Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y019158 | OT / RA |
REDNESS; ITCHINESS AT INJECTION SITE; LOCAL SWELLING; Information has been received from the Food Drug Administration (FDA) (agency number 2849342-1) on 16-SEP-2025. This spontaneous report refers to a 81-year-old female patient. The patient's medical history was not reported. The patient's medical history included diabetic and high blood pressure. Concurrent conditions and concomitant therapies were not reported. On 05-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (valid lot #Y019158, expiration date: 20-May-2026) administered by intramuscular route in right arm for prophylaxis. On 05-Jul-2025, the patient experienced local swelling (injection site swelling), redness (injection site erythema) and itchiness at injection site injection site (injection site pruritus). The patient had improved and helped with icing. The patient recovered from all the events on an unspecified date. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXINE) regarding the events was not applicable. The causal relationship between all the events and the suspect vaccine was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-09-16 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2849342 , Central date : 2025-09-16 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Medical History/Concurrent Conditions: Blood pressure high; Diabetic