Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
had some swelling at the injection site immediately after the injection.; had redness and swelling of the arm and it had "migrated down the arm towards the elbow"; had redness and swelling of the arm and it had "migrated down the arm towards the elbow"; arm was slightly warm to the touch; This spontaneous report was received from a pharmacist via Company representative concerning to a female patient of unspecified age. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On approximately 17-FEB-2025 (reported as "approximately 2 weeks ago"), the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection pre-filled syringe, 1 dosage form (dosage regimen, lot #, route of administration and expiration date were not reported) administered in an unspecified arm as prophylaxis. On the same date, immediately after the injection, the patient had some swelling at the injection site (vaccination site swelling). Pharmacist reported the patient then came back a week later and since an unspecified date in February 2005, she still had redness (vaccination site erythema) and swelling of the arm, and it had "migrated down the arm towards the elbow" (extensive swelling of vaccinated limb). Pharmacist stated arm was slightly warm to the touch (vaccination site warmth), but she did not think it was an infection, so she gave the patient some diphenhydramine (BENADRYL), and told her to ice the swelling and keep an eye on it. At the reporting time, the outcome of the events was not known, as pharmacist had reached out to the patient a couple of times since, but had not been able to get a hold of them to check in. No additional information was available. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. Lot # is being requested and will be submitted if received.