Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Joint swelling, Magnetic resonance imaging, Myalgia, Ocular hyperaemia
Clinical narrative: Diarrhea; Eye itching; Eye red; Numbness; Flushing; Feeling hot; Long term adverse reactions; irritation; Low energy; Fatigue; Pain in the hip; Muscle pain; Pain in shoulder of the right arm (injection site); Pain in the pelvis/ lower back/ upper back; Swelling in the hands; Inability to complete daily tasks; Pain in thighs; Swelling in the wrists; pelvic pain; Swelling of joints; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), EYE PRURITUS (Eye itching), OCULAR HYPERAEMIA (Eye red), HYPOAESTHESIA (Numbness), FLUSHING (Flushing) and FEELING HOT (Feeling hot) 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 occurrence of additional non-serious events is detailed below.     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, 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) (Intramuscular) 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) (seriousness criterion hospitalization), OCULAR HYPERAEMIA (Eye red) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness) (seriousness criterion hospitalization), FLUSHING (Flushing) (seriousness criterion hospitalization), FEELING HOT (Feeling hot) (seriousness criterion hospitalization), IMPAIRED WORK ABILITY (Inability to complete daily tasks) and PELVIC PAIN (pelvic pain). 27-Feb-2021, the patient experienced PAIN (Pain in the pelvis/ lower back/ upper back), PERIPHERAL SWELLING (Swelling in the hands), PAIN IN EXTREMITY (Pain in thighs), JOINT SWELLING (Swelling in the wrists), SWELLING (Swelling of joints), ASTHENIA (Low energy), FATIGUE (Fatigue), ARTHRALGIA (Pain in the hip), MYALGIA (Muscle pain) and INJECTION SITE PAIN (Pain in shoulder of the right arm (injection site)). On an unknown date, the patient experienced SKIN IRRITATION (irritation) and VACCINATION COMPLICATION (Long term adverse reactions). 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, PAIN (Pain in the pelvis/ lower back/ upper back), PERIPHERAL SWELLING (Swelling in the hands), IMPAIRED WORK ABILITY (Inability to complete daily tasks), PAIN IN EXTREMITY (Pain in thighs), JOINT SWELLING (Swelling in the wrists), SWELLING (Swelling of joints), ASTHENIA (Low energy), FATIGUE (Fatigue), ARTHRALGIA (Pain in the hip), MYALGIA (Muscle pain) and INJECTION SITE PAIN (Pain in shoulder of the right arm (injection site)) had resolved. At the time of the report, DIARRHOEA (Diarrhea), EYE PRURITUS (Eye itching), OCULAR HYPERAEMIA (Eye red), HYPOAESTHESIA (Numbness), FLUSHING (Flushing), FEELING HOT (Feeling hot), PELVIC PAIN (pelvic pain) and SKIN IRRITATION (irritation) 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) (Intramuscular), 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 specialy sitting and getting up. She was on medications like destoratadine 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 and multiple allergies, who experienced the unexpected serious events of Diarrhoea, Eye pruritus, Ocular hyperaemia, Hypoaesthesia, Flushing and Feeling hot. 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 benefit-risk relationship is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up added- event added as long term adverse reactions to vaccine On 29-Jul-2021: Follow-up contains Non-Significant Information. On 22-Sep-2021: Updated relevant medical history, Allergies, lab details added, Concomitant medication added, new events added.; Sender's Comments: This case concerns a 77-year-old female patient with relevant medical history of Hypothyroidism, Hypertension and multiple allergies, who experienced the unexpected serious events of Diarrhoea, Eye pruritus, Ocular hyperaemia, Hypoaesthesia, Flushing and Feeling hot. 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 benefit-risk relationship is not affected by this report.