Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Extra dose administered, Fatigue, Full blood count abnormal, Headache
Clinical narrative: Abnormal CBC; being awake from sleep; severe, "all over" pain; receiving booster dose/ receiving first and second doses in 2018; pain in both hands; exacerbated pre-existing cough; joint pain in all joints, most severe in both hands; Pain in spine; pain in bones; heart pain (angina); Upset stomach; Headache; Fatigue; cramping in both feet; This case was reported by a consumer via call center representative and described the occurrence of anginal pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone propionate, salmeterol xinafoate (Advair Diskus) inhalation powder for product used for unknown indication and fluticasone propionate+salmeterol xinafoate diskus dry powder inhaler device (Advair Diskus Dry Powder Inhaler Device) inhaler for product used for unknown indication.   Previously administered products included Shingrix (received 1st and 2nd dose of Shingrix in 2018). Concurrent medical conditions included cough (booster dose exacerbated pre-existing cough).   On 19th August 2021, the patient received Shingrix. On an unknown date, the patient started Advair Diskus at an unknown dose and frequency and Advair Diskus Dry Powder Inhaler Device. In August 2021, less than a week after receiving Shingrix and not applicable after starting Advair Diskus and Advair Diskus Dry Powder Inhaler Device, the patient experienced anginal pain (serious criteria GSK medically significant), foot cramps, pain in spine and bone pain. On 19th August 2021, the patient experienced upset stomach, headache, joint pain, pain in hand, cough aggravated and extra dose administered. On 20th August 2021 04:00, the patient experienced wakefulness and general body pain. On 9th September 2021, the patient experienced complete blood count abnormal. On an unknown date, the patient experienced fatigue. The patient was treated with glyceryl trinitrate (Nitroglycerin Spray). Advair Diskus was interrupted. On an unknown date, the outcome of the anginal pain, upset stomach, headache, fatigue, foot cramps, general body pain, joint pain, pain in spine and bone pain were recovered/resolved and the outcome of the wakefulness, pain in hand and extra dose administered were unknown and the outcome of the cough aggravated and complete blood count abnormal were not recovered/not resolved.   It was unknown if the reporter considered the anginal pain, upset stomach, headache, fatigue, foot cramps, wakefulness, general body pain, joint pain, pain in spine, bone pain and pain in hand to be related to Shingrix. The reporter considered the cough aggravated and complete blood count abnormal to be possibly related to Shingrix. The reporter considered the cough aggravated to be possibly related to 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 details provided were as follows: The case was reported by patient herself. The patient received the booster dose of Shingrix in left arm which led to extra dose administered and immediately experienced headache, upset stomach, joint pain in all joints, with pain being most severe in both hands. The patient reported 1 day after vaccination, being awakened at approximately 4 am in severe all over pain. Within 3 days of receiving booster dose, patient experienced heart pain (angina), and pain in the spine and bones and cramping in both feet at night, only. The patient also experienced fatigue. The patient reported headache, upset stomach, fatigue, angina and pain in spine and bones lasted approximately 3 days and had since resolved. The patient reported that she would need to utilize nitroglycerin spray to relieve angina. The patient reported cramping lasted approximately 2 to 3 days and had since resolved. The patient reported joint pain resolved approximately 4 to 5 days after receiving booster dose. The patient reported belief receipt of booster dose exacerbated pre-existing cough and this exacerbation began immediately after receiving booster dose. The patient believed Advair Diskus also exacerbated pre-existing cough and discontinued the medication as a result. The patient reported that cough was ongoing.  On 9th September 2021, 21 days after vaccination, the patient reported that being made aware of abnormal CBC (complete blood count) values and believed this could be attributed to receiving booster dose of Shingrix, due to having never had an abnormal CBC prior. The patient reported booster dose was administered by pharmacist, who stated that patient was in need of booster dose, after receiving 1st and 2nd dose of Shingrix in 2018. The reporter consented to follow-up.