Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Z005765 | OT / RA |
CHILLS; FATIGUE; HEADACHE; INDURATION; INJECTION SITE PAIN; PAIN IN EXTREMITY; PERIPHERAL SWELLING; Information has been received from Food and Drug Administration (FDA) and refers to 57-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and ibuprofen . On 02-Jun-2025, the patient was vaccinated with the first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Z005765, expiration date: 23-Nov-2026), administered by intramuscular route in right arm as prophylaxis. The patient messaged in stating: It hurt quite a bit at the time of vaccination, but did not think anything of it. On 03-Jun-2025 (approximately 24 hours after vaccination), the patient experienced fatigue (Severe), chills, headache, induration, injection site pain, pain in extremity and peripheral swelling. The patient's arm has continued to hurt since, is swollen and hard and is red 1/4 down my arm now. She was advised to be seen for potential cellulitis. She had office visit at walk-in clinic on 05-JUN-25 for cellulitis, and emergency room (ER) visit on 06-JUN-25 for concerns this is worsening. The patient was placed on antibiotics. 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 Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.; Sender's Comments: Priority : 5 , Is case serious : No Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2844223 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Medical History/Concurrent Conditions: Depression
Wellbutrin; ibuprofen