Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | Y014059 | RA |
Hyperglycemia; This spontaneous report was received from a Nurse Practitioner regarding a 42-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included Insulin dependent diabetes. Historical drugs included Insulin. Concomitant therapies, past drug reactions and allergies were not reported. On 18-Feb-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection administered intramuscularly for prophylaxis (dose, vaccination scheme frequency, lot number, expiration date and anatomical site of injection were not reported). It was reported that on that same date, prior to the vaccination, the patient's blood sugar was 80 (units not provided) and approximately two hours after administering the vaccine, after the patient left the office, they called the HCP to report that her blood sugar had spike to 400 (units not provided) (Blood glucose increased). The reporter stated that no medical treatment was needed, and the patient just gave herself a bolus of insulin at home to bring the number down. At the time of the report, the patient was recovering from the event of Blood glucose increased. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. Follow up information was received from a nurse practitioner. Concomitant therapy included cabergoline, insulin pump, lexapro, metformin and levonorgestrel (MIRENA). Current conditions included also situsitis. Lot # of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was Y014059, espiry date was 01-NOV-2025, site was right deltoid. The event term was changed to hyperglycemia, it occurred two hours after vaccination. The patient received increased exogenous insulin and it was reported that the event was controlled. In approximately February 2025, the patient recovered from hyperglicemia. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was changed to possibly related.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : US-009507513-2256278 , Central date : 2025-02-24 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Insulin dependent diabetic; Sinusitis
lexapro; metformin; Mirena; cabergoline; insuline
Test Date: 20250218; Test Name: Blood sugar; Result Unstructured Data: spiked to 400 (units not provided); Test Date: 20250218; Test Name: Blood sugar level prior to vaccination; Result Unstructured Data: 80 (units not provided)