Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Hives at arm and waist; Hives at arm and waist; This spontaneous case, initially received on 03-Nov-2025, was reported by a non health professional (patient) and concerns an elderly female patient. Drug history included Penicillin (Reaction: Hives). Administration of company suspect drug: On 28-Oct-2025, the patient received Fluad (TIV) for Indication not reported, Dose regimen: not reported, route of administration: not reported, Anatomical Location: Arm, Lot number: No batch number available and would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On 30-Oct-2025, the patient experienced Hives at arm and waist (outcome: Recovered / Resolved, stop date: 31-Oct-2025). On 01-Nov-2025, the patient experienced Hives at arm and waist (outcome: Recovering / Resolving). Consumer reported: She had been having the flu vaccines for over 20 years and never had any reaction before. Last Tuesday 28-Oct-2025 she had got the flu vaccine and two days later she developed hives on her arm and around her waist. She thought they were insect bites but it was hives and she used an anti-itch medication and the next day it seemed it disappeared. However, the next day it came back again so she used the anti-itch medication again and then she also took an antihistamine Claritin so that cleared it up. She just wanted to know if there was something different about the flu vaccine this year some ingredient that was different because she needed to also make a decision next year whether she should get the flu vaccine again. It was recommended to discuss with her HCP whether or not she should receive the vaccine next time. Again, she had always been getting the flu vaccine and she knew that they changed the ingredients and they were not always the same, but she was just wondering what it was in that flu vaccine this year that caused she such a reaction. She knew that came from the vaccine because she was not exposed to anything else that could have created that. The anti-itch Sarna really helped but she needed to take the antihistamine really to get rid of it. When asked if the consumer had seen a Health Care Professional, she mentioned she would have if it had not gone away it just came and when it showed up it was in the evening kind of late at night so she did not want to go to an emergency room, she used the anti-itch medication and the next day it disappeared then she knew for sure that was hives because mosquito bites do not disappear like that and she thought she was good so the next evening she had it again around the waist and then on the arm and then she did a research and read that the first line of treatment for hives was an antihistamine. So, she had Claritin at home and tried the antihistamine and saw if it helped and it did but if that had not helped she would have gone to an urgent care but she was able to take care of it on her own. She had hives once before years ago to penicillin and the case was so bad that it took three weeks to get rid of the hives it was all over her body. Fluad (TIV) action taken: Not Applicable Treatment medication: Claritin, Sarna Reporter's assessment: The reporter assessed the events Hives at arm and waist and Hives at arm and waist related to the administration of Fluad (TIV) and did not provide the seriousness.; Reporter's Comments: Due to the spontaneous nature of the case, the events Hives at arm and waist and Hives at arm and waist are considered related for reporting purposes.