Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
weakness; muscle pain; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), MYALGIA (muscle pain), FATIGUE (fatigue) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 09-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 09-Oct-2025, the patient experienced ASTHENIA (weakness), MYALGIA (muscle pain), FATIGUE (fatigue) and HEADACHE (headache). On 10-Oct-2025, ASTHENIA (weakness), MYALGIA (muscle pain), FATIGUE (fatigue) and HEADACHE (headache) had resolved. The patient's date of birth was reported as December 1970. No concomitant medications were reported. It was reported that, approximately 6 hours after receiving COVID booster, began feeling muscle pain, weakness, fatigue and headache that was similar to a very bad case of the flu. It came on very suddenly and was quite severe. She did not have a fever. Lasted approximately 12 hours then wore off and she was completely fine. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.