Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Bowel movement irregularity, Diet refusal, Hypophagia, Irritability, Muscle spasms
Clinical narrative: Information has been received from a consumer concerning his 3 month old son with no medical history and no drug allergies, who on 06-DEC-2007 was vaccinated with a first dose of PedvaxHIB. Concomitant suspect vaccinations included Rotateq. Other concomitant vaccinations included Pediarix. Subsequently, "about a day or two post vaccination" on approximately 08-DEC-2007, the patient was fussy, did not want to eat, was cramping up, and was vomiting. The patient did not have a bowel movement for 3 days. It was also reported that the patient had not really eaten for two days and was still throwing up. The patient was given Pedialite and was taking some of it down but not much. The physician was contacted. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  3/5/08 Seen in pcp office 12/13 & 12/14/2007 for viral gastroenteritis.  On 12/14 referred to ER.  PCP called ER on 12/14 but unclear from pcp notes whether patient admitted or released.  PCP not available at this time.  Will request hospital/ER records.  No further visit until well child vs for vax 2/2008. PedvaxHib 0437U, Pediarix AC21B124CA, Rotateq 0236U and Prevnar B08700D.  3/19/08 Reviewed ER medical records of 12/14/2007. FINAL DX: Vomiting Records reveal patient experienced vomiting, irritability, decreased oral intake, decreased UO x 3 days.  Exam revealed sunken fontanelle & dry mucous membranes.  Tx w/IVF & antiemetics.  D/C to home to f/u next day w/pcp. 02/18/09 This is in follow-up to report(s) previously submitted on 2/18/2008. Initial and follow-up information has been received from a consumer concerning his 3 month old son with no medical history and no drug allergies, who on 06-DEC-2007 at 11:00 was vaccinated intramuscularly with a first dose of PEDVAXHIB (OMPC) (Lot# 656522/0437U). Concomitant suspect vaccinations included a first dose of ROTATEQ (Lot# 656390/0236U) administered by mouth. Other concomitant vaccinations included a first dose of PEDIARIX (Lot# AC21B124CA) administered intramuscularly, and a first dose PREVNAR (Lot# B08700D) administered intramuscularly. Subsequently, "about a day or two post vaccination" on approximately 08-DEC-2007, the patient was fussy, and was cramping up. On 11-DEC-2007 at 18:00 the patient was vomiting and had decreased po intake. The patient did not have a bowel movement for 3 days. It was also reported that the patient had not really eaten for two days and was still throwing up. The patient was given Pedialite and was taking some of it down but not much. The physician was contacted. The patient was seen by the physician on 13-DEC-2007 and went to the emergency room on 14-DEC-2007. No laboratory diagnostics were performed. On 14-DEC-2007 the patient recovered from vomiting and decreased po intake. At the time of the report, the outcome of the patient being fussy and cramping up were unknown (previously reported as the patient had not recovered). No product quality complaint was involved. Additional information has been requested.