Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure like phenomena
Clinical narrative: seizure like activity, arms clenched, body stiffened and unresponsive for several seconds; This report was identified from a line listing obtained on request by a health care professional on 18-AUG-2020 concerning a 13-year-old White hispanic or latino female patient. The patient's medical history included seizure like activity following unspecified vaccine. It was unknown if the patient had allergies to medications, food or other products or had chronic or long-standing health condition. Also, it was not mentioned that if the patient experienced illnesses at the time of the vaccination and up to one month prior.   On 22-AUG-2019, the patient was vaccinated at school or student health clinic with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose not reported) lot # R019470 expiration date not reported but upon internal validation established as 10-APR-2021, intramuscular in the right arm for prophylaxis.   On the same date "reported as after administration of the vaccine", the patient had seizure like activity, arms clenched, body stiffened and unresponsive for several seconds. It was mentioned that no medical test was performed, and laboratory results were not received.   At the time of the reporting, the outcome of seizure was reported as recovered on an unknown date in August 2019.  The reporter did not report causal relationship between adverse event and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  Follow up information has been received from a health care professional on 30-SEP-2020 concerning a healthy 13 years old female patient with normal growth and development. It was unknown if the patient had concomitant medications. Illness at the time of the vaccination were reported as none as well as pre-existing physician diagnosed allergies, birth effects or medical conditions. It was unknown if the patient had any brothers or sisters. It was reported that 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) intramuscularly in the right deltoid. It was mentioned that this vaccine was purchased with public funds. The expiration date of the vaccine was confirmed as 10-APR-2021. Temperature excursion did not occur as a result of a reading from a Digital Data Logger.   The patient had seizure like activity that lasted for less than 2 minutes and following the episode the patient was allowed to lay down, rest and get water. She was feeling better and able to proceed with "unable word to read" of visit. 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: R019470; expirationdate: 10-APR-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