Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
sore arm where the shot was given, and it is red and warm to the touch; sore arm where the shot was given, and it is red and warm to the touch; feels tired; sore arm where the shot was given; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (sore arm where the shot was given, and it is red and warm to the touch), FEELING HOT (sore arm where the shot was given, and it is red and warm to the touch), FATIGUE (feels tired) and VACCINATION SITE PAIN (sore arm where the shot was given) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Flu shot, Flu shot, Flu shot, Pfizer, Pfizer, Pfizer, Pfizer and Flu shot. Past adverse reactions to the above products included Localised erythema with Flu shot and Pfizer; Localised feeling of warmth with Flu shot and Pfizer; Tiredness with Flu shot and Pfizer; and Vaccination site pain with Flu shot and Pfizer. On an unknown date, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced ERYTHEMA (sore arm where the shot was given, and it is red and warm to the touch), FEELING HOT (sore arm where the shot was given, and it is red and warm to the touch), FATIGUE (feels tired) and VACCINATION SITE PAIN (sore arm where the shot was given). At the time of the report, ERYTHEMA (sore arm where the shot was given, and it is red and warm to the touch), FEELING HOT (sore arm where the shot was given, and it is red and warm to the touch), FATIGUE (feels tired) and VACCINATION SITE PAIN (sore arm where the shot was given) had resolved. No concomitant medication was reported. She had received COVID shots twice a year since they had been offered. She received Pfizer at the beginning but then switched to Moderna since she thinks she had a better response from the Moderna product. The patient definitely felt the effects of the vaccine and if this was what the vaccination was like, she really did not want COVID. The patient had noticeable effects every single time she received a COVID vaccination, and it didn't 'slam her' but it woke up her immune system and, like it said, 'pay attention', which means it was really working. The patient experienced a sore arm where the shot was given, and it was red and warm to the touch. She did not experience a fever, but felt tired, but was still fully functionable. She experienced these effects for the first 48 hours and considered these to be "normal side effects." Her experience wasn't any different to her than every other COVID shot she's had, nor was it different from every other flu shot she's ever had. It's nothing extreme; she was not passing out or having extreme reactions. The reporter declined to provide any additional details. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not provided. This case was linked to MOD-2025-790756 (Patient Link). Reporter did not allow further contact