Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
aches; muscle and joint pain; 103.5 fever; severe chills; muscle and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), ARTHRALGIA (muscle and joint pain), PYREXIA (103.5 fever), CHILLS (severe chills) and MYALGIA (muscle and joint pain) in a female patient of an unknown age who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 02-Dec-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 03-Dec-2025, the patient experienced PAIN (aches), ARTHRALGIA (muscle and joint pain), PYREXIA (103.5 fever), CHILLS (severe chills) and MYALGIA (muscle and joint pain). At the time of the report, PAIN (aches), PYREXIA (103.5 fever), CHILLS (severe chills) and MYALGIA (muscle and joint pain) was resolving and ARTHRALGIA (muscle and joint pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2025, Body temperature: 103.5. On 03-Dec-2025, SARS-CoV-2 test: Negative. On 04-Dec-2025, Body temperature: 102.4. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as unknown. The patient received the COVID vaccine on Tuesday evening at MNEXSPIKE 2025-26. The next day, at noon, the patient had side effects: 103.5 fever, severe chills, aches, muscle and joint pain. That came suddenly. 03-Dec-2025, night the patient had a Covid/Flu nasal swab test, which came out negative. On 04-Dec-2025, the oral temp was still 102.5, a bit lower, chills not as bad as the previous day. The patient was lying low on the day of reporting, hydrating, joint pain worse. The patient had no congestion and no cough. The patient was able to taste and smell, so hoping just to wait out the side effects. The patient did not take Tylenol on the 03-Dec-2025 or 04-Dec-2025, hoping not to diminish her immune system. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. The reported causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-792259 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-792259:Husband case
Test Date: 20251203; Test Name: Body Temperature; Result Unstructured Data: 103.5; Test Date: 20251204; Test Name: Body Temperature; Result Unstructured Data: 102.4; Test Date: 20251203; Test Name: COVID/Flu Nasal Swab; Test Result: Negative