Received Mar 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | 1 | — | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | — | IM / RA |
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | IM / LA |
| 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 |
Bursitis; Joint swelling; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2025-NVX-US-00214 (Novavax). A 75-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 03Jan2025 as dose 1, single (Batch/Lot number: unknown) intramuscular for immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 03Jan2025 as dose 1, single) intramuscular for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 03Jan2025 as dose 1, single) intramuscular for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN; TYLENOL; VITAMINS NOS; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]; OMEPRAZOLE. The following information was reported: BURSITIS (medically significant) with onset 18Jan2025, outcome "unknown"; JOINT SWELLING (non-serious) with onset 18Jan2025, outcome "unknown". Therapeutic measures were taken as a result of bursitis. Clinical course: On 07Feb2025, a non-serious initial Regulatory Authority report was reported by a consumer or other non health professional via Centers of Disease Control and Prevention via Vaccine Adverse Event Reporting System (VAERS ID: 2825282-1) and was received by Novavax on 17Mar2025 and concerns a 75 year-old female who experienced JOINT SWELLING and BURSITIS on 18Jan2025 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on 16 Day. FLUZONE HIGH DOSE and ABRYSVO were also considered suspect. Treatment included Joint fluid drainage and Medrol. At the time of the report, the outcome of the events of Joint swelling, Bursitis was Unknown. The CDC's adverse event description (narrative) was provided as follows: Don't know that elbow bursitis is a reaction. Swelling of elbow. It was drained today and Medrol was prescribed. A discrepancy was identified where the event of Joint fluid drainage was captured as a treatment based on the information provided in the adverse event description section of the source document. Company Remarks (Sender's Comments) : This 75 year-old female experienced Joint swelling and Bursitis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Joint swelling was reported as non-serious. The event Bursitis was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between the vaccine and the events is considered Possible. Batch/lot number is not provided, and it cannot be obtained.
ROSUVASTATIN; TYLENOL; VITAMINS NOS; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]; OMEPRAZOLE