Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram T wave inversion, Electrocardiogram abnormal, Endocrine disorder, Exercise tolerance decreased, Fatigue
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. A 14 year old female patient with a history of scoliosis, brace user and no known drug allergies was vaccinated on 11-JUL-2011 with the first dose of GARDASIL, (lot # 668554/0306AA), I.M, in the right arm. There was no concomitant medication reported. On 13-JUL-2011, two days later developed nausea, vomiting, diarrhea and abdominal pain. Symptoms continued over summer, fall & into winter. Weight loss of 26 pounds. Extensive evaluation non-diagnostic. Patient was hospitalized for this and found to have Addison's disease and thyroiditis. The following information was obtained through follow-up and/or provided by the government. 15-FEB-2012. Consultant records several office visits (OV) during day of service (DOS) 8/1/11 l 213/12. Diagnosis (DX): Addison's disease; amenorrhea; depression. Chief complaint (CC): initial visit with fatigue for 2 weeks; nausea; vomiting; occasional diarrhea; stomach pains; weight (wt) loss; decreased appetite. Physical examination (PE): pale; diffuse abdomen (abd) tenderness. Diagnostic tests done. Residential treatment center (RTC) 03-AUG-2011. CC: same as previously noted. RTC 16-AUG-2011. CC: continued malaise; exercise intolerance; headache (HA); poor appetite. RTC 20-OCT-2011 for follow-up (f/u) of persistent symptoms. Some improvement noted, but not back to baseline. RTC 12-SEP-2011. CC: amenorrhea; continued unintentional wt loss. Diagnostic tests scheduled. RTC 04-JAN-2012. CC: persistent vomiting, weakness et wt loss. Gastrointestinal tests negative so far. Physical examination (PE): exaggerated gag reflex; peculiar continuous movements. RTC 03-FEB-2012 to f/u hospitalization for 1 week. The patient (Pt) was admitted with dehydration and diagnosed with Addison's disease. Patient's weight was improving; on medication. 21-FEB-2012. Emergency room (ER) records DOS 04-JAN-2012. DX: 1) T wave inversion; 2) eating disorder; 3) vomiting; 4) dehydration; 5) mild hypothyroidism. CC: vomiting after eating; fatigue; nausea; centralized abd pain. PE: palpable curved spine; flat affect. Treated with antiemetics and intravenous fluids (IVF); the patient was released to home in stable condition. 06-MAR-2012. Hospital records DOS 05-JAN-2012 to 13-JAN-2012. DX: eating disorder, NOS. CC: 34 lb wgt loss; restricting food; vomiting; dizziness. Admitted to specialty clinic for eating disorder (ED). During work-up, ascertained to have endocrinal issues, transferred to inpatient (inpt) medical facility. Admitted DOS 13-JAN-2012 to 20-JAN-2012. DX: 1) adrenal insufficiency (Addison's disease), improving; 2) eating disorder, unspecified l resolved; 3) dizziness, resolved, 4) weakness, improving; 5) hypotension, improved, 6) fatigue, improving, 7) nausea, improving; 8) pneumonia, LLL; 9) vitamin A deficiency; 10) abnormal electrocardiogram (EKG); 11) secondary amenorrhea; 12) anemia, persistent; 13) hyponatraemia, resolved; 14) abdominal pain, resolved; 15) dehydration, resolved; 16) orthostatic heart rate, persistent; 17) malnutrition, improving; 18) abnormal thyroid stimulating hormone (TSH). CC: abnormal wgt loss; fatigue; abd pain post eating; feeling full. Hospital course characterized by negative (NGT) feeding; physical therapy/occupational therapy (PT/OT). Discharged (DC) in stable condition to f/u with endocrinologist and PCP. The patient has been seen in specialty clinic several times for f/u. Laboratory tests included: adrenocorticotropic hormone (ACTH) 1724; Cortisol level - 1; thyroid-stimulating hormone (TSH) 0.11; tissue plasminogen activator (TPA) 124. The following information was obtained through follow-up and/or provided by the government. 15-FEB-2012. Consultant records. Urine white blood cell count (Ur WBC) 10-14 (H), urine protein (ur protein) 2+ (H), WBC 4.6 (L). 21-FEB-2012. ER records. Electrocardiogram (EKG): right bundle branch block (RBBB); L posterior fascicular block; bifascicular block; T wave abnormality. 06-MAR-2012. Hospital records. Erythrocyte sedimentation rate (ESR) 30 (H), Iron (Fe) 29 (L), total iron-binding capacity (TISC) 247 (L), Fe saturation 12% (L), sodium (Na) 133 (L), lactate dehydrogenase (LDH) 197 (H), amylase 15 (L), total proteins 5.5 (L), albumin 3.5 (L), cortisol < 1 (L). Chest X-ray (CXR): hazy, increased density in at left lung (LL) base, hematocrit 31% (L). 06-MAR-2012. Labs/diagnostics. "Nil new". This report was considered serious, hospitalization required, immediately life threatening and cause of permanent disability by the agency for all of the adverse events. It required emergency room / doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 449312. A priority lot check investigation has been finalized. All in-process quality checks for the lot number 668554/0306A were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.