Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypersensitivity, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean platelet volume decreased, Nausea
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 week male patient with no known drug allergies who on 13-JUL-2011 was vaccinated with a first dose of ROTATEQ, PO (dose and lot # not reported) and on 14-SEP-2011 was vaccinated with a dose of ROTATEQ (Lot # 669529/0548AA, Expiry date 20-SEP-2012), PO (dose and route not reported). Secondary suspect therapy included PEDIARIX, ACTHIB and PREVNAR. There were no concomitant medications. The certified medical assistant reported that on 15-SEP-2011 the patient experienced hives (red raised bumps) on his legs, coughing and difficulty breathing after his second dose of ROTATEQ. The certified medical assistant also reported that the patient was examined in the emergency room but was not hospitalized. A complete blood cell count (CBC) was performed (no results provided). Ibuprofen was given as a treatment for the events. At the time of the report, the patient's outcome was unknown. Information received from medical records concerning a 5 month old male with a history of neonatal jaundice who on 14-Sep-2011 at 17:00 was vaccinated with a second dose of ROTATEQ (Lot # 669529/0548AA). At the same time the patient received a second dose of the following vaccinations: ACTHIB and PREVNAR. On 15-Sep-2011 at 11:04 the patient was seen in the emergency room for hives on his legs. The patient's mother reported that the patient had a choking episode and could not catch his breath. The patient also had a decreased appetite and experienced nausea and vomiting x two during the previous night. It was noted that the patient was being breast fed. The patient's mother reported that at 0730 the patient received 1.3 ml of TYLENOL. The patient's vital signs in the emergency room were: temperature of 100.2 rectally, pulse of 160 and respirations of 24. His oxygen saturation was 99% on room air. The patient was alert, appeared well nourished with no respiratory distress noted. At 13:28 the patient received 4 cc of ibuprofen. At 14:26 a repeat temperature was 100 temporarily. At 14:36 the patient was sleeping. The following laboratory results were obtained: blood count with differential was within normal range except for a mean corpuscular hemoglobin concentration (MCHC) of 35, mean platelet volume (MPV) of 6.5, platelet of 405, neutrophils of 58 and lymphocytes of 34. The absolute cell count was within normal range with the exception of absolute neutrophils of 9.3. The patient was discharged at 15:00 with a diagnosis of acute allergic reaction. Discharge instructions given to the patient's mother included: TYLENOL or ibuprofen for fever and follow up with their physician. It was reported that the patient was recovered on 15-Jul-2011. 15Sep2011 abnormal laboratory results received included: absolute neutrophils of 9.3 x1000/uL, mean corpuscular hemoglobin concentration(MCHC) of 35g/dL, mean platelet volume (MPV) of 6.5fL and platelet count of 405x1000/uL. Upon receipt of medical records the following adverse events were removed as they were considered symptoms of an acute allergic reaction: difficulty breathing, coughing and hives on legs. Additional information has been requested.