Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC | PNEUMO (PREVNAR) | PFIZER\WYETH | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM |
her arm is swollen and excruciatingly painful; her arm is swollen and excruciatingly painful.; didn't have the energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm is swollen and excruciatingly painful), PERIPHERAL SWELLING (her arm is swollen and excruciatingly painful.) and ASTHENIA (didn't have the energy) in a 59-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Pneumococcal vaccine conj 7v (CRM197) (Prevnar) for an unknown indication. Concurrent medical conditions included Sjogren's. On 13-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter and dose of Pneumococcal vaccine conj 7v (CRM197) (Prevnar) (unknown route) .5 milliliter. In September 2025, the patient experienced PAIN IN EXTREMITY (her arm is swollen and excruciatingly painful), PERIPHERAL SWELLING (her arm is swollen and excruciatingly painful.) and ASTHENIA (didn't have the energy). The patient was treated with Naproxen for Inflammation, at an unspecified dose and frequency and Paracetamol (Tylenol) for Inflammation, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her arm is swollen and excruciatingly painful), PERIPHERAL SWELLING (her arm is swollen and excruciatingly painful.) and ASTHENIA (didn't have the energy) had not resolved. The concomitant medication was not reported by the reporter. On 13-Sep-2025, the patient received mNEXSPIKE 2025-2026 around 9:35 AM and reported that her arm was swollen and excruciatingly painful. She said that she went to a dental appointment, where it was pointed out that her arm was swollen and that she should go to the emergency room. She mentioned that she had worked all day and did not have the energy. She took naproxen for inflammation but had stopped it due to the pharmacist recommended Tylenol. It was unknown if the patient experienced any additional symptoms or events.
Sjogren's