Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Feeling hot, Injection site rash, Lacrimation increased, Rash
Clinical narrative: Initial and follow up information has been received from a nurse concerning a 4 yo male pt with no illness at the time of vaccination, no hx of allergies to any food or medication, no hx of previous reactions to any vaccinations and who was born prematurely at approximately 23 weeks gestation weighing 1lb 5ounces. On 15MAR2004 at 12:00 PM the pt was vaccinated subcutaneously in the right thigh with a first dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine. Concomitant therapy included vaccination at 12:00 PM on 15MAR2004 with a 4th dose of DTP given IM in the left thigh. The pt experienced watery eyes, rash, wheezing, vomiting and fainting. On follow up it was reported that on 15MAR2004 the pt began with watering eyes and faint rash at 12:20PM and after five minutes the rash was more intense with warmth to touch, more rash, vomiting and wheezing. The pt was not hospitalized. The pt was seen by the doctor and was treated with one dose of epinephrine, oral Benadryl and Xopenex inhaler. The pt recovered on 15MAR204. The nurse reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about twenty minutes after vaccination. Follow up information indicated that measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine was considered to be the primary suspect because the rash started at the measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine injection site and spread from there. It was reported that the measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh. Upon internal review anaphylactic reaction was determined to be an other important medical event (OMIC). Additional information is not expected. This is in follow-up to report (s) previously submitted on 5/28/2004. Initial and follow up information has been received from a health professional and a nurse concerning a 4 year old male patient with no illness at the time of vaccination, no history of allergies to any food or medication, no history of previous reactions to any vaccinations and who was born prematurely at approximately 23 weeks gestation (also reported as approximately 34 weeks) weighing 1 pound 5 ounces (also reported as 1 1/2 pounds). On 15-MAR-2004 at 12:00 PM the patient was vaccinated subcutaneously in the right thigh with a first dose of MMR II (lot#646740/0822M). Concomitant therapy included vaccination at 12:00PM on 15-MAR-2004 with a fourth dose of DAPTACEL (Lot#C1679AA) given IM in the left thigh and with a third dose of IPOL (lot# X0707) given SQ in the left thigh. The patient experienced watery eyes, rash, wheezing, vomiting and fainting (also reported as within five minutes of receiving the vaccines, the patient developed generalized hives, vomiting, watery eyes, wheezing and became faint). It was not reported whether the patient lost conciousness. On follow up it was reported that on 15-MAR-2004 the patient began with watering eyes and faint rash at 12:20 PM and after five minutes the rash was more intense with warmth to touch (97.5 AX), more rash, vomiting and wheezing. The patient was not hospitalized. The patient was seen by the doctor and was treated with one dose of epinephrine, oral BENADRYL and XOPENEX Inhaler. The patient recovered on 15-MAR-2004. The nurse reported on follow up that the patient's reaction was considered to be an anaphylactic reaction with an onset of about twenty minutes after vaccination. Follow up information indicated that MMR II vaccine was considered to be the primary suspect because the rash started at the MMR II injection site and spread from there. It was reported that the MMR II vaccine was the only vaccination given in the child's thigh where the rash started. The other two vaccinations were given in the child's other thigh. Upon internal review anaphylactic reaction was determined to be an other important medical event. The nurse also reported that a male patient experienced an anaphylactic reaction following vaccination with MMR II vaccine (Wistar RA 27/3) (WAES#0403USA02072). Additional information is not expected. Other business partner number includes 2004-01262.