Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Cerebrovascular accident, Eye colour change, Hepatic enzyme, Hepatic enzyme abnormal
Clinical narrative: Anaphylactic reaction; Sign and symptoms like severe migraine and stroke; Sign and symptoms like severe migraine and stroke; Liver enzyme abnormal; Yellowing of the eyes; Pulmonary deficits requiring BiPap Machine; This is a spontaneous report from a contactable Nurse (patient)  A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot Number: ER8733) as SINGLE DOSE for covid-19 immunisation  .   Medical history included Allergy with Shellfish, dizziness, stroke, vertigo, Osteoporosis in cervical spine and thoracic spine, Chronic basilar migraine, asthma, hysterectomy, Myeloma tumor removal ,microcytic anaemia, Iron deficiency, Cataract removal and Abdominoplasty.Concomitant medication(s) included azelastine (AZELASTINE)  Nasal spray 137 micro grams, "22 per mere" (not clarified) per day taken for an unspecified indication, start and stop date were not reported; estriol (ESTRIOL) at : 0.5 mg daily taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) at 10 mg daily taken for an unspecified indication, start and stop date were not reported; aceclofenac, paracetamol (ACIMOL [ACECLOFENAC;PARACETAMOL]) at 150 mg once a month taken for an unspecified indication, start and stop date were not reported; ubrogepant (UBRELVY) taken for an unspecified indication, start and stop date were not reported at 50 mg.  The patient experienced anaphylactic reaction  (hospitalization) on 27Mar2021 with outcome of not recovered , extreme red all over body, red face on 27Mar2021 with outcome of not recovered , shortness of breath; hard time deep breathing on 27Mar2021 with outcome of not recovered , Sign and symptoms like severe migraine and stroke on 27Mar2021 with outcome of unknown , liver enzyme abnormal  on 27Mar2021 with outcome of unknown , yellowing of the eyes on 27Mar2021 with outcome of unknown , pulmonary deficits requiring bipap machine on 27Mar2021 with outcome of not recovered.  The patient was hospitalized for anaphylactic reaction (anaphylactic reaction) from 27Mar2021 to 31Mar2021. The clinical course was reported as follows: "When probed for second dose due date, Nurse stated, "I am not getting the second dose I am still having reactions from the first dose. It started within 5 minutes and I went an anaphylactic, I was brought to Emergency room there at least 8 hours then went home on prednisone and Benadryl it's too "intestacy me walker" (not clarified) within 2 days I developed an extreme I was red all over, extreme red face completely body was red, shortness of breath having a hard time deep breathing and rushed back to the Emergence room, again for another anaphylactic reactions which I received "Pfizer one" (not clarified) in the Emergency room was put on BiPap Machine and the step down unit I developed severe migraine and I developed sign and symptoms of stroke like "deficit"(not clarified). Then I was transferred through the rapid response to the intensive care, in the intensive care, my liver enzyme starting failing and  I had severe abnormal, liver enzymes goes, yellowing of the eyes and I was having antihistaminic response I regained 15 pounds of fluids also, it's not administered to me my body did it on its own. It's was due to my reaction I still continue to have Pulmonary deficits, that's the breathing goes, requiring BiPap machine and requiring respiratory treatment I was receiving Benadryl 50 mg every 4 hours I.V, I was receiving Solumedrol every 6 hours around the clock and first I received Epinephrine shots I got in the beginning.Nurse stated, "I was receiving Racine like too the epinephrine dose if it doesn't help, it helps you breath rest all the time by the way I was COVID negative. This is all from the vaccine."When probed for date of Hospitalization, Nurse stated, "The first day was 27Mar and then I went back end its 31st when I called my doctor, he told me to come in the evening."When probed for vaccination date, Nurse stated, "It's probably 1 o'clock in the morning.".Nurse added, "I have not even told what happening to me in past two weeks. I have not even told you what happening to me in the past two weeks. I had more reactions heart been affected, liver been affected, eye sight been effected, track of life been affected, every organ of my body. What day I can walk, I can live thing, I want to know is that like to this medication how it is going to stop and nobody has this kind of issues as my body."The patient underwent lab tests and procedures which included hepatic enzyme: abnormal on unkown date.Treatmente received for some events. Outcome of the events Anaphylactic reaction , extreme red all over body, red face, Shortness of breath; hard time deep breathing , severe migraine and Pulmonary deficits requiring BiPap Machine was not recovered the outcome of the other events was unkown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Anaphylactic reaction and the suspect drug BNT162B2. While causality for the other events cannot be totally excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.