Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052035 | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8874BA | IM / LA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z007870 | IM / LA |
Patient's arm below vaccine sites is red and warm/Injection site erythema; Patient's arm below vaccine sites is red and warm/Injection site warmth; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Patient's arm below vaccine sites is red and warm/Injection site erythema) and VACCINATION SITE WARMTH (Patient's arm below vaccine sites is red and warm/Injection site warmth) in a 65-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052035) for COVID-19 prophylaxis. Suspect product included Pre-filled Syringe injection (batch no. 3052035) for COVID-19 prophylaxis and co-suspect non-company products included Influenza vaccine inact split 3v (Fluzone high dose) for an unknown indication and Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication. Concurrent medical conditions included Heart disorder (HEART). Concomitant products included Testosterone, Colecalciferol (Vitamin d3), Tamsulosin hydrochloride (Tamsulosin), Lidocaine hydrochloride (Lidocaine), Tadalafil, Fluoxetine hydrochloride (Fluoxetine), Clopidogrel bisulfate (Clopidogrel) and Metoprolol tartrate (Metoprolol) for an unknown indication. On 08-Nov-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form, dose of Influenza vaccine inact split 3v (Fluzone high dose) (Intramuscular use) 1 dosage form and dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 09-Nov-2025, the patient experienced VACCINATION SITE ERYTHEMA (Patient's arm below vaccine sites is red and warm/Injection site erythema) and VACCINATION SITE WARMTH (Patient's arm below vaccine sites is red and warm/Injection site warmth). At the time of the report, VACCINATION SITE ERYTHEMA (Patient's arm below vaccine sites is red and warm/Injection site erythema) and VACCINATION SITE WARMTH (Patient's arm below vaccine sites is red and warm/Injection site warmth) outcome was unknown. Treatment information was not reported.
Heart disorder (HEART)
Testosterone; Vitamin d3; Tamsulosin; Lidocaine; Tadalafil; Fluoxetine; Clopidogrel; Metoprolol