Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation, Renal failure, SARS-CoV-2 test, Vaccination failure
Clinical narrative: KIDNEY FAILURE; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a health care professional via Other Company (Pfizer) concerned a 55 year old female of an unspecified ethnic origin. The patient's weight was 88.45 kilograms, and height was 173 centimeters. The patient's concurrent conditions included: sinus tachycardia (Sinus tachycardia Had complete heart work, did not find anything, might have real mild form POTS syndrome (Postural orthostatic tachycardia syndrome), asthma, hypothyroidism, reflux, sulfa allergy (Broke out in rash), and PEG (Poly Ethylene Glycol) allergy, and other pre-existing medical conditions included: The patient was a nurse by profession. The patient had reactions in the past to other vaccines, like when she was a kid, she always got softball sized welts. The patient did not have any prior vaccinations within 4 weeks. The patient had no Family Medical History relevant to Adverse Events. On 17-DEC-2020, the patient received first dose with Pfizer Biontech Covid-19 Vaccine (tozinameran), (Dose number in series 1), (form of admin, route of admin, and batch number: OR5730, expiry: UNKNOWN) dose was not reported, administered for covid-19 prophylaxis.  On 19-DEC-2020 at 10:00, the patient experienced anaphylactic reaction (dose number in series 1). The patient was treated with Benadryl and Allegra before getting the Covid shot. Felt ok the first day. The second day, did not feel bad. The third morning, had delayed reaction, her throat swelled, could not breathe, chest tightness, her lip, eyelid and tongue swelled. Was sent to a specialist who said that it was a reaction to the polyethyleneglycol. It had been all these years and did not know it. The patient was injected with steroid and got a rash and had broken out in hives and was injected again but did not break out. They gave her epinephrine and IV Solumedrol and IV Pepcid. Was feeling well enough to leave the emergency room and by the next morning, after all the steroids, she was feeling tremendously better.  The patient was previously treated with prednisone. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 in total, administered on 22-NOV-2021 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine. The batch number was not reported and has been requested. Age at time of vaccination 55 years old. Concomitant medications included levothyroxine sodium for hypothyroidism, famotidine for reflux, atenolol for sinus tachycardia, and acetylsalicylic acid. The patient used asthma inhaler only certain times of the year, when asthma flare-up or sick. On an unspecified date in 2022, Laboratory data included: COVID-19 virus test Positive (dose number in series 2). End of or around middle of JAN-2022, about an year ago, the patient experienced covid-19 and got pretty sick but did not have to go to the hospital which was coded as confirmed covid-19 infection that lead to confirmed clinical vaccine failure and ended up with some kidney failure too (dose number in series 2). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose was not reported, administered on 25-APR-2022 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, confirmed clinical vaccine failure, kidney failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230119419- kidney failure. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.   20230119419-confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.