Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM |
nausea; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 11-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) had not resolved. No concomitant medication was reported. The patient had nausea, headache, and chills. The patient did not experience any additional symptoms/events. Reporter causality was not reported. No treatment medication was reported. Reporter did not allow further contact