Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Chills, Condition aggravated
Clinical narrative: body ache from head to toe; chills; sore throat worsening; sore throat worsening; fever of 101.8F; dry cough; weakness; This is a spontaneous report from a contactable nurse reporting for herself.   A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number reported as "G or E N6202"), intramuscular in left arm on 27Feb2021 (age at vaccination 68-year-old) at 11.30 at single dose for COVID-19 immunization. She is due to take the second dose of the vaccine on 20Mar2021. Medical history included: she has history of AFIB but has been in regular rhythm and has not taken any medications since 3-4 years ago.  Her blood pressure is so low and she was falling all the time, was dizzy and bumping into wall.  The doctor said it was a good thing she is off.  Her blood pressure is still 90's/60/s. She got shingles two shots and she got it last fall.  Those were pretty awful.  She had a lot of local tenderness, trouble lifting arm up and the next two days, she felt blah and had pain in clavicle and scapula on left side.  That pain in the bone lasted about a week afterwards;  diagnosed allergies, compromised immune status,  respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, she has had low white cell all of her adult life (she has gone between 3.5 and 4.0).  Family medical history: Cardiac history.  Concomitant medication included: eye vitamins and that kind of stuff. She did not take Tylenol or aspirin two days prior. On 09Mar2021, 11 days after getting the first dose of the vaccine, she had symptoms namely sore throat, chills, body ache from head to toe, dry cough, fever and weakness. She said that it lasted for 36 hours. She felt so crappy on 09Mar she did not take her temperature. She did not take it until 10Mar2021 when it reached a maximum of 101.8 degrees. Patient said she now feels pretty good except she has no energy at times. She wondered if she had COVID, so she got a test on 10Mar2021 and it was negative. Patient reported that she actually had a sore throat for about a year.  That may not have been started with the vaccine, but it may have been exacerbated. She thinks she may have Reflux.  She made an appointment with her gastroenterologist.  She said her throat was red when she went to Urgent care to get the COVID test.  She has had a dry cough for about a year.  That could be related as well to the reflux.  That did not seem to increase since the vaccine. Reporter considered events fever, chills and ached from head to toe as medically significant. Outcome of events sore throat worsening, asthenia was not recovered, chills, ached from head to toe, fever was recovering, of event cough was unknown.  Information about Batch/Lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Fever, Ache, and Chills cannot be excluded.  The case will be reassessed if additional information becomes available.  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.