Received Nov 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Sore throat; Productive coughing with mucus; Runny nose; 101.4 F fever; Runny nose; Dry cough; Severe joint pain; Sneezing; Weakness; Injection site soreness; Tired; Getting chills; Feeling dizzy; Red skin rash; Skin itching; This spontaneous case, initially received on 23-Oct-2025, was reported by a non health professional and concerns a patient of unknown age/gender. Medical history and concomitant medication were reported as unknown. Administration of company suspect drug: On 17-Oct-2025, the patient received Fluad (TIV) for Indication not reported, dose regimen: not reported, route of administration: not reported, anatomical location: not reported. Lot number: No batch number available and requested upon follow-up. Adverse reactions/events and outcomes: On 18-Oct-2025, the patient experienced 101.4 F fever (outcome: Recovering / Resolving), Runny nose (outcome: Unknown), Dry cough (outcome: Unknown), Severe joint pain (outcome: Unknown), Sneezing (outcome: Unknown), Weakness (outcome: Unknown). On 19-Oct-2025, the patient experienced Productive coughing with mucus (outcome: Unknown), Runny nose (outcome: Unknown). On 21-Oct-2025, the patient experienced Sore throat (outcome: Unknown). On Oct-2025, the patient experienced Injection site soreness (outcome: Unknown), Tired (outcome: Unknown), Getting chills (outcome: Unknown), Feeling dizzy (outcome: Unknown), Red skin rash (outcome: Unknown), Skin itching (outcome: Unknown). On 17-Oct-2025, reporter was given an injection of the Fluad 65+ vaccine at reporter's local pharmacy. Within 7 hours of receiving the vaccination, reporter had the usual injection site soreness and was tired. During this time, reporter also started getting chills, feeling dizzy and developed a 1 1/2 red skin rash on reporter's opposite arm. By the next morning, reporter was running a 101.4°F fever, had a runny nose and a dry cough, severe joint pain, sneezing and weakness. It took several days for reporter's fever to subside. Reporter was taking ibuprofen and cetirizine hydrochloride to control the skin itching/rash and fever/joint pain. At days 34, reporter had productive coughing with mucus and runny nose. At day 5, reporter had a sore throat that only subsided that night. Reporter reported these symptoms to reporter's doctors and filed a report with VAERS. Note: Reporter had had other flu vaccines for seniors over the past seven years and none of them gave such an extreme reaction other than 2 days of tiredness and a sore arm at the injection site. Reporter suspected that the adjuvant used in this vaccine was responsible for this extreme reaction. Fluad (TIV) action taken: Not Applicable Treatment medication: Cetirizine dihydrochloride , Ibuprofen Reporter's assessment: The reporter assessed serioussness as unknown for events and causality was not provided.; Reporter's Comments: Due to the spontaneous nature of the case, events are considered related for reporting purposes
Comments: None