Received Feb 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z012682 | — |
no effects reported. / No additional AE; syringe did not have the usual connection for attaching a needle and referred to the missing connection as "needle hub and tip cap"; Caller reports when he pushes the plunger product does leak out of the affected syringe.; Caller reported a small amount of the product leaked on his skin and the area was washed immediately with no effects reported; This spontaneous report was received from a pharmacist and refers to himself, a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-Feb-2026, one Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) syringe (lot # Z012682, with valid expiration date reported as 24-May-2027) (dose, route of administration and vaccination site were not reported) did not have the usual connection for attaching a needle and the missing connection was referred to as "needle hub and tip cap" (device connection issue). The reporter was not certain of the components name. There was no place to attach the needle. Only one Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) syringe was affected and the other 9 syringes all appeared to be normal. When the pharmacist pushed the plunger, product did leak out of the affected syringe (syringe issue). A small amount of the product leaked on the pharmacist's skin and the area was washed immediately with no effects reported (occupational exposure to product; no adverse event). The product was available for retrieval. No additional adverse event (AE) and no product quality complaint (PQC) was noted.