Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM / LA |
no appetite; Patient had huge swelling, the size of a goose egg, it was very hot, very red; Patient had huge swelling, the size of a goose egg, it was very hot, very red; Patient had huge swelling, the size of a goose egg, it was very hot, very red; very sore to touch on her arm, where the injection went in (left arm)/tenderness in her arm; incredible fatigue; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), VACCINATION SITE WARMTH (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE ERYTHEMA (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE SWELLING (Patient had huge swelling, the size of a goose egg, it was very hot, very red) and VACCINATION SITE PAIN (very sore to touch on her arm, where the injection went in (left arm)/tenderness in her arm) in a 67-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse effect with Pfizer. Concurrent medical conditions included Celiac disease (Patient had it for 35 years). On 21-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 22-Sep-2025, the patient experienced DECREASED APPETITE (no appetite), VACCINATION SITE WARMTH (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE ERYTHEMA (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE SWELLING (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE PAIN (very sore to touch on her arm, where the injection went in (left arm)/tenderness in her arm), FATIGUE (incredible fatigue), HEADACHE (headache) and NAUSEA (nausea). In 2025, DECREASED APPETITE (no appetite), HEADACHE (headache) and NAUSEA (nausea) had resolved. At the time of the report, VACCINATION SITE WARMTH (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE ERYTHEMA (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE SWELLING (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE PAIN (very sore to touch on her arm, where the injection went in (left arm)/tenderness in her arm) and FATIGUE (incredible fatigue) had not resolved. No concomitant medications were provided. It was reported that she usually got Pfizer vaccine. It was reported that she got sicker than she ever had with any vaccine in all of her 67 years. Her symptoms started the day after the vaccine. Most of her side effects were abated but she was going into week 3 now and she still had incredible fatigue. It also reported that she had huge swellings, the size of a goose egg, it was very hot, very red and very sore to touch on her arm, where the injection went in (left arm). She had extreme fatigue and could not even get out of bed, only to use the bathroom. She had a headache, nausea, absolutely no appetite and no fever. She still had some of them, but the worst of the symptoms lasted a week and a half. She still had tenderness in her arm and a pink outline of where that goose egg was. She still had fatigue, but it was better to the point where she can get out of bed, but it was a good thing she was not working or else she would have been in real trouble. She was surprised that she so violently reacted to the vaccine. Patient thought to herself, what in the heck did they put in that vaccine to be that sick. The patient never had COVID. It was unusual for her to get that from a vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided.
Celiac disease (Patient had it for 35 years)