Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | OT / LA |
The patient did not complain about the injection or any other issues.; The pharmacist is unsure if the problem was the prefilled Gardasil 9 syringe or something else but a significant amount of the medication came out of the injection site.; significant amount of the medication came out of the injection site; Does the syringe have a broken component? YES; The cap came off of the the syringe prior to administration and the pharmacist needed to put the cap and the syringe in the sharps container/LUER LOCK DETACHED; This spontaneous report was received from a Pharmacist and refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant therapies were not provided. On 26-APR-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9), administered by intramuscular route in the left arm for prophylaxis (lot # and expiration date were not reported). The pharmacist was unsure if the problem was the prefilled Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) or something else, but a significant amount of the medication came out of the injection site (Accidental underdose); it leaked from the same location, also potentially due to a luer lock breakage during administration, however HCP could not confirm the exact malfunction (Syringe issue, Poor quality device used). The patient did not complain about the injection or any other issues (No adverse event). The pharmacist also stated that another prefilled syringe of the suspect vaccine from the same box had an issue, but was not administered to a patient; the luer lock fell off and became detached from the rest of the syringe/ the cap came off of the syringe prior to administration and the pharmacist needed to put the cap and the syringe in the sharps container (Device connection issue). The syringe carton was not damaged prior to use. The syringe tray was intact and undamaged on receipt. Products and pictures were not available. At the reporting time, the outcome of the events was not known. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported but established as not applicable.