Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Hyperthyroidism, Nephrolithiasis, Scan
Clinical narrative: Hyperthyroidism; graves disease; Kidney stone; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTHYROIDISM (Hyperthyroidism), BASEDOW'S DISEASE (graves disease) and NEPHROLITHIASIS (Kidney stone) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 010A21A and 013M201A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia in 2011, Kidney stones, Fibroids (Tumor) in December 2020, Hysterectomy on 20-Apr-2021 and Extracorporeal shock wave lithotripsy (to get rid of the stone on march 31st it was 8.5.) on 31-Mar-2021. Concurrent medical conditions included Drug allergy (Topomax caused me kidney stones), Hyperthyroidism and Graves' disease.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criterion medically significant). In May 2021, the patient experienced HYPERTHYROIDISM (Hyperthyroidism) (seriousness criterion medically significant) and BASEDOW'S DISEASE (graves disease) (seriousness criterion medically significant). On 31-Mar-2021, NEPHROLITHIASIS (Kidney stone) had resolved. At the time of the report, HYPERTHYROIDISM (Hyperthyroidism) and BASEDOW'S DISEASE (graves disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Scan: abnormal (abnormal) scanned for the stone on march 16th at urgent care..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was reported as acidity medication. Treatment information was not provided. Patient reported that she had gotten a kidney stone after taking a medication a long time ago. After she stopped taking the medication, the kidney stone went away. They said it was because of the acidity of the medication. They did not confirm that the kidney stones was from the Moderna COVID19 Vaccine.  It was stated that the patient had used to get kidney stones about 10-15 years ago caused by a medication to prevent migraine topomax. After receiving 2 vaccines and then patient had stone within two weeks after the second dose of vaccine. Patient was scanned for the stone on march16th at urgent care. Patient had extracorporeal shock wave lithotripsy to remove stone on Mar 31st stone size was 8.5. Patient received the booster dose on 05 Dec 2021. Kidney stone was caused by topomax they informed about the acidity of the drug. When a small fibroid tumor they would watch and check in another year (found 12/20) when patient went in for the kidney stone they found a large mass, it was the fibroid tumor that had rapidly grew into a softball size tumor, they removed it with the uterus, tubes and cervix in april. Patient then developed graves disease/hyperthytoidism in May 2021. Company comment: This spontaneous case concerns a 54 year old female with relevant medical history kidney stones ( related to drug intake of Topomax)  ,  S/P removal of fibroid tumor , (TAHBSO )  , May 2021, Hyperthyroidism  and Basedow disease, who experienced Serious ( Medically significant ) , unexpected event of kidney stone after vaccination with the 1st and 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . This patient then received her 3rd doseof mRNA-1273 vaccine  but based on the report there was no clear narration that the event  nephrolithiasis  recurred after the 3rd dose .  This patient underwent ESWL last   March 31 ,  2021 that removed the stone. It was reported that this patient consulted a kidney doctor who did not confirm the  relation of the kidney stone  with her history of  vaccination with mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ). The re-challenge for this case is not applicable since the event happened after the 3rd dose and no additional doses will be given. however based on dose 1 and dose 2 there is possible positive re-challenge for the event kidney stones. The history of previous kidney stones is considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.    This case was linked to MOD-2021-395991, MOD-2021-396406 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Significant follow up received included medical history, patient demographics, dose 3 info, event information and narrative was updated.; Sender's Comments: This spontaneous case concerns a 54 year old female with relevant medical history kidney stones ( related to drug intake of Topomax)  ,  S/P removal of fibroid tumor , (TAHBSO )  , May 2021, Hyperthyroidism  and Basedow disease, who experienced Serious ( Medically significant ) , unexpected event of kidney stone after vaccination with the 1st and 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . This patient then received her 3rd doseof mRNA-1273 vaccine  but based on the report there was no clear narration that the event  nephrolithiasis  recurred after the 3rd dose .  This patient underwent ESWL last   March 31 ,  2021 that removed the stone.  It was reported that this patient consulted a kidney doctor who did not confirm the  relation of the kidney stone  with her history of  vaccination with mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ). The re-challenge for this case is not applicable since the event happened after the 3rd dose and no additional doses will be given. however based on dose 1 and dose 2 there is possible positive re-challenge for the event kidney stones. The history of previous kidney stones is considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.