Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Asthenia, Computerised tomogram head normal, Condition aggravated, Decreased appetite, Drug screen negative
Clinical narrative: Information has been received from a physician via Pfizer, Inc., (Mfr Control # 2016284061) for TRUMENBA on 11-JUL-2016. This spontaneous report was received from a physician via Medical Records concerning a 16 year old male patient with attention deficit/hyperactivity disorder and who suffered from migraine. The patient's pertinent medical history was not reported. It was reported that on 20-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9 Lot # L044475 (dose was not reported), intramuscularly into his right arm. Other secondary suspect vaccines given on the same date included dose of TRUMENBA (Lot # M37314; expiration date: 30-APR-2017), 1 unit (dose not reported) intramuscularly into his right arm and the second dose of MENACTRA (Lot # U5228BA) (dose was not reported) intramuscularly into his left arm. Concomitant therapies included FOCALIN. It was reported that he had received the immunizations prior 2 days (on 20-APR-2016), and when he returned home, he did not feel like eating, he did not feel that good, but wanted to go to his basketball practice, so he went and then he started to feel even worse. On 21-APR-2016, reported as yesterday, he did not feel well when he woke up then around 1:00 p.m., he got migraine headaches and pain in the arms at the site of shots. The mother saw him flushed in face and he was weak and could not even walk, so she took him to the Emergency Room (E.R) and he fainted in the parking lot. Then, he was in E.R and he got oral BENADRYL; 10 and 15 minutes later, he could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. After that, Computerized tomogram (CT) of head was done and was normal and his urine drug screen was normal as well. The complete blood count (CBC) and Comprehensive Metabolic function Panel (CMP) were showing normal and after that, on 22-APR-2016, (conflicting information: also reported as 21-APR-2016), he was admitted for 1 day (overnight stay) to pediatrics for further evaluation and treatment. Physical examination: General: then, he was alert, nontoxic and not in acute distress; HEENT: Normal; NECK: Supple; CHEST: Clear; CARDIOVASCULR: Absent heart murmur; NEUROLOGICAL: He had normal neurological exam, no muscle weakness and no focal deficit; SKIN: Intact. The diagnosis at admission was weakness and the patient was discharged on 23-APR-2016 (also reported as 22-APR-2016) 1 day after admission. Plan: IV fluids, regular diet and observation. At the time of the report, the outcome of dyspnoea, rash, pharyngeal oedema, syncope, eating disorder, malaise, injection site pain, migraine, flushing and asthenia was reported as recovered. The reporting physician considered dyspnoea, rash, pharyngeal oedema, syncope, eating disorder, malaise, injection site pain, migraine, flushing and asthenia to be related to GARDASIL 9, TRUMENBA (which was permanently discontinued) and MENACTRA. There was no PQC involved. Upon internal review dyspnea, pharyngeal edema and rash were determined to be other important medical events as the patient was given epinephrine shot. All available medical records will be provided upon request. Additional information has been requested.