Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
significant body pain; fever; Nausea; general malaise; Initial information received on 07-Nov-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves Adult male patient (185.42 cm and 79.55 kg) who had significant body pain, fever, nausea and general malaise after receiving influenza vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity with Carbamazepine 100 Mg Tab Chew, Tegretol 200 Mg Tablet, Sucralfate 1 Gm Tablet, Captopril 25 Mg Tablet, Honey Bee Venom Protein Vl, Sulfamethoxazole-Tmp Ss Tablet, Sulfacetamide 10% Eye Drops, Lisinopril 10 Mg Tablet, Lisinopril 10 Mg Tablet, Levofloxacin 250 Mg Tablet. Concomitant medications included epinephrine; normal saline; fluticasone propionate; methocarbamol; zyrtec [cetirizine hydrochloride]; percocet [oxycodone hydrochloride;paracetamol]; sodium chloride; hydrocodone bitartrate, paracetamol (hydrocodone/acetaminophen); losartan potassium; omeprazole (protonix); agalsidase beta (fabrazyme); diphenhydramine hydrochloride (diphenhydramine); gabapentin; aspirin [acetylsalicylic acid]; ibuprofen; paracetamol (tylenol extra-strength); and finasteride. On an unknown date, the patient received unknown dose of suspect influenza vaccine (Unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) On an unknown date the patient developed significant body pain (pain), fever (pyrexia), nausea and general malaise (malaise) (unknown latency) following the administration of influenza vaccine. Action taken was not applicable. It was not reported if the patient received corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events.; Sender's Comments: US-SA-2025SA305737:
Drug allergy (Allergies: Carbamazepine 100 Mg Tab Chew,Tegretol 200 Mg Tablet,Sucralfate 1 Gm Tablet,Captopril 25 Mg Tablet,Honey Bee Venom Protein Vl,Sulfamethoxazole-Tmp Ss Tablet,Sulfacetamide 10% Eye Drops,Lisinopril 10 Mg Tablet,Lisinopril 10 Mg Tablet,Levofloxacin 250 Mg Tablet)
EPINEPHRINE; NORMAL SALINE; FLUTICASONE PROPIONATE; METHOCARBAMOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]; SODIUM CHLORIDE; HYDROCODONE/ACETAMINOPHEN; LOSARTAN POTASSIUM; PROTONIX [OMEPRAZOLE]; FAB