Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Inflammation, Injection site pruritus, Intervertebral disc disorder, Lacrimation increased
Clinical narrative: feeling hot; Discopathy; drug interaction; extremities itchy sensation/ arm itch real bad after covid-19 vaccine/itching on legs; feeling bad; eye flare up itchy ,red and watery; eye red; eye watery; inflamation; cold; eye swelling; yeast infection of the skin; neck pain; Pain; itchiness; Nausea; knee spasm; tongue biting; rash; Allergic reaction; Diarrhea; leg spasms; Kidney stones; stuffy nose; Tongue sore; arthritis all over back; swollen leg; This spontaneous case was reported by a physician and describes the occurrence of NEPHROLITHIASIS (Kidney stones) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for an unknown indication and OXYBUTYNIN for an unknown indication.    The patient's past medical history included Surgery (Hernia surgery and mesh) in 2018. Concurrent medical conditions included Rheumatoid arthritis since 2013, Hypertension, Schizophrenia, Sleep disorder, Diarrhea, Anemia, Calcium deficiency, Homozygous familial hypercholesterolaemia and Stomach ulcer. Concomitant products included FERROUS SULFATE (FEROSUL) for Anemia, COLECALCIFEROL (VITAMIN D 3) for Calcium deficiency, LOPERAMIDE HYDROCHLORIDE (IMODIUM N) for Diarrhea, ATORVASTATIN for High cholesterol, LOSARTAN for Hypertension, TIZANIDINE for Leg spasm, PROMETHAZINE for Nausea, ARIPIPRAZOLE (ABILIFY) and ARIPIPRAZOLE for Schizophrenia, TRAZODONE for Sleep disorder, FAMOTIDINE for Stomach ulcer, AZITHROMYCIN (Z-PAK) for an unknown indication.   In 2013, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg once a week. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-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 started PROMETHAZINE (PHENERGAN [PROMETHAZINE]) (unknown route) at an unspecified dose and OXYBUTYNIN (unknown route) at an unspecified dose. In March 2021, the patient experienced PERIPHERAL SWELLING (swollen leg) and ARTHRITIS (arthritis all over back). On 01-Apr-2021, the patient experienced NASAL DISCOMFORT (stuffy nose). 01-Apr-2021, the patient experienced GLOSSODYNIA (Tongue sore). On 27-Apr-2021, the patient experienced NEPHROLITHIASIS (Kidney stones) (seriousness criterion medically significant). On 04-May-2021, the patient experienced MUSCLE SPASMS (leg spasms). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction), DIARRHOEA (Diarrhea), FEELING HOT (feeling hot), INTERVERTEBRAL DISC DISORDER (Discopathy), DRUG INTERACTION (drug interaction), PRURITUS (extremities itchy sensation/ arm itch real bad after covid-19 vaccine/itching on legs), FEELING ABNORMAL (feeling bad), EYE PRURITUS (eye flare up itchy ,red and watery), OCULAR HYPERAEMIA (eye red), LACRIMATION INCREASED (eye watery), INFLAMMATION (inflamation), NASOPHARYNGITIS (cold), EYE SWELLING (eye swelling), FUNGAL SKIN INFECTION (yeast infection of the skin), NECK PAIN (neck pain), PAIN (Pain), TONGUE BITING (tongue biting), INJECTION SITE PRURITUS (itchiness), RASH (rash), NAUSEA (Nausea) and ARTHRALGIA (knee spasm). The patient was treated with TRAMADOL at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; HYDROCODONE at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 20-May-2021, NASAL DISCOMFORT (stuffy nose) had resolved. At the time of the report, NEPHROLITHIASIS (Kidney stones), HYPERSENSITIVITY (Allergic reaction), DIARRHOEA (Diarrhea), INTERVERTEBRAL DISC DISORDER (Discopathy), DRUG INTERACTION (drug interaction), PERIPHERAL SWELLING (swollen leg), ARTHRITIS (arthritis all over back), FEELING ABNORMAL (feeling bad), EYE PRURITUS (eye flare up itchy ,red and watery), OCULAR HYPERAEMIA (eye red), LACRIMATION INCREASED (eye watery), INFLAMMATION (inflamation), NASOPHARYNGITIS (cold), EYE SWELLING (eye swelling), FUNGAL SKIN INFECTION (yeast infection of the skin), NECK PAIN (neck pain), PAIN (Pain), MUSCLE SPASMS (leg spasms), TONGUE BITING (tongue biting), RASH (rash), NAUSEA (Nausea) and ARTHRALGIA (knee spasm) outcome was unknown, FEELING HOT (feeling hot) was resolving and PRURITUS (extremities itchy sensation/ arm itch real bad after covid-19 vaccine/itching on legs), GLOSSODYNIA (Tongue sore) and INJECTION SITE PRURITUS (itchiness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Magnetic resonance imaging: chronic arthritis in the back. In May 2021, X-ray: arthritis. On an unknown date, Pain assessment: 8, high and 8, High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient suffered from multiple adverse events as a result of multiple suspect drugs interaction.  On 18-MAY-2021 Patient did ultra sound of Kidney, Pelvic and  bladder, but result are not provided at the time of report. On 27 -APR_2021 urine test was perform and on an unknown date Uric acid test was done but no reports were provide by reporter.  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. The event nephrolithiasis and Intervertebral disc disorder are considered as not related to mRNA-1273 vaccine due to short latency and the nature of the events. The case is confounded by multiple comorbidities or polypharmacy.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Upon internal review on 13-Jun-2023, significant correction was performed to upgrade the event Nephrolithiasis peripheral to serious medically significant.