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Life Threatening? No
Write-up: Anaphylaxis/anaphylaxis symptom/ itching in both arms, itching that could hardly bear, redness in both arms/ dyspnoea/ had consciousness twilight/ Exanthema generalised, blood pressure 160/98 mmhg; This is a spontaneous report received from a contactable other health professional and a contactable physician via a Pfizer sales representative. The patient was a 49-year-old female. Primary disease and Complication included Lumbago. Past drug included Loxoprofen used from 21Apr2021 to 19May2021 orally for Lumbago. On 04Jun2021 (the day of vaccination), the patient received the unspecified dose of bnt162b2 (COMIRNATY, intramuscular injection, Lot number not provided) intramuscular as a single dose at the age of 49-year-old for COVID-19 immunization. On 04Jun2021 (the day of vaccination), the patient experienced anaphylaxis symptom, transported to PRIVACY hospital urgently. On 04Jun2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: 5 minutes after the vaccination, there was itching in both arms, itching that could hardly bear, redness in both arms. There was no rash on the back. 10 minutes after the vaccination, the patient started to have dyspnoea, SPO2 was 98 at the moment. 15 minutes after the vaccination, the patient had consciousness twilight, the patient treated the patient with Epipen. At this moment there was Exanthema generalised, blood pressure 160/98. After the treatment of Epipen, the patient was temporary recovered. 20 minutes after the vaccination (5 minutes after Epipen was treated), the patient had dyspnoea again, therefore the second dose of Epipen performed. After that, the patient was in twilight state, transferred to privacy hospital in emergency and treated. The patient was recovered. The reporter classified the event as serious (Other important medical event) and assessed the causality between the event and bnt162b2 as probably related. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the event anaphylaxis cannot be excluded.
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