Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | 2 | 6315MF002C | OT / RA |
little sore in arm; Initial information received on 17-Oct-2025 and 20-Oct-2025 processed together with agency 17-Oct-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 73 years old female patient (59.09 kg) who had little sore in arm after receiving NVX-COV2373 (original) adjuvanted vaccine [Nuvaxovid]. The patient's past vaccination(s) included NUVAXOVID on 01-NOV-2024 and INFLUENZA VACCINE on 02-OCT-2025 (Lot Number: Not provided; Route: Intramuscularly; Body site: Right arm; Dose in number of series: Not provided.) The patient's past medical history, past medical treatment and family history were not provided. Medical history and other illnesses at the time of vaccination and up to one month prior: No Allergies to drugs, food or other products: No Concomitant medications included Atorvastatin (Atorvastatin) for Blood cholesterol abnormal; and Raloxifene hydrochloride (Evista) for Osteoporosis. Consumer stated, "I take a bone pill raloxifene, which I think is Evista. It's for bones, for osteoporosis. I take a vitamin, I was taking a cholesterol, atorvastatin. I take a vitamin B2 or B12, calcium. And then I take a Redoxon, which is vitamin C." On 16-Oct-2025, the patient received unknown dose (dose 2) of suspect NVX-COV2373 (original) adjuvanted vaccine, Injection (strength; Not reported; lot 6315MF002C; Expiration Date: 31-DEC-2025) via intramuscular route in the right arm for prophylactic vaccination. On 16-Oct-2025 on same day the patient had little sore in arm (pain in extremity). Consumer called and stated, "I had that company on the other line, so I apologize. I hope you were going to call me today. I'll answer any of your questions, but I do have a question for you. I got the one vaccine, the Novavax on Thursday, okay: Today is Monday. Do I need to get a second Novavax? I had a Novavax vaccine last year, November 1st of 2024. And now I got another one Thursday. Do I need to get another one, a booster or anything else? And I'm 73 years old." Regarding the pain in the arm the patient received the vaccine, consumer stated, "I didn't really have any pain. I mean, it was a little sore. I mean, I could feel it, but it was no, it was not a, it was not noticeable. It wasn't a problem." Action taken: Not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Recovered / Resolved on unknown date in October 2025 for the event.
Atorvastatin; Evista