Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Oral intake reduced, Pallor, Pyrexia
Clinical narrative: Initial report received on 30 July 2007 from another manufacturer, report# WAES 0705USA02526. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 4 year-old female with no known allergies or pertinent medical history who on 10-MAY-2007 was vaccinated with a dose of ProQuad (lot# 657297/0429U). Concomitant therapy included a dose of Tripedia (lot# U2059AA) and a dose of IPOL (lot# Z0326-2). Subsequently, in the evening, following vaccination, the patient developed a fever, vomiting, a rash, and injection site pain. The patient presented to the emergency room and was treated for dehydration with intravenous fluid replacement. No lab studies were performed. There was no product quality complaint involved. No further information was provided. The reporter considered the patient's events to be life threatening. A lot check has been requested. 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. Additional information has been received from a registered nurse and medical records. This 4 year-old female with a penicillin allergy (hives) a possible metabolic disorder, vomiting, diarrhea and dehydration, was vaccinated at 10:00 on 10-MAY-2007 with a first dose of ProQuad (lot # 657297/0729U) SC in the right arm. Concomitant therapy at the same time included a fifth dose of Tripedia (lot# U2059AA) given IM in the left deltoid and a fourth dose of IPOL (lot # Z0326-2), given SC in the left arm. There was no illness at the time of vaccination. Subsequently at 20:00 (also reported as 16:00) on 10-MAY-2007 the patient developed a fever, vomiting, small hives on back of legs, dehydration, crying all night, stomachache, grinding of teeth/involuntary jaw slamming, weakness, pallor, decreased urine output, decreased po intake, decreased activity, injection site swelling, pain and redness (redness was noted at the Tripedia: injection site) and was hospitalized. On 11-MAY-2007 the patient presented to the emergency room with these symptoms. The patient was admitted to the hospital with an admission diagnosis of vomiting and dehydration (it was also noted that the patient may have had a local reaction to Tripedia (lot # U2059AA; and a questionable systemic reaction to ProQuad (lot # 657297/0429U). Labs were performed. It was noted that the patient's CBC was within normal limits (except for a left shift), chem 12 was normal, UA was negative except for 1+ ketones. The patient was placed on a clear liquid diet. The patient was placed IV fluids Dextrose 5% with 0.2 % NaCl and KCl 20 mEq/L at 62 mL/hr. The patient was given a 400 mL IV bolus of 0.9% Sodium Chloride. The patient was ordered acetaminophen (TYLENOL) po or rectally prn for pain or temperature >101. The patient was given ondansetron hydrochloride 2mg IV x1 (with orders to repeat q8 hours prn for nausea and vomiting). On 12-MAY-2007 it was noted that the patient was tolerating po fluids well and wanted to eat. The patient voided a large volume of clear urine. The patient's vomiting and dehydration were considered resolved at that time. The patient's diet was advanced. On 12-MAY-2007 the patient was discharged to home. On an unspecified date the patient fully recovered. The patient's vaccination history included first, second, third and fourth doses of DTaP (manufacturer unknown) on 10-JUL-2003, 10-SEP-2006, 10-NOV-2003 and 10-MAY-2004; first second and third doses of hepatitis B virus vaccine rHBsAg (manufacturer unknown) on 08-MAY-2003, 09-JUN-2003 and 10-NOV-2003; first, second, third and fourth doses of Hib conj vaccine (manufacturer unknown) on 10-JUL-2003, 10-SEP-2003, 10-NOV-2003 and 16-AUG-2004; a first dose of Fluzone on 14-NOV-2007;  a first dose of MMR II on 10-MAY-2004; a first, second, third and fourth dose of Prevnar on 10-JUL-2003, 10-SEP-2003, 10-NOV-2003 and 17-NOV-2004; first, second and third doses of IPOL (manufacturer unknown) on 10-JUL-2003, 10-SEP-2003 and 17-NOV-2004 and a first dose of Varivax on 10-MAY-2004. The patient's events were considered serious for hospitalization. Additional information is not expected. All available medical records will be provided upon request."