Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 7fqy52 | — |
Swelling,; rash; severe nausea,; headache,; dizziness/lightheaded; swollen tongue; This non-serious case was reported by a consumer and described the occurrence of swelling in a 31-year-old female patient who received Flu unspecified (Influenza vaccine) (batch number 7fqy52) for prophylaxis. Concomitant products included methotrexate sodium (Methotrexate), belimumab (Benlysta), hydroxychloroquine phosphate (Plaquenil), methylphenidate hydrochloride (Concerta) and propranolol (Propanolol). On 07-OCT-2025, the patient received Influenza vaccine. On 07-OCT-2025, less than a day after receiving Influenza vaccine, the patient experienced swelling (Verbatim: Swelling,), rash (Verbatim: rash), nausea (Verbatim: severe nausea,), headache (Verbatim: headache,), dizziness (Verbatim: dizziness/lightheaded) and swollen tongue (Verbatim: swollen tongue). The outcome of the swelling, rash, nausea, headache, dizziness and swollen tongue were unknown. It was unknown if the reporter considered the swelling, rash, nausea, headache, dizziness and swollen tongue to be related to Influenza vaccine. It was unknown if the company considered the swelling, rash, nausea, headache, dizziness and swollen tongue to be related to Influenza vaccine. Additional Information: GSK Receipt Date: 07-OCT-2025 The reporter reported that the patient received Flu shot and had swelling, rash, severe nausea, headache, dizziness, lightheaded, swollen tongue.
Methotrexate; Benlysta; Plaquenil; Concerta; Propanolol