Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
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 VACCINATION SITE WARMTH (sore arm where the shot was given, and it is red and warm to the touch), VACCINATION SITE ERYTHEMA (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 SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect products included non-company products Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication and Influenza vaccine for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form, dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (sore arm where the shot was given, and it is red and warm to the touch), VACCINATION SITE ERYTHEMA (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, VACCINATION SITE WARMTH (sore arm where the shot was given, and it is red and warm to the touch), VACCINATION SITE ERYTHEMA (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. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. 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-2025-790527 (Patient Link). Reporter did not allow further contact