Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient arm was red around the injection site/red/redness is only a little bigger than a quarter; Patient arm was firm, tender to the touch, and sore today around the injection site/arm was sore to lift up/pain had worsened since yesterday; Patient arm was raised; Patient had hard welt at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Patient arm was red around the injection site/red/redness is only a little bigger than a quarter), VACCINATION SITE PAIN (Patient arm was firm, tender to the touch, and sore today around the injection site/arm was sore to lift up/pain had worsened since yesterday), VACCINATION SITE SWELLING (Patient arm was raised) and URTICARIA (Patient had hard welt at injection site) in a 37-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7144B, 034F21A, 019B21A and 012A21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 18-Nov-2021, received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 08-Sep-2022, received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022, the patient experienced VACCINATION SITE ERYTHEMA (Patient arm was red around the injection site/red/redness is only a little bigger than a quarter), VACCINATION SITE PAIN (Patient arm was firm, tender to the touch, and sore today around the injection site/arm was sore to lift up/pain had worsened since yesterday), VACCINATION SITE SWELLING (Patient arm was raised) and URTICARIA (Patient had hard welt at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Patient arm was red around the injection site/red/redness is only a little bigger than a quarter), VACCINATION SITE PAIN (Patient arm was firm, tender to the touch, and sore today around the injection site/arm was sore to lift up/pain had worsened since yesterday), VACCINATION SITE SWELLING (Patient arm was raised) and URTICARIA (Patient had hard welt at injection site) had not resolved.            Patient received second booster dose on 08-Sep-2022  It was reported that when the pharmacist withdrew the syringe from patient arm, patient felt liquid running down her arm. It was just a couple drops of clear liquid.  Pharmacist stated that these leaks sometimes occur and gauged that no more than 1 or 2 tear drops worth had came out.  Vaccination provider further stated to patient  that she does not need to repeat the dose  Patient also states that she had similar symptoms every time she has received a dose of the Moderna COVID-19 vaccine (primary series and 1st booster)  No treatment medication were provided.   This case was linked to MOD-2022-643616 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2022: Live follow up received contains significant information: Updated reporter information, concomitant medication, suspect product details, and events