Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Blood pressure spiked; Gritty feeling in eye; Dry skin; Delayed reaction five days later at the injection site; It was red and hot to touch; Itching/terrible itching on elbow to shoulder which got sore; Redness at the site of injection/it was red and hot; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure spiked), FOREIGN BODY SENSATION IN EYES (Gritty feeling in eye), DRY SKIN (Dry skin), VACCINATION COMPLICATION (Delayed reaction five days later at the injection site) and VACCINATION SITE WARMTH (It was red and hot to touch) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and AMLODIPINE BESILATE (NORVASC) for Hypertension.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching/terrible itching on elbow to shoulder which got sore) and VACCINATION SITE ERYTHEMA (Redness at the site of injection/it was red and hot). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure spiked), FOREIGN BODY SENSATION IN EYES (Gritty feeling in eye), DRY SKIN (Dry skin), VACCINATION COMPLICATION (Delayed reaction five days later at the injection site) and VACCINATION SITE WARMTH (It was red and hot to touch). On 22-Jan-2021, VACCINATION SITE PRURITUS (Itching/terrible itching on elbow to shoulder which got sore) and VACCINATION SITE ERYTHEMA (Redness at the site of injection/it was red and hot) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure spiked), FOREIGN BODY SENSATION IN EYES (Gritty feeling in eye), VACCINATION COMPLICATION (Delayed reaction five days later at the injection site) and VACCINATION SITE WARMTH (It was red and hot to touch) outcome was unknown and DRY SKIN (Dry skin) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that patient was treated with steroid eye drops, 1-3 times a day and an ointment for dry skin.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-053334 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received included lab data. On 14-Jun-2021: Follow up received included new event (Blood Pressure Spiked). On 24-Jun-2021: Follow-up received included new events (Delayed reaction 5 days later at the injection site, it was red and hot to touch); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.