Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Rash
Clinical narrative: had a lot of flare-up for asthma; not sleep; has been feeling fatigued; Headache; Shingles few days after 1st dose/shingles rash resolved after about 1 week; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder for asthma, fluticasone fur+umeclidinium+vilanterol ellipta dry powder inhaler device (Trelegy Ellipta Dry Powder Inhaler Device) inhaler (batch number unk, expiry date unknown) for asthma, prednisone for asthma and COVID-19 VACCINE (COVID 19 BOOSTER) for prophylaxis.   Concurrent medical conditions included asthma. Concomitant products included fluticasone propionate (Fluticasone Nasal Spray) and montelukast sodium (Singulair).   In July 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Trelegy Ellipta at an unknown dose and frequency, Trelegy Ellipta Dry Powder Inhaler Device and prednisone 10 mg at an unknown frequency. On 5th July 2022, the patient received the 2nd dose of COVID 19 BOOSTER. In July 2022, less than a month after receiving Shingrix and an unknown time after starting Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device, the patient experienced headache. On an unknown date, the patient experienced shingles, asthma aggravated, insomnia and fatigue. The action taken with Trelegy Ellipta was unknown. The action taken with prednisone was unknown. On an unknown date, the outcome of the headache, asthma aggravated and insomnia were not recovered/not resolved and the outcome of the shingles was recovered/resolved and the outcome of the fatigue was unknown.   It was unknown if the reporter considered the headache, shingles, asthma aggravated, insomnia and fatigue to be related to Shingrix, Trelegy Ellipta and Trelegy Ellipta 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.   Linked case(s) involving the same patient:  US2022120178   Additional Information: Additional Information: GSK Receipt date-6 July 2022 Reporters comment-This case was reported by call center representative, Consumer reported that Reporter was the patient. The patient used TRELEGY 200/62.5/25mcg. The patient stated she received a second COVID vaccine booster yesterday (July 5, 2022). Today, she was experiencing a headache, AE(adverse event) filed. Did not consent to follow-up. Call Notes: Reporter provided limited information   Follow-up information received on 17-AUG-2022. This follow-up was considered significant. Reporter's Comments: The reporter reported that patient took Trelegy for her asthma. The patient had a lot of flare-up for her asthma and had been taking prednisone 10 mg. The patient thinks the prednisone was causing her to not sleep and she had been feeling fatigued.  The patient took first dose in July 2022 and few days after receiving Shingrix she developed shingles.  The patient was treated with valacyclovir and the shingles rash was resolved after about 1 week.  Less than 2 months after receiving Shingrix patient experienced asthma aggravated, insomnia and fatigue. The reporter did not consent to follow up. It was unknown if the reporter considered the headache, shingles, asthma aggravated, insomnia and fatigue to be related to covid booster. It was unknown if the reporter considered the headache, shingles, asthma aggravated to be related to prednisone. The reporter considered the insomnia and fatigue to be possibly related to prednisone, Summary of Changes: Suspect product and there details, concomitant product details, new events and there details and narrative was updated.; Sender's Comments:  US-GSK-US2022120178:Same reporter.