Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Urinary tract infection
Clinical narrative: Chest pain; Urinary tract infection; Ill feeling; Sore throat; General body pain; COVID-19; Kidney infection; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection) in a 39-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 product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    There was no reported medical history.  Concurrent medical conditions included Crohn's disease.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced KIDNEY INFECTION (Kidney infection) (seriousness criterion medically significant), MALAISE (Ill feeling), OROPHARYNGEAL PAIN (Sore throat), PAIN (General body pain) and COVID-19 (COVID-19). In November 2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). On 03-Dec-2021, the patient experienced CHEST PAIN (Chest pain). At the time of the report, KIDNEY INFECTION (Kidney infection), MALAISE (Ill feeling), OROPHARYNGEAL PAIN (Sore throat), PAIN (General body pain), CHEST PAIN (Chest pain) and COVID-19 (COVID-19) had not resolved and URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 39-year-old female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Kidney infection, and the unexpected and non-serious AESI of COVID-19, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for Crohn´s disease. SARS-CoV-2 test was performed with positive result. No information disclosed about treatments received. At the time of the report, the events had not resolved. COVID-19 was considered unrelated to mRNA-1273 vaccine per the reporter's assessment. Underlying Crohn´s disease could be a confounding factor for Kidney infection. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 39-year-old female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Kidney infection, and the unexpected and non-serious AESI of COVID-19, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for Crohn´s disease. SARS-CoV-2 test was performed with positive result. No information disclosed about treatments received. At the time of the report, the events had not resolved. COVID-19 was considered unrelated to mRNA-1273 vaccine per the reporter's assessment. Underlying Crohn´s disease could be a confounding factor for Kidney infection. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.