Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Crying, Fluid intake reduced, Nausea, Pain, Pyrexia
Clinical narrative: Crying; not wanting to drink fluids; body aches; Nausea; fever/Temp got up to 102; This report was identified from a line listing obtained on request by the Company from the FDA (HA # 703291) under the Freedom of Information Act.  This spontaneous report as received from a regulatory authority refers to a 11-year-old male patient. The patient had no current illnesses, history, and other medications.  On 28-JUN-2017, 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) (lot # N001533, expiration date: 16-OCT-2019; intramuscularly in the right arm; dose was not provided). Other suspect therapies included the first dose of meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) given intramuscularly in the left arm (lot# U5514AB; dose was not provided) and fifth dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) given intramuscularly in the left arm (lot#U5603AA; dose was not provided). On the same day, around 14:00, the patient experienced nausea, body aches, and fever. By 20:00, the child was crying and not wanting to drink fluids. The patient's mother was a nurse and had him drink water and used cool cloth for fever. Temperature got up to 102 (unit not provided) even with acetaminophen (TYLENOL) and ibuprofen staggered dosing. Felt better next day and by 17:00 on 29-JUN-2017 he was completely recovered. The patient's mother talked with provider and described event and he offered intravenous fluids if she thought he needed. The patient was drinking better by then, so she deferred this in the evening of 28-JUN-2017. The patient was drinking better that evening.  The relatedness between all adverse events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), meningococcal acyw conj vaccine (dip toxoid)(MENACTRA), and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) was not provided.  Follow up information was received on 15-APR-2019 from FDA (HA # 703291).  He had no allergies to medications, food, or other products. He had never had an adverse event following any previous vaccine. He was vaccinated with suspected vaccines at 9:45 in public health.  Follow up information was received on 08-JUL-2019.  Patient details were updated. Anatomical region of vaccination was updated to left deltoid for meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL); right deltoid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The previous dose of pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL)was received on 05-JAN-2010. It was reported that the patient was doing physical activities "sports" and received 3 adolescent vaccines. He was hurt soon after and went to sleep that afternoon, woke up with fever greater than 100 (units not reported) and nausea. The patient felt better after 24hours. On 08-JUN-2018, the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with no problems.