Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site irritation, Vaccination site pain, Vaccination site pruritus
Clinical narrative: numbness in the nerve on that area; neurologist told her...arm nerve was inflamed...might be caused by the way the vaccine was injected.; Itchiness was milder; Weird sensation in the muscle where she was vaccinated; Feels a tightness sensation on the muscle she was injected/ this muscle was harder than other arm/tight when tries to extend arm/a muscle tightness on her left arm; hardness on the injection site; Arm in injected area started to have the skin irritated; Injection site was swollen/started to become bigger and bigger till 4 inch long and 3 inch wide; red in area of injection and goes a bit down/redness on injection site; Pain/tenderness at injection site; Pain in the arm of the injection the first 2 days after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (Weird sensation in the muscle where she was vaccinated), MUSCLE TIGHTNESS (Feels a tightness sensation on the muscle she was injected/ this muscle was harder than other arm/tight when tries to extend arm/a muscle tightness on her left arm), VACCINATION SITE IRRITATION (Arm in injected area started to have the skin irritated), VACCINATION SITE ANAESTHESIA (numbness in the nerve on that area) and NEURITIS (neurologist told her...arm nerve was inflamed...might be caused by the way the vaccine was injected.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Blood pressure high (Had since she was 24 years old), Gastritis (Had for 15-20 years), Hypertriglyceridemia, Heart murmur and Osteoporosis (Had approximately 15 years). Concomitant products included ESCITALOPRAM for Anxiety, METOPROLOL from 21-Jun-2021 to an unknown date and OLMESARTAN from an unknown date to 17-Jun-2021 for Blood pressure high, PANTOPRAZOLE for Gastritis, FENOFIBRATE for Hypercholesteraemia, FISH OIL (OMEGA 3 [FISH OIL]), CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D), MAGNESIUM CITRATE, POTASSIUM CITRATE (POTASSIUM MAGNESIUM CITRATE [MAGNESIUM CITRATE;POTASSIUM CITRATE]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication, VITAMIN C [ASCORBIC ACID].   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm of the injection the first 2 days after the vaccination) and VACCINATION SITE PAIN (Pain/tenderness at injection site). On 14-Mar-2021, the patient experienced VACCINATION SITE IRRITATION (Arm in injected area started to have the skin irritated) and VACCINATION SITE ERYTHEMA (red in area of injection and goes a bit down/redness on injection site). 14-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection site was swollen/started to become bigger and bigger till 4 inch long and 3 inch wide). On 15-Mar-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (Weird sensation in the muscle where she was vaccinated). 15-Mar-2021, the patient experienced MUSCLE TIGHTNESS (Feels a tightness sensation on the muscle she was injected/ this muscle was harder than other arm/tight when tries to extend arm/a muscle tightness on her left arm) and VACCINATION SITE INDURATION (hardness on the injection site). On 21-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness was milder). On an unknown date, the patient experienced VACCINATION SITE ANAESTHESIA (numbness in the nerve on that area) and NEURITIS (neurologist told her...arm nerve was inflamed...might be caused by the way the vaccine was injected.). The patient was treated with CORTISONE (topical) on 18-Mar-2021 for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and GABAPENTIN ongoing since an unknown date at a dose of 1 dosage form. On 08-Mar-2021, VACCINATION SITE PAIN (Pain/tenderness at injection site) had resolved. On 21-Mar-2021, VACCINATION SITE SWELLING (Injection site was swollen/started to become bigger and bigger till 4 inch long and 3 inch wide) had resolved. On 20-Jun-2021, MUSCLE TIGHTNESS (Feels a tightness sensation on the muscle she was injected/ this muscle was harder than other arm/tight when tries to extend arm/a muscle tightness on her left arm), VACCINATION SITE IRRITATION (Arm in injected area started to have the skin irritated), PAIN IN EXTREMITY (Pain in the arm of the injection the first 2 days after the vaccination), VACCINATION SITE INDURATION (hardness on the injection site) and VACCINATION SITE ERYTHEMA (red in area of injection and goes a bit down/redness on injection site) had resolved, VACCINATION SITE PRURITUS (Itchiness was milder) was resolving. At the time of the report, VACCINATION SITE DYSAESTHESIA (Weird sensation in the muscle where she was vaccinated), VACCINATION SITE ANAESTHESIA (numbness in the nerve on that area) and NEURITIS (neurologist told her..arm nerve was inflamed..might be caused by the way the vaccine was injected.) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included pills for triglycerides.   This case was linked to MOD-2021-065259 (E2B Linked Report). This case was linked to MOD-2021-254158 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Additional patient follow-up was received. Information included additional patient medical history, concomitant medications, treatment medications, non serious events and updated events outcomes. On 12-Jul-2021: Additional patient follow-up and ADR form were received: Information included additional medical history, product dose details, additional concomitant medications and updates and treatment medications were updated.; Sender's Comments:  MOD-2021-065259:Duplicate case -deleted