Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Malaise, Nephrolithiasis, Rash, Rash erythematous
Clinical narrative: Stomach/ abdominal pain; Looks like it got a sunburn over her shoulder; Rash to the back; Kidney Stone; Feeling Shaky; Feeling sick/not well; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney Stone) in a 65-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 DUPILUMAB (DUPIXENT) injection for Atopic dermatitis.    Concurrent medical conditions included Rash pruritic since 2020, Rash (At the time of the event, the patient had a rash that comes back intermittently, it's still coming back, it was black, dry and itchy, it's on her abdomen, shoulder, back of neck, and her face under her nostrils, she has allergies to many several things, the rash has been on and off for about a year.) since 2020, Hypersensitivity since 2020, Allergy (Patient is allergic to several things.) and Sleep disorder. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleep disorder, HYDROCORTISONE ACETATE (HYDROCORT [HYDROCORTISONE ACETATE]) for an unknown indication.   On 04-May-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 mg once. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced TREMOR (Feeling Shaky) and MALAISE (Feeling sick/not well). On 20-May-2021, the patient experienced NEPHROLITHIASIS (Kidney Stone) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach/ abdominal pain), RASH ERYTHEMATOUS (Looks like it got a sunburn over her shoulder) and RASH (Rash to the back). The patient was treated with PARACETAMOL (TYLENOL) for Nervousness and Feeling sick, at an unspecified dose and frequency. At the time of the report, NEPHROLITHIASIS (Kidney Stone), TREMOR (Feeling Shaky), MALAISE (Feeling sick/not well), ABDOMINAL PAIN UPPER (Stomach/ abdominal pain), RASH ERYTHEMATOUS (Looks like it got a sunburn over her shoulder) and RASH (Rash to the back) outcome was unknown.            The patient reported that she was participating in a patient support program and was receiving dupilumab injections subcutaneously for atopic dermatitis every other week. Post the second dose of m-RNA 1273 vaccine, she reported feeling shaky and being not well. The nurse from the doctor's office advised her to take Tylenol and after two days the patient reported feeling better. On 18-May-2021, she missed her maintenance dose injection of dupilumab as she was feeling sick with rash to the back and stomach pain. On 20-May-2021, the patient went to emergency room due to abdominal pain and was noted to have kidney stones.   Treatment included nurse from the doctor's office advised to take Tylenol (acetaminophen), then 2 days later, she was better. No other treatment mentioned.  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. Further information has been requested.   This case was linked to MOD-2021-215094 (Patient Link).; 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. Further information has been requested.