Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Muscle spasms, Nephrolithiasis, Vertebroplasty
Clinical narrative: KYPHOPLASTY ON BACK; AFTER FIRST MODERNA INJECTION PATIENT WAS VERY TIRED; KIDNEY STONE; INCREASED CRAMPING; INCREASED OF LOOSE STOOLS; This spontaneous case was reported by a consumer and describes the occurrence of VERTEBROPLASTY (KYPHOPLASTY ON BACK) and NEPHROLITHIASIS (KIDNEY STONE) 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) for Crohn's disease.    Concurrent medical conditions included Crohn's disease. Concomitant products included TERIPARATIDE (FORTEO) for Osteoarthritis.   In 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On 02-Sep-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Citrate free. On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced NEPHROLITHIASIS (KIDNEY STONE) (seriousness criterion medically significant), MUSCLE SPASMS (INCREASED CRAMPING) and DIARRHOEA (INCREASED OF LOOSE STOOLS). On 20-Oct-2021, the patient experienced FATIGUE (AFTER FIRST MODERNA INJECTION PATIENT WAS VERY TIRED). On 10-Nov-2021, the patient experienced VERTEBROPLASTY (KYPHOPLASTY ON BACK) (seriousness criterion medically significant). The patient was treated with Surgery for Nephrolithiasis. At the time of the report, VERTEBROPLASTY (KYPHOPLASTY ON BACK), NEPHROLITHIASIS (KIDNEY STONE), MUSCLE SPASMS (INCREASED CRAMPING) and DIARRHOEA (INCREASED OF LOOSE STOOLS) outcome was unknown and FATIGUE (AFTER FIRST MODERNA INJECTION PATIENT WAS VERY TIRED) had resolved.            The patient medical history was not reported in narrative.  In Nov 2021, the patient had her kidney stone removed and she still had a stint in place as of 2 Dec 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication 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.  Company comment: This is a spontaneous case concerning a 60-year-old female patient with Crohn´s disease on treatment with Adalimumab, who experienced the serious (medically significant) unexpected events nephrolithiasis and vertebroplasty. The event  vertebroplasty occurred 21 days after the first dose of mRNA-1273 and kidney stone was removed on the next following month after vaccination. Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-621211.; Sender's Comments: Company comment: This is a spontaneous case concerning a 60-year-old female patient with Crohn´s disease on treatment with Adalimumab, who experienced the serious (medically significant) unexpected events nephrolithiasis and vertebroplasty. The event  vertebroplasty occurred 21 days after the first dose of mRNA-1273 and kidney stone was removed on the next following month after vaccination.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.