Received Jan 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 407261 | — |
Feels like it's crawling out of his skin, his skin its creepy and its sensitive; Feels like his head hurts so bad; Broke out in hive; Barely walk thought the house right now; Severe migraines/temporal migraines; This spontaneous case initially received on 05-Dec-2025, was reported by a non health professional and concerns an elderly male patient. Administration of company suspect drug: On 18-Sep-2025, the patient received Fluad (TIV) for Not reported indication, Dose regimen: not reported, route of administration: not reported, Anatomical location: not reported, Lot number: 407261. No additional suspect drugs. Adverse reactions/events and outcomes: On Sep-2025, the patient experienced Broke out in hive (outcome: Unknown), Feels like his head hurts so bad (outcome: Unknown). On 2025, the patient experienced Severe migraines/temporal migraines (outcome: Unknown), Barely walk thought the house right now (outcome: Unknown). On an unknown date, the patient experienced Feels like it's crawling out of his skin, his skin its creepy and its sensitive (outcome: Unknown). The consumer had called and stated per verbatim that her husband had gone to the facility on 18-Sep-2025 and had received one of the flu shots. Since then, he had developed hives and had begun experiencing severe migraines. She had asked whether she needed to report the reaction, whether this reaction had happened to other people, or if she could receive any help. The consumer had stated that she did not know the exact product name her husband had received, only that it had been an Influenza Trivalent vaccine. She had provided the lot number 407261. She had explained that within three days of receiving the flu shot, the patient had developed hives. Per her verbatim statement, he had been miserable, had needed to take medications, and if he did not take them, he had felt as though his skin was crawling. She had further stated that he had then begun experiencing severe migraines along with the hives, making him extremely uncomfortable. The consumer had explained that within a couple of days of receiving the shot, he had broken out in hives. They had contacted the doctor, who had advised taking Benadryl, which she had given him; however, because he rarely took medication, it had completely knocked him out. Therefore, he had been switched to Allegra, which he had taken approximately every three days; otherwise, he would get such severe hives that his skin would feel extremely sensitive and uncomfortable. She had reported that he had then started experiencing migraines, beginning roughly two weeks prior, describing them as temporal migraines. She stated that his head had hurt so severely that he could barely walk through the house. They had to put him in the car and vent air toward him to help alleviate his symptoms, though nothing seemed to help. She added that they felt at a loss. The consumer had further stated that the doctor had advised continuing Allegra for the hives and that the migraines were new. They had consulted two additional doctors at the facility, and those doctors had also told them that flu shots remained in the system, meaning he might continue experiencing symptoms until around March through May. She had explained that he had never had a problem with a flu shot before, but now, due to this reaction, she believed he would not receive another one in the future. Fluad (TIV) action taken: Not Applicable Treatment medication: Allegra (Twice a week), Benadryl Reporter's assessment: The reporter did not provide the seriousness and causality of the events.; Reporter's Comments: The events assessed as related due to pharmacological/ biological plausibility