Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Insomnia, Irritable bowel syndrome, Laboratory test, Lethargy, Musculoskeletal chest pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 6 years old female patient. The patient was vaccinated with, 0.5 ml VARIVAX (Merck) by a single subcutaneous injection on 13-JUL-2012. (Product Lot#: 0399AE; Exp Date: 22-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. On 20-JUL-2012 the patient was vomiting and had severe abdominal pain. She was taken to the HCP and he diagnosed the flu. On 21-JUL-2012 the patient could not sleep and had her first trip to the ER. On 22-JUL-2012 the patient had small, fine blisters on her hands (which have not yet gone away). She stopped eating and was then given a diagnosis of stomach flu, or hand, foot and mouth disease. She has no sores in either foot or in the mouth. The HCP diagnosed her as constipated and she was given a laxative. On 24-JUL-2012 the patient experienced temperature dropped to 95.6 degrees. She went again to the ER and was given IV fluids for dehydration. On 26-JUL-2012 she was again seen by the HCP because she could not walk (disability). She was taken to the ER again. Her heart rate increased to 160 and the injection site was swollen. On 26-JUL-2012 she slept until 3pm and was completely lethargic. She became hungry for the first time in days. She still has dark circles under her eyes, massive melt downs and little energy. She still has pains under her armpits, in her chest and under her rib cage. She is down to 37 pounds. She is hungry all the time but can not gain weight. On 15-AUG-2012, 34 days after onset of therapy, she was seen by a GI specialist and diagnosed with Irritable Bowel syndrome. She has been to 2 different Emergency Rooms. She went through Epstein-Barr virus (EBV) testing and tested "reactive". On an unspecified date, X ray and lab work were performed (results not provided). It was reported that she was treated with ZANTAC and PEPCID AC. The outcome of small, fine blisters on her hands were reported as not recovered. The outcome of irritable bowel syndrome, EBV tested "reactive", hand, foot and mouth disease, can not gain weight, she is hungry all the time, she is down to 37 pounds, pains under her armpits, pain in her chest and under her rib cage, massive melt downs, dark circles under her eyes, little energy, she slept until 3pm, was completely lethargic, injection site was swollen, her heart rate increased to 160, she could not walk, was given IV fluids for dehydration, temperature dropped to 95.6 degrees, constipated, stomach flu, could not sleep and flu was reported as not recovered. The relatedness for irritable bowel syndrome, EBV tested "reactive", hand, foot and mouth disease, small, fine blisters on her hands, can not gain weight, she is hungry all the time, she is down to 37 pounds, pains under the armpits, pains in her chest and under her rib cage, massive melt downs, dark circles under her eyes, little energy, she slept until 3pm, was completely lethargic, injection site was swollen, her heart rate increased to 160, she could not walk, was given IV fluids for dehydration, temperature dropped to 95.6 degrees, constipated, stomach flu, could not sleep and flu was not reported for VARIVAX (Merck). Additional information has been requested.