Sex: M
Vaccine: PNC
Symptoms: Aphasia, Balance disorder, Crying, Decreased eye contact, Developmental delay
Clinical narrative: Information has been downloaded from database (HQWYE560316AUG06). Information has been received from a physician referring to a 1 year old male patient. The patient's medical history included cold (reported as mild virus (cold) prior to receiving the 4th dose of PREVNAR), otitis media (diagnosed and treated with cefazolin sodium (ANCEF) at an Urgent Care 21-NOV-2005), motor dysfunction (assessed as gross motor delay with normal muscle tone and drag of right foot with attempted walking) and pharyngeal erythema (assessed on 28-NOV-2005). The patient's historical medication included PREVNAR (started on 02-NOV-2004 and 04-JAN-2005 separately and both experienced fever, swelling NOS and irritability) for immunisation. The patient's concurrent condition was not reported. The patient did not have concomitant medication. On 10-SEP-2004 the patient was vaccinated with ENGERIX-B (1 dosage form (DF); lot # BVP012AB; strength, indication and expiration date were unknown) intramuscularly. On 02-NOV-2004 the patient was vaccinated with pneumococcal conj vaccine (CRM197) injection (1 DF, strength, indication, lot # and expiration date were unknown) intramuscularly, poliovirus vaccine inactivated (unspecified) (1 DF; strength, route, lot # and expiration date were unknown) for immunisation and Hib conj vaccine (unspecified carrier) injection (1 DF; strength, route, indication, lot # and expiration date were unknown). On 12-NOV-2004 the patient was vaccinated with diphtheria toxoid (+) tetanus toxoid (1 DF; lot # 41538A; route, strength, indication and expiration date were unknown). On 04-JAN-2005 the patient was vaccinated with pneumococcal conj vaccine (CRM197) injection (1 DF, strength, indication, lot # and expiration date were unknown) intramuscularly, poliovirus vaccine inactivated (unspecified) (1 DF; strength, route, indication, lot # and expiration date were unknown), Hib conj vaccine (unspecified carrier) injection (1 DF; strength, route, lot # and expiration date were unknown) for immunisation and diphtheria toxoid (+) tetanus toxoid (1 DF; lot # 41538A; route, strength, indication and expiration date were unknown). On 05-MAR-2005 the patient was vaccinated with Hib conj vaccine (unspecified carrier) injection (1 gram; strength, route, indication, lot # and expiration date were unknown). On 15-MAR-2005 the patient was vaccinated with pneumococcal conj vaccine (CRM197) injection (1 DF, strength, lot # and expiration date were unknown) and diphtheria toxoid (+) tetanus toxoid (1 DF; lot # 41538A; route, strength and expiration date were unknown) for immunisation. On 22-JUN-2005 the patient was vaccinated with ENGERIX-B (1 DF; lot # BVP012AB; strength and expiration date were unknown) intramuscularly for immunisation. On 30-AUG-2005 the patient was vaccinated with VARIVAX (1 DF, lot # reported as 0841P was invalid; strength, route and expiration date were unknown), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (1 DF; lot # reported as 0483R; strength, route, therapy type and expiration date were unknown) and ENGERIX-B (1 DF; lot # BVP012AB; strength and expiration date were unknown) intramuscularly for immunisation. On 05-DEC-2005 the patient was vaccinated with diphtheria toxoid (+) tetanus toxoid (1 DF; lot # 41538A; strength and expiration date were unknown) intramuscularly for immunisation. On 08-DEC-2005 the patient was vaccinated with PREVNAR injection (1 DF; lot # A98341C; strength and expiration date were unknown) intramuscularly for immunisation. In December 2005 the patient was treated for aluminum toxicity, he also experienced not sleeping, delayed walker: reverted to crawling in circles, banging his head, cry through the night and when trying to sleep, dizziness, reduced eye contact, no longer answered to name, developed balance problems and started to drag one leg, fever (for 5 days), became limp and stopped speech completely for 2 1/2 weeks. On 15-DEC-2005 the patient screamed for several hours and recovered on the same day. In December 2005 the patient recovered from fever. In March 2006 the patient recovered from cry through the night and when trying to sleep. In 2006 the patient recovered from aluminum toxicity, balance problems, limp, reduced eye contact, dizziness, delayed walker: reverted to crawling in circles, banging his head and not sleeping. On unknown date, the patient recovered from stopped speech completely for 2 1/2 weeks. Action taken with suspect vaccines was not applicable. The causality assessment was not reported. All the events were considered to be medically significant by the reporter.