Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Rash
Clinical narrative: kidney stones; skin got painful; skin got red; skin got damp; little bit of phlegm; redness to shoulders, neck/gotten worse characterized by it seems to have spread and is more red in color; rash to the front side of the body, bilateral legs, underneath bra area, the rash has spread to the back area as well as the front; This spontaneous case was reported by a non-health professional and describes the occurrence of NEPHROLITHIASIS (kidney stones) in a 72-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 products included non-company products DUPILUMAB (DUPIXENT) for Atopic dermatitis and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.    Concomitant products included TERIFLUNOMIDE for an unknown indication.   On 04-Oct-2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On 12-Nov-2019, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ALENDRONATE SODIUM (FOSAMAX) (unknown route) dosage form. On an unknown date, the patient experienced NEPHROLITHIASIS (kidney stones) (seriousness criterion medically significant), PAIN OF SKIN (skin got painful), ERYTHEMA (skin got red), COLD SWEAT (skin got damp), PRODUCTIVE COUGH (little bit of phlegm), CONDITION AGGRAVATED (redness to shoulders, neck/gotten worse characterized by it seems to have spread and is more red in color) and RASH (rash to the front side of the body, bilateral legs, underneath bra area, the rash has spread to the back area as well as the front). The patient was treated with PREDNISONE for Pain of skin, Skin red and Cold sweat, at a dose of UNK dosage form. At the time of the report, NEPHROLITHIASIS (kidney stones), CONDITION AGGRAVATED (redness to shoulders, neck/gotten worse characterized by it seems to have spread and is more red in color) and RASH (rash to the front side of the body, bilateral legs, underneath bra area, the rash has spread to the back area as well as the front) outcome was unknown, PAIN OF SKIN (skin got painful), ERYTHEMA (skin got red) and COLD SWEAT (skin got damp) was resolving and PRODUCTIVE COUGH (little bit of phlegm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 04-Oct-2019, it was reported that the patient experienced widespread rash and erythema, post loading dose of dupilumab and the condition worsened. On 19-Dec-2019, the patient experienced kidney stones, following dose of dupilumab. Additional information was received on 26-Dec-2019 included a new event, a little bit of phlegm, experienced by the patient. The case was upgraded to serious, and alendronate sodium was added as co-suspect product. Additional information received on 18-May-2021 from patient included the new events, skin got red, skin got painful, skin got damp. On an unknown date, the patient received Moderna covid-19 vaccine. The patient reported that after taking vaccine, and then taking dupilumab, skin got painful, red and damp.  Treatment medication included prednisone.  Reporter causality for alendronate sodium was reported as related for kidney stones.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.