Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Connective tissue disorder, Decreased appetite, Endoscopy, Haematocrit, Immune system disorder
Clinical narrative: I can't use my fingers, they are swollen, look like sausages; 24-hour tingling in fingers; Ankles are also swollen; It destroyed my immune system; My body doesn't absorb iron or vitamin B12; My body doesn't absorb iron; Connective tissue disease; loss of appetite; loss of taste; started losing weight; very weak; nausea; I developed Anemia; This spontaneous case was reported by a consumer and describes the occurrence of CONNECTIVE TISSUE DISORDER (Connective tissue disease), PERIPHERAL SWELLING (I can't use my fingers, they are swollen, look like sausages), PARAESTHESIA (24-hour tingling in fingers), JOINT SWELLING (Ankles are also swollen) and IMMUNE SYSTEM DISORDER (It destroyed my immune system) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included H.pylori gastrointestinal disease, Urinary infection and Blood loss anemia. Previously administered products included for Product used for unknown indication: Levothyroxine (50 mcg and Tablet.) from 01-Jul-2019 to 15-Oct-2021. Past adverse reactions to the above products included No adverse event with Levothyroxine. Concurrent medical conditions included Hypothyroidism since 01-Jul-2019 and Osteoarthritis. Concomitant products included COLECALCIFEROL (D3) from 01-Jun-2016 to an unknown date, PYRIDOXINE HYDROCHLORIDE (B6) from 01-Jun-2016 to an unknown date and LEVOTHYROXINE from 15-Oct-2021 to an unknown date for an unknown indication.   On 09-Feb-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ANAEMIA (I developed Anemia), DECREASED APPETITE (loss of appetite), AGEUSIA (loss of taste), WEIGHT DECREASED (started losing weight), ASTHENIA (very weak) and NAUSEA (nausea). On 11-Oct-2021, the patient experienced CONNECTIVE TISSUE DISORDER (Connective tissue disease). On an unknown date, the patient experienced PERIPHERAL SWELLING (I can't use my fingers, they are swollen, look like sausages), PARAESTHESIA (24-hour tingling in fingers), JOINT SWELLING (Ankles are also swollen), IMMUNE SYSTEM DISORDER (It destroyed my immune system), VITAMIN B12 DEFICIENCY (My body doesn't absorb iron or vitamin B12) and IRON METABOLISM DISORDER (My body doesn't absorb iron). The patient was treated with IBUPROFEN ongoing since an unknown date for Pain, at a dose of 600 mg twice a day; METHOTREXATE (oral) at a dose of 2.5 mg once a week and FOLIC ACID at a dose of 1 mg. At the time of the report, CONNECTIVE TISSUE DISORDER (Connective tissue disease), ANAEMIA (I developed Anemia), DECREASED APPETITE (loss of appetite), AGEUSIA (loss of taste), WEIGHT DECREASED (started losing weight), ASTHENIA (very weak) and NAUSEA (nausea) had not resolved and PERIPHERAL SWELLING (I can't use my fingers, they are swollen, look like sausages), PARAESTHESIA (24-hour tingling in fingers), JOINT SWELLING (Ankles are also swollen), IMMUNE SYSTEM DISORDER (It destroyed my immune system), VITAMIN B12 DEFICIENCY (My body doesn't absorb iron or vitamin B12) and IRON METABOLISM DISORDER (My body doesn't absorb iron) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Colonoscopy: negative (Negative) Negative. In March 2021, Endoscopy: negative (Negative) Negative. In March 2021, Haematocrit: low (Low) Hematocrit was found to be low.. In March 2021, Platelet count: high (High) The platelet count was doubled.. On 16-Mar-2021, Blood test: iron deficiency anemia (Low) iron deficiency anemia. In October 2021, Blood test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The last Rheumatologist diagnosed connective tissue disease which is so rare that shouldn't happen to someone 75 years old, as it happens to much younger women, sometimes to kids, as reported by the patient. There is no medicine or cure for the disease, it doesn't go into remission, it's terminal. The patient couldn't use his fingers, they were swollen, look like sausages and had 24-hour tingling. Ankles were also swollen. The patient strongly believe it's due to the vaccine. It destroyed his immune system. The patient developed Anemia, which didn't have before and his body doesn't absorb iron or vitamin B12, as reported.  This case concerns a 74-year-old, female patient with medical history of  H.pylori gastrointestinal disease, Urinary infection, Blood loss anemia, hypothyroidism and osteoarthritis, who experienced the unexpected events of connective tissue disorder, peripheral swelling, immune system disorder, anemia, decreased appetite, ageusia, weight decreased, asthenia, joint swelling, iron metabolism disorder, vitamin B12 deficiency, and paresthesia and expected event of nausea. The events of anemia, decreased appetite, ageusia, weight decreased asthenia and nausea occurred approximately 1 day after the first dose of mRNA-1273, the event of connective tissue disorder was diagnosed 6 and a half months following the second dose while the onset date for the rest of the events is unclear. The rechallenge not applicable as events occurred following second dose and outcome of events was unknown. The reporter assessed the events as related to the product. The above mentioned medical history remains a confounder. The patient was diagnosed with unspecified connective tissue disease which could have contributed to development of the rest of the symptoms described. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-374240 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received: Contains Patient race, Height, Weight, Concomitants, Events and Sender's comment updated.; Sender's Comments: This case concerns a 74-year-old, female patient with medical history of  H.pylori gastrointestinal disease, Urinary infection, Blood loss anemia, hypothyroidism and osteoarthritis, who experienced the unexpected events of connective tissue disorder, peripheral swelling, immune system disorder, anemia, decreased appetite, ageusia, weight decreased, asthenia, joint swelling, iron metabolism disorder, vitamin B12 deficiency, and paresthesia and expected event of nausea. The events of anemia, decreased appetite, ageusia, weight decreased asthenia and nausea occurred approximately 1 day after the first dose of mRNA-1273, the event of connective tissue disorder was diagnosed 6 and a half months following the second dose while the onset date for the rest of the events is unclear. The rechallenge not applicable as events occurred following second dose and outcome of events was unknown. The reporter assessed the events as related to the product. The above mentioned medical history remains a confounder. The patient was diagnosed with unspecified connective tissue disease which could have contributed to development of the rest of the symptoms described. The benefit-risk relationship of mRNA-1273 is not affected by this report.