Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site reaction, Vaccination site swelling
Clinical narrative: blood pressure has been a little high, 163,95 this morning; started sneezing all day and night; runny nose; very hot, hurts, bump, painful; itchy, continued to get worse, today it's probably 3 inches by 2 inches; injection site swelling; redness; Rash is elevated, Rash is bumpy; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), BLOOD PRESSURE INCREASED (blood pressure has been a little high, 163,95 this morning), SNEEZING (started sneezing all day and night), RHINORRHOEA (runny nose) and VACCINATION SITE PRURITUS (itchy, continued to get worse, today it's probably 3 inches by 2 inches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 046B21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pulmonary hypertension (at high risk for COVID due to this). Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), METOPROLOL, LEVOTHYROXINE and CLONAZEPAM for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE RASH (Rash is elevated, Rash is bumpy). On 20-Dec-2021, the patient experienced VACCINATION SITE PRURITUS (itchy, continued to get worse, today it's probably 3 inches by 2 inches), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (redness). On 21-Dec-2021, the patient experienced SNEEZING (started sneezing all day and night), RHINORRHOEA (runny nose) and VACCINATION SITE PAIN (very hot, hurts, bump, painful). On 22-Dec-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure has been a little high, 163,95 this morning). The patient was treated with CORTISONE (topical) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (COVID arm), BLOOD PRESSURE INCREASED (blood pressure has been a little high, 163,95 this morning), SNEEZING (started sneezing all day and night), RHINORRHOEA (runny nose), VACCINATION SITE PRURITUS (itchy, continued to get worse, today it's probably 3 inches by 2 inches), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PAIN (very hot, hurts, bump, painful) and VACCINATION SITE RASH (Rash is elevated, Rash is bumpy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, Blood pressure measurement: little high (High) 163/95, which is on the higher side.         Concomitant medications included Platonix and Vitamins. Treatment medications included Benadryl and Advil.  She states that at the injection site there was swelling, redness, and itching. It started out the evening of 20 DEC 2021 and was very small initially. She says that today 22 DEC 2021 the size was at least 3 inches by 2 inches. It was very hot and hurts to touch it. She also says the swelling looks like a bump. She had taken Benadryl, Advil and applied topical cortisone to the injection site. She says that it had gotten worse since it first started.   She says that she was going to be had open heart surgery in 3 weeks. This surgery was planned before she received the booster dose and it was for the pulmonary hypertension where they will repair her mitral valve. She does use oxygen at night due to the pulmonary issues.  It was reported that 24 hrs post injection Upper and 48 hrs post injection circled with marker at 24 hrs.   Most recent FOLLOW-UP information incorporated above includes: On 22-Dec-2021: Follow up received 22-Dec-2021 included updated newevent information Rash elevated, Rash is bumpy.