Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Gastric disorder, Gastrooesophageal reflux disease, Lymphadenopathy, Nausea
Clinical narrative: This spontaneous report as received from a consumer refers to her 18 year old son with drug allergies to CEFZIL, ELAVIL, REGLAN. The patient's medical history included acid reflux and IBS (irritable bowel syndrome). In 2013 the patient was vaccinated with his three doses of GARDASIL (dose, strength, route, lot number were unknown) separately. Concomitant therapies included CELEXA 25mg, omeprazole (manufacturer unknown) 40mg and hyoscyamine sulfate 125 mg. In the "latter part of the 2013 school year" the patient had been experiencing tiredness, shortness of breath and continued stomach problems since receiving the GARDASIL vaccines. The mother provided additional details such as that her son's blood work at an unspecific date showed his "white blood cell count was high" and he was given an ultrasound of his thyroid, and showed swollen lymph nodes. She indicated that was after the second shot that her son had "unusual tiredness" and that 2-3 weeks after the final dose he developed stomach problems. He had also had dizziness, chills, and "almost passed out" in HCP's office. He was diagnosed with anxiety, but the anxiety medication "didn't help." He was taking unspecified "supplements" and "immune boosters". After the unspecified naturopath exposed the patient to "HPV serum." Reporter believed this verified that GARDASIL caused the AE. Patient sought unspecified medical attention. At the time of the report, the outcome of events was reported as not recovered/not resolved. Follow up information has been received from a physician refers to the patient. The patient's medical history included acid reflux which was treated with omeprazole 40mg. The patient's drug reactions included ELAVIL caused tachycardia. She reported that the patient received his 3rd dose of GARDASIL (lot# J010668, expire date 29-APR-2016, 0.5ml, intramuscular) on 18-JUN-2014. Concomitant medication included sitagliptin phosphate (manufacture unknown). On an unspecified date in 2014, within two weeks of administration, the patient experienced rash on chest, dyspnea/shortness of breath, enlarged lymph nodes in neck, syncope, worsening of existing acid reflux (manifested by increasing nausea), low grade fever, night sweats and chills. Patient was taken "a few times", dates unspecified, to Emergency room for these issues. Patient was not admitted during any Emergency Room visit. Patient saw multiple (unspecified) Specialists for dyspnea/shortness of breath and was trialed on unspecified asthma medication but has stopped taking it at this time due to some improvement (but not complete improvement per physician) in dyspnea/shortness of breath. Patient was also trialed on hyoscyamine sulfate for unspecified reason. Patient treated with amoxicillin, alprazolam, and increased doses of omeprazole (manufacture unknown). Patient had been taking omeprazole (manufacture unknown) 20mg, which was increased to 40mg due to patient's increased acid reflux/nausea. Physician stated the patient would consider these events a "significant disability/incapacity" as they affected his overall health and enjoyment of his summer and his entrance into college. The outcome of the events were not reported. Additional information has been requested.