Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood potassium decreased, Glycosylated haemoglobin, Headache, Hypertension
Clinical narrative: blotchy; scratching; Not feeling very good; Really bad headache; Rashes; Blood pressure was way out, sky-high; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN5318, expiration date: 31May2021), via an unspecified route of administration, administered in upper left arm on 08Feb2021 09:50 (at the age of 80-years-old) as dose 2, single for Covid-19 immunization. The patient medical history included surgeries (Reported had Bowel obstruction that she had to go to the emergency room for from all the adhesions from all of her surgeries), polymyalgia rheumatica (Reported she has had Polymyalgia rheumatica (PMR) which she reported is a prerequisite for Rheumatoid arthritis which she has now. Probably one of the worst things that causes her the most pain), rheumatoid arthritis (Probably one of the worst things that causes her the most pain), mild glaucoma, slight hearing loss, fibromyalgia, osteopenia, high blood pressure (She has had high blood pressure since she was in her early 50s probably), allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity. Concomitant medications included bisoprolol fumarate/HCT (10mg/6.25mg) taken for hypertension and ongoing taken for many years, potassium chloride (3 daily: 30mg taken daily) taken for hypokalemia, hydroxychloroquine taken for malaria, ezetimibe taken for blood cholesterol increased, prednisone (4mg taken daily) taken for polymyalgia rheumatica, raloxifene hydrochloride (60mg) taken for osteoporosis. The patient historical vaccine included first dose of BNT162B2 (lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 18Jan2021 09:47 as dose 1, single for COVID-19 immunization. The patient historical vaccine also included flu shots taken in 1998, on an unspecified date, in Aug2020 and patient experienced fever, achy, arm was sore, little tender (She has been taking flu shots since about 1998 and events depends; the first years she took the flu shot she would get a little fever and feel achy. Sometimes her arm hurts for a day. The last flu shot she was administered in Aug2020 her arm was sore for like 1 day with, a little tender, but not incapacitating, Vaccine/Brand Names/Lots/NDCs/Expiries were unknown other than that they were flu shots that she gets at Publix grocery store pharmacy counter, does not have any of the products or further information with her). No additional vaccines were administered to the patient on same date of the pfizer suspect. The patient did not receive any prior vaccinations within 4 weeks. It was reported that, this consumer is the patient who was administered her first dose of Pfizer-BioNTech COVID-19 Vaccine 18Jan2021 and second dose of Pfizer-BioNTech COVID-19 Vaccine 08Feb2021. Approximately 01Mar2021 or 02Mar2021 she went in for her checkup with her Nurse Practitioner because she was was not feeling very good, had really bad headache. During that checkup they told her that her blood pressure was way out, sky-high. Since about 01Mar2021 she has had rashes which have worsened. She asked if these events are reactions to the second dose of the Pfizer-BioNTech COVID-19 Vaccine. She gained 10lbs in this COVID year. Blood pressure was way out, sky-high: Onset date approximately 01Mar2021 or 02Mar2021. She has had high blood pressure since she was in her early 50s probably, but her blood pressure has been under control with medication Bisoprolol fumarate/HCT until after the second dose of Pfizer-BioNTech COVID-19 Vaccine. The provider adjusted her blood pressure medication which seemed to control the blood pressure. Outcome of this event is unknown, she has not taken blood pressure again but she has a really bad headache so she knows her blood pressure is going to be high. She will have to go to the emergency room to bring her blood pressure down because she does not know how to bring her blood pressure down herself; she has never had this problem before because her high blood pressure has always been under control before this event. Described as slight rashes, that were very light starting approximately 01Mar2021 on her hands. She did not think anything of it at that time, thought maybe it was from washing dishes or something, but did not initially associate rashes with the Pfizer-BioNTech COVID-19 Vaccine. The rashes then left her hands and went to her wrists and lower arms. The rashes sort of died down but now, 5 weeks out from the second dose of Pfizer-BioNTech COVID-19 Vaccine, have gotten really bad; up her arms and what caller initially reported as all over her neck almost to her shoulders. She later clarified that the rashes are all the way up to her neck and looks like a collar around the bottom of her neck, like a big red blotchy itchy stuff; got really bad last night and she was scratching and scratching. When she got up and looked in the mirror it looked like someone took a blow torch and put a collar around her neck about 5 inches wide just below her neck. Patient reported that she had some lab work done on 03Mar2021: A1C because the rheumatologist said her sugar counts were too high so they ran an A1C for her sugar which is borderline; they also did a BMP w/GFR which she does not know what is, but it's a list with all the labs like creatinine, potassium-her potassium tends to run low, that is why she was started on Potassium chloride to make up for diuretic draining the potassium out; she also had another blood test but did not get a copy of that. The only product she was able to provide at time of the call was Prolia. She took Prolia for 2 years as 1 injection every 6 months. Prolia was stopped in 2018 because she is one of the rare people that Prolia inhibited the circulation of blood in the upper jaw of so she had to stop taking that. She found this out because she went in to have an implant put in and discovered she did not have enough circulation to perform the implant. She had to stop Prolia and wait almost a year before she could proceed with the bone graft for the implant. She did not keep track of all the medications she is allergic to and has no further information to provide at the time of the call. She reported that there is a lot wrong with her, a lot of surgeries and emergency room visits, hospitalizations. She is on a lot of medications but declined to provide further information on other medical conditions, concomitant products and medical history at this time. If someone wants her to fax that information to them she can fax her whole medical record and the sheet that she has it all listed on, all the medications, ailments, major surgeries and times she was in the hospital, the last time was last year in 2020. The patient underwent lab tests and procedures which included (HBA1c) glycosylated haemoglobin: borderline on 03Mar2021, creatinine (blood creatinine): unknown result on 03Mar2021, potassium (blood potassium decreased): tends to run low on 03Mar2021. The adverse events not feeling very good; really bad headache; blood pressure was way out, sky-high resulted in physician office. The patient was not hospitalized. The outcome of the event rashes was not recovered and outcome was unknown for other events. No follow-up attempts are needed. No further information is expected.