Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
reported intense pain immediately after administration; swelling, raised rash and redness that spread several inches below injection site; swelling, raised rash and redness that spread several inches below injection site; severe lethargy; swelling, raised rash and redness that spread several inches below injection site; skin on her arm started peeling; This spontaneous report was received from a pharmacist via Company representative, concerning a female patient of unspecified age. The patient's medical history, past medications, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unspecified date in 2026, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) solution for injection, 0.5 mL administered by a healthcare professional as prophylaxis (dosage regimen, batch/lot#, expiry date, anatomical location and route of administration were not reported.) On unspecified date in 2026 (reported as "within the last 30 days") immediately after administration, the patient reported intense pain, followed by swelling, raised rash and redness that spread several inches below injection site (vaccination site swelling) (vaccination site rash) (vaccination site erythema). She also reported severe lethargy, and that on unspecified date in 2026, 4 days after her injection, the skin on her arm started peeling (skin exfoliation.) At the reporting time, the outcome of the events was not provided. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. This was one of two reports received from the same reporter.