Age: 5.0
Sex: M
Vaccine: IPV, MMR, TDAP, MEN, MMR, TDAP
Symptoms: Anaphylactic reaction, Blood pressure increased, Dyspnoea, Erythema, Face oedema
Clinical narrative: Initial report received from another manufacturer, report number WAES0510USA01787 on Nov 16 2005. A fiver year old healthy male with no significant medical history had received an administration (route and site not reported) of IPOL, lot number Y0496, a 0.5 ml subcutaneous injection of another manufacturers measles mumps rubella II vaccine, lot number 649675/0240R, in the left arm and an administration (route and site not reported of Boostrix , lot number AC14A00AA in the left thigh on Oct 4 2005. The patient had no illness and was using no other medications at the time of the vaccination. About three - five minutes later the patient sneezed three timed, began wheezing, experienced trouble breathing and developed hives. It was also noted that he had elevated blood pressure, tachycardia, skin erythematous all over and swelling of the face and lips. He was treated in the physicians office with epinephrine, Benadryl, Proventil and Decadron. The nurse reported that the child was subsequently sent to the hospital with a diagnosis of anaphylactic reaction. The child was admitted for observation only, was discharged on the same day and recovered. The nurse reported that it was not determined what vaccine the anaphylactic reaction was due to. There was no product complaint involved. The patient was admitted to the hospital from the office on Oct 4 2005 after an anaphylactic reaction. Follow up medical records information received by the other manufacturer indicated that the patient was admitted to the hospital from the office on Oct 4 2005 after an anaphylactic reaction. He received his immunizations and then began having urticaria, itchy skin, difficulty breathing, wheezing and swelling of face and lips. In the office he was given an injection of 0.25 cc of epinephrine, four mg of Decadron intramuscularly, 0.5 cc of Proventil, two cc of saline aerosol and Benadryl by mouth. Because of little improvement, he was admitted to the hospital for further observation. Benadryl was administered intravenously and he received intravenous fluids. The parents reported that on the way to the hospital the patient began with emesis which continued through his admission, however, he had no further emesis. He had been able to eat a regular diet. He had no further breathing difficulties and required no further treatments for any breathing difficulties. He had one does of intravenous Benadryl and had continued on intravenous fluids. That evening, the patient was back to normal. He had clear lungs. His heart revealed a regular rate and rhythm. He had no urticaria and no itching. His face was normal color and there was no swelling of the face or lips. He was discharged to home and activity was to be as tolerated. He was instructed to take one Benadryl every four to six hours for three days. Anaphylactic reaction was considered to be immediately life threatening, disabling and other important medical events by the reporting physician (OMIC). The outcome was recovered on Oct 4 2005. There were no adverse events of the patient or the sibling following prior vaccinations.