Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Headache, Insomnia, Pain, Pain in extremity, Pharyngeal oedema
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 604526). This spontaneous report refers to a 13 year old male patient. Reason for primary care physician (PCP) office visit on 14-OCT-2015 included 1) asthma: onset gradually. The severity of the problem was mild and the problem has worsened. The frequency of symptoms was intermittent and it occurred seasonally. Symptoms are associated with recent exposure to animals and recent exposure to smoke. Aggravating factors include animal dander, smoke and weather changes. Associated symptoms include cough, rash and wheezing. Pertinent negatives include abdominal pain, accelerated respiration, chest congestion, decreased appetite, decreased fluid intake, decreased sleep, decreased urine output, fatigue, fever or headache. Patient had a history of asthma and he was exposed to a black cat which increased wheezing. Patient's grandfather smokes in front of him and in the car. Patient had well child check with abnormal findings and moderate persistent asthma without complication. Patient was directed to take medications and should have inhaler with him all the time and one at school as well. Patient should return to the office in one week or sooner if needed. Grandmother of patient verbalizes concerns related to possible allergic reaction to two vaccines received on 14-OCT-2015. Patient was vaccinated with GARDASIL 9 lot # L013429, dose 2 (also reported as three), intramuscularly in the right arm and FLUZONE QUADRIVALENT lot # UH443AC, dose 6, intramuscularly in the right arm and complained of sudden onset of headache pain. Patient stated that "pain goes from my head down to my toes and feels like it is going to explode". Patient denies any difficulty in breathing. The patient went to facility for a checkup and he's been wheezing for the last week. Later on in the day, the patient started to experience body pains and he described it in his joints. He had some difficulty walking. He also described that he felt there was some sensation of swelling in his throat. He did not develop a rash and he did not have any fainting episodes. The grandmother was concerned so she brought him up for evaluation and he had no fever. ED medical decision making (MDM) states that: This was a 13 year old male patient that was seen at the family doctor today. He received vaccinations and now appears to have some sort of adverse reaction. I would not call this true allergy and certainly not anaphylactic reaction. He describes joint pain and sensation in his throat was closing. He has no tongue swelling or rash. He was given some TYLENOL, BENADRYL, and oral prednisone. He was observed for a couple of hours and had no deterioration of his condition. I am not certain why he was having that type of reaction. I did tell the (grand) mother to continue using albuterol, prednisone, ZYRTEC and BENADRYL. Told him to return if worse. I called his grandmother on 23-OCT-2015 at 14:11 and she said except for his asthma, "He is doing a lot better. All other symptoms have subsided. The outcome of all the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.