Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphagia, Gallbladder disorder, Herpes zoster, Injection site rash, Ophthalmic herpes zoster
Clinical narrative: cataract surgery on right eye; shingles out break in; chronic cough and throat issue; Throat issue; swallowing issues; gall bladder disorder; shingles outbreak / at the instrument insertion site /  in her eye following that surgery; chronic abdominal pain; shingles outbreak  in October of 2019 / shingles out break in her eye; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (diagnosed in 2003 and had shingles outbreaks since then every 2-3 months). Concurrent medical conditions included drug allergy (patient was allergic to many different medications).   In April 2019, the patient received the 1st dose of Shingrix. In September 2019, the patient received the 2nd dose of Shingrix. In October 2019, between 5 and 7 months after receiving Shingrix and less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and chronic abdominal pain. On an unknown date, the patient experienced cataract (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), chronic cough, throat discomfort, swallowing difficult and gallbladder disorder. On an unknown date, the outcome of the vaccination failure, cataract, ophthalmic herpes zoster, shingles, chronic abdominal pain, chronic cough, throat discomfort, swallowing difficult and gallbladder disorder were unknown.   It was unknown if the reporter considered the vaccination failure, cataract, ophthalmic herpes zoster, shingles, chronic abdominal pain, chronic cough, throat discomfort, swallowing difficult and gallbladder disorder to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had a medical history of shingles, diagnosed in 2003, and had shingles outbreaks since then every 2-3 months.  The patient received dose 1 of Shingrix in April of 2019.  With the dose 1 of Shingrix she developed a large rash at the injection site two days after receiving the vaccine, and this rash lasted for 4 days and resolved.  The patient received dose 2 of Shingrix in September 2019 and in October 2019 she had gall bladder removal surgery and had chronic abdominal pain of unknown origin since October of 2019. She stated that she had a shingles outbreak in October of 2019 at the instrument insertion site for her gall bladder surgery.  The patient underwent cataract surgery on her right eye 24th June 2020 and had a shingles out break in her eye following that surgery. The patient stated she had a chronic cough and throat issue following a surgical procedure, unknown date of this procedure.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020193845:same patient, same reporter, different dose