Age: 11.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Confusional state, Dizziness, Dyskinesia, Muscle rigidity, Oral disorder
Clinical narrative: while calling her name and patient did not respond; she felt dizzy; extremities shot out rigid; started jerky movements; patient's mouth clamped shut; Information has been received from a healthcare professional via FDA (Agency # 825402) under the Freedom of Information Act on 14-JUL-2020 regarding a non-pregnant 11-year-old female patient with seasonal allergy. The patient had no known drug allergies (NKDA) or other illnesses at the time of vaccination    On 25-JUL-2019 at 08:30, the patient was vaccinated with her second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # R023607, expiration date not reported but upon internal validation established as 06-MAY-2021, intramuscular in the left deltoid for prophylaxis. Concomitant therapies included montelukast sodium(SINGULAIR) and cetirizine hydrochloride(ZYRTEC).    The patient seated in chair and visibly nervous prior to vaccine, squeezing on stress ball to help relax. Once the vaccine was given, the patient stated "I did it!" and then stated she felt dizzy (dizziness). Nurse had patient remain seated and as nurse was explaining possible syncope after vaccines, the patient slumped over onto nurse. Nurse attempted to lift patient's head while calling her name and patient did not respond (unresponsive to stimuli). The patient's mouth clamped shut (oral disorder), extremities shot out rigid (muscle rigidity), and started jerky movements that lasted 7 seconds (dyskinesia). Nurse instructed mother to open the door and call for help while nurse gently moved patient to a supine position on the floor. Once placed cool tile floor, the patient immediately opened her mouth and took a breath, jerky movements stopped, patient's extremities softened and patient opened her eyes with confused look. Patient was able to respond to nurse's questions appropriately. Nurse explained to patient what was going on and asked he to remain in supine position on the floor. The physician entered the room and examined the patient. Nurse applied wet cloth to patient's neck and patient reported that helped. Patient denied any continued dizziness or other symptoms. Patient moved to sitting position without issue. Mother reported patient had just eaten breakfast, no known history of seizure activity or issues with vaccines other than she usually cries due to extreme nervousness. Limited family history available as patient was adopted. Vitals taken and stable. Patient continued to state she felt fine and was able to walk out of clinic without issue.   The causality assessment between the events dizziness, oral disorder, dyskinesia, muscle rigidity, unresponsive to stimuli, and the vaccination with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  Follow up Information was received on 13-AUG-2020 from a nurse at the physician's office through an inbound call. It was reported that after providing the date of the adverse event the nurse was able to find the correct patient. The nurse was uncertain if there were any additional details that she would be able to provide but would look over the form and fax it back if there was. 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: R023607; expirationdate: 06-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent