Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Increased insulin requirement, Tremor
Clinical narrative: Blood sugar increased; Neurological event, wobbles in hand/ got stronger after the second dose; has had to double up on her diabetes medicine/ Insulin- this is new medication she just started; However, after the second dose she felt hypertension; flare up of her psoriatic arthritis/ it was more of an arthritis flare up and having joint pain; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on an unspecified date around 2:00 PM-3:30PM (62-year-old at time of vaccination), at single dose, for COVID-19 immunisation. The patient's medical history included ongoing type II diabetes, ongoing psoriatic arthritis, ongoing fibromyalgia, ongoing asthma (Haven't used inhalers in while, does not use each day. Only use bronchial), kidney infections (she gets kidney infections frequently/constantly), Barret's esophagus, GERD, and anti-depressant. Concomitant medications included ongoing omeprazole for Barret's esophagus and GERD; ongoing dicycloverine (DICYCLOMINE) for Barret's esophagus and GERD; ongoing duloxetine for anti-depressant and fibromyalgia; ongoing glimepiride for diabetes; ongoing metformin for diabetes; ongoing sitagliptin phosphate (JANUVIA) for diabetes. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) in left arm on an unspecified date (62-year-old at time of vaccination) for COVID-19 immunisation and experienced "She had wobbles in the right hand, from left to right. It was not just the shakes, but like a neurological event", kidney infection, and sore arm. The patient received Flu shot in Sep2020. Additional vaccines administered on same date of the Pfizer suspect was none. Prior Vaccinations (within 4 weeks) was none. Adverse event following prior vaccinations was none. Patient on the line is calling about the Pfizer COVID Vaccine. Patient explained the networking "we" have in regards to reporting reactions to this vaccine is unacceptable to anyone who gets the shot. It's not necessarily pinpointing just our manufactured vaccine, but any others as well. The health department does not have the correct information, doctors have no information. It's not safe. Patient explained she is upset. She has contacted the health department to find out where to report these details. She has sent an email and reported on a website that was provided to her, but she does not know what website that was and no one has called her back. After getting the seconds shot a few days later she noticed she had high numbers, later clarified as blood sugar, as she has Type II Diabetes. She has never had high numbers before even with the Cortisone shots she takes for arthritis. Her blood sugar numbers range from the 400s-500s. It is uncontrollable. Her A1C has normally always been 6.7 and 7.5 at it's highest. Now is on fast and long acting Insulin, and she has had to double up on her diabetes medicine and nothing is working. She has tried to call various numbers she has been provided with and it is like falling on death ears and it seems like no one is concerned.  Neurological event, wobbles in hand: This is in right hand. It happens randomly. At first she was not too concerned about it and did not pay attention to it. She clarified it did first start after the first dose within a week. However, it got stronger after the second dose. It is not controllable. It happens on it's own. She has to grab her hand to make it stop. Blood sugar increased: This was a strong reaction after the second dose. Then mentioned after the first dose she had a sore arm. Her blood sugar numbers have been controllable for several years. She was not really checking her blood sugar after the first dose. However, after the second dose she felt hypertension. She did not feel good and could tell something to do with blood sugar being high. She noticed this increase within first week of second shot. She then started checking her blood sugar and couple days it was not good. She would check it several times to make sure accurate. She added, even with taking Cortisone shots for psoriatic arthritis and fibromyalgia her numbers have never been high like this. She was added on Lantus and long term shots. Even still her blood sugar numbers at night are high and like 350-400 when waking up. The blood sugar is not controllable and totally out of wack, her system is out of wack. It does not matter if she eats a hard boiled egg, fruit, sugar, nothing. No matter what she puts inside her stomach numbers are high. Even if she eats a high protein diet it's high and it's never been than high. Product Details: She does not remember the exact date she got the first dose. She got the second dose like 30 days later as opposed to the three weeks. Where she got the vaccine they were trying to cycle people out. She got the vaccine at the (privacy). She does not have her vaccination card to provide lot/exp/NDC. It is in the car. Patient later clarified details regarding her diabetes medication: Insulin- this is new medication she just started; Lantus- 100 units, takes 10 units at night (Lot: 1F7507A Exp: expires in a week); Humalog quick pen-dose based on sliding scale, however, recently has been taking 8-10units every time eat or drink (Lot: D338405C Exp: Oct2023); Glimepiride- Commented now up to 1mg twice a day, once in morning and once at night, takes in the morning and night; Metoformin-500mg two at a time in morning and night (expiration date of 18May2022); Januvia- 100mg once in the morning (Lot U007683, Exp: 02Dec2023); She confirmed she was already taking at the time of event: Glimepiride, Metformin, and Januvia. Investigations:  A1C has been low for a low long time and never had high numbers before. What she is going through is frightening, numbers have been crazy. A1C just got one a little over two months ago. Things are like flying by. One was like 7.1. Historically, she never really had to test her blood sugar. The only time was when she took a quick pen in the past when she started on Cortisone shots for Psoriatic arthritis because she was informed Cortisone shots could raise it. So she was provided with the quick pen to help with that. She later found out with Cortisone she was having more of a hypoglycemic reaction. That is how her body reacted. It was never high and never had to worry about high numbers. When she did it was only like 220 on the high side and she was eating stuff. Now she is waking up and her blood sugar is in the 300-400 range. She can eat a balanced meal, have a small bowl of cereal, and will wake up to blood sugar of 352, 400. It is all over the board. There is no control even with the shots. This all started within the first week of the second shot. Cortisone- She gets it from the doctor's. Has not had any in 8-9 months. At end of call she added she knew she was getting the COVID Vaccine and she has not taken the Cortisone shot in sometime. She remembered she heard a lot of people mentioned being on Cortisone and having a sore arm after getting the COVID shot and flu like symptoms. She had a flare up of her psoriatic arthritis starting around midnight of the night after the second shot. She did not really remember having flu-like symptoms, but it was more of an arthritis flare up and having joint pain. Adverse events did not require a visit to emergency room or physician office. She had a kidney infection a couple of weeks ago. She had called and told the nurse about the events. However, she could not be seen by her regular doctor, as all booked up. She was informed a message was left for the doctor and the doctor called in the Lantus and Quick Pen. She went to be seen for the kidney infection last week, but saw a different doctor. She told the doctor about the about the wobble in her hand and blood sugar and the doctor informed her he did not think it was from the shot. It was like brushed off. Patient clarified she gets kidney infections frequently/constantly. She was prescribed an antibiotic. Therapeutic measures were taken as a result of the event blood sugar increased. The outcome of the event "Neurological event, wobbles in hand/ got stronger after the second dose" and Blood sugar increased was not recovered; outcome of other events was unknown.  Information on the lot/batch number has been requested.