Reporte zur Charge U68078BA

Symptomtext

This spontaneous report was received from a nurse prescriber referring to a 11-year-old female patient. Concomitant therapies included MENACTRA and ADACEL. The patient had no pertinent medical history or drug reactions/ allergies. On 29-MAR-2021 the patient was vaccinated with the first dose of GARDASIL 9 (lot # T026954, expiration date 13-APR-2022, 0.5 milliliter, once) via intramuscular for vaccination. On 29-MAR-2021, the patient experienced seizure like tonic-clonic movement with syncope after receiving first dose of GARDASIL 9 along with MENACTRA and ADACEL. The patient recovered after 15 minutes (on 29-MAR-2021). The patient was given cool compress and maintained a supine position as treatment. No lab diagnostics/studies were performed. The patient had sought medical attention. The events were not cancer, and the patient was not overdose. Device was not available for evaluation (obtain was false). The causality between GARDASIL 9 and the events was not reported. Upon internal review, seizure like tonic-clonic movement with syncope were determined to be medically significant. Combination product report: Yes; Brand name: GARDASIL 9 SYRINGE (DEVICE); common device name: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp. device lot number: T026954; expiration date: 13-APR-2022; device age and unit: 0 ; malfunction: Unknown; product available for evaluation: No; device usage: Initial; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp reprationale: Case information does not suggest a causal association with the device or device constituent.