Received Jan 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Allergy to the flu shot; Rash; Couldn't move arm, couldn't rotate arm; Got that pain, arm was so painful; Had a 6-inch circle that was red; This spontaneous case initially received on 22-Dec-2025, was reported by a non health professional and concerns an elderly female patient. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for not reported indication, Dose regimen: not reported, route of administration: not reported, Anatomical location: not reported, Lot number: No batch number available and would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Allergy to the flu shot (outcome: Not recovered / Not resolved), Rash (outcome: Not recovered / Not resolved), Couldn't move arm, couldn't rotate arm (outcome: Not recovered / Not resolved), Got that pain, arm was so painful (outcome: Not recovered / Not resolved), Had a 6-inch circle that was red (outcome: Not recovered / Not resolved). The consumer stated, she had an allergy to the flu shot. It was like a year ago, it was a rash, and she couldn't move her arm, and she had it twice. There was an article in the paper that said (patient can get a single-dose shot that was a prefilled syringe, and it's thimerosal-free). She wanted to know if company had that shot. The big thing was knowing that it was Thimerosal-free. She wanted to know that at pharmacy when she go to get a flu shot, did that contain thimerosal. She got the shot twice there. The first time, everybody says the arm hurts afterward, but it was a full year she couldn't put her coat on. The next year when she got it, she got that pain. she looked in the mirror, and she had a 6-inch circle that was red, and again her arm was so painful for a year, and her arm had never been the same, she couldn't rotate her arm. Tried to collect the product name for the adverse event but she wasn't able to help. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality of the events.; Reporter's Comments: The events are related due to chronological plausibility
Comments: None