Age: 14.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MMR, MNQ, TDAP, VARCEL, FLU4, HEPA, HPV9, MMR, MNQ, TDAP, VARCEL
Symptoms: Blood creatine phosphokinase increased, Dehydration, Gait disturbance, Laboratory test, Muscular weakness
Clinical narrative: Blood creatine phosphokinase increased; Dehydration; Gait disturbance; Laboratory test; Muscular weakness; Rhabdomyolysis; Vaccination complication; This spontaneous report was identified from a line listing obtained on a request by the Company from the FDA under the Freedom of Information Act (agency number 796630), received from a physician assistant and refers to a 14-year-old male patient. The patient's mother was concerned the patient ate a lot and did not gain weight. No past medical history and no other medications were reported. Vaccines were given according to schedule. The patient moved from another country in November 2018.  On 15-JAN-2019, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # R008393 with expiration date on 20-MAR-2020, subcutaneously in the right arm, concomitantly with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA) (lot # N024703 with expiration date on 08-SEP-2019, subcutaneously in the left arm), the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R009614 with expiration date on 30-NOV-2020, intramuscularly in the right arm), the first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) (lot # XJ5L2, intramuscularly in the left arm; expiry date not provided), the second dose of hepatitis a virus vaccine inactivated (HAVRIX) (lot # 2GY7E,  intramuscularly in the left arm; expiry date not provided); the first dose of influenza virus split virion 4v vaccine inactivated (FLUZONE) (lot # Ul982AB, intramuscularly in the right arm; expiry date not provided); the first dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (lot # U5986AA, intramuscularly in the right arm, expiry date not provided), all of them for prophylaxis. The vaccines were given as listed according to schedule. On the same date, the patient experienced blood creatine phosphokinase (CPK) increased, vaccination complication, rhabdomyolysis, muscular weakness, laboratory test, gait disturbance and dehydration. On 16-JAN-2019, he was brought in by his mother to the reporting clinic, to Urgent Care. The patient was examined by a physician assistant. A pediatrician was consulted with and examined the patient. The patient complained of weakness and trouble with lower extremities last and was still having difficulty walking. The pediatrician recommended that the patient go to the emergency room (ER) for further evaluation and possible spinal tap. On 18-JAN-2019, the patient was in hospital. At the reporting time, hospital records indicated the patient was still hospitalized. The diagnosis was "elevated CPK, likely secondary to reactive rhabdomyolysis from recent influenza vaccination, however dehydration might had also contributed". The outcome of the events was reported as not recovered (continued).  The relatedness between the events and the other suspect therapies was not reported.  Follow-up information was received on 03-JUL-2019 from a healthcare professional via the FDA under the Freedom of Information Act (VAERS # 796630). The patient's details were updated. He had no known allergies. The patient received aforementioned vaccines on 15-JAN-2019 at 13:53. On the same date at 18:00, he started experiencing reported adverse events.  As of 10-OCT-2019 all telephone attempts trying to obtain additional information has been unsuccessful.