Sex: M
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Medication error
Clinical narrative: Bilirubin was high; GARDASIL 9 was inadvertently given to a patient who was pregnant; Information has been received from a physician, for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), a Pregnancy Registry product, concerning a 14-year-old female patient (mother) and a male infant patient. The mother's concurrent conditions included depression and suicidal ideation. The mother's concomitant medication included ethinyl estradiol (+) norgestimate for abnormal menses. The mother had no previous drug allergies or reactions.       On 13-MAR-2017, the mother was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 intramuscular injection as prophylaxis (strength, anatomical location, lot number and expiration date were not reported).  On an unspecified date, the mother experienced irregular bleeding (menstruation irregular).  The mother presented to the physician's office on 31-JAN-2020 for a well child exam and was due to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine, then the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), Lot # R029512, expiration date on 08-JUL-2021, intramuscularly, in the right deltoid, for prophylaxis, was administered (inappropriate schedule of product administration). No other vaccines were administered within 4 weeks prior to the vaccination date. The mother was vaccinated at private Doctor's/Office/Hospital, the vaccine was purchased with private funds. She denied being sexually active. After vaccine was given, the mother discussed abnormal menses, and it was decided to start medroxiprogesterona (DEPO-PROVERA) injection. A urine pregnancy test was given prior to medroxiprogesterona (DEPO-PROVERA) injection but the test resulted positive. Medroxiprogesterona (DEPO-PROVERA) injection was not administered. During the office visit, it was discussed possible complications of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine while pregnant (foetal exposure during pregnancy). The last menstrual period (LMP), the estimated date of delivery (EDD), and the estimated date of conception were not reported. The mother delivered a male infant with weight 7lbs 15ozs and height 205mm. The pregnancy outcome was live birth. The delivery type was not provided. The infant patient was normal and the APGAR scores were 8 at one minute and 9 at five minutes. On an unknown date in 2020, the infant's bilirubin was high. He went under bili light therapy.  The outcome of foetal exposure during pregnancy was recovered. The outcome of bilirubin high was unknown. The causal relationship between the suspect vaccine and the events was not reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029512; expirationdate: 08-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2002USA000615: