Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 410515 | — |
Difficulty hearing; Wasn't feeling great; Headache; Feeling a little bit achy; Nauseous; Might be affecting the nerves; Very nervous; Difficulty with my ears, they were feeling clogged, or like full; This spontaneous case, initially received on 10-Nov-2025, was reported by a non-health professional and concerns an adult female patient. Concomitant medication: refer to appropriate report section. Historical vaccines included Flu shot (reaction: soreness in my arm). Administration of company suspect drug: On 06-Nov-2025, the patient received Flucelvax (TIV) for Indicated for active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not Reported, Lot number: 410515. No additional suspect drugs. Adverse reactions/events and outcomes: On 07-Nov-2025, 1 day after vaccination, the patient experienced Difficulty with my ears, they were feeling clogged, or like full (outcome: Not recovered / Not resolved), Wasn't feeling great (outcome: Not recovered / Not resolved), Headache (outcome: Not recovered / Not resolved), Feeling a little bit achy (outcome: Not recovered / Not resolved), Nauseous (outcome: Not recovered / Not resolved), Might be affecting the nerves (outcome: Not recovered / Not resolved), Very nervous (outcome: Not recovered / Not resolved). On 08-Nov-2025, 2 days after vaccination, the patient experienced Difficulty hearing (outcome: Not recovered / Not resolved). The patient reported that she was calling to report a medical reaction to the flu vaccine that she received. She received the flu vaccine at her local pharmacy on Thursday (06-Nov-2025). On Friday (07-Nov-2025) she woke up, and she was not feeling great she had a headache, she was feeling a little bit achy and nauseous, almost like she has a type of the flu, but nothing crazy, it was taking easy. By that night, that evening on Friday, she was having difficulty with her ears, they were feeling clogged, or like full, and by Saturday she woke up and she had difficulty hearing, so she went directly to the ear, nose, and throat (ENT) to get her ears checked and there was nothing going on in her ears at all, they look completely healthy, she had no history of any ear issues, but she was experiencing some hearing issues then, after having the vaccine. And she was on her way right then to the doctor again to get a hearing exam. They put her on a high dose of steroid to try to mitigate whatever was going on. It appeared like reacting poorly to the vaccine and it might be affecting the nerves instead of her ears. She did speak with the pharmacy and they said they did report it also, but she wanted to make sure she was calling because this was really distressing for her. She literally never experienced any issues ever, with her ears, she had the flu shot every year. She never had a reaction to a flu shot before, never. The only reaction she had ever had in her life was like soreness in her arm, that was it. She also mentioned that she would really appreciate someone calling her because she was really very nervous. She did not know what was going on, she wanted to know if other people were experiencing this issue, and she wanted to make sure that the treatment she was receiving was adequate. The only medication she was taking was Minoxidil 2.5mg a day. She was healthy, she did not take any medications, she did not have a history of any medical issues, never had any hearing issues in her life, nothing at all. They were having her on a steroid, 60mg for 10 days and then she tapered it off, that was it, there was nothing else she could do right then, and she was going to get the hearing test and see what says. There was nothing else to report. Flucelvax (TIV) action taken: Not Applicable Treatment medication: unspecified steroids Reporter's assessment: The reporter assessed the events (Difficulty with my ears, they were feeling clogged, or like full, Wasn't feeling great, Headache, Feeling a little bit achy, Nauseous, Might be affecting the nerves, Very nervous, Difficulty hearing) as non-serious and causality assessment was not provided.; Reporter's Comments: Due to the spontaneous nature of the case, the events (Difficulty with my ears, they were feeling clogged, or like full, Wasn't feeling great, Headache, Feeling a little bit achy, Nauseous, Might be affecting the nerves, Very nervous, Difficulty hearing) are considered related for reporting purposes
Comments: None
Minoxidil