Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | OT |
COVID 19 Infection; COVID 19 Infection; The initial case was missing the following minimum criteria: [ICH-Unidentifiable patient]. Upon receipt of follow-up information on (24Jul2025), this case now contains all required information to be considered valid. This is a literature report. A 26-year-old female patient received BNT162b2 (BNT162B2), on 17May2021 as dose 1, single (Batch/Lot number: unknown) and on 07Jun2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; nvx cov 2373 (NVX COV 2373), on 12Jul2022 as dose 3 (booster), single and on 27Mar2023 as dose 4 (booster), single, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "dysfunctional uterine bleeding" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "Attention-deficit hyperactivity disorder" (unspecified if ongoing); "depression" (unspecified if ongoing); "hypogonadism" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE taken for insomnia; LEVONORGESTREL taken for contraception; TESTOSTERONE taken for hypogonadism; BUSPIRONE taken for anxiety; SERTRALINE taken for depression. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Apr2023, outcome "recovered" (14Apr2023) and all described as "COVID 19 Infection". Therapeutic measures were taken as a result of drug ineffective, covid-19. The reporter considered "covid 19 infection" related to BNT162b2.; Sender's Comments: There is not a reasonable possibility that the reported event covid-19 was related to the suspect product event most likely due to patient underlying contributory factors.,Linked Report(s) : US-PFIZER INC-PV202500078537 Same article, drug, event and different patient;
Medical History/Concurrent Conditions: Anxiety; Attention deficit hyperactivity disorder; Depression; Dysfunctional uterine bleeding; Hypogonadism; Insomnia; Obesity
TRAZODONE; LEVONORGESTREL; TESTOSTERONE; BUSPIRONE; SERTRALINE