Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Blister, Herpes zoster, Rash pustular, Transmission of an infectious agent via product, Urticaria papular
Clinical narrative: This case was reported by a physician and described the occurrence of reactivation of herpes zoster in a 50-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), FLUZONE (non-gsk). Concurrent medical conditions included Hashimoto's thyroiditis. On 30 November 2012 at 14:00 the subject received 1st dose of BOOSTRIX (unknown, left deltoid), On 29 November 2012 the subject received 1st dose of FLUZONE (unknown). On 7 December 2012, 7 days after vaccination with BOOSTRIX, 8 days after vaccination with FLUZONE, the subject experienced activated zoster, rash on right arm and redness. The physician, who is also the subject, reported he received BOOSTRIX in his left arm and after one week he noticed a rash on his right arm near his elbow. He believes it is a reactivated zoster due to the BOOSTRIX. He also received a FLUZONE vaccine on the previous day (29 November 2012) and stated that it too could be also what caused the zoster reactivation. He received FLUZONE in previous years without any side effects. He thought that the different strains in this year's flu vaccine may also be a cause. At the time of reporting the activated zoster, rash on right arm and redness were improved. The physician considered the events were probably related to vaccination with BOOSTRIX and FLUZONE. Follow up was received from the physician (also subject) on 5 March 2013. The physician documented that he reported the events to Sanofi "who said they will file it with VAERS." The physician documented that both vaccinations were given intramuscularly in the left deltoid. On 1 December 2012, 1 day after vaccination with BOOSTRIX, 2 days after vaccination with FLUZONE, the subject experienced activated zoster, rash on right arm and redness. Previously the subject had reported the onset of events as 7 December 2013. The physician reported that all events had resolved; however, he also documented that he "still" experienced "rash remnent." The physician documented that these events were not serious. The physician documented that he received FLUZONE the previous year without any side effects; however, previously this was reported as he had received FLUZONE in "previous years years without side effects." Follow up was received from the subject's physician on 26 March 2013. The subject's physician documented that this case has not been reported to a Regulatory Agency. The subject's physician documented that on approximately 1 December 2012, the subject also experienced vesicle and vesiculopustular rash (described as "papules, small pustular, vesicles, linear orientation"), and papular urticaria. The subject's physician did not confirm reactivation of herpes zoster stating that "herpes zoster was possible, but no conclusive. This could have been popular urticaria." The subject's physician reported that the events were possibly related to BOOSTRIX, previously this was reported as a probably relationship by the subject. The subject's physician identified "either influenza or Tdap vaccine" (BOOSTRIX) as the suspect products. The subject's physician did not consider this case to be serious. The subject's physician documented that as treatment he recommended to keep lesions covered and recommended meticulous hand washing. The subject's physician stated that he was uncertain if medical history could have been associated with the events; he felt that the events were "not likely" associated with lack of efficacy, erroneous administration, or suspected transmission of an infectious agent via a medicinal product. A biopsy was not performed. The subject's physician documented that the subject had not experienced any adverse events following previous vaccinations.