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Life Threatening? No
Write-up: the fetus is unfortunatelly without cardiac action, the pregnancy has to be terminated by revision; strong headache; chills; This is a spontaneous report from a contactable nurse (patient) received via a Pfizer Medical Information team. A 36-year-old female patient received second dose of BNT162B2 (COMIRNATY, lot number: EJ6797), intramuscularly administered in arm left, on 28Jan2021 at age, at single dose, for covid-19 immunisation. Medical history included prothrombin mutation 20210GA, heterozygote from Nov2019; Von Willebrand disease type I -diagnosed in Nov2019; submucous myoma resection twice Sep2019, Nov2019; delivery in Mar2012 (Number of previous pregnancies/other children: delivery Mar2012, induced due to Intrauterine growth retardation (IUGR), 39th week of pregnancy, daughter, 3190 g, 49 cm, post delivery adaptation ongoing hyposaturation, transferred to superior department, diagnosis severe persistent pulmonary hypertension of the newborn). Concomitant medication included tranexamic acid (EXACYL). Historical vaccines included inactivated influenza vaccine (VAXIGRIP TETRA, lot number U3H622V) on 13Nov2020 at age of 35 years old and the patient was not aware of any adverse events; and the first dose of BNT162B2 (COMIRNATY, lot number: EL1484), via intramuscular administered in arm left, on 07Jan2021 at years old, at single dose, for covid-19 immunization. First day of last menstrual period was 26Jan2021. Estimated date of conception was 13Feb2021. Pregnancy discovered on 05Mar2021. Estimated delivery date was 06Nov2021. Gestational period at time of initial exposure was 1st trimester (also reported as 19th day of the cycle). After 2nd dose of BNT162B2 applied on 28Jan2021, the patient experienced strong headache approximately 3 days and chills. Laboratory tests included Ante-natal check-up/fetal ultrasound: gestational sac on 09Mar2021; and gestational sac, embryo relevant to 6th week of pregnancy with cardiac action on 17Mar2021. 11th-13th week, screening examinations. From 12th week observation in practice due to risk pregnancy, due to above mentioned diagnosis also observed in hematological center. The mother did not smoke, drink alcohol or use illicit drugs during this pregnancy. The pregnancy went well so far, waiting for the screening examinations. On 08Apr2021, it was reported that "on 07Apr2021, gynecological examination was performed, the fetus is unfortunately without cardiac action, the pregnancy has to be terminated by revision". The outcome of events was unknown. Follow-up (08Apr2021): New information received from the same contactable nurse (patient) includes: new event (fetus is unfortunately without cardiac action, the pregnancy has to be terminated by revision, this was upgraded to serious, medically significant). Follow-up attempts are completed. No further information is expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event foetal death and the suspect vaccine BNT162B2. 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.
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