Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
pretty bad headache; spot on my arm/white in the center and red around that white dot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PUSTULE (spot on my arm/white in the center and red around that white dot) and HEADACHE (pretty bad headache) in a 73-year-old female patient 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: COVID-19 shot. Past adverse reactions to the above products included No adverse effect with COVID-19 shot. Concurrent medical conditions included Rotator cuff tear. On 24-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced VACCINATION SITE PUSTULE (spot on my arm/white in the center and red around that white dot). On 25-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced HEADACHE (pretty bad headache). In 2025, HEADACHE (pretty bad headache) had resolved. At the time of the report, VACCINATION SITE PUSTULE (spot on my arm/white in the center and red around that white dot) was resolving. No concomitant medication was reported. Patient had unsure when she took the vaccine either on Thursday 23-Oct-2025 or Friday 24-Oct-2025. Later confirmed, she had received her vaccine about a week ago on Friday, it had been a little over a week, and patient still had a spot on her arm. It was white in the center and red around that white dot, and patient never had a reaction to any of the other COVID shots. This was the only thing. Patient was not sure which Moderna COVID19 vaccine she received (mnexspike or Spikevax). It was still there, but it looked better. The day after, patient had a pretty bad headache but it went away but patient knew those were normal side effects so that did not bother her, but these never happened and patient had all the shots. Patient also had a torn rotator cuff and would get a steroid injection on 05-Nov-2025. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.
Rotator cuff tear