Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Lethargy, Malaise, No reaction on previous exposure to drug, Oxygen supplementation, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 5-year-old male with a history of oesophageal reflux and no drug reactions/allergies who on 31-MAY-2006 was vaccinated with a second dose of MMR II (Lot 3 649811/0491R). There was no concomitant medication. On 31-MAY-2006, after vaccination, the patient had an anaphylactic reaction. The patient had the reaction at the physician's office, and the pharmacist "thinks that the doctor have administered epinephrine to keep the patient going before EMS arrived". The patient was hospitalized for several days (also noted to be an overnight stay) and discharged on 01-JUN-2006 or 02-JUN-2006. Upon discharge, the patient was given a prescription for a steroid for 5 days, and a proton pump inhibitor and antihistamine for 1 month and epipen. The patient recovered on 05-JUN-2006 with the steroid, proton pump inhibitor, and antihistamine therapy. It was noted that the first dose of MMR II (Lot # 642645/0527M) was administered on 29-AUG-2002 with no problems. Follow up information indicated that the patient has had no further immunizations since  his reaction. Follow up information received front medical records and a physician indicated that the patient had no known allergies and a history of periodic breathing and gastroesphageal reflux and some type of swelling over the left pinna (which needed an operation) and a family history of diabetes and dermatitis. He was also noted to have no pre-existing allergies, birth defects, or medical conditions. He was perfectly fine when he arrived at the pediatrician at 2PM on 31-MAY-2006 for his 5-year physical. After being examined by the physician, the patient was vaccinated at 3:15PM with a second dose of MMR II (administered SC in the right thigh). There was no illness at the time of vaccination. Concomitant vaccinations that day at 3:15PM included a fifth dose of Infanrix (Batch # AC14B008AA) administered IM in the left thigh and a fourth dose of IPOL (Batch # Y0298) administered IM  in the left thigh. There were no other concomitant medication. Within 10 minutes (also noted as 3:15PM), he was uncomfortable, not feeling well, and began to severely vomit. This was seen followed by extreme itchiness of the feet and then redness of the whole body with hives on the left shoulder. This happened very quickly within 10-15 minutes. The patient also was having difficulty staying awake, was fussy, disoriented, lethargic,a nd wanted to sleep. He received oxygen and an EpiPen. His baseline blood pressure prior to being vaccinated was 80mm systolic and during the reaction, the systolic blood pressure dropped down to 40mm, and he was transported vi ambulance to the ER. When seen in the ER, he was somewhat unresponsive, needing a lot of stimulation to be awakened. He was erythematous all over, but there were no hives. The vital signs were stable with blood pressure having to come up to more than 80mm Hg systolic. He was given IV fluids, a second dose of epinephrine, Zantac, Zyrtec, and Solu-Medrol. By 5PM, the erythematous skin resolved. The impression was anaphylactic reaction, likely secondary to MMR II. The plan was IV fluids. The patient was hospitalized for 1 day. The outcome was reported as recovered on 01-JUN-2006. The mother denied any systemic illness in the patient in the days prior to vaccination. There was no history of reactions to any foods or medications in the past. The boy was not stung by any insects. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Anaphylactic reaction was considered to be immediately life-threatening, disabling, and an other important medical event by the reporter. No additional information is expected.