Received Oct 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT |
The caller stated that the injection site itself was not itchy, but the edges of the redness were; Consumer calling to report an AE on CAPVAXIVE. Caller stated that she received CAPVAXIVE at her local pharmacy on 09/17/2025. The caller stated that she had the "typical reaction" at first including redness and soreness at the injection site; the "typical reaction" at first including redness and soreness at the injection site along with chills and fatigue; the "typical reaction" at first including redness and soreness at the injection site along with chills and fatigue; the "typical reaction" at first including redness and soreness at the injection site along with chills and fatigue; The caller stated that she suspects she had an allergic reaction to one of the components of the vaccine; This spontaneous report was received from a consumer or other non-health professional and refers to a(n) 63-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 17-Sep-2025, the patient was vaccinated with dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (formulation, lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. On the same day, the patient experienced vaccination site pain, vaccination site erythema, chills and fatigue. The caller stated that she had the "typical reaction" at first including redness and soreness at the injection site along with chills and fatigue. On 19-Sep-2025 (reported as: about a day and a half after receiving the vaccine), the patient experienced pruritus. It was reported that, the redness at the injection site spread to be about the size of a dollar bill. The caller stated that the injection site itself was not itchy, but the edges of the redness were. The caller stated that she did not speak with her HCP about this but would have if it got worse. The caller stated that she put Hydrocortisone cream on the area and that helped. On 22-Sep-2025, the patient recovering from the event of vaccination site erythema (the redness is just about gone). On an unknown exact day in September 2025, the patient experienced allergic reaction (the caller stated that she suspects she had an allergic reaction to one of the components of the vaccine). At the reporting time, the outcome of the events vaccination site pain, chills, fatigue, pruritus and allergic reaction was unknown. The causal relationship between the reported events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown/not reported/not provided.