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From the 11/19/2021 release of VAERS data:

Found 2,686 cases where Vaccine is COVID19 and Symptom is Aborted pregnancy or Abortion or Abortion complete or Abortion early or Abortion incomplete or Abortion induced or Abortion late or Abortion missed or Abortion of ectopic pregnancy or Abortion spontaneous or Abortion spontaneous complete or Abortion spontaneous incomplete or Foetal cardiac arrest or Foetal death or Premature baby death or Premature delivery or Stillbirth

Government Disclaimer on use of this data



Case Details (Sorted by Onset Date)

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VAERS ID: 1638710 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101038883

Write-up: Miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer, downloaded from the regulatory authority-WEB, Regulatory authority number: NL-LRB-00661325. A 35-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 29Jul2021 (Batch/Lot Number: Unknown) as dose 1, single (at the age of 35-years-old) for Covid-19 immunisation. Medical history included pregnancy. The patient had no previous Covid-19 infection. The patient''s concomitant medications were not reported. The patient was exposed to the vaccine on 29Jul2021. The mother reported she became pregnant while taking bnt162b2. The mother was 9 weeks pregnant at the onset of the event. The patient had a miscarriage on 30Jul2021. The pregnancy resulted in spontaneous abortion. The patient felt a strange feeling in her lower abdomen for 2/3 days and was not otherwise ill and had a miscarriage. The event outcome was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1642781 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-07-29
   Days after vaccination:90
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; FERROUS SULFATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Polycystic ovarian syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: Ultrasound; Result Unstructured Data: Test Result:Absent fetal cranium with hernation of brain tissu; Comments: IMP: Anencephaly and Exanencephaly
CDC Split Type: SAPFIZER INC202101048808

Write-up: Maternal exposure during pregnancy; Pregnancy termination; This is a spontaneous report from a contactable health care professional (pharmacist) who reports about EDP by a patient. This pharmacist reported information for mother. This is a mother case. A 33-years-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), intramuscular on 30Apr2021 as dose 1, single for Covid-19 immunization; clomifene citrate (CLOMID), route of administration, start and stop date, lot number and dose were not reported taken for polycystic ovaries. Medical history included PCOs (Polycystic ovarian syndrome). The patient had no known allergies. Concomitant medications included folic acid (FOLIC ACID) and ferrous sulfate (FERROUS SULFATE). It was unknown if the patient received any other vaccine in four weeks. It was unknown whether the patient had covid prior vaccination and covid test post vaccination. The patient had delivered 4 years back a live full-term baby with spontaneous vaginal delivery with no complication (body weight was 3.5 kg). She got pregnant by induction using clomid (In private hospital) and she was on folic acid for 5 months before pregnancy. During her pregnancy, she was on only ferrous sulfate and folic acid and she took the Covid-19 Vaccine (Pfizer) on 30 April 2021 which it was during the time of conception. Her last menstrual period was 23Apr2021, the estimated due date for labor was 30Jan2022, gestational period 2. On 29July2021: Her Ultrasound report showed Single viable fetus. FL: 11 mm = 13+4 weeks. Absent fetal cranium with hernation of brain tissue; IMP: Anencephaly and Exanencephaly. Therefore, she was admitted for pregnancy termination. This ADR may be related to the Clomid or the Covid-19 vaccine. The patient received treatment in response to events. Action taken for Clomid was unknown. The outcome of events was resolved.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of maternal exposure during pregnancy,pregnancy termination cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : SA-PFIZER INC-202101063129 Mother case 202101048808, Fetus case 202101063129


VAERS ID: 1656923 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-29
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101055019

Write-up: Pregnancy loss <20 weeks gestation/Miscarriage at 5 weeks; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PB20215061. This consumer reported information for both the mother and the fetus. This is the maternal report. A 33-year-old pregnant female patient received bnt162b2 (COMIRNATY), intramuscular on 16Jul2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 29Jul2021, it was reported that the patient experienced pregnancy loss <20 weeks gestation/miscarriage at 5 weeks, 2 weeks after the 1st injection (unaware of pregnancy during the 1st injection). The patient had a miscarriage at 5 weeks of amenorrhea. The event required medical consolation and considered by the reporter as serious for malformation or abnormality associated with exposure to a medication before birth. The fetal outcome was intrauterine death. The patient was tested for SARS-CoV-2 on 23Jul2021 with negative result. The outcome of the event was recovered with sequelae on 29Jul2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1664947 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101073176

Write-up: Miscarriage; COVID-19 vaccine exposure during pregnancy week: 3 weeks; Not feeling well; Cold shivers; Nausea; This is a spontaneous report from a contactable Consumer or other non HCP downloaded from the regulatory authority-WEB NL-LRB-00666784. This is a maternal report. A 35-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FF4213), via an unspecified route of administration on 28Jul2021 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, Formulation: Solution for injection), via an unspecified route of administration on 22Jun2021 as DOSE 1, SINGLE for covid-19 immunisation and experienced no adverse event. On 29Jul2021, the patient experienced miscarriage, covid-19 vaccine exposure during pregnancy week: 3 weeks, not feeling well, cold shivers, nausea. One day after the vaccination, the miscarriage occurred. Treatment: Maternal exposure during pregnancy is treated with Removal of the baby and miscarriage is treated with Removal of the baby. The mother was 3 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Therapeutic measures were taken as a result of miscarriage, covid-19 vaccine exposure during pregnancy week: 3 weeks. The outcome of events not feeling well, cold shivers, nausea were recovered on 31Jul2021 and other events were unknown at the time of report. Health Authority Comment: Seriousness of miscarriage was changed from "death" to "other medically important condition". Case summary: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: No Date: 22Jun2021, confounding factors: COVID-19 vaccine exposure during pregnancy week: 3 weeks. Previous COVID-19 infection: No. diagnostic procedures: I don''t have the test results yet. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: No Date: 22Jun2021, confounding factors: COVID-19 vaccine exposure during pregnancy week: 3 weeks. Previous COVID-19 infection: No. diagnostic procedures: I don''t have the test results yet


VAERS ID: 1669099 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-29
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Interchange of vaccine products, Off label use, Premature rupture of membranes
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101055332

Write-up: Due to no more amniotic fluid given birth at 17+0 weeks, baby died.; patient previously received 1st dose of Vaxzevria/ patient received bnt162b2 (COMIRNATY), dose 2; patient previously received 1st dose of Vaxzevria/ patient received bnt162b2 (COMIRNATY), dose 2; Immature ruptured membranes at 16w2d gestational age; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB NL-LRB-00657303. This physician reported information for both mother and fetus/baby. This is a maternal report. A 34-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 22Jul2021 as dose 2 (initial pfizer dose), single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received 1st dose of Vaxzevria on 13Mar2021 for covid-19 immunisation and experienced no adverse reaction. The patient experienced due to no more amniotic fluid given birth at 17+0 weeks, baby died, immature ruptured membranes at 16w2d gestational age on 29Jul2021. The reporter mentioned she was vaccinated at a pregnancy duration of 15+2. At a pregnancy duration of 16+2 her membranes ruptured. The child was born death at a pregnancy duration of 17 weeks. Premature rupture of membranes in 7 days after start. The pregnancy resulted in spontaneous abortion. The fetal outcome is neonatal death. The outcome of events was unknown. Reporter comment:- BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs(adverse drug reactions): No Date: 13Mar2021 - Immature ruptured membranes at gestational age 16w2d Information RA other or disabling information: Due to no more amniotic fluid given birth at 17+0 weeks, baby died. BSN available: yes - confounding factors COVID-19 vaccine exposure during pregnancy week: 15+2 - COVID-19 Previous COVID-19 infection: No - Other diagnostic procedures: Additional research into other causes of immature rupture of membranes has been initiated. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Summary of Reporter Comment BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs(adverse drug reactions): No Date: 13Mar2021 - Immature ruptured membranes at gestational age 16w2d Information RA other or disabling information: Due to no more amniotic fluid given birth at 17+0 weeks, baby died.


VAERS ID: 1671548 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-29
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: internal scan; Result Unstructured Data: Test Result:slow development of baby following vaccine; Test Date: 20210729; Test Name: Ultrasound; Result Unstructured Data: Test Result:Complete miscarriage.; Comments: Complete miscarriage had on 29/07/21
CDC Split Type: GBPFIZER INC202101081238

Write-up: bleeding; miscarriage/miscarriage of pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108191617237890-0DGOO. Safety Report Unique Identifier GB-MHRA-ADR 25824094. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included lactation decreased, pregnancy (Patient no longer pregnant at the time of reporting), folic acid supplementation from an unknown date and unknown if ongoing. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on an unspecified date with outcome of unknown, bleeding on an unspecified date with outcome of recovering, miscarriage/miscarriage of pregnancy on 29Jul2021 with outcome of unknown. The patient underwent lab tests and procedures which included Covid-19 virus test: No - Negative COVID-19 test, on an unspecified date; internal scans: slow development of baby following vaccine on an unspecified date, ultrasound: complete miscarriage on 29Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as serious, congenital anomaly and medically significant by regulatory authority. Additional Information: Scans showed slow development of baby following vaccine, heavy bleeding started on 29th July 2021 and complete miscarriage confirmed the following week. Did the medicine have an adverse effect on any aspect of the pregnancy: Unsure. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Complete miscarriage had on 29Jul2021. Rrelevant investigations or tests conducted: "Ultrasound and internal scans". No previous medical issues No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1701245 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Anaemia, Anembryonic gestation, Haematocrit, Haemoglobin, Off label use, Platelet count, Post abortion haemorrhage, Product use issue, Ultrasound scan vagina, White blood cell count
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow), Medication errors (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Hematocrit; Test Result: 34.3 %; Comments: Prior to admission; Test Name: Hematocrit; Test Result: 20.7 %; Comments: Post-transfusion analysis of two packed red blood cells; Test Date: 20210808; Test Name: Hematocrit; Test Result: 15.3 %; Comments: Post-surgical analysis; Test Name: Hemoglobin; Result Unstructured Data: Test Result:11.7 g/dl; Comments: Prior to admission; Test Name: Hemoglobin; Result Unstructured Data: Test Result:7 g/dl; Comments: Post-transfusion analysis of two packed red blood cells; Test Date: 20210808; Test Name: Hemoglobin; Result Unstructured Data: Test Result:5 g/dl; Comments: Post-surgical analysis; Test Name: Platelets; Result Unstructured Data: Test Result:326000; Comments: Prior to admission; Test Name: Platelets; Result Unstructured Data: Test Result:147000; Comments: Post-transfusion analysis of two packed red blood cells; Test Date: 20210808; Test Name: Platelets; Result Unstructured Data: Test Result:138000; Comments: Post-surgical analysis; Test Date: 20210808; Test Name: Vaginal ultrasound; Result Unstructured Data: Test Result:uterus in anteversion and anteflexion; Comments: Vaginal ultrasound: uterus in anteversion and anteflexion with gestational sac of 20 mm without embryonic structures inside, detached, decidualized endometrium of 18 mm.; Test Name: Leukocytes; Result Unstructured Data: Test Result:9380; Comments: Prior to admission; Test Date: 20210808; Test Name: Leukocytes; Result Unstructured Data: Test Result:7890; Comments: Post-surgical analysis
CDC Split Type: ESPFIZER INC202101174573

Write-up: Miscarriage, but the adverse effect caused hemorrhage so severe that almost killed me; gestational sac of 20 mm without embryonic structures inside; Miscarriage; with anemia of 5 gr/dl; currently breastfeeding; currently breastfeeding; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is ES-AEMPS-981426. This contactable consumer reported adverse events for the mother, a fetus and a child under Comirnaty. This is the first of four reports, for the mother second dose. A 32-years-old female patient received second dose of bnt162b2 (COMIRNATY), at the age of 32-years-old via an unspecified route of administration, administered in Arm Left on 29Jul2021 (Lot Number: FE8405) as single dose for covid-19 immunisation. Medical history included breast feeding from Aug2020 and ongoing. The patient''s concomitant medications were not reported. The patient previous took first dose of bnt162b2 (COMIRNATY), administered in Arm left on 08Jul2021 (Lot number: FC1435) as single dose for covid-19 immunisation, and experienced patient is currently breastfeeding. The patient experienced miscarriage, but the adverse effect caused hemorrhage so severe that almost killed patient (life threatening) on 08Aug2021. It was reported that gynecologists who performed curettage and saved patient life, surprised by the reaction of her body, had never seen such an abortion. Hemorrhage as a side effect covid vaccine, second dose 29Jul2021 and hemorrhage 08Aug2021. Abortion in progress of 5 gestation week on 08Aug2021 that required urgent obstetric curettage, with anemia of 5 g/dl, which required transfusion of 3 packed red blood cells. 08Aug2021 Vaginal ultrasound: uterus in anteversion and anteflexion with gestational sac of 20 mm without embryonic structures inside, detached, decidualized endometrium of 18 mm. Post-surgical analysis: Hemoglobin 5 g/dl, Hematocrit 15.3%, Platelets 138000, Leukocytes 7890. Prior to admission: Hemoglobin 11.7g/dl, Hematocrit 34.3%, Platelets 326000, Leukocytes 9380. Post-transfusion analysis of two packed red blood cells: Hemoglobin 7 g/dL, Hematocrit 20.7%, Platelets 147000. The mother reported she became pregnant while taking bnt162b2. The mother was 5 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The outcome of post abortion haemorrhage, Anembryonic gestation, Abortion spontaneous was recovering, of other events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : ES-PFIZER INC-202101187850 same patient, different vaccine dose;ES-PFIZER INC-202101187848 child case


VAERS ID: 1705555 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lipoma excision; Mood disorder NOS; Primiparous
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101143323

Write-up: Foetal death in utero; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-RS20212778. A 39-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 29Jul2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for Covid-19 immunization; and aripiprazole (ABILIFY), oral from an unspecified date (Batch/Lot Number: Unknown) to 27Jul2021 for affective disorder. Historical vaccine included 1st dose of Comirnaty on 08Jul2021 for Covid-19 immunization where the patient had maternal exposure during pregnancy, second trimester. Medical history included mood disorder, primiparous, lipoma excision. The patient''s concomitant medications were not reported. The patient experienced foetal death in utero. The patient was hospitalized on an unspecified date. The patient underwent lab tests and procedures which included Sars-Cov-2 test: negative on 29Jul2021. The action taken in response to the event for aripiprazole was not applicable. The outcome of event was recovered with sequel on an unspecified date (as reported). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738405 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Premature rupture of membranes, Ultrasound uterus
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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: 1st trimester ultrasound; Result Unstructured Data: Test Result:small hematoma observed on the placenta.; Comments: small hematoma observed on the placenta.
CDC Split Type: FRPFIZER INC202101194972

Write-up: Miscarriage; rupture of membranes; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB FR-AFSSAPS-LY20219950. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 28Jul2021 (Batch/Lot Number: FF0688) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (L-THYROXINE ROCHE) taken for an unspecified indication, start and stop date were not reported. On 29Jul2021, the patient experienced miscarriage at 7 weeks of pregnancy and reports a rupture of membranes in the 16th week of pregnancy, leading to a miscarriage. The patient reported she became pregnant while taking bnt162b2. The patient delivered the pregnancy on 29Jul2021. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included 1st trimester ultrasound: small hematoma observed on the placenta. The outcome of the events was recovered on unspecified date.


VAERS ID: 1826937 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-07-29
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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:everything looked alright; Comments: the heart was beating well; at a pregnancy duration of 9 weeks
CDC Split Type: NLPFIZER INC202101370277

Write-up: The Covid vaccinations took place a few months before the pregnancy; Miscarriage at 11 weeks; This is a spontaneous report from a contactable consumer, downloaded from a Regulatory Authority NL-LRB-00696660, Safety Report Unique Identifier NL-LRB-00698110. A 28-year-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 29Jan2021 (Batch/Lot Number: Unknown) single, for COVID-19 immunization. Medical history included disease risk factor. The patient''s concomitant medications were not reported. The patient received the first dose of BNT162B2 on 08Jan2021 (Batch/Lot Number: Unknown). The COVID vaccinations took place a few months before the pregnancy. The miscarriage occurred at a pregnancy duration of about 11 weeks, on an unspecified date. Onset latency of the miscarriage was reported as 6 months after start. During the echo at a pregnancy duration of 9 weeks, everything looked alright and the heart was beating well. Unfortunately, it suddenly went wrong after that. The miscarriage occurred after a good ultrasound. It was reported that this was more and more common since vaccinations. Outcome of the events was unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the health authority, the reaction was considered as serious by a regulatory authority. Reporter''s comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 08Jan2021. Additional information on ADR available. Previous COVID-19 infection: No. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information expected.; Reporter''s Comments: Summary of reporter''s comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 08Jan2021 Additional information on ADR available Previous COVID-19 infection: No


VAERS ID: 1837940 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
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, Haemorrhage in pregnancy, Maternal exposure during pregnancy, SARS-CoV-2 test, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), 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: 20210512; Test Name: SARS-CoV-2 test; Test Result: Negative; Test Date: 20210728; Test Name: ultrasound; Result Unstructured Data: Test Result: baby was doing very well.
CDC Split Type: FRPFIZER INC202101394639

Write-up: Antepartum bleeding; suspected a miscarriage; pregnant patient received bnt162b2/5 months pregnant; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-LL20216831. A 30-year-old pregnant female patient received bnt162b2 (COMIRNATY), intramuscular, administered in the left arm on 29Jul2021 (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have COVID, tested on 12May2021 (negative). On 29Jul2021, the pregnant patient received bnt162b2. On 31Jul2021. the patient experienced antepartum bleeding. The events were further described as: A female patient vaccinated with COMIRNATY. 48 hours later she reported symptoms. She suspected a miscarriage even though an ultrasound was done the day before the vaccine and the baby was doing very well (5 months pregnant). No information on the outcome of the vaccination and the pregnancy. The outcome of antepartum bleeding was not recovered. The outcome of suspected a miscarriage was unknown. Note: Accountability without prejudice to further investigations that could be carried out as part of legal or amicable compensation procedures. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1640972 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Amniotic fluid index decreased, Autopsy, Delivery, Exposure during pregnancy, Foetal death, Foetal growth restriction, Foetal heart rate abnormal, Induced labour, 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), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal, DHA/omega, Vitamin D, zinc
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: 8/5/21: Ultrasound showing the baby was measuring 17w2d but should have been at 18w1d, low amniotic fluid around the baby 8/7/21: Ultrasound showed the baby no longer had a heartbeat; followup ultrasound at hospital confirmed fetal demise 8/8/21: Delivered baby; autopsy showed no abnormal structural issues
CDC Split Type:

Write-up: I was 17 weeks and 2 days pregnant (from an IVF cycle with a donor egg) the day I received the vaccine. My baby stopped growing the same day I received the vaccine - (subsequent ultrasounds showed no growth beyond 17 weeks and 2 days. The baby''s heartbeat stopped sometime around one week after the vaccine. I had to get induced on Saturday August 7th and delivered the baby on Sunday August 8th. The reason listed on the autopsy is fetal demise.


VAERS ID: 1670775 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-02-19
Onset:2021-07-30
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030M20A / 2 RA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, Laboratory test normal
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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Advair, Zyrtec
Current Illness: none
Preexisting Conditions: Asthma
Allergies: Bactrim (sulfa)
Diagnostic Lab Data: Unknown tests - all yielded normal results
CDC Split Type:

Write-up: Pregnancy loss at 16 weeks 3 days.


VAERS ID: 1550027 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-12
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: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 2)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210817233

Write-up: COVID-19 VACCINE EXPOSURE DURING PREGNANCY WEEK: 2; MISSED MENSTRUATION AND EVENTUALLY MISCARRIED 11 WEEKS LATER; This spontaneous pregnancy report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00650114] concerned a 29 year old female of unspecified race and ethnic origin. The patient''s weight was 55 kilograms, and height was 168 centimeters. The patient''s concurrent conditions included maternal vaccine exposure. The patient received Covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: XD955, and expiry: unknown) 1 dosage forms, 1 total administered on 30-APR-2021 for covid-19 immunisation. No concomitant medications were reported. On 30-JUL-2021, the patient missed menstruation and eventually had miscarriage 11 weeks later. On an unspecified date, she had vaccine exposure during second week of pregnancy. The action taken with Covid-19 vaccine ad26.cov2. s was not applicable. The outcome of the covid-19 vaccine exposure during pregnancy week: 2 and missed menstruation and eventually miscarried 11 weeks later was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210817233 -covid-19 vaccine ad26.cov2.s- missed menstruation and eventually miscarried 11 weeks later, covid-19 vaccine exposure during pregnancy week: 2. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1555578 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 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 INC202100977027

Write-up: Patient was exposed to the medicine first-trimester (1-12 weeks).; Miscarriage; 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-202107311613306250-I8N9I, Safety Report Unique Identifier is GB-MHRA-ADR 25737276. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 37-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 27Jul2021 as dose 2, single for COVID-19 immunization. Medical history included pregnancy (Patient no longer pregnant at the time of reporting), folic acid supplementation. Concomitant medication included Folic acid as Folic acid supplementation. Patient was pregnant at the time of vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test Patient was not currently breastfeeding. On an unspecified date, patient experienced maternal exposure during pregnancy, On 30Jul2021, patient experienced miscarriage. The mother reported she became pregnant while taking BNT162B2. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. BNT162B2 vaccine has affected on aspect of the pregnancy because the patient had miscarriage after pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). The outcome of the event miscarriage was recovered with sequel. No follow-up attempts are possible; information about lot/batch number cannot be obtained


VAERS ID: 1589219 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-30
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Anembryonic gestation, 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: Lactation decreased
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:blighted ovum
CDC Split Type: GBPFIZER INC202100998466

Write-up: blighted ovum; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number (GB-MHRA-WEBCOVID-202108031351093360-EUYYR), Safety Report Unique Identifier (GB-MHRA-ADR 25746988). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: EW3143), via an unspecified route of administration at dose 1, single on 01Jun2021 for COVID-19 immunization. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient experienced miscarriage of pregnancy on 30Jul2021 with outcome of recovering. Patient was exposed to the medicine during first trimester (1-12 weeks). Details of scans or investigations revealed blighted ovum (outcome was unknown). The patient underwent lab tests and procedures which included Negative COVID-19 test. Patient was no longer pregnant at the time of reporting. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1654833 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-30
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gestational diabetes
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: Examination; Result Unstructured Data: Test Result:Fetal heartbeat had stopped
CDC Split Type: JPPFIZER INC202101058227

Write-up: Stillbirth; This is a spontaneous report from a contactable physician. A pregnant 36-year-old female (gestational period was 35 weeks) received BNT162b2 (COMIRNATY) intramuscular injection in the left arm, on 06Jul2021 at 11:00 (Lot number FA2453, Expiration date 31Aug2021), as first single dose, for COVID-19 immunization. Relevant medical history included gestational diabetes. The patient received Insulin self-injection within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 29Jul2021, it was found that the fetal heartbeat had stopped, and the patient was hospitalized. On 30July2021, the patient experienced stillbirth and the exact cause of the stillbirth was unknown. The outcome of the event was unknown. It was unknown whether there was any treatment performed to the patient or not. It was unknown whether the patient had been tested for COVID-19 or not since the vaccination. The reporter classified the events as serious and stated the events resulted in hospitalization.; Sender''s Comments: Based on the close temporal association there is possibility of causal association between the event Stillbirth and the suspect drug BNT162B2.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1664099 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYCLOGEST; FOLIC ACID; PROGYNOVA [ESTRADIOL VALERATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Infertility; Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Scan; Result Unstructured Data: Test Result:No heart beat; Comments: No heart beat at 8 week scan
CDC Split Type: GBPFIZER INC202101069251

Write-up: Maternal exposure during pregnancy first-trimester (1-12 weeks).; Miscarriage; This is a spontaneous report from a contactable consumer or other non HCP. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108170908318680-YSLOM. Safety Report Unique Identifier GB-MHRA-ADR 25809022. A 41-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Lot number was unknown), via an unspecified route of administration on 17Jul2021, as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation, pregnancy (Patient no longer pregnant at the time of reporting), infertility, and Folic acid supplementation, all were from an unknown date and unknown if ongoing. Concomitant medications included progesterone (CYCLOGEST) taken for infertility, start and stop date were not reported; folic acid, 400ug taken for vitamin supplementation, start and stop date were not reported; estradiol valerate (PROGYNOVA [ESTRADIOL VALERATE]) taken for infertility, start and stop date were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Unsure the medicine has an adverse effect on any aspect of the pregnancy. The patient previously received first dose of BNT162B2((PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Lot number was unknown), via an unknown route on unspecified date as dose 1, single for COVID-19 immunisation. The patient experienced maternal exposure during pregnancy first-trimester (1-12 weeks) on an unspecified date. On 30Jul2021, 13 days after second dose the patient had miscarriage. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - Negative COVID-19 test), scan: no heartbeat (No heartbeat at 8 week scan) on unspecified date. The outcome of the event miscarriage was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1682270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-09-08
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 INC202101104346

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 607815. A 38-years-old female patient received unknown dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced abortion spontaneous on 30Jul2021. Onset time in days was not reported. The outcome of the event was reported as Recovered (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: 1709830 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-30
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027-L728 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Investigation, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: investigation; Result Unstructured Data: Test Result:No fetal heartbeat discovered at 9.5 weeks; Test Date: 20210613; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101153159

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109032008191660-KRNJ0, Safety Report Unique Identifier GB-MHRA-ADR 25894352. A 31-year-old pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA1027-L728) via an unspecified route of administration on 23Jun2021 (at the age of 31 years old) as single dose for COVID-19 immunisation. Medical history was not reported. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. Patient was pregnant and exposed to vaccine in first-trimester (1-12 weeks). The patient experienced miscarriage (hospitalization, medically significant) on 30Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test on 13Jun2021: Negative COVID-19 test, investigation: no fetal heartbeat discovered at 9.5 weeks on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had no previous miscarriages. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1720608 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101166460

Write-up: Early miscarriage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, Regulatory Authority number FR-AFSSAPS-LY20219859. A 43-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via intramuscular administered in Arm Left on 26Jul2021 at single dose for COVID-19 immunisation. The patient was pregnant at the time of vaccination. No relevant medical history and concomitant medications were provided. Pre vaccination COVID-19 test was not done. On 30Jul2021, on Day 5, she had a miscarriage at home at 4 weeks. The patient was not aware that she was pregnant. She discussed it with her general practitioner upon taking the second dose of the COMIRNATY vaccine. The event resolved on unknown date in 2021 (as reported). No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1746749 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-07-30
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: GBPFIZER INC202101225096

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161534063210-YCGMM. Safety Report Unique Identifier [GB-MHRA-ADR 25953571]. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 05Jun2021 (Lot number was not reported) as first dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient experienced miscarriage on 30Jul2021 with outcome of recovered on an unspecified date. "I''m not sure if the vaccine contributed to the miscarriage but given the reports on period changes I thought it was worth reporting." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1787030 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / 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? 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: NOMODERNATX, INC.MOD20213

Write-up: Spontanabort; Maternal exposure during pregnancy; This case was received via Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00052718) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS in a 30-year-old female patient who received mRNA-1273 (Spikevax) for Vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 03-Sep-2021, the patient experienced ABORTION SPONTANEOUS (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 30-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 23-Sep-2021, ABORTION SPONTANEOUS (Spontanabort) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment information was not provided. Company Comment: This case concerns 30-year-old, female patient with no relevant medical history. The patient presents with serious event of Abortion spontaneous, and a non-serious event Maternal exposure during pregnancy 1 month 5 days after first dose of Spikevax. The reporter didn''t provide the causality of event. Patient experienced AEs after the first dose and no information about second dose is available rechallenge unknown. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Translation document received on 07-oct-2021 contains Non-significant information.; Reporter''s Comments: Upgraded to Serious due to SPONTANEOUS ABORTION : Important Medical Events.; Sender''s Comments: This case concerns 30-year-old, female patient with no relevant medical history. The patient presents with serious event of Abortion spontaneous, and a non-serious event Maternal exposure during pregnancy 1 month 5 days after first dose of Spikevax. The reporter didn''t provide the causality of event. Patient experienced AEs after the first dose and no information about second dose is available rechallenge unknown. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1833829 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Fatigue, Haemorrhage, Lymphadenopathy, Myalgia, Ultrasound scan, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211008; Test Name: Blood test; Result Unstructured Data: Test Result:results unknown; Test Date: 20211008; Test Name: ultrasound; Result Unstructured Data: Test Result:Empty amniotic sac on ultrasound
CDC Split Type: BEPFIZER INC202101384518

Write-up: Pregnant Loss of blood; Injection site reaction; Fatigue; Swelling in the neck gland, 3 days.; Miscarriage; Muscle pain; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number is BE-FAMHP-DHH-N2021-107598. A 31-year-old pregnant female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Jul2021 (at the age of 31-year-old) as dose 2, single for covid-19 immunization. Patient was pregnant at the time of vaccination. The patient medical history was none. Patient concomitant medications were not reported. On 30Jul2021, the patient experienced injection site reaction, fatigue, swelling in the neck gland, 3 days (coded as swollen glands), miscarriage, muscle pain (coded as myalgia) and pregnant loss of blood on 17Sep2021. It was reported that patient became pregnant while taking BNT162B2. Patient last menstrual period date was reported as 06Jul2021. The patient was pregnant (1st Trimester) at the onset of the event. Patient reported that pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included blood test with results unknown, ultrasound scan: empty amniotic sac on 08Oct2021. Patient had not received any treatment for the events. Outcome of the events Injection site reaction, fatigue, swollen glands, miscarriage and myalgia were recovered on 08Oct2021, and pregnant loss of blood was unknown. Health authority comment: Treatment - No. Evolution of the ADR - Examinations - Blood collection PRIVACY 08Oct2021. Second dose administered Menstruation 06Jul2021.Ovulation 20Jul21 Pregnant Loss of blood 17Sep2021. Empty amniotic sac on ultrasound 08Oct2021. No follow-up attempts possible. No further information expected. Information about lot/batch# cannot be obtain.; Reporter''s Comments: Treatment - No. Evolution of the ADR - Examinations - Blood collection PRIVACY 08Oct2021. Second dose administered Menstruation 06Jul2021.Ovulation 20Jul21 Pregnant Loss of blood 17Sep2021. Empty amniotic sac on ultrasound 08Oct2021.


VAERS ID: 1571378 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Miscarriage; Fever; Maternal exposure during pregnancy; Early miscarriage; Feverish; This regulatory authority pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage), ABORTION SPONTANEOUS (Early miscarriage), PYREXIA (Feverish) and PYREXIA (Fever) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Miscarriage, Lactation decreased and Pregnancy (Patient no longer pregnant at the time of reporting.). Concomitant products included FOLIC ACID for Folic acid supplementation. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 31-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Early miscarriage) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 31-Jul-2021, PYREXIA (Feverish) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), PYREXIA (Fever) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown and ABORTION SPONTANEOUS (Early miscarriage) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient''s pregnancy symptoms all suddenly disappeared by the morning after her fever had resolved. Spotting started approximately 12 hours after fever and then progressed to a miscarriage. It was unknown whether the fever caused the early miscarriage. Patient was exposed to the medicine first-trimester (1-12 weeks). On 28-Jul-2021, patient had a positive pregnancy test. This is a case of product exposure during pregnancy with associated AEs for this 31-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient''s past medical history of miscarriages may be contributory to the occurrence of this pregnancy loss. No further follow-up information is expected.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AEs for this 31-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient''s past medical history of miscarriages may be contributory to the occurrence of this pregnancy loss. No further follow-up information is expected.


VAERS ID: 1576015 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984302

Write-up: pain; miscarriage; Pelvic pain; 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-202108011837093110-LVAG3, Safety Report Unique Identifier GB-MHRA-ADR 25738290. A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on 31Jul2021 (at the age of 36-years-old) as second dose, single for COVID-19 immunization. Medical history included abortion spontaneous and suppressed lactation. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced pain, miscarriage. On 31Jul2021 (same day of vaccination), the patient experienced pelvic pain. Further explained that miscarriage within the last 10 days. The pain was exactly like the pain during the miscarriage. Which had previously stopped 9 days ago. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on an unspecified date. The outcome of pain, miscarriage was recovered on an unspecified date while for pelvic pain was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1625714 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Body temperature, Body temperature increased, Fatigue, Malaise, Myalgia, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling, Vaginal haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), 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)

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: 20210801; Test Name: body temperature increased; Result Unstructured Data: Test Result:37.5 up to 38 Centigrade
CDC Split Type: NLPFIZER INC202101016745

Write-up: Possible miscarriage (bleeding with clots); Possible miscarriage (bleeding with clots); Fatigue; Not feeling well; Fever 37.5 up to 38 Celsius degrees; Muscle pain; Inflammatory reaction at the reaction site: pain, swelling, occurring within a week after vaccination; Reaction at or around the injection site: swelling, occurring within a week of vaccination; Reaction at or around the injection site: pain; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00650253. A 34 years old female patient received second dose of bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration at age of 34 years old on 31Jul2021 (Lot Number: FE8405) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on 26Jun2021 for COVID-19 immunisation and experienced Injection site pain. The patient experienced possible miscarriage (bleeding with clots) on 02Aug2021, inflammatory reaction at the reaction site: pain, swelling, occurring within a week after vaccination on 31Jul2021, not feeling well on 01Aug2021, fever 37.5 up to 38 celsius degrees on 01Aug2021, muscle pain on 31Jul2021, reaction at or around the injection site: pain on 31Jul2021, fatigue on 01Aug2021, possible miscarriage (bleeding with clots) on 02Aug2021. The mother reported she became pregnant while taking second dose bnt162b2. The mother was 1 Trimester pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Treatment: Body temperature increased was treated with Paracetamol. The patient had not recovered from vaginal bleeding, was recovering from fatigue, inflammatory reaction at the reaction site: pain, swelling, malaise, myalgia, recovered from body temperature increased on 02Aug2021. The assumed miscarriage occurred at a pregnancy duration of about 5 weeks. This was the second Covid vaccination, which took place at a pregnancy duration of about 4,5 weeks. The first Covid vaccination took place before pregnancy. Event Abortion spontaneous was reported as serious other medically important condition. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the HA critera, the reaction (Possible miscarriage (bleeding with clots)) was considered as serious by the regulatory authority. Sender''s Diagnosis: Injection site inflammation Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Sore injection site Date: 26Jun2021 Extensive swelling of vaccinated limb: no Possible miscarriage (bleeding with clots) I was about 5 weeks pregnant (didn''t know when I got the injection) and today I started bleeding. confounding factors COVID-19 vaccine exposure during pregnancy week: 0 (second injection at 4/5 weeks) Previous COVID-19 infection: No No follow-up attempts possible. No further information expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Sore injection site Date: 26Jun2021 Extensive swelling of vaccinated limb: no Possible miscarriage (bleeding with clots) I was about 5 weeks pregnant (didn''t know when I got the injection) and today I started bleeding. confounding factors COVID-19 vaccine exposure during pregnancy week: 0 (second injection at 4/5 weeks) Previous COVID-19 infection: No


VAERS ID: 1633670 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Decreased embryo viability, Foetal death, Foetal monitoring, Maternal exposure during pregnancy, Off label use, Placental insufficiency, Ultrasound foetal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SERTRALIN ACCORD; INNOVAIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Obsessive-compulsive disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Cardiotocography; Result Unstructured Data: Test Result:gave suspicion of affected fetus; Test Date: 20210803; Test Name: Ultrasound fetal; Result Unstructured Data: Test Result:shows severely affected blood flow
CDC Split Type: DKPFIZER INC202101045442

Write-up: Dead fetus; Severe impact on the blood supply to the fetus; Feels less life from the fetus; Maternal exposure during pregnancy; off-label; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DK-DKMA-WBS-0082469. This is the first of two reports, only this one is serious. A 31-year-old pregnant female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: FD4555, pregnant at the time of vaccination) via intramuscular route of administration on 31Jul2021 (age at the time of vaccination was not provided) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history included was obsessive-compulsive disorder from 2017 to an unspecified stop date and asthma from an unspecified date to an unspecified date and unknown if ongoing. The concomitant medications included sertraline hydrochloride (SERTRALIN ACCORD, 100mg) 100mg 1x/day, taken for obsessive-compulsive disorder from 2017 to an unspecified stop date, beclomethasone dipropionate, formoterol fumarate (INNOVAIR, beclomethasone dipropionate 200 ug, formoterol fumarate 6 ug) at 2 DF, 1x/day, taken for asthma from 2018 to an unspecified stop date. The historical vaccine included as received bnt162b2 (COMIRNATY, Batch/Lot Number: EJ6134 and Expiration date: 30Apr2021) dose 1, via an unspecified route of administration on 15Jan2021 as DOSE 1, SINGLE for covid-19 immunisation and experienced maternal exposure during pregnancy and off label use on 15Jan2021. On 02Aug2021, the patient experienced dead fetus, severe impact on the blood supply to the fetus, feels less life from the fetus. On 31Jul2021, the patient had maternal exposure during pregnancy, and off-label use. The mother reported she became pregnant while taking bnt162b2. The mother was 30 Weeks pregnant (Gestation Period 30 weeks) at the onset of the event. The patient underwent lab tests and procedures which included foetal monitoring: gave suspicion of affected fetus on 03Aug2021, ultrasound foetal: shows severely affected blood flow on 03Aug2021. The ADRs were by the reporter reported as resulting in hospitalisation. The ADRs were by the reporter reported as resulting in hospitalisation and it was unknown if any treatment due to the ADRs was reported. The outcome of the events dead fetus, Severe impact on the blood supply to the fetus, and feels less life from the fetus was not recovered and event maternal exposure during pregnancy was recovered on 31Jul2021 and while for off-label use it was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : DK-PFIZER INC-202101053823 1st/2nd dose


VAERS ID: 1638709 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210627; Test Name: Body temperature; Result Unstructured Data: Test Result:38-40.5 Centigrade; Comments: Fever: 38 to 40.5 degrees Celsius; Test Name: Ultrasound examination; Result Unstructured Data: Test Result:unknown results; Comments: unknown results
CDC Split Type: NLPFIZER INC202101038947

Write-up: Miscarriage; Pyrexia; Headache; Malaise; Fatigue; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00660747. This consumer reported information for both mother and fetus. This is first of three reports (maternal report concerning 2nd dose of vaccine). A 29-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: FE4728) (at the age of 29 years old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took Amoxicillin and had allergy. No previous COVID-19 infection. The patient previously took first dose of BioNTech/Pfizer vaccin (Comirnaty) on 25Jun2021 for COVID-19 immunisation and experienced headache, fever, malaise, fatigue and maternal exposure during pregnancy, first trimester (4 weeks). On 31Jul2021 (as reported), patient experienced fatigue. On 01Aug2021 (1 day after start), patient had headache and malaise. On 05Aug2021 (5 days after start), patient had pyrexia. The patient experienced miscarriage on 05Aug2021. The miscarriage occurred at a pregnancy duration of about 10 weeks. The first COVID-19 vaccination took place at a pregnancy duration of about 4 weeks, and the second COVID-19 vaccination took place at a pregnancy duration of about 9 weeks. The mother reported she became pregnant while taking bnt162b2. The mother was 10 weeks pregnant at the onset of the event. The mother delivered the pregnancy on 05Aug2021. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. Fetus has stopped growing after a few weeks of vaccination. The patient underwent lab tests and procedures which included body temperature: 38-40.5 centigrade on 27Jun2021 (Fever: 38 to 40.5 degrees Celsius) and ultrasound examination: unknown results on unspecified date. The outcome of the events fatigue, headache and pyrexia was not recovered; event malaise was recovered on 04Aug2021. Sender''s comments: HA death and birth defect altered in cioms other medically important condition. Reporter''s comments: -BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Headache, tired, feeling unwell, fever Date: 25Jun2021. -Miscarriage Additional information ADR: fetus has stopped growing after a few weeks of vaccination. - confounding factors allergy: Amoxicillin. COVID-19 vaccine exposure during pregnancy week: 4. - COVID-19 Previous COVID-19 infection: No. - Other diagnostic procedures: Ultrasound examination. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Past drug therapy (Comirnaty) ADRs: Headache, tired, feeling unwell, fever -Miscarriage -fetus has stopped growing after a few weeks of vaccination -exposure during pregnancy week: 4; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101082456 same patient/ drug, different events and dose;NL-PFIZER INC-202101082457 fetus case


VAERS ID: 1640849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 6742981-8 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Back pain, Blood test, Headache, Malaise, Myalgia, Neck pain, Peripartum haemorrhage, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUPHASTON
Current Illness:
Preexisting Conditions: Comments:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood tests; Result Unstructured Data: Test Result:miscarriage
CDC Split Type: BEPFIZER INC202101054455

Write-up: Fever; Malaise/felt unwell; Headache; Neck pain; Back pain; Myalgia; Bleeding peripartum/Blood loss; Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-103971. This consumer reported information for mother. This is a maternal report. A 31-year-old pregnant (including at the time of vaccination) female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: 6742981-8) as dose 2, single for COVID-19 immunization. Medical history was not reported. Concomitant medication included dydrogesterone (DUPHASTON 10mg strength) taken for unspecified indication and therapy date. It was reported that the patient had fever, felt unwell/malaise, headache, myalgia, neck and back pain on 31Jul2021 (in the days after the vaccine). The mother was first trimester pregnant at the onset of the event. It was mentioned that pregnancy progressed with no problems before the vaccine. It was also mentioned that the patient had bleeding peripartum/blood loss started the day after the vaccine (31Jul2021) and the pregnancy ended in a miscarriage. Blood tests showed miscarriage in the days after the vaccine. No treatment was received for the events. The events were considered as serious (medically significant). Outcome of miscarriage was unknown and recovered from the remaining events on 04Aug2021 (but also reported as recovering). Reporter comment: Treatment: No No follow-up attempts are possible. No further information is expected. ; Reporter''s Comments: Treatment: No


VAERS ID: 1664437 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-07-31
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101075633

Write-up: Early miscarriage; This is a non-interventional study/solicited report from a contactable consumer received from the Regulatory Agency (RA), Yellow Card Vaccine Monitor program. The regulatory authority report number is GB-MHRA-YCVM-202108182031190660-HIC9N. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25820414. This is a maternal report. A 43-years-old pregnant female patient (last menstrual period date: 06May2021, Gestation period: 12 weeks, 12 Weeks pregnant at the onset of the event) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW3143), via an unspecified route of administration on 27May2021 as dose 1, single for covid-19 vaccination (covid-19 immunization). Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. The mother was due to deliver on 10Feb2022. It was stated that, on 31Jul2021, the patient experienced early miscarriage. The event was reported as serious with seriousness criteria as hospitalization on an unknown date in 2021. Patient was not enrolled in clinical trial. The outcome for the event was reported as recovered on 07Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1667010 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Arthralgia, Chills, Fatigue, Headache, Nausea, Oropharyngeal pain
SMQs:, Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101079176

Write-up: Nausea; Arthralgia; Sore throat; Shivering; Fatigue; Early miscarriage; Headache; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority, regulatory authority number BE-FAMHP-DHH-N2021-104924. A 33-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: FF0900) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 31Jul2021, the patient experienced nausea, arthralgia, sore throat, shivering, fatigue, early miscarriage, and headache. All events were medically significant with outcome of unknown. Treatment, evolution of the Adverse Drug Reaction (ADR) and situations were not mentioned in the report.


VAERS ID: 1765990 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, Uterine pain, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPEGIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Delivery; In vitro fertilisation (at term on 08Dec2018); In vitro fertilization (start of pregnancy); Pregnancy ((by IVF) at term on 08/12/2018.)
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: HCG rate; Test Result: 5409 [iU]; Test Date: 20210802; Test Name: HCG rate; Test Result: 1590 [iU]
CDC Split Type: FRPFIZER INC202101256649

Write-up: vaginal bleeding; severe uterine pain; Pregnancy loss <20 weeks gestation; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (RA)-WEB. The regulatory authority number FR-AFSSAPS-LY202110311. A 37-year-old pregnant female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 30Jul2021 (Batch/Lot Number: FD0785) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included in vitro fertilisation from an unknown date and unknown if ongoing at term on 08Dec2018, pregnancy from an unknown date and unknown if ongoing (by IVF) at term on 08/12/2018, delivery on 08Dec2018. It was further reported that the start of pregnancy was on 12Jun2021 (frozen embryo transfer). The patient has no history of miscarriage. Concomitant medication included acetylsalicylate lysine (ASPEGIC) taken for an unspecified indication, start and stop date were not reported. The patient experienced vaginal bleeding and severe uterine pain on an unspecified date and had pregnancy loss <20 weeks gestation on 31Jul2021. The mother reported she became pregnant while taking bnt162b2. The mother was 4 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included human chorionic gonadotropin (HCG) was 5409 iU on 31Jul2021 and HCG rate of 1590 iU on 02Aug2021.The outcome of the event Pregnancy loss <20 weeks gestation was resolved and unknown outcome for the remaining events. No follow-up attempts possible. No further information expected. Information about batch/lot already obtained.


VAERS ID: 1852308 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-31
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Human chorionic gonadotropin, Intermenstrual bleeding
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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to analgesics; Hypersensitivity; Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: beta HCG; Result Unstructured Data: Test Result:130 IU/l; Test Date: 20210801; Test Name: beta HCG; Result Unstructured Data: Test Result:230 IU/l; Test Date: 20210803; Test Name: beta HCG; Result Unstructured Data: Test Result:36.3 IU/l; Test Date: 20210810; Test Name: beta HCG; Test Result: Negative
CDC Split Type: FRPFIZER INC202101435877

Write-up: Early miscarriage; Metrorrhagia; Abdominal pain; This is a spontaneous report from a contactable consumer and Other Health Professional downloaded from the regulatory authority number FR-AFSSAPS-NC20214915. A 25-year-old female patient received the first dose of bnt162b2 (COMIRNATY) on 20Jul2021 (lot number: FE7010) Intramuscularly at single dose for COVID-19 immunisation. Medical history included Hypersensitivity; Penicillin allergy; Allergy to non-steroidal anti-inflammatory drugs. Concomitant medications were not reported. Date of last menstrual period was 09May2021 (long cycle), start of pregnancy was not known. On 31Jul2021 or 11 days after vaccination: metrorrhagia and abdominal pain, term around 4 weeks of amenorrhoea according to Beta HCG dosage. On 03Aug2021, that was 14 days after vaccination: diagnosis of miscarriage, less significant metrorrhagia and pain stopped since 02Aug2021. Lab data included Beta HCG dosage on 29Jul2021: 130 iU/l; Beta HCG dosage on 01Aug2021: 230 iU/l; Beta HCG dosage on 03Aug2021: 36.3 iU/l; Beta HCG dosage on 10Aug2021: negative. The events were required Emergency consultation. Conclusion: Early miscarriage after vaccination with Comirnaty. The outcome of the event Early miscarriage was recovered in 2021. The outcome of other events was recovered on 02Aug2021.


VAERS ID: 1578405 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-01
Onset:2021-08-01
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8736 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Foetal heart rate abnormal, Menstruation irregular, Pregnancy, Ultrasound foetal abnormal
SMQs:, Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Fertility disorders (broad)

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

Write-up: After receiving each COVID vaccine, had a couple of irregular periods. Became pregnant about 1 month after receiving 2nd dose of vaccine. At 8.5 week ultrasound, was told baby was only 6.5 weeks judging by size and heart rate. At 10.5 weeks, went in for another ultrasound and there was no heartbeat - baby measured about 6 weeks. Miscarriage.


VAERS ID: 1617371 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Delaware  
Vaccinated:2021-03-09
Onset:2021-08-01
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Cardiolipin antibody
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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamin, probiotic
Current Illness: N/a
Preexisting Conditions: N/a
Allergies: Augments
Diagnostic Lab Data: Elevated cardiolipin igm
CDC Split Type:

Write-up: Second trimester miscarriage


VAERS ID: 1750525 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-05-22
Onset:2021-08-01
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 RA / IM

Administered by: School       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin positive, Ultrasound uterus abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tumour markers (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Confirmation of miscarriages via ultrasound and beta HCG. Patient bled heavily and symptomatic. She is a very healthy fitness instructor, sadly this was her second miscarriage post-vaccine.
CDC Split Type:

Write-up: First miscarriage, 06/2021 Second miscarriage, 08/2021


VAERS ID: 1750533 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-04-01
Onset:2021-08-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 2 LA / IM

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

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: Vit-C (OTC)
Current Illness: None
Preexisting Conditions: None
Allergies: Shrimp
Diagnostic Lab Data: Confirmation of miscarriage via ultrasound and beta HCG.
CDC Split Type:

Write-up: LMP, 12/2020; Miscarriage, 08/2021


VAERS ID: 1750563 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-03-18
Onset:2021-08-01
   Days after vaccination:136
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6204 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 2 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, Ultrasound scan abnormal, Uterine dilation and curettage
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? Yes
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: Levothyroxine
Current Illness: None
Preexisting Conditions: Hypothyrodism
Allergies: None
Diagnostic Lab Data: Confirmation of miscarriage via ultrasound and beta HCG. PATIENT UNDERWENT EMERGENCY DILATION AND CURETTAGE.
CDC Split Type:

Write-up: LMP, 05/30/2021 Miscarriage, 08/2021


VAERS ID: 1752835 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-02-07
Onset:2021-08-01
   Days after vaccination:175
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6204 / 2 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage, Human chorionic gonadotropin, Ultrasound foetal abnormal, Uterine dilation and curettage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

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

Write-up: EDD: 01/27/2022 Miscarriage, 08/2021


VAERS ID: 1752840 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-03-24
Onset:2021-08-01
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Emotional disorder, Human chorionic gonadotropin negative, Injury, Ultrasound antenatal screen abnormal, Uterine dilation and curettage
SMQs:, Accidents and injuries (narrow), Hostility/aggression (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)

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

Write-up: Miscarriage, 08/2021


VAERS ID: 1823558 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-20
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Cardiac disorder, Diarrhoea, Gait disturbance, Illness, Lymphadenopathy, Malaise, Palpitations
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Termination of pregnancy and risk of abortion (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple sclerosis (diagnosed in 1991)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101360502

Write-up: she found out an aborted baby in her body as she is struggling to walk; struggling to walk; got so sick; not felt well/has not been well; diarrhea; swollen lymph nodes; feels like her "heart hiccups"/"beating against a fluid sack"; feels like she has fluid on her heart when she lays down/goes to bed; This is a spontaneous report from a contactable consumer (patient). A 59-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 20Aug2021 (Batch/Lot Number: FC3182, Expiry date: unknown) (at the age of 58-years-old) as dose 2, single for COVID-19 immunisation. Vaccination facility type was pharmacy/drug store. The patient was pregnant at time of vaccination. Medical history included multiple sclerosis diagnosed in 1991 and ongoing. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 27Jul2021 (Batch/Lot Number: FA7484) (at the age of 58-years-old) as dose 1, single for COVID-19 immunisation and experienced maternal vaccine exposure. The patient stated that she got so sick, has not felt well/has not been well since the second dose and has had diarrhea ever since and swollen lymph nodes on unspecified date in Aug2021. She further stated that it feels like her "heart hiccups", feels like she has fluid on her heart when she lays down/goes to bed and feels like it is "beating against a fluid sack" and this has been ongoing since vaccination. But now (in Oct2021), she found out an aborted baby in her body as she is struggling to walk (as reported). She stated she read this when she went to Pfizer research. She does have MS (Multiple Sclerosis) and is unable to determine if it is related to that. Patient stated she is pro-life and wanted to know if there are aborted babies in the vaccines. She stated her husband got Moderna and she got the Pfizer vaccine. She stated that she also sees a nurse practitioner. After vaccination, she was given a factsheet that stated that the vaccine may not protect everyone, and she would like to know why. She would like information on booster doses of Pfizer Covid 19 vaccine and would like to know if she should receive Ivermectin. The patient was referred to provider for further consultation and medical advice. The outcome of all the events was not recovered, except for abortion spontaneous and struggling to walk which was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1579313 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, SARS-CoV-2 test, Uterine haemorrhage, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEINE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Early miscarriage; Lactation decreased; Miscarriage
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: HCG level blood tests; Result Unstructured Data: Test Result:Miscarriage; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984753

Write-up: miscarriage; brown spotting/Red blood and brown blood (with some small clots) continued over the day; Uterine bleeding; 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-202108011911048630-LHSJG. Safety Report Unique Identifier GB-MHRA-ADR 25738317 . A 34-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 21Jul2021 (Batch/Lot Number: FC9001) as dose 1 ,single for Covid-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient had an early miscarriage in May2021; this did not complete (confirmed by weekly HCG level blood tests) until 9th July 2021. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included codeine and paracetamol taken for miscarriage from 05Jun2021 to 07Jun2021. The patient experienced miscarriage on an unspecified date with outcome of unknown, uterine bleeding on 01Aug2021 with outcome of not recovered, and brown spotting/red blood and brown blood (with some small clots) continued over the day on an unspecified date with outcome of unknown. The patient underwent lab tests which included human chorionic gonadotropin: miscarriage on 09Jul2021 and Covid-19 virus test: No - Negative COVID-19 test, on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as non-serious by regulatory authority. The clinical course was reported as follows: Noticed this morning that there was brown spotting in panty-liner - upon wiping, there was red blood. Red blood and brown blood (with some small clots) continued over the day. Not yet finished. The only other thing relevant here is that I recently had a miscarriage (May-July 2021) and this had completed early July. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1625713 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101016780

Write-up: had a miscarriage.; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00648178. This is the first out of two reports, for the second dose. A 33-year-old female patient received the second dose of bnt162b2 (COMIRNATY) covid-19 vaccine pfizer injection fluid on 01Aug2021 (lot number: unknown) (at the age of 33-years-old) via unknown route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient was not Previous COVID-19 infection. Patient previously received the first dose of BioNTech/Pfizer vaccin (Comirnaty) on 24Jun2021 via unknown route of administration at single dose for covid-19 immunisation, experienced fever and cramps. Patient experienced Miscarriage on 01Aug2021. The miscarriage occurred at a pregnancy duration of about 4,5 weeks. This was the second Covid vaccination, which took place at a pregnancy duration of about 4,5 weeks. The first Covid vaccination took place before pregnancy. The outcome of the event was unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the HA critera, the reaction (miscariage) was considered as serious by the regulatory authority. Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 24Jun2021. I have previously reported side effects including fever, today I had a miscarriage. Additional information ADR: No idea of course if it has anything to do with the vaccine but Friday I got a fever, Saturday cramps and today a miscarriage. COVID-19 vaccine exposure during pregnancy week: Second time at 4.5 weeks. Previous COVID-19 infection: No. No follow-up attempts possible. No further information expected. Information about lot/batch# cannot be obtain.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 24Jun2021 I have previously reported side effects including fever, today I had a miscarriage Additional information ADR: No idea of course if it has anything to do with the vaccine but Friday I got a fever, Saturday cramps and today a miscarriage confounding factors COVID-19 vaccine exposure during pregnancy week: Second time at 4.5 weeks Previous COVID-19 infection: No; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101061081 same patient; different dose of vaccine


VAERS ID: 1629677 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101022737

Write-up: miscarriage; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female pregnant patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on 07Aug2021 (batch/lot number FE7051 and expiry date unknown) at 34 years of age as dose 1, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received her first injection on Saturday 07Aug2021, but on Friday (in Aug2021) she discovered that she was 3 to 4 weeks pregnant but did not tell her partner. The patient informed that when filling in the questionnaire, she did not mention it. The patient informed that during the night she had blood loss, so she went to the emergency room and later learned that she had a miscarriage. The patient experienced miscarriage in Aug2021, maternal exposure during pregnancy, first trimester (week 1 through 13 (months 1 to 3)). The mother reported she became pregnant while taking bnt162b2. The outcome of the event was unknown.


VAERS ID: 1633296 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004493 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Biopsy tendon, 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: ELTROXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fever (The patient experienced the ADR, fever, after treatment with Cytotec (Misoprostol))
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Biopsy tendon; Result Unstructured Data: Biopsy from fetal Achilles tendon
CDC Split Type: DKMODERNATX, INC.MOD20212

Write-up: Complete spontaneous abortion at 17+5 weeks, without complications and without evacuation. The patient had no symptoms of pregnancy loss; Maternal exposure during pregnancy; This case was received via the regulatory authority (Reference number: 25770243) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (Complete spontaneous abortion at 17+5 weeks, without complications and without evacuation. The patient had no symptoms of pregnancy loss) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004493) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Fever (The patient experienced the ADR, fever, after treatment with Cytotec (Misoprostol)) on 17-Jan-2021. Previously administered products included for Induced abortion: CYTOTEC on 17-Jan-2021. Past adverse reactions to the above products included Fever with CYTOTEC. Concomitant products included LEVOTHYROXINE SODIUM (ELTROXIN) from 24-Jun-2019 to an unknown date for Hypothyroidism. On 01-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 07-Aug-2021, the patient experienced ABORTION SPONTANEOUS (Complete spontaneous abortion at 17+5 weeks, without complications and without evacuation. The patient had no symptoms of pregnancy loss) (seriousness criterion medically significant). The delivery occurred on 07-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 07-Aug-2021, ABORTION SPONTANEOUS (Complete spontaneous abortion at 17+5 weeks, without complications and without evacuation. The patient had no symptoms of pregnancy loss) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Biopsy tendon: biopsy from fetal achilles tendon Biopsy from fetal Achilles tendon. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Diagnostic information in Aug-2021, Laboratory test performed with Investigations (NOS), Re etiology with Awaiting results, Blood test was performed with TORCH panel to screen for virus infection with unknown results. Pathology test performed for Placental pathology and no results reported. Autopsy performed for Fetal autopsy with no results reported. Culture performed for Placental cultures and no results reported. No treatment information was provided. Company Comment - This is a case of product exposure during pregnancy that resulted in a spontaneous abortion for this 32-year-old female. All adverse events listed maybe a result of being expose to the product while pregnant. Patient will continue to be contacted for further monitoring of AEs. This case was linked to DK-DKMA-WBS-0029168 (E2B Linked Report).; Sender''s Comments: This is a case of product exposure during pregnancy that resulted in a spontaneous abortion for this 32-year-old female. All adverse events listed maybe a result of being expose to the product while pregnant. Patient will continue to be contacted for further monitoring of AEs DK-DKMA-WBS-0029168:


VAERS ID: 1636049 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-08-01
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Inappropriate schedule of product administration, Maternal exposure during pregnancy, 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), 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: Lactation decreased; Miscarriage; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during pregnancy; Miscarriage; Inappropriate schedule of vaccine administration; This case was received via the Regulatory Authority RA (Reference number: 25813463) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Miscarriage (Miscarriage), Pregnancy (Pregnancy) and Lactation decreased (Lactation decreased). Concomitant products included FOLIC ACID for Folic acid supplementation. On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). On 06-Aug-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). The delivery occurred which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. Unsure Details of previous pregnancies: Second pregnancy (first pregnancy resulted in live birth). Miscarriage at 10 weeks. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Miscarriage at 10 weeks confirmed at hospital. On 01-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) was resolving and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. This is a case of Maternal exposure during pregnancy with associated AE (Spontaneous abortion) for this 34-year-old female. This is also a case of Inappropriate schedule of vaccine administration for mRNA-1273, lot # unknown, where the interval between the two doses were 71 days. This being a report from a regulatory authority, there are no contact details, hence no further information is expected.; Sender''s Comments: This is a case of Maternal exposure during pregnancy with associated AE (Spontaneous abortion) for this 34-year-old female. This is also a case of Inappropriate schedule of vaccine administration for mRNA-1273, lot # unknown, where the interval between the two doses were 71 days. This being a report from a regulatory authority, there are no contact details, hence no further information is expected.


VAERS ID: 1638708 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101038910

Write-up: miscarriage occurred at a pregnancy duration of about 11 weeks/at 11 weeks of pregnancy, the heart stopped beating, exactly around the date of vaccination.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, Regulatory authority report number NL-LRB-00660593. This is a maternal report. A pregnant 36-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 31Jul2021 (Lot Number: FE8405, unknown expiration) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. No previous COVID-19 infection. The patient previously received first dose of COMIRNATY on 20Jun2021 for COVID-19 immunisation and experienced maternal vaccine exposure (first COVID vaccination took place at a pregnancy duration of about 5 weeks; no adverse event). The second COVID vaccination took place at a pregnancy duration of about 11 weeks. The patient experienced miscarriage following administration of COVID-19 vaccine Pfizer injection on 01Aug2021 (1 day after start). The miscarriage occurred at a pregnancy duration of about 11 weeks. At 11 weeks of pregnancy, the heart stopped beating, exactly around the date of vaccination. Outcome of the event was unknown. The event was assessed as serious (medically significant). Sender''s comment: HA death altered in HA other medically important condition. No follow-up attempts are possible; information about batch number was already obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101082710 baby case


VAERS ID: 1656864 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-08-01
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Echocardiogram, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Factor V Leiden carrier; Renal agenesis; Spontaneous abortion (at 6 weeks of pregnancy)
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: echo; Result Unstructured Data: Test Result:pregnancy; Test Date: 20210801; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101055710

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BR20213093. A 29-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 19May2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included Factor V Leiden carrier, renal agenesis, and spontaneous abortion from 05Dec2020 (at 6 weeks of pregnancy). The patient''s concomitant medications were not reported. The patient experienced miscarriage (hospitalization) on 01Aug2021 with outcome of recovered with sequelae. The report was about the 29-year-old patient who started a pregnancy dated by echo on 19May2021 (LMP: 04May2021). Received a 1st injection of COMIRNATY, batch unknown, on 19May2021. Occurrence of a miscarriage on 01Aug2021 during the first trimester of pregnancy. The mother was 12 Weeks pregnant at the onset of the event. The mother was due to deliver on 08Feb2022. The mother delivered the pregnancy on 01Aug2021. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included echocardiogram: pregnancy on 19May2021 and sars-cov-2 test: negative on 01Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1664075 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Lymph node pain, Lymphadenopathy, Off label use, Product use issue
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DICLOFENAC; FOLIC ACID
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101034104

Write-up: Miscarriage; Swollen lymph nodes; Painful lymph nodes in armpit; maternal exposure during breast feeding; maternal exposure during breast feeding; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number {GB-MHRA-WEBCOVID-202108102158130710-JPS7V}, Safety Report Unique Identifier {GB-MHRA-ADR 25782441}. This is the first of three reports. This consumer reported information for both mother and baby. This is the maternal report. Only this case is serious. A 33-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 08Aug2021 (Lot number unknown), dose 2, single for COVID-19 immunisation. Medical history included endometriosis, pregnancy, however patient is no longer pregnant at the time of reporting, breast feeding which is continuing and miscarriage. It was unsure if the medicine had an adverse effect on any aspect of the pregnancy. The patient had not had symptoms associated with COVID-19 and was not enrolled in the clinical trial. Concomitant medications included diclofenac from an unknown date for endometriosis, folic acid from an unknown date for folic acid supplementation and vitamins (unspecified). The patient previously took dose 1 of BNT162B2 (Lot number was not reported) for COVID-19 immunisation and experienced maternal exposure during pregnancy. The patient did not undergo COVID-19 test. Since the vaccination, the patient had not been tested positive for COVID-19. On 09Aug2021, the patient experienced swollen lymph nodes and painful lymph nodes in armpit. On 11Aug2021, the patient experienced miscarriage. The patient was 3 weeks and 6 days pregnant at the time of vaccination. Pregnancy ended at 4 weeks and 2 days. The events were assessed as serious and medically significant. It was also reported that in Aug2021, the patient experienced maternal exposure during breast feeding. The clinical outcome of the events swollen lymph nodes and painful lymph nodes in armpit were not recovered, miscarriage was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101097903 baby case;GB-PFIZER INC-202101097904 same patient, different dose/event


VAERS ID: 1669316 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-08-01
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
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: SEPFIZER INC202101079688

Write-up: MISSFALL; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency-WEB, regulatory authority number SE-MPA-2021-072149. A 29-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 13Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced missfall (abortion spontaneous) on 01Aug2021. Reported suspected adverse reaction was miscarriage at week 5, 19 days after vaccination. The mother was 5 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The patient stated that she exercises, eats well and is not overweight. Outcome of the event was unknown. Sequence: Unknown. The case was judged to be serious. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1690963 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Ultrasound; Result Unstructured Data: Test Result:the embryo appeared too small and; Comments: there was no heart beat
CDC Split Type: NLPFIZER INC202101182270

Write-up: Maternal Exposure During Pregnancy, first trimester; Heart stopped beating; Embryo too small; This is as spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00672339. The consumer reported events for both mother and fetus. This is the fetus case. A fetus patient of an unspecified gender received BNT162B2 (COMIRNATY), via transplacental route on 13Aug2021 (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''s mother previously received BNT162B2 (COMIRNATY) on 28Jun2021 (Lot# unknown) for COVID-19 immunisation. The patient experienced heart stopped beating (cardiac arrest) (death) in Aug2021, maternal exposure during pregnancy, first trimester on 13Aug2021. On an unspecified date in Aug2021, during the first vitality ultrasound around 7-8 weeks, the embryo appeared too small and there was no heart beat; classified as a missed abortion. The patient died on an unspecified date in Aug2021. It was unknown if autopsy was done. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101182271 Maternal case;NL-PFIZER INC-202101125600 Maternal master case; Reported Cause(s) of Death: Heart stopped beating


VAERS ID: 1698521 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Biopsy chorionic villous, Blood grouping, Coagulation test, Foetal death, Gynaecological examination, HIV antibody, Hepatitis B virus test, Hepatitis C virus test, Immune agglutinins, Investigation, Karyotype analysis, Oligohydramnios, Placental disorder, Rubella, Serology test, Syphilis, Toxoplasmosis, Trisomy 21, Ultrasound scan, Urine cytology, Varicella
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROX; UVEDOSE; SPASFON [PHLOROGLUCINOL]; PARACETAMOL; HYDROCORTISONE; INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Addison''s disease; Cervical laser therapy; Condyloma (Vulvar laser for condyloma (2019)); Hypothyroidism; Laser therapy (Vulvar laser for condyloma (2019)); Penicillin allergy; Pregnancy (1 pregnancy, no delivery); Schmidt''s syndrome; Surgery; Type I diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: Chorionic villus puncture; Result Unstructured Data: Test Result:unknown result; Test Name: Blood group; Result Unstructured Data: Test Result:B+; Test Name: Coagulation test; Result Unstructured Data: Test Result:Normal; Test Name: Vaginal swab; Test Result: Negative ; Test Name: Hepatitis B virus; Test Result: Negative ; Test Name: Hepatitis C virus; Test Result: Negative ; Test Name: Human immunodeficiency virus; Test Result: Negative ; Test Name: irregular agglutinins screening; Test Result: Negative ; Test Date: 202108; Test Name: monitoring; Result Unstructured Data: Test Result:no audible heart sounds; Test Name: Cord blood sampling for foetal karyotype; Result Unstructured Data: Test Result:unknown result; Test Name: Placental anapathology; Result Unstructured Data: Test Result:unknown result; Test Name: Rubella; Test Result: Positive ; Test Name: Serological assessment; Result Unstructured Data: Test Result:normal; Test Name: Syphilis; Test Result: Negative ; Test Name: Toxoplasmosis; Test Result: Negative ; Test Name: Down syndrome screening (T21); Result Unstructured Data: Test Result:< 1/1000; Test Name: Monthly follow-up ultrasound; Result Unstructured Data: Test Result:no morphological abnormality; Test Date: 202108; Test Name: ultrasound monitoring; Result Unstructured Data: Test Result:No cardiac activity, no fetal movement; Comments: No cardiac activity, no fetal movement, oligohydramnios, high anterior placenta, no image of haematoma.; Test Name: Urine cytobacteriological examination; Result Unstructured Data: Test Result:sterile; Test Name: Varicella; Test Result: Positive
CDC Split Type: FRPFIZER INC202101131236

Write-up: Foetal death in utero; Oligohydramnios; This is a spontaneous report from a contactable physician. This is the first of two reports. The first report is a report downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-SE20212241. A 22-year-old female patient received the second dose of bnt162b2 (COMIRNATY), intramuscular on 10Aug2021 (Lot Number: FE7051) as single dose for covid-19 immunisation. Medical history included Hypothyroidism (also family history), Addison''s disease, Type I diabetes mellitus from 2006, Schmidt''s syndrome, Cervical laser for low grade dysplasia from 2019, Vulvar laser for condyloma (2019), Right nymphoplasty from 2015, 1 pregnancy, no delivery, Allergy to penicillin. Concomitant medications included levothyroxine sodium (LEVOTHYROX) from Oct2020; colecalciferol (UVEDOSE) from 09Jun2021; phloroglucinol (SPASFON); paracetamol; hydrocortisone; insulin taken for type 1 diabetes mellitus. The patient previously took ibuprofen and experienced hypersensitivity. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 20Jul2021 for COVID-19 immunization. The patient experienced foetal death in utero (medically significant) on 17Aug2021, oligohydramnios (medically significant) on Aug2021. The clinical course was reported as follows: Last menses on 04Dec2020. Pregnancy start date 24Dec2020. The mother was due to deliver on 10Sep2021. Blood group B+, irregular agglutinins screening negative. Early pregnancy check-up: Toxoplasmosis negative(-) ; Hepatitis B virus (-) ; Hepatitis C virus (-) ; Rubella (+) ; Human immunodeficiency virus (-) ; Syphilis (-) ; Varicella (+) ; Down syndrome screening (T21) < 1/1000. Monthly follow-up ultrasound: no morphological abnormality. Poorly controlled diabetes during pregnancy, foetal macrosomia, induction was planned at 38 weeks. On 17Aug2021 (Day 7 of the 2nd dose of COMIRNATY), the patient, at week 35 of amenorrhea + 5 days, consulted the Gynaecological Emergency Room for absence of active foetal movements for 3 days. On monitoring: no audible heart sounds. On ultrasound monitoring: No cardiac activity, no fetal movement, oligohydramnios, high anterior placenta, no image of haematoma. Labour induced on 20Aug2021. On 21Aug2021: A stillborn male child was delivered by vaginal delivery at 9:18 am. Autopsy was pending. Foetal death in utero discovered at week 35 of amenorrhea + 5 days, on Day 8 of a 2nd dose of COMIRNATY, in a 22-year-old woman with an autoimmune background (Schmidt syndrome) but no obstetrical history. The patient underwent lab tests and procedures which included Chorionic villus puncture: unknown result, Blood group: B+, Coagulation test: Normal, Vaginal swab: Negative, Hepatitis B virus: negative, Hepatitis C virus: negative, Human immunodeficiency virus: negative, irregular agglutinins screening: negative, Cord blood sampling for foetal karyotype: unknown result, Placental anapathology: unknown result, Rubella: positive, Serological assessment: normal, Syphilis: negative, Toxoplasmosis: negative, Down syndrome screening (T21): < 1/1000, Monthly follow-up ultrasound: no morphological abnormality, Urine cytobacteriological examination: sterile, Varicella: positive; Monitoring: no audible heart sounds on Aug2021, ultrasound monitoring: No cardiac activity, no fetal movement, oligohydramnios, high anterior placenta, no image of haematoma on Aug2021. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101183106 same reporter, different patient( fetus)


VAERS ID: 1698681 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: SCAN; Result Unstructured Data: Test Result:8-week scan was fine; Test Name: SCAN; Result Unstructured Data: Test Result:11 weeks baby''s heart stopped; Comments: 12-week scan revealed baby''s heart had stopped at 11 weeks
CDC Split Type: GBPFIZER INC202101118685

Write-up: Dose 1 on 10Jun2021 and Dose 2 on 06Aug2021 (Outside range of 19-42 days); Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108272145226060-SJDYM, Safety Report Unique Identifier GB-MHRA-ADR 25862305. A 40-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number FE3380), via an unspecified route of administration on 06Aug2021 as dose 2, single for COVID-19 immunization. Patient was not currently breast feeding. Medical history included lactation decreased and pregnancy (Patient was no longer pregnant at the time of reporting). Concomitant medications included folic acid (MANUFACTURER UNKNOWN) taken for Folic acid supplementation. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number FC8089) via an unspecified route of administration on 10Jun2021 as dose 1, single for COVID-19 immunization. It was stated that patient was exposed to the medicine first-trimester (1-12 weeks). The patient had an inappropriate schedule of product administration (Dose 1 on 10Jun2021 and Dose 2 on 06Aug2021), which was outside range of 19-42 days. On an unspecified date in Aug2021, the patient experienced miscarriage of pregnancy. The event miscarriage of pregnancy was serious (medically significant and congenital anomaly). It was reported as unsure if the medicine had an adverse effect on any aspect of the pregnancy. The patient underwent lab tests and procedures which included SARS CoV-2 test: Negative (No - Negative COVID-19 test), and Scan: 8-week scan was fine, and 12-week scan revealed baby''s heart had stopped at 11 weeks, on an unspecified date. The details of relevant investigations or tests conducted was reported as ongoing. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was reported as recovered on an unspecified date in Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1701623 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101144512

Write-up: missed miscarriage discovered at 11 weeks pregnant; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number not provided), via an unspecified route of administration on an unspecified date in 2021 (at the age of 36 years old) as single dose for COVID-19 immunisation. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient''s medical history and concomitant medications were not reported. The patient experienced missed miscarriage discovered at 11 weeks pregnant in Aug2021. The mother reported she became pregnant while taking BNT162B2 in 2021. The mother was 4 Weeks pregnant at the onset of the event. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn''t been tested for COVID-19. The outcome of the event was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1702691 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ovarian cyst
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: TVS; Result Unstructured Data: Test Result:pregnant at that time; Test Date: 20210824; Test Name: TVS; Result Unstructured Data: Test Result:confirm the miscarriage
CDC Split Type: PHPFIZER INC202101143992

Write-up: miscarriage; fever; back ache; abdominal pain; This is a spontaneous report from a contactable nurse. This is the first of two reports for the first dose. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 03Aug2021 (at the age of 33 years old, Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included ovarian cyst. concomitant medications were not reported. The patient experienced miscarriage on 24Aug2021 with outcome of unknown, fever on 03Aug2021 with outcome of unknown, back ache on 03Aug2021 with outcome of unknown, abdominal pain in Aug2021 with outcome of unknown, maternal exposure (1st trimester) on 03Aug2021 with outcome of unknown. The patient experienced fever and back ache started after vaccination (same day), these events were non-serious. No value was given to the reporter for the fever temp. The patient had experienced severe abdominal pain in Aug2021 after the first dose and thought that her ovarian cyst would explode so she seek consult and had a Ultrasound scan vagina (TVS) done in Aug2021 but found out that she was pregnant at that time. Her last menstrual cycle was 23Jun2021. She was 6 Weeks pregnant at the onset of the event. She was due to deliver on 30Mar2022. The pregnancy resulted in spontaneous abortion. She had severe vaginal bleeding on 24Aug2021 which prompted for her to get another TVS after consulting a physician regarding the her unusual vaginal bleeding. She had another TVS done on 24Aug2021 that confirm the miscarriage. The abdominal pain became severe after the first dose was on 24Aug2021 when the miscarriage occurred.The patient complaint about abdominal pain and was inquiring if this was a normal since she experienced on both doses. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the reported information ,a causal relationship between the event Abortion spontaneous and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : PH-PFIZER INC-202101143994 same patient, product, similar events and different dose


VAERS ID: 1706171 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: echo; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: NLPFIZER INC202101143255

Write-up: Miscarriage; Miscarriage due to bleeding; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00674407 and the safety report unique identifier is NL-LRB-00675615. A 27-year-old female patient received BNT162B2 (COMIRNATY, lot number: FE8235), via an unspecified route of administration on 10Aug2021 at dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. She has no previous COVID-19 infection. The patient previously received BNT162B2 (COMIRNATY, lot number and expiration date were not provided), via an unspecified route of administration on 06Jul2021 at dose 1, 0.3 mL single for COVID-19 immunisation. It was reported that the first COVID vaccination took place before pregnancy. On 18Aug2021, the patient experienced miscarriage due to bleeding which started from Aug2021. It started at a pregnancy duration of about 6 weeks and occurred at a pregnancy duration of about 7 weeks (as reported). These occurred after the second dose of COMIRNATY which took place at a pregnancy duration of about 5 weeks. The patient underwent lab test and procedure which included echo on an unspecified date in 2021 with unknown result. The outcome of the event miscarriage was recovered on 23Aug2021 and unknown for the other event. The event miscarriage was reported as serious, medically significant. Reporter''s Comment: BioNTech/Pfizer vaccine (Comirnaty): Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): Yes. ADRs: No (as reported). Date: 06Jul2021. Miscarriage: Additional information ADR: Miscarriage due to bleeding. Confounding factors: COVID-19 vaccine exposure during pregnancy week: 0 (as reported). COVID-19: Previous COVID-19 infection: No. Other: Diagnostic procedures: Echo. Follow-up: 31Aug2021 Received follow-up: At 7 weeks of pregnancy. I received the second vaccination at 5 weeks of pregnancy. I indicated this and the advice was a vaccination. Miscarriage stop date: 23Aug2021. Sender''s Comment: Since the nature of the reported reaction does imply seriousness according to one of the regulatory authority criteria, the reaction was considered as serious by the lab. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): Yes. ADRs: No. Date: 06Jul2021. Miscarriage: Additional information: Miscarriage due to bleeding. Confounding factors: COVID-19 vaccine exposure during pregnancy week: 0. Previous COVID-19 infection: No. Diagnostic procedures: Echo. Follow-up: 31Aug2021 Received follow-up: At 7 weeks of pregnancy. I received the second vaccination at 5 weeks of pregnancy. I indicated this and the advice was a vaccination. Miscarriage stop date: 23Aug2021.


VAERS ID: 1717624 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-08-01
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101155564

Write-up: SPONTANEOUS ABORTION; MENSTRUAL CYCLE ABNORMAL; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-PASRAPP-2021-Ud2q51. A 38-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for Injection, Batch/Lot Number: unknown), via intramuscular route of administration, administered in arm left on 28Jun2021 at 20:00 as dose 1, single for vaccination. The patient medical history was not reported. The patient concomitant medication included folic acid taken for an unspecified indication, start and stop date were not reported. The patient experienced menstrual cycle abnormal on an unspecified date in 2021, spontaneous abortion (medically significant) on 01Aug2021. Contact with healthcare professionals: Physician. The reporter reported that she was not sure if the adverse reaction was caused by the vaccine, but that she had a menstrual cycle abnormal compared to usual. The reactions/case was considered to be serious due to (other serious (important medical events)). Outcome of the event menstrual cycle abnormal was unknown and spontaneous abortion was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724333 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-08-01
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Maternal exposure before 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: FIPFIZER INC202101167213

Write-up: Heavy menstrual bleeding; Miscarriage; Vaccine exposure before pregnancy; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20214397. A 23-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in the right upper arm on May2021 (Batch/Lot Number: UNKNOWN) as dose 1, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 01Aug2021, the patient experienced heavy menstrual bleeding, miscarriage and vaccine exposure before pregnancy. The patient reported that she received the first dose in May2021 after which she got pregnant. She had a miscarriage on week 6+ and she have never before had a miscarriage. She added that currently her period is totally bloody big and they have never before been this big. She was very upset because she possibly can never make babies because of this vaccine and the period will be directly from hell. The vaccine will spoil many young peoples lives. She will not take the second vaccine and will not recommend it to anyone else either. The outcome of the events was not recovered. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1750940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Blood test, Maternal exposure during pregnancy, Pain, SARS-CoV-2 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), 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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:UNKNOWN; Comments: monitoring my current hcg levels. result UNKNOWN; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225008

Write-up: Miscarriage; Bleed continuous for 2 weeks with severe pain; Bleed continuous for 2 weeks with severe pain; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109161743325140-0ZYDF, Safety Report Unique Identifier GB-MHRA-ADR 25954472. A 36-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Lot number FD8813), via an unspecified route of administration on 30Jul2021 as dose 2, single for covid-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing. Patient no longer pregnant at the time of reporting. Concomitant medication(s) included folic acid taken for Folic acid supplementation, start and stop date were not reported, Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. On an unspecified date in Aug 2021 patient experienced bleed continuous for 2 weeks with severe pain, maternal exposure during pregnancy medically significant, on 02Aug2021 miscarriage. Seriousness criteria for all events was medically significant. The patient underwent lab tests which included COVID-19 virus test: no - negative covid-19 test. blood tests monitoring my current hcg levels result unknown. The clinical course was reported as follows: Started bleeding 4 days after the 2nd dose of Pfizer. bleed continuous for 2 weeks with severe pain, which led to hospital investigation and ongoing blood tests. Was discovered that we had lost our baby and the blood tests are monitoring my current hcg levels. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Did the medicine have an adverse effect on any aspect of the pregnancy: Yes. Pregnancy adverse effects details: 3 days after 2nd vaccine, extreme pain and bleeding led to losing baby. Details of previous pregnancies: First child. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Regular blood tests and hospital investigation still ongoing. Suspect Reactions Please provide details of any relevant investigations or tests conducted: "Blood tests and scans". Verbatim RA medical history: Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. The outcome for bleed continuous for 2 weeks with severe pain and pain was recovering and for miscarriage it was recovered with sequelae on unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1783372 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: First pregnancy; Comments: The patient had no other reported health issues
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: Ultrasound uterus; Result Unstructured Data: Test Result:embryo was assessed dead in week 7+4
CDC Split Type: DKPFIZER INC202101298547

Write-up: The patient started bleeding, at ultrasound it was assessed that the patient had aborted and the embryo was assessed dead in week 7+4; The patient felt different compared to her first pregnancy, she felt something was wrong; This is a spontaneous report from a contactable consumer (patient) downloaded from a regulatory authority-WEB, regulatory authority number is DK-DKMA-WBS-0088724. Safety Report Unique Identifier is DK-DKMA-ADR 25967185. A 32-year-old pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FD4555; Expiration Date: 30Sep2021), via an unspecified route of administration on 04Aug2021 as dose 2, single for COVID-19 immunization. Medical history included first pregnancy, she had no other reported health issues. Concomitant medications were not reported. Historical vaccine included dose 1 of COMIRNATY (Lot Number: FC1433; Expiration Date: 31Oct2021), received on 07Jul2021 for COVID-19 immunization. In Aug2021, the patient was feeling unwell, and on 29Aug2021 the patient experienced a spontaneous abortion. The events were reported as serious per other medically important condition. The mother underwent therapeutic abortion. The fetal outcome was intrauterine death. The patient underwent lab tests and procedures which included ultrasound uterus: embryo was assessed dead in week 7+4 on 29Aug2021. The events were reported as follows: The patient was in gestation week 3+5 or 3+6 when she received the second vaccine. The patient felt different compared to her first pregnancy, she felt something was wrong. The patient started bleeding, at ultrasound it was assessed that the patient had aborted, and the embryo was assessed dead in week 7+4. Spontaneous abortion was assessed medically significant by the a regulatory authority due to abortion spontaneous being on the IME list. The patient was treated with a medically induced abortion. The outcome of the event feeling unwell was recovered on an unspecified date in 2021, while outcome of spontaneous abortion was reported as not recovered. No follow up attempts are possible. No further information is expected.


VAERS ID: 1798869 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-08-01
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: Gynaecological examination; Result Unstructured Data: Test Result: confirmed the pregnancy at week 8; Comments: but without fetal heart rate; Test Date: 202107; Test Name: Pregnancy test; Test Result: Negative; Test Date: 20210802; Test Name: Pregnancy test; Test Result: Positive.
CDC Split Type: CZPFIZER INC202101322732

Write-up: Missed abortion; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB, regulatory authority number CZ-CZSUKL-21008222. A 40-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 05Jul2021 (Lot Number: FA4598) as dose 2, single for covid-19 immunisation. patient medical history was not reported. There were no concomitant medications. The patient experienced missed abortion on an unspecified date in Aug2021. The patient previously received first dose of bnt162b2 (COMIRNATY) on 24May2021 for COVID-19 immunisation. The patient was 8 weeks pregnant at the onset of the event. The patient was due to deliver on 10Mar2022. The fetal outcome was intrauterine death. The patient underwent lab tests and procedures which included gynaecological examination: confirmed the pregnancy at week 8, but without fetal heart rate on 04Aug2021, pregnancy test: negative in Jul2021, pregnancy test: positive on 02Aug2021. The outcome of the event was unknown. The clinical course was reported as follows: The patient has always had regular periods. After the 1st dose, she still menstruated on June 3, 2021. Then no more. The patient took a pregnancy test (07/2021), the result was negative. The next menstruation was to come at the end of July, it did not appear. On August 2, 2021, the patient underwent a pregnancy test again, and the result was positive. On August 4, 2021, the patient was examined at gynecology, and the doctor confirmed the pregnancy at week 8, but without fetal heart rate. No follow up attempts are possible. No further information is expected.


VAERS ID: 1803005 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-29
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Biopsy fetal; Test Result: Inconclusive ; Result Unstructured Data: achelles biopsy: unknown; Test Date: 2021; Test Name: Biopsy placenta; Test Result: Inconclusive ; Result Unstructured Data: unknown
CDC Split Type: DKMODERNATX, INC.MOD20213

Write-up: Maternal exposure during pregnancy, second trimester; Missed abortion at gestation age 12+5 weeks, confirmed on 26Sep2021; This case was received (Reference number: DK-DKMA-ADR 26022037) on 12-Oct-2021 and was forwarded to Moderna on 12-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of ABORTION MISSED (Missed abortion at gestation age 12+5 weeks, confirmed on 26Sep2021) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, second trimester) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 immunisation. No Medical History information was reported. On 29-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In August 2021, the patient experienced ABORTION MISSED (Missed abortion at gestation age 12+5 weeks, confirmed on 26Sep2021) (seriousness criterion medically significant). On 29-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, second trimester) (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. Patient Missed abortion at gestation age 12+5 weeks and was confirmed on 26Sep2021. On 29-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, second trimester) had resolved. At the time of the report, ABORTION MISSED (Missed abortion at gestation age 12+5 weeks, confirmed on 26Sep2021) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy foetal: achelles biopsy: unknown (Inconclusive) achelles biopsy: unknown. In 2021, Biopsy placenta: unknown (Inconclusive) unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medication were provided This case of maternal exposure during pregnancy, second trimester rconcerning a 33-year-old, female patient with no reported medical, obstetric or gynecological history, who experienced the unexpected event of missed abortion. The event occurred at 12+5 weeks, confirmed on gestational age of fetus. The patient received the first dose of vaccine within second trimester of pregnancy. LMP was not provided. Spontaneous abortion occurred on an unknown date after the first dose of Spikevax. Causality assessment with product use was not provided by the reporter. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case of maternal exposure during pregnancy, second trimester rconcerning a 33-year-old, female patient with no reported medical, obstetric or gynecological history, who experienced the unexpected event of missed abortion. The event occurred at 12+5 weeks, confirmed on gestational age of fetus. The patient received the first dose of vaccine within second trimester of pregnancy. LMP was not provided. Spontaneous abortion occurred on an unknown date after the first dose of Spikevax. Causality assessment with product use was not provided by the reporter. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1826934 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-08-01
   Days after vaccination:164
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Ultrasound uterus; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: NLPFIZER INC202101370070

Write-up: As a result, had a miscarriage on 04Sep2021; menstrual irregularities; a lot of blood loss; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB NL-LRB-00695302. A 30-year-old female patient received bnt162b2 (COMIRNATY, strength: 0.3 ml), via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation; and ethinylestradiol, levonorgestrel (tablet 20/100ug), via an unspecified route of administration from May2021 (Batch/Lot Number: Unknown) to 01Sep2021, at 1x a day for an unspecified indication. The patient''s medical history and concomitant medications were not reported. No previous COVID-19. The patient previously received Comirnaty (COVID-19 vaccine Pfizer solution for injection, strength: 0.3 ml, Batch/lot number: Unknown) on 24Jan2021 at dose 1 for COVID-19 immunisation with no adverse event. On 01Aug2021 (5 months after start of vaccination), patient had menstrual irregularities (menstruation irregular) and a lot of blood loss/menorrhagia (heavy menstrual bleeding). The patient reported she became pregnant while taking bnt162b2 and ethinylestradiol, levonorgestrel (as reported). The pregnancy resulted in spontaneous abortion. Irregular menstrual cycle (Information other or disabling information: a lot of blood loss. As a result, had a miscarriage on 04Sep2021 (6 months after start of vaccination). Irregular menstrual cycle and menorrhagia were treated with a check-up obstetrician and gynecologist. Reported action taken was finished the cure. Patient had vaccination before pregnancy. The pregnancy duration at time of the miscarriage was unknown. The COVID vaccinations took place 7 months before the miscarriage (as reported). The patient underwent lab tests and procedures which included ultrasound of the uterus: with unknown results on unspecified date. The action taken in response to the events for ethinylestradiol, levonorgestrel was post therapy. The patient was recovering from irregular menstrual cycle and menorrhagia. Reporter Comment: BioNTech/Pfizer vaccin (Comirnaty): Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes. ADRs: No. Date: 24Jan2021. ETHINYLESTRADIOL/LEVONORGESTREL: Action Taken: Finished the cure. Irregular menstrual cycle: Information CIOMS other or disabling information: a lot of blood loss. Additional information ADR: As a result, had a miscarriage on 04Sep2021. COVID19: Previous COVID-19 infection: No. Other: diagnostic procedures: ultrasound of the uterus. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes. ADRs: No. Date: 24Jan2021. Additional information on ADR available COVID19: Previous COVID-19 infection: No. Other: diagnostic procedures: ultrasound of the uterus.


VAERS ID: 1829979 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: Ultrasound uterus; Result Unstructured Data: Test Result: the embryo was 3 mm and had no cardiac activity; Test Date: 20210923; Test Name: Ultrasound uterus; Result Unstructured Data: Test Result: confirmed the fact that the embryo had stopped..; Comments: ..its development at 6 weeks of amenorrhea
CDC Split Type: FRPFIZER INC202101453140

Write-up: Maternal exposure during pregnancy, first trimester; Embryo had stopped its development at 6 weeks of amenorrhea; No cardiac activity; This is a spontaneous report from a contactable consumer (parent) downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-NT20214727. This consumer reported events for the mother and fetus/baby. This is the 3rd of three reports. A fetus patient of an unspecified gender received BNT162B2 (COMIRNATY; solution for injection; lot number: FE8235), via transplacental route (received intramuscularly by the mother) on 13Aug2021 (gestation period at exposure: 5 weeks) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY; solution for injection) via transplacental route on 23Jul2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The mother was a 35-year-old female with history of hypersensitivity, asthma, Widal''s disease, NSAIDs allergy, and nasal polyp with nasal polyp surgery. The mother''s gestation period at the time of events was 6 weeks. Her last menstrual period was on 05Jul2021 and her expected due date would''ve been on 11Apr2022. On 02Aug2021, between doses, the patient''s mother''s pregnancy was diagnosed. Her date of last menstruation was on 05Jul2021. At this time, vaccination in the first trimester was already authorized. On 13Aug2021, the patient experienced maternal exposure during pregnancy, first trimester. On 16Sep2021, at almost 11 weeks of amenorrhea, after brown discharge, an ultrasound was performed which revealed that the embryo was 3 mm and had no cardiac activity. On 23Sep2021, a second ultrasound confirmed the fact that the embryo had stopped its development at 6 weeks of amenorrhea (Aug2021). Following the ultrasound on 23Sep2021 which confirmed the diagnosis, a first medical pregnancy termination was performed on the mother on 25Sep2021 then another on 28Sep2021 since the first was not enough to expel the sac were carried. The patient died in Aug2021 due to "embryo had stopped its development at 6 weeks of amenorrhea" and "no cardiac activity". It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101436699 master case, maternal case regarding events after 2nd dose; FR-PFIZER INC-202101453139 maternal case regarding events after 1st dose; Reported Cause(s) of Death: No cardiac activity; Embryo had stopped its development at 6 weeks of amenorrhea


VAERS ID: 1834418 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101391028

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the regulatory authority-WEB:FI-FIMEA-20215602. A 34-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via intramuscular on 13Aug2021 (Batch/Lot Number: FF4213) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced miscarriage about a couple of weeks after the first vaccine (Aug2021). The patient recovered from the event. The patient received the second dose of the vaccine on 05Oct2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1845643 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-08-01
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Chromosomal analysis, Foetal exposure during pregnancy, Human chorionic gonadotropin, Hydrops foetalis, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Protein total, Ultrasound antenatal screen
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), Medication errors (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOMID; PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: Chromosomal analysis; Result Unstructured Data: Normal; Test Date: 20210825; Test Name: Blood human chorionic gonadotrophin; Result Unstructured Data: 21.30 IU/L; Test Date: 20210825; Test Name: plasma protein A; Result Unstructured Data: 3701.00 mIU/L Pregnancy-associated; Test Date: 20210825; Test Name: Foetal nuchal translucency ultrasound; Result Unstructured Data: 1.2 mm
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Foetal exposure during pregnancy; Maternal Exposure during pregnancy; Miscarriage; Inappropriate schedule of vaccine administered; Hydrops foetalis; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26128944) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of HYDROPS FOETALIS (Hydrops foetalis), ABORTION SPONTANEOUS (Miscarriage) and FOETAL EXPOSURE DURING PREGNANCY (Foetal exposure during pregnancy) in a 38-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Non-smoker. Concomitant products included CLOMIFENE CITRATE (CLOMID) and PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;IRON;MAGNESIUM;NICOTINAMIDE;PHYTOMENADIONE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;SELENIUM;THIAMINE MONONITRATE;TOCOPHERYL for an unknown indication. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient''s last menstrual period was on 06-Jun-2021 and the estimated date of delivery was 13-Mar-2022. In August 2021, the patient experienced HYDROPS FOETALIS (Hydrops foetalis) (seriousness criteria medically significant and congenital anomaly). On 28-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 30-Aug-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria medically significant and congenital anomaly). On an unknown date, the patient experienced FOETAL EXPOSURE DURING PREGNANCY (Foetal exposure during pregnancy) (seriousness criterion congenital anomaly) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal Exposure during pregnancy). The patient received mRNA-1273 (Moderna CoviD-19 Vaccine) beginning around the eleventh week of the pregnancy. The delivery occurred on 30-Aug-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 28-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 30-Aug-2021, ABORTION SPONTANEOUS (Miscarriage) had resolved. At the time of the report, HYDROPS FOETALIS (Hydrops foetalis) had not resolved and FOETAL EXPOSURE DURING PREGNANCY (Foetal exposure during pregnancy) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal Exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Human chorionic gonadotropin: 21.30 iu/l 21.30 IU/L. On 25-Aug-2021, Protein total: 3701.00 miu/l 3701.00 mIU/L Pregnancy-associated. On 25-Aug-2021, Ultrasound antenatal screen: 1.2 mm 1.2 mm. On an unknown date, Chromosomal analysis: normal (normal) Normal. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The first vaccination was given on 5th June. The patient started having some abdominal pain and noticed bleeding and went in to get a scan where it was confirmed the baby had died and showed evidence of fetal hydrops, this was not evident on the 12 week scan. The Early Pregnancy Unit stated the baby had died not less than a week ago 1st Sept. Any problems with the foetus identified before or after the pregnancy loss the patient had two early pregnancy scans at 6.5 (21st july) and 9 weeks (10th August), the harmony blood test and scan at 10.5 weeks (18th August) and a 12 week dating scan at 11 weeks 3 days (25th August) which moved my estimated due date to 8th march 2022 from 13th March 2022. The patient also had the three trisomy screening for trisomy 21, 18 and 13. All scans were normal and both the harmony test and the trisomy screening all returned low risk and normal. Company Comment: This case concerns a 38 year old female with no reported medical history , who experienced the Serious , unexpected event of Hydrops fetalis which occurred at an unknown date in Aug 2021 after vaccination with the 2nd dose of mRNA-1273 (Moderna Covid 19 vaccine ) , Abortion ( 12 weeks AOG) and Fetal exposure during pregnancy occurred 2 days after vaccination with the 2nd dose. Additional event of Inappropriate Schedule of Drug Administered was also coded for this case. This patient was exposed to mRNA -1273 (Moderna Covid 19 vaccine) The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna Covid 19 vaccine ) is not affected by this report.Per medical reviewer''s assessment the event fetal exposure during pregnancy should be maternal exposure during pregnancy. This case was linked to GB-MHRA-WEBCOVID-202109160936520010-LVWRC (E2B Linked Report).; Sender''s Comments: This case concerns a 38 year old female with no reported medical history , who experienced the Serious , unexpected event of Hydrops fetalis which occurred at an unknown date in Aug 2021 after vaccination with the 2nd dose of mRNA-1273 (Moderna Covid 19 vaccine ) , Abortion ( 12 weeks AOG) and Fetal exposure during pregnancy occurred 2 days after vaccination with the 2nd dose. Additional event of Inappropriate Schedule of Drug Administered was also coded for this case. This patient was exposed to mRNA -1273 (Moderna Covid 19 vaccine) The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna Covid 19 vaccine ) is not affected by this report.Per medical reviewer''s assessment the event fetal exposure during pregnancy should be maternal exposure during pregnancy. GB-MHRA-WEBCOVID-202109160936520010-LVWRC:


VAERS ID: 1629720 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-18
Onset:2021-08-02
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033C21A / 2 LA / IM

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

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

Write-up: Late July 2021 I had a bartholin gland infection and also a miscarriage around 6 weeks the first/second week of August. The bartholin gland infection required antibiotic treatment and an incision to drain. I don''t think either of these are related to the vaccine, I just noted these issues because the questionnaire asked about health issues that I have experienced since my last check in, so I''m filling out the report as requested. I have fully recovered from both issues.


VAERS ID: 1625717 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Headache, 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: DULOXETINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Echo; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC202101016956

Write-up: Miscarriage; Headache; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00655086. A 33-year-old female patient received 2nd single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT/Batch number: FE4728, expiration date unknown) via an unspecified route of administration on 01Aug2021 at 0.3 mL for COVID-19 immunisation. Medical history was not reported. Concomitant medications included duloxetine. Patient previously received 1st single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT/Batch number and expiration date unknown) on 25Jun2021 for COVID-19 immunization and the first Covid vaccination took place before pregnancy. Patient had no previous COVID-19 infection. Other diagnostic procedures was Echo with unknown results. The patient experienced miscarriage (other medically important condition) on 02Aug2021, headache on 02Aug2021. This was the second Covid vaccination, which took place at a pregnancy duration of about 4 weeks. The miscarriage occurred 1 day after this vaccination. The first Covid vaccination took place before pregnancy. Headache was treated with unknown treatment. Outcome of miscarriage was unknown, of headache was not recovered. No follow-up attempts are possible; no further information expected.


VAERS ID: 1634104 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-08-02
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown; Comments: Blood test every other day to check levels are lowering; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101040717

Write-up: bleeding; Foetal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108111239567850-PAHJF, Safety Report Unique Identification Number: GB-MHRA-ADR 25784296. A 30-years-old female patient received bnt162b2 ( PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 30Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing, vitamin supplementation from an unknown date and unknown if ongoing. Concomitant medication(s) included folic acid taken for vitamin supplementation, start and stop date were not reported. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. On an unspecified date, the patient experienced bleeding and fetal exposure during pregnancy. On 02Aug2021, the patient experienced miscarriage (abortion spontaneous). It was reported that Bleeding on the 2nd August, went to A n E. The blood tests showed as pregnant. Levels at 118. The scan showed no baby in the womb so had miscarried. Child was exposured to the medicine: first-trimester (1-12 weeks). Patient was exposed to the medicine first-trimester (1-12 weeks). Had the vaccine at 5 weeks pregnant. Miscarried at 8-10 weeks pregnant. Details of previous pregnancies included one previous pregnancy. Full time. No problems. The patient''s hospitalization was prolonged as a result of bleeding. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included blood test: unknown Blood test every other day to check levels are lowering, sars-cov-2 test: no - negative covid-19 test on an unknown dates. The clinical outcome of the events bleeding was unknown and miscarriage was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1634324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-08-02
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:No heartbeat of baby
CDC Split Type: GBPFIZER INC202101069399

Write-up: Maternal exposure during pregnancy; miscarriage / early miscarraige; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108171728557980-VHYXI. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Fa1027, expiry date: not reported), dose 1 via an unspecified route of administration on 16Jun2021 as single dose for covid-19 immunisation. Medical history included pregnancy, Patient no longer pregnant at the time of reporting. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation. On 02Aug2021, the patient experienced early miscarriage/ miscarriage. On an unspecified date, the patient experienced maternal exposure during pregnancy. Additional information as reported: Got pregnant. The mother reported she became pregnant while taking bnt162b2. Had vaccine 1/2 after Had early miscarriage 8 weeks after. The mother was 1 Trimester pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. It was unsure if the medicine had an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). On an unspecified date, the patient underwent lab tests and procedures which included scan: no heartbeat. The baby died on an unspecified date. The autopsy was bit performed. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1642161 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-08-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101054006

Write-up: Pregnancy loss <20 weeks gestation/miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB with regulatory authority report number FR-AFSSAPS-RS20212625. A 26-year-old pregnant female patient received the first dose of BNT162B2 (COMIRNATY, lot number and expiry date unknown), intramuscularly administered in arm left on 19Jul2021 as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. SARS-CoV-2 test was negative on 10Jul2021. 19Jul2021: dose 1 of COMIRNATY. 2 weeks later, on 02Aug2021, the patient experienced pregnancy loss <20 weeks gestation/miscarriage. Additional information obtained by the regulatory authority: date of last menstrual period: 23Jun2021. Delivery due date: 30Mar2022. Due date at the time of miscarriage: 5 weeks and 5 days of amenorrhea. In total, miscarriage at 5.7 weeks of pregnancy 2 weeks after dose 1 COMIRNATY in a 26-year-old woman. Gestation period when reaction/event was observed in the foetus: 5.7 week. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The outcome of the event was not recovered. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1698154 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004672 / 1 LA / OT

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

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

Write-up: Metrorrhagia; maternal exposure during pregnancy; This case was initially received via regulatory authority.(Reference number: ES-AEMPS-987981) on 03-Sep-2021. The most recent information was received on 03-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABORTION and INTERMENSTRUAL BLEEDING (Metrorrhagia) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 3004672) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 24-Aug-2021, the patient experienced ABORTION (seriousness criterion medically significant) and INTERMENSTRUAL BLEEDING (Metrorrhagia) (seriousness criterion medically significant). The delivery occurred , which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. Gestation Period: 10.1 weeks. On 02-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION and INTERMENSTRUAL BLEEDING (Metrorrhagia) was resolving. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 02-Aug-2021. Concomitant product use was not provided by the reporter. ?No treatment information was provided. Company Comment: This is a case of Maternal exposure during pregnancy with associated AEs for this unknown age female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Translation received includes dosage text and reaction/event as reported by primary source translated; Sender''s Comments: This is a case of product exposure during pregnancy with associated AEs for this female of unknown age. 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: 1724146 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-08-02
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9234 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101166551

Write-up: Missed abortion in 9th week of pregnancy; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number DE-PEI-CADR2021162115, with Safety report unique identifier DE-PEI-202100167155. A 34-year-old female patient received BNT162B2 (COMIRNATY 0.3 mL), via an unspecified route of administration on 16Jun2021 (Batch/Lot Number: FD9234) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced missed abortion in 9th week of pregnancy on 02Aug2021. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. Scrapping of the dead fetus was performed. The outcome of event was unknown. This report is serious - hospitalization. Relatedness Assessment of event Abortion missed was D. Unclassifiable (Source of assessment: Agency). Sender Comment: Missed abortion, scrapping of the dead fetus


VAERS ID: 1742266 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Intermenstrual bleeding, Physical examination, Ultrasound scan vagina
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: Pfizer, Inc. EUA 027034
Current Illness: Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial insemination; COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: obstetrics; Result Unstructured Data: Test Result:unknown; Test Date: 2021; Test Name: Echography transvaginal; Result Unstructured Data: Test Result:uterus in anterovertinflexion with 25mm vgiu; Comments: embryo inside 13mm. heartbeat negative; Test Date: 20210731; Test Name: Echography transvaginal; Result Unstructured Data: Test Result:regular uterus with anterovertinflexion with VGIU; Comments: embryo with Cephalo-caudal length 14mm. positive heartbeat
CDC Split Type: ESPFIZER INC202101193721

Write-up: Miscarriage; Metrorrhagia; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. Regulatory authority number is ES-AEMPS-992584. This consumer reported information for both mother and fetus. This is a maternal report. A 38-year-old female patient received first dose of BNT162B2 (COMIRNATY; Lot Number: FE6208), intramuscular on 12Jul2021 as dose 1, single and second dose of BNT162B2 (COMIRNATY; Lot Number: FE8405) intramuscular in left arm on 02Aug2021 as dose 2, single for COVID-19 immunization. Medical history included artificial insemination in 03Jun2021, COVID-19 and ongoing hypothyroidism. Concomitant medication included levothyroxine sodium (T4) taken for hypothyroidism. The patient experienced metrorrhagia (medically significant) on 02Aug2021 and miscarriage (medically significant) on 04Aug2021. The patient reported she became pregnant while taking BNT162B2. The mother was 9 Weeks pregnant at the onset of the event. The patient underwent lab tests and procedures which included physical examination on an unspecified date in 2021 and the result was unknown, Echography transvaginal on an unspecified date in 2021: uterus in anterovertinflexion with 25mm VGIU, embryo inside 13mm. heartbeat negative. Echography transvaginal performed on 31Jul2021 showed regular uterus with anterovertinflexion with VGIU; embryo with Cephalo-caudal length 14mm. positive heartbeat. The events resulted in emergency room visit. Outcome of events Metrorrhagia was resolved on an unspecified date. Outcome of Miscarriage was unknown. It was reported that after explaining diagnostic and treatment the patient wants a medical treatment abortion. They send her Cytotec, enantyum, gamma globulin (prescribed) and analgesia. On the day of this report, she went to obstetrics for control and decide treatment 31Aug2021 cited for control of first trimester. Patient said that she has lost it. Patient said that physically she was fine. But she is accepting it. Already had menstruation. She is going to try it again with assisted reproduction the next month to attempt a new pregnancy.


VAERS ID: 1769202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-08-02
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Ultrasound scan vagina
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: Ultrasound scan vagina; Result Unstructured Data: Test Result:fetus in blighted ovum, gestation age 8+5; Comments: no fetal heartbeat; Test Date: 20210816; Test Name: Ultrasound scan vagina; Result Unstructured Data: Test Result:No fetus present
CDC Split Type: DKPFIZER INC202101285275

Write-up: Spontaneous abortion/early abortion week 8+5; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number DK-DKMA-WBS-0085049. This physician reported information for both mother and fetus. This is a mother report. A 40-year-old female patient received bnt162b2 (COMIRNATY) dose 1 intramuscular on 28Jun2021 (Lot Number: FE2090; Expiration Date: 30Sep2021) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was vaccinated during pregnancy at week 3+5 on 28Jun2021. The patient experienced spontaneous abortion/early abortion week 8+5 on 02Aug2021 with outcome of not recovered. The mother was 9 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Due to a scan on 12Aug2021 the fetus had stopped growing in gestation week 8+5 on 02Aug2021. No treatment due to the ADRs was reported. 2nd vaccine dose was given on 16Aug2021. Test results: Ultrasound scan vagina, 12Aug2021: fetus in blighted ovum, gestation age 8+5. no fetal heartbeat. Ultrasound scan vagina, 16Aug2021: No fetus present. Causality: The reporter states that the patient age increases different risk factors related to spontaneous abortion. The patient did not know she was pregnant at the time of her first vaccination with Comirnaty. No follow up attempts possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DK-PFIZER INC-202101321374 mother/baby cases


VAERS ID: 1736946 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-16
Onset:2021-08-03
   Days after vaccination:109
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Condition aggravated, Trisomy 13, Uterine dilation and curettage
SMQs:, Congenital, familial and genetic 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 vitamins, proair, singular
Current Illness: none
Preexisting Conditions: Miscarriage at 10 weeks due to Trisomy13
Allergies: none
Diagnostic Lab Data: D&C
CDC Split Type:

Write-up: Miscarriage at 10 weeks due to Trisomy13


VAERS ID: 1571105 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: spotting; pain; Maternal exposure during pregnancy; fetal death; This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FOETAL DEATH (fetal death) and VAGINAL HAEMORRHAGE (spotting) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Aug-2021, the patient experienced FOETAL DEATH (fetal death) (seriousness criterion medically significant). On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (spotting) (seriousness criterion medically significant), PAIN (pain) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. Pregnant for 2 months. The patient was treated with Surgery (Procedure to remove fetus) for Foetal death. At the time of the report, FOETAL DEATH (fetal death), VAGINAL HAEMORRHAGE (spotting) and PAIN (pain) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided. The patient had received the first dose of the Moderna vaccine a week before the patient got pregnant. The patient visited the gynecologist three to four times already and blood samples were drawn from the patient. On an unknown date, the heart of the fetus stopped beating. Later, the patient would undergo a procedure for extraction of the dead fetus. Company comment: This is a case of product exposure during pregnancy with an associated adverse events. Based on temporal association a causal relationship cannot be excluded. The patient had received the first dose of the Moderna vaccine a week before the patient got pregnant. Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Live follow up : additional event of pain; Sender''s Comments: This is a case of product exposure during pregnancy with an associated adverse events. Based on temporal association a causal relationship cannot be excluded. The patient had received the first dose of the Moderna vaccine a week before the patient got pregnant.


VAERS ID: 1634338 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-03
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Investigation, 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: Pregnancy (Estimated due date: 20220226)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: scans or investigations; Result Unstructured Data: Test Result:missed; Comments: Missed miscarriage diagnosed; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101034132

Write-up: Early miscarriage; This is a solicited report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-YCVM-202108110730369300-YIMNS, Safety Report Unique Identifier GB-MHRA-ADR 25782987. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01Jul2021 (Lot Number: FD5613) as single dose; dose 1 via an unspecified route of administration on 25May2021 (Lot Number: ET8885) as single dose for COVID-19 vaccination. Medical history included ongoing pregnancy (as reported) Estimated due date: 26Feb2022. Concomitant medications included folic acid taken for folic acid supplementation. The patient experienced maternal exposure during pregnancy (First pregnancy) and early miscarriage on 03Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative, scans or investigations: Missed miscarriage diagnosed. Patient was not enrolled in clinical trial. The outcome of event was unknown. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1669101 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-03
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 11935933 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Menstruation delayed, Myalgia, Nausea, Pregnancy test, Uterine spasm
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Pregnancy test; Test Result: Negative ; Test Name: Pregnancy test; Test Result: Positive
CDC Split Type: NLPFIZER INC202101055308

Write-up: then miscarriage: Pregnancy test negative first, then positive. 2 days ago miscarriage.; Nausea; heavy legs/muscle pain; terrible cramps in the uterus; Fatigue; No period: 25 days late; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00658150. A 40-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 26Jul2021 (Lot Number: 11935933) as Dose 2, single for covid-19 immunisation. Medical history was unknown. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 21Jun2021 for COVID-19 immunization and experienced short menstruation and Maternal Exposure During Pregnancy, first trimester. The patient experienced then miscarriage: pregnancy test negative first, then positive. 2 days ago miscarriage on 04Aug2021, nausea on 04Aug2021, heavy legs/muscle pain on 04Aug2021, no period: 25 days late (menstruation delayed) on 03Aug2021, terrible cramps in the uterus on 04Aug2021, fatigue on 04Aug2021. Clinical course reported as: This patient had a delayed menstruation, after which the pregnancy test was positive. The second covid vaccination took place at a pregnancy duration of about 6 weeks, and a miscarriage occurred at a pregnancy duration of about 7+2 weeks. Outcome of Miscarriage was unknown, other events was recovering Event Miscarriage was reported as serious medically significant. Sender Comment: Since the nature of (some of) the reported reactions does imply seriousness according to one of the HA critera, the report was considered as serious by the regulatory authority. Reporter''s Comments - BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: A shortened menstrual period Date: 21Jun2021 - Absence of menstruation and subsequent miscarriage Additional information ADR: 25 days late. Pregnancy test negative first, then positive. 2 days ago miscarriage. Tired, nauseous, heavy legs / muscle pain, terrible cramps in the uterus- confounding factors. COVID-19 vaccine exposure during pregnancy week: 1.5 months. - COVID-19. Previous COVID-19 infection: No No follow-up attempts possible. No further information expected.; Reporter''s Comments: - BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: A shortened menstrual period Date: 21Jun2021 - Absence of menstruation and subsequent miscarriage Additional information ADR: 25 days late. Pregnancy test negative first, then positive. 2 days ago miscarriage. Tired, nauseous, heavy legs / muscle pain, terrible cramps in the uterus- confounding factors. COVID-19 vaccine exposure during pregnancy week: 1.5 months. - COVID-19. Previous COVID-19 infection: No


VAERS ID: 1671532 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101086838

Write-up: Early miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB FR-AFSSAPS-TO20216806. A 34-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 29Jul2021 (Batch/Lot Number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 03Aug2021, the patient experienced early miscarriage. The spontaneous miscarriage was in early pregnancy (1st trimester, without further details). The outcome of the event was unknown. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.


VAERS ID: 1701251 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion induced, Blood pressure measurement, Body temperature, Exposure during pregnancy, Oligohydramnios, Premature rupture of membranes, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Name: body temperature; Result Unstructured Data: Test Result:apyretic
CDC Split Type: ESPFIZER INC202101174679

Write-up: Premature rupture of membranes; severe oligoamnion/This situation supposes a pregnancy classified as "unviable" by not having amniotic fluid; Drug exposure during pregnancy, second trimester/in the 20th week of gestation; Abortion/A legal pregnancy interruption was carried out 16Aug2021 without incident; Bleeding vaginal/Slight bleeding; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB ES-AEMPS-986657. A 35-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 03Aug2021 (Lot Number: FF2752, at the age of 35-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced drug exposure during pregnancy, second trimester on 03Aug2021, premature rupture of membranes on 04Aug2021, abortion on 16Aug2021, and bleeding vaginal on 16Aug2021. The clinical course was as follows: A 20 weeks pregnant woman who was admitted on 04Aug2021 due to premature rupture of membranes. Echo single fetus in breech position, positive fetal beat, normoinserted placenta, severe oligoamnion. Patient with the aforementioned history who was admitted after premature rupture of the membranes a week ago. She was in the 20th week of gestation. This situation supposes a pregnancy classified as "unviable" by not having amniotic fluid and not presenting the ideal conditions for the correct development of the fetus. The fetus was still alive but pregnancy and healthy development was unfeasible. A legal pregnancy interruption was carried out 16Aug2021 without incident. She was fine. Apyretic, Slight bleeding. No pain. On 16Aug2021, patient was put on anti-D immunoglobulin. Apyretic and normotensive. The patient underwent lab tests and procedures which included blood pressure: normal, body temperature: apyretic. All events was considered as life-threatening. The outcome of the events "Abortion/A legal pregnancy interruption was carried out 16Aug2021 without incident" and "Bleeding vaginal/Slight bleeding" was recovered on unspecified date in 2021, for other events was recovering.


VAERS ID: 1743321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-08-03
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101264041

Write-up: Myalgia; Not feeling well; Fatigue; Miscarriage; COVID-19 INTENSIVE MONITORING This is a Non-Interventional Study report from a contactable consumer (patient) which reported different events for both doses of Comirnaty for the same patient. This is the second of two reports. The first report was downloaded from the regulatory authority-WEB NL-LRB-COVID-00600554. A 31-years-old female patient received bnt162b2 (COMIRNATY, strength: 0.3 ml), dose 2 via an unspecified route of administration on 23Jul2021 (Batch/Lot Number: FF0688) as DOSE 2, SINGLE for covid-19 vaccination. The patient''s medical history was not reported. Concomitant medication included caffeine, paracetamol (PARACETAMOL/COFFEINE) taken for an unspecified indication from 01Jan2021 to an unspecified stop date. The patient previously received the first dose of bnt162b2 (COMIRNATY, Batch FC3098) on 18Jun2021 for covid-19 immunisation, and experienced abdominal discomfort, dizziness, concentration loss, chills, presyncope, malaise. The patient experienced miscarriage on 03Aug2021 with outcome of recovered on 05Aug2021, fatigue on 04Aug2021 with outcome of recovering, not feeling well on 07Aug2021 with outcome of recovering, myalgia on 08Aug2021 with outcome of not recovered. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts possible. No further information expected.; Sender''s Comments: As per available information, the causal association between the events miscarriage, fatigue, malaise and myalgia and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : NL-PFIZER INC-2021824958 same patient, different dose, different events


VAERS ID: 1743366 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-08-03
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101209460

Write-up: I was unaware that I was pregnant when i had the second dose, which was taken on the 30th of July 2021 and ended up having a miscarriage 4 days after I took the second shot.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (COMIRNATY, Lot Number: FD8274), via intramuscular, administered in Arm Left on 02Jul2021 at 14:00 at the age of 41-year-old as dose 1 single and second dose of BNT162B2 (COMIRNATY, Lot Number: FE4728), via intramuscular, administered in Arm Left on 30Jul2021 11:00 at the age of 41-year-old as dose 2 single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included vitamin d and folic acid taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient was unaware that she was pregnant when she received the second dose of BNT162B2 and ended up having a miscarriage 4 days after vaccination. The mother was 5 Weeks pregnant at the onset of the event and was due to deliver on 04Apr2022. The mother reported she became pregnant while taking bnt162b2. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1824116 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: Gynaecological examination; Result Unstructured Data: Scan, termination of pregnancy confirmed
CDC Split Type: DKMODERNATX, INC.MOD20213

Write-up: Spontaneous abortion; Maternal exposure during pregnancy; This case was received via the Agency (Reference number: DK-DKMA-ADR 25983094) on 20-Oct-2021 and was forwarded to Moderna on 20-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous abortion) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004959) for COVID-19 immunisation. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). On 17-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced ABORTION SPONTANEOUS (Spontaneous abortion) (seriousness criterion medically significant). The delivery was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 03-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Spontaneous abortion) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Gynaecological examination: termination (abnormal) Scan, termination of pregnancy confirmed. Concomitant product use was not provided by the reporter. ? No treatment information was provided. CC: This case concerns a 34-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of ABORTION SPONTANEOUS and MATERNAL EXPOSURE DURING PREGNANCY. The event of abortion spontaneous occurred approximately 17 days after receiving the second dose of Spikevax. No details were provided regarding gestation period. The rechallenge is not applicable. The benefit risk relation of Spikevax is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 34-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of ABORTION SPONTANEOUS and MATERNAL EXPOSURE DURING PREGNANCY. The event of abortion spontaneous occurred approximately 17 days after receiving the second dose of Spikevax. No details were provided regarding gestation period. The rechallenge is not applicable. The benefit risk relation of Spikevax is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting.


VAERS ID: 1578679 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-08
Onset:2021-08-04
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

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

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

Write-up: One month after receiving the vaccine I had a miscarriage. I saw an OBGYN who said I was healthy and had no concerns for future pregnancy prior to becoming pregnant. I also carried 2 children in the past which were both heathy Normal pregnancies.


VAERS ID: 1589634 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998827

Write-up: Dosage text: Dose 1, Date of start of drug: 25May2021; Dosage text: Dose 2, Date of start of drug: 31Jul2021; Miscarriage; This is a spontaneous report from a contactable consumer (Patient). This case pertained for second dose of vaccine: A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 31Jul2021 14:00 (Lot Number: Ff3319) as a single dose, for COVID-19 immunisation. There was no medical history. Concomitant medications were Oestrogen, progesterone, pregnancy supplement given within 2 weeks of vaccination. The patient experienced miscarriage on 04Aug2021 at 12:00 with outcome of not recovered, 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 07Apr2022. The mother delivered the pregnancy on 01Apr2022. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior and since the vaccination the patient was not diagnosed with COVID-19; Sender''s Comments: Linked Report(s) : 202101019455 different dose


VAERS ID: 1589645 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-08-04
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: GBPFIZER INC202101019455

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer (Patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW3143) via an unspecified route of administration, administered in left arm on 25May2021 at 12:45 pm as DOSE 1, SINGLE for COVID-19 immunization. Medical history included none. The patient''s concomitant medications included oestrogen, progesterone, pregnancy supplement. On 04ug2021 12:00, the patient experienced miscarriage. The mother reported she was pregnant while taking BNT162B2. The mother was 5 Weeks pregnant at the onset of the event. The mother was due to deliver on 07Apr2022. The mother was due to deliver on 01Apr2022. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested since the vaccination. The outcome of the event was not recovered.


VAERS ID: 1593414 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test, Ultrasound scan vagina
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; Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210220; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Test Name: Scan confirmed miscarriage; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC202101040989

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108110943098070-GWJA1, Safety Report Unique Identification Number: GB-MHRA-ADR 25783307. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on 31Jul2021 as 2nd dose, single for COVID-19 immunization. Patient''s medical history included suppressed lactation, pregnancy from an unknown date and unknown if ongoing, pregnancy and folic acid deficiency. Patient was no longer pregnant at the time of reporting, suspected COVID-19 from 20Feb2021 to 27Feb2021. No medical history to note. Patient is not currently breastfeeding. Patient''s concomitant medications included folic acid taken for vitamin supplementation, start and stop date were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported), via an unspecified route on an unknown date for covid-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced maternal exposure during pregnancy on an unspecified date and miscarriage on 04Aug2021. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included positive SARS-CoV-2 test yes-positive covid-19 test on 20Feb2021 and ultrasound scan vagina confirmed miscarriage on an unspecified date. The outcome of miscarriage was recovering, while outcome of another event was unknown. It was unsure if medicine have an adverse effect on any aspect of the pregnancy. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1634648 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-08-04
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: histopathology; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: PLPFIZER INC202101032810

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer received from Pfizer sponsored program. A female patient received 1st dose of BNT162B2 (COMIRNATY) on 23Jul2021 single dose for COVID-19 immunisation. Medical history and concomitant drugs were not provided. The patient wanted to postpone the second dose of vaccination because on 04Aug2021 a miscarriage was performed. The doctor did not indicate a link vaccine with miscarriage - he recommended to postpone the second vaccination until the results of the tests (histopathology) are known. The outcome of the event was unknown.


VAERS ID: 1640874 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: Internal ultrasound; Result Unstructured Data: Test Result:unknown result
CDC Split Type: BEPFIZER INC202101053899

Write-up: 2 days later miscarriage; 1 hour after puncture vaginal bleeding (7 weeks pregnant); This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-104257. A 30-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Aug2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. The patient''s medical history and patient''s concomitant medications were not reported. On 04Aug2021, 1 hour after puncture, the patient experienced vaginal bleeding (7 weeks pregnant) and 2 days later miscarriage (06Aug2021). However, on 03Aug2021 a vital pregnancy was detected. Examinations included internal ultrasound on 06Aug2021. Outcome of the events was not recovered. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1668367 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-08-04
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy (1st preg healthy, normal, 2nd preg (no longer pregnant at the time reporting,preg when vaccinated).)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101105437

Write-up: Early miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108250809169140-HJST9, Safety Report Unique Identifier GB-MHRA-ADR 25845116. This consumer reported information for both mother and baby. This is the maternal report. A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Jul2021 (Lot Number: FD3319) as single dose for COVID-19 immunisation. Medical history included lactation decreased; previous first pregnancy (first was entirely healthy and normal) and second pregnancy (the patient no longer pregnant at the time of reporting but was pregnant when vaccinated). Patient had not symptoms associated with COVID-19. Patient was not currently breastfeeding. Concomitant medications included folic acid taken as folic acid supplementation. Historical Vaccine included the first dose of BNT162B2 on an unknown date as single dose for COVID-19 immunisation. The patient experienced early miscarriage (medically significant) on 04Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test on an unspecified date: No - Negative COVID-19 test. The outcome of event early miscarriage was recovered on 09Aug2021. The clinical course was reported as follows: This was my second pregnancy. My first was entirely healthy and normal, my second I miscarried at 4+3 weeks. Patient was exposed to the medicine first-trimester (1-12 weeks). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1717284 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-08-04
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: Hashimoto''s thyroiditis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101155941

Write-up: Spontaneous abortion at 6 weeks + 4. First dose of Pfizer Covid-19 vaccine: 29Jun2021. Conception: 10Jul2021 Miscarriage: 04Aug2021; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority number is IT-MINISAL02-778643. A 31-year-old female patient received BNT162b2 (COMIRNATY), intramuscular, administered in right arm (also reported as right shoulder) on 29Jun2021 (Batch/Lot Number: FC5089) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient was pregnant at time of vaccination. Medical history included Hashimoto''s thyroiditis. The patient''s concomitant medications were not reported. Impact on quality of life was 10/10. The patient experienced spontaneous abortion at 6 weeks + 4 (as reported). First dose of Pfizer COVID-19 vaccine was on 29Jun2021; conception was on 10Jul2021 and miscarriage occurred on 04Aug2021. The event was considered serious (disability). The outcome of the event miscarriage was unknown. Reporter''s comment: Hashimoto''s thyroiditis with euthyroid function (therefore not in treatment with Levothyroxine on control and endocrinological opinion. In follow-up). Additional information on drug: Professional exposure. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Hashimoto''s thyroiditis with euthyroid function (therefore not in treatment with Levothyroxine on control and endocrinological opinion. In follow-up). Additional information on drug: Professional exposure.


VAERS ID: 1751352 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004492 / 1 LA / 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchial asthma; Drug allergy (Cefalosporine)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Maternal exposure during pregnancy; This case was received via a regulatory authority (Reference number: IT-MINISAL02-785401) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of ABORTION SPONTANEOUS in a 37-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004492) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Cefalosporine) and Bronchial asthma. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. Last menstrual period and estimated date of delivery were not provided. On 04-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 29-Aug-2021, the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For fetus 1, The outcome was reported as Spontaneous Abortion NOS. On 04-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 13-Sep-2021, ABORTION SPONTANEOUS had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication list was not provided. Treatment information was not provided. Patient had miscarriage at seven weeks of pregnancy. Company Comment: This case concerns a 37 year-old, female subject, with a non relevant clinical history, who experienced the unexpected serious (IME) event of ABORTION SPONTANEOUS and the unexpected non-serious event of MATERNAL EXPOSURE DURING PREGNANCY. The event occurred approximately 25 days after the first dose of [Spikevax] The rechallenge was not applicable (first dose only) The event was considered related to the study drug per the reporter''s assessment The event is consistent with the current understanding of the mechanism of action of the study medication The benefit-risk relationship of the vaccine is not affected by this report This case concerns a 37-year-old female patient with no previous relevant medical history, who experienced the unexpected non serious events of Maternal exposure during pregnancy and the unexpected serious event of Spontaneous abortion after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The patient received the first dose of vaccine at 4 weeks of gestation. The event Spontaneous abortion occurred approximately 26 days after the first dose of Spikevax. The benefit-risk relationship of Spikevax vaccine is not affected by this report Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation received on 28-Sep-21, for initial source document: Added anatomical location, gestation period at exposure and updated narrative supplement. On 22-Sep-2021: Follow-up received on 22-SEP-2021, had no new information. On 23-Sep-2021: Follow-up received on 23-SEP-2021, added medical history..; Reporter''s Comments: Inoculation site: DELTOID SX Other information: VACCINATED AT THE 4 WEEK OF GESTATION; DISCOVERED PREGNANCY THE DAY BEFORE THE ADMINISTRATION OF THE FIRST DOSE; Sender''s Comments: This case concerns a 37-year-old female patient with no previous relevant medical history, who experienced the unexpected non serious events of Maternal exposure during pregnancy and the unexpected serious event of Spontaneous abortion after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The patient received the first dose of vaccine at 4 weeks of gestation. The event Spontaneous abortion occurred approximately 26 days after the first dose of Spikevax. The benefit-risk relationship of Spikevax vaccine is not affected by this report


VAERS ID: 1838514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:an empty amniotic sac without an embryo
CDC Split Type: NLPFIZER INC202101398822

Write-up: miscarriage; The first echo showed that there was an anembryonic pregnancy; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (RA)-WEB:NL-LRB-00687467. A 26-years-old female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Aug2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced miscarriage (other medically important condition) on 04Aug2021, maternal exposure during pregnancy, anembryonic gestation (other medically important condition) on 04Aug2021 following administration of covid-19 vaccine pfizer injectable solution. This was the first Covid vaccination, which took place at a pregnancy duration of about 3 weeks. The first echo showed that there was an anembryonic pregnancy, which resulted in a miscarriage. The day after patient took the first vaccination she was found to be 3 weeks pregnant. The first ultrasound showed an empty amniotic sac with no embryo. The pregnancy could not be completed and was therefore terminated. Outcome of events were unknown. Sender''s comments: Since the nature of the reported reaction does imply seriousness according to one of the Agency critera, the reaction was considered as serious by the Centre. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1656307 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-02
Onset:2021-08-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA CUS 17801 / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin decreased, Human chorionic gonadotropin positive, Pregnancy test positive, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: adderall
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: 1. 8/2/21: 2 at home positive pregnancy tests 2. 8/3/21: Lab Work done confirming pregnancy 3. 8/5/21: Lab Work showing significant drop in HGC levels 4. 8/7/21: Bleeding from Vaginal Area
CDC Split Type:

Write-up: Right after getting the first vaccine of Moderna I took 2 at home pregnancy tests, both showed up positive. I did not realize I was pregnant before getting the vaccine. My doctor had me go get blood work on Tuesday the 3rd of August and my pregnancy was confirmed. I got bloodwork again on the Thursday the 5th and found out on Friday the 6th that my HGC levels had dropped from 17 to 1.5. On Saturday the 7th I spent the day in the shower bleeding as I had miscarriage. I am not sure if this was related to the Covid Vaccine, but the timing is extremely coincidental.


VAERS ID: 1754754 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-05
Onset:2021-08-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: Shortly after my second dose I was told I was 6 weeks pregnant and just miscarried a couple days ago. Just thought you should know for data research incase this vaccine does in fact put women in danger for future fertility.
CDC Split Type:

Write-up: Headache and body aches


VAERS ID: 1757064 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-08-04
Onset:2021-08-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / SYR

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

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

Write-up: I was in my first trimester of pregnancy. I had covid like symptoms for over two weeks after the first shot. I got tested twice for covid during this time. Both tests were negative. I later suffered an abnormal miscarriage.


VAERS ID: 1642659 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-08-05
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy, SARS-CoV-2 test positive
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201028; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC202101045810

Write-up: She got pregnant right after Covid vaccination; Miscarriage between 5 and 6 weeks of pregnancy; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority WEB NL-LRB-00658691, Sender''s (Case) Safety Report Unique Identifier NL-LRB-00664180. A 28-year-old female patient received bnt162b2 (COMIRNATY), dose 1 on 07Jul2021as dose 1, single (Lot # FE7010) for covid-19 immunisation. Medical history included COVID-19 from 28Oct2020. She was miscarriage, miscarriage: 29 days after start on 05Aug2021 (other medically important condition), maternal exposure before pregnancy following administration of covid-19 pfizer vaccine injection for covid 19 immunisation. She got pregnant right after Covid vaccination, unfortunately this pregnancy ended in early miscarriage with spontaneous abortion, delivery date was 05Aug2021. Miscarriage between 5 and 6 weeks of pregnancy. This was the first Covid vaccination, which took place before pregnancy. Since the nature of the reported reaction does imply seriousness according to one of the Council for International Organizations of Medical Sciences criteria, the reaction (miscarriage) was considered as serious by the Netherlands Pharmacovigilance Centre PRIVACY. Lab data included corona, confirmed with test positive on 28Oct2020. Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1663744 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101073157

Write-up: Pregnancy loss <20 weeks gestation; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB with regulatory authority number FR-AFSSAPS-PB20215393. A 28-year-old pregnant female patient received the second dose of BNT162B2 (COMIRNATY, lot number FE2707), intramuscular on 04Aug2021 as dose 2, single for covid-19 immunisation. The patient has no medical history. The patient had a negative sars-cov-2 test on 03Aug2021. The patient''s concomitant medications were not reported. The patient experienced pregnancy loss <20 weeks gestation on 05Aug2021. The patient presented slight bleeding and then more significant blood loss on 05Aug2021 - a miscarriage at 9 weeks of gestation + 3. Management: going to the emergency room without hospitalization. The birth type was spontaneous abortion. The outcome of the event was reported as recovering. No follow-up attempts are possible. No further information is expected.


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https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=22&PERPAGE=100&ESORT=ONSET-DATE&SYMPTOMS[]=Aborted_pregnancy_%2810000209%29&SYMPTOMS[]=Abortion_%2810000210%29&SYMPTOMS[]=Abortion_complete_%2810061614%29&SYMPTOMS[]=Abortion_early_%2810052846%29&SYMPTOMS[]=Abortion_incomplete_%2810000217%29&SYMPTOMS[]=Abortion_induced_%2810000220%29&SYMPTOMS[]=Abortion_late_%2810052847%29&SYMPTOMS[]=Abortion_missed_%2810000230%29&SYMPTOMS[]=Abortion_of_ectopic_pregnancy_%2810066266%29&SYMPTOMS[]=Abortion_spontaneous_%2810000234%29&SYMPTOMS[]=Abortion_spontaneous_complete_%2810061616%29&SYMPTOMS[]=Abortion_spontaneous_incomplete_%2810061617%29&SYMPTOMS[]=Foetal_cardiac_arrest_%2810084280%29&SYMPTOMS[]=Foetal_death_%2810055690%29&SYMPTOMS[]=Premature_baby_death_%2810076700%29&SYMPTOMS[]=Premature_delivery_%2810036595%29&SYMPTOMS[]=Stillbirth_%2810042062%29&VAX=COVID19


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