Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dyspnoea, Incomplete course of vaccination, Therapy cessation, Tinnitus
Clinical narrative: Breathing difficulty; Ringing in both ears/ringing has worsened; Lightheadedness; 1st dose on May 2022, 2nd not received; ceasing use of Advair 100/50 without guidance of HCP; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, fluticasone propionate, salmeterol xinafoate (Advair Diskus) inhalation powder for asthma, fluticasone propionate+salmeterol xinafoate diskus dry powder inhaler device (Advair Diskus Dry Powder Inhaler Device) inhaler (batch number UNK, expiry date unknown) for asthma, fluticasone propionate, salmeterol xinafoate (Advair Diskus) inhalation powder (batch number F67V, expiry date unknown) for asthma and fluticasone propionate+salmeterol xinafoate diskus dry powder inhaler device (Advair Diskus Dry Powder Inhaler Device) inhaler (batch number F67V, expiry date unknown) for asthma.   Concurrent medical conditions included asthma.   In May 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix, Advair Diskus at an unknown dose and frequency, Advair Diskus Dry Powder Inhaler Device, Advair Diskus at an unknown dose and frequency and Advair Diskus Dry Powder Inhaler Device. On an unknown date, less than 9 months after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting Advair Diskus, Advair Diskus Dry Powder Inhaler Device, Advair Diskus and Advair Diskus Dry Powder Inhaler Device, the patient experienced difficulty breathing, ringing in ears, light headedness, incomplete course of vaccination and therapy cessation by patient. The action taken with Advair Diskus was unknown. The action taken with Advair Diskus was unknown. On an unknown date, the outcome of the difficulty breathing, light headedness, incomplete course of vaccination and therapy cessation by patient were unknown and the outcome of the ringing in ears was not recovered/not resolved.   The reporter considered the difficulty breathing to be possibly related to Shingrix. It was unknown if the reporter considered the ringing in ears and light headedness to be related to Shingrix, Advair Diskus, Advair Diskus Dry Powder Inhaler Device, Advair Diskus and Advair Diskus Dry Powder Inhaler Device. It was unknown if the reporter considered the difficulty breathing and therapy cessation by patient to be related to Advair Diskus, Advair Diskus Dry Powder Inhaler Device, Advair Diskus and Advair Diskus Dry Powder 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-DEC-2022 Reporter's Comment: The patient was self-reported this case. The patient reported that she received 1st dose of Shingrix vaccine in May 2022. The patient belief that Shingrix vaccine triggered asthma and resulted in breathing difficulty. The patient stated that she was put on Advair 100/50 for address asthma symptoms. The patient was receiving testing to discern which Shingrix ingredient may had caused asthma flare up and was told they reacted to ingredient in the Shingrix. The patient ceased use of Advair 100/50 without guidance of HCP at the end of July 2022. The patient stated that she was being free of asthma symptoms until approximately one month when she once again began experiencing breathing difficulty The patient was prescribed Advair 250/50.  The patient was experienced ringing in both ears after first dose of Advair 250/50. The ringing was worsened since it began approximately one month ago. The patient was also experienced lightheadedness while using the Advair 250/50. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.