Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y013009 | OT / RA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 7ZM55 | OT |
DYSSTASIA; FEELING ABNORMAL; PAIN; Information has been received from a Regulatory Authority (agency # 2833086-1) and refers to a 68-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 20-MAR-2025, the patient was vaccinated with the first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), Injection, lot #Y013009, expiration date was not reported but upon internal validation, was established as 17-Nov-2025, administered by Intramuscular in her Right Arm; and with a dose of (Varicella zoster vaccine rgE (CHO)) (SHINGRIX), lot #7ZM55 (expiration date, dose and strength were not reported), administered by Intramuscular route in her right arm; both vaccines were administered for prophylaxis. On 21-MAR-2025, the Patient stated that she felt achy, tired and had difficulty getting up and about like being hatted with a baseball bat. Reaction did not improve, and she saw her physician 2 days following administration. The physician gave her two "shots", but she was not sure what they were. Patient started feeling two days following being seen by her physician. In March 2025, the patient recovered from the events. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine was not provided. However, it was stated that MD told her "definitely due to (Varicella zoster vaccine rgE (CHO)) vaccine".; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-05-13 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2833086 , Central date : 2025-05-13 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :