Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune system disorder, Immunisation reaction, Influenza like illness, Interchange of vaccine products, Kidney infection
Clinical narrative: Flu like symptoms; Weak immune system; infection; Kidney stones/ Blockage; Sepsis/Infection; last vaccination had affected her for 12 hours.; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of OBSTRUCTIVE NEPHROPATHY (Kidney stones/ Blockage), UROSEPSIS (Sepsis/Infection), INFLUENZA LIKE ILLNESS (Flu like symptoms), IMMUNE SYSTEM DISORDER (Weak immune system) and KIDNEY INFECTION (infection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and COVID-19 VACCINE MRNA (BNT162B2) for COVID-19 vaccination.    Concurrent medical conditions included Immune system disorder.   On 29-Dec-2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose every two weeks. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose every three weeks and first dose of COVID-19 VACCINE MRNA (BNT162B2) (Intramuscular) 1 dosage form. On an unknown date, received second dose of COVID-19 VACCINE MRNA (BNT162B2) (Intramuscular) dosage was changed to 1 dosage form and third dose of COVID-19 VACCINE MRNA (BNT162B2) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OBSTRUCTIVE NEPHROPATHY (Kidney stones/ Blockage) (seriousness criteria hospitalization and medically significant), UROSEPSIS (Sepsis/Infection) (seriousness criteria hospitalization and medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion hospitalization), IMMUNE SYSTEM DISORDER (Weak immune system) (seriousness criterion hospitalization), KIDNEY INFECTION (infection) (seriousness criteria hospitalization and medically significant), IMMUNISATION REACTION (last vaccination had affected her for 12 hours.) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was hospitalized from 08-Jul-2021 to 12-Jul-2021 due to IMMUNE SYSTEM DISORDER, KIDNEY INFECTION, OBSTRUCTIVE NEPHROPATHY and UROSEPSIS, and then from 08-Jul-2021 to 12-Jul-2021 due to INFLUENZA LIKE ILLNESS. The patient was treated with Surgery (surgery to remove stones and stents placement) for Obstructive nephropathy. At the time of the report, OBSTRUCTIVE NEPHROPATHY (Kidney stones/ Blockage), UROSEPSIS (Sepsis/Infection), INFLUENZA LIKE ILLNESS (Flu like symptoms) and KIDNEY INFECTION (infection) had resolved and IMMUNE SYSTEM DISORDER (Weak immune system), IMMUNISATION REACTION (last vaccination had affected her for 12 hours.) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: kidney stones Kidney stones.         No concomitant medications were reported. The patient developed kidney stones, and a blockage, which led to an infection and was hospitalized for four days from 08-Jul-2021 to 12-Jul-2021. She had the surgery to remove stones and stents placement. She was hospitalized as she developed sepsis from a kidney stone. She had been cleared. Her physician had adjusted the dosage frequency with Humira to every three weeks. She received periodic ultrasounds to check on stone development. She had a weak immune system and this was determined to influence the infection. She had flu like. symptoms with each vaccination. The last vaccination had affected her for 12 hours. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 49-year-old female patient with a medical history of weak immune system, who experienced the unexpected serious (hospitalization and medically significant) events of Obstructive nephropathy, Kidney infection and Urosepsis, unexpected serious (medically significant) event Influenza like illness and unexpected serious (hospitalization) event of Weak immune system unspecified days after the fourth dose of mRNA-1273 vaccine in covid vaccination series. The patient developed kidney stones, and a blockage, which led to an infection and sepsis and was hospitalized for four days from 08-Jul-2021 to 12-Jul-2021. She had the surgery to remove stones and stents placement. She received periodic ultrasounds to check on stone development. She also had flu like symptoms with each vaccination and she had immunization reaction with last vaccination lasting for 12 hours. The patient was noted to have received three doses with COVID-19 VACCINE MRNA (BNT162B2) prior to current vaccination (interchange of vaccine products). Patients medical history of weak immune system could be confounding for the events Kidney infection and Urosepsis. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 49-year-old female patient with a medical history of weak immune system, who experienced the unexpected serious (hospitalization and medically significant) events of Obstructive nephropathy, Kidney infection and Urosepsis, unexpected serious (medically significant) event Influenza like illness and unexpected serious (hospitalization) event of Weak immune system unspecified days after the fourth dose of mRNA-1273 vaccine in covid vaccination series. The patient developed kidney stones, and a blockage, which led to an infection and sepsis and was hospitalized for four days from 08-Jul-2021 to 12-Jul-2021. She had the surgery to remove stones and stents placement. She received periodic ultrasounds to check on stone development. She also had flu like symptoms with each vaccination and she had immunization reaction with last vaccination lasting for 12 hours. The patient was noted to have received three doses with COVID-19 VACCINE MRNA (BNT162B2) prior to current vaccination (interchange of vaccine products). Patients medical history of weak immune system could be confounding for the events Kidney infection and Urosepsis. The benefit-risk relationship of mRNA-1273 is not affected by this report.