Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Hearing loss; Raised blisters on left arm; Abdominal cramps; Fever; Headache; Clogged feeling in the left ear; Body aches; Severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss), BLISTER (Raised blisters on left arm), ABDOMINAL PAIN (Abdominal cramps), PYREXIA (Fever) and HEADACHE (Headache) in a 55-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. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. No Medical History information was reported. On 29-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 29-Sep-2025, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant), BLISTER (Raised blisters on left arm) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal cramps) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), EAR DISCOMFORT (Clogged feeling in the left ear), PAIN (Body aches) and DIARRHOEA (Severe diarrhea). At the time of the report, DEAFNESS (Hearing loss), BLISTER (Raised blisters on left arm), ABDOMINAL PAIN (Abdominal cramps), PYREXIA (Fever), HEADACHE (Headache), EAR DISCOMFORT (Clogged feeling in the left ear), PAIN (Body aches) and DIARRHOEA (Severe diarrhea) was resolving. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. Patient had no medical history, concomitant disease or risk factor. There were no lab data or results available. Patient did not experience any additional symptoms or events. Treatment information was not reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.