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This is VAERS ID 1193958

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First Appeared on 7/2/2021

VAERS ID: 1193958
VAERS Form:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other      Purchased by: ??
Symptoms: Glucose tolerance test, Stillbirth, Ultrasound antenatal screen, X-ray, Laboratory test, Histology, Prenatal screening test, SARS-CoV-2 test

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multigravida; Ovarian cyst; Slipped disc; Thalassemia minor; Varicose veins of lower extremities
Diagnostic Lab Data: Test Name: OGTT; Result Unstructured Data: Test Result:normal; Test Name: histological check of the placenta; Result Unstructured Data: Test Result:unknown results; Test Name: genetic test; Result Unstructured Data: Test Result:unknown results; Test Name: Growth rate week 32; Result Unstructured Data: Test Result:normal; Test Name: integrated test; Result Unstructured Data: Test Result:normal; Test Name: PCR test for COVID 19; Result Unstructured Data: Test Result:negative; Test Name: Late (anatomy) ultrasound; Result Unstructured Data: Test Result:normal; Test Name: Nuchal translucency screening; Result Unstructured Data: Test Result:1:800; Test Name: ultrasound check; Result Unstructured Data: Test Result:fetus with no heartbeat and no movement; Test Name: x-ray; Result Unstructured Data: Test Result:unknown results
CDC 'Split Type': ILPFIZER INC2021353566

Write-up: In an ultrasound check it showed a fetus with no heartbeat and no movement/ IUFD; This is a spontaneous report received from a contactable other healthcare professional. This other healthcare professional reported information for both mother and fetus. This is the maternal report. A 40-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 17Feb2021 at a single dose for COVID-19 immunization. Medical history included thalassemia minor, varicose veins in the legs, slipped disc, simple ovarian cyst removal, and 6th pregnancy. The patient was pregnant at the time of vaccination, at 34 weeks age of gestation. Concomitant medications were not reported. After she felt lessening of fetal movement in the course of the night and in the morning, she woke up and did not feel fetal movement. Negated water secretion, labor or bleeding. This refers to a woman aged 40, healthy except for Thalassemia minor, Varicose veins in the legs, status after a slipped disc and simple ovarian cyst removal. The patient was in week 34+1 of her 6th pregnancy (3 children). According to the report, the pregnancy was spontaneous. Nuchal translucency screening was normal. Integrated test 1:800. Did not have an amniocentesis. Late (anatomy) ultrasound normal, normal OGTT. Growth rate week 32 summarized as normal. The day before (on 17Feb2021) received the first injection of the vaccine for COVID 19 in a community setting. When she was given it there was no fetal heartbeat. In an ultrasound check it showed a fetus with no heartbeat and no movement. PCR test for COVID 19 when she was admitted was negative. The patient gave birth on 19Feb2021 in the evening and the fetus was without external birth defects except for syndactyly in fingers 4-5 in the right leg. Even with request and repeated explanation, the woman refused an autopsy but agreed to a genetic test, x-rays, medical photographs and histological check of the placenta in addition to a corona test from the placenta and from the fetus. Reason for hospitalization/diagnosis on hospitalization was IUFD (intrauterine fetal death). At the time of report, patient hospitalization status was "released". Outcome of the event was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Stillbirth cannot be totally excluded. It is possible that there was no fetal heartbeat prior to administrating the vaccine (When she was given it there was no fetal heartbeat.). The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2021348948 Fetus case

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