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Administered by: Private Purchased by: Private
Life Threatening? Yes
Write-up: Information has been received from a Registered Nurse concerning her 16 year old daughter who on 29-JUN-2007 was vaccinated with a first dose of GARDASIL (lot # not reported). On 29-AUG-2007 she received second dose of GARDASIL (lot # not reported). On 02-JAN-2008 she received third dose of GARDASIL (lot # not reported). On 29-APR-2009 the patient experienced acute pancreatitis and was hospitalized. On an unspecified date the patient recovered from acute pancreatitis. Laboratory test revealed: Amylase level: 3200 and lipase level 2000. Follow up information has been received on 30-SEP-2009 via telephone call from Medical Assistant (the patient''s mother) (previously reported as Registered Nurse). The Medical Assistant stated that her daughter received first dose of GARDASIL (lot # 657736/0389U) on 29-JUN-2007. On 29-AUG-2007 she received second dose of GARDASIL (lot # 657736/0389U). On 02 - JAN-2008 (previously reported as 02-JAN-2007) she received third dose of GARDASIL (lot # 659055/1522U). The patient did not receive any concomitant vaccinations when GARDASIL vaccinations were administered. The Medical Assistant stated that the patient experienced abdominal pain on 29-MAR-2009. The patient was taken to the hospital but was not admitted. Later that day, the patient was taken to other hospital. The patient was admitted with complaint of abdominal pain on 29-MAR-2009 (previously reported as 29-APR-2009) and was diagnosed with acute pancreatitis. The patient was discharged on 01-APR-2009. The patient had recovered. The name of the Primary Care physician was provided. The patient complained of abdominal pain, (date not reported). In May 2009 the patient had her gall bladder removed (hospitalization dates unknown to reporter). On an unspecified date the patient recovered. On 31-AUG-2009, the patient complained of abdominal pain and was taken to the hospital. The patient''s blood tests (test unspecified) were normal. The patient was not admitted to the hospital. The Medical Assistant stated that the patient had experienced abdominal pain "now and then". The mother (medical assistant) felt that acute pancreatitis was immediately life-threatening and was disabling. "A lot check has been initiated." Additional information has been requested. A standard lot check investigation has been finalized. All in-process quality checks for the lots number 653055/15220 and 657736/0389U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information received from the physician indicated that patient was vaccinated with her first and second doses into her left arm at 15:00 on 29-JUN-2007 and 29-AUG-2007, respectively. She received her third dose in her right arm at 15:00 on 02-JAN-2008. It was reported that the 29-MAR-2009 hospitalization lasted 4 days. On 04-MAY-2008 the patient had recurrent pancreatitis and was treated at the hospital again. The physician stated there was no evidence of any relation to HPV rL1 6 12 16 18 VLP vaccine (yeast) given 2 years later. The patient recovered on SEP-2009. The physician felt that acute pancreatitis and recurrent pancreatitis were immediately life-threatening and they required medical/surgical intervention. No further information is available. 01/07/10 and 01/08/10 MR and DC summary received for DOS 03/29/09-04/01/09. DX: Acute pancreatitis. Pt NPO, clear diet. Tx: IVF, Dilaudid, Zofran, Hydrocodone. Pancreas enzyme levels high on admission, but improved on discharge. Pt started a normal diet. Pt improved and discharged home. Pt to follow up with GI specialist.
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