Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate, Glomerular filtration rate decreased, Hypotension, Investigation, Nausea
Clinical narrative: didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; blood pressure 82/50; skin tenting; dizziness/orthostatic dizziness/dizzy; Nausea vomiting; Nausea vomiting; chills and cold sweats; chills and cold sweats/all sweaty, cold; felt blah; sore arm after 2nd dose; This is a spontaneous report from a contactable nurse reporting for herself. A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received BNT162B2 on 16Mar2021 (at the age of 73-years-old) for COVID-19 immunisation and experienced Sore arm and feeling blah. Clinical course was as follows: She spent 50 years in neurology and neuroscience, she was a crazy RN that did neurology right out of school, she was recommended for that specialty. She is not sure if she had a reaction to the vaccine or if it is just her. Her 2nd dose was last Wednesday, 07Apr2021. She had a sore arm and felt blah. Just like after the 1st shot. On Saturday night (10Apr2021) at 0200, she was awakened with chills, cold sweat, dizziness, nausea and vomiting. She was sick as a dog for 2 days and didn't eat or drink much of anything. She went to the doctor who sent her to an infusion center. She is down to 5' 2" and weighed too much. She has not been able to lose weight for a couple years. She gained 40 pounds when she turned 50 years old. After the shot, she had a sore arm and felt blah like she did after the first dose, but she thought everyone felt that way. She missed a day of gym class because of her really sore arm. This got better like after a flu shot, it was nothing. This time she had a really sore arm and felt blah after the shot but then on Saturday morning this whole thing started happening. She woke up very restless, was all sweaty, cold, dizzy and was too miserable to try and take her blood pressure. Her blood pressure tends to run low. Her symptoms of the sore arm resolved at 06:00 Saturday (08Apr2021). She had nausea and vomiting and couldn't eat or drink. That lasted through Monday morning. She had some back pain with this, but she has back pain normally as she is a little old lady. She had a scheduled Oncology appointment Monday, as did her husband. She experienced orthostatic dizziness. She woke up plain dizzy. Her doctor gave her a liter of fluids and it helped her. This was something that needed to be addressed. It was serious. It was all serious. She had nothing left to vomit. She is an old lady with Breast Cancer. Her creatinine level of 1.10 which dropped her GFR of 52, she calculated the GFR using a computer program. This is what lead to the doctor giving her a liter of fluid. She had an appointment scheduled and her doctor sent her to the infusion centers for a liter of D5NS. She was sent home afterwards and encouraged to drink fluids. She also had a CBC and chemistry panel with her blood work. She was worried because her skin was tenting badly, and she couldn't keep anything down. She was probably dehydrated. Her blood pressure at the doctor's office was 82/50. She didn't care that her skin was tenting. She has been drinking a lot of fluids as advised after her liter of fluids at the infusion center. She is interested in researching the MRNA process because it is used it in other things. The way the vaccine was developed, it should have dissipated after 48 hours. She likes to research everything. She and her husband experienced a year from Hell starting in August of last year. All events are considered serious. The patient underwent lab tests and procedures which included blood creatinine: 1.10 and blood pressure measurement: 82/50 on 12Apr2021, blood test, full blood count and investigation with unknown results and glomerular filtration rate: 52 on an unspecified date. The outcome of the events chills and cold sweat was recovered on 12Apr2021, skin tenting and orthostatic dizziness was recovered on 13Apr2021, vomiting and nausea was recovered on 14Apr2021, pain in arm was recovered on 10Apr2021, feeling abnormal was recovered on an unspecified date, while of the rest was unknown.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2.  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.