Age: 10.0
Sex: M
Vaccine: HPV9, HPV9, TDAP
Symptoms: Abdominal pain upper, Dehydration, Diarrhoea, Intensive care, Laboratory test normal
Clinical narrative: severe body aches; severe stomach aches; diarrhea; throw up; sepsis; he was in an induced coma for approximately 10 days; he was dehydrated to the point of death; This initial information was identified from a line listing obtained on request by the Company from the FDA (Agency number 867696) under the Freedom of Information Act, and was received from a consumer referring to a 10-year-old White male patient. The patient's concurrent conditions included mild asthma and hay fever. Concomitant medications included unspecified "asthma inhaler" and loratadine (CLARITIN). The patient had no other illnesses at the time of vaccination and up to one month prior, and had never had an adverse event following any previous vaccine.  On 10-APR-2019 at 3:00 hours, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in his arm (dose, route of administration were not reported;  lot number was reported as R011630, expiration date was not reported but upon internal validation established as 12-DEC-2020). Other suspect therapies included first dose of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) in his left arm (dose and route of administration were not reported; lot number was reported as U6141AB), both administered as prophylaxis.  On 12-APR-2019 at 7:30 hours, the patient experienced severe stomach aches (abdominal pain upper) and diarrhea. He would occasionally throw up (vomiting), and this went on for about 3 or 4 days. He had severe body aches (pain) and was taken to urgent care. The physician thought it was the patient's appendix, and referred the patient to the emergency room. In the emergency room, the patient was administered intravenous saline and several tests were performed; however, nothing was found and the patient was sent home.  On the next day, the patient continued vomiting and having diarrhea, so they took him back to the emergency room and he was admitted. On approximately 16-APR-2019 (also reported as "by Tuesday night") he was in the intensive care unit and was in an induced coma for approximately 10 days. The physicians could never figure out what the patient had. It was reported that they figured out that the patient was dehydrated "to the point of death" (dehydration), so they gave the patient an amount of fluids that were "too much and almost killed him" (also reported as "sepsis, I think they called it"). There were "too many" unspecified medical tests and laboratory results related to the adverse events done; however, no results were reported.  At the time of the report, the patient had recovered from dehydration, sepsis, coma, pain, abdominal pain upper, diarrhea and vomiting. The causality assessment between the suspect therapies and the aforementioned events was not reported.  The Agency considered the events to be life threatening, and they considered the events to be serious due to hospitalization.  As of 06-OCT-2020, all telephone attempts trying to obtain additional information had been unsuccessful. 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: R011630; expirationdate: 12-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent