Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Cough, Dyspnoea, Oropharyngeal pain
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in an infant male subject who was vaccinated with Dtap vaccine (manufacturer unspecified), Hepatitis A vaccine, MMR vaccine (non-GSK) and IPV (non-GSK). The subject's medical history included premature birth at 30 weeks gestation. Concurrent medical conditions included cataract, lens replacement, latex allergy and Ig E positive for gelatin. On an unspecified date the subject received unspecified dose of Dtap vaccine (unknown route, unknown lot number), unspecified dose of Hepatitis A vaccine (unknown route, unknown lot number), unspecified dose of MMR vaccine (Non-GSK) (unknown route, unknown lot number), unspecified dose of IPV (Non-GSK) (unknown route, unknown lot number). 2 hours after vaccination with Dtap vaccine, Hepatitis A vaccine, MMR vaccine (Non-GSK) and IPV (Non-GSK), the subject experienced anaphylaxis, cough, sore throat, welt, shortness of breath, wheezing and urticaria. This case was assessed as medically serious by GSK. The subject was treated with Oral steroids and diphenhydramine. At the time of reporting the events were resolved. The Program was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for several vaccines. In 2009, the Program charged the Institute with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute's review, the author undertook a systematic analysis of the Program's anaphylaxis case experiences. The Program administrative database was queried for all cases submitted to the Program alleging anaphylaxis or anaphylactic shock for the 10-year period from January 1, 2000 through December 31, 2009. Cases were categorized as anaphylaxis, possibly allergic-not anaphylaxis, and not anaphylaxis or allergic. The anaphylaxis cases all met the agency case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria, with level 1 being the greatest level of certainty. Possibly allergic cases were defined as those for which there were signs and/or symptoms compatible with an allergic reaction occurring within 4 hours of injection but that did not meet any of the agency case definitions for anaphylaxis. All of our anaphylaxis cases met the agency diagnostic certainty and, with an interval of 0 to 4 hours, are consistent with the current VIT. This case was classified at level 1 of certainty. The subject had previous testing demonstrating elevated IgE levels to gelatin, a known risk factor for vaccine-associated anaphylaxis. This review represented the first systematic approach in analyzing the Program experience with anaphylaxis and will be useful when the VIT is updated. This is one of 9 cases reported in the same article and represented 8 different vaccines containing at least 11 different vaccine antigens.