Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, HPV4, MEN, TDAP
Symptoms: Arthralgia, Balance disorder, Blood test, Chest X-ray, Computerised tomogram
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 12 year old female patient (daughter). The patient's concurrent conditions included unspecified seasonal allergies, obesity and eczema. On 24-SEP-2014 the patient was vaccinated with the second dose (previously reported as the first dose) of GARDASIL intramuscular. On the same day the patient was vaccinated with TDAP and meningococcal vaccine unspecified route for both last therapies. The patient's mother said that the daughter had been experiencing chronic long-term side effects after receiving GARDASIL. The patient developed a fever and decreased appetite within 24-hours after receiving first dose of a series of three recommended doses of GARDASIL (estimated date September 2014). The other patient's symptoms developed in the first weeks of October 2014 which included chronic cough, shortness of breath, loss of balance, hip pain, pain down her leg, "shaking hand", headaches and nerve pain. The patient experienced also vomiting, nausea, loss of appetite, loss of weight of 20 lbs, persistent fever, "she could not hold any fluids" therefore she went to the emergency room and was diagnosed with Mesenteric Adenitis on 28-OCT-2014. The patient's fever "maintained" at about 101 degrees and lasted for a total of 6 weeks. The patient sought a medical attention, she was under Pediatric Care since October 2014. There were lab diagnostics studies performed: computerized tomography (CT) scan, chest X-rays, blood work (results not provided). There was no treatment given for the adverse events, because they were of viral origin and would resolve on their own. The outcome of mesenteric adenitis, pain down her leg, hip pain, headaches, chronic cough, nerve pain, hand shaking, weight loss, loss of balance and shortness of breath was unknown. The outcome of decreased appetite was reported as recovered/resolved (reported also as "appetite is back") (date unspecified). The relatedness between the event and GARDASIL was not reported. Lot number U006236 is an invalid lot number for GARDASIL. Follow up has been received from the responsible physician on 7-APR-2015 refers to a 12 year old female with eczema and obesity, who on 24-SEP-2015 at 15:48 hs was vaccinated with the second dose (previously reported as the first dose) of GARDASIL (Lot No. J006236 (previously reported as U006236), Expiration date 26-FEB-2016) in the left deltoid. On the same day the patient was also vaccinated at 15:47 hs with the second doses of TDAP (lot No. 4EK53, expiration date not provided) in right deltoid and meningococcal vaccine (lot No. 44677AA, expiration date not provided) in right deltoid. Reporter stated that Mesenteric adenitis resulted in persisting or significant disability/incapacity. The outcome of Mesenteric adenitis was reported as recovered/resolved and it was gradual. Additional information has been requested. The following fields have been updated: Reporter information. Patient demographics. Patient current conditions. Vaccines Lot numbers, manufacturer and doses. Laboratory values. Events Seriousness Criteria and outcome. Narrative.