Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Haemoglobin decreased, Irritability, Lip swelling, Lymphocyte count decreased, Lymphocyte percentage
Clinical narrative: Initial report received from a nurse practitioner via Merck (MFR control number WAES 1010USA01288) on 02 November 2010. The following initial information was verbatim from the report: "Information has been received from a nurse practitioner concerning a 16 week old patient who "last Thursday" on 07-OCT-2010 was vaccinated with a dose of ROTATEQ (Lot# unknown) along with 2 other vaccines which were unspecified. The nurse reported that "the next day" on 08-OCT-2010, the patient experienced hives, swollen lips, trouble breathing and was a bluish color. The nurse stated that the patient was treated in the Emergency Room with an oral steroid, oxygen and an intravenous fluid. At the time of the report, the patient was recovering. Follow up information has been received from a Registered Nurse and a medical record. It was reported that the patient was a 17 week old (previously reported as 16) male patient with no known drug allergies and a history of dermatitis atopic, eczema, circumcision and who was delivered at 37 weeks by cesarean section. The grandmother indicated that second degree relative passed away at 6 months of age due to allergic reaction to vaccination. The patient had not been exposed to second-hand smoke at home. No infectious disease exposure. On 30-SEP-2010 at 15:00, the patient was vaccinated orally with the second dose of ROTATEQ (lot # 664949/1586Y). Concomitant therapy included the second dose of PENTACEL IM, in the left arm (lot # C3563AA) and the second dose of PREVNAR IM, in the right arm (lot # E69592). On the night of 30-SEP-2010 and on the morning of 01-OCT-2010, the mother gave the patient TYLENOL. On 30-SEP-2010, the patient was fussy and on 01-OCT-2010, he vomited. The patient's mother called the physician and stated that the patient had an itchy rash located on the chest. The rash was not hives. It was reported by the patient's mother that the patient's lips were swollen and the patient's feet were slightly blue in color. The patient was taken to a hospital's emergency room. On the arrival the patient had a skin rash that started just prior to arrival and was still present, but was better at that moment. It had been constant. It had been generalized in location. It was described as itchy. A possible cause had been identified (immunizations). The recent exposure occurred at home. No known contact with a sick individual. The patient had not had similar symptoms previously. The patient had had a subjective low grade fever. He has been fussy (started yesterday after immunizations). He has had vomiting (starting the morning, 5 times). All systems otherwise negative, except as recorded above. It was reported that the patient had an eczema, was seen by a dermatologist and was being treated with two types of steroid creams. The patient was given TYLENOL infants oral 40 mg (last dose at 14:15). The physical examine was within normal limits except for the temperature that was 99.3 (rectal). The patient   [Due to memory limitations, the remainder of this text could not be compared.]  patient had no respiratory distress, breath sounds were normal. Pulse oximetry on room air was 97-100%. At 17:31, clear liquid diet was offered (given PEDIALYTE SOLUTION). At 19:12, the mother was instructed to feed smaller amounts. The patient was still not feeding well on breast milk. The patient vomited it. The patient was treated with intravenous fluids (initial bolus 100 ml) and dexamethasone 2 mg orally and laboratories tests were performed. Lab results revealed: serum sodium test 139, potassium 4.3, chloride 104, carbon dioxide 22, anion gap 17.3, glucose 113, blood urea nitrogen 3, creatinine 0.3, blood urea nitrogen/creatinine ratio 10, calcium test 9.8, white blood cell count 14.5, red blood cell count 3.72, hemoglobin test 9.9, hematocrit 28.9, mean corpuscular volume 77.7, mean corpuscular hemoglobin 26.6, mean corpuscular hemoglobin concentration 34.3, red cell distribution width test 12.1, platelet 389, mean platelet volume 10.6, neutrophil 42.4 %, lymphocyte, monocyte 5%, blood eosinophilic leukocyte count 6%, blood basophilic leukocyte count 0.6%, blood neutrophil count # 6.1, blood lymphocyte count # 6.7, monocyte count # 0.7, blood eosinophilic leukocyte count # 0.9, blood basophilic leukocyte count #0.1 and stool culture test was negative for rotavirus. It was reported in medical records that there was no evidence of anaphylaxis, respiratory distress, or dehydration. At 20:49 the mother reported that the patient was breast fed for 10 minutes and tolerated it well. At 21:03, the patient's symptoms were better, physical exam findings were improved. The patient was alert and in no acute distress. The rash had decreased, patient color looked better. On recheck, the patient was stable, in no acute distress and non-toxic at the time of discharge. There were no findings for peritonitis, intussusception, or sepsis. Clinical impression was acute urticaria, eczema, and acute gastroenteritis. It was not quite clear if hives earlier (never seen) were related to immunizations or current viral illness causing vomit/diarrhea. The same day the patient was in good and stable condition and was discharged from the hospital. Instructions were given to give the patient TYLENOL or MOTRIN as needed for fever control, to take medication according to label instructions and to drink plenty of fluids. (Discussed with PMD about next series of shots and where to give them or not with hives). The patient was said to continue taking the steroid cream as prescribed and was placed on BENADRYL liquid 12.5 mg/5ml, 2 ml orally every 6 hours as needed for itching. The nurse stated that according to the mother's report of the child's condition, it was considered that the patient's adverse experiences were disabling and life threatening. The nurse stated that the hospital ER report did not mention that the lips were swollen, or that the patient's feet were slightly blue. The patient did not receive oxygen therapy in the ER. The patient was not hospitalized. The nurse stated that the ER report stated that the patient had an allergic reaction to the immunizations. A lot check has been initiated. This is an amended report, lot number was validated, changed in narrative and added to therapy screen. No further information is available. All available medical records will be provided upon request." Hospital identifier removed. Documents held by sender: None.