Age: 1.34
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, PPV
Symptoms: Myositis, Speech disorder, Tympanic membrane hyperaemia, Weight bearing difficulty
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inability to speak in a 16-month-old male subject who was vaccinated with DTAP, (manufacturer unspecified), pneumococcal vaccines (non-gsk), HIB (non-gsk) and MMR (non-gsk). The subject's medical history included undetermined neurological disorder. Previous vaccination included DTAP; manufacturer unspecified; unknown; unknown given on 10 August 20004 and 8 December 2004; HIB (non-gsk); non-GSK manufacturer; unknown; unknown given on 10 August 2004 and 8 December 2004; hepatitis B vaccine; manufacturer unspecified; unknown; unknown given on 10 August 2004 and 8 December 2004; pneumococcal vaccines (non-GSK manufacturer; unknown; unknown given on 10 August 2004 and 8 December 2004. On 2 August 2005 the subject received 3rd dose of DTAP vaccine (unknown), 3rd dose Pneumococcal vaccine (unknown) 3rd dose of HIB (Non-GSK) (unknown); unspecified dose of MMR vaccine (Non-GSK) (unknown). The vaccinations were administered in the subject's arm and bilateral legs; specific details were not provided. In August 2005, during the same week after vaccination with DTAP vaccine; HIB (Non-GSK); MMR vaccine (Non-GSK) and Pneumococcal vaccine, the subject experienced myositis, crying, unable to bear weight on the left leg, fussy, injection site induration and injection site tenderness. The subject also experienced inability to speak and decreased speech. on 05 August 2005, the subject experienced persistent crying and favoring of the left leg. It was reported that the subject had been doing well up to that point following his vaccinations. He was evaluated by a nurse practitioner at the reporter's office and was described as alert, fussy, favoring left leg, temperature of 97.1 axillary, erythematous tympanic membrane due to crying, good light reflex, neurologically intact, responsive, equal and reactive pupils, and grumpy. On palpation of left leg the subject had a minimal area of induration at injection site. He had a good range of motion of his hip, but with tenderness at injection site on anterior thigh. The nurse practitioner's assessment was likely myositis secondary to immunizations. The subject was a treated with ibuprofen, TYLENOL and warm compress. It was subsequently reported in the subject's medical records that on an unspecified date within one and a half months after vaccination with DTAP vaccine, HIB (Non-GSK), MMR vaccine (Non-GSK) and Pneumococcal vaccine, the subject lost his ability to speak. The subject's parents reported that he seemed to take a large back step and went from multiple word sentences at 16-months-old to barely saying any words. The subject returned to speech therapy. This case was assessed as medically serious by GSK. At the time of reporting the myositis, inability to speak and decreased speech were resolved and the outcome of the other events was unspecified. The healthcare professional considered the event of myositis related to vaccination with DTAP vaccine, Pneumococcal vaccine, HIB (Non-GSK) and MMR vaccine (Non-GSK). An attribution of the other events to the vaccinations was not provided. At 6-years-old the subject experienced adverse events following vaccination with KINRIX (see case ID A0868814A for details).