Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain oedema, Fatigue, Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown.   Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship.  The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events.  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.