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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician via regulatory authority and described the occurrence of pain in extremity in a 15-year-old female patient who received TWINRIX pediatric (batch number BHABB210BB, expiry date unknown). Co-suspect products included PRIORIX (batch number A69CC807A, expiry date unknown) and GARDASIL. Previously administered products included TWINRIX Paediatric (Dose 1), PRIORIX (Dose 1) and GARDASIL (Dose 1 and 2). Concurrent medical conditions included celiac disease. On 23rd May 2012, the patient received the 2nd dose of TWINRIX pediatric (intramuscular) 1 dosage form and the 2nd dose of PRIORIX (intramuscular) 1 dosage form. On 21st November 2012, the patient received the 3rd dose of GARDASIL (intramuscular) 1 dosage form. On 15th January 2015, 2 years and 237 days after receiving TWINRIX pediatric and PRIORIX, the patient experienced pain in extremity (serious criteria disability). On an unknown date, the outcome of the pain in extremity was recovering/resolving. It was unknown if the reporter considered the pain in extremity to be related to TWINRIX pediatric and PRIORIX. Initial Regulatory Authority Verbatim: Adverse event: Regional extremity pain. Other vaccines: No. Other medicines: No. Follow up Regulatory Authority verbatim: Update from Regulatory Authority, 27-MAY-2016 (002): Correction: The MMR vaccine is recoded from M-M-RVAXPRO to PRIORIX. There is no new information on the case.
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