Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Fatigue, Injection site swelling, Injury associated with device, Muscle spasms
Clinical narrative: Needle stick/puncture; Cramps; Tiredness; Injection site swelling; Diarrhoea; Nephrolithiasis; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Nephrolithiasis) in a 60-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) solution for injection for Crohn's disease.    There was no reported medical history.  Concomitant products included TERIPARATIDE (FORTEO) from 29-Oct-2021 to an unknown date for Osteoarthritis.   In 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 02-Sep-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced NEPHROLITHIASIS (Nephrolithiasis) (seriousness criterion medically significant) and DIARRHOEA (Diarrhoea). In November 2021, the patient experienced MUSCLE SPASMS (Cramps), FATIGUE (Tiredness) and INJECTION SITE SWELLING (Injection site swelling). On 02-Dec-2021, the patient experienced INJURY ASSOCIATED WITH DEVICE (Needle stick/puncture). The patient was treated with Surgery (Renal stone removal (Nov 2021)) for Nephrolithiasis. In 2021, FATIGUE (Tiredness) and INJECTION SITE SWELLING (Injection site swelling) had resolved. On 02-Dec-2021, INJURY ASSOCIATED WITH DEVICE (Needle stick/puncture) had resolved. At the time of the report, NEPHROLITHIASIS (Nephrolithiasis), MUSCLE SPASMS (Cramps) and DIARRHOEA (Diarrhoea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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 spontaneous case concerns a 60  year  old female patient, in treatment with concomitant Teriparatide, who experienced the serious medically significant unexpected event of nephrolithiasis, which occurred in the same year of vaccination with mRNA  1273 vaccine. The same month the patient received the second dose of mRNA  1273 she had her kidney stone removed. Co-suspect product included Adalimumab. Patient´s concomitant medication Teriparatide could be a confounding factor since it could produce hypercalcemia, which is a risk factor for nephrolithiasis. The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-621207 (Patient Link).; Sender's Comments: This spontaneous case concerns a 60  year  old female patient, in treatment with concomitant Teriparatide, who experienced the serious medically significant unexpected event of nephrolithiasis, which occurred in the same year of vaccination with mRNA  1273 vaccine. The same month the patient received the second dose of mRNA  1273 she had her kidney stone removed. Co-suspect product included Adalimumab. Patient´s concomitant medication Teriparatide could be a confounding factor since it could produce hypercalcemia, which is a risk factor for nephrolithiasis. The benefit risk relationship of mRNA-1273 is not affected by this report.