Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | U8859CA | OT |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8859CA | — |
headache with light sensitivity; fibromyalgia flare up; cold sore; Pain/ all over body pain; light sensitivity; Bedridden; felt like she had the flu; sick/ sick out of her mind/ extremely sick; extremely upset; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 68-year-old female patient who received Flu unspecified (Flu vaccine) (batch number U8859CA) for prophylaxis. Concurrent medical conditions included fibromyalgia (Fibromyalgia). On 01-OCT-2025, the patient received Flu vaccine. On 01-OCT-2025, less than 2 weeks after receiving Flu vaccine, the patient experienced emotional distress (Verbatim: extremely upset). On 02-OCT-2025, the patient experienced pain (Verbatim: Pain/ all over body pain), bedridden (Verbatim: Bedridden), influenza like illness (Verbatim: felt like she had the flu), sickness (Verbatim: sick/ sick out of her mind/ extremely sick) and photophobia (Verbatim: light sensitivity). On an unknown date, the patient experienced headache (Verbatim: headache with light sensitivity), fibromyalgia worsened (Verbatim: fibromyalgia flare up) and cold sores (Verbatim: cold sore). The outcome of the pain, headache, fibromyalgia worsened and emotional distress were not resolved and the outcome of the bedridden, influenza like illness, sickness and cold sores were unknown and the outcome of the photophobia was not reported. It was unknown if the reporter considered the pain, headache, fibromyalgia worsened, bedridden, influenza like illness, sickness, cold sores, emotional distress and photophobia to be related to Flu vaccine. It was unknown if the company considered the pain, headache, fibromyalgia worsened, bedridden, influenza like illness, sickness, cold sores, emotional distress and photophobia to be related to Flu vaccine. Additional Information: GSK receipt date: 13-OCT-2025 The reporter was the patient. Stated she received a GSK flu vaccine on 01st October 2025. The reporter stated she had the worst reaction to the vaccine. The patient has never had the flu and never gets sick so she was concerned the person administering the shot tampered with the medication causing the patient to get extremely sick. The patient stated on 02nd October she was so sick that she was bedridden. The patient stated she was in pain and felt as if she had the flu, had a headache and was sensitive to light. The patient stated approximately one week after the flu shot was administered, she had a flare-up of her fibromyalgia. Consumer stated the fibromyalgia flare up caused her to have all over body pain. Then approximately two weeks after the flu shot was administered, she had a cold sore. The patient stated she had the cold sore outbreak because she was extremely upset about being sick after the dose was administered. Consumer extremely upset because she was supposed to meet her new granddaughter, but due to the cold sore she was unable to meet her. The patient stated two weeks after the injection she still has a headache with light sensitivity. The patient stated she took Ibuprofen and Acetaminophen for the pain (dose/frequency not disclosed.) On 9 Oct 2025 the patient went to her doctor's office and she was tested for flu, covid, and rsv. The patient reported all tests came back negative. The patient stated after the flu vaccine was administered, she has been sick out of her mind. The patient was not provided with the name of the flu vaccine. She was told by her doctor the vaccine was manufactured by GSK. The patient was contacting her doctor for the name and lot number of the vaccine. The patient would update case with the information. No other information was provided.
Fibromyalgia (Fibromyalgia)