Received Jan 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Z003579 | OT / RA |
ARTHRALGIA; INJECTION SITE SWELLING; NECK PAIN; LYMPH NODE PAIN; INJECTION SITE PAIN; PAIN; Information has been received via Vaccine Adverse Event Reporting System (agency # 2870660-1) on 28-Jan-2026. This spontaneous report refers to a 59-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported. On 28-Oct-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 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 the right arm, for prophylaxis. On 30-Oct-2025, the patient experienced injection site swelling, neck pain, lymph node pain, injection site pain, arthralgia and pain. At the reporting time, the patient had not recovered from the events. The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2026-01-28 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2870660 , Central date : 2026-01-28 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :