Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Diarrhoea, Eye pruritus, Fatigue
Clinical narrative: Diarrhea; Eye itching/ Eye pruritus; Eye red/ Ocular hyperaemia; Numbness/ Hypoaesthesia; Flushing; Feeling hot; Low energy/ asthenia; Fatigue; Pain in the hip/ arthralgia; Pain in shoulder of the right arm (injection site)/ Injection site pain; Vaccination complication; Long term adverse reactions; Muscle pain/ Myalgia; Pain in the pelvis/ lower back/ upper back/ Pain; Swelling in the hands/ Peripheral swelling; Inability to complete daily tasks/ Impaired work ability; Pain in thighs/ Pain in extremity; Swelling in the wrists/ Joint swelling; Pelvic pain; Swelling of joints/ Swelling; irritation/ Skin irritation; This case was initially received via FDA VAERS (Reference number: 1751603) on 27-Jul-2021. The most recent information was received on 12-Oct-2021 and was forwarded to Moderna on 12-Oct-2021.    This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), EYE PRURITUS (Eye itching/ Eye pruritus), OCULAR HYPERAEMIA (Eye red/ Ocular hyperaemia), HYPOAESTHESIA (Numbness/ Hypoaesthesia), FLUSHING (Flushing), FEELING HOT (Feeling hot), PAIN (Pain in the pelvis/ lower back/ upper back/ Pain), PERIPHERAL SWELLING (Swelling in the hands/ Peripheral swelling), IMPAIRED WORK ABILITY (Inability to complete daily tasks/ Impaired work ability), PAIN IN EXTREMITY (Pain in thighs/ Pain in extremity), JOINT SWELLING (Swelling in the wrists/ Joint swelling), PELVIC PAIN (Pelvic pain), SWELLING (Swelling of joints/ Swelling), SKIN IRRITATION (irritation/ Skin irritation), ASTHENIA (Low energy/ asthenia), VACCINATION COMPLICATION (Long term adverse reactions), FATIGUE (Fatigue), ARTHRALGIA (Pain in the hip/ arthralgia), MYALGIA (Muscle pain/ Myalgia), INJECTION SITE PAIN (Pain in shoulder of the right arm (injection site)/ Injection site pain) and VACCINATION COMPLICATION (Vaccination complication) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Hay fever. Concurrent medical conditions included Hypothyroidism in 1999, Asthma (Restarting serum shots since september), Blood pressure high (High blood pressure (at the time)), Pre-diabetic (pre- diabetic but since Steroidson med) since 2021, Drug allergy (Eye drop solution, swollen eyes area, ichy and burning sensation for 5 days even with antiisthamine) since 2015, Latex allergy (Result in rash,itchy rash around mouth at dentist after work was done) since 1980, Drug allergy (Cipro,maybe digestive) since 2018, Drug allergy (Crestor (Statin),myalgias) since 1995, Drug allergy (Percocet) and Osteoarthritis (left shoulder operated on 01-15-2021) since 2005. Concomitant products included LEVOTHYROXINE from 04-Mar-2017 to an unknown date, ACETAMINOPHEN, AMOXICILLIN from 04-Mar-2017 to an unknown date, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM/HCTZ), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 04-Mar-2017 to an unknown date, MELATONIN and PROBIOTICS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), EYE PRURITUS (Eye itching/ Eye pruritus) (seriousness criterion hospitalization), OCULAR HYPERAEMIA (Eye red/ Ocular hyperaemia) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness/ Hypoaesthesia) (seriousness criterion hospitalization), IMPAIRED WORK ABILITY (Inability to complete daily tasks/ Impaired work ability) (seriousness criterion hospitalization) and SKIN IRRITATION (irritation/ Skin irritation) (seriousness criterion hospitalization). 27-Feb-2021, the patient experienced FLUSHING (Flushing) (seriousness criterion hospitalization), FEELING HOT (Feeling hot) (seriousness criterion hospitalization), PELVIC PAIN (Pelvic pain) (seriousness criterion hospitalization), FATIGUE (Fatigue) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (Vaccination complication) (seriousness criterion hospitalization). 27-Feb-2021, the patient experienced PAIN (Pain in the pelvis/ lower back/ upper back/ Pain) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Swelling in the hands/ Peripheral swelling) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Pain in thighs/ Pain in extremity) (seriousness criterion hospitalization), JOINT SWELLING (Swelling in the wrists/ Joint swelling) (seriousness criterion hospitalization), SWELLING (Swelling of joints/ Swelling) (seriousness criterion hospitalization), ASTHENIA (Low energy/ asthenia) (seriousness criterion hospitalization), ARTHRALGIA (Pain in the hip/ arthralgia) (seriousness criterion hospitalization), MYALGIA (Muscle pain/ Myalgia) (seriousness criterion hospitalization) and INJECTION SITE PAIN (Pain in shoulder of the right arm (injection site)/ Injection site pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION COMPLICATION (Long term adverse reactions) (seriousness criterion hospitalization). The patient was hospitalized on 08-Mar-2021 due to DIARRHOEA, EYE PRURITUS, FEELING HOT, FLUSHING, HYPOAESTHESIA and OCULAR HYPERAEMIA. The patient was treated with PREDNISONE (oral) from 09-Mar-2021 to 09-Jul-2021 at a dose of 30 mg; PARACETAMOL (TYLENOL) at a dose of 600 mg every eight hours and CELECOXIB from 03-Aug-2021 to 18-Sep-2021 at a dose of 200 mg. On 27-Jul-2021, FATIGUE (Fatigue) had not resolved. At the time of the report, DIARRHOEA (Diarrhea), EYE PRURITUS (Eye itching/ Eye pruritus), OCULAR HYPERAEMIA (Eye red/ Ocular hyperaemia), HYPOAESTHESIA (Numbness/ Hypoaesthesia), FLUSHING (Flushing), FEELING HOT (Feeling hot), PAIN (Pain in the pelvis/ lower back/ upper back/ Pain), PERIPHERAL SWELLING (Swelling in the hands/ Peripheral swelling), IMPAIRED WORK ABILITY (Inability to complete daily tasks/ Impaired work ability), PAIN IN EXTREMITY (Pain in thighs/ Pain in extremity), JOINT SWELLING (Swelling in the wrists/ Joint swelling), PELVIC PAIN (Pelvic pain), SWELLING (Swelling of joints/ Swelling), SKIN IRRITATION (irritation/ Skin irritation), ASTHENIA (Low energy/ asthenia), ARTHRALGIA (Pain in the hip/ arthralgia), MYALGIA (Muscle pain/ Myalgia), INJECTION SITE PAIN (Pain in shoulder of the right arm (injection site)/ Injection site pain) and VACCINATION COMPLICATION (Vaccination complication) had not resolved and VACCINATION COMPLICATION (Long term adverse reactions) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Magnetic resonance imaging: normal (normal) she did not have Carpal Tunnel Syndrome in right hand. On an unknown date, Heart rate: abnormal (abnormal) Heart rate greater than100 beats per min.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 27 Aug, she visited to Rheumatologist and hands was still swollen and painful, so he prescribed a MRI for the left hand.  Still she had pain around the pelvis area since stopping Prednisone, problems specially sitting and getting up. She was on medications like desloratadine 5 mg tablet 1 tablet daily when needed, Centrum silver 1 tablet daily started on 04-03-2017, Caltrate 600 plus Vit D tablets, taking 1 a day started on 04-03-2017, Tinnitus 911, 2 tablets a day started in 2020 November at the time of vaccines.  Company Comment: This case concerns a 77-year-old female patient with relevant medical history of Hypothyroidism, Hypertension, drug hypersensitivity and osteoarthitis, who experienced the unexpected, serious (hospitalization) events of Diarrhoea, Eye pruritus, Ocular hyperaemia, Hypoaesthesia, Flushing, Feeling hot, pelvic pain, peripheral and joint swelling, impaired work ability and vaccination complication. The events occurred approximately 2 days after the second dose of Moderna COVID-19 Vaccine administration.  The rechallenge was not applicable as no events reported after the first dose and no additional dosing will be given. The medical history of Hypothyroidism, Hypertension, drug hypersensitivity and osteoarthitis are confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received contains non significant information. Updated reporter details. On 12-Oct-2021: Follow up received contains significant information. Updated reporter information and outcome of events.; Sender's Comments: This case concerns a 77-year-old female patient with relevant medical history of Hypothyroidism, Hypertension, drug hypersensitivity and osteoarthitis, who experienced the unexpected, serious (hospitalization) events of Diarrhoea, Eye pruritus, Ocular hyperaemia, Hypoaesthesia, Flushing, Feeling hot, pelvic pain, peripheral and joint swelling, impaired work ability and vaccination complication. The events occurred approximately 2 days after the second dose of Moderna COVID-19 Vaccine administration.  The rechallenge was not applicable as no events reported after the first dose and no additional dosing will be given. The medical history of Hypothyroidism, Hypertension, drug hypersensitivity and osteoarthitis are confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.