Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Paraesthesia, Pruritus, Rash, Urticaria
Clinical narrative: Chronic spontaneous urticaria; Elevated heart rate or work load; Redness/erythema Generalized; Itching/pruritus; Prickling/Tingling sensation; noticed hives on stomach/Hives/urticaria/but has increased to other parts of body like thighs, neck, hands and face; Rash Generalized; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Elevated heart rate or work load), ERYTHEMA (Redness/erythema Generalized), CHRONIC SPONTANEOUS URTICARIA (Chronic spontaneous urticaria), PRURITUS (Itching/pruritus) and PARAESTHESIA (Prickling/Tingling sensation) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069h21a, 032bz1a and 047a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN from 01-Jan-2012 to an unknown date, METOPROLOL from 01-Jan-2012 to an unknown date and CLOPIDOGREL from 01-Jan-2012 to an unknown date for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2022, the patient experienced ERYTHEMA (Redness/erythema Generalized), PRURITUS (Itching/pruritus), PARAESTHESIA (Prickling/Tingling sensation), URTICARIA (noticed hives on stomach/Hives/urticaria/but has increased to other parts of body like thighs, neck, hands and face) and RASH (Rash Generalized). On an unknown date, the patient experienced HEART RATE INCREASED (Elevated heart rate or work load) and CHRONIC SPONTANEOUS URTICARIA (Chronic spontaneous urticaria). At the time of the report, HEART RATE INCREASED (Elevated heart rate or work load) outcome was unknown and ERYTHEMA (Redness/erythema Generalized), CHRONIC SPONTANEOUS URTICARIA (Chronic spontaneous urticaria), PRURITUS (Itching/pruritus), PARAESTHESIA (Prickling/Tingling sensation), URTICARIA (noticed hives on stomach/Hives/urticaria/but has increased to other parts of body like thighs, neck, hands and face) and RASH (Rash Generalized) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2022, Full blood count: all within range (normal) all within range. On 07-Mar-2022, Metabolic function test: all within range (normal) all within range. On an unknown date, Heart rate: elevated (High) elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HEART RATE INCREASED (Elevated heart rate or work load), ERYTHEMA (Redness/erythema Generalized), CHRONIC SPONTANEOUS URTICARIA (Chronic spontaneous urticaria), PRURITUS (Itching/pruritus), PARAESTHESIA (Prickling/Tingling sensation), URTICARIA (noticed hives on stomach/Hives/urticaria/but has increased to other parts of body like thighs, neck, hands and face) and RASH (Rash Generalized) to be related.    The patient had no new medications or shots taken in last 5 years and had never had hives before this issue.  No new soaps or lotions. The patient had the same diet as in last 5 years and was living in same house-area for the last 25 years. The patient had no hives experience after 1st or 2nd Moderna shot.  Reportedly, the condition started around 3 weeks after the Moderna booster shot. The first reported issue on stomach but had increased to other parts of body like thighs, neck, hands, and face. It seems to come out after an elevated heart rate or workload. One occurrence happened after shoveling snow without gloves, hives started up on hands. The patient stated that it seemed to be getting worse in the last month. The patient also reported that it normally would happen 4-5 times per week.  Treatment medication reported included Antihistamines which the patient was still taking as needed and it was reported that the patient started to taking Antihistamines from 07-Mar-2022.