Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Z002626 | IM / RA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z002626 | OT |
patient developed a rash and cellulitis on the arm where the vaccine was administered; patient developed a rash and cellulitis on the arm where the vaccine was administered; The spontaneous report was received from a nurse referring to a 54-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant therapy, drug Reactions and allergies were not reported. On 18-Apr-2025, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) Injection (CAPVAXIVE) 168 mcg/ml (vaccination scheme frequency, anatomical location, and dose were not reported) (lot #Z002626, expiration date was not reported, but upon internal validation established as 04-Sep-2026) administered by intramuscular (IM) route for prophylaxis. Approximately 3 days after administration (on 21-Apr-2025), the patient developed a rash and cellulitis on the arm where the vaccine was administered. The reporter reported treatment was not necessary and the patient has now recovered from both events. No additional details reported. The causal relationship between both events and Hepatitis B Vaccine (Recombinant) (CAPVAXIVE) was unknown.