Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | LM2210 | IM / LA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 94612 | IM / RA |
Product lack efficiacy/ did not work as expected; Coughing; Fatigue; Congestion; COVID antigen home test positive; This spontaneous case, initially received on 24-Feb-2025, was reported by a non health professional and concerns an adult male patient. No any medical history, chronic condition to report. Drug history included Covid-19 Pfizer (Booster, left deltoid, Lot number: 6J6739) Covid-19 Pfizer (Booster, left deltoid, Lot number: HF9298) No any allergic to this vaccination. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On 03-Oct-2024, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: 0.5 ml, Route of administration: Intramuscular, annual booster, Anatomical location: Right Deltoid, Lot number: 94612. CSL batch number unable to match. Non-company suspect drugs: On 03-Oct-2024, the patient received Pfizer BioNTech COVID-19 vaccine (Tozinameran) for Indication not reported, booster dose , Anatomical location: Left upper deltoid, Lot number: LM2210 Adverse reactions/events and outcomes: On 01-Jan-2025, the patient experienced Coughing (outcome: Recovered / Resolved), Fatigue (outcome: Recovered / Resolved), Congestion (outcome: Recovered / Resolved). On an unknown date, the patient experienced Product lack efficiacy/ did not work as expected (Medically Significant, outcome: Not Reported) On 01-Jan-2025, patient had COVID positive (outcome: Not Reported) Patient did not received any other vaccine within 4 weeks prior to the first administration of suspect vaccine. Primary infection site was not known. There were no any predisposing factors. Culture was not performed. No any antipyretic product used around the date of vaccination. Adverse event did not required to visit emergency room.. No physician office visit. On 01-Jan-2025, LUCIRA by Pfizer COVID-19 & Flu Home Test shows COVID positive, Flu A, Flu B negative. On 05-Jan-2025, COVID antigen home test: COVID positive. On 08-Jan-2025, COVID antigen home test: COVID positive. On 15-Jan-2025, Flowflex COVID antigen home test: COVID negative. Flucelvax (TIV) action taken: Not Applicable Treatment medication: Dayquil As needed, Nyquil As needed Reporter assessment: The reporter considered the event as non serious and did not report the causality assessment for the events.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. However, the reported symptoms coughing, fatigue and congestion are attributed to covid antigen test positive. Hence, Vaccination failure is more plausibly explained by covid antigen positive and attributed to non-company Covid-19 vaccine.
Loratadine; Naprozen