Received Dec 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | 3053388 | OT / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8844CA | OT / LA |
allergic reaction which led to a skin infection; allergic reaction which led to a skin infection; Initial information received on 25-Nov-2025 regarding an unsolicited valid non-serious courtesy case received from a pharmacist. This case involves an unknown age and unknown gender patient who experienced allergic reaction which led to a skin infection after receiving SPIKEVAX [COVID-19 VACCINE MRNA OMICRON (JN.1) MODERNA] and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. The patient's past medical treatment included Codeine, Tramadol, KETOROLAC and TALWIN [PENTAZOCINE]. The patient's past vaccination(s) included Pfizer BioNTech COVID-19 vaccine and Influenza vaccine. The patient's past medical history and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity. No concomitant medication was reported. On 04-Nov-2025, the patient received a 1 dosage form (DF) dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (lot U8844CA, with unknown expiry and strength) via intramuscular route in the left arm as prophylactic vaccination. On 04-Nov-2025, the patient received a 0.5 ml dose of suspect SPIKEVAX [COVID-19 VACCINE MRNA OMICRON (JN.1) MODERNA] injection not produced by Sanofi Pasteur (lot 3053388, expiry: 30-Jun-2026, with unknown strength) via intramuscular route in the left arm as COVID-19 prophylaxis. On 04-NOV-2025 the patient developed a non-serious allergic reaction which led to a skin infection (skin infection) (hypersensitivity) (Latency: same day). It was reported, "The reporter stated that a dose of Spikevax (2025-2026) and high dose Fluzone were administered to a patient in left arm on 04-Nov-2025 at store. The patient had received Pfizer COVID vaccines in the past, and this was first Moderna COVID vaccine. The patient had received flu shots in the past. However, since was this was first year receiving the high-dose flu shot. On 06-Nov-2025, the patient contacted the pharmacy to report that left arm was really swollen, itchy and red, but not painful. symptoms were worse On 07-Nov-2025, was getting better. On 08-Nov-2025, the patient ended up going to the hospital as arm became swollen and red again with heat around the area. was given prednisone, an antibiotic called cephalexin for skin infection, and cetirizine, the antihistamine. The hospital suspected that it was an allergic reaction potentially caused by Moderna which led to a skin infection. The hospital advised that it was most likely from Moderna because had all Pfizer before, and they knew had received a high dose for the first time, but they were still leaning more towards potentially allergy. No other details were provided." Action taken: not applicable. Treatment: The patient was treated with Hydrocortisone on 06-Nov-2025 for Itch, at an unspecified dose and frequency; Prednisone from 08-Nov-2025 to 15-Nov-2025 for Skin infection, at a dose of 5 milligram once a day; Cefalexin (Keflex) from 08-Nov-2025 to 12-Nov-2025 for Skin infection, at a dose of 500 milligram once a day and Cetirizine hydrochloride (Cetirizine) from 08-Nov-2025 to 15-Nov-2025 for Skin infection, at a dose of 2 milligram once a day. The reporter instructed to use ice for swelling. At time of reporting, the outcome was Recovered / Resolved on 08-Nov-2025 for the events.
Drug allergy