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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information was received from SPMSD (manufacturer control number 2016002340) on 16-MAR-2016. This case was received from RA (Ref no. IE-HPRA-2016-026120) on 11-MAR-2016. Initial case received from a consumer/other non-health professional concerns a 13-year-old female adolescent patient received GARDASIL (batch number NM31130) via intramuscular route in arm site on 08-OCT-2010, GARDASIL (batch number NM46680, lot number NK44350, expiry date 31-MAY-2012) via intramuscular route in arm site on an unknown date, GARDASIL (batch number NM46680, lot number NK44350, expiry date 31-MAY-2012) via intramuscular route in arm site on 10-MAY-2011. Concomitant medications: None. Medical history/concurrent conditions: The reporter indicated that the patient was perfectly healthy before GARDASIL. The patient experienced pancreatitis on 25-OCT-2010. The patient was admitted to hospital on an unspecified date. The reporter indicated that the patient has been in and out of hospital since the age of 13. The patient received corrective treatment with pain relief whilst in hospital. The patient also takes medication daily as she is now a chronic pancreatic patient. The reporter assessed the causal relationship between pancreatitis and GARDASIL as unknown. The patient''s outcome was reported as not recovered/not resolved. This case is linked to ref no. 2016-026118 provided by RA. (Patient''s sister). Information was received from SPMSD (manufacturer control number 2016002340) on 29-APR-2016. Follow up received from the RA on 28-APR-2016 under reference number IE-HPRA-2016-026120. The reporter indicated that the patient now has chronic pancreatitis. The patient got her first ever episode of acute pancreatitis 2 1/2 weeks after her first HPV injection. (October 2010).
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