Age: 67.0
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of therapy non-responder in a adult female patient who received HAVRIX 1440 adult (batch number 23F25, expiry date unknown). On 18th August 2016, the patient received the 1st dose of HAVRIX 1440 adult. In November 2016, less than a year after receiving HAVRIX 1440 adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered therapy non-responder to be related to HAVRIX 1440 adult. Additional details were provided as follows: The batch number for HAVRIX 1440 adult was not clear on the document (either 200F25 or 23F25). The patient was vaccinated in preparation for extended overseas travel. It was not clear if the patient received anti-malarial prophylaxis or other vaccine at that time. There was an outbreak of hepatitis A in the Summer of 2016. The pharmacist did not know if the store in question was otherwise having difficulty obtaining hepatitis A vaccine. In November 2016, the patient was in another country and went to a medical office for the second dose of hepatitis A vaccine. For an unknown reason, the health care provider ordered a hepatitis A serology test to see if they had hepatitis A and if the second dose was necessary. The health care provider reported that the test was negative for any evidence of hepatitis A infection or hepatitis A vaccination (possible lack of immune response to HAVRIX).The patient then posted a message on the pharmacy web page notifying of the serology test results and their concern that the vaccine was a dud. The patient expressed concern that other people may also have received a vaccine that did not elicit an immune response. According to the pharmacist, the web page notice was reviewed by several administrative layers at the pharmacy and was reported to VAERS. The pharmacist only became aware of the question in May 2017 and tried to call the patient via cell phone, but was unsuccessful. He had an email contact with the patient in which the patient asked what the Center for Disease Control (CDC) and manufacturer was doing about the report. The pharmacist then contacted medical science liaison (MSL) to report the question directly GlaxoSmithKline. The pharmacist said that the pharmacy was willing to accept the invoice for additional serologic testing and if necessary the second dose of vaccine. The pharmacist was reminded that HAVRIX is a two dose vaccine and recommended that the initial focus should be on medical care for the patient, especially since the patient was still travelling overseas. The patient was recommended repeat serologic testing and administration of the second doses of vaccine. Also, it was recommended to obtain details of the serologic test if possible. The sales representative would follow up with pharmacist during the week of 15th May 2017. There were no seriousness criteria (death, hospitalization, disabling, congenital anomaly, life-threatening and clinical intervention required) associated with the reported event. This case is linked with US2017GSK068092 (husband's case), reported by the same reporter.