Sex: U
Vaccine: TDAP, DTAP, TDAP
Symptoms: Allergy to vaccine, Anaphylactic reaction, Angioedema, Blood immunoglobulin E increased, Cough
Clinical narrative: This case is a cluster of 7 unidentified patients' who experienced similar events following vaccination with ADACEL. Initial case was retrieved from the scientific literature on 22 March 2011. The article reported 7 cases of anaphylactic reactions in children. A group of seven unidentified children, with milk-allergies, received injection (route and site not reported) of ADACEL, same lot (not reported) between September 2007 and March 2010. "Seven milk-allergic children in one practice developed anaphylactic reactions to dTap vaccines over a two and a half-year period. They all received ADACEL from the lot between September 2007 and March 2010. Although vials from the suspect lot was not available for testing, researchers at a Food Allergy Institute at a School of Medicine tested two other lots and found milk protein in one (30 ng/ml). The outcomes were not reported. Follow-up information was retrieved from the scientific literature on 25 March 2011. The article reported 7 cases of anaphylactic reactions in children. Follow-up information received on 25 March 2011 from the scientific literature reported that "Some children highly allergic to milk products should be watched with caution when receiving the DPT vaccine because trace milk proteins in the vaccine could trigger reactions, researchers suggested. "We identified seven patients who reported convincing allergic reactions to tetanus vaccines," reported a professor of pediatrics, during his poster presentation at an annual meeting. "We observed several children with severe milk allergy to have reacted to the common childhood vaccine called the DPT or tetanus booster," the professor explained in an email in response to questions. "We believe that the vaccine may have very trace milk protein in some lots." The findings came from a chart review of patients seen who had reported allergic reactions after receiving the vaccine (primary or booster doses) from September 2007 to March 2010. The patients in question, five boys and two girls, had a median age of 11. "These cases were an observation in a relatively short period of two and one-half years where we encountered seven children with milk allergy having a severe anaphylactic reaction to the injection of the DPT shot." said a co-author, director of the Food Allergy Institute. "These were all children who had high levels of immunoglobulin antibody to milk protein," he remarked at a press briefing. "In two of the cases were were able to find that even though the children were from different areas they received the same lot of vaccine." "We then used a very sensitive immunoassay to look for the presence of milk protein in vials of ADACEL which was the DPT that they received. Of the two vials we looked at, one of them clearly had milk protein in it," he added. "We are looking at more lots to get an idea whether this is an uncommon phenomenon or not," he said. "We were struck by the fact that just in our practice we had seven patients with milk allergy who had these severe reactions and we believe it is due to contamination of milk protein in this vaccine." "This is very preliminary," he commented, "but if I had an extremely milk allergic subject I would take caution." He suggested that more studies are needed to understand the problems raised by the observations. The doctors noted that six of the patients had prior allergic reactions to cow's milk. Of those seven reactions, he and colleagues classified five as severe reactions. In the study, the researchers reported that after receiving the vaccine, the children exhibited the following symptoms: Wheezing was observed in five of the seven children; Urticaria was observed in five of the children; Sneezing and/or nasal congestion were reported in three children; Angioedema occurred in three children; Repetitive cough was experienced by two children. Five of the children were treated with antihistamines and three were treated with epinephrine. Three of the seven children were also administered inhaled beta-agonists and two were given corticosteroids, either as monotherapy or in combination, the researchers reported." Follow-up information was received 02 May 2011 from the scientific literature report regarding post-vaccine anaphylaxis seen in eight "kids" in one practice. Food allergy researchers were advising caution in giving highly sensitive milk-allergic children diphtheria-tetanus-acellular pertussis vaccines. The warning followed the discovery of eight (previously reported as seven) milk allergic children in a practice who developed anaphylactic reactions to the vaccines over a two-and-a-half year period. Two of the patients received ADACEL from the same lot between September 2007 and March 2010. The suspect lot was not available for testing, however, two other lots were tested by researchers at a Food Allergy Institute at a School of Medicine who found one lot contained milk protein (30 ng/ml). Findings thus far provided circumstantial evidence that there was sufficient milk protein in certain lots, that if given to highly allergic children, they might have a reaction. The article further explained that both Tdap and DTaP vaccines were known to be processed in a medium containing casamino acids derived from cow's milk. Of the eight children referenced, seven children had prior allergic reactions to cow's milk, and one was diagnosed with milk allergy based on serologic testing. Their milk specific serum IgE levels, documented within two years of the reaction were "very high", with levels greater than 100 kilounites of antibody per litre in five children. The recorded levels were far above those that typically correlate with reactivity. Three children had reactions to Tdap vaccine and four to DTaP, while the specific vaccine the eight child reacted to wasn't known. All of the children had multiple systems involved in their anaphylactic reactions within one our of vaccination, and developed respiratory symptoms with wheezing and/or cough. Outcomes were not reported. Follow-up information was retrieved from the literature on 11 May 2011. The article reported 7 cases of anaphylactic reactions in children. Follow-up information received on 11 May 2011 from the scientific literature reported that "This was a chart review of patients seen in our practice who had reported allergic reactions after receiving tetanus vaccine (primary or booster doses) from September 2007 to March 2010. An inhibition-ELISA was performed to determine the presence of milk protein in the vaccines. We identified seven patients (5 male, 2 female; median age 11 years; range 5-17), who reported convincing allergic reactions to tetanus vaccines. Six patients had prior allergic reactions to cow's milk, including severe reactions (5) and or reactions to trace exposures (4); one was diagnosed with milk allergy based on serologic testing. All patients had elevated milk specific IgE levels documented within 2 years of their reactions to the vaccine: 59. 96, and 5 patients >100 kUA/L. Each reported symptoms consistent with a diagnosis of anaphylaxis promptly after receiving the vaccine. Symptoms included: wheezing (5/7), urticaria (5/7), sneezing/nasal congestion (3/7), angioedema (3/7), and repetitive cough (2/7). Assays were performed on 2 different lots of the tetanus, diphtheria, and acellular pertussis vaccine, confirming the presence of milk protein in one lot (30 ng/ml). The outcomes were not reported. The reporter of this case was the same as cases 2011-01616, 2011-01728 and 2011-02653. Documents held by sender: None.