Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Paraesthesia, Pyrexia, Sensation of foreign body
Clinical narrative: woke up in the middle of the night; lower legs felt kind of numb and tingly; weak; nausea; anaphylactic reaction; hot flash started on my head, went over my body; dizzy/lightheaded; blurred vision; chest became very tight/chest tightness; throat felt like there was a lump in it; coughing; irritated throat; heart rate was in the 140s; sinus tachycardia; lower legs felt kind of numb and tingly; chills; fever; body aches; diarrhea; This is a spontaneous report from a contactable nurse. A 26-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899) via an unspecified route of administration on 29Dec2020 07:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction, hot flash started on my head, went over my body, dizzy, lightheaded, blurred vision, chest became very tight/chest tightness, throat felt like there was a lump in it, coughing, irritated throat, heart rate was in the 140s, sinus tachycardia, fever, chills, body aches, diarrhea, lower legs felt kind of numb and tingly, weak, all on 29Dec2020 and , woke up in the middle of the night on an unspecified date. She reported severe reaction to Pfizer COVID-19 Vaccine onset 8 minutes after being administered that first dose. She asked for information regarding her severe reaction related to the product. This event started with a hot flash that started in her head and went all the way through her body; became really lightheaded; dizzy; her chest became really tight; felt like there was a lump in her throat closing her throat up. They took her to the emergency room where she was treated and kept for a couple of hours, but was not admitted to the hospital in response to this event. While in the hospital she received IV fluids; steroids clarified as Prednisone; Benadryl; Pepcid; and was sent home. On 30Dec2020 afternoon she ended up with the same type of severe reaction: her chest felt tight, she felt her throat closing and itching; she started coughing. She went back to the emergency room in response to the severe reaction. The emergency room thinks it was the same thing again as on 29Dec2020; she again was not admitted to the hospital in response to this event, but was treated and kept for a couple of hours; while in emergency room they again gave her IV fluids; steroids clarified as Prednisone; Benadryl, and because her heart rate was like in the 140s also gave her Ativan to help bring her heart rate down. The anaphylactic aspect of the severe reaction is not ongoing any longer. She then developed fever; body aches; nausea; diarrhea; all the kind of what you would call normal side effects. She reported that on 03Jan2021 morning she woke super dizzy, lightheaded and her vision was blurred. In response to those events she went to her Primary Care Physician on 04Jan2021. The Primary Care Physician told patient to just ride it out for a little bit to see what happens; so that is what the patient has been doing. The dizziness and blurred vision have improved over the last couple of days; but last night she was up all night because she felt a numbness in her lower legs; she can still walk, it is not painful; it's just a weird numbness, tingling kind of feeling. Severe reaction events reported as improved, but ongoing.  The patient underwent lab tests and procedures which included electrocardiogram: sinus tachycardia on 30Dec2020, heart rate: was in the 140s on 29Dec2020. The outcome of anaphylactic reaction was recovering, of hot flash started on my head, went over my body, dizzy/lightheaded, blurred vision, chest became very tight/chest tightness, throat felt like there was a lump in it, coughing, irritated throat, heart rate was in the 140s, sinus tachycardia, fever, chills, body aches, diarrhea, woke up in the middle of the night, lower legs felt kind of numb and tingly, weak was unknown. Caller explained she will not receive the second dose.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset anaphylactic reactions cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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.