Age: 52.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Oedema peripheral, Pruritus genital, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 52-year-old female subject who was vaccinated with ENGERIX-B (GlaxoSmithKline) and HAVRIX. A physician or other health care professional has not verified this report. Past medical history included hysterectomy. Concurrent medical conditions included allergies to egg, citrus, wheat, dairy, pork, caffeine, tomato and melon and genital herpes. On 25 June 2009 at 09:30 the subject received 1st dose of ENGERIX-B (unknown, unknown arm), and 1st dose of HAVRIX (unknown, unknown arm). One vaccination was given in each arm. On 27 June 2009, 2 days after vaccination with ENGERIX-B and HAVRIX, the subject experienced fever. On 28 June 2009, 3 days after vaccination with ENGERIX-B and HAVRIX, the subject experienced flu like symptoms. On 29 June 2009, 4 days after vaccination with ENGERIX-B and HAVRIX, the subject experienced severe itchy breakout in genital area. On the unspecified date(s) in 2009, the subject experienced swelling, swelling from her mid-section to the mid-portion of her thighs, enlarged lymph nodes under arm, swollen lymph gland groin, inability to walk, unable to go out, inability to work, bad reaction and possible genital herpes. The subject was treated with acupuncture and both oral and topical herbal medicine. The consumer reported that she experienced multiple side effects within a few days of receiving both hepatitis A and hepatitis B vaccinations. Based on the lot numbers that her physician provided, the subject was given ENGERIX and HAVRIX. The lot number for HAVRIX was reported as AHAVB309. One vaccination was given in each arm. Her reactions included fever, flu-like symptoms, severe breakout, and swelling. She reported that she swelled up in her mid-section to the mid-portion of thighs. Her lymph nodes in her groin area swelled up "like baseballs", and her lymph under her arms swelled up "like ping pong balls". Her genital areas broke out into a big, oozy, itchy scab. At first, the subject thought it was genital herpes. The subject reported that it was so severe she could barely walk. The subject reported she was homebound for four weeks and was unable to work for six weeks. The subject did not visit her primary physician initially because it was so severe that she knew she would be hospitalized (and she did not want to go to the hospital). The subject visited her primary care physician after about two months (once it was much improved). The physician indicated that it was the "worst reaction he had ever seen". During that time, the subject also visited her acupuncturist who treated her symptoms with acupuncture and both topical and oral herbal medicines. At the time of reporting, the subject's fever, flu like symptoms, severe, itchy breakout in genital area and swelling were resolved. The outcome of swelling, swelling from her mid-section to the mid-portion of her thighs, enlarged lymph nodes under arm, swollen lymph gland groin, inability to walk, unable to go out, inability to work, bad reaction and possible genital herpes was unspecified. Follow-up information was received on 04 January 2010, via subject who reported that she had the first of the three dose series on 25 June 2009 of Hepatitis A and Hepatitis B vaccines. The subject stated she has an existing Herpes virus in her system. She developed a severe herpes outbreak in both her genital and mouth areas. The genital area was significantly worse and spread over her entire buttocks, hips, and upper thigh. The subject dealt with open wounds and oozing that changed to a dramatic rash and itchiness. The symptoms kept her home bound for three to four weeks and was unable to work for six weeks. The subject continues with an outbreak on her thumb described as "spot on her right thumb". The recent outbreak included swelling, lesions, and discharge; genital area was the worst. The immunization series has been discontinued due to "dramatic and painful reaction" to the first dose; also described as a severe reaction. The subject also experienced discomfort. The subject was managing the symptoms with homeopathic remedies; not all of the symptoms have resolved.