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Life Threatening? No
Write-up: Maternal exposure during pregnancy, second trimester; Meconium Aspiration; baby died 2 hours; severe prematurity; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other HCP (parent). This other HCP reported information for both mother and fetus/baby case. This is the baby report. This 38-year-old female patient was pregnant of a male fetus and received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 24Feb2021 08:15 (Batch/Lot Number: EL9261) and the second dose on 17Mar2021 (Batch/Lot Number: EL9261), both as single dose for COVID-19 immunisation. Relevant medical history of the mother included atopic dermatitis. Concomitant medications included crisaborole (EUCRISA) taken for dermatitis atopic from an unspecified start date and ongoing and loratadine taken for hypersensitivity, start and stop date were not reported. First day of last menstrual period: 29Oct2020. Estimated date of conception: 12Nov2020. Estimated delivery date: 05Aug2021. Gestational period at time of initial exposure: 16 weeks and 5 days. Second trimester. The male fetus had a premature birth on 30Mar2021 and experienced meconium aspiration on an unspecified date. The fetus died on 30Mar2021, 2 hours after the delivery. The mother went into preterm labor on 29Mar2021 which was 12 days after second Pfizer vaccine. She delivered on 30Mar2021 at 21 weeks and 5 days. She was diagnosed with chorioamnioitis due to a staph aureus infection. Leading up to the hospital admission and after first and second vaccines she had frequent headaches, fatigue which she related to the vaccine. She also had chills and body aches. On admission she had a fever. Results of serology tests, e.g., rubella, toxoplasmosis, etc: HIV negative, Rubeola immune, HBSag negative, VISRL no reactive. Ante-natal check-up (specify dates and results) e.g., fetal ultrasound, serum markers, etc: 20 wk fetal surgery, 25Mar2021, normal growing, normal anatomy, male fetus. The mother presented ruptured membrane with chorioamnionitis, treated with antibiotics, and changed postpartum day. Mode of delivery: Vaginal delivery. Outcome of pregnancy: Premature live birth: Baby lived 2 hours. Date of Outcome of Pregnancy: 30Mar2021. Gestational age at birth in weeks: 21 weeks and 5 days.; Sender''s Comments: Based on the information currently available, there is not a reasonable possibility reported events were related to BNT162B2 vaccine administration. It was noted that patients mother was diagnosed with chorioamnionitis due to a staph aureus infection which could be contributory. Case will be reassessed upon receipt of additional information. 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) : US-PFIZER INC-2021392327 Mother/Fetus baby case;US-PFIZER INC-2021390010 Mother/Fetus baby case; Reported Cause(s) of Death: Unknown cause of death
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