Received Jan 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 816743 | IM |
flu symptoms/cough/terrible chills/pounding headache/massive headache/body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms/cough/terrible chills/pounding headache/massive headache/body aches) in a 37-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 816743) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 816743) for COVID-19 prophylaxis. On 13-Jan-2026, 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 13-Jan-2026, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced INFLUENZA (flu symptoms/cough/terrible chills/pounding headache/massive headache/body aches). The patient was treated with Ibuprofen in January 2026 at an unspecified dose and frequency. At the time of the report, INFLUENZA (flu symptoms/cough/terrible chills/pounding headache/massive headache/body aches) had not resolved. The patient had no medical history, concomitant disease or risk factor. No concomitant medication was reported. It started off as flu symptoms about six hours after the patient received the vaccination. The patient proceeded to get a cough and had a terrible chill and a pounding headache. This was going on for over 48 hours and never had this reaction before. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. Patient have taken ibuprofen continuously to help with the chills, body aches, and massive headache.