Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Crying, Insomnia, Irritability, Liver function test abnormal, Malaise
Clinical narrative: The event "liver enzymes were off" was considered medically important (OMIC). Information regarding Prevnar was received from a consumer regarding a 2 month old male pt who received his first dose on 6/16/03 along with his first doses of Tripedia, IPOL, ActHIB and Recombivax HB vaccines. The pt's concurrent illness includes "reflux." Indication for Prevnar was immunization. Product was administered on 6/16/03. Dose regimen was one dose IM. Concomitant therapy included Zantac. The pt "didn't feel well by the 2nd day," and three days after the injection his "stomach was gurgling." On 6/20/03, he "didn't sleep. On 6/21/03 he "did not eat until night," "looked grey-white," and "didn't drink." He was vomiting but had no fever. That same day lab tests showed that his "urine was abnormal" and his "liver enzymes were off"; therefore, a "hepatitis work up" was performed. "A week later he was fine." Urine analysis and liver function test abnormal were done on 6/21/03. See related case (s): HQWYE403428AUG03 (The infant developed a fever, fussing, screaming, crying, vomiting, and looked grey-white following receipt of his second dose of Prevnar, Tripedia, IPOL, ActHIB, and Recombivax HB vaccines on 8/19/03 at 4 months of age). Information regarding these events has been forwarded to the manufacturers of the concomitantly administered vaccines. No additional info was available at the date of this report.  Follow up on 10/01/2003: "Follow up information received from the patient's physician on 09/22/2003 provided family history.  Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein injection) was received from a consumer regarding a 2-month-old male patient who received his first dose on 06/16/2003 along with his first doses of Tripedia (AP), IPOL (AP), ActHIB (AP), and recombivax HB (Merck) vaccines.  MEDICAL HISTORY: The patients concurrent illness includes "reflux."  The physician indicated that there is a strong family history of "unusucal allergic reactions" to medications and vaccines.  PRODUCT DETAILS: Indication for Prevnar was immunization.  Product was administered on 06/16/2003.  Dose regimen was one dose (IM).  CONCOMITANT THERAPY: Concomitant therapy included Zantac (ranitidine hydrochloride).  EVENT DETAILS:  The patient "didn't feel well by the 2nd day" (feeling abnormal), and three days after the injection his "stomach was gurgling" (unevaluable reaction).  On 06/20/2003, he "didn't sleep" (insomnia).  On 06/21/2003 he "did not eat until night" (feeding problem in newborn), "looked grey-white" (pallor), and "didn't drink" (thirst decreased).  He was vomiting (vomiting NOS) but had no fever.  That same day laboratory tests showed that his "urine was abnormal" (urine abnormal NOS) and his "liver enzymes were off" (liver function test abnormal); therefore, a "hepatitis work up" was performed.  "A week later he was fine." RELATED CASE(S): See related case(s): HQWYE403428AUG03 (the infant developed a fever, fussing, screaming, crying, vomiting, and looked grey-white following receipt of his second dose of Prevnar, Tripedia (AP), IPOL (AP), ActHIB (AP), and Recombivax HB (Merck) vaccines on 08/19/2003 at 4 months of age).  MANUFACTURER'S COMMENT: Information regarding these events has been forwarded to the manufacturers of the concomitantly administered vaccines."