Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nephrolithiasis, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Kidney stone; Lack of drug effect; Covid 19 antibody test was positive /She currently feels very weak, sick, kind of like out of breath/ she can't really smell anything /coughing; This spontaneous case was reported by an other health care professional and describes the occurrence of NEPHROLITHIASIS (Kidney stone) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 026520-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Covid 19 antibody test was positive /She currently feels very weak, sick, kind of like out of breath/ she can't really smell anything /coughing). On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NEPHROLITHIASIS (Kidney stone), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Covid 19 antibody test was positive /She currently feels very weak, sick, kind of like out of breath/ she can't really smell anything /coughing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. On 07-Sep-2021, SARS-CoV-2 antibody test: 4.05 (High) High. On 07-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient has received 2 doses of the Moderna covid-19 vaccine by intramuscular injection on 29DEC2020 (lot number 026520-2A, expiration date unknown), and 26JAN2021 (lot number 043L20A, expiration date unknown). She has been fine throughout most the pandemic. She went to the hospital on 23AUG2021 for a lithotripsy for a kidney stone. This was an outpatient procedure and she felt like she never recovered. She was staying at her daughter's house after the procedure. 1 week later, on 31AUG2021, her son in lawand 9 months pregnant daughter, both in their 30s, tested positive for covid-19.   Because she continued to not feel right, like she had a little bit of a cold, she was tested for covid-19 on 4SEP2021 which was negative. She went for another swab and antibody test on 7SEP2021 which was positive and the antibody test showed a result of 4.05. She currently feels very weak, sick, kind of like out of breath, and like she basically can't do anything. She has been a little nauseous, finds it very hard to eat something, she can't really smell anything and everything tastes like dust or something. She also feels very dizzy, weak, disoriented, and like she was on another planet. Last night she started coughing a lot, with a dry cough that won't stop once you start coughing. She has been taking Tylenol for her symptoms. She has also talked to her nephrologist who said the shot probably saved her life.  Company Comment: This case concerns a 56-year-old, female patient with no relevant medical history, who experienced the unexpected events of nephrolithiasis and COVID 19. Additional event of drug ineffective was also considered. The events occurred approximately 7 months after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 56-year-old, female patient with no relevant medical history, who experienced the unexpected events of nephrolithiasis and COVID 19. Additional event of drug ineffective was also considered. The events occurred approximately 7 months after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.