Age: 0.2
Sex: M
Vaccine: HIBV, RV5
Symptoms: Lethargy, Product quality issue, Pyrexia, Screaming, Somnolence
Clinical narrative: Information has been received from a consumer concerning her 6 week old son with sensitivity to milk protein in formula and no other allergies who was born three weeks early who on 8-AUG-2008 was vaccinated with a 0.5ml dose of HIB (lot# 656522/0437U) from a lot number that was recalled. It was noted that the patient received two vaccinations (names unspecified) about a week prior to vaccination with HIB (lot # 656522/0437U). The mother reported that within 24 hours of vaccination with HIB (lot # 656522/0437U) her son was Lethargic, not responsive to things around him, very sleepy, fussy and would stare off. The patient's symptoms were reported to his physician by his mother. There were no lab studies performed. Subsequently, the patient recovered on an unspecified date. It was noted that the patient's symptoms lasted for several days. There was no product quality complaint involved. Follow up information from the patient's mother indicated that the patient also experienced behavior change, diarrhea and weakness within 24 hours after vaccination with a recalled lot number of HIB (lot # 656522/0437U). It was noted that the patient recovered on an unspecified date. Additional information has been requested. This is in follow-up to report (s) previously submittedon 2/18/2009. Information has been received from a consumer concerning her 6 week old son with sensitivity to milk proteinin formula and noother allergies who was born three weeks early who on 08-AUG-2008 was vaccinated with a 0.5 ml dose of OMPC (lot #656522/0437U) from a lot number that was recalled. It was noted that the patient received two vaccinations (names unspecified) about a week prior to vaccination with OMPC (lot #656522/0437U). The mother reported that within 24 hours of vacciantion with OMPC (lot #656522/0437U) Subsequently, the patient recovered on an unspecified date. It was noted that the patient's symptoms lasted for several days. There was no product quality complaint involved. Follow-up information from the patient's mother indicated that the patient also experienced behavior change, diarrhea and weakness within 24 hours after vaccination with a recalled lot number of OMPC (lot #656522/0437U). It was noted that the patient recovered onan unspecified date. Follow-up information from the patient's mother indicated that the patient also experienced high pitched and unusual cry and screamand gastrointestinal pain as evidence by him drawing up his legs and finding a little relief after a bowel movement and expecially with a warmbath or massageof his stomach. It was noted that these adverse events and the adverse events of irritability/fussiness and diarrhea lasted for approximately 5 days. It was also noted that the adverse events of sleepiness and significantly decreased response tohis environment lasted more than a week. Follow up information with indicated that the patient was also vaccinated on 28-Jul-2008 with a dose of 2 mL first dose of ROTATEQ (lot # 660847/0302X) and on 08-AUG-2008 a 0.5 mL first dose of HIB (unspecified carrier) (manufacturer unknown) (lot #UF522AA). Other vaccinations given on 28-JUL-2008 included a 0.5 mL first dose of TRIPEDIA (lot #U2290AA), a 0.5 mL first dose of PREVNAR (lot# C99642), and a 0.5 mL first dose of IPOL (lot# A0169). On 29-SEP-2008 the patient received a 0.5 mL second dose of TRIPEDIA (lot# A0836-2), a 0.5 mL second dose of PREVNAR (lot# D16281) and a 2 mL second dose of ROTATEQ (lot # 661037/0641X). On 01-DEC-2008 the patient received a 0.25 mL first dose of FLUZONE (lot#U2898FA). On 05-DEC-2008 the patient received a 0.5 mL third doseo fl INFANRIX (lot# AC14B064AA), a 0.5 mL dose of IPOL (lot# A08.6-2), a 0.5 mL third dose of PREVNAR (lot# C46480), and a 2 mL third dose of ROTATEQ (lot#660847/0302X). On 31-DEC-2008 the patient received a 0.25 mL second dose of FLUZONE (lot# U2941AA). The patient was seen for fever of 97.8 after the vaccination. On 10-AUG-2008 the patient was seen at the clinic due to parental concern. The reason was the patient had a decreased appetite, feed time and activity. At the time of this report the patient recovered and was alert, active and afebrile, with an appropriate weight gain for age. No further information is available.