Age: 65.0
Sex: M
Vaccine: HEPAB
Symptoms: Selective IgG subclass deficiency, Upper respiratory tract infection, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer and described the occurrence of immunodeficiency disorder in a 65-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline), INFLUENZA. A physician or other health care professional has not verified this report. Medical history included a history of colds as a child, but no history as an adult. The subject reported one case of sinusitis and one case of bronchitis in the 20 years before the TWINRIX. Concurrent vaccination included Typhoid vaccine (manufacturer unspecified) given on 9 June 2010 and FLUARIX 2011-12 (manufacturer unspecified) given on an unspecified date. Concurrent medications included Lisinopril, Gemfibrozil, CRESTOR, DILANTIN, Phenobarbital, Pilocarpine, unknown concurrent medication (Tinoptic) and VIAGRA. In the late morning on 9 June 2010, the subject received 1st dose TWINRIX at 1.0 ml in the left arm. About 3 to 5 days after vaccination (around 12 June 2010) the subject experienced a bad upper respiratory infection with clear nasal discharge and other respiratory symptoms of upper respiratory infection. The symptoms reported to have cleared within 7 to 10 days. Profuse rhinitis was also reported with onset of 13 June 2010. Resolution was not specifically reported. The subject received a 2nd dose of TWINRIX on 14 July 2010 and within 3 to 5 days (around 14 July 2010) experienced the exact same upper respiratory symptoms that followed the 1st dose including upper respiratory infection with clear nasal discharge and other respiratory symptoms of upper respiratory infection. These events went away after 7 to 10 days. In September 2010, the subject again experienced upper respiratory infection with clear nasal discharge and other respiratory symptoms of upper respiratory infection. Symptoms resolved within 7 to 10 days. At the end of October 2010 and beginning of November 2010, the subject caught a cold after a long plane ride. The subject noted that he "felt like he had no immunity to the cold." He remarked that he had not had a cold like that since he was a child. The cold resolved after 7 to 10 days. On 1 January 2011 the subject received unspecified dose of INFLUENZA shot via a local pharmacy. Almost exactly 48 hours after vaccination with INFLUENZA shot (around 03 January 2011), the subject experienced the same upper respiratory symptoms that he had after receiving TWINRIX, including upper respiratory infection with clear nasal discharge and other respiratory symptoms of upper respiratory infection. He noted that he never had a reaction to the flu vaccine before. The subject received treatment with antibiotic. The "infection" lasted 3 weeks. The subject noted that starting in the Spring of 2011, he had gotten upper respiratory infections about 1 to 2 a month with the infections getting more frequent. In the summer of 2011, the subject saw an infectious disease specialist. The subject's immune system was tested and he was diagnosed with a subclass  immune deficiency disorder. It was reported that his IgG subclasses 1 and 3 were deficient making him more susceptible to respiratory infections. It was noted that the subject had multiple unspecified tests performed since the diagnosis and all have showed the same problem. Note was made that the subject was sick 1 to 2 times a month with upper respiratory symptoms that went from his ear to his nose to his lungs and back again. The subject saw a respiratory disease specialist and it was reported that he was not getting enough oxygen as a result of all the infections. He saw an allergist that works with immune problems who suggested he see a hematologist. Since the winter of 2011-2012, the subject had "gotten sick" twice a month with the same symptoms. His primary care physician and infectious disease specialist recommend IgG replacement therapy. The subject has had many lab tests and antibiotic prophylaxis, but the symptoms had not stopped. It was reported that most recent lab tests show that the subject's subclass IgG levels have gone down further. It was noted that the subject did not have a reaction after his flu vaccination "last fall/winter" (2011-2012). The subject stated that he did not get colds or upper respiratory infections prior to receiving TWINRIX. He discontinued the TWINRIX series following the 2nd dose. The event of subclass immune deficiency disorder was unresolved at the time of reporting. This case was assessed as medically serious by GSK. Similar events occurred with the reporter's girlfriend following administration of TWINRIX. For details regarding this case, refer to case number A0985330A.