Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Rash, Rash pruritic, Sleep disorder
Clinical narrative: Generalized itching /Pruritus; Prickling/Tingling sensation; Feeling hot; Redness/erythema; Severe pains in both arms and it goes up through her arm; Blood pressure is really high; Shooting pains; arthritis, usually get flare ups on cold wet rainy days but now it is constant; Can hardly sleep; rash; Nausea/Vomiting; Shoulder pain; very fatigued all the time; Nausea/Vomiting; Rash spread a little on her arm and increased to a size of golf ball at the injection site after; Quarter size rash at the injection site after second vaccine dose; Rash is itchy after second vaccine dose; Quarter size rash at the injection site after second vaccine dose and it is hot to the touch, itchy, and has a burning sensation; Itching at the injection site immediately after the second vaccine dose/Rash is itchy after second vaccine dose; diagnosed as hypersensitivity reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE DYSAESTHESIA (Quarter size rash at the injection site after second vaccine dose and it is hot to the touch, itchy, and has a burning sensation), PRURITUS (Generalized itching /Pruritus), PARAESTHESIA (Prickling/Tingling sensation), FEELING HOT (Feeling hot) and ERYTHEMA (Redness/erythema) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Neck surgery (Neck fusion) on 06-Dec-2018. Concurrent medical conditions included Arthritis since 2016, Blood pressure high since 2020, Allergy to lanolin, Allergy to wool, Latex allergy, Sleep apnea, Back disorder NOS (back issues) and Joint disorder NOS (Joints more inflamed, lots of pain). Concomitant products included LOSARTAN for Blood pressure high, MULTIVITAMINS [VITAMINS NOS], ZINC, VALERIAN [VALERIANA OFFICINALIS], COLECALCIFEROL (VITAMIN D 3) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced HYPERSENSITIVITY (diagnosed as hypersensitivity reaction). 16-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site immediately after the second vaccine dose/Rash is itchy after second vaccine dose). On 17-Apr-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (Quarter size rash at the injection site after second vaccine dose and it is hot to the touch, itchy, and has a burning sensation) and VACCINATION SITE SWELLING (Rash spread a little on her arm and increased to a size of golf ball at the injection site after). 17-Apr-2021, the patient experienced RASH PRURITIC (Rash is itchy after second vaccine dose). 17-Apr-2021, the patient experienced VACCINATION SITE RASH (Quarter size rash at the injection site after second vaccine dose). On an unknown date, the patient experienced PRURITUS (Generalized itching /Pruritus), PARAESTHESIA (Prickling/Tingling sensation), FEELING HOT (Feeling hot), ERYTHEMA (Redness/erythema), PAIN IN EXTREMITY (Severe pains in both arms and it goes up through her arm), HYPERTENSION (Blood pressure is really high), PAIN (Shooting pains), ARTHRITIS (arthritis, usually get flare ups on cold wet rainy days but now it is constant), SLEEP DISORDER (Can hardly sleep), RASH (rash), NAUSEA (Nausea/Vomiting), ARTHRALGIA (Shoulder pain) and VOMITING (Nausea/Vomiting). an unknown date, the patient experienced FATIGUE (very fatigued all the time). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 10 milligram. At the time of the report, VACCINATION SITE DYSAESTHESIA (Quarter size rash at the injection site after second vaccine dose and it is hot to the touch, itchy, and has a burning sensation), PRURITUS (Generalized itching /Pruritus), PARAESTHESIA (Prickling/Tingling sensation), FEELING HOT (Feeling hot), ERYTHEMA (Redness/erythema), PAIN IN EXTREMITY (Severe pains in both arms and it goes up through her arm), HYPERTENSION (Blood pressure is really high), PAIN (Shooting pains), RASH PRURITIC (Rash is itchy after second vaccine dose), ARTHRITIS (arthritis, usually get flare ups on cold wet rainy days but now it is constant), SLEEP DISORDER (Can hardly sleep), HYPERSENSITIVITY (diagnosed as hypersensitivity reaction), RASH (rash), VACCINATION SITE PRURITUS (Itching at the injection site immediately after the second vaccine dose/Rash is itchy after second vaccine dose), NAUSEA (Nausea/Vomiting), ARTHRALGIA (Shoulder pain), FATIGUE (very fatigued all the time), VOMITING (Nausea/Vomiting), VACCINATION SITE SWELLING (Rash spread a little on her arm and increased to a size of golf ball at the injection site after) and VACCINATION SITE RASH (Quarter size rash at the injection site after second vaccine dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was on Tonic Water before she received the vaccine.   This case was linked to MOD-2021-214280 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received and updated Reporter details, Patient demography and medical history,  Additional events and Concomitant products. On 15-Jul-2021: Follow-up information received and added events and concomitant medications (vitamin c). On 21-Jul-2021: Follow up received and contains No New Information