Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
feeling under the weather; headaches/she stated headaches mainly; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling under the weather) and HEADACHE (headaches/she stated headaches mainly) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling under the weather) and HEADACHE (headaches/she stated headaches mainly). At the time of the report, MALAISE (feeling under the weather) and HEADACHE (headaches/she stated headaches mainly) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient got weaker reaction. She had headaches mainly and felt under the weather. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787139 (E2B Linked Report). This case was linked to MOD-2021-030965 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 29-May-2025: Live Follow up contains significant information received: event verbatim updated for headaches, Outcome of event feeling under the weather updated to recovered from unknown and reference added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787139:Mother case