Sex: M
Vaccine: HPV9
Symptoms: Headache, Hepatic enzyme increased, Hypothyroidism, Insomnia, Laboratory test abnormal
Clinical narrative: Patient's 'labs were off with Patient's potassium being high and Patient was transferred to hospital; was transferred to hospital where Patient was diagnosed with hypothyroidism, elevated liver enzymes, protein in Patient's Spinal Fluid; was admitted to hospital and was experiencing chest pain/ 'seeing things, hearing things,' and wanted to commit suicide/ transferred to hospital emergency room where Patient was still having chest pains; was transferred to hospital where Patient was diagnosed with hypothyroidism, elevated liver enzymes, protein in Patient's Spinal Fluid; was transferred to hospital where Patient was diagnosed with hypothyroidism, elevated liver enzymes, protein in Patient's Spinal Fluid; was admitted to hospital / Patient's White Blood Cell (WBC) Count being high; had experienced headaches, insomnia, depression; had experienced headaches, insomnia, depression; had experienced headaches, insomnia, depression; Patient's blood pressure being elevated; 'seeing things, hearing things,' and wanted to commit suicide/ transferred to hospital emergency room where Patient had experienced acute psychosis; Patient wanted to commit suicide / 'seeing things, hearing things,' and wanted to commit suicide; This spontaneous report was received from patient's mother and refers to a 15-year-old male patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 12-AUG-2021, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly for prophylaxis (exact dose, dose number, lot #, expiration date and anatomical location of administration were not reported). On 12-AUG-2021, after being administered the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient had experienced headaches, insomnia, depression. On unspecified date, approximately in 2021, the patient wanted to commit suicide and on unknown, previous date, patient was admitted to hospital, was experiencing chest pain (electrocardiogram (EKG) looked fine) with patient's White Blood Cell (WBC) count being high. Patient was then transferred to a mental health facility to address patient's depression where he started 'seeing things, hearing things,' and wanted to commit suicide. On unknown, previous date in 2021, while at mental health facility, the patient was administered nadolol in response to patient's blood pressure being elevated. Patient was transferred to hospital emergency room where had experienced acute psychosis and was still having chest pains at which point computer tomography scan was performed. On unknown date in 2021, he was transferred to 'another mental health facility,' second, separate, mental health facility, where patient's acute psychosis was better; however, his labs were off with potassium being high, and the patient was transferred to hospital where was diagnosed with hypothyroidism, elevated liver enzymes, protein in patient's spinal fluid. He was stabilized at hospital, and was sent to third, separate, mental health facility; where the physician's advice was for patient to remain hospitalized. The outcome of all the events was reported as not recovered/not resolved. The causality assessment between all the events and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided. The reporter considered all the events as life threatening, and as significant disability or incapacity.  Upon internal review, the events of suicidal intention, acute psychosis, CSF protein abnormal and hypothyroidism were determined to be medically significant.