Received Jun 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
covid; covid; This is a spontaneous report received from a Physician from medical information team, Program ID. An 80-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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "recovering" and all described as "covid". The event "covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (2025) Unknown results; Influenza A virus test: (2025) Unknown results; Influenza B virus test: (2025) Unknown results; Respiratory syncytial virus test: (2025) Unknown results; SARS-CoV-2 test: (2025) Positive, notes: 3rd or 4th day tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was the first time both reporter (husband) and his wife (the patient) had COVID since the beginning of the year. 3rd or 4th day, tested positive. They were put on Paxlovid and symptoms went absolutely away progressively. 5 days when they were on it, nasal drainage was much less, and it was putrid and coughing started to clear quite a bit. After 5th day, it was like a reticence of the disease and it was worse that they have ever had and next 2 or 3 days it was progressively worse and worse and worse. At time of report, week after that, and they seem to be doing well.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with COMIRNATY (2024-2025 FORMULA can not be fully excluded.
Test Date: 2025; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 2025; Test Name: Flu A; Result Unstructured Data: Test Result:Unknown results; Test Date: 2025; Test Name: Flu B; Result Unstructured Data: Test Result:Unknown results; Test Date: 2025; Test Name: RSV; Result Unstructured Data: Test Result:Unknown results; Test Date: 2025; Test Name: Covid-19; Test Result: Positive ; Comments: 3rd or 4th day tested positive