Sex: F
Vaccine: COVID19
Symptoms: Chills, Cholelithiasis, Fatigue, Malaise, Pain in extremity
Clinical narrative: LOW BLOOD SUGAR; LOST 45 LBS; ARM LITTLE SORE; CHILLS; TIRED; DECREASED KIDNEY FUNCTION; GALLSTONES; GENERALLY NOT WELL/ SICK; LOW-GRADE FEVER; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, heart transplant, and immunosuppressed, and other pre-existing medical conditions included: Family history of heart issues. Patient was at high risk of getting Covid-19 and estimated glomerular filtration rate was stable at 20. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: unknown) dose was not reported, 1 total administered to left arm on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included insulin glargine and insulin lispro for diabetes.  On 13-MAR-2021, patient stated 36 hours later vaccination I had the side effects, horrendous pain, throwing up, low grade fever, generally sick and it didn't last long, only a couple of days was sick. On MAR-2021, Laboratory data included: Laboratory test (NR: not provided) Not reported.  On 17-MAR-2021, Laboratory data included: Estimated glomerular filtration rate (NR: not provided) 23.  On 23-MAR-2021, Laboratory data included: Blood creatinine (NR: not provided) High, Blood glucose (NR: not provided) Not reported, and Creatinine urine (NR: not provided) Very low.  On 01-APR-2021, the patient had blood work, which showed her estimated glomerular filtration rate down to 14 and endocrinologist estimated glomerular filtration rate 16 and was having low blood sugar due to her kidneys not filtering out the insulin. The patient stated having an evaluation for kidney transplant and might need dialysis. The patient later on the call, stated she her arm was a little sore after vaccine and also complained of chills, clarified pain mentioned before was a sharp pain to her stomach, or right above her stomach, and she was tired for a bit longer. The patient was still tired now but that was related to her decreased kidney function and blood sugar issues. The patient mentioned that gallstones were found later on so that could be the reason for the stomach pain and throwing up. The nephrologist thought it was the shot and told her to go to hospital but consumer started reviewing her medical records online, stated the problem started pretty quickly after vaccination because her blood sugar "all went wacky" and provided the following information. On 20-APR-2021, Laboratory data included: Estimated glomerular filtration rate (NR: not provided) 14. On 05-MAY-2021, estimated glomerular filtration rate has gone back to 17 ever since. The patient had changes to her immunosuppressant and insulin drugs. The patient stated that the state was encouraging a booster shot but she doesn't want it as she was scared and her doctors have different opinions, two doctors said not to get booster because of timing of symptoms and first vaccine, other doctors and heart transplant team say to do it anyways because she was at a high risk of getting COVID-19. The patient stated that before vaccine, she was going on a slow trajectory downward, but very slow, but suddenly and provided permission to access her medical records. On an unspecified date, the patient lost 45 lbs. Ultrasound kidneys (NR: not provided) Not reported, and Weight (NR: not provided) 45 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and low-grade fever, was recovering from low blood sugar, and tired, and the outcome of generally not well/ sick, arm little sore, lost 45 lbs, decreased kidney function and gallstones was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211142268- Covid-19 vaccine ad26.cov2.s- Decreased kidney function. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).