Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash pruritic, Rhinitis allergic, Rhinorrhoea, Sneezing, Swelling face
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male with a pollen allergy, a grass allergy, tree pollen allergy, mold spore allergy, dust mite allergy, cat dander allergy, perennial and seasonal allergic rhinitis, and a history of ostium primum atrial septal defect, ventral septal defect repair, and mitral repair who on 23-MAR-2006 at 11:00 am was vaccinated SC in the right arm with a second dose of MMR II (lot # 649756/0381R). Suspect vaccination administered that day at 11:00 am included an IM fifth dose in the left arm of DAPTACEL (lot # C2375AA) and an IM fourth dose in the right arm of IPOL (lot # X0575). There was no illness at the time of vaccination. After vaccination with all three vaccines the patient had an anaphylactic reaction. An Allergy test was performed and it was discovered that the patient was allergic to bovine and porcine gelatins. Medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. Follow up information from the registered nurse and medical record indicated that within twenty minutes of the administration of the vaccinations the patient developed a diffuse, red, raised and intensely pruritic rash, facial swelling and had difficulty swallowing. It was reported that on 23-MAR-2006 at 1:50 PM the patient returned to the office and complained of eyes hurting, sore throat, facial swelling, white itchy blotches. On exam the patient had a few hives on his face, a papular scattered rash on his chest, neck and abdomen. His lungs were clear, he had no wheezing, and he was alert and active. This was reportedly the only episode of any reaction to vaccines, as the patient had no previous difficulties whatsoever. it was reported that the trigger fro this reaction was unknown, as a matter of fact. The patient's mother denied any history of egg allergy. The patient's nasal symptoms included persistent congestion. Triggers were not well recognized. There was some associated post-nasal drainage and occasional symptoms of itchy eyes/nose and sneezing. It was noted that the family did not appreciate any rhinorrhea. The patient's nasal allergies were being treated with BENADRYL, which was taken on an as needed basis. On diagnostic testing the patient tested positive to bovine and porcine gelatin. Testing to egg, shrimp, and tuna was negative. In regards to his environmental testing, he tested highly positive to grass, pollen and to lesser extent tree pollen, mold spores, dust mite, and cat dander. Based on the positive results of testing, the physician strongly suspected that gelatin was likely the cause of the reaction.  There was no evidence that egg allergy played any significant role. It was strongly recommended that the patient avoid any vaccines containing gelatin in the future. The patient recovered on 23-MAR-2006. Follow-up information from the registered nurse indicated that the patient was "doing fine now". She explained that he experienced facial swelling, difficulty breathing and confirmed the previously reported symptoms. She felt that the patient's experienced were serious, but not life threatening. The patient was treated in the office with BENADRYL and was not seen in the emergency room. He recovered the same day and was doing fine now. She reported that the patient "now has " allergic rhinitis, which he never previously had. The reporter indicated that if his allergic rhinitis continued they would treat him. Anaphylactic reaction was considered to be an other important medical event. Additional information has been requested.