Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Hypersensitivity, Loss of consciousness, Pruritus
Clinical narrative: felt like she was having an allergic reaction; almost like anaphylactic reaction; skin itching and burning/feels like she is itching all over from the inside out; skin itching and burning; throat started itching and was scratchy; difficulty swallowing; lightheaded; blacked out; lost vision; blurred vision; trouble with her vision in the right eye; headache; skin is very red; vomiting; diarrhea; felt like her throat was closing up; This is a spontaneous report from a contactable nurse. A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jul2021 (Batch/Lot number was not reported) (at the age of 21-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation then felt weak and fatigue. The patient previously took hydrochlorothiazide, and Lexapro (prior to getting the Covid vaccines). Patient got the second dose sometime in July2021. In Jul2021, patient reported problems as skin itching and burning, felt like she was having an allergic reaction to a lot of things that she had not been allergic to prior (almost like anaphylactic reaction). Patient reported that 1-2 days after getting the second dose, she was eating dinner and ordered Mexican fajitas and her throat started itching and was scratchy. Felt like she had difficulty swallowing, was lightheaded, blacked out, lost vision.  Has had blurred vision, trouble with her vision in the right eye, headaches. Her skin is very red and whelping up, has been vomiting, had diarrhea, feels like she is itching all over from the inside out. The patient went to emergency room when she felt like her throat was closing up. The patient felt that these events are medically significant but could potentially be life threatening if the throat continues to feel like it will close up. The patient stated they put her on Claritin, Pepcid twice daily, steroid dose pack and steroid injection, but they stopped the steroids today since she was not able to handle them. Outcome of events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Hypersensitivity, Anaphylactic reaction, Pruritus , Skin burning sensation, Throat irritation, Dysphagia, Dizziness, Loss of consciousness , Blindness, Vision blurred , Visual impairment, Headache, Erythema, Vomiting , Diarrhoea , Throat tightness cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.