Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Pruritus, Rash erythematous, Vaccination site haemorrhage
Clinical narrative: Arm started rashing/ raised, rough, red and splotchy from the shoulder to the elbow; Arm started Itching / itchy / tchy took a bad turn; Slight headache; Bled a little at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bled a little at injection site), PRURITUS (Arm started Itching / itchy / tchy took a bad turn), RASH ERYTHEMATOUS (Arm started rashing/ raised, rough, red and splotchy from the shoulder to the elbow) and HEADACHE (Slight headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021b21a and 026A21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Used oxygen cylinder when necessary and currently not using as the heart rate was improved) in February 2020. Concurrent medical conditions included Allergy multiple (Medications and other common allergens), Congestive heart failure since 2020, Neuropathy, Chronic obstructive pulmonary disease, Lung cancer, Fibromyalgia, Autoimmune disorder, Neck discomfort, Breathing difficult, Kidney function abnormal, Hypothyroidism and Diabetes. Concomitant products included TICAGRELOR (BRILINTA) for Congestive heart failure, INSULIN GLARGINE (LANTUS) for Diabetes and Insulin, INSULIN LISPRO (HUMALOG) for Diabetic, LEVOTHYROXINE SODIUM (TIROSINT) for Hypothyroidism, FUROSEMIDE (LASIX [FUROSEMIDE]) for Kidney disorder, ASPIRIN [ACETYLSALICYLIC ACID], ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D [VITAMIN D NOS], VITAMIN B NOS and APPLE CIDER VINEGAR for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE HAEMORRHAGE (Bled a little at injection site). On 08-Apr-2021 at 5:00 PM, the patient experienced HEADACHE (Slight headache). On 11-Apr-2021, the patient experienced PRURITUS (Arm started Itching / itchy / tchy took a bad turn). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Arm started rashing/ raised, rough, red and splotchy from the shoulder to the elbow). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE HAEMORRHAGE (Bled a little at injection site), PRURITUS (Arm started Itching / itchy / tchy took a bad turn), RASH ERYTHEMATOUS (Arm started rashing/ raised, rough, red and splotchy from the shoulder to the elbow) and HEADACHE (Slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: decrease (Low) Decrease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included diuretic.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-073218 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Patient's medical history added. Concomitant medications were added.