Age: 16.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Alopecia, Anxiety, Fatigue, Headache, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from the patient's mother refers to her daughter, a 16 year old female patient with asthma, Hashimoto's thyroiditis and seasonal allergy. On unspecified dates, the patient was vaccinated with doses of RECOMBIVAX HB, (dose, route of administration, injection site, lot number and expiration date were not reported). On an unknown date, the patient showed a negative titer toward Hepatitis B virus. As the patient volunteered at an unspecified hospital, she was recommended a revaccination of the three series of RECOMBIVAX HB. On 24-NOV-2015, the patient received her first revaccination dose of RECOMBIVAX HB injection, dose, route of administration, lot number and expiration date were not reported. The second dose was administered on 19-FEB-2016 (inappropriate schedule of vaccine administered). There were no concomitant medications reported. On 29-FEB-2016, about ten days after receiving the second dose of RECOMBIVAX HB, the patient started to experience severe hair loss. The reporter stated that her "daughter's hair started coming out in clumps". It was also reported that the patient had "anxiety, fatigue and headaches" (since an unknown date in approximately 2016). The patient sought medical attention via calling her primary care physician. No other laboratory diagnostic studies were performed. The patient was given oral contraception for the treatment of severe hair loss, fatigue, anxiety and headaches. It was also reported that the patient's physician advised against the patient being administered a third dose of RECOMBIVAX HB. Therefore, therapy with RECOMBIVAX HB was discontinued on 19-FEB-2016 and the vaccine was not reintroduced. At the time of the report, the patient did not recover from the events of anxiety, fatigue, headaches and severe hair loss and had been referred to a dermatologist. The outcome of showing a negative titer toward Hepatitis B virus was unknown. The relatedness between the events and suspect therapy was not provided. Follow up information has been received from the physician on 17-MAY-2016. The reporter stated that he or she provided the mother with all relevant information that was requested and a HIPPA complaint release form to sign. Until the reporter received the release form, he or she was unable to provide any further information. Follow up information was received from the physician, on 23-MAY-2016. The patient historical conditions including allergy to KEFLEX, tree nuts, peanuts, soy and pollen. She was a non-smoker and at the time of vaccination she had no illnesses. The patient did not experience adverse events following prior vaccination and she did not have siblings. It was confirmed that the third dose of RECOMBIVAX HB vaccine had a lot number of K022265 and the fourth dose, a lot number of L033343 expiry date not reported. On 01-FEB-2015, concomitant vaccine FLUZOLE which had a lot number 45338 was given to the patient. It was confirm that on approximately 29-FEB-2016, that the patient experienced alopecia aerate, fatigue, and anxiety. Additionally, on the same date she experienced joint pain. At the reporting time, the outcome of the alopecia aerate, fatigue, anxiety and joint pain was reported as unknown. Upon internal review, the events of the alopecia aerate, fatigue, anxiety and joint pain were considered serious as them resulted in persistent or significant disability. Additional information has been requested. Patient demographics, reporter details, product information and narrative were updated.