Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
COVID arm; Sore arm; Red rash around the injection site (unspecified which arm); Red rash around the injection site (unspecified which arm); Being tired the next day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (Red rash around the injection site (unspecified which arm)), VACCINATION SITE RASH (Red rash around the injection site (unspecified which arm)) and FATIGUE (Being tired the next day) in a 74-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Allergy NOS (Different allergies). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (Red rash around the injection site (unspecified which arm)), VACCINATION SITE RASH (Red rash around the injection site (unspecified which arm)) and FATIGUE (Being tired the next day). At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (Red rash around the injection site (unspecified which arm)), VACCINATION SITE RASH (Red rash around the injection site (unspecified which arm)) and FATIGUE (Being tired the next day) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. Previously, the patient received the Moderna COVID-19 shots. The products were okay in your vaccine, so the patient was right with that. The patient had quite a few of the Moderna COVID-19 shots in the past, saying she had it since the beginning but added she had done that only once and had the other one. The patient did not experience any additional symptoms/events. Treatment medication use information was not provided by reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-789965 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789965:Husband case
Allergy NOS (Different allergies)