Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Opisthotonus, Syncope, Tonic clonic movements, Tremor, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 11 year old non-pregnant female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-JAN-2016, the patient was vaccinated with a dose of (reported as "1 shot") of GARDASIL (lot # K010215, expiry date May 2017, dose and anatomical location not reported, intramuscularly). On 20-JAN-2016, within a minute or two of receiving the dose of GARDASIL, the patient had syncope. After recovering from fainting, she experienced tonic-clonic movement with generalized stiffness in her muscles. No treatment was given for the symptoms, they just held her for a period of observation and gave her juice. The patient fully recovered. It was reported that the patient sought medical attention and that vaccination with GARDASIL was not reintroduced. The outcome of syncope and tonic-clonic movement with generalized stiffness in muscles was recovered (on 20-JAN-2016). The relatedness between the adverse events and GARDASIL was not provided. Follow up has been received from the physician on 11-MAR-2016. Physician reported that immediately after receiving the vaccine from nurse on 20-JAN-2016, the patient arched her back and she became unresponsive and stiff with mild shaking. After this, the patient complained of neck and back pain. These symptoms lasted only for a couple of seconds and the patient regained her consciousness. Reporting physician stated that after 15 minutes of observation, the patient perked up and looked fine. Outcome of all the events were reported as recovered. Follow up information has been received from on physician on 21-OCT-2016. Concomitant medications included CONCERTA. The patient had no history of seizures, no recent intake of alcohol, no sleep deprivation, no exposure to flashes, no recent intake of large amounts of coffee or energy boosting supplements, no history of brain tumor, stroke, Alzheimer disease, head trauma, CNS infections, diabetes, hyperglycemia, hypoglycemia or electrolyte imbalance. On 20-JAN-2016, after first dose of GARDASIL was administered in the right arm the patient arched her back and head back and then she fainted which only lasted a couple of seconds. The reaction was almost immediate after the injection. Her body was still and there was slight shaking. The patient had no seizure only loss of consciousness. The patient was responsive after but subdued. The patient complained that her neck and back were sore and there were no similar pain episodes experienced prior to the episode currently being reported. No treatment was given for neck and back pain. The patient was observed for 15 minutes and she was given sugar and drink. The onset of the events were reported as 20-JAN-2016. The patient was sitting on the exam table at the time of event onset post injection. The patient had recovered from all the events on 20-JAN-2016 and the duration of events were reported as 15 minutes. Causality was unknown. Upon internal review, loss of consciousness, tonic clonic movements, opisthotonus and unresponsive to stimuli were determined to be medically significant. Additional information has been requested. Event and serious criteria added, and narrative were updated.