Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Inappropriate schedule of product administration, Nephrolithiasis, Sepsis, Vomiting
Clinical narrative: kidney stone; turned septic from the vomiting; abdominal pain; vomiting, vomiting and vomiting; 1st dose was administered on 20-May-2021 and 2nd dose was on 13-Jun-2021; This spontaneous case was reported by a patient and describes the occurrence of NEPHROLITHIASIS (kidney stone), SEPSIS (turned septic from the vomiting), ABDOMINAL PAIN (abdominal pain) and VOMITING (vomiting, vomiting and vomiting) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 022B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: IMMUNOGLOBULINS NOS (she has been ion IVIG infusion every 3 weeks for 3 days prior to getting the 1st dose of the vaccine). Past adverse reactions to the above products included No adverse event with IMMUNOGLOBULINS NOS. Concurrent medical conditions included Latex allergy, Fruit allergy (Allergy to mango. she blows up like crazy when she ate.), Fruit allergy (Allergy to banana. she blows up like crazy when she ate.), Fruit allergy (Allergy to pineapple. she blows up like crazy when she ate.), Asthma (Patient had rescue inhaler and she had not experienced acute attacks in the recent past.), Guillain-Barre syndrome and Chronic inflammatory demyelinating polyradiculoneuropathy (she has been ion IVIG infusion every 3 weeks for 3 days prior to getting the 1st dose of the vaccine).   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 20-May-2021 and 2nd dose was on 13-Jun-2021). In January 2022, the patient experienced NEPHROLITHIASIS (kidney stone) (seriousness criteria hospitalization and medically significant), SEPSIS (turned septic from the vomiting) (seriousness criteria hospitalization and medically significant), ABDOMINAL PAIN (abdominal pain) (seriousness criterion hospitalization) and VOMITING (vomiting, vomiting and vomiting) (seriousness criterion hospitalization). The patient was hospitalized for 6 days due to ABDOMINAL PAIN, NEPHROLITHIASIS, SEPSIS and VOMITING. At the time of the report, NEPHROLITHIASIS (kidney stone), SEPSIS (turned septic from the vomiting), ABDOMINAL PAIN (abdominal pain) and VOMITING (vomiting, vomiting and vomiting) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 20-May-2021 and 2nd dose was on 13-Jun-2021) outcome was unknown.            Concomitant medication were IVIG infusion and inhaler. Patient did not have COVID positive test or diagnosis. Patient had 1st booster dose on 28-Feb-2022 with lot number 0075212A. It was reported that patient had to call an ambulance and was brought to the hospital where she was confined for 6 days in the ICU. It turned out that she had turned septic from the vomiting. And she was diagnosed to have kidney stone. Two other stones were found, the latest one was last week (Oct-2022). She was not currently taking any medications for the stones but would be seeing a nephrologist. The patient did not experience a similar event in the past. There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No treatment medication was reported.  Company comment: This spontaneous case concerns a 63-year-old female patient with no relevant medical history reported, who experienced serious  (hospitalization and medically significant )unexpected events of nephrolithiasis and sepsis, and serious (hospitalization) unexpected events of vomiting and abdominal pain. Additionally, there was an inappropriate schedule of vaccine administration as time between the first two doses was less than 4 weeks. The events occurred approximately 7 months after the 2nd dose of the mRNA-1273. Reportedly, the patient developed vomiting due to abdominal pain and was hospitalized for 6 days and admitted into the ICU. The patient also noted becoming septic due to the events. Later, she was also diagnosed with kidney stones. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-209253, MOD-2022-573638 (Patient Link).; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with no relevant medical history reported, who experienced serious  (hospitalization and medically significant )unexpected events of nephrolithiasis and sepsis, and serious (hospitalization) unexpected events of vomiting and abdominal pain. Additionally, there was an inappropriate schedule of vaccine administration as time between the first two doses was less than 4 weeks. The events occurred approximately 7 months after the 2nd dose of the mRNA-1273. Reportedly, the patient developed vomiting due to abdominal pain and was hospitalized for 6 days and admitted into the ICU. The patient also noted becoming septic due to the events. Later, she was also diagnosed with kidney stones. The benefit-risk relationship of mRNA-1273 is not affected by this report.