Received Nov 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 409608 | LA |
Rash like reaction on his upper left arm while still local to the injection site; This spontaneous case, initially received on 20-Oct-2025, (Including additional information received on 06-Nov-2025) was reported by a non-health professional and concerns a child male patient. Drug history included flu vaccine. The concomitant medication and medical history were reported as unknown. Administration of company suspect drug: On 18-Oct-2025, the patient received Flucelvax (TIV) for Unknown indication, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Left Deltoid (upper left arm), Lot number: 409608, Expiry date: 30-Jun-2026. No additional suspect drugs. Adverse reactions/events and outcomes: On 19-Oct-2025, the patient experienced Rash like reaction on his upper left arm while still local to the injection site (outcome: Unknown). On 19-Oct-2025, the patient's family member saw noticeably large rash like reaction on his upper left arm while local to the injection site. It might be 3-5 inches in diameter. He had not mentioned any itching, pain or discomfort of any sort up to that point. When asked, he told the reporter that it did not hurt or itch and he felt fine. His temperature was normal the forehead thermometer used. The reporter known those were not very accurate. The patient's father took pictures of his arm for documentation and mentioned he had no history of reaction to an injection of any type, including prior vaccination and specifically flu vaccine. He had previously gotten vaccine at family clinic as well as other locations from other manufacturer. Outcome of event: Unknown Treatment measure associated with event: Unknown Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide seriousness and causality assessment.; Reporter's Comments: The event is related due to spontaneous nature of event
Comments: None