Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: Shortness of breath; pain; Didn't feel well at all; fatigue; I was in A-fib; sick; This is a spontaneous report from a contactable Nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9269, Expiration date: Unknown), via an unspecified route of administration on 09Jan2021 (at the age of 65-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Hodgkin's disease, Alopecia, Alopecia areata, Asthma, Back pain, Heartburn, Pulmonary embolism. The patient previously took Diltiazem and experienced allergic reaction. Concomitant medications included biotin (BIOTIN) taken for alopecia, finasteride (FINASTERIDE) taken for alopecia areata, hair fall; colecalciferol (VITAMIN D3) taken as a supplement, calcium (CALCIUM) taken for an unspecified indication, (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma, clobetasol propionate (CLOBETASOL PROPIONATE) topical solution that I put in my scalp for my alopecia, tramadol hydrochloride (ULTRAM [TRAMADOL HYDROCHLORIDE]) as Occasionally taken for back pain, lorazepam (LORAZEPAM) taken for PRN, for sleeping at night, rivaroxaban (XARELTO) Strength:20 mg taken for pulmonary embolism, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) as PRN taken for Heart burn, levothyroxine (LEVOTHYROXINE) I take that because my thyroid was killed after radiation from having Hodgkin's disease cancer, Docusate sodium with Senna (DOCUSATE SODIUM & SENNA) taken for an unspecified indication. It was also reported that the patient took, unspecified steroid injection in scalp for Alopecia. It was reported that, "I received the COVID-19 Vaccine on 09Jan2021 and the second one on 29Jan2021 Lot number EN6198 and about two weeks, let me go back to my calendar about four day after the first one I had my oral surgery on an unspecified date in Jan2021 and the next, they gave me a narcotic, Norco for pain. I took four of them and it was making me sick, so I stop taking it. The next day I didn't feel well at all. I actually felt like I was through Pulmonary embolism and I have a history of that (Consumer was unsure hence, Pulmonary embolism was not captured as event). So, I called doctor's office, it was closed so we messaged him and Monday he called and said you are on blood thinners you are not going through PE, I think you have been through a lot with the COVID-19 Vaccine then you had oral surgery and here you took Norco and he just said, just let your body rest, so I try to feel better in the next few weeks. The next time I saw a doctor I mentioned this to her that was on 10Feb2021 and it was a dermatologist that I see for alopecia areata (History) and I told her I am having shortness of breath on an unspecified date and lot of fatigue and she said that could be related to the COVID-19 Vaccine, you need to report that and I thought okay, you know she said you need time to get to your doctor. I said, I did, And he told me that it wasn't PE I just need to give my body time to recover from everything. She said (withheld) something is going on, shortness of breath and the fatigue that you are having doesn't sound right. She looked, the next day she called me at home and she looked up some stuff on COVID-19 and she said I really think you should report this and you really need to call the doctor now. So, I called the pulmonologist so again he didn't want to see me, he said you are not going through PE and you need to see cardiologist. So next week I had an appointment with the cardiologist on 19Feb2021. They said I was in A-fib on an unspecified date and they put me on cardiac medications you know to try and to get me medically to convert back into sinus rhythm and that was in February. In March I had an allergic reaction to Diltiazem they switched me to Metoprolol and then two and half months later I was still in A-fib, they sent me to electrophysiologist and Monday I had a cardio version done and so since then I see the dermatologist again for my alopecia and she said, did you ever contacted Covid or you know Pfizer you know you got that paper, when you got the vaccine they give you piece of paper that had phone number on it, I really think you need to let them know everything that happened and its all been since COVID-19 Vaccine. So I am just reporting what I have been through and by the way I am in sinus rhythm now but I am still having symptoms shortness of breath and fatigue. I messaged my doctor yesterday and I am waiting for a response from the electrophysiologist to find out you know why, when I am out of A-fib why I am still having the same symptoms. I take Metoprolol (treatment) because I was in A-fib they are trying to medically convert me and right now my dose has been tapered because I am back in sinus rhythm. So in a month I will be off of it. "Consumer further stated, "No, I just wanted you guys to be aware because my one doctor really insisted that I should call you. I mean I don't know if the Covid-19 vaccine has anything to do with all this or not I am just letting you know as a courtesy. The patient underwent lab tests and procedures which included EKG: unknown result on an unspecified date in Dec2020, EKG: unknown result on an unspecified date in Mar2021 (echo my ejection fraction was 55% and labs were done like in December because then I will have my annual physical done). The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2 ,a temporal association between the event atrial fibrillation and administration of BNT162B2 cannot be 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.