Age: 71.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood bilirubin increased, Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old female patient who received Hepatitis A vaccine. Co-suspect products included Hepatitis A vaccine and Atorvastatin unknown for an unknown indication. Concomitant products included estradiol and PNEUMOVAX. On 28th August 2015, the patient received the 2nd dose of Hepatitis A vaccine. On 19th February 2015, the patient received the 1st dose of Hepatitis A vaccine. In September 2015, the patient started Atorvastatin at an unknown dose and frequency. On 30th September 2015, 33 days after receiving Hepatitis A vaccine, 223 days after receiving Hepatitis A vaccine and not applicable after starting Atorvastatin, the patient experienced vaccination failure (serious criteria GSK medically significant), hepatitis A, upper respiratory tract infection, chills, sweating, weakness, energy decreased and appetite absent. On 3rd October 2015, the patient experienced nausea, taste altered, tremor and fever. On 4th October 2015, the patient experienced urine discoloration. On an unknown date, the patient experienced elevated liver enzymes. On 3rd October 2015, the outcome of the upper respiratory tract infection, chills, sweating and appetite absent were recovered/resolved. On 4th October 2015, the outcome of the tremor and fever were recovered/resolved. On an unknown date, the outcome of the vaccination failure, hepatitis A and elevated liver enzymes were unknown and the outcome of the weakness, energy decreased, nausea and taste altered were recovering/resolving and the outcome of the urine discoloration was unchanged. It was unknown if the reporter considered the vaccination failure, hepatitis A, upper respiratory tract infection, chills, sweating, weakness, energy decreased, appetite absent, nausea, taste altered, tremor, fever, elevated liver enzymes and urine discoloration to be related to Hepatitis A vaccine, Hepatitis A vaccine and Atorvastatin. Additional details were provided as follows: The patient reported that she received her first dose of hepatitis A vaccine on 19th February 2015. She received her second dose on 28th August 2015. As of July 2015, her lab values were normal. The patient reported that around 30th September 2015 she started experiencing issues that included an upper respiratory infection, chills, sweating, low energy, no appetite and weakness. Over the past weekend beginning, 3rd October 2015 she experienced nausea, food tasted bad, shaking and a fever of 104 degrees Fahrenheit. The patient went to the doctor and after lab work was completed her results showed elevated liver enzymes including ALT, AST and Bilirubin. She reported that her Hepatitis A panel was reactive as well and she was told that she had Hepatitis A. This case was considered as a vaccination failure case. The patient stated that she started Atorvastatin about a month ago and she felt that this product was actually the cause of all of her issues and not the hepatitis A vaccine.