage / heavy bleeding, 07/2021


VAERS ID: 1558051 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Sertraline 75mg PregOmega plus multivitamin Iron supplement
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Miscarried at 18 weeks. Bleeding started 1 day after receiving dose. I have had 2 healthy pregnancies prior.


VAERS ID: 1579544 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-07-27
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Congestive cardiomyopathy, Haemoglobin, Haemorrhage, Maternal exposure during pregnancy, Morning sickness, SARS-CoV-2 test, Scan, Ultrasound scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Cardiomyopathy (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage
Allergies:
Diagnostic Lab Data: Test Name: iron count; Result Unstructured Data: Test Result:Good iron count (14); Test Date: 20210728; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Scan; Result Unstructured Data: Test Result:death at approx. 9 weeks; Comments: 12 weeks scan revealed death at 9 weeks; Test Name: ultrasound; Result Unstructured Data: Test Result:no signs of infection
CDC Split Type: GBPFIZER INC202100992016

Write-up: blood loss; morning sickness; cervix dilated; Maternal exposure during pregnancy; Spotting; Miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108021934539200-N5LJ3, Safety Report Unique Identifier is GB-MHRA-ADR 25743259. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Apr2021 (Expiry date not reported) as DOSE 1, single for COVID-19 immunization. Medical history included abortion spontaneous (miscarriage) and vitamin supplementation (folic acid supplementation). Healthy mother with previous uncomplicated birth. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was pregnant at the time of vaccination but was no longer pregnant at the time of reporting. Concomitant medication included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient experienced cervix dilated on an unspecified date with outcome of unknown, blood loss on an unspecified date with outcome of unknown, miscarriage on 27Jul2021 with outcome of recovering, morning sickness on an unspecified date with outcome of unknown, spotting on 27Jul2021 with outcome of unknown, and maternal exposure during pregnancy on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included haemoglobin: good iron count (14) on an unspecified date, sars-cov-2 test: negative on 28Jul2021 No - Negative COVID-19 test, scan: death at approx. 9 weeks on 12 weeks scan revealed death at 9 weeks, and ultrasound scan: no signs of infection on an unspecified date. The events cervix dilated, blood loss, miscarriage, morning sickness and spotting were reported as life-threatening by the health authority. Blood loss resulted to hospitalization. Case narrative: Began as normal pregnancy. No complications or problems advised at 8 week midwifery appointment. Morning sickness ceased at 9 weeks. Spotting began 27Jul2021. Visit to maternity unit resulted in ultrasound as no signs of infection. Scan revealed death at approx. 9 weeks. Returned home to miscarry naturally. Cervix dilated and fetus passed but incomplete on evening of 28Jul2021 resulting in rapid heavy blood loss (2 litres greater) and admission to hospital. WHO recommendation that Neither Moderna not Pfizer Ben given to pregnant or expecting women. Patients best friend also received jab with exactly the same result - miscarriage at 8/9 weeks approx. Prime Minister''s wife recently revealed miscarriage in Jan2021 - following vaccination. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The medicine had an adverse effect on any aspect of the pregnancy. Pregnancy adverse effects details: Miscarriage occurred at 9 weeks. Silently miscarriage with spotting beginning at 12 weeks. Details of previous pregnancies: No complications previous pregnancy (1 son 2 years old) healthy mother. Good iron count (14). Silent miscarriage. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: 12 weeks scan revealed death at 9 weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1579943 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-07-27
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: ; This case was received via regulatory authority (Reference number: 00646439) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS in a 31-year-old female patient who received mRNA-1273 (batch no. 3002537) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-May-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 11-Jun-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 27-Jul-2021, after starting mRNA-1273 , the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. The delivery occurred which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS and MATERNAL EXPOSURE DURING PREGNANCY outcome 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 the associated AE of abortion spontaneous for this 31-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The causality for maternal exposure during pregnancy is not applicable. Further information is not expected.; Sender''s Comments: This is a case of product exposure during pregnancy with the associated AE of abortion spontaneous for this 31-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The causality for maternal exposure during pregnancy is not applicable. Further information is not expected.


VAERS ID: 1660371 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-27
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion, Blood test, Bradycardia, Bradycardia foetal, Corneal endothelial microscopy, Haemorrhage, Maternal exposure during breast feeding, Off label use, Product use issue, SARS-CoV-2 test, Ultrasound scan vagina
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Congenital and neonatal arrhythmias (broad), Neonatal exposures via breast milk (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CY
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: routine blood investigations; Result Unstructured Data: Test Result:unknown; Test Name: Fetal bradycardia; Result Unstructured Data: Test Result:unknown; Test Name: Speculum examination; Result Unstructured Data: Test Result:unknown; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: transvaginal ultrasound; Result Unstructured Data: Test Result:unknown
CDC Split Type: GBPFIZER INC202101081116

Write-up: bradycardia; bleeding; Maternal exposure during breast feeding; Drug use in unapproved population; Off-label use; Abortion; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is and Safety Report Unique Identifier is . A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW3143), dose 2 via an unspecified route of administration on 09Jul2021 as dose 2, single for covid-19 immunisation. Medical history included pregnancy, pregnancy. Patient no longer pregnant at the time of reporting , ongoing breast feeding. Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation; ascorbic acid, betacarotene, biotin, calcium pantothenate, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, magnesium, nicotinamide, phytomenadione, pyridoxine hydrochloride, riboflavin, selenium, thiamine mononitrate, tocopheryl acid succinate, zinc (PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;IRON;MAGNESIUM;NICOTINAMIDE;PHYTOMENADIONE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;SELENIUM;THIAMINE MONONITRATE;TOCOPHERYL) from 15Jul2021 to 18Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced bradycardia, bleeding, maternal exposure during breast feeding. On 27Jul2021, the patient experienced abortion (medically significant). First bleeding start around 3 weeks post vaccination (end of Jul2021). It was streak of blood and only once. Then following next week (early Aug/2021) it bleeds again. One episode. Two weeks later, On 12Aug2021 more bleeding occured. Went to gynaecology emergency unit and get it checked. It was threatened abortion at this stage with fetak bradycardia and small gestational week. The bleeding continues for a week and result in misscarriage on 18Aug2021. Tissue of fetus was expelled. Waiting for scan on 26Aug2021 to determine either it''s completed or incomplete misscarriage. Was unsure if the medicine had an adverse effect on any aspect of the pregnancy. Details of previous pregnancies: Bleeding per vagina and following misscarriage. First pregnancy in 2017 was successfull. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included sars-cov-2 test: negative. No - Negative COVID-19 test, blood test: unknown, bradycardia foetal: unknown, corneal endothelial microscopy: unknown, sars-cov-2 test: negative. No - Negative COVID-19 test, ultrasound scan vagina: unknown. The outcome of the event abortion was reported as not recovered and outcome of all the other events was reported as unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1668365 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-07-27
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101105604

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108242354587870-Y8ORJ. Safety Report Unique Identifier GB-MHRA-ADR 25844412 A 33-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration on 26May2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included pregnancy. The patient''s concomitant medications were not reported. The patient experienced miscarriage on 27Jul2021 with outcome of recovering. Seriousness criteria reported as medical significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. 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. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1715991 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage, Maternal exposure during pregnancy, Product use issue
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (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 INC202101155415

Write-up: Miscarriage; Beginning of bleeding 4 days after vaccination; Drug use in unapproved population; Maternal Exposure During Pregnancy, first trimester; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-RN20212662.This consumer reported information for both mother and fetus/baby. This is a maternal report. A 32-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot number: FE8244 and expiry date was no reported), intramuscularly in Arm right on 27Jul2021,as single dose for covid-19 immunization. The patient was pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number and expiry date was no reported), via unspecified route of administration, on unspecified date, as single dose for covid-19 immunization. The patient reported she became pregnant while taking bnt162b2. The patient was 1 Trimester pregnant at the onset of the event. On an unspecified date in 2021 the patient experienced maternal exposure during pregnancy, first trimester and on 27Jul2021 the patient experienced drug use in unapproved population. On 31Jul2021, Beginning of bleeding 4 days after vaccination and miscarriage noticed by a gynaecologist the following week during a check-up. Outcome of the events were recovered with sequel on an unspecified date. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1789242 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-27
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101300930

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109301016192070-ZMLVK, Safety Report Unique Identifier GB-MHRA-ADR 26014962. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jun2021 (at the age of 25-year-old) (Lot Number: FD5613) as dose 1, single for COVID-19 immunisation. Medical history included pregnancy (patient no longer pregnant at the time of reporting), vitamin supplementation. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. Patient was not enrolled in clinical trial. The patient experienced maternal exposure during pregnancy in 2021, miscarriage (medically significant) on 27Jul2021 with outcome of unknown. Patient was exposed to the medicine Before pregnancy. Patient had not a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1806829 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-27
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: Maternal exposure during pregnancy; Miscarriage of pregnancy; This case was received (Reference number: GB-MHRA-ADR 26068420) on 13-Oct-2021 and was forwarded to Moderna on 13-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage of pregnancy) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Pregnancy (Patient no longer pregnant at the time of reporting.). Concomitant products included FOLIC ACID for Folic acid supplementation. On an unknown date, the patient received 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 27-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage of pregnancy) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 27-Jul-2021, ABORTION SPONTANEOUS (Miscarriage of pregnancy) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was exposed to the medicine first-trimester (1-12 weeks). Company Comment: This case of Maternal exposure during pregnancy concerns a 39-year-old, female patient with no relevant medical history, who experienced the unexpected event of Abortion spontaneous. The patient received the dose of Moderna CoviD-19 Vaccine in the first trimester of pregnancy. Spontaneous abortion occurred on 27-Jul-2021. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case of Maternal exposure during pregnancy concerns a 39-year-old, female patient with no relevant medical history, who experienced the unexpected event of Abortion spontaneous. The patient received the dose of Moderna CoviD-19 Vaccine in the first trimester of pregnancy. Spontaneous abortion occurred on 27-Jul-2021. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1807177 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Interchange of vaccine products, Off label use, Pregnancy test
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data: Test Date: 20210314; Test Name: Positieve pregnancy test; Test Result: Positive ; Test Date: 20210816; Test Name: Positieve pregnancy test; Test Result: Positive
CDC Split Type: NLPFIZER INC202101339752

Write-up: Miscarriage at 9 weeks of pregnancy. Embryo died at 6+3 weeks.; Off-Label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority NL-LRB-00691090. A 40-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 27Jul2021 (Lot Number: Unknown) as DOSE 2 (INITIAL PFIZER DOSE), SINGLE for COVID-19 immunisation. Medical history included disease risk factor from. The patient''s concomitant medications were not reported. The patient previously received first dose of covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), Covid-19 vaccine Astrazeneca dispersion for injection on 24Feb2021 for COVID-19 immunisation, a positive pregnancy test was on 14Mar2021 and experienced a miscarriage at a pregnancy duration of about 15 weeks. The patient experienced Interchange of vaccine products and off label use on 27Jul2021. This was the second vaccination (Pfizer), which took place on 27Jul2021, after which the pregnancy test was positive on 16Aug2021. Embryonic demise happened at a pregnancy duration of 6 weeks and 3 days and she had a miscarriage at a pregnancy duration of about 9 weeks. The outcome of event was unknown. Sender Comment: Seriousness of miscarriage was changed from "death" to "other medically important condition". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1675804 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-02-02
Onset:2021-07-28
   Days after vaccination:176
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Caesarean section, Exposure during pregnancy, Macrosomia, Placenta praevia, Premature delivery, Premature separation of placenta, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: pre-natal
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Confirmed pregnancy on 1/25/21, estimated due date 8/22/21. Diagnosed with placenta previa on 3/22/21. On 7/28/21, experienced vaginal bleeding. Was admitted to hospital with vaginal bleeding, placenta previa and macrosomia which all required urgent c-section. During c-section, also noted placental abruption. Baby was born prematurely, underdeveloped lungs and required a NICU stay of 7 days.


VAERS ID: 1637914 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 2 - / -

Administered by: Other       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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: Ultrasound; Result Unstructured Data: Test Result:Normal immediate ultrasound control; Test Date: 20210730; Test Name: Ultrasound; Result Unstructured Data: Test Result:fetus with negative heartbeat; Comments: 48 hours after vaccination
CDC Split Type: ESPFIZER INC202101032013

Write-up: Abortion missed; Metrorrhagia; pregnant female patient received COMIRNATY dose 2; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is ES-AEMPS-968509. A 36-year-old pregnant female patient received BNT162B2 (COMIRNATY; lot number: FF2752), via an unspecified route of administration in the arm on 28Jul2021, dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY; lot number: FE3065) administered via an unspecified route of administration in the arm on 07Jul2021, dose 1, single for COVID-19 immunisation. On 28Jul2021, at two hours after the vaccination, the pregnant patient had metrorrhagia. The patient had a normal immediate ultrasound control. A new control done at 48 hours after vaccination showed fetus with negative heartbeat, diagnosed as deferred abortion (abortion missed) on 30Jul2021. The event abortion missed was assessed as serious (medically significant). The outcome of the event abortion missed was reported as recovered on 30Jul2021 and outcome of other events was unknown. No follow-up attempts are possible; No further information is expected.


VAERS ID: 1638141 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-07-28
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101038751

Write-up: Pregnancy loss <20 weeks gestation; maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-ST20213031. A 32-years-old female patient received the second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 15Jun2021 (Batch/Lot Number: FC5435) as Dose 2, 0.3 mL single for covid-19 immunisation. Medical history included ongoing obesity. The patient''s concomitant medications were not reported. The patient experienced pregnancy loss <20 weeks gestation on 28Jul2021. The patient was hospitalized for the event on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The mother was 1 Trimester pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20May2021. Therapeutic measures were taken as a result of pregnancy loss <20 weeks gestation included operation. Outcome of the event was recovered with sequelae on 28Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1671644 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300608 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test; Test Date: 20210719; Test Name: Ultrasound; Test Result: Inconclusive ; Result Unstructured Data: Heartbeat seen.; Test Date: 20210728; Test Name: Ultrasound; Test Result: Inconclusive ; Result Unstructured Data: 12 week scan and baby had died.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: missed miscarriage; Maternal exposure during pregnancy; Miscarriage of pregnancy; This case was initially received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25847741) on 26-Aug-2021. The most recent information was received on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (missed miscarriage), ABORTION SPONTANEOUS (Miscarriage of pregnancy) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 300608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased (Lactation decreased) and Pregnancy (Patient no longer pregnant at the time of reporting.). Concomitant products included FOLIC ACID for Folic acid supplementation. On 27-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage of pregnancy) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ABORTION SPONTANEOUS (missed miscarriage) (seriousness criteria hospitalization and medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion hospitalization). The cesarean delivery occurred on 28-Jul-2021, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. Patient was exposed to the medicine first-trimester (1-12 weeks). On the 19-Jul-2021 at 6.5 weeks gestation a heartbeat was seen on a scan. According to 2x sonographers and a senior Gyno consultant on 20-Aug-2021 at a routine12 week scan baby had died on 28-Jul-2021 at 7 plus 6 days gestation. The diagnosis was that of a missed miscarriage and this was treated with surgical management. At the time of the report, ABORTION SPONTANEOUS (missed miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown and ABORTION SPONTANEOUS (Miscarriage of pregnancy) was resolving. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2021, Ultrasound scan: not provided Heartbeat seen.. On 28-Jul-2021, Ultrasound scan: 12 week scan 12 week scan and baby had died.. 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. Treatment included Surgical management. Company Comment: This is a case of Maternal exposure during pregnancy with associated AE (Abortion spontaneous) for this 37-year-old female. Patient was exposed to the medicine during first trimester of pregnancy. This being a report from a regulatory authority, there are no contact details, hence no further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow-up document received, include Laboratory data was added and Checked event cause hospitalization and Hospitalization prolonged was unchecked in the events tab and treatment information added in I narrative supplement.; Sender''s Comments: This is a case of Maternal exposure during pregnancy with associated AE (Abortion spontaneous) for this 37-year-old female. Patient was exposed to the medicine during first trimester of pregnancy. This being a report from a regulatory authority, there are no contact details, hence no further information is expected.


VAERS ID: 1716630 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal death, Haemorrhage in pregnancy, Inappropriate schedule of product administration, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow)

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: Menstruation abnormal; Miscarriage (1 miscarriage, "A four-year-old")
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: ultrasound; Result Unstructured Data: Test Result:couldn''t see formed embryo well,; Comments: but could hear heartbeat.; Test Date: 20210731; Test Name: ultrasound; Result Unstructured Data: Test Result:heart stopped beating
CDC Split Type: FRPFIZER INC202101155243

Write-up: Miscarriage; miscarriage/ Loss of baby; blood loss; patient received the first dose of COMIRNATY on 26May2021 and the second dose on 28Jul2021; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-LL20215923. This physician reported information for both mother and fetus/baby. This is the maternal report. A 28-year-old female patient received BNT162B2 (COMIRNATY, lot number: FF0680), intramuscular in left arm on 28Jul2021 (at the age of 28-years-old) at dose 2, single for COVID-19 immunisation. Medical history included 1 miscarriage from 01Mar2021 to 01Mar2021 which was not ongoing and was reported as "a four-year-old" and peculiar periods from 25May2021. She was not considered to be at risk and has no history of COVID and was not tested for it. Concomitant medications were reported as none. She has no long-term treatment. The patient previously received BNT162B2 (COMIRNATY, lot number and expiration date were not provided), via an unspecified route of administration on 26May2021 at dose 1, single for COVID-19 immunisation. She was pregnant at the time of first vaccination. The date of start of pregnancy according to the gynaecologist was 20May2021. On 25May2021, the patient described peculiar periods. The patient received the first dose of COMIRNATY on 26May2021. On 20Jul2021, ultrasound could not see formed embryo well, but could hear the heartbeat. The patient received the second dose of COMIRNATY on 28Jul2021 and on 30Jul2021, she experienced blood loss and she suffered a miscarriage and lost her baby on 31Jul2021. Ultrasound on 31Jul2021 showed that the fetus'' heart stopped beating. Loss of baby was also stated to have occurred at "estimated at 12 weeks + 4 days of gestation" by the gynaecologist (as reported). The outcome of the event miscarriage was not recovered an unknown for all other events. Note: Accountability without prejudice to the elements of investigation which could be carried out as part of legal or amicable compensation procedures. Comments: complete documentation. Additional information obtained by the regulatory authority. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101205844 fetus case


VAERS ID: 1739564 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Asthenopia, Headache, Human chorionic gonadotropin, Pain in extremity, Photophobia, Pregnancy test, Vision blurred, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOMETASON SANDOZ
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Nasal congestion; Nasal polyps; Non-smoker; Tinnitus
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood human chorionic gonadotrophin; Result Unstructured Data: Test Result:4; Test Date: 2021; Test Name: Blood human chorionic gonadotrophin; Result Unstructured Data: Test Result:0; Test Date: 20210805; Test Name: Blood human chorionic gonadotrophin; Result Unstructured Data: Test Result:34; Comments: 34; Test Date: 20210812; Test Name: Blood human chorionic gonadotrophin; Result Unstructured Data: Test Result:21; Comments: 21.; Test Date: 20210727; Test Name: Pregnancy test; Test Result: Negative ; Test Date: 20210729; Test Name: Pregnancy test; Test Result: Negative ; Test Date: 20210802; Test Name: Pregnancy test; Test Result: Positive
CDC Split Type: NOPFIZER INC202101193814

Write-up: possible miscarriage/ SPONTANEOUS ABORTION; Spots before eyes; Light sensitivity to eye; The vision has also become more blurred, I feel.; HEADACHE; his eyes felt strained; This lasted throughout the day at the same time as I had increased pain in my arm which then lasted for a couple of days; This is a spontaneous report from a non-contactable consumer (patient) downloaded from the regulatory authority-WEB NO-NOMAADVRE-PASRAPP-2021-U15arx. A 35-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left arm on 28Jul2021 10:47 (Batch/Lot number was not reported) (at the age of 35 years old) as dose 1, single for COVID-19 immunization. Medical history included nasal polyps, nasal congestion, tinnitus and non-smoker. The patient does not have any known diseases, good health, rarely drinks alcohol, and is on no special diets. Concomitant medications included mometasone furoate (MOMETASON SANDOZ) (The patient reports using Mometazone sandoz (generic to Nasonex)) taken for nasal polyps and chronic nasal congestion from 13Jun2021 to 29Aug2021. At the vaccination time she had finished 7 weeks of the treatment. A couple of minutes after vaccination with Pfizer on 28Jul2021, she experienced headache and eye strain. This lasted throughout the day at the same time as I had increased pain in my arm which then lasted for a couple of days. The eye strain continued, and 4-5 days later she experienced spots before eyes. She had not experienced this before, and it was perceived as troublesome when reading on big screens, or moved the eyes in a light room. It looks like a rain of streaks and dots when the eyes moved vertically, and horizontally. Description as reported for event light sensitivity to eye: The eyes continued and felt strained and 4-5 days later she suddenly get a lot of shadows on my eyesight. This was something she has not had before and find it annoying when she read on big screens or move her gaze in a bright room. She also experience more of a cloudy vision. It was first after receiving the vaccine that she experienced spots before eyes and cloudy vision (in Aug2021). She was not sure if it was caused by the vaccine, but reported it as a precaution. In Aug2021, the patient experienced possible miscarriage. The patient reported she became pregnant while taking bnt162b2. The mother was 5 weeks pregnant at the onset of the event. The patient was approximately 4 weeks pregnant at the time of vaccination (as reported). Patient reported that she knew that she and her husband had been a bit careless one day. As her menstruation did not arrive at the expected time she took a new pregnancy test which showed a weak positive result on 02Aug2021. This was 5 days after the 1st dose, and since she knows the time of fertilization she was approximately 4 weeks pregnant at the vaccination time. The pregnancy was therefore caught early in the pregnancy. Approximately, 1 week after vaccination, spontaneous abortion which was proven by blood human chorionic gonadotropin taken with 1 week intervals to the test went to 0. The first blood human chorionic gonadotropin was taken 05Aug2021 and had a value of 34, one week later it was 21, thereafter 4, and then 0. The patient developed spots/streaks before eyes, spontaneous abortion, headache, eye strain, pain in arm, cloudy vision and light sensitivity to eye. Relevant laboratory findings and investigations included pregnancy test: negative on 27Jul2021, negative on 29Jul2021, and positive on 02Aug2021; and blood human chorionic gonadotropin on 34 05Aug2021, 21 on 12Aug2021, 4 on unknown date in 2021 and 0 on unknown date in 2021. The case was considered to be Serious due to (Other Serious (Important Medical Events)). The event spontaneous abortion was recovered in Aug20121; event spots before eyes was not recovered; and unknown outcome for the other events. The regulatory authority did not provide a causality assessment. Reporter Comment: The reporter reports not having any known diseases, good health, rarely drinks alcohol, and is on no special diets, NON-SMOKER, and has TINNITUS. At the vaccination time she was on a 12-week treatment with Mometazone Sandoz cortison nasal spray (same as Nasonex) to treat CHRONIC NASAL CONGESTION. At the vaccination time she had finished 7 weeks of the treatment. It was first after receiving the vaccine that she experienced SPOTS BEFORE EYES and CLOUDY VISION. She is not sure if it is caused by the vaccine, but reports it as a precaution. A couple of minutes after vaccination with Pfizer she experienced HEADACHE, and EYE STRAIN. This went on throughout the day simultaneously as she felt an increasing PAIN IN ARM, which lasted for a couple of days. The EYE STRAIN continued, and 4-5 days later she experienced SPOTS BEFORE EYES. She had not experienced this before, and it was perceived as troublesome when reading on big screens, or moved the eyes in a light room. It looks like a rain of streaks and dots when the eyes moved vertically, and horizontally. She also experience more of a CLOUDY VISION. 27Jul2021: Negative PREGNANCY TEST. 29Jul2021: Negative PREGNANCY TEST. 02Aug2021: She knew that she and her husband had been a bit careless one day. As her menstruation did not arrive at the expected time she took a new PREGNANCY TEST which showed a weak positive result. This was 5 days after the 1st dose, and since she knows the time of fertilization she was approximately 4 weeks pregnant at the vaccination time. The pregnancy was therefore caught early in the pregnancy. Approximately 1 week after vaccination: SPONTANEOUS ABORTION which was proven by BLOOD HUMAN CHORIONIC GONADOTROPHIN taken with 1 week intervals to the test went to 0. The first BLOOD HUMAN CHORIONIC GONADOTROPHIN was taken 05Aug2021 and had a value of 34, one week later it was 21, thereafter 4, and then 0. Latency of SPOTS/STREAKS BEFORE EYES is reported to be 4-6 days. Latency of SPONTANEOUS APORTION is reported to be a little over 1 week. Sender Comment: Upgraded to Serious due to spontaneous abortion: Important Medical Events. No follow-up attempts are possible; Information on batch/lot number cannot be obtained. No further information is expected.; Reporter''s Comments: Summary: Relevant Med History: NON-SMOKER, TINNITUS. Concomitant: Mometazone Sandoz Events: SPOTS BEFORE EYES, CLOUDY VISION, HEADACHE, EYE STRAIN, PAIN IN ARM, SPONTANEOUS ABORTION. Lab Data: PREGNANCY TEST (3 times), BLOOD HUMAN CHORIONIC GONADOTROPHIN (4 times). Approximately 4 weeks pregnant at the vaccination time. Approximately 1 week after vaccination: SPONTANEOUS ABORTION.


VAERS ID: 1796911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-28
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101312983

Write-up: Miscarriage at 10 weeks; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB [NL-LRB-00689415]. A 31-year-old pregnant female patient received the second dose of BNT162B2 (COMIRNATY solution for injection; lot number: unknown), via an unspecified route of administration on 20Jul2021 (at an unspecified age) at dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has no history of COVID-19 infection. Historical vaccine included the first dose of BNT162B2 (COMIRNATY) received on 15Jun2021 for COVID-19 immunisation at dose 1, single and experienced feeling intoxicated and maternal exposure during pregnancy, first trimester. The patient was 9 weeks pregnant at the time of second dose vaccination. On 28Jul2021, a week after the second dose vaccination, the patient experienced miscarriage at 10 weeks of pregnancy. Outcome of the event was unknown. Sender''s Comment: seriousness of miscarriage was changed from "death" to "other medically important condition". Reporter''s comment: Past drug therapy with BioNTech/Pfizer vaccine (COMIRNATY) (first dose) on 15Jun2021 with normal side effects such as feeling intoxicated all day as if had a lot of alcohol. Vaccine exposure during pregnancy at first dose. The patient experienced miscarriage at 10 weeks of pregnancy a week after the second dose vaccination. The patient has no history of COVID-19 infection. 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 with BioNTech/Pfizer vaccine (COMIRNATY) (first dose) on 15Jun2021 with normal side effects such as feeling intoxicated all day as if had a lot of alcohol. Vaccine exposure during pregnancy at first dose. The patient experienced miscarriage at 10 weeks of pregnancy a week after the second dose vaccination. The patient has no history of COVID-19 infection.


VAERS ID: 1819466 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Body temperature, Catarrh, Human chorionic gonadotropin, Investigation, Myalgia, Odynophagia, Pregnancy test, Pyrexia, SARS-CoV-2 test, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210914; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Test Date: 20210827; Test Name: Human chorionic gonadotropin; Result Unstructured Data: Test Result:732.4; Test Date: 20210828; Test Name: Human chorionic gonadotropin; Result Unstructured Data: Test Result:2441; Test Date: 20210921; Test Name: Human chorionic gonadotropin; Result Unstructured Data: Test Result:1500; Test Date: 20210923; Test Name: Human chorionic gonadotropin; Result Unstructured Data: Test Result:500; Test Date: 20210904; Test Name: investigation; Result Unstructured Data: Test Result:gestational sac was identified; Comments: gestational sac was identified that corresponds to 5+2 weeks; Test Date: 20210827; Test Name: pregnancy test; Test Result: Positive ; Test Date: 20210914; Test Name: COVID-19 rapid POC test; Test Result: Negative ; Test Date: 20210915; Test Name: ultrasound; Result Unstructured Data: Test Result:the sac was oblate and the fetal pole was without; Comments: the sac was oblate and the fetal pole was without cardiac function and corresponded to a fetus of 5+3 weeks; Test Date: 20210922; Test Name: ultrasound; Result Unstructured Data: Test Result:remnants of the tissue of the chorionic villus wit; Comments: remnants of the tissue of the chorionic villus with accompanying small vaginal bleeding
CDC Split Type: GRPFIZER INC202101350411

Write-up: FIRST SEMESTER MISCARRIAGE OF PREGNANCY; Swallowing painful; Feverish; Catarrh; Myalgia; Arthralgia; fever of 38 degrees Celsius; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number GR-GREOF-202108472. A 37-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 27Jul2021, at the age of 37 years, (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced first semester miscarriage of pregnancy on 15Sep2021. On 28Jul2021, patient experienced myalgia, arthralgia and fever of 38 degrees Celsius. On 14Sep2021 patient experienced swallowing difficult, feverish and catarrh. The clinical course was reported as follows: The next day she presented with fever of 38 degrees Celsius with accompanying arthralgia and myalgia that lasted for 24 hours. She received paracetamol and the symptoms subsided. 30 days later on 27Aug2021 she had a positive pregnancy test (bHCG=732.4 on 27Aug2021, bHCG=2441 on 28Aug2021). On 04Sep2021 a gestational sac was identified that corresponds to 5+2 weeks. On 14Sep2021 she presented with catarrh and painful swallowing and mild fever up to 37.5 degrees Celsius with a negative Rapid COVID-19 test. On 15Sep2021 she was examined by the reporting obstetrician for the viability of the pregnancy but from the ultrasound the sac was oblate and the fetal pole was without cardiac function and corresponded to a fetus of 5+3 weeks. The pregnancy is characterized as missed abortion. The next day the patient reported increased vaginal bleeding with clots. On 22Sep2021 on the ultrasound there are remnants of the tissue of the chorionic villus with accompanying small vaginal bleeding. The bHCG =1500 on 21Sep2021 and bHCG=500 on 23Sep2021. In conclusion, it was a first semester miscarriage with direct temporal link to the second dose of the vaccine Comirnaty according to the reporting obstetrician. The outcome for the event first semester miscarriage of pregnancy was recovering; outcome for myalgia, arthralgia and fever of 38 degrees Celsius was recovered on 29Jul2021; outcome for swallowing difficult, feverish and catarrh was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516537 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, Maternal exposure during pregnancy, Progesterone
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: Benadryl, albuterol, Pepcid, melatonin, Lexapro, klonopin, simethicone
Current Illness: None
Preexisting Conditions: Asthma
Allergies: None
Diagnostic Lab Data: Hcg and progesterone levels to confirm lack of pregnancy
CDC Split Type:

Write-up: Pregnancy loss 2 days after receiving 2nd dose


VAERS ID: 1569080 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-05-27
Onset:2021-07-29
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin decreased, 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), Normal pregnancy conditions and outcomes (narrow), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft Fish oil Prenatal Vitamin daily Vitamin B complex once weekly Vitamin D3
Current Illness: Pregnancy starting May 28, 2021 (first day last menstrual cycle)
Preexisting Conditions: Asthma Obesity
Allergies: Minocycline- hives
Diagnostic Lab Data: Intravaginal ultrasound- no fetal pulse HCG- dropping level
CDC Split Type:

Write-up: Miscarriage Treatment- D&C x2


VAERS ID: 1691926 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 024021A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Deep vein thrombosis, Dizziness, Fear, Gait disturbance, Haemorrhage, Illness, Maternal exposure during pregnancy, Pain, Pain in extremity, Pregnancy test, Ultrasound scan
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: DVT (History of DVT with her first pregnancy 4 years ago but hasn''t been taking blood thinners or presented any symptoms since); Pregnancy (her first pregnancy 4 years ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: DVT; Test Result: Negative ; Result Unstructured Data: tested negative for DVT (Deep vein thrombosis).; Test Date: 20210801; Test Name: Pregnancy Test; Test Result: Positive ; Result Unstructured Data: She was three weeks a long, got pregnant between the two doses.; Test Date: 20210820; Test Name: sonogram; Test Result: Inconclusive ; Result Unstructured Data: confirmed that everything came out
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: crumping (in pain); miscarriage; bleeding/ still bleeding "so heavy"/ still bleeding; felt dizzy; pain in her left calf; feared a blood clot; so much pain she couldn''t walk/limping; whole body was sick; Maternal exposure during pregnancy; hand was hurting/hand was sore; This spontaneous retrospective pregnancy case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (miscarriage) and HAEMORRHAGE (bleeding/ still bleeding "so heavy"/ still bleeding) in a 40-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included DVT (History of DVT with her first pregnancy 4 years ago but hasn''t been taking blood thinners or presented any symptoms since) and Pregnancy (her first pregnancy 4 years ago). Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 29-Jul-2021, the patient experienced ILLNESS (whole body was sick), PAIN IN EXTREMITY (hand was hurting/hand was sore) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 30-Jul-2021, the patient experienced GAIT DISTURBANCE (so much pain she couldn''t walk/limping). On 01-Aug-2021, the patient experienced FEAR (feared a blood clot) and PAIN IN EXTREMITY (pain in her left calf). On 06-Aug-2021, the patient experienced ABORTION SPONTANEOUS (miscarriage) (seriousness criterion medically significant), HAEMORRHAGE (bleeding/ still bleeding "so heavy"/ still bleeding) (seriousness criterion medically significant) and DIZZINESS (felt dizzy). On 20-Aug-2021, the patient experienced PAIN (crumping (in pain)). The delivery occurred on 06-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 29-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (miscarriage), ILLNESS (whole body was sick), FEAR (feared a blood clot), DIZZINESS (felt dizzy), GAIT DISTURBANCE (so much pain she couldn''t walk/limping), PAIN (crumping (in pain)), PAIN IN EXTREMITY (hand was hurting/hand was sore) and PAIN IN EXTREMITY (pain in her left calf) outcome was unknown and HAEMORRHAGE (bleeding/ still bleeding "so heavy"/ still bleeding) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Deep vein thrombosis: negative (Negative) tested negative for DVT (Deep vein thrombosis).. On 01-Aug-2021, Pregnancy test: positive (Positive) She was three weeks a long, got pregnant between the two doses.. On 20-Aug-2021, Ultrasound scan: inconclusive (Inconclusive) confirmed that everything came out. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 01-Aug-2021, the patient went to emergency department. On 20-Aug-2021, she had a sonogram and confirmed everything came out. Treatment medication were not reported. Action taken was not applicable. This is a case of maternal exposure during pregnancy with associated AEs of abortion spontaneous, haemorrhage, illness, fear, dizziness, gait disturbance, pain and pain in extremity. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-303234 (Patient Link).; Sender''s Comments: This is a case of maternal exposure during pregnancy with associated AEs of abortion spontaneous, haemorrhage, illness, fear, dizziness, gait disturbance, pain and pain in extremity. 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: 1554636 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100975273

Write-up: bleeding/We were cleaning up pools and pools of blood all night; heart breaking/my partner has been very poorly; Maternal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer or other non hcp received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202107300713472400-RVR4E. Safety Report Unique Identifier GB-MHRA-ADR 25730895. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included miscarriage, pregnancy (Patient no longer pregnant at the time of reporting, two pregnancies in the past) and folic acid supplementation. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation. It was reported that the patient was almost 10 weeks pregnant, she had the vaccine 1 week ago (as reported). Up until now, it has been the perfect pregnancy, just like her other two. There is too much of a coincidence for there not to be a link. There needs to be more awareness out there, it was mentioned that they cannot sit back and allow others to go through this. They were cleaning up pools and pools of blood all night, this is heart breaking. The patient was promised the vaccine would be 100% safe for pregnant people, although they were hesitant, they trusted the advice of the professionals and wanted to show their support for the vaccine and for the Country. They feel cheated and heart broken, this will stay with them forever. The patient began to bleed on an unspecified date and after calling the doctor, they were told not to worry and that bleeding is very common in the first trimester, she went on to say that they will have a scan. Overnight, the patient has been very poorly and thought that it''s clear what the answer will be when she have the scan. At 10 weeks pregnant, the patient suffered a miscarriage on 29Jul2021. Exactly 1 week after her second Pfizer vaccine (as reported). Patient was exposed to the medicine first-trimester (1-12 weeks). The patient will be going for a scan today to verify. The patient was reported as a very healthy individual. The events bleeding and miscarriage were assessed as serious (medically significant). The outcome of the event bleeding was recovering, while unknown for the rest of the events. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1630252 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREGABALIN PFIZER
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRPFIZER INC202101061918

Write-up: Spontaneous abortion; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB regulatory authority number HR-HALMEDAPP-202107301414508240-WB0OS, Safety Report Unique Identifier HR-HALMED-300050289. A 30-years-old female patient received bnt162b2 (COMIRNATY), intramuscular in 2021 (Batch/Lot number was not reported) as 0.3 mL, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included pregabalin (PREGABALIN PFIZER) taken for an unspecified indication, start and stop date were not reported. The patient experienced spontaneous abortion on 29Jul2021 with outcome of recovered with sequelae. The event was reported as serious (life threatening). The mother reported she became pregnant while taking bnt162b2. The mother was 1 Trimester pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The patient reported after Pfizer vaccination for the Corona, she had a miscarriage. She got pregnant a month and a half ago not knowing about the pregnancy, she decided to get vaccinated with Pfizer, a week after receiving the vaccine she had a miscarriage. Comirnaty: ADR is adequately labelled: no. A casual relationship between Comirnaty and event spontaneous abortion was assessed as possible by HA (Method of assessment: HA Causality). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


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