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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: This is a 7-day report. This case was unblinded, the patient received Prevnar. Information regarding Prevnar was received from an investigator regarding a 2-month-old male participant in a study who experienced death. The participant received the first dose on 30-AUG-2007. On 11-Sep-2007, the patient was found in the crib at Day Care on his back, unresponsive, blue and not breathing. Day Care workers initiated cardiopulmonary resuscitation and contacted 911 emergency response. Upon emergency medical response arrival , the child was noted to be apneic and pulseless. The patient was intubated without difficulty and cardiopulmonary resuscitation was continued. An intraosseous line was placed in the left lower extremity that was infusing well. A total of 4 doses of epinephrine were given without any response. The child remained apneic and pulseless. Upon arrival to the emergency room the child had blood pooling on the posterior back and neck area. On physical examination pupils were fixed at approximately 2-3 mm. bilaterally and no pulse was noted. The physician also noted hypothermia and stiffness. The patient was pronounced dead at 12:42 in the afternoon at the hospital. The cause of death was reported as unknown. The parents reported the child had been completely healthy up to this point. No additional information was available at the time of this report. The investigator(s) considered death possibly related to the study product. The medical monitor(s) considered death not related to the study product because temporal relationship 12 days after vaccination does not suggest causal relationship.
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