Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Electrocardiogram abnormal, Electrocardiogram repolarisation abnormality, Fall, Fatigue, Generalised tonic-clonic seizure
Clinical narrative: Information has been received from a Certificate Medical Assistant referring to a 18 year old male patient. The patient had no pertinent medical history and no drug reactions/allergies. On 10-APR-2015, the patient was vaccinated with a dose of 0.5 ml GARDASIL 9 (Lot No. L001312, exp. not reported) intramuscularly. No concomitant medication reported. On 10-APR-2015, within 5 seconds of vaccination the patient slumped over, fell off the table, hit his head, became unconscious, started having tonic clonic movements and experienced incontinence urinating on himself. The patient came to after about 3 minutes but he had no recollection of the events, he was sweaty and nauseous. The patient was transported to the Emergency Room. The patient was not admitted to the hospital and was released the same day (10-APR-2015). The patient was diagnosed with closed head injury from the fainting episode. When asked the patient present status the medical assistant stated the "patient was ok but still felt tired". The reporter was requesting a lot check. Follow-up information was received on 16-APR-2015, from a company representative. Medical history and concomitant medications were not reported. The field representative stated that the physician reported that on 10-APR-2015, the patient had been sitting on the examination table when the dose of GARDASIL 9 was administered. She stated that the patient fell off the table after the GARDASIL 9 was administered and the patient landed "head first". She stated that the tonic-clonic movements occurred after the patient hit his head. The physician reported that "because the symptoms occurred after the head injury, the symptoms could be related to a closed head injury". Follow up information was received on 14-APR-2016 from the Certified Medical Assistant. The patient had no history of seizures, convulsion, epilepsy, brain tumor, stroke, Alzheimer disease, abuse of alcohol or illicit drugs, central nervous system infections, diabetes, hyperglycemia, hypoglycemia nor electrolyte imbalance. One month prior the event the patient did not use any concomitant medication(s), over the counter, herbal or nutritional products. The patient did not have recent intake of alcohol, no sleep deprivation, no exposure to flashes of light (stroboscope or television or video games) or strident sound. No recent intake of large amounts of coffee nor energy boosting supplements. As well as no other risk factors. On 10-APR-2015, 11:59, the patient was vaccinated with dose 1 GARDASIL 9 in the left deltoid. On the same date the patient was concomitantly vaccinated with a dose of MENACTRA in the left deltoid and a dose of Tdap (manufacturer unknown) in the right deltoid. As described by the witness, on 10-APR-2015, after getting the GARDASIL 9 the patient went unconscious (also reported as "immediately passed out"), had tonic clonic movements (also reported as "the patient began seizing"), incontinence, postictal stage and head trauma. The patient experienced muscle weakness post seizure and 911 was called and was transferred by "EMS" to a local emergency department. The duration of the events was of 30 minutes. On 10-APR-2015, an electrocardiogram was performed which results were abnormal, sinus bradycardia with sinus arrhythmia, ST elevation, early repolarization; CMP abnormal; glucose 106 (units not reported); "all other labs normal" and an unremarkable computerized tomography of the head: spine except for minimal patchy ethmoid mucosal thickening. On an unknown date the patient recovered from the aforementioned events. Accordingly to the 1981 Classification for seizures of the Agency the event was classified by the reporter as "generalized seizures, tonic-clonic seizure". Upon internal review generalized tonic-clonic seizure was considered serious as medically significant. As of 27-MAY-2016 and 02-JUN-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative updated.