Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray normal, Dyspnoea, Electrocardiogram normal, Gait disturbance, Herpes zoster
Clinical narrative: Suspected vaccination failure; 2 outbreaks of shingles after receiving the 2 doses of Shingrix.; Cannot get enough air/ getting harder for her to breath; Cannot walk up steps/ she could no longer walk up steps; This serious 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 and fluticasone propionate (Flovent Hfa) inhaler (batch number WC4A, expiry date 30-APR-2025) for product used for unknown indication.   Concomitant products included prednisone acetate (Prednisone).   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Flovent Hfa (inhaled) 44 ug twice a day (88 ug daily). In APR-2024, an unknown time after receiving Shingrix, Shingrix and Flovent Hfa, the patient experienced difficulty breathing (Verbatim: Cannot get enough air/ getting harder for her to breath) and walking difficulty (Verbatim: Cannot walk up steps/ she could no longer walk up steps). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 2 outbreaks of shingles after receiving the 2 doses of Shingrix.). Flovent Hfa was discontinued. The outcome of the vaccination failure, shingles, difficulty breathing and walking difficulty were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, difficulty breathing and walking difficulty to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles, difficulty breathing and walking difficulty to be related to Flovent Hfa and Flovent Hfa Metered Dose Inhaler Device.     It was unknown if the company considered the vaccination failure, shingles, difficulty breathing and walking difficulty to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles, difficulty breathing and walking difficulty to be related to Flovent Hfa and Flovent Hfa Metered Dose Inhaler Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2024 The reporter reported that she had been on Flovent HFA for years, and reported that at the beginning of April 2024, it was getting harder for her to breath. The reporter also reported that her breathing was so bad that she could no longer walk up steps , she cannot get enough air, she used to use her rescue inhaler (unknown product information) once a week, but now she was using it three times a day.  The patient reported that she did see a doctor that put her on Prednisone (unknown product information) for 5 days.  The patient also had a chest x-ray and an EKG on 9th May 2024, and both came back clear.  The patient also said the doctor. wanted to double her dose of Flovent HFA, but that did not happened because her insurance would not cover it. Because of the discontinuation of Flovent the patient had been switched to a Diskus (unknown product information). The patient also reported that she received 2 doses of Shingrix five years ago (no specific dates provided). The patient reported that she had 2 outbreaks of shingles after receiving the 2 doses of Shingrix. She not had an outbreak in the last 1 and 1/2 years of shingles. The patient had no information about the Shingrix vaccine to provide, no Lot/expiry/route of administration/dates received, but did not had records. The patient had no dates to provide for the outbreaks of shingles.  This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.