Age: 12.0
Sex: F
Vaccine: HEP, HPV9, IPV, TD
Symptoms: Fall, Head injury, Posture abnormal, Syncope
Clinical narrative: hit head on floor/ hit her forehead; patient was slumping down and fell out of chair, fainted slid out of the chair; This spontaneous report was identified from a line listing obtained on request by the Company from the FDA (Agency number 826528) under the Act as received from a health professional referring to a 13-year-old female patient. It was unknown if there were prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination, or allergies. The patient had no other illnesses at the time of vaccination and up to one month prior or chronic or long-standing health conditions.   On 01-AUG-2019 at 10:30, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose not reported) lot number 1602283, expiration date was not provided but upon internal validation it was established as 18-AUG-2021, intramuscularly in right arm; with the third dose of Hepatitis B Vaccine (Recombinant) thimerosal free (RECOMBIVAX HB) (exact dose not reported; ) lot number R021372, expiration date was not provided but upon internal validation it was established as 25-MAY-2021, intramuscularly in right arm; with the third dose of diphtheria toxoid, tetanus toxoid (TENIVAC) (exact dose and expiration date were not reported) lot number U6091AA, intramuscularly in left arm; and with the third dose of poliovirus vaccine inactivated (Vero) (IPOL) (exact dose and expiration date were not reported) lot number P1E701M, subcutaneously in the left arm., all for prophylaxis.  On the same day at 10:35, after receiving injections, the patient was sitting in chair while they were completing Immunization paper work. Looked over and patient was slumping down and fell out of chair, fainted and hit head on floor. Patient was assisted up, ice pack was applied to head, no open wounds no lumps noted. The outcome of head injury and syncope was reported as resolved.   The Agency did not assess the causality between the events and the suspect therapies.   Follow-up information has been received from the health care professional on 01-SEP-2020. The patient details were updated, she was 12-year-old at the time of vaccination. HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), Hepatitis B Vaccine (Recombinant) thimerosal free (RECOMBIVAX HB) and diphtheria toxoid, tetanus toxoid (TENIVAC) were administered in deltoid. Expiration date of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was reported as 16-AUG-2021. Expiration dates of poliovirus vaccine inactivated (Vero) (IPOL) and diphtheria toxoid, tetanus toxoid (TENIVAC) were 09-NOV-2020 and 12-OCT-2020, respectively.   The reporter consider faint and hit head on floor to be related to suspected vaccines. The events were assessed by the reporter to be important medical events. 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1602283; expirationdate: 18-AUG-2021; 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