Received Mar 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | 1 | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | — | OT |
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | OT |
Joint swelling; Bursitis; Initial information received on 25-Mar-2025 regarding an unsolicited valid non-serious courtesy case received from a consumer/ Non-Healthcare Professional. This case involves a 75 year old female patient who experienced joint swelling and bursitis after receiving influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone High Dose], COVID-19 vaccine prot. subunit (NVX CoV 2373) [Novavax COVID-19 Vaccine] and RSV vaccine prot. subunit PreF 2v [Abrysvo]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rosuvastatin; Omeprazole; Chondroitin sulfate, Glucosamine hydrochloride (Osteo bi-flex) for Product used for unknown indication; Vitamins NOS; and Paracetamol (Tylenol) all for Product used for unknown indication. On 03-Jan-2025, the patient received an unknown dose 1 of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via intramuscular route in unknown administration site for prophylactic vaccination, received an unknown dose 1 of Abrysvo not produced by Sanofi Pasteur Injection (strength, expiry date and lot number not reported) via intramuscular route in unknown administration site for prophylactic vaccination and received an unknown dose 1 of Novavax COVID-19 Vaccine not produced by Sanofi Pasteur lot number not reported via intramuscular route in unknown administration site for COVID-19 immunization. On 18-Jan-2025 the patient developed joint swelling and bursitis (latency- 15 days). Information on the batch number cannot be requested corresponding to the one at time of event occurrence. Reportedly, swelling of elbow. Action taken was not applicable. The patient was treated methylprednisolone (MEDROL A) and Joint fluid drainage for both the events. At time of reporting, the outcome was Unknown for both the events.
Rosuvastatin; Omeprazole; Osteo bi-flex; Vitamins nos; Tylenol