Received Jan 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 948402 | IM / LA |
Subacute thyroiditis; Expired vaccine used; This spontaneous case initially received on 06-Dec-2025, was reported by a non health professional and concerns a male patient. The concomitant medication, medical history were reported as unknown. Administration of company suspect drug: On 16-Oct-2025, the patient received Flucelvax (TIV) for influenza prophylaxis, Dose regimen: 0.5 ml, Route of administration: Intramuscular, Anatomical location: left deltoid, Lot number: 948402, expiry date: 31-Jan-2025 No additional suspect drugs. Adverse reactions/events and outcomes: On 16-Oct-2025, the patient experienced Expired vaccine used (outcome: Not Reported). On 19-Oct-2025, the patient experienced Subacute thyroiditis (outcome: Unknown, stop date: 19-Oct-2025). Consumer reported developed subacute thyroiditis a few days after receiving Flucelvax vaccine IM in left deltoid on 16-Oct-2025 at his workplace. Stated that it has been a horrible, horrible experience. Consumer stated can't find much literature on the web about subacute thyroiditis following flu vaccine and was hoping for some information Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter assessed event Subacute thyroiditis as non-serious and did not provide seriousness for event Expired vaccine used and causality assessment were not provided for all events; Reporter's Comments: The event Subacute thyroiditis is related due to temporal relationship plausibility The event Expired vaccine used is not related due to nature of event (special situation)