Received Feb 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 946624 | LA |
Vaccination failure; Lingering cough; Tested positive for Flu A; This spontaneous case initially received on 03-Feb-2025, was reported by a non health professional and concerns a child male patient. At the time of the event the patient had allergy to Peanuts. No concomitant medications were reported. There was no product complaint associated with this case. Administration of company suspect drug: On 26-Oct-2024, the patient received Flucelvax (TIV) for Active immunization against influenza disease, dose and route of administration: not reported, anatomical location: Left Deltoid, Lot number: 946624. No additional suspect drugs. Adverse reactions/events and outcomes: On 31-Jan-2025, the patient experienced Tested positive for Flu A (Medically Significant, outcome: Recovered / Resolved, stop date: 03-Feb-2025). Associated symptoms included: Lingering cough. On an unknown date, the patient experienced Vaccination failure (Medically Significant, outcome: Not Reported). The reporter informed that the vaccination was given on a clinic, flu was verified by nasal swab and the source of infection was school or wrestling. The patient Recovered as of 03-Feb-2025 with lingering cough. Case was upgraded to serious upon company assessment of the reported event (Tested positive for Flu A) clinical significance. Flucelvax (TIV) action taken: Not Applicable Treatment medication: Ibuprofen, Oscillococcinum Reporter assessment: The reporter assessed the event Tested positive for Flu A as non serious and did not provide seriousness for Vaccination failure and did not provide a causality assessment for the events.; Reporter's Comments: Causality: Related. Due to the spontaneous nature of the case, it is considered related for reporting purposes. Vaccination failure and Influenza is assessed as related due to provided approximate time frame from the date of vaccine which is plausible.
Peanut allergy