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Write-up: Dyspnoea; cough; mild wheezing; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111840. A 45-year and 2-month-old female patient received first dose of BNT162B2 (COMIRNATY, Lot Number: FA2453; Expiration Date: 31Aug2021) via unspecified route single dose for COVID-19 immunisation on 04Jun2021 14:00, at 45-year-old. Medical history included asthma, lumbago. Body temperature before vaccination was 35.6 degrees Centigrade. Concomitant medications included: alisma plantago-aquatica var. orient. tuber, angelica acutiloba root, atractylodes lancea rhizome, cnidium officinale rhizome, paeonia lactiflora root, poria cocos sclerotium (TOKISHAKUYAKUSAN); coix lacryma-jobi subsp. ma-yuen seed, ephedra spp. herb, glycyrrhiza spp. root, prunus spp. seed (MAKYOYOKUKANTO); diclofenac; rebamipide; pregabalin; clorazepate dipotassium (MENDON); areca catechu seed, aucklandia costus root, cinnamomum cassia bark, citrus spp. fruit peel, glycyrrhiza spp. root, magnolia spp. bark, perilla frutescens var. crispa herb, poria cocos sclerotium, rheum spp. rhizome, tetradium ruticarpum fruit, zingiber officinale rhizome (KUMIBINROTO, reported as Kotaro KUMIBINROTO extract fine granules). The course of event was as follows: The event onset date was reported as 04Jun2021 at 14:00 (same day of vaccination). After the first inoculation of the BNT162B2, the patient experienced Dyspnoea. Although one tablet of Loratadine was took orally, and then the patient started to cough. Right chest auscultation, and there was a mild wheezing. Intravenous drip of hydrocortisone sodium succinate (SOLU-CORTEF), it recovered after using hydrocortisone sodium succinate. On 04Jun2021 (same day after the vaccination), the outcome of the event was recovered. The reporting physician classified the event as non-serious and assessed the causality between the event and BNT162B2 as unassessable. The reporting physician commented as follows: Originally the patient had asthma, relationship was unknown.
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