Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | Y019459 | — |
heart failure exacerbation; This spontaneous report was received from a physician and refers to a 56-year-old male patient. The reporter stated that the patient was a Clinical Study participant enrolled in clinical trial for "GARDASIL 9" (however, no information regarding the study was reported). The patient's medical history was not reported. As concurrent conditions was reported "history" of heart failure. Concomitant therapies were not reported (discrepant information also reported that the patient "running out of medication" an unspecified medication). On 21-May-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y019459, expiration date: 16-Feb-2027), dose number 1, (First Dose) (anatomical location and administration route were not reported) as prophylaxis. On 07-Jul-2025 (reported as "after a couple of weeks"), the patient experienced heart failure exacerbation. The reporting physician stated that patient was then admitted to the hospital on the same date 07-Jul-2025 for heart failure exacerbation due to "running out of medication". The reporter did not provide name of medication. During the hospitalization, some laboratory tests were performed (Aspiration of joint, blood work, X-Ray and computerized (CT) scan) but results were not provided. The patient recovered from the event on 11-Jul-2025 and was discharged from hospital on the same date. The physician stated that the event did not seem to be linked to vaccine with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and categorized the heart failure exacerbation as serious, however reiterated the hospitalization appears to be due to running out of medication and not linked to vaccine.; Sender's Comments: Based on the clinically relevant information currently available for this individual case, the reported event of cardiac failure is considered unlikely related to the GARDASIL 9 vaccine. The evidence is not sufficient to suggest a relationship between the vaccine and the reported serious adverse event. The causality assessment is impacted by the confounding factors of the patient's concurrent condition of heart failure and the mentioned etiology of exacerbation as being out of medication. No changes to the product safety information are warranted at this time. Merck Sharp & Dohme LLC continues to monitor the safety profile of the product
Heart failure