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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

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Case Details (Sorted by Onset Date)

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VAERS ID: 1816076 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-28
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Amniotic fluid volume decreased, Echocardiogram, Foetal death, Physical examination
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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Delivery (40+1 weeks of gestation); Delivery (39+6 weeks of gestation).
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: Eco/Echo; Result Unstructured Data: Test Result: apparent normality; Comments: Single gestation with embryo of 68 mm CRL corresponding to 13 + 0 weeks of gestation. 18mm DBP. Sonoluscence of 1.81 mm, pulsatility index of the ductus venosus of 1.05. The: skull, spine, abdominal wall, stomach, 4 cardiac chambers, bladder, upper limbs, lower limbs, nasal bone present have been visualized with normal appearance. Amniotic Fluid: Normal. Umbilical Cord Insertion: Central. Placenta inserted posteriorly. There are no adnexal alterations at the time of the examination.; Test Date: 20210828; Test Name: Eco/Echo; Result Unstructured Data: Test Result: negative fetal heartbeat. Oligoamnios; Comments: fetus in breech position with negative fetal heartbeat. Oligoamnios; Test Date: 20210707; Test Name: Physical examination; Result Unstructured Data: Test Result: apparent normality; Test Date: 20210828; Test Name: Physical examination; Result Unstructured Data: Test Result: the abdomen was soft, depressible, and not painful; Comments: the abdomen was soft, depressible, and not painful. No increase in uterine tone. Uterine height according to gestational age.
CDC Split Type: ESPFIZER INC202101350897

Write-up: Fetal death 20 + 4 weeks of gestation; Oligoamnios; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB ES-AEMPS-1010878. This consumer reported information for both mother and fetus. This is a mother report. A 39-year-old pregnant female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 18Aug2021 (Lot Number: FG4442) as single dose for covid-19 immunisation. Medical history included Spontaneous delivery in 2011 (39+6 weeks of gestation), Spontaneous delivery in 2018 (40+1 weeks of gestation). The patient''s concomitant medications were not reported. Female of 39, pregnant of 20 + 4 weeks of gestation. In control of 07Jul2021: gestation of 12 + 3 (13 + 0 sg by ultrasound). Physical examination and ECO with results within apparent normality. ECOGRAPHY: Single gestation with embryo of 68 mm CRL corresponding to 13 + 0 weeks of gestation. 18mm DBP. Sonoluscence of 1.81 mm, pulsatility index of the ductus venosus of 1.05. The skull, spine, abdominal wall, stomach, 4 cardiac chambers, bladder, upper limbs, lower limbs, nasal bone present have been visualized with normal appearance. Amniotic Fluid: Normal. Umbilical Cord Insertion: Central. Placenta inserted posteriorly. There are no adnexal alterations at the time of the examination. She went to the emergency room (28Aug2021) due to the absence of perception of fetal movements. There are no other accompanying symptoms. On physical examination: the abdomen was soft, depressible, and not painful. No increase in uterine tone. Uterine height according to gestational age. Abdominal ECHO: fetus in breech position with negative fetal heartbeat. Oligoamnios. Diagnosis: Fetal death 20 + 4 weeks of gestation. 29Aug2021 Pharmacological protocol for late abortion begins. Fetus expelled en bloc with integrated amniotic bag. Assessment of the fetus: In the delivery room, the bag ruptures artificially. Non-malodorous stained amniotic fluid. A fetus with a female phenotype, which presents significant maceration and size according to 17-18 weeks of gestation. Presents two tight circular. The events resulted in hospitalization. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1855688 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-08-28
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-11-09
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, Pregnancy test
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: 20210819; Test Name: Pregnancy test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: DKMODERNATX, INC.MOD20213

Write-up: The patient had a positive pregnancy test on 19Aug2021; Spontaneous abortion; This case was received via regulatory authority(Reference number: DK-DKMA-ADR 26078150) on 29-Oct-2021 and was forwarded to Moderna on 29-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous abortion) and MATERNAL EXPOSURE DURING PREGNANCY (The patient had a positive pregnancy test on 19Aug2021) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 immunisation. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced ABORTION SPONTANEOUS (Spontaneous abortion) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (The patient had a positive pregnancy test on 19Aug2021) (seriousness criterion medically significant). The delivery occurred on 28-Aug-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 (Spontaneous abortion) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (The patient had a positive pregnancy test on 19Aug2021) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, Pregnancy test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medication were provided Action taken with suspect was not applicable. Company Comment: This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Spontaneous abortion. Reportedly, this case also concerns an event of Maternal exposure during pregnancy, as it was stated that the patient had a positive pregnancy test two days after she received the second dose of the Spikevax. However, it was not specified at which week of gestation the patient was at the time of the first and at the time of the second vaccination, as well (the LMP was not provided). Spontaneous abortion occurred 11 days after the second dose of Spikevax. No further information regarding the event of Spontaneous abortion was provided. The company causality of the event of Maternal exposure during pregnancy is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Spontaneous abortion. Reportedly, this case also concerns an event of Maternal exposure during pregnancy, as it was stated that the patient had a positive pregnancy test two days after she received the second dose of the Spikevax. However, it was not specified at which week of gestation the patient was at the time of the first and at the time of the second vaccination, as well (the LMP was not provided). Spontaneous abortion occurred 11 days after the second dose of Spikevax. No further information regarding the event of Spontaneous abortion was provided. The company causality of the event of Maternal exposure during pregnancy is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1859212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage in pregnancy, Ultrasound abdomen, 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypogastric pain
Preexisting Conditions: Medical History/Concurrent Conditions: Abortion threatened (hypogastric pain and metrorrhagia, meeting criteria for threatened abortion); Metrorrhagia
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: Ultrasound abdomen; Result Unstructured Data: Test Result:live fetus in an indifferent position. Amniotic fl; Comments: live fetus in an indifferent position. Amniotic fluid. Placenta normal insert; Test Date: 20210901; Test Name: ultrasound; Result Unstructured Data: Test Result:intrauterine remains
CDC Split Type: ESPFIZER INC202101455030

Write-up: Abortion spontaneous; vaginal bleeding; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number is ES-AEMPS-1034222. A 43-year-old pregnant female patient received bnt162b2 (COMIRNATY), intramuscular on 27Aug2021 (Batch/Lot Number: FG4686) as dose 1, 0.3 mL single for COVID-19 immunisation. Medical history included abortion threatened from 15Aug2021 to 16Aug2021: hypogastric pain and metrorrhagia, meeting criteria for threatened abortion. Concomitant medications were not reported. On 28Aug2021, the patient experienced vaginal bleeding. On 01Sep2021, the patient experienced abortion spontaneous. The events were further described as: She came to the emergency room on 30Aug2021 due to vaginal bleeding of 48 hours of evolution. Ultrasound abdomen was performed with finding a "live fetus in an indifferent position. Amniotic fluid. Placenta normal insert" and she was referred to the home. She came back on 01Sep2021, referred from an external center for late abortion. During admission, medical treatment was carried out, with which intrauterine content was expelled. A follow-up ultrasound revealed intrauterine remains, for which an evacuator curettage was performed. Good post-surgical evolution, discharge at home. Fetal pathological history pending. The mother was 14 weeks pregnant at the onset of the event. The mother was due to deliver on 24Feb2022. The pregnancy resulted in spontaneous abortion. The patient was hospitalized for abortion spontaneous. The patient recovered from abortion spontaneous on 03Sep2021. The outcome of vaginal bleeding was unknown. The patient received second dose of COMIRNATY on 17Sep2021, dose 2, 0.3 mL single, batch/lot number: FG7898, intramuscular. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1676252 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-28
Onset:2021-08-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test urine positive, Ultrasound scan vagina
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline 50mg One a Day Women?s Complete Multivitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None known
Diagnostic Lab Data: Pregnancy test (urine) - positive (9-2-21), HCG, Intact + Beta Subunit, Quant, Serum or Plasma - 102 (9-2-21), US, Obstetric, Transvaginal (9-2-21), beta- HCG, Quantitative, Serum or Plasma - 35 (9-5-21)
CDC Split Type:

Write-up: Miscarriage First known pregnancy, no estimated date of delivery or birth weight, approx. 4 weeks pregnant


VAERS ID: 1711657 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-29
Onset:2021-08-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / UNK LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Back pain, Dyspnoea, Loss of consciousness, Tremor, Vaginal haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Termination of pregnancy and risk of abortion (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Non-smoker; Pregnant
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101147161

Write-up: miscarry her baby; vaginal bleeding; back pain; difficulty breathing; body began to shake; felt like passing out; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 29Aug2021 (Lot Number: FF2588, at the age of 37-year-old) as single dose for covid-19 immunisation. Medical history included pregnant at time of vaccination, non smoker and non-alcoholic. The concomitant product included prenatal vitamins. There were no other vaccine in four weeks. There were no covid prior vaccination. There were no covid tested post vaccination. Within one to two hours after the vaccine on 29Aug2021 patient felt like passing out, difficulty breathing and her body began to shake. Patient was pregnant at the time. She was previously healthy with no existing health conditions. She did not smoke, drink, or use drugs. At 24 hours post vaccine on 30Aug2021 she began to miscarry her baby. She had severe back pain with vaginal bleeding. This continues as of today. Treatment for events included blood work, intravenous (IV) fluids, and monitoring. The events resulted in emergency room/department or urgent care. Last menstrual date was on 23Jul2021. The mother was due to deliver on 29Apr2022. Gestational period was 5 weeks. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1714331 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-08-17
Onset:2021-08-29
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, First trimester pregnancy, Full blood count, Human chorionic gonadotropin increased, Pregnancy test positive, Primigravida, Rhesus antigen positive, Ultrasound scan vagina
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins daily
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Hcg levels at date of miscarriage (8/29/21) were 247, which suggests patient had lost the baby several days prior. Transvaginal ultrasound on 8/29 showed small bits of tissue still in the cervix, but most had been passed before arrival to hospital. CBC and type and screen done, patient was Rh+.
CDC Split Type:

Write-up: Positive home pregnancy test 2 days after second dose of Pfizer covid vaccine, 8/19/21. Estimated due date based off last menstrual period was April 12, 2022. 12 days after second dose of Pfizer covid vaccine, patient experienced spontaneous miscarriage at 7 weeks 5 days. First pregnancy.


VAERS ID: 1840446 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-01
Onset:2021-08-29
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

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

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

Write-up: miscarriage


VAERS ID: 1678427 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-29
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN D [COLECALCIFEROL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown result
CDC Split Type: AUPFIZER INC202101118450

Write-up: miscarriage; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: unknown and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 13Aug2021 at 15:45 (at the age of 34-year-old) as DOSE 1, SINGLE for covid-19 immunization in regulatory authority facility. The patient medical history was not reported. Concomitant medications included cholecalciferol (VITAMIN D). The patient had no known allergies. The patient was 3 weeks pregnant at time of vaccination. The patient experienced miscarriage on 29Aug2021 at 15:00. The patient was due to deliver on 26Apr2022. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient stated that, she can''t prove it''s from the vaccine but would like to know if we can prove that it''s not from the vaccine side effects and also stated that, Please stop advising women who are either trying to get pregnant or in their first trimester that it''s safe, the body is dealing with enough changes. It was reported that events result in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood test: unknown result. Therapeutic measures were taken as a result of event included pain medication. The outcome of the event was recovering at time of report. The lot number for BNT162B2, was not provided and will be requested during follow up


VAERS ID: 1700985 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEXAPRO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101147197

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient). A 27-years-old pregnant female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 24Aug2021 17:15 (Batch/Lot Number: Unknown) as single dose (at the age of 27) for covid-19 immunisation. Prior and since the vaccination, the patient was not diagnosed with COVID-19. Medical history included anxiety. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient experienced miscarriage (hospitalization, medically significant) on 29Aug2021 18:00. The outcome was unknown. The patient was hospitalized for miscarriage for 2 days. No treatment received. No covid test done prior or post vaccination. The mother was 9 weeks pregnant at the onset of the event. The mother was due to deliver on 06Apr2022. Last menstrual date was 27Jun2021. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1717267 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Blood thyroid stimulating hormone, Foetal death, Foetal-maternal haemorrhage, Glycosylated haemoglobin, Investigation, Ultrasound foetal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUTIROX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Thyroid stimulating hormone; Test Result: Negative ; Test Name: Maternal fetal hemorrhage test; Test Result: Negative ; Test Name: Glycated hemoglobin; Test Result: Negative ; Test Name: Maternal infectious diseases tests; Test Result: Negative ; Test Date: 20210829; Test Name: obstetric PS; Result Unstructured Data: Test Result:Finding of intrauterine death; Comments: Finding of intrauterine death of the fetus; Test Name: Ultrasound evaluation; Result Unstructured Data: Test Result:appropriate fetal biometry
CDC Split Type: ITPFIZER INC202101157970

Write-up: Access to obstetric PS at 34 weeks and 1 day due to lack of perception of fetal movements. Finding of intrauterine death of the fetus.; 1 day of amenorrhea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-778418. A 27-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Deltoid Left ("left shoulder") on 27Aug2021 10:11 (Lot Number: FG4686; Expiration Date: 30Nov2021) as 0.3 mL for COVID-19 immunization. The patient''s medical history was not reported. Concomitant medication included levothyroxine sodium (EUTIROX). The patient experienced access to obstetric PS at 34 weeks and 1 day due to lack of perception of fetal movements. Finding of intrauterine death of the fetus on 29Aug2021, and 1 day of amenorrhea on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The mother was 34 Weeks pregnant at the onset of the event. The pregnancy resulted in still birth. The fetal outcome is intrauterine death. SARS CoV 2 vaccination done 3 days ago (also reported as "26Aug2021") with no immediate problems. Initial investigations (maternal infectious diseases tests, maternal fetal hemorrhage test, glycated hemoglobin, thyroid stimulating hormone), negative results. Ultrasound evaluation: appropriate fetal biometry. Ongoing induction of labor: tests will be done. The outcome of the events was unknown. The event Death fetal was considered as serious (medically significant). Reporter comment: Fetal intrauterine death discovered on 29Aug2021 (lack of perception of fetal movements from the previous day) at 34 weeks and 1 day of amenorrhea. First pregnancy.; Reporter''s Comments: Fetal intrauterine death discovered on 29Aug2021 (lack of perception of fetal movements from the previous day) at 34 weeks and 1 day of amenorrhea. First pregnancy.


VAERS ID: 1747298 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-29
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 (start date 24Mar2021 22:00)
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC202101180378

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB NL-LRB-00676567. A 36-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 12Aug2021 (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from 24Mar2021 22:00 (disease symptoms: quite). The patient''s concomitant medications were not reported. The miscarriage occurred at a pregnancy duration of about 5 weeks on 29Aug2021 (17 days after vaccination). This was the first COVID vaccination, which took place at a pregnancy duration of about 2,5 weeks (as reported). Pregnancy and vaccination were in the same period. Coincidence or a connection between the two was not known. The outcome of the events was recovered on 02Sep2021 (as reported). Sender''s comments: Since the nature of the reported reaction does imply seriousness according to one of the regulatory authority criteria, the reaction was considered as serious by the regulatory authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1859878 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-29
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4509 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnant
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101455205

Write-up: Miscarriage; menstrual disorder; breakthrough bleeding; menstrual disorder; breakthrough bleeding; This is a spontaneous report from a contactable consumer downloaded from the , regulatory authority number NL-LRB-00691217. A 30-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FG4509), via an unspecified route of administration on 17Aug2021 as dose 1, single for COVID-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced miscarriage, menstrual disorder; breakthrough bleeding on 29Aug2021. The pregnancy resulted in spontaneous abortion. The patient did not have previous COVID-19 infection. The outcome of the event miscarriage was unknown while the outcome of all other events was not recovered. Sender Comment: Since the nature of (some of) the reported reactions does imply seriousness according to one of the CIOMS critera. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1731402 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-18
Onset:2021-08-30
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: None
Allergies: NKA
Diagnostic Lab Data: urine test and blood test. Will possibly require ultrasound.
CDC Split Type:

Write-up: Miscarriage 4 months after second dose of Moderna vaccine.


VAERS ID: 1737410 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-19
Onset:2021-08-30
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin, Ultrasound scan, 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: Viread 300mg
Current Illness: Na
Preexisting Conditions: Chronic hep b
Allergies: Na
Diagnostic Lab Data: obgyn and hcg level with ultrasounds 8/30 through 9/17
CDC Split Type:

Write-up: Was in 1st trimester pregnant and began bleeding shortly after and ended up miscarrying approx 3 weeks later. Embryo stopped developing after shot


VAERS ID: 1821945 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-02-04
Onset:2021-08-30
   Days after vaccination:207
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: prenatal vitamins
Current Illness: none
Preexisting Conditions: none
Allergies: no known allergies
Diagnostic Lab Data: placenta was sent to pathology and there were no signs of infection, no known cause for pre-term labor
CDC Split Type:

Write-up: Pre-term labor and delivery (unknown if caused by vaccine, but the woman who called me and said it should be reported) I was 6 weeks pregnant when I received the first dose of Moderna vaccine and 10 weeks pregnant at the second dose. This was my first pregnancy and there were no complications during the pregnancy. I had a normal ultrasound at 9 weeks. My due date was 10/1/2021 and my baby was born 9/1/2021 at 5 lbs 8 oz. He had an 8 day stay in the ICU and was discharged on 9/9/2021.


VAERS ID: 1852051 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-08
Onset:2021-08-30
   Days after vaccination:144
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin, possibly Zyrtec allergy medicine.
Current Illness: No
Preexisting Conditions: No
Allergies: No just seasonal allergies
Diagnostic Lab Data: Ultrasound 9/15/21 Bloodwork 10/29/21 for hairloss. Checked thyroid and vitamin D which I was a little low in.
CDC Split Type:

Write-up: I went to my OBGYN 9/15/21 for my first ultrasound which I should''ve been around 10 weeks pregnant where they were not able to find a heartbeat. The baby was only measuring about 8.5 weeks along in size which was when I felt symptoms drop off. I have one healthy 3 year old and this was my first miscarriage along with two of my sister-in-laws which we are all vaccinated and conceived around the same time. I didn''t miscarry on my own but took medicine that night to speed along the process. I was also asking the doctor about a significant amount of hair loss I was having before the miscarriage which seems to have slowed down but to me is a very noticeable difference.


VAERS ID: 1706175 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-08-30
   Days after vaccination:192
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:unknown result
CDC Split Type: NLPFIZER INC202101150030

Write-up: Death of baby during pregnancy; 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 NL-LRB-00675563. A 25-years-old female patient received second dose of BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 19Feb2021 as single dose for covid-19 immunisation. Medical history was not reported. The patient received first dose of BNT162B2 (COMIRNATY) on 22Jan2021 at single dose. The patient''s concomitant medications were not reported. The patient was vaccinated with second dose at pregnancy of about 3.5 weeks, her first vaccination took place before pregnancy. On 30Aug2021 the patient experienced death of baby during pregnancy serious for hospitalization and as medically significant. The mother reported she became pregnant while taking BNT162B2. The mother was 31 weeks pregnant at the onset of the event. Sender comment: Since the nature of the reported reaction does not imply ''death'' of the patient according to the CIOMS criteria, it was replaced by ''other'' by the Netherlands Pharmacovigilance Centre Lareb. No follow up attempts possible. No further information is expected. Lot/batch number was not provided and unable to obtain.


VAERS ID: 1759978 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-30
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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
Allergies:
Diagnostic Lab Data: Test Date: 20210901; Test Name: beta-human chorionic gonadotropin (beta-hCG); Result Unstructured Data: Test Result:2874; Comments: Unit: UI/L; Test Date: 20210903; Test Name: beta-human chorionic gonadotropin (beta-hCG); Result Unstructured Data: Test Result:868; Comments: Unit: UI/L; Test Date: 20210824; Test Name: Ultrasound; Result Unstructured Data: Test Result:Single intrauterine pregnancy; Comments: Single intrauterine pregnancy. Date of the start of pregnancy estimated on 05Aug2021 (as reported) by the cranio-caudal length today. The embryo is already visible.
CDC Split Type: FRPFIZER INC202101239531

Write-up: Miscarriage; metrorrhagia for 7 days; This is a spontaneous report from a contactable consumer (patient) and healthcare professional downloaded from the regulatory authority-WEB [FR-AFSSAPS-NC20214272]. A 35-year-old female patient received the first dose of BNT162B2 (COMIRNATY solution for injection; lot number: FE8244), via intramuscular on 30Jul2021 (at an unspecified age) at dose 1, single in the left deltoid for COVID-19 immunisation. Medical history included penicillin allergy. The patient''s concomitant medications were not reported. The patient was pregnant at the time of vaccination. The patient''s date of last menstrual period was on 16Jul2021 (start date of pregnancy was reported as 05Aug2021). The patient had amenorrhea. On 30Aug2021, the patient experienced miscarriage and metrorrhagia for 7 days. The patient underwent lab tests and procedures which included: Ultrasound on 24Aug2021: Single intrauterine pregnancy. Date of the start of pregnancy estimated on 05Aug2021 (as reported) by the cranio-caudal length today. The embryo is already visible; beta-human chorionic gonadotropin (beta-hCG) on 01Sep2021 was 2874 UI/L and on 03Sep2021 was 868 UI/L. It was concluded that the patient had a miscarriage post-vaccination of BNT162B2 (COMIRNATY). Outcome of the event miscarriage was recovered on an unspecified date in 2021, and for metrorrhagia was recovered on 06Sep2021.


VAERS ID: 1772907 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-30
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101311141

Write-up: Pregnancy loss; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202110021805128520-G9SEI, Safety Report Unique Identifier GB-MHRA-ADR 26027695. A pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pregnancy loss (hospitalization, disability, medically significant) on 30Aug2021 with outcome of recovered in 2021 with sequelae. Week of baby not growing occurred the week of the jab. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1777770 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-28
Onset:2021-08-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test, Ultrasound foetal
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? 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: 20210901; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Test Date: 20210824; Test Name: ultrasound; Result Unstructured Data: Test Result:8 weeks pregnant
CDC Split Type: FRPFIZER INC202101273390

Write-up: Early miscarriage; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB [FR-AFSSAPS-RN20212788]. A 22-year-old pregnant female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 28Aug2021 (Batch/Lot Number: FF2834) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced early miscarriage on 30Aug2021 with outcome of recovered with sequelae. On 30Aug2021, onset of abdominal pain with consultation with the attending physician on 01Sep2021: diagnosis of spontaneous miscarriage confirmed. In total, 22-year-old patient, presenting a spontaneous miscarriage at 8 weeks'' gestation, occurring 3 days after a 2nd dose of COMIRNATY. The mother was 8 Weeks pregnant at the onset of the event. The mother was due to deliver on 04Apr2022. The mother delivered the pregnancy on 30Aug2021. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Sep2021, ultrasound foetal: 8 weeks pregnant on 24Aug2021. The event was reported as serious, medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1800009 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-08-30
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Maternal vaccine exposure
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101339832

Write-up: Miscarriage at 8 weeks; This is a spontaneous report received from a contactable consumer or other non HCP (patient) downloaded from the Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00691513. A 32-year-old female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included maternal vaccine exposure (vaccine exposure during pregnancy week). Concomitant medications were not provided. No previous COVID-19 infection. On 30Aug2021, the patient experienced miscarriage (other medically important condition). The miscarriage occurred at a pregnancy duration of about 8 weeks. This was the first Covid vaccination, which took place before the pregnancy (vaccination before pregnancy). Outcome of the events was unknown. This report was assessed by the reporting patient as serious. Reporter Comment: BioNTech/Pfizer vaccine (Comirnaty): Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Miscarriage: Additional information ADR: had my 1st shot on 07Jul2021. And 30Aug2021 miscarriage at 8 weeks. BSN available: yes. Confounding factors: vaccine exposure during pregnancy week. COVID-19: Previous COVID-19 infection: No. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the RA critera, the reaction was considered as serious by the Regulatory Authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty): Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no Miscarriage: Additional information ADR: had my 1st shot on 07Jul2021. And 30Aug2021 miscarriage at 8 weeks BSN available: yes Confounding factors: vaccine exposure during pregnancy week: COVID-19 Previous COVID-19 infection: No


VAERS ID: 1730052 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-31
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002615-CDC / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: antenatal care; Result Unstructured Data: Normal
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Miscarriage; 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 (Moderna COVID-19 Vaccine) (batch no. 3002615-CDC) for COVID-19 vaccination. No Medical History information was reported. On 06-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 31-Aug-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (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. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Ultrasound antenatal screen: normal (normal) Normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. On 31-Aug-2021, there was no fetal movement for 4 to 5 days.After examination by the physician, it was confirmed that the fetus had no heart beat, and labor induction was scheduled. The physician did not said that the fetus was in 25 weeks, the cause of stillbirth, and was not clear whether it was vaccine-related. No treatment medications were reported. This regulatory authority retrospective pregnancy case concerns a 30-year-old female patient with no relevant medical history reported who experienced serious unexpected event of abortus spontaneous. The event occurred approximately 25 days after the second dose of Spikevax. Rechallenge was not applicable. The reporter did not provide causality assessment. Per RA SD, the outcome of pregnancy was reported as stillbirth which is highly unlikely since the reported event is miscarriage and there was no foetal movement for 4 to 5 days and no foetal heartbeat prior to labor induction.; Sender''s Comments: This regulatory authority retrospective pregnancy case concerns a 30-year-old female patient with no relevant medical history reported who experienced serious unexpected event of abortus spontaneous. The event occurred approximately 25 days after the second dose of Spikevax. Rechallenge was not applicable. The reporter did not provide causality assessment. Per RA SD, the outcome of pregnancy was reported as stillbirth which is highly unlikely since the reported event is miscarriage and there was no foetal movement for 4 to 5 days and no foetal heartbeat prior to labor induction.


VAERS ID: 1769205 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-08-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-07
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENLAFAXIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: Amniocentesis; Result Unstructured Data: Test Result:Unknown result; Test Date: 202109; Test Name: Laboratory test; Result Unstructured Data: Test Result:Unknown result; Comments: Test for fetomaternal bleeding; Test Date: 202109; Test Name: Laboratory test; Result Unstructured Data: Test Result:Unknown result; Comments: TORCH tests
CDC Split Type: DKPFIZER INC202101313959

Write-up: The mother felt decreased foetal movements in week GA 35+3; Fetus mors; Maternal exposure during pregnancy, third trimester; This is a spontaneous report from a contactable physician. The mother case was downloaded from the Regulatory Authority-WEB DK-DKMA-WBS-0088449. This physician reported information for both mother and fetus/baby. This is a fetus report. A fetus patient of an unspecified gender received second dose BNT162B2 (COMIRNATY, Lot Number: FD4555; Expiration Date: 30Sep2021), transplacental on 31Aug2021 at single dose for covid-19 immunisation. The patient''s mother medical history included ongoing depression and ongoing cholestasis of pregnancy (Newly diagnosed with intrahepatic cholestasis of pregnancy (ICP), not started treatment for this). Concomitant medication included venlafaxine hydrochloride (VENLAFAXIN) taken for depression from 01Jul2021 to an unspecified stop date. The patient''s mother previously received first dose of BNT162B2(COMIRNATY, Batch number: FC5029, expiry: 31Oct2021) on 10Aug2021 for COVID-19 immunisation. On 07Sep2021, 7 days after the second dose was given, the patient''s mother felt decreased foetal movements in week ga 35+3, fetus mors on 07Sep2021, maternal exposure during pregnancy, third trimester on 31Aug2021. The events were serious for being medical significant and death. On an unspecified date in Sep2021, the patient underwent lab tests included amniocentesis: unknown result, laboratory test: test for fetomaternal bleeding, unknown result, laboratory test: torch tests, unknown result. No treatment or medical procedure due to the ADRs were reported. The outcome of events was fatal. The patient died on 07Sep2021. It was not reported if an autopsy was performed. No follow up attempts possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DK-PFIZER INC-202101273304 mother/ baby cases; Reported Cause(s) of Death: Foetal movements decreased; Fetus mors; Maternal exposure during pregnancy, third trimester


VAERS ID: 1783546 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-08-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCEL5 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Genital herpes, Human chorionic gonadotropin, Lymphadenitis, Lymphadenopathy, SARS-CoV-2 test, Ultrasound scan
SMQs:, Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastrooesophageal reflux; Miscarriage (two miscarriage); Pregnancy (twice pregnant)
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: B-HCG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210905; Test Name: B-HCG; Result Unstructured Data: Test Result:7484 IU/l; Test Date: 20210828; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210905; Test Name: ultrasound; Result Unstructured Data: Test Result:2 Intrauterine gestational sac; Comments: seen, without embryos; Test Date: 20210910; Test Name: ultrasound; Result Unstructured Data: Test Result:2 intrauterine hypotonic anechoic images; Comments: of 14 and 12 mm longest axis, without VV or embryo; Test Date: 20210916; Test Name: ultrasound; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: FRPFIZER INC202101291868

Write-up: lymphadenopathy in the left clavicular region; Genital herpes; Miscarriage; Adenitis cervical; This is a spontaneous report from a contactable consumer and a HCP downloaded from a regulatory authority-WEB FR-AFSSAPS-PB20216327. This consumer reported different events for different vaccine doses. This is the first of two report. A 44-year-old female patient (pregnant; Due Date: 15Apr2021; Gestation Period: 7 weeks) received the second dose of BNT162B2 (COMIRNATY) via intramuscular on 30Aug2021 (Lot Number: SCEL5) as single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux, miscarriage and twice pregnant. The date of last period: 09Jul2021 8 weeks pregnant + 2 days. Concomitant medication was not reported. The patient previously received the first dose of BNT162VB2 via an unspecified route of administration on 22Jul2021 as single dose for COVID-19 immunization. After 2nd injection, she presented with disappearance of the sympathetic signs of pregnancy (nausea + breast tension) with lymphadenopathy in the left clavicular region. On 01Sep2021, the patient presented an episode of genital herpes. On 05Sep2021, emergency room with ultrasound: 2 Intrauterine gestational sac seen, without embryos. B-HCG = 7484 IU / L. The diagnosis of pregnancy of uncertain evolution is retained. She was reconvened on 10Sep2021 for control of B-HCG + ultrasound: 2 intrauterine hypotonic anechoic images of 14 and 12 mm longest axis, without VV or embryo. She returned to the emergency room on 16Sep2021 for control ultrasound +/- endo-uterine aspiration for stopped pregnancy. The patient thinks she has expelled with good uterine emptiness: complete spontaneous miscarriage no indication for endo uterine aspiration. The outcome of lymphadenopathy was unknown. The outcome of other events was recovered.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101303582 PFIZER INC


VAERS ID: 1786898 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-31
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20211015149

Write-up: MATERNAL EXPOSURE DURING PREGNANCY; MISCARRIAGE; This spontaneous pregnancy report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, NL-LRB-00695241) on 08-OCT-2021 and concerned a 31 year old female. The patient''s weight was 61 kilograms and height was 163 centimeters. No past medical history or concurrent conditions were reported. The patient was gravida 1, para 0. The gestation period was 17 weeks with retrospective pregnancy and outcome spontaneous abortion. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C10-02 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 12-MAY-2021 for covid-19 immunisation. No concomitant medications were reported. On 31-AUG-2021, the patient had miscarriage (Still born baby at 17 weeks gestation). On an unspecified date, the patient had maternal exposure during pregnancy. The date of the patient''s last menstrual period and expected delivery date were not reported. The pregnancy resulted in miscarriage on 31-AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the miscarriage and maternal exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1809362 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-08-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Abortion spontaneous; Maternal exposure during pregnancy; This case was received via Agency (Reference number: FR-AFSSAPS-ST20213662) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a pharmacist and describes the occurrence of ABORTION SPONTANEOUS (Abortion spontaneous) in a 42-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 ml. Last menstrual period and estimated date of delivery were not provided. On 31-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 09-Sep-2021, the patient experienced ABORTION SPONTANEOUS (Abortion spontaneous) (seriousness criterion medically significant). The delivery occurred on 09-Sep-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 31-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 09-Sep-2021, ABORTION SPONTANEOUS (Abortion spontaneous) had resolved with sequelae. 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 were provided No treatment medications were provided This case concerns a 42 year-old female patient with no reported relevant medical history who experienced the unexpected serious event of spontaneous abortion. The event occurred approximately 10 days after the first dose of mRNA-1273 (Spikevax). The rechallenge was unknown as only the first dose was administered. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Translation Document received on 15-OCT-2021 No new information; Sender''s Comments: This case concerns a 42 year-old female patient with no reported relevant medical history who experienced the unexpected serious event of spontaneous abortion. The event occurred approximately 10 days after the first dose of mRNA-1273 (Spikevax). The rechallenge was unknown as only the first dose was administered. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.


VAERS ID: 1845061 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-08-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Chills, Dysmenorrhoea, Fatigue, Headache, Heavy menstrual bleeding, Malaise, Myalgia, Pyrexia, SARS-CoV-2 test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (9 months before vaccination with severe symptoms, but no hospitalization,)
Allergies:
Diagnostic Lab Data: Test Date: 20210901; Test Name: pyrexia; Result Unstructured Data: Test Result:Fever: 38 to 40.5 Celsius grades; Test Date: 20201201; Test Name: Coronavirus, confirmed by a test; Result Unstructured Data: Test Result:Positive,
CDC Split Type: NLPFIZER INC202101437685

Write-up: Miscarriage; Blood clots and very heavy menstruation/Menorrhagia; Menstrual cramps; Chills; Not feeling well/Malaise; Headache; Muscle pain/Myalgia; Fatigue; Fever: 38 to 40.5 Celsius grades/Pyrexia; Severe abdominal pain; This is a spontaneous report from a contactable consumer or other non-health professional downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00695600. A 45-year-old pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on 31Aug2021 (at the age of 45 years old) as dose number unknown, single for COVID-19 immunization. Medical history included COVID-19 from 01Dec2020 (9 months before vaccination with severe symptoms, but no hospitalization). The patient''s concomitant medications were not reported. On 31Aug2021 the patient experienced miscarriage, blood clots and very heavy menstruation/menorrhagia, menstrual cramps, chills, not feeling well/malaise, headache, muscle pain/myalgia, fatigue, fever: 38 to 40.5 Celsius grades/pyrexia, severe abdominal pain. The mother reported she became pregnant while taking bnt162b2.The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The patient underwent lab tests and procedures which included pyrexia: fever: 38 to 40.5 Celsius grades on 01Sep2021, sars-cov-2 test positive: positive on 01Dec2020. Therapeutic measures were taken because of, fever: 38 to 40.5 Celsius grades/pyrexia. Pyrexia was treated with paracetamol. The outcome of events was not recovered for miscarriage, blood clots and very heavy menstruation/menorrhagia, menstrual cramps, not feeling well/malaise, fatigue, recovering for headache, recovered for muscle pain/myalgia on 05Sep2021, fever: 38 to 40.5 Celsius grades/pyrexia on 31Aug2021 and chills on 03Sep2021, unknown for severe abdominal pain. Sender Comment: Since the nature of the reported reactions imply seriousness according to one of the CIOMS critera, reactions (miscarriage, menorrhagia and menstrual cramps) were considered as serious by the Pharmacovigilance Centre Lareb. Reporter comment: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no. miscarriage and Blood clots and very heavy menstruation. Additional information ADR: severe abdominal pain and blood loss and large blood clots. BSN available: yes. Previous COVID-19 infection: disease symptoms: quite. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information is expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no miscarriage and Blood clots and very heavy menstruation Additional information ADR: severe abdominal pain and and blood loss and large blood clots BSN available: yes Previous COVID-19 infection: disease symptoms: quite


VAERS ID: 1862441 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-31
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: ultrasound; Result Unstructured Data: Test Result:diagnosis of pregnancy termination after 10 weeks
CDC Split Type: FRPFIZER INC202101455361

Write-up: Foetal death in utero; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PP20211527. This reporter informed different events for the two vaccine doses. This is the first of two reports, which corresponds to the first dose. A 23-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 21Aug2021 (Lot Number: FF2834) as single for COVID-19 immunisation. The patient''s medical history was not reported. The patient has no medical history of COVID. There were no concomitant medications. The patient presented with a spontaneous miscarriage without expulsion of the embryo at 10 days after first vaccination with Pfizer/BioNTech COMIRNATY. During the ultrasound (Aug2021) at 12 weeks, diagnosis of pregnancy termination after 10 weeks + 1, 61 days of amenorrhea, corresponding to 31Aug2021. Had to undergo surgical aspiration for terminated pregnancy (did not manifest spontaneous miscarriage). Event serious due to hospitalization and medically significant. Last menstrual period was 21Jun2021. The mother was due to deliver on 28Mar2022. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1674646 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-26
Onset:2021-09-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: I had had a perfect ultrasound of my 12 week baby. Only to have it die 3 days after receiving the vaccine. I have 3 live children and zero miscarriages. Stop promoting this vaccine for pregnant women it kills babies.


VAERS ID: 1759257 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-03-31
Onset:2021-09-01
   Days after vaccination:154
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6208 / 1 RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8730 / UNK - / SYR

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

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

Write-up: COVID-19 9/1/21 miscarriage 9/7/21


VAERS ID: 1844551 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-09-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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

Write-up: Miscarriage at 8 weeks. Blighted ovum measuring 5 weeks, 6 days. Due date was 4/2022.


VAERS ID: 1699159 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual 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: GBMODERNATX, INC.MOD20213

Write-up: Miscarriage; Menstrual flooding; Maternal exposure during pregnancy; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25896806) on 05-Sep-2021 and was forwarded to Moderna on 05-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Sep-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 01-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 02-Sep-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Menstrual flooding). On an unknown date, 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 01-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) had resolved and HEAVY MENSTRUAL BLEEDING (Menstrual flooding) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medication information provided. This is the heaviest period ever she had. She was trying to conceive, and she took a pregnancy test on the day of vaccine just in case, but it was negative, but it may have been too early to tell. She had a missed miscarriage and D&C in late June so it may be all related to these things. She was having to change a super tampon every 1-2 hours. She usually only had to change a regular tampon every 4- 6 hours on her normal periods before the vaccine. No treatment information was provided. Patient has not had symptoms associated with COVID-19; Not had a COVID-19 test and was not enrolled in clinical trial. This is a case of product exposure during pregnancy with associated adverse events 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.; Sender''s Comments: This is a case of product exposure during pregnancy with associated adverse events 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: 1704902 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-09-01
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Pregnancy (Successful, Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 2021; Test Name: Internal scan; Result Unstructured Data: Test Result:Baby stopped developing past 8+3
CDC Split Type: GBPFIZER INC202101152056

Write-up: Carried baby to 13 weeks but passed away at 8 + 3/ missed 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-202109022014136420-WSUOX with Safety Report Unique Identifier GB-MHRA-ADR 25889155. This consumer reported information for both mother and fetus. This is the maternal report. A 35-year-old pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW3143) via an unspecified route of administration on 09Jun2021 as a single dose for COVID-19 immunisation. Medical history included miscarriage; pregnancy (successful) not ongoing. Concomitant medication included folic acid (MANUFACTURER UNKNOWN) from an unknown date taken for folic acid supplementation and unknown if ongoing. Patient had no symptoms associated with COVID-19 and was not enrolled in a clinical trial. The patient was not breastfeeding. On 09Jun2021, during her first trimester, the patient had exposure during pregnancy. The patient carried baby to 13 weeks. On an unknown date in 2021, the patient underwent an internal scan and it was found that the baby stopped developing past 8+3 and passed away. On 01Sep2021, the patient experienced a missed miscarriage. The event was reported as serious for being medically significant. It was unsure if medicine had an adverse effect on any aspect of the pregnancy. On an unknown date, the patient underwent a COVID-19 virus test and the result was negative. The patient had not been tested positive for COVID-19 since having the vaccine. The outcome of the event was not resolved. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101181231 Fetus case


VAERS ID: 1725071 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-09-01
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, 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: 20210901; Test Name: ultrasound; Result Unstructured Data: Test Result:miscarriage
CDC Split Type: NLPFIZER INC202101174829

Write-up: miscarriage; This is a spontaneous report from a contactable consumer or other non-health professional (patient) downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00676439. A 36-year-old female pregnant patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 31Jul2021 (batch/lot number: unknown) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had no COVID-19 infection. The patient previously took the dose 1 of bnt162b2 (COMIRNATY) for covid-19 immunization on 26Jun2021 as 0.3 ml single dose. The patient experienced miscarriage (other medically important condition) on 01Sep2021, maternal exposure during pregnancy following administration of covid-19 vaccine Pfizer injection. Clinical course: 2 days later, patient found out she was pregnant. The ultrasound showed a miscarriage on 01Sep2021. The miscarriage occurred at a pregnancy duration of about 6.5 weeks. This was the second Covid vaccination, which took place around the time of conception. COVID-19 vaccine exposure during pregnancy week was probably 1-2 weeks. She wanted to report her miscarriage because her 2nd injection and the conception of her pregnancy took place during the same period. She had 2 healthy children and wonder whether there''s a connection between the vaccine and conception and why it went wrong. Outcome of miscarriage was unknown. Sender comment: Since the nature of the reported reaction does imply seriousness according to one of the regulatory authority criteria, the reaction was considered as serious by PRIVACY. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1732525 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCTP7 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage in pregnancy, Sluggishness
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

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: Migraine with aura; Pregnant
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101229112

Write-up: Miscarriage; sluggishness; Hemorrhage in pregnancy; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the a regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021179928. A 29-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via unspecified route of administration on 01Sep2021 (Batch/Lot Number: SCTP7) as single dose for COVID-19 immunisation. The patient relevant medical history included pregnant, migraine with neurological deficits (aura). No concomitant medication reported. The patient experienced miscarriage, hemorrhage in pregnancy. One week after the COVID vaccination (Sep2021), the patient suffered a premature birth in the 22nd week of pregnancy with sudden bleeding and sluggishness. Death of the child. This report is serious - other. The patient was not resolved. PEI assessed the relatedness of drug to the event was D. Unclassifiable. No follow-up attempts are possible, no information is expected.


VAERS ID: 1733554 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-09-01
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor.
Allergies:
Diagnostic Lab Data: Test Name: ECHO; Result Unstructured Data: Test Result: unknown result.
CDC Split Type: NLPFIZER INC202101193496

Write-up: This is a spontaneous report from a contactable consumer (patient), downloaded via the regulatory authority (NL-LRB-00678792). A 29-year-old female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), via an unspecified route of administration, on May 11, 2021, single dose, for COVID-19 immunisation. Medical history included disease risk factor. The patient did not have COVID-19 prior the vaccination. The patient''s concomitant medications not reported. Historical vaccine included the dose 1 of Comirnaty, received on Apr 1, 2021. The pregnancy started within 3 months after the COVID-19 vaccinations. On Sep 1, 2021, patient experienced miscarriage. The patient underwent labs, which included ECHO with unknown result. The outcome of the event: unknown. No follow-up attempts possible. Information on batch number cannot be obtained.


VAERS ID: 1780438 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-21
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101287281

Write-up: Maternal exposure during pregnancy/Patient was exposed to the medicine first-trimester (1-12 weeks); The patient received BNT162B2 on 21Sep2021 and influenza vaccine on 21Sep2021; The patient received BNT162B2 on 21Sep2021 and influenza vaccine on 21Sep2021; Pregnancy loss; felt unwell; This is a spontaneous report from a contactable Other Health Professional. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109281508538950-YL9P2. Safety Report Unique Identifier GB-MHRA-ADR 26005797. A 25-year-old female patient (pregnant) received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: solution for injection), via an unspecified route of administration on 21Sep2021 (Lot Number: FF2153, at the age of 25-year-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient was pregnant at the time of vaccination. The patient was not currently breastfeeding. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Medical history included pregnancy. The patient no longer pregnant at the time of reporting. The concomitant medication includes influenza vaccine (INFLUENZA VIRUS), via an unspecified route of administration on 21Sep2021 (Batch/Lot number was not reported), at DOSE NUMBER UNKNOWN, SINGLE for an immunization. The patient received BNT162B2 on 21Sep2021 and influenza vaccine on 21Sep2021. On an unspecified date in Sep2021, the patient experienced pregnancy loss and felt unwell. The patient was exposed to the medicine first-trimester (1-12 weeks). It was reported that the patient was planned for Covid PCR test on 28Sep2021 and unknown if it was performed. The patient was not enrolled in clinical trial. It was unsure if medicine had an adverse effect on any aspect of the pregnancy. The patient outcome of the event Pregnancy loss was Resolved with Sequel on an unspecified date in Sep2021 and the outcome of the other event was unknown at the time of this report. No follow-up attempts are needed. No further information is expected


VAERS ID: 1842415 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-18
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, COVID-19 immunisation, 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), COVID-19 (narrow)

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

Write-up: Miscarriage; Revaccination with different COVID-19 vaccine; Vaccine exposure during pregnancy; This case was received via regulatory authority (Reference number: FI-FIMEA-20215779) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 18-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In September 2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) was resolving and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medication provided by reporter. No treatment medication provided by reporter. Company comment: This is a case of Covid-19 immunization (revaccination with different Covid-19 vaccine) and maternal exposure during pregnancy of this 29-year-old, female patient with no known medical history, who experienced the serious unexpected event of spontaneous abortion. The patient received unspecified dose of Spikevax at unknown weeks of gestation. Spontaneous abortion occurred on unspecified date after the patient received unspecified dose of Spikevax. The patient receiving a different Covid-19 vaccine may be a confounding factor to the event. The benefit-risk relationship of Spikevax is not affected by this report. Events maternal exposure during pregnancy and Covid-19 immunization were assessed as serious by the Regulatory Authority, however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the said events are considered serious. This case was linked to FI-FIMEA-20215776 (E2B Linked Report).; Sender''s Comments: This is a case of Covid-19 immunization (revaccination with different Covid-19 vaccine) and maternal exposure during pregnancy of this 29-year-old, female patient with no known medical history, who experienced the serious unexpected event of spontaneous abortion. The patient received unspecified dose of Spikevax at unknown weeks of gestation. Spontaneous abortion occurred on unspecified date after the patient received unspecified dose of Spikevax. The patient receiving a different Covid-19 vaccine may be a confounding factor to the event. The benefit-risk relationship of Spikevax is not affected by this report. Events maternal exposure during pregnancy and Covid-19 immunization were assessed as serious by the Regulatory Authority, however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the said events are considered serious. FI-FIMEA-20215776:


VAERS ID: 1851935 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-09-01
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101435874

Write-up: Miscarriage. Growth of the embryo since the second vaccination dose (Biontech) is no longer sufficient. Termination of pregnancy (abortion) therefore necessary.; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021174265. This consumer or other non hcp reported information for both mother and fetus/baby. This is the maternal report. A 31-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 11Aug2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3ML SINGLE for covid-19 immunisation. Medical history included pregnancy. The patient''s concomitant medications were not reported. On 01Sep2021 the patient experienced Miscarriage, Abortion. Miscarriage. growth of the embryo since the second vaccination dose (biontech) is no longer sufficient. termination of pregnancy (abortion) therefore necessary. The mother reported she became pregnant while taking bnt162b2. The mother was 2 Months pregnant at the onset of the event. The outcome of the event was recovered. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101455654 mother/fetus events


VAERS ID: 1871102 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-09-01
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101489981

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer or other non-health professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20215880. A 37-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left upper arm on 07Jun2021 (Batch/Lot Number: UNKNOWN) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced miscarriage on 01Sep2021. The event was reported as serious (medically significant). The mother reported she became pregnant while taking bnt162b2. The pregnancy resulted in spontaneous abortion. Outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1787009 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: NOMODERNATX, INC.MOD20213

Write-up: Spontanabort; bl?dninger; Maternal exposure during pergnancy; This case was received via (Reference number: NO-NOMAADVRE-E2B_00052019) 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 (Spontanabort) and VAGINAL HAEMORRHAGE (bl?dninger) in a 38-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pergnancy). On 08-Sep-2021, the patient experienced ABORTION SPONTANEOUS (Spontanabort) (seriousness criterion medically significant) and VAGINAL HAEMORRHAGE (bl?dninger) (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-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pergnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Spontanabort) and VAGINAL HAEMORRHAGE (bl?dninger) had not resolved. The action taken with mRNA-1273 (Intramuscular) was unknown. No Concomitant medications were reported. No Treatment information was reported. This case of maternal exposure during pregnancy, concerns a 38-year-old female patient (gestational age at the time of exposure unknown) with no relevant medical history, who experienced the unexpected serious events of spontaneous abortion and vaginal hemorrhage. The events occurred 6 days after receiving the Moderna mRNA-1273 vaccine. The rechallenge is not applicable. The benefit-risk relationship of mRNA vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Translation received 06-OCT-2021 contain No new information.; Sender''s Comments: This case of maternal exposure during pregnancy, concerns a 38-year-old female patient (gestational age at the time of exposure unknown) with no relevant medical history, who experienced the unexpected serious events of spontaneous abortion and vaginal hemorrhage. The events occurred 6 days after receiving the Moderna mRNA-1273 vaccine . The rechallenge is not applicable. The benefit-risk relationship of mRNA vaccine is not affected by this report.


VAERS ID: 1842431 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion induced, Chest X-ray, Maternal exposure during pregnancy, Pneumonia, Pyrexia, Systemic lupus erythematosus
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CxR; Result Unstructured Data: CxR condition of the patient was poor
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: pneumonia; Fever; patient terminated the pregnancy; Lupus erythematosus; Maternal exposure during pregnancy; This regulatory authority retrospective pregnancy case was reported by an other health care professional and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus erythematosus), ABORTION INDUCED (patient terminated the pregnancy) and PNEUMONIA (pneumonia) in a 27-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 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 13-Sep-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant). On 16-Sep-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus erythematosus) (seriousness criteria hospitalization prolonged, medically significant and life threatening). On 20-Sep-2021, the patient experienced ABORTION INDUCED (patient terminated the pregnancy) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced PYREXIA (Fever). The patient was hospitalized from 13-Sep-2021 to 28-Sep-2021 due to PNEUMONIA, and then from 16-Sep-2021 to 28-Sep-2021 due to SYSTEMIC LUPUS ERYTHEMATOSUS. The delivery occurred on 20-Sep-2021, which was reported as Elective Termination. For foetus 1, The outcome was reported as Elective Termination NOS. On 02-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus erythematosus), ABORTION INDUCED (patient terminated the pregnancy), PNEUMONIA (pneumonia) and PYREXIA (Fever) had not resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: abnormal (abnormal) CxR condition of the patient was poor. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported No treatment medications were reported On 16-Sep-2021 patient was transferred to Hospital and admitted to the ICU due to changes of condition. On 23-SEP-2021 patient was transferred to the general ward for observation and treatment and on 28-Sep-2021 patient was discharged. Company comment: This case of maternal exposure during pregnancy concerns a 27-year-old female patient, with no reported relevant medical history, who experienced the serious unexpected events of PNEUMONIA, SYSTEMIC LUPUS ERYTHEMATOSUS and ABORTION INDUCED. The events occurred approximately 11 days, 14 days, and 19 days respectively for described events after the administration of the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender''s Comments: This case of maternal exposure during pregnancy concerns a 27-year-old female patient, with no reported relevant medical history, who experienced the serious unexpected events of PNEUMONIA, SYSTEMIC LUPUS ERYTHEMATOSUS and ABORTION INDUCED. The events occurred approximately 11 days, 14 days, and 19 days respectively for described events after the administration of the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1720044 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-08-31
Onset:2021-09-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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:

Write-up: Miscarriage - patient disclosed when she came in for 2nd shot appointment


VAERS ID: 1724086 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-20
Onset:2021-09-03
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Abortion complete, Abortion spontaneous, Blood test, Exposure during pregnancy, Muscle spasms, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Thrombophlebitis (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin, probiotic
Current Illness: None
Preexisting Conditions: None
Allergies: Penicillin, Keflex, Sulfa
Diagnostic Lab Data: Blood test done at the Healthcare Group, Dr. on September 7th.
CDC Split Type:

Write-up: I was pregnant at the time of my first Covid vaccine, but didn?t receive a test confirmation of pregnancy until the following Monday, August 23rd. Around the 1st of September I started experiencing some cramping and on the morning of September 3rd I woke up with clots and started to miscarry. The miscarriage was complete and confirmed by a blood test on September 7th (this was holiday weekend so I had to wait to see the doctor).


VAERS ID: 1754772 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-02
Onset:2021-09-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 RA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish Oil 1200mg Prenatal Multi +DHA 200mg DHA
Current Illness: None
Preexisting Conditions: Cold sores on occasion
Allergies: None
Diagnostic Lab Data: Went to the ER on 09/04 and was told I might be in early stage of a miscarriage.
CDC Split Type:

Write-up: I was 12 weeks, 1 day pregnant and 28 hours later I started to hemorrhage and continued to bleed for hours. I almost had a miscarriage.


VAERS ID: 1695079 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Body temperature, Cold sweat, Dizziness, Dry mouth, Headache, Maternal exposure during pregnancy, Myalgia, Nasal congestion, Nausea, Pyrexia, SARS-CoV-2 test, Tension headache
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (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), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 38 Degree Celsius; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Miscarriage; Maternal exposure during pregnancy; Fever; Chronic headaches; Joint ache; Cold sweat; Muscle ache; Nausea; Nose congestion; Mouth dry; Tension headache; Dizziness; This case was received via regulatory authority (Reference number: GB-MHRA-WEBCOVID-202109041125148520-SNEOK ) on 05-Sep-2021 and was forwarded to Moderna on 05-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage), PYREXIA (Fever), HEADACHE (Chronic headaches), ARTHRALGIA (Joint ache), COLD SWEAT (Cold sweat), MYALGIA (Muscle ache), NAUSEA (Nausea), NASAL CONGESTION (Nose congestion), DRY MOUTH (Mouth dry), TENSION HEADACHE (Tension headache) and DIZZINESS (Dizziness) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included FOLIC ACID for Folic acid supplementation. On 03-Sep-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 03-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion disability), HEADACHE (Chronic headaches) (seriousness criterion disability), ARTHRALGIA (Joint ache) (seriousness criterion disability), COLD SWEAT (Cold sweat) (seriousness criterion disability), MYALGIA (Muscle ache) (seriousness criterion disability), NAUSEA (Nausea) (seriousness criterion disability), NASAL CONGESTION (Nose congestion) (seriousness criterion disability), DRY MOUTH (Mouth dry) (seriousness criterion disability), TENSION HEADACHE (Tension headache) (seriousness criterion disability) and DIZZINESS (Dizziness) (seriousness criterion disability). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria disability and medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown, PYREXIA (Fever), HEADACHE (Chronic headaches), ARTHRALGIA (Joint ache), COLD SWEAT (Cold sweat), MYALGIA (Muscle ache), NAUSEA (Nausea), NASAL CONGESTION (Nose congestion), TENSION HEADACHE (Tension headache) and DIZZINESS (Dizziness) had not resolved and DRY MOUTH (Mouth dry) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 38 degree celsius (abnormal) 38 Degree Celsius. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Details of scans or investigations of the patient are reported as Miscarriage. Company comment: This is a RA case of maternal exposure during pregnancy with associated adverse events, including spontaneous abortion after the second dose of the product, in a 30 years old woman whose medical history was not provided. Based on temporal association a causal relationship cannot be excluded. As per first dose date was not provided, the schedule of product administration is unknown. Events seriousness captured as per Regulatory Authority assessment; Sender''s Comments: This is a RA case of maternal exposure during pregnancy with associated adverse events, including spontaneous abortion after the second dose of the product, in a 30 years old woman whose medical history was not provided. Based on temporal association a causal relationship cannot be excluded. As per first dose date was not provided, the schedule of product administration is unknown. Events seriousness captured as per Regulatory Authority assessment


VAERS ID: 1709824 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-09-03
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101153224

Write-up: Early miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109031853438250-8ENK0. Safety Report Unique GB-MHRA-ADR 25893859. A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Jun2021 at dose 1, single for COVID-19 immunisation. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Medical history included pregnancy (Patient no longer pregnant at the time of reporting), folic acid supplementation. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced early miscarriage (serious as medically significant) on 03Sep2021 with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: No - Negative COVID-19 test on an unknown date. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Pregnancy adverse effects details reported as Miscarriage at 12 week 4 days. Patient was exposed to the medicine first-trimester (1-12 weeks). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1761152 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-09-03
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101244241

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. The regulatory authority report number is 626856. A 32-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot number was not reported), via an unspecified route of administration, on 18Aug2021, as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 03Sep2021, it was reported that the patient experienced abortion spontaneous (medically significant). The outcome of the event was recovered on unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1769516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative
CDC Split Type: FRPFIZER INC202101262659

Write-up: Miscarriage; Influenza like illness; This is a spontaneous report from a contactable consumer or other non hcp (patient) downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number FR-AFSSAPS-TS20214682. A 32-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FG6273, Expiry date was not reported) via intramuscular route of administration, administered on 03Sep2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The mother reported she became pregnant while taking bnt162b2. The mother was 5 Weeks pregnant at the onset of the event. The mother was due to deliver on 04May2022. On 03Sep2021 the patient experienced influenza like illness and on 10Sep2021 the patient experienced miscarriage on Day 7 of Dose 2 from Comirnaty, in a patient who did not know she was pregnant (irregular periods, last menstruation on 28Jul2021) confirmed by the dosage of beta-HCG. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 19Jul2021. The outcome of the event influenza like illness was recovered and miscarriage was recovering. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1685468 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-28
Onset:2021-09-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy, Haemorrhage in pregnancy, Human chorionic gonadotropin decreased, 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), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: Codeine
Diagnostic Lab Data: Blood test to check HCG level performed on Wednesday September 8th 2021 due to the bleeding. Results indicated that I suffered a miscarriage.
CDC Split Type:

Write-up: I obtained the first dose of the Covid 19 Pfizer vaccine on Saturday August 28 2021 after discovering that I was pregnant the same day. My blood test was drawn to check my HCG levels on Tuesday August 31st 2021 and Thursday September 2nd 2021 and results showed that pregnancy was progressing normally based on the levels obtained these two days. On Saturday September 4th 2021 I started to bleed (light bleeding, spotting). It happened in the morning then stopped a bit and it happened again in the afternoon. I experienced light bleeding and spotting again on Sunday September 5th 2021. On Monday September 6th I continued to experience light bleeding during the day but the the flow of blood increased at night. I contacted my doctor on Monday September 6th she advised me to get another blood test to check my HCG level on Wednesday September 8th 2021. On Tuesday September 7th the bleeding became heavy like a period. I continued to bleed heavily on Wednesday September 8th 2021. I got my blood test done on Wednesday September 8th 2021 per my doctor''s instruction. Today Thursday September 9th 2021 I got my results back and my HCG level dropped to non pregnant level. I spoke with my doctor''s nurse today Thursday September 9th and after she reviewed the HCG number she informed me that I had suffered a miscarriage. I am still experiencing bleeding today Thursday September 9th 2021.


VAERS ID: 1694542 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-31
Onset:2021-09-04
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 9639902 / 2 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Labatelol, digoxin, baby aspirin, prenatal vitamins. A couple days before I got a blood thinner injection and switched to Metropolal
Current Illness: No, only going into SVT sometimes due to my ASD heart condition but I was taking medicine for it.
Preexisting Conditions: Hypertension, Atrial Septal Defect since birth
Allergies: None
Diagnostic Lab Data: Cervical test showed I was dilated at a 6 when I went into hospital to check for bleeding.
CDC Split Type:

Write-up: My due date was December 17th but I had my baby at 25 weeks 1 day on September 4th. She weighed 1 lb 11 oz. She''s currently fighting for her life in the level 4 NICU.


VAERS ID: 1718856 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-08-27
Onset:2021-09-04
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Exposure during pregnancy, Pregnancy test
SMQs:, Acute pancreatitis (broad), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal Vitamins Ubiquinol Q10 Probiotics
Current Illness: None
Preexisting Conditions: Pancreatitis
Allergies: None
Diagnostic Lab Data: Two separate HCG test were conducted and confirmed miscarriage
CDC Split Type:

Write-up: 4 weeks pregnant when received the vaccines. Started having sharp abdominal pain approximately one week later, which led to miscarriage at 5 weeks


VAERS ID: 1753247 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: D.C.  
Vaccinated:2021-08-24
Onset:2021-09-04
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Military       Purchased by: ?
Symptoms: Abortion spontaneous, COVID-19, Exposure during pregnancy, SARS-CoV-2 test positive, Thrombosis, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: No
Diagnostic Lab Data: Positive COVID test result on Sep 6 while at the ER
CDC Split Type:

Write-up: I was 9 weeks pregnant when I had my first COVID vaccine on Aug 24. My estimated due date was March 22, 2022. I started spotting 11 days after the vaccine, on Sep 4. The spotting gradually increased. Two days later to large blood clots and the blood loss was so much that I went to the ER. I miscarried on Sep 6 at 11 weeks pregnant. A D&C procedure was performed to complete the tissue removal. A blood transfusion was thought to be necessary but I did not end up having one.


VAERS ID: 1777624 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-08-26
Onset:2021-09-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage, Inappropriate schedule of product administration, Muscle spasms, Peripheral swelling, Transfusion, Uterine dilation and curettage
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow)

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

Write-up: Patient came in in 8/29/21 and got her 1st dose of Moderna Covid vaccine. she returned to the pharmacy on 10/11/21 for her 2nd dose and upon reviewing her questionnaire, I questioned her about the blood transfusion she indicated that she recieved in the past 4 weeks. I then called the CDC to advise me on what to do regarding the 2nd dose but CDC referred me to MODERNA. I called MODERNA and after relating the issue with the female representative, she asked to speak with the patient and in my presence, the patient gave further details relating to her experience She stated that a week after her 1st moderna shot, she started cramping and her hand had swelled up. She said she went to the ER and it was determined that her baby''s heartbeat had stopped. She eventually suffered a miscarriage and had D&C. She stated that that caused her to lose a lot of blood and she eventually got a blood transfusion. The representative advised me to hold off on giving the 2nd dose and she also gave me a case #: MOD 21-151604.


VAERS ID: 1794348 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-06-22
Onset:2021-09-04
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051C21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test abnormal, Menstruation irregular, Pregnancy, Ultrasound scan abnormal, Urine analysis abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Blood, urine, and vaginal ultrasound done on Sept 5th, 2021 proved I was having a miscarriage. More blood, ultrasounds, and pelvic exams on Sept 6th proved a miscarriage.
CDC Split Type:

Write-up: After the first shot my period suddenly came back after not having one since having my daughter a year before. Then I got the second shot. I became pregnant shortly after. I then had a miscarriage that started with slight bleeding on the 4th. More bleeding on the 5th. Then on the 6th I had to go to my third hospital due to extreme bleeding. I?m now having a period every other week that starts with spotting for 3 days and then bleeding for 5.


VAERS ID: 1783853 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101316943

Write-up: Miscarriage; 1st dose on 19Jul2021 and 2nd dose on 04Sep2021; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110040926195600-BYDQL, safety report unique identifier is GB-MHRA-ADR 26032120. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on 04Sep2021 as dose 2, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on 19Jul2021 at single dose for Covid-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 09Sep2021, 5 days after vaccination, patient had miscarriage (hospitalization, medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: negative. The outcome of event was recovering at the time of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1807265 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   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 FE4721 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Chills, Maternal exposure during pregnancy, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: SEPFIZER INC202101331502

Write-up: miscarriage of pregnancy; abdominal pain / extreme pains (abdominal); fever; chills; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number SE-MPA-2021-086644. Safety Report Unique Identifier SE-VISMA-1632913641910. A 37-year-old pregnant female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Sep2021 (Batch/Lot Number: FE4721) (at the age of 37 years old) as single dose for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was pregnant (maternal exposure during pregnancy) at the time of vaccination. After vaccination on 04Sep2021, the patient experienced fever and chills. Three days after vaccination, on 07Sep2021, the patient had abdominal pain, she had extreme pains (abdominal). The patient contacted her healthcare/physician. Miscarriage of pregnancy was confirmed on 09Sep2021. The mother was 8 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The events miscarriage of pregnancy, maternal exposure during pregnancy, and abdominal pain caused disability and resulted in physician office visit. The patient was healthy and did not have any miscarriage before. The patient was recovering from miscarriage of pregnancy. Outcome of the other events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1816316 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-09-04
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: FRPFIZER INC202101351018

Write-up: Miscarriage; This is a spontaneous report from a contactable physician downloaded from the s Agency. Regulatory authority report number FR-AFSSAPS-TO20218220. A 40-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: Unknown), via intramuscular on 10Aug2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Pregnancy in progress, start of pregnancy on 21May2021. The patient was due to deliver on 25Feb2022. The patient received a second injection of BNT162B2 on 10Aug2021. On 04Sep2021, she presented a spontaneous miscarriage, at 14th week, but probably dating from a week before the exam. Duration was reported as 1 day. Management with hospitalization and curettage. Outcome of event was recovered on 04Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1794222 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-30
Onset:2021-09-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048F21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy, Muscle spasms, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRENATAL VITAMINS
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data: Blood work was performed and it was normal.
CDC Split Type:

Write-up: On August 30,2021, patient received her 1st Covid vaccine. 6 days later she began cramping. It continued til the 18th of September when she began bleeding. On the 19th she passed the baby at home (at 16 weeks) and went to ER where she passed the placenta. She was treated and sent home. Her due date was March 20th and a C-section was scheduled for the 13th.


VAERS ID: 1742441 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-09-05
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101204398

Write-up: miscarriage; psychological pain; This is a spontaneous report from a contactable consumer (patient) reference number FR-COVAES-9b33d19a-8caa-4cd1-98c9-f3f94cb6ebb0. This consumer or other non hcp reported information for both mother and fetus/baby. This is the maternal report. A 32-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration, administered in Arm Left on 15Jul2021 (at the age of 32 years old) (Batch/Lot Number: Unknown) as dose number unknown, single for COVID-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s and concomitant medications were not reported. The patient reported she was 2 weeks pregnant at the time of injection on 15Jul2021 (last menstrual period on 29Jun2021; pregnancy due date 29Mar2022). Then she reported that on 05Sep2021 (at 9 weeks), her baby''s heart suddenly stopped without reason one and a half month after the injection whereas there was no anomaly. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient also experienced psychological pain after the miscarriage. Since the vaccination, the patient has not been tested for COVID-19. The events resulted in Emergency room/department or urgent care. The outcome of the events was reported as not recovered.


VAERS ID: 1780201 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-28
Onset:2021-09-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101278906

Write-up: Early miscarriage; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB. The regulatory authority report number is FR-AFSSAPS-MP20217643. A 38-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: FG7387), via intramuscular, on 28Aug2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has not had COVID-19, and has not been tested. On 05Sep2021, it was reported that the patient experienced an occurrence of early miscarriage (medically significant), around 6 WA (as reported). "Concept" of loss of a baby at a more advanced term than the one concerned in this report. The outcome of the event was recovered on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724466 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-27
Onset:2021-09-06
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Back pain, Exposure during pregnancy, Haemorrhage, Human chorionic gonadotropin increased, Laboratory test, Pregnancy test positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin
Current Illness: N/A. Previously healthy.
Preexisting Conditions: Previously healthy.
Allergies: NKDA. Seasonal allergies.
Diagnostic Lab Data: Sept 6 2021 lab results and sept 8 2021
CDC Split Type:

Write-up: Pfizer injected to arm by nurse. They asked if I was pregnant. I indicated I wasn?t pregnant. A few weeks later I had a positive pregnancy test indicated I would have been pregnant at the time of the vaccine. High levels of HCG. On sept 6 2021 I had severe back pain, moderate bleeding , and after a confirmation from the ER doctor I had a miscarriage. Previously healthy. Unknown aetiology for miscarriage.


VAERS ID: 1787289 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210907; Test Name: Pregnancy test; Test Result: Positive
CDC Split Type: SEPFIZER INC202101274013

Write-up: VAGINAL BLEEDING; MISCARRIAGE; MATERNAL EXPOSURE DURING PREGNANCY; This is a spontaneous report received from a contactable consumer downloaded from the WEB. The regulatory authority report number is SE-MPA-2021-084286. Safety Report Unique Identifier SE-VISMA-1631794496989. A 33-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 06Sep2021 at age of 33-years-old as DOSE 2, SINGLE for covid-19 immunisation . The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced maternal exposure during pregnancy on 06Sep2021 with outcome of unknown , vaginal bleeding, miscarriage on 08Sep2021 with outcome of unknown. Reported suspect adverse event was miscarriage of pregnancy during week 4 of pregnancy. On 07Sep2021, the patient did pregnancy test and it was positive. The reporter assessed the report as non-serious while the regulatory authority assessed the report as serious as medically significant. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.


VAERS ID: 1866237 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Miscarriage; Maternal vaccine exposure; This case was received via Regulatory Authority (Reference number: FI-FIMEA-20216049) on 05-Nov-2021 and was forwarded to Moderna on 05-Nov-2021. This regulatory authority retrospective pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE TIMING UNSPECIFIED (Maternal vaccine exposure) in a 40-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. In 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 06-Sep-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria disability and medically significant) and MATERNAL EXPOSURE TIMING UNSPECIFIED (Maternal vaccine exposure) (seriousness criterion disability). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion w Cong Anomaly. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE TIMING UNSPECIFIED (Maternal vaccine exposure) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter. Company comment:This is a regulatory authority case concerning a 40-year-old, female patient with materal exposure to the vaccine and unknown medical history, who experienced the unexpected serious (disability and medically significant) event of Abortion Spontaneous. The event occurred with unknown latency to the first dose of Moderna COVID 19 vaccine. Patient?s age is a confounder for the event, that was reported with this seriousness criteria. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 40-year-old, female patient with materal exposure to the vaccine and unknown medical history, who experienced the unexpected serious (disability and medically significant) event of Abortion Spontaneous. The event occurred with unknown latency to the first dose of Moderna COVID 19 vaccine. Patient?s age is a confounder for the event, that was reported with this seriousness criteria. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.


VAERS ID: 1734968 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-08
Onset:2021-09-07
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / SYR

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

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

Write-up: I was 3 weeks pregnant when I received my first dose of Pfizer vaccine. At my first ultrasound they could not detect a heartbeat and I had a miscarriage. I had undergone alot of testing before I got pregnant and all my tests showed that I was perfectly healthy.


VAERS ID: 1782871 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-09
Onset:2021-09-07
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 2 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pre natal vitamin, 250 mg magnesium and 100 mg CoQ10
Current Illness: none. Relating to Item 8: I was 8 weeks pregnant when I had a miscarriage on September 7.
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was 8 weeks pregnant when I had a miscarriage on September 7th. Estimated due date was April 22. This was my second pregnancy. 1st pregnancy had no complications during pregnancy and birth, had a healthy baby boy on July 23, 2020.


VAERS ID: 1816459 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-26
Onset:2021-09-07
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EYO584 / 2 AR / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO196 / 1 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test abnormal, Cardiolipin antibody, Pregnancy
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: n/a
Preexisting Conditions:
Allergies: Allergy to aspirin
Diagnostic Lab Data: Elevated cardiolipin IgM detected in subsequent blood work (24 MPL) on 9/20. Chromosome analysis of f?tus came back normal.
CDC Split Type:

Write-up: Miscarriage on 9/7 (5w3d pregnant). Pregnancy conceived less than 30 days after 2nd shot (conception date around mid-August).


VAERS ID: 1837415 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-08-26
Onset:2021-09-07
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Beta HCG on 9/3 - 39 Beta HCG on 9/9 - 0
CDC Split Type:

Write-up: Miscarriage at estimated 5.5 weeks


VAERS ID: 1746109 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-07
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Miscarriage; Maternal exposure during pregnancy; This case was received via Regulatory Authority (Reference number: FI-FIMEA-20214665) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Sep-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). 07-Sep-2021, 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 Abortion NOS. 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 (Maternal exposure during pregnancy) was resolving. The action taken with mRNA-1273 (Intramuscular) was unknown. No concomitant and treatment medication were provided Company Comment: This case concerns a pregnant female of unknown age with no relevant medical history, who experienced the unexpected non-serious events of maternal exposure during pregnancy and spontaneous abortion. The event spontaneous abortion occurred 5 days after the first dose of Moderna mRNA-1273 vaccine. The gestational age of pregnancy/LMP was not reported. The rechallenge is not applicable as the events occurred after the first dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA vaccine in not affected by this report.; Sender''s Comments: This case concerns a pregnant female of unknown age with no relevant medical history, who experienced the unexpected non-serious events of maternal exposure during pregnancy and spontaneous abortion. The event spontaneous abortion occurred 5 days after the first dose of Moderna mRNA-1273 vaccine. The gestational age of pregnancy/LMP was not reported. The rechallenge is not applicable as the events occurred after the first dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA vaccine in not affected by this report.


VAERS ID: 1770099 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-09-07
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 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: NOPFIZER INC202101263076

Write-up: ABORTION SPONTANEOUS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB NO-NOMAADVRE-FHI-2021-Ug9ngr. A 26-year-old female patient received the first dose of bnt162b2 (COMIRNATY; Batch/Lot Number: FE7053) intramuscularly administered in Arm Left on 04Aug2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient was pregnant at the time of vaccination. The patient experienced abortion spontaneous on 07Sep2021 at 7 weeks pregnant. No relevant laboratory findings or investigations were included in this report. Outcome of event was recovered on an unspecified date. Relatedness of drug to reaction/event Comirnaty/all events/Center/Possible No follow-up attempts are possible. No further information is expected.


VAERS ID: 1782081 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
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: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101284141

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health professional via the regulatory agncy. Regulatory authority report number is 630777. A 28-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on unspecified date of 2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced abortion spontaneous on 07Sep2021. The seriousness of the event was medically significant. The outcome of event was recovered with sequelae on unspecified date of 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1783551 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-09-07
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (But CoVid-19 test was not performed)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101291345

Write-up: Miscarriage; First trimester of pregnancy; This is a spontaneous report from a contactable consumer or other non health professional downloaded from a regulatory authority-WEB FR-AFSSAPS-PC20213933. A 28-years-old pregnant female patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: unknown), via intramuscularly in the right arm on 25Aug2021 (at the age of 28-years-old) as dose 2, 0.3 ml single for covid-19 immunization. Medical history included Covid-19, But CoVid-19 test was not performed. No other history was reported. Concomitant medication was reported as none. It was reporter that the patient was in first trimester of pregnancy. On 07Sep2021 the patient miscarries, leading to an emergency room. In total, miscarriage, in a patient who was in her first trimester of pregnancy, on D14 of D2 of the COMIRNATY vaccine (batch unknown). The outcome of the the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1838019 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-09-07
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2021-11-02
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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101394823

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number FR-AFSSAPS-TO20218392. A 39-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date not reported), intramuscular, administered in left arm on 15Jun2021 as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 07Sep2021, she presented with a miscarriage for which she was hospitalized for 2 days in 2021. The mother reported she became pregnant while taking bnt162b2. The mother was at first (1) trimester pregnant at the onset of the event. The mother was due to deliver on 12Mar2022. It was mentioned that patient''s last menstrual period was on 05Jun2021. The patient was recovered with sequelae on 07Sep2021 (as reported). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1682656 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-25
Onset:2021-09-08
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin, zyrtec
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Sonogram confirmed no heartbeat and dated pregnancy one week behind.
CDC Split Type:

Write-up: Miscarriage confirmed 9/8/21 at routine appointment Due : 4/2022 Pregnancy history- 3 pregnancies 1 termination 1 full term birth 1 miscarriage


VAERS ID: 1749635 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-09-03
Onset:2021-09-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 2 LA / -

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

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, Compound Thyroid, Vitamin D, Omega 3
Current Illness: N/A
Preexisting Conditions: Auto-Immune Thyroid
Allergies:
Diagnostic Lab Data: I had an ultrasound on 9/10/21 that confirmed my baby was no longer growing.
CDC Split Type:

Write-up: I started cramping and when the ultrasound was done on September 10 2021, I measured 5 weeks 2 days and I should have been 6 weeks 2 days. My baby stopped growing the day I received the second vaccination, which then resulted in a miscarriage.


VAERS ID: 1775015 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-05-20
Onset:2021-09-08
   Days after vaccination:111
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004C21A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053C21A / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal heart rate abnormal, Labour induction, Stillbirth, Ultrasound antenatal screen abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

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

Write-up: In April, I became pregnant with my second child. After heavy advising, I recieved the first dose of the covid vaccine in May, my first month of being pregnant. I received the second dose in June, my second month of pregnancy. On Sept 8th, during a routine scheduled ultrasound, the fetus was found to have no heartbeat. Which resulted in an emergency induction of labor. I had a stillbirth delivery the next day, Sept 9th.


VAERS ID: 1790939 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-08-16
Onset:2021-09-08
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / -

Administered by: Public       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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101292972

Write-up: MISCARRIAGE; This is a spontaneous report received from a contactable consumer (patient). This is a maternal report. A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 16Aug2021 10:00 (Batch/Lot number was not reported) at the age of 37-years-old as SINGLE DOSE for covid-19 immunisation. Vaccine was administered at Public Health Clinic/Military Administration facility. The patient''s medical history was not reported. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. The patient experienced miscarriage on 08Sep2021. Event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Dilatation and Curettage (D&C). The mother reported she pregnant while taking bnt162b2. The mother was 8 Weeks pregnant at the onset of the event. The mother was due to deliver on 16Apr2022. The last menstrual period (LMP) was on 10Jul2021. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1794030 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-04
Onset:2021-09-08
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037FZIA / 1 LA / IM

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

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

Write-up: Miscarriage, was due April 2022. At time of vaccine I was 6 weeks and 1 day. The baby stopped growing around 6 weeks 4 days.


VAERS ID: 1845471 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-05
Onset:2021-09-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pathology test, Premature separation of placenta, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

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, 4 days
   Extended hospital stay? No
Previous Vaccinations: Pfizer, 08/05/2021
Other Medications: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Surgical Pathology Report 09/14/2021
CDC Split Type:

Write-up: I was 6 months pregnant, due date December 15. Baby and I were healthy we just had a check up two weeks before this happened. Lost baby to placenta abruption from a blood clot. She weight 1 lb and 11 oz.


VAERS ID: 1732912 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101214750

Write-up: Maternal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer. This is a report downloaded from a regulatory authority-WEB, Regulatory authority number GB-MHRA-WEBCOVID-202109100955404850-8ULLC. Safety Report unique Identifier GB-MHRA-ADR 25922890.This consumer reported information for both mother and fetus. This is a maternal report. A 37-year-old female pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 08Sep2021 (Batch/Lot number was not reported) (at the age of 37-years-old) as dose 1, single for COVID-19 immunization. Medical history included pregnancy from an unknown date. Patient no longer pregnant at the time of reporting, Folic acid supplementation from an unknown date. Concomitant medication included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. Patient did not had symptoms associated with COVID-19, did not had a COVID-19 test. Patient is not currently breastfeeding. The patient experienced miscarriage on 08Sep2021, maternal exposure during pregnancy on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The event miscarriage was serous medically significant. The outcome the event miscarriage was recovered on 09Sep2021 and maternal exposure during pregnancy was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1777512 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-09-08
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation delayed
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: FIPFIZER INC202101272932

Write-up: Menorrhagia; Early miscarriage; Menstruation delayed; Abdominal cramps; Dysmenorrhoea; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Agency (A) -WEB, regulatory authority number FI-FIMEA-20214923. A 29-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 09Aug2021 (Batch/Lot Number: UNKNOWN) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced menorrhagia, early miscarriage, menstruation delayed, abdominal cramps and dysmenorrhoea on 08Sep2021 with outcome of recovered on an unspecified date. Further ADR description stated that menstruation following the second dose of vaccine began three days later than expected and was exceptionally painful and profuse. Her stomach cramped for three days so that she needed painkillers in order to be able to work in the sitting position. The patient mentioned that normally, her menstrual cycle was very regular 28.5 days (+/- 1), she only got stomach cramps on the first day of her period and she usually do not need painkillers for the pain. She mentioned that it was also possible that this was an early miscarriage. The mother reported she became pregnant while taking bnt162b2. Therapeutic measures were taken as a result of abdominal cramps. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1777796 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-09-08
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abortion induced
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Name: USG; Result Unstructured Data: Test Result:did not find any embryonic cardiac activity
CDC Split Type: FRPFIZER INC202101273302

Write-up: miscarriage at 12 WA + 5 days; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number FR-AFSSAPS-TS20214703. A 33-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 06Aug2021 (Lot Number: J07BX03) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included voluntary termination of pregnancy, haemorrhagic abortion and emergency curettage followed by transfusion in 2019. The patient''s concomitant medications were not reported. On 08Sep2021 (12 WA + 5 days) (D33 from the vaccination), the dating ultrasound did not find any embryonic cardiac activity. Diagnosis of interrupted pregnancy (craniocaudal length corresponding to 7 WA + 2 days). The patient is referred to the emergency room for further treatment. In total, miscarriage at 12 WA + 5 days. The mother reported she became pregnant while taking bnt162b2. The mother was 12 Weeks pregnant at the onset of the event. The mother was pregnant with 1 baby. The mother was due to deliver on 01Apr2022. The mother delivered the pregnancy on 08Sep2021 resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient underwent SARS-CoV-2 test: negative on unspecified date. The patient was hospitalized due to event and the outcome was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1856217 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting. have had a healthy pregnancy in 2017.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101466582

Write-up: Miscarriage; received first dose on 21Jun2021/received second dose on 08Sep2021; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is [GB-MHRA-WEBCOVID-202110251504112850-3W10O]. A 30-year-old female patient (pregnant) received BNT162B2 (COMIRNATY; batch/lot number and expiration date not provided) via an unspecified route of administration on 08Sep2021 as DOSE 2, SINGLE for COVID-19 immunisation. Patient''s medical history included pregnancy from 2017 (reported as healthy pregnancy in 2017) to an unspecified date and folic acid supplementation from an unspecified date and unknown if ongoing. It was also reported that patient was exposed to the medicine before pregnancy (as reported). Patient is not currently breastfeeding. Patient was not pregnant at the time of reporting (as reported). Patient is not enrolled in clinical trial. Concomitant medication included folic acid from an unspecified date and unknown if ongoing for folic acid supplementation. Patient previously took first dose of BNT162B2 (COMIRNATY; batch/lot number: FC9001; expiration date not provided) via an unspecified route of administration on 21Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation and experienced pregnancy loss. The patient experienced miscarriage on an unspecified date and ''received first dose on 21Jun2021/received second dose on 08Sep2021'' on 08Sep2021. Patient''s clinical course was as follows: it was reported that patient had 2 miscarriages in 4 months after having both jabs of COVID. It was unsure if the medicine has an adverse effect on any aspect of pregnancy (as reported). The event miscarriage was assessed as serious (medically significant), the event ''received first dose on 21Jun2021/received second dose on 08Sep2021'' was assessed as non-serious. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test with result of ''negative; No - Negative COVID-19 test'' on an unspecified date. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1704563 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-21
Onset:2021-09-09
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, 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), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin, doxylamine, metoclopramide, prenatal vitamins, pyridoxine.
Current Illness: COVID-19 infection 8/26/21, asymptomatic GBS UTI at initial prenatal visit
Preexisting Conditions: Chronic hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fetal demise discovered at 26w4d. EDD 12/12/21. Patient had 2 unremarkable vaginal deliveries, the third vaginal delivery complicated by gestational hypertension. This pregnancy was complicated by chronic hypertension and asymptomatic GBS UTI at initial prenatal visit.


VAERS ID: 1738897 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-09
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown; Comments: Unknown
CDC Split Type: GBPFIZER INC202101217706

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109151348523710-FYNKP. Safety Report Unique Identifier GB-MHRA-ADR 25945573. This consumer reported information for both mother and fetus/baby. This is a maternal report. A pregnant female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not known), via an unspecified route of administration, on an unspecified date, as dose 2, single for COVID-19 immunization. The patient''s medical history included pregnancy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not known), via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization. The patient experienced miscarriage on 09Sep2021. The mother reported she became pregnant while taking bnt162b2. Patient has not had symptoms associated with COVID-19. Miscarriage patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test/ COVID-19 virus test was negative on 10Sep2021 (No - Negative COVID-19 test) and ultrasound scan result was unknown on an unspecified date. The event was serious (hospitalization, medically significant, congenital anomaly). Patient was not enrolled in clinical trial. Outcome of the event miscarriage was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1755161 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
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, Investigation, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: scans or investigations; Result Unstructured Data: Test Result:I went into labour the same night I got my vaccine; Comments: baby was 17+4 weeks gestation; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101266221

Write-up: Late miscarriage; first dose on 15-JUL-2021/second dose on 9-SEP-2021; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109250819407140-L79AG, Safety Report Unique Identifier GB-MHRA-ADR 25994306. A pregnant 29-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Sep2021 (Batch/Lot Number: Not known) as single dose for COVID-19 immunization. Medical history included pregnancy. The patient was no longer pregnant at the time of reporting. The patient has not had symptoms associated with COVID-19 and was not currently breastfeeding. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation. On 09Sep2021 the patient experienced late miscarriage, assessed as medically significant and requiring patient''s hospitalization, moreover an inappropriate schedule of vaccine was administered. The patient reported that later in the night of the second vaccine dose her body started the process of labour. Her mucus plug came away at around 10pm, she then began having bleeding, cramping/contractions, intense pain in my lower back. These symptoms continued until 4pm on Sunday 12Sep2021 when she delivered her baby at just 17+4 weeks gestation. The baby was delivered premature. The fetal outcome was neonatal death. Her baby did not survive. Her placenta then wouldn''t deliver itself so the patient had to go to theatre for a procedure to remove it. The previous 2 pregnancy''s were both successful, both full term healthy babies. The patient took folic acid and all vitamins prescribed by doctors throughout pregnancy, with no problems.. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: the patient went into labour the same night she got her vaccine, baby was 17+4 weeks gestation. Post-mortem is being done on baby and results will be submitted once this is complete. On an unknown date the patient underwent SARS-CoV-2 test which was negative. The event outcome was unknown at the time of the report. 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-202101275895 Same patient, different dose drug/event.


VAERS ID: 1809507 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? 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:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101342428

Write-up: Miscarriage; maternal exposure during pregnancy/patient was exposed to the medicine first-trimester (1-12 weeks).; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The Regulatory authority report number is GB-MHRA-WEBCOVID-202110082332411530-ENQFA and the Safety Report Unique Identifier is GB-MHRA-ADR 26055887. A 25-year-old pregnant female patient received second dose of BNT162B2 (COMIRNATY, PFIZER-BIOINTECH COVID-19 VACCINE), via an unspecified route of administration on 09Sep2021 (batch/lot number was not reported) as single dose for COVID-19 immunization. Medical history included suspected COVID-19 from 12Jul2021 to 26Jul2021. Patient was not currently breastfeeding and was not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation. The patient experienced maternal exposure during pregnancy on 09Sep2021 and miscarriage on 13Sep2021. Case narrative: Jab given in early pregnancy (was not aware of pregnancy at the time). Given on Thursday. Found out pregnant Saturday. Miscarried Monday. The medicine had an adverse effect on aspect/s of the pregnancy. Pregnancy adverse effect was miscarriage. She was exposed to the medicine first-trimester (1-12 weeks). She was no longer pregnant at the time of reporting. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: yes - positive COVID-19 test on 13Jul2021. The patient recovered from miscarriage on 18Sep2021. Case reported as serious by health authority (hospitalization and medically significant). No follow-up attempts are possible. information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1830343 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Hospitalisation, Maternal exposure during pregnancy, Premature delivery
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VITAMIN D [VITAMIN D NOS]; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]; MULTICENTRUM MYOMEGA3
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:110/75; Comments: before vaccination; Test Date: 20210913; Test Name: blood pressure; Result Unstructured Data: Test Result:140/90; Comments: 4 days after 2nd dose, an abnormal blood pressure rise; Test Date: 202109; Test Name: blood pressure; Result Unstructured Data: Test Result:150/98; Comments: one week after 2nd dose
CDC Split Type: ITPFIZER INC202101385831

Write-up: required hospitalization.; An abnormal blood pressure rise; maternal exposure during pregnancy, third trimester; delivery was carried out with an anticipation of ten days with respect to the expected date; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-798594. This consumer or other non hcp reported information for both mother and fetus/baby. This is a maternal report. A 34-year-old pregnant female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Not reported), via intramuscular route of administration, administered in arm left on 09Sep2021 (at the age of 34-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient was pregnant at the time of vaccination. Patient gestation period at time of exposure was 9 months. The patient concomitant medications included vitamin D (VITAMIN D NOS), omega 3 (DOCOSAHEXAENOIC ACID; EICOSAPENTAENOIC ACID; TOCOPHEROL), multicentrum myomega3 (FISH OIL, UBIDECARENONE), all drugs taken for an unspecified indication, start and stop date were not reported. On an unspecified date in 2021, delivery was carried out with an anticipation of ten days with respect to the expected date. On 09Sep2021, maternal exposure during pregnancy, third trimester. On 13Sep2021, the patient experienced required hospitalization, an abnormal blood pressure rise. The mother reported she became pregnant while taking bnt162b2. The mother was 9 months pregnant at the onset of the event. The baby was delivered premature. An abnormal blood pressure rise was detected 4 days after the second dose, which persisted throughout the week until the time of delivery. The rise in blood pressure required hospitalization. After hospitalization, delivery was carried out with an anticipation of ten days with respect to the expected date. Pregnancy (yes) - Impact on quality of life (9/10). The patient underwent lab tests and procedures which included blood pressure: 110/75 before vaccination on an unspecified date; blood pressure: 150/98 one week after 2nd dose on an unspecified date in Sep2021; blood pressure: 140/90 4 days after 2nd dose, an abnormal blood pressure rise on 13Sep2021. The outcome of the events required hospitalization, an abnormal blood pressure rise was recovering; delivery was carried out with an anticipation of ten days with respect to the expected date was unknown. Reporter comment: The pregnancy was physiological up to week 37, with a constantly updated blood pressure diary and values never exceeded 110/75. 4 days after the second dose, the pressure detected was 140/90 to reach peaks of 150/98 after one week from the second dose. Other products taken: Multicentrum mamma, omega 3, vitamin d. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1730431 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-09-04
Onset:2021-09-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (If covid prior vaccination: Yes); Pregnancy (I have had two healthy pregnancies and no issues)
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Test Result: Positive ; Comments: I have taken five tests, all positive.; Test Date: 20210910; Test Name: pregnancy test; Result Unstructured Data: Test Result:do not show a strong pregnancy line
CDC Split Type: USPFIZER INC202101190065

Write-up: miscarriage; This is a spontaneous report from a contactable consumer. This 33-year old female consumer (patient) reported for herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot Ew0185) on 04Sep2021 07:30 AM at right arm for COVID-19 immunization. Age at vaccination: 33 years old. Medical history included Covid-19 and two healthy pregnancies with no issues. Concomitant drugs were not provided. The patient received the shot on 04Sep2021 and found out she was pregnant on 06Sep2021. She had five tests, all positive. On 10Sep2021 07:30 AM, she woke up bleeding and did not show a strong pregnancy line on the tests. The patient had miscarriage. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The patient needed to call doctor and see what to do next. Outcome of the event was unknown. Second Pfizer Covid-19 vaccine was scheduled for 25Sep2021.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101190080 mother/baby case


VAERS ID: 1732926 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-09-10
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; LEVOTHYROXINE; METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Overweight; Polycystic ovary; Thyroid disorder
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: scan; Result Unstructured Data: Test Result:baby''s heartbeat couldn''t be found
CDC Split Type: GBPFIZER INC202101191474

Write-up: Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109102339493490-VXFUG. Safety Report Unique Identifier GB-MHRA-ADR 25926921. A 28-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 05Aug2021 (Lot Number: FF3319) as dose 2, single for COVID-19 immunization. Medical history included thyroid disorder, a bit overweight, Polycystic ovary, and hypothyroidism. Her thyroid level had always been at a steady level and her doctor suspected she might have very mild PCOs although not confirmed with a scan, therefore she was on metformin for this. She was a bit overweight but fairly fit and do regular weekly exercise. The patient doesn''t smoke and drink much. She doesn''t take drugs. She eats fairly healthily with minimal red meats. Unsure if patient has 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; levothyroxine taken for hypothyroidism from 01Aug2018 to an unspecified stop date; and metformin taken for polycystic ovaries from 01Jun2021 to an unspecified stop date. The patient experienced miscarriage of pregnancy (assessed as medically significant) on 10Sep2021 with outcome of not recovered. The patient was around 6 weeks pregnant when she had her second Pfizer vaccine and a scan at 11 weeks confirmed she had a missed miscarriage as the baby''s heartbeat couldn''t be found. She was told the baby had died at around 9 weeks. This means the baby died 2-3 weeks after the vaccine and she can''t help but wonder if the second vaccine could have caused this. The patient underwent lab tests and procedures which included Negative COVID-19 test on an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This was her first pregnancy. The patient had her second Pfizer vaccine when she was 6 weeks pregnant. No follow-up attempts are Needed. No further information is expected.


VAERS ID: 1776249 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101282466

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 627805. A 36-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via unspecified route of administration on an unspecified date as dose number unknown for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 10Sep2021, the patient experienced abortion spontaneous (medically significant). The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1817746 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101361563

Write-up: Abortion spontaneous; Intermenstrual bleeding; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 639211. A 34-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 10Sep2021, the patient experienced abortion spontaneous and intermenstrual bleeding. The outcome of the events abortion spontaneous and intermenstrual bleeding was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1693827 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: California  
Vaccinated:2020-12-24
Onset:2021-09-11
   Days after vaccination:261
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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

Write-up: 2 miscarriages this year following vaccination


VAERS ID: 1704003 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-09-02
Onset:2021-09-11
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Sulfa allergy
Diagnostic Lab Data: Hcg blood test 9/13/21 Ultrasound 9/13/21
CDC Split Type:

Write-up: Miscarriage; tested positive for pregnancy on 9/4/21 and 9-9/21. Began cramping and bleeding 9/11/21, miscarriage confirmed 9/13/21.


VAERS ID: 1763090 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-08-31
Onset:2021-09-11
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 1 LA / IM

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

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

Write-up: Received 1st dose when approximately 6.5 weeks pregnant. Had a miscarriage 11 days post vaccine. Estimated due date was 4/22/2022


VAERS ID: 1779582 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-10
Onset:2021-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Chills, Condition aggravated, Exposure during pregnancy, Haemorrhage, Joint range of motion decreased, Muscle spasms, Pyrexia, Ultrasound antenatal screen abnormal, Uterine spasm
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu vaccine, similar spasms
Other Medications: Prenatal vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: Latex
Diagnostic Lab Data: Ultrasound, miscarriage. Ultrasound, normal.
CDC Split Type: vsafe

Write-up: The night when I got the vaccine I felt a lot of spams on my neck all the way to my lower back. I could not turn my neck from left to right. I took Tylenol. I had the common side effects like fever and chills but I also had a lot of cramping and spasms in my lower pelvic area, I felt like it was my uterus. I started having bleeding. Even if I got up soon or put on force on those muscles to walk I would get spasms in that area. The bleeding kept going. I called the advised line and they said it was normal to bleed a little. I called back. I had an ultrasound because the bleeding continued and I ended up losing that pregnancy. I had my last ultrasound today and everything is cleared. Pregnancy history: I have 2 babies and I had a previous miscarriage prior to this. Estimated date of delivery: 05/04/2021.


VAERS ID: 1786072 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-09-11
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5029 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood grouping, Blood pressure measurement, Blood test, Body mass index, Coagulation factor, Fluid balance assessment, Foetal death, Haemoglobin, Head circumference, Hepatic enzyme, Physical examination, Ultrasound foetal
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pre-eclampsia (Mild pre-eclampsia in previous pregnancy); Pregnancy; Comments: The mother has previous given birth to a large child GA 41+6 (4485 g). On 30Aug2021 the foetus was turned from seat position to head position (uncomplicated procedure).
Allergies:
Diagnostic Lab Data: Test Name: Blood grouping; Result Unstructured Data: Test Result:Rhesus positive; Test Name: Blood pressure; Result Unstructured Data: Test Result:Normal during pregnancy, no further risk factors; Test Name: Blood test; Result Unstructured Data: Test Result:TORCH titer and Infection parameters awaiting; Test Name: Blood test; Result Unstructured Data: Test Result:Fetal-maternal hemorrhage (FMH), awaiting; Test Name: Body mass index; Result Unstructured Data: Test Result:Before pregnancy: 29 kg/m2; Test Name: Coagulation factor; Result Unstructured Data: Test Result:Awaiting; Test Name: Fluid balance assessment; Result Unstructured Data: Test Result:Awaiting; Test Name: Haemoglobin; Result Unstructured Data: Test Result:Awaiting; Test Date: 20210901; Test Name: Head circumference; Result Unstructured Data: Test Result:A little less than the previous scans,; Comments: A little less than the previous scans, however no indication for additional; Test Name: Hepatic enzyme; Result Unstructured Data: Test Result:Awaiting; Test Date: 20210909; Test Name: Physical examination; Result Unstructured Data: Test Result:By midwife: Normal fetal movements and heartsound; Test Name: Ultrasound foetal; Result Unstructured Data: Test Result:The fetus has previous been followed with Foetal; Comments: The fetus has previous been followed with Foetal ultrasound/weight scans due to slightly small foetal estimate.; Test Date: 20210901; Test Name: Ultrasound foetal; Result Unstructured Data: Test Result:-15.9 %
CDC Split Type: DKPFIZER INC202101285247

Write-up: Foetus mortus GA 38+5; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number DK-DKMA-WBS-0088235. This physician reported information for both mother and fetus. This is the maternal report. A 31-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 21Aug2021 (Batch/Lot Number: FC5029; Expiration Date: 31Oct2021) as dose 2, single for Covid-19 immunisation. Medical history included pre-eclampsia (mild pre-eclampsia in previous pregnancy). The mother has previous given birth to a large child GA 41+6 (4485 g). The patient''s concomitant medications were not reported. The patient received the dose 1 of Comirnaty for Covid-19 immunisation on 23Jul2021 (Batch/lot number FD4555; Expiration Date: 30Sep2021) and experienced maternal exposure during pregnancy, third trimester. On 30Aug2021, the foetus was turned from seat position to head position (uncomplicated procedure). The mother experienced foetus mortus GA 38+5 (dead fetus) on 11Sep2021 with outcome of not recovered. The mother reported she became pregnant while taking bnt162b2. The mother was 38 weeks pregnant at the onset of the event. The patient underwent lab tests and procedures which included blood grouping: rhesus positive on an unspecified date, blood pressure: normal during pregnancy, no further risk factors on an unspecified date, blood test: TORCH titer and infection parameters awaiting on an unspecified date, blood test: fetal-maternal hemorrhage (FMH), awaiting on an unspecified date, body mass index: before pregnancy: 29 kg/m2 on an unspecified date, coagulation factor, fluid balance assessment, haemoglobin, hepatic enzyme all awaiting on an unspecified date, head circumference: a little less than the previous scans, on 01Sep2021, head circumference: however no indication for additional on 01Sep2021, physical examination: by midwife: normal fetal movements and heartsound on 09Sep2021, ultrasound foetal: the fetus has previous been followed with foetal on an unspecified date, ultrasound foetal: ultrasound/weight scans due to slightly small foetal estimate on an unspecified date and -15.9% on 01Sep2021. No treatment or medical procedure due to the ADRs was reported. Additional information: The physician states that cause of dead fetus is unknown because the mother has not yet given birth to the foetus. It is unknown if the parents want an autopsy or genetic tests to be performed. In connection with the birth usual blood tests in relation to dead fetus will be performed (Haemoglobin, Coagulation factor, TORCH titer, Infection parameters, Fluid balance assessment, Hepatic enzyme and Fetal-maternal hemorrhage (FMH)). Because there is no amniotic fluid, amino synthesis has not been performed. Causality: The physician stated that it is difficult to assess if Comirnaty has contributed to dead fetus. Dead fetus and Fetal movements decreased were by the agency assessed medically significant due to Fetal death (PT) and Foetal hypokinesia (PT) being on the IME list. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : DK-PFIZER INC-202101323012 same patient, different dose/event;DK-PFIZER INC-202101323227 fetal case


VAERS ID: 1829939 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-24
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRANDATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101437787

Write-up: Foetal death in utero; Maternal exposure during pregnancy / mother was 25 weeks pregnant; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-MA20214477. This physician reported information for both mother and fetus/baby. This is a baby report. A 1-day-old male patient received BNT162b2 (COMIRNATY), dose 1 via transplacental on 11Sep2021 (Batch/Lot Number: FG4493) as single dose for Covid-19 immunisation. The patient''s medical history was not reported. Concomitant medication included labetalol hydrochloride (TRANDATE) via transplacental at 200 mg, 2x/day taken for essential hypertension from May2021 and ongoing. The patient experienced maternal exposure during pregnancy on 11Sep2021, the mother was 25 weeks pregnant. On 24Sep2021, foetal death in utero was reported. It was reported that the newborn (patient) died in utero on the 13th day (as reported) after the mother''s first dose of BNT162b2. Breech birth of a boy born lifeless and weighing 960g. The patient died on 24Sep2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101437813 mother case; Reported Cause(s) of Death: Maternal exposure during pregnancy / mother was 25 weeks pregnant; Foetal death in utero


VAERS ID: 1834525 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-09-11
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Contusion, Ecchymosis, Malaise
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101391375

Write-up: miscarriage/loss pregnancy < 20 weeks gestation; Malaise; Ecchymoses; discomfort with abdominal pain; Bruising; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NY20214641. This is the first of two reports. A 29-year-old female patient received bnt162b2 (COMIRNATY, lot number: FE8235), dose 2 intramuscular on 17Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, lot number: FD7959) on 19Jul2021 administered in right arm for COVID-19 Immunization. On 11Sep2021, 25 Day after drug administration, the patient developed ecchymosis which required hospitalization or prolongation of hospitalization. On 16Sep2021, 30 Day after drug administration, the patient developed malaise which required hospitalization or prolongation of hospitalization. On 17Sep2021, the patient experienced miscarriage/loss pregnancy < 20 weeks gestation which required hospitalization or prolongation of hospitalization. The patient experienced bruising (on 11Sep2021), discomfort with abdominal pain (on 16Sep2021) and discovery of pregnancy termination/miscarriage <20 weeks gestation (on 17Sep2021) one month after the second injection of the COMIRNATY vaccine (lot FE8235). In recovery. CYTOTEC treatment for expulsion, miscarriage in progress. The outcome of the events was resolving. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : 202101406454 same patient, different dose, different events


VAERS ID: 1818028 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-09-09
Onset:2021-09-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / IM

Administered by: Military       Purchased by: ?
Symptoms: Blood test, Caesarean section, Exposure during pregnancy, Foetal death, Premature separation of placenta, Transfusion
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? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: I was taking prenatal vitamins and iron.
Current Illness: I was not experiencing any illness.
Preexisting Conditions: I do not have any chronic or long standing health conditions.
Allergies: I do not have any allergies.
Diagnostic Lab Data: I had an emergency C-section and blood drawn.
CDC Split Type: vsafe

Write-up: At the time of vaccination I was 27 weeks pregnant. Three days after receiving my vaccine my husband took me to Hospital ER with a concealed placenta abruption. I lost my baby. She was due on 12/09/2021. I do not have any previous history of miscarriages. This was my first pregnancy. I had to have an emergency C-section. I was prescribed hydrocodone, but it was not working. I was given oxycodone and stool softener. I also had to have blood transfusions.


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