Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Hyperhidrosis, Malaise, Nausea, Proctalgia, Sneezing
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 ID-651735). This spontaneous report refers to a 12 year old male patient. The patient's current illnesses included nausea for 2-3 days. The patient had no known allergies. Information on patient's other medications was not reported. The patient told his mother that he had nausea since two days prior to vaccination (on Sunday, 04-SEP-2016). On 06-SEP-2016 the patient was vaccinated with GARDASIL 9 lot # M021407 dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On 06-SEP-2016 after vaccination, the patient complained of nausea and dizziness and he vomited the next day. On 08-SEP-2016, the patient went back to office with complaints of continuing nausea, vomiting and dizziness. Patient's mother said that she was not sure if it was related to child's signs and symptoms, but the patient also got GARDASIL 9 shot on that day. The patient's mother told that if she had known that her child was not feeling well, they would have waited on vaccination. The patient mentioned about his nausea only after vaccination. He also stood up to do chicken arms right after shot was given, despite the nurse telling him to be seated. For the past 2 days after the shot was given, the patient had dizziness which was variable (dizziness postural). It never occurred when he was supine. It occurred with sitting and especially more often when standing. The longer he stood, the dizzier and more nauseous he felt and had resulted in vomiting 2-3 times/day since shot was given. Last emesis was in the morning of that day. The patient had noticed mild alternating chills and sweats for past two days since the shot was given but with no fever. The patient had been back to school since last week. First month was always stressful and tends to fuel his anxiety disorder. Anxiety could make him nauseous but had never made him vomit. He admitted that anxiety may be playing a mild role that week with back to school, but he also felt there was true nausea. He did travel 3 weeks ago. They returned 1 week prior to school start. He did have mild nausea while travelling in car, something he never had before. He attributed it to using IPad in the car and refused to discuss it further. He had constipation with infrequent, large, hard stools in past 2-3 months. He sometimes had anal pain and abdominal pain with passage of stool. He had anal hemorrhage. He prevented the condition with 1-2 snacks of salted cucumbers. Mother planned to treat his nausea and constipation that day with sausages and fatty food. She tried meatballs last night, but that made him vomit. He has had mild cough for past 5 plus months. This cough occurred most often when he was eating ice cream and relaxed, but it can occur at any time. The patient was very intolerant to dairy products. The only dairy he used to take was ice cream and that was his way to relax. He has not been eating as much ice cream all summer because his stress has been lower. However, with back to school, the patient had stress for past 10-14 days and was taking ice cream one to two times a day with no taste perversion. The patient had cough which was not productive. He felt like his throat was closing up. It opened back up again after coughing. He used to cough more when his parents told him not to. He denied congestion or "RN". He sneezed occasionally. For months, his eyes would wander when parents were talking to him. His father noticed this a lot, but mother did not seem to experience it. During a 30 plus minute encounter with the patient, his eyes only wandered a few times in a normal way for wandering attention of his age. The patient's mother brought this concern up at the end of encounter and his eyes were wandering frequently as 5 times in 30 seconds or more. The patient was accompanied by his mother and he had no fever. The outcome of the events was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.