Sex: F
Vaccine: FLUC4, HPV9
Symptoms: Dyskinesia, Joint hyperextension, Lip discolouration, Loss of consciousness, Muscle contractions involuntary
Clinical narrative: One leg was extended and stiff and her arms were pulled into her chest with stiffness and jerking; Blacked out; Unwitnessed seizure-like activity; She seemed as if she was not there/father was touching pts face and asking if she was okay but was ""unresponsive""; Feeling nauseous; Patient was very pale appearing; Vasovagal syncopal episode; Child's lips were pale and white; One leg was extended and stiff and her arms were pulled into her chest with stiffness and jerking; Flucelvax and Gardasil 9 were both administered in the right arm; Information has been downloaded from regulatory authority (US-SEQIRUS-202000599).  This spontaneous report was received from a consumer referring to a 15-year-old female patient of unspecified race. The patient did not have any medical history or concurrent conditions to be reported. Previous drug reactions/allergies and concomitant medications were not provided.  On 09-NOV-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), lot number: S005524, which has been verified to be a valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast), expiration date not reported, but upon internal validation established as 29-SEP-2021 (strength, dose, frequency and indication not provided). On the same date, she was concomitantly vaccinated with influenza virus sAg 4v vaccine inactivated (MDCK cell) (FLUCELVAX QUADRIVALENT) injection, lot number: 259809 (strength, dose, frequency, indication and expiration date not reported). Both vaccines were administered intramuscularly in the right arm (product administration error).  On the same day of vaccination, the patient had one leg extended and stiff and her arms were pulled into her chest with stiffness and jerking (musculoskeletal stiffness and dyskinesia), she had a vasovagal syncopal episode (syncope) and she blacked out (loss of consciousness), she experienced unwitnessed seizure-like activity (seizure like phenomena) and she seemed as if she was not there as her father was touching points of her face and asking if she was okay but she was unresponsive (unresponsive to stimuli). Additionally, the patient was feeling nauseous (nausea), she was very pale appearing (pallor) and her lips were pale and white (lip discolouration). The patient's vital signs (VS) were measured on that day and were assessed as stable. The outcome of the events aforementioned was unknown.   The causality assessment between the suspect vaccines and the events occurrence was not provided.  The events loss of consciousness, seizure like phenomena, unresponsive to stimuli and syncope were considered by the reporter as medically significant. 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: S005524; expirationdate: 29-SEP-2021; deviceage and unit: 0 ; malfunction: No; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability