Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Coeliac disease, Dyspepsia, Nephrolithiasis, Post procedural complication
Clinical narrative: PURPLE LINES UNDER ARMPITS; SCALP ITCHY; Celiac disease; HEART BURN FROM BREATHING TUBE; ENDOMETRIAL MASS; SYMPTOMS OF KIDNEY STONES; Had complications due to surgery anesthesia; This spontaneous case was reported by a consumer and describes the occurrence of UTERINE MASS (ENDOMETRIAL MASS), NEPHROLITHIASIS (SYMPTOMS OF KIDNEY STONES) and COELIAC DISEASE (Celiac disease) in a 39-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 ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included Iron deficiency, Chronic heartburn, Heavy periods, Mass, Endometriosis, Polycystic ovarian syndrome and Gastrointestinal disorder. Concurrent medical conditions included Psoriatic arthritis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In May 2022, the patient experienced COELIAC DISEASE (Celiac disease) (seriousness criterion medically significant). In 2022, the patient experienced UTERINE MASS (ENDOMETRIAL MASS) (seriousness criterion medically significant), NEPHROLITHIASIS (SYMPTOMS OF KIDNEY STONES) (seriousness criterion medically significant), DYSPEPSIA (HEART BURN FROM BREATHING TUBE) and POST PROCEDURAL COMPLICATION (Had complications due to surgery anesthesia). In August 2022, the patient experienced SKIN DISCOLOURATION (PURPLE LINES UNDER ARMPITS) and PRURITUS (SCALP ITCHY). The last dose administered for ADALIMUMAB (HUMIRA) was on 06-Aug-2022. At the time of the report, UTERINE MASS (ENDOMETRIAL MASS), NEPHROLITHIASIS (SYMPTOMS OF KIDNEY STONES) and DYSPEPSIA (HEART BURN FROM BREATHING TUBE) outcome was unknown, COELIAC DISEASE (Celiac disease), SKIN DISCOLOURATION (PURPLE LINES UNDER ARMPITS) and PRURITUS (SCALP ITCHY) had not resolved and POST PROCEDURAL COMPLICATION (Had complications due to surgery anesthesia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Celiac Disease.         No concomitant medicine were reported.  On 05 Sep 2022, she went to the emergency room as she had symptoms of kidney stones. The physicians did emergency surgery. She had three surgeries in 19 days. She had complications due to surgery anesthesia and was diagnosed with Celiac Disease. The onset date for CELIAC DISEASE was May 2022. The onset date for SCALP ITCHY and PURPLE LINES UNDER ARMPITS was Aug 2022. The onset date for ENDOMETRIAL MASS, SYMPTOMS OF KIDNEY STONES, HEART BURN FROM BREATHING TUBE AND Had complications due to surgery anesthesia was 2022 and cessation date for Had complications due to surgery anesthesia was 2022. The lab test was performed in 2022.  For Humira, the reporter causality for the events of Celiac disease, Endometrial mass, Heart burn from breathing tube, had complications due to surgery anesthesia, Purple lines under armpits, Scalp itchy and symptoms of kidney stones with Adalimumab Solution for Injection was Not Provided.  No treatment medicine were reported.  Company comment: This spontaneous case concerns a 39-year-old female patient with medical history of endometriosis, Polycystic ovarian syndrome, psoratic arthritis that started with Adalimumab almost one week after the second vaccine, who experienced the unexpected, serious (medically significant) events of uterine mass, nephrolithiasis and Coeliac disease. Coeliac disease occurred on the same month that the patient started with Adalimumab. The patient received the first dose of mRNA-1273 vaccine. The event onset dates for uterine mass and nephrolithiasis were unknown, thus exact latency between vaccination and onset of the events could not be assessed. Approximately five months after the third dose of mRNA-1273, the patient went to the emergency room as she had symptoms of kidney stones. She was treated with emergency surgery. She had three surgeries in 19 days, complications due to surgery anesthesia and was diagnosed with Celiac Disease. The Lab test was performed but no results provided. No further clinical information was available for review. The mentioned medical history could be associated with uterine mass. Adalimumab could be a co-suspect drug due to the temporal relationship. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 39-year-old female patient with medical history of endometriosis, Polycystic ovarian syndrome, psoratic arthritis that started with Adalimumab almost one week after the second vaccine, who experienced the unexpected, serious (medically significant) events of uterine mass, nephrolithiasis and Coeliac disease. Coeliac disease occurred on the same month that the patient started with Adalimumab. The patient received the first dose of mRNA-1273 vaccine. The event onset dates for uterine mass and nephrolithiasis were unknown, thus exact latency between vaccination and onset of the events could not be assessed. Approximately five months after the third dose of mRNA-1273, the patient went to the emergency room as she had symptoms of kidney stones. She was treated with emergency surgery. She had three surgeries in 19 days, complications due to surgery anesthesia and was diagnosed with Celiac Disease. The Lab test was performed but no results provided. No further clinical information was available for review. The mentioned medical history could be associated with uterine mass. Adalimumab could be a co-suspect drug due to the temporal relationship. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.