Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | NDC 80777-112-9 | IM |
chest congestion; light asthma; couldn't lift arm on injection; fever; chills; headache; muscle ache; This spontaneous case was reported by a physician and describes the occurrence of RESPIRATORY TRACT CONGESTION (chest congestion), ASTHMA (light asthma), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift arm on injection), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle ache) in a 30-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. NDC 80777-112-96) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 15-Sep-2025, the patient experienced RESPIRATORY TRACT CONGESTION (chest congestion) (seriousness criterion medically significant), ASTHMA (light asthma) (seriousness criterion medically significant), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift arm on injection) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant) and MYALGIA (muscle ache) (seriousness criterion medically significant). At the time of the report, RESPIRATORY TRACT CONGESTION (chest congestion), ASTHMA (light asthma), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift arm on injection), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle ache) was resolving. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.