Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Z002437 | — |
No AE/PQC; poor quality device administered; syringe broke off on the Luer Lock area; This spontaneous report was received from a/an Pharmacist and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 11-Sep-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Z002437, expiration date: 11-Aug-2027) 1 dosage form (exact dose, anatomical location and route of administration were not reported) as prophylaxis. On the same date, syringe broke off on the Luer Lock area (Syringe broken) (Poor quality device administered). At the reporting time, the outcome of syringe broke off on the Luer Lock area and poor quality device administered was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was reported as not applicable. This is an invalid case due to lack of patient's identifier. Follow-up information was received from the reporter on 15-Sep-2025. There was no adverse event. Reporter sent pictures associated with this case. No additional information.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02871963-02871960 , CLIC number : , ESTAR number : , IRMS number : 500UW00000lPYmdYAG|16092025230034|2948 , Central date : 2025-09-17 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2329675 , MNSC case number : 02871963 , MNSC interaction number : 02871960 , Integration log UniqueID : 500UW00000lPYmdYAG|16092025230034|2948 , Service cloud CaseID : 500UW00000lPYmdYAG