Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Incorrect dose administered, Infection, Pain in extremity
Clinical narrative: Inappropriate schedule of vaccine administered; She's worried about that not all the injection went into the muscle; Arm started hurting from the shoulder to the elbow/ it hurt to lay on it; Really itchy/ has a two inches circumference; Headache and stuff; It's red/it's very pale/slightly red/has a two inches circumference/feels a flat sort of area under the skin/it's different.; It's firm where the injection was/almost hard/it was itchy/a drop of liquid that came out of it, not a lot, just one drop/Currently it's much flatter; Doctor got worried that she got an infection.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting from the shoulder to the elbow/ it hurt to lay on it), PRURITUS (Really itchy/ has a two inches circumference), INFECTION (Doctor got worried that she got an infection.), HEADACHE (Headache and stuff) and VACCINATION SITE ERYTHEMA (It's red/it's very pale/slightly red/has a two inches circumference/feels a flat sort of area under the skin/it's different.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A, 022M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anaemic and Cancer. Concomitant products included PROGESTERONE, ESTRADIOL (ESTROGEN) and CELECOXIB (CELEBREX) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INFECTION (Doctor got worried that she got an infection.). In August 2021, the patient experienced PAIN IN EXTREMITY (Arm started hurting from the shoulder to the elbow/ it hurt to lay on it), PRURITUS (Really itchy/ has a two inches circumference), HEADACHE (Headache and stuff), VACCINATION SITE ERYTHEMA (It's red/it's very pale/slightly red/has a two inches circumference/feels a flat sort of area under the skin/it's different.) and VACCINATION SITE INDURATION (It's firm where the injection was/almost hard/it was itchy/a drop of liquid that came out of it, not a lot, just one drop/Currently it's much flatter). On 26-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and INCORRECT DOSE ADMINISTERED (She's worried about that not all the injection went into the muscle). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in August 2021 for Adverse event, at a dose of 1 dosage form. On 26-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and INCORRECT DOSE ADMINISTERED (She's worried about that not all the injection went into the muscle) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm started hurting from the shoulder to the elbow/ it hurt to lay on it), INFECTION (Doctor got worried that she got an infection.) and HEADACHE (Headache and stuff) outcome was unknown and PRURITUS (Really itchy/ has a two inches circumference), VACCINATION SITE ERYTHEMA (It's red/it's very pale/slightly red/has a two inches circumference/feels a flat sort of area under the skin/it's different.) and VACCINATION SITE INDURATION (It's firm where the injection was/almost hard/it was itchy/a drop of liquid that came out of it, not a lot, just one drop/Currently it's much flatter) was resolving.            Concomitant medication also include Thyroid medication.  Reporter states on 28Aug2021 or 29Aug she took a Benadryl, and itchiness got better and redness reduced. Currently it's much flatter, it's very pale, slightly red, feels a flat sort of area under the skin, does not hurt but it's firm and it's different.  Caller states that she had no changes on her regular medications since the first dose of the vaccine.