Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
COVID-19; COVID-19; This is a spontaneous report received from a consumer. A 62-year-old female patient received BNT162b2 Omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Allergic to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (DOSE 1), for COVID-19 immunization; Pfizer covid-19 vaccine (DOSE 2), for COVID-19 immunization; Pfizer covid-19 vaccine (DOSE 3 (BOOSTER)), for COVID-19 immunization. The patient had 4 Pfizer vaccinations. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2025, outcome "recovered with sequelae" (10Aug2025) and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ritonavir (PAXLOVID), first dose on 04Aug2025. COVID-19 was negative and patient was symptom-free on the morning of 10Aug2025. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500196265 Same patient and drug; different event and dose;
Medical History/Concurrent Conditions: Penicillin allergy
Test Date: 20250810; Test Name: COVID-19 test; Test Result: Negative