Received Dec 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z003579 | OT / RA |
INJECTION SITE ERYTHEMA; INJECTION SITE SWELLING; INJECTION SITE PAIN; Information has been received from FDA via Vaccine Adverse Event Reporting System (agency # 2856948) on 22-DEC-2025. This spontaneous report refers to a 51-year-old female patient. The patient's medical history included migraines. The patient's concurrent conditions included Egg allergy. Concomitant therapies were not reported. On 29-Aug-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine, lot #Z003579 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 07-Sep-2026. (Dose 1), administered by Intramuscular route in Right Arm for prophylaxis. On 01-sep-2025, the patient experienced injection site swelling, the patient experienced injection site erythema (conflicting information, also reported as redness of arm, below and down past elbow) and injection site pain. Reported as very tender and swollen. Pt went to the doctor on 04-Sep-2025 and received antibiotics. At the reporting time, the outcome of the events was unknown. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : @merck.com , Index date : 2025-12-22 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2856948 , Central date : 2025-12-22 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Egg allergy
Medical History/Concurrent Conditions: Migraine