Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, HPV9
Symptoms: Magnetic resonance imaging normal, Menstruation irregular, Postictal state, Sleep deficit, Tremor
Clinical narrative: Generalized tonic clonic seizur / 2 minutes of BUE contraction with extension of BLE and shakking head up / Second episode 20 min into a nap had 1-2 minutes of simIar activity, post ictal 30 min; eyes rolled up / Second episode 20 min into a nap had 1-2 minutes of simIar activity, post ictal 30 min; Some sleep deprivation; Information has been received from Food and Drug Administration (FDA) on 04-FEB-2021.  This spontaneous reported was received a physician and refers to a 16-year-old  female patient. In May 2014 (reported as two months before the vaccination), the patient had menarche. She had allergy to amoxicillin sodium (+) clavulanate potassium (AUMENTIN). Her prescriptions, over-the counter medications, dietary supplement, or herbal remedies being taken at the time of vaccination were reported as none. Also her chronic or long-standing health conditions were reported as none.  On an unspecified date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route and site of administration were not reported) for prophylaxis.  On 31-JUL-2014, at age of 13 years old, she was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # reported as K001500 (discrepancy: lot # not valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), however valid for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) with expiration date 06-NOV-2016), in left arm, intramuscularly (dose and expiration date were not reported) for prophylaxis and with the first dose of hepatitis a vaccine inact (HAVRIX) lot # A7HC5, , in right arm, intramuscularly (dose and expiration date were not reported) for prophylaxis.  On 12-NOV-2017, at 08:00 o'clock, the patient experienced generalized tonic-clonic seizure. 2 minutes of bilateral upper extremity (BUE) contraction with extension of bilateral lower extremity (BLE) and shaking head up and eyes rolled up. Post ictal 10-15 min. Menses was 2 day prior. She also had second episode, 20 min into a nap had 1-2 minutes of similar activity. Post ictal 30 min. The patient also experienced some sleep deprivation. Menses was 3 days later. The patient had doctor or other healthcare professional office/clinic visit due to the events. On an unknown date, she had computed tomography (CT) and Magnetic resonance imaging (MRI) performed with result reported as normal. On an unspecified date, the patient had electroencephalogram (EEG) described as right temporal right slowing. It was reported that the patient did not recovered from the events.  The causality assessment between the events and the suspect vaccines was not provided.  The agency assessed the case as non-serious.  Follow up information has been received from a nurse on 07-MAR-2022. The reporter said there was no information such as name or date of birth for her to find the patient and fill out the form. The case was thoroughly reviewed with the reporter who said she felt like she was a good detective and might be able to find the information Merck was looking for with the additional information shared from the case. The reporter asked if she was able find the original finished copy of the VAERS they completed, could she fax it to Merck. How to attach the form and Fax it in with the HCP Vaccine-Device form were explained, and also pointed out a few items Merck still needed information on.