Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 7+ | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
her arm started beginning to feel sore/her arm was so sore, it was so painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm started beginning to feel sore/her arm was so sore, it was so painful) in a 67-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 7, last vaccine before that was a year ago) in 2024, PFIZER BIONTECH COVID-19 VACCINE (Dose 2), PFIZER BIONTECH COVID-19 VACCINE (Dose 6), PFIZER BIONTECH COVID-19 VACCINE (Dose 4), PFIZER BIONTECH COVID-19 VACCINE (Dose 5), PFIZER BIONTECH COVID-19 VACCINE (Dose 1) and PFIZER BIONTECH COVID-19 VACCINE (Dose 3). Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. On 17-Oct-2025, the patient received eighth dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 17-Oct-2025, the patient experienced PAIN IN EXTREMITY (her arm started beginning to feel sore/her arm was so sore, it was so painful). On 19-Oct-2022, PAIN IN EXTREMITY (her arm started beginning to feel sore/her arm was so sore, it was so painful) had resolved. No concomitant medication was reported. It was mentioned she has an oncologist that she would see on Monday. Patient had only had Pfizer covid vaccines before mNEXSPIKE. It was stated so far, she did not fall sick, so it was fine, it was only a very sore arm, but it was fine. Patient received mNEXSPIKE in the morning of 17-Oct-2025 and late in the afternoon that day, her arm started beginning to feel sore. It was pretty sore for 2 days, and then it was fine. She did not get fever. She was worried she might get fever since it was a change from a different manufacturer. Patient has had 7 previous covid vaccinations. It was noted she got the influenza vaccine on the same day at the same time in the same arm as mNEXSPIKE and said maybe that was why her arm was so sore, why it was so painful. It was unknown if the patient experienced any additional symptoms/events. No treatment information as reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790469 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790469:Caller's friend