Received May 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y013009 | OT / RA |
less range of motion due to discomfort; radiating pain of R shoulder; radiating pain of R shoulder; numbness from shoulder to fingers; less range of motion due to discomfort; Information has been received from the agency Food and Drug Administration (FDA) on 21-APR-2025 and refers to a(n) 51-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included chronic hip pain. Concomitant medications included gabapentin, paracetamol (TYLENOL) and ibuprofen. On 13-Dec-2024, the patient was vaccinated with the first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (valid lot #Y013009, expiration date: 17-Nov-2025), administered by Intramuscular route in Right Arm for Prophylaxis. On 03-Jan-2025, the patient adiating pain of R shoulder with numbness from shoulder to fingers. Patient also experiencing less range of motion due to discomfort. Per patient has not seeked medical attention for shoulder pain. referred patientto PCP for follow up. At the reporting time, the patient had not recovered from the events The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable. The causal relationship between the events and the suspect vaccine was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-04-21 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2825370-1 , Central date : 2025-04-21 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Pain in hip
Gabapentin; tylenol; IBU