Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Gastric disorder, Inappropriate schedule of product administration, Nephrolithiasis, SARS-CoV-2 test
Clinical narrative: Kidney stones; gastric issues; Took first dose on 05-Aug-2021 and second dose on 13-Sep-2021; Tested positive for COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of NEPHROLITHIASIS (Kidney stones) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F214, 020F128 and 939902) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ENCORAFENIB (BRAFTOVI) capsule for Cancer and CETUXIMAB (ERBITUX) for Cancer.    Concurrent medical conditions included Colorectal cancer stage III since November 2017.   In 2021, the patient ENCORAFENIB (BRAFTOVI) (Oral) dosage was changed to 75 milligram four times per day. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ENCORAFENIB (BRAFTOVI) (Oral) at an unspecified dose and CETUXIMAB (ERBITUX) (Intravenous) at an unspecified dose every two weeks. On 08-Feb-2022, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stones) (seriousness criterion medically significant), GASTRIC DISORDER (gastric issues) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took first dose on 05-Aug-2021 and second dose on 13-Sep-2021). At the time of the report, NEPHROLITHIASIS (Kidney stones) and GASTRIC DISORDER (gastric issues) outcome was unknown, COVID-19 (Tested positive for COVID-19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took first dose on 05-Aug-2021 and second dose on 13-Sep-2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a 77-year-old female patient with Colorectal cancer stage III on treatment with encorafenib and Erbitux, who experienced the non-serious unexpected AESI COVID-19, on an unknown lapse of time after receiving the booster dose of mRNA-1273. Patient was tested positive twice and reported had no symptoms. Inappropriate schedule of product administration was also captured as an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No relevant concomitant medications were reported.   She has tested positive for COVID-19 with home test and at the clinic she also tested positive. She has had so many medical problems to include kidney stones and gastric issues. She has been in since 2017 with stage III for Colorectal Cancer. She was diagnosed in Nov 2017. She had surgery in April 2018 after radiation and a month of those treatments together.  No treatment information was provided.  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.; Sender's Comments: Company comment: This is a spontaneous case concerning a 77-year-old female patient with Colorectal cancer stage III on treatment with encorafenib and erbitux, who experienced the   unexpected non-serious AESI COVID-19 and the serious event nephrolithiasis. More than four months after receiving the booster dose of mRNA-1273, patient was tested positive twice and reported had no symptoms of COVID-19. Start date, clinical findings, diagnostic tests and treatment details regarding nephrolithiasis were not provided. Innappropriate schedule of product administration was also captured as an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.