Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Abdominal pain upper, Activities of daily living impaired, Acute disseminated encephalomyelitis, Antibody test abnormal, Antinuclear antibody positive
Clinical narrative: This case was initially received from the FDA on 10 April 2009. Additional information was extracted from the VAERS database on 13 April 2009 (reference number 323722). A 14-year-old female patient with a previous history of thyroiditis (Hashimoto's), was found to have acute disseminated encephalomyelitis 70 days after she had received MENACTRA (lot number not reported, route unknown), (GARDASIL, manufacturer and lot number not reported, route unknown), and Hepatitis A (manufacturer and lot number not reported). The patient had a history of thyroiditis (Hashimoto's) treated with 75 mcg SYNTHROID and she was an athletic volleyball player underwent vigorous training with complaints of exhaustion a few weeks post vaccination. It was also reported that the patient had received Hepatitis A vaccination due to planned travel outside of the country later in the year. On 18 September 2007, 70 days after she had received the vaccines (onset also reported as mid September), the patient experienced stomach pains and back muscle pain which was attributed to playing volleyball. The patient had marked difference in her stamina by 01 October 2007 at which time the pain and muscle weakness became more obvious. The patient had previously been able to serve ten to 15 serves in a row during a game, but now could barely put two or three serves over the net. In mid October, she was evaluated by her pediatrician who could find nothing wrong. By the end of October, the patient "could barely carry her book bag in school and could barely walk the hallways during a full day of school". During the first week in November, she was evaluated by her endocrinologist as part of her regular check up and reported her symptom of exhaustion during that visit. Laboratory work was performed which indicated "that if there was something wrong, it was not due to her thyroid which was functioning normally". Two weeks later, she was again evaluated by her pediatrician with no diagnosis was determined at that time. One week later, she went to her pediatrician and had lab work performed to rule out Strep and mononucleosis. Seven days later, her mono titer was found to be positive and it was assumed to be the cause of her fatigue. After days of bed rest, the patient had not improved. Three weeks later, "she was -- positive ANA - which was later (months later reverted back to negative". Additional testing included MRI of the brain with showed a a cerebral peduncle lesion. A follow-up MRI was scheduled for "September 08". A soft tissue ultrasound was performed on 18 January 2008 which was negative. Total bilirubin was 2.3, direct 0.3, indirect (not reported). The patient recovered from the event on an unspecified date. The report outcome indicated that the patient had been hospitalized (dates and duration not reported). Additional MeDRA coding in the VAERS database included Autoimmune disorder, Asthenia, Axillary pain and body temperature fluctuation. Per the FDA, this case meets the agency probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.