Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Decreased appetite, Insomnia, Irritability, Medication error, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a healthcare worker concerning a 10 week old female pt with no known allergies and no known medical history who on 29-JUN-2004 at approximately 11:30 AM was vaccinated in the right thigh with a first dose of MMR II (lot #647345/1037N0. Concomitant vaccinations on 29-JUN-2004 included a first dose in the right thigh of ActHib, a first dose in the left thigh of DTaP and a first dose in the left thigh of IPV. It was also noted on 21-MAY-2004 at approximately 12:30 pm a first dose in the left thigh of hepatitis B virus vaccine rHBsAg (lot number 647396/1215N) was given. On 29-JUN-2004, the pt was inadvertently vaccinated with MMR II outside of the indicated vaccination schedule. There was no illness at the time of vaccination. On 06-Jul-2004, "on day 6 after vaccines given", the pt started with a temp of 100.1 degrees, was "crabby", not sleeping well, had a decrease in eating, was scratching her head, and pulling above her left ear. A follow-up call to the parent on 12-Jul-2004 was placed and a message was left to contact the office to follow-up call to the parent on 12-Jul-2004 was placed and a message was left to contact the office to follow-up. The parent called back on 16-Jul-2004 and stated the pt had slight cold symptoms, was pulling at ears and was fussy. An appointment was made that day to see the pt. No further details were provided. The outcome of the inadvertent vaccination was made that day to see the pt. No further details were provided. The outcome of inadvertent vaccination was not reported. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. Follow-up received:  This is in follow-up to report (s) previously submitted on 5/27/2005.  Initial and follow-up information has been received from a healthcare worker concerning a 10 week-old female patient with no known allergies and no known medical history who on 29-JUN-2004 at approximately 11:30 am was vaccinated in the right thigh with a first dose of MMRII (Lot # 647345/1037N).  Concomitant vaccinations on 29-JUN-2004 included a first dose in the right thigh of ACTHIB (Lot # VE177AA), a first dose in the left thigh of DAPTACEL (Lot # C1634AA), and a first dose in the left thigh of IPOL (Lot # X0772).  It was also noted on 21-MAY-2004 at approximately 12:30 pm a first dose in the left thigh of hepatitis B virus vaccine rHBsAg (yeast) (MSD) (Lot number 647396/1215N) was given.  On 29-JUN-2004, the patient was inadvertently vaccinated with MMRII outside of the indicated vaccination schedule.  There was no illness at the time of vaccination.  On 06-JUL-2004, "on day 6 after vaccines given" the patient started with temp.  of 100.1 degrees, was "crabby",  not sleeping well, had a decrease in eating, was scratching her head, and pulling above her left ear.  A follow-up call to the parent on 12-JUL2004 was placed and a message was left to contact the office to follow-up.  The parent called back on 16-JUL-2004 and stated the patient had slight cold symptoms, was pulling at ears and was fussy.  An appointment was made that day to see the patient.  No further details were provided.  The outcome of the inadvertent vaccination was not reported.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested .  This is an amended report.  The lot numbers for ACTHIB, DAPTACEL and IPOL have been added.  This report is corrected, as amended.