Age: 62.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Abdominal discomfort, Diplopia, Disturbance in attention, Drug administered at inappropriate site, Influenza like illness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 62-year-old male patient who received RABAVERT (batch number 28011A, expiry date 1st April 2020). On 23rd September 2017, the patient received RABAVERT. In September 2017, less than a week after receiving RABAVERT, the patient experienced nervous. On 23rd September 2017, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the nervous and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the nervous to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a molecular biologist who worked at a hospital and called on behalf of the physician worked with. The health care professional stated that a dose of RABAVERT for pre-exposure was administered to the patient in the front of thigh and not in the deltoid muscle, which led to vaccine administered at inappropriate site. The health care professional stated that the patient became nervous after administration because the patient read the prescribing information. The reporter did not have lot number or expiration date of the vaccine or further patient information. Follow up information received from physician on 13th December 2017: The patient's demographic details and reporter's details were added. Co-suspect products included RABAVERT (batch number 627011A, expiry date 30th March 2020) and RABAVERT (batch number SWPD06AA, expiry date 1st March 2021). On an unknown date, the patient received the 1st dose of RABAVERT and the 2nd dose of RABAVERT. On 23rd September 2017, the patient received the 3rd dose of RABAVERT. On an unknown  date, the 3rd dose was an unknown dose. In September 2017, less than a month after receiving RABAVERT and RABAVERT and an  unknown time after receiving RABAVERT, the patient experienced nervous. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), rabies (serious criteria GSK medically significant), upset stomach, concentration impaired, feeling unwell, influenza-like symptoms and double vision. On an unknown date, the outcome of the vaccination failure, rabies, nervous, upset stomach, concentration impaired, feeling unwell, influenza-like symptoms, double vision and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the vaccination failure, rabies, nervous, upset stomach, concentration impaired, feeling unwell, influenza-like symptoms and double vision to be related to RABAVERT. The patient called and stated that he had been reaching out to GSK for 3 months regarding the vaccines. They were not providing him with information. The patient was wondering if there were any issues during the manufacture of the lots provided. The patient stated they advised him they were not manufactured by GSK and they did not have any information. The patient wanted to know if he needed a new injection. The patient was reaching the time frame where, bad things could start to happen. The physician did advise the patient several times that they no longer handle RABAVERT but the patient was desperate and looking for help. The physician asked the patient if something was wrong and he just stated I want to know if there was an issue during manufacturing. On 14th December 2017, an other health care professional reported that the patient reported, not feeling well, described as like the flu. The patient also believed they may have developed rabies. Adverse event was previously reported by the patient. Health care professional was unsure if reported lot number, SWPD06AA was the diluent portion of the vaccine. The consumer called back with lot numbers and seemed to know if what adverse events or if deaths had been reported with the specific lots. The reporter never provided specific events of his experience. Lot numbers 627011A, which was a legend Novartis product. Lots 628011AA and SWPD06AA could not be found in database as Novartis or GSK products. The patient reported the above side effects to the Novartis representative last night so GSK safety might not have them as yet. The patient did not have lot number from the 3rd shot in the series nor the expiration date of the 1st shot. The patient had an extensive history with contacting GSK since September of 2017 requesting information about the specific lots and other questions. The patient had posed as an HCP and contacted Medical Information as well. Novartis was asking that his request for someone to assist him be escalated to a supervisor. This case was considered as suspected vaccination failure case as the vaccination schedule and time to event onset of the event was unknown at the time of reporting. GSK case number US2017GSK194098 and US2017GSK155527 are duplicates of US2017GSK149004. All future correspondence will be submitted to US2017GSK149004, which stands as case of record for this patient.