Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Arm was extremely swollen; Arm is hard; Arm Feverish; Its itchy/itchiness is in any part of her body that comes and goes away; Can barely lift the right arm; Arm really red; Chills; Right arm was sore/ extremely sore; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore/ extremely sore), PERIPHERAL SWELLING (Arm was extremely swollen), INDURATION (Arm is hard), SKIN WARM (Arm Feverish) and PRURITUS (Its itchy/itchiness is in any part of her body that comes and goes away) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Neck surgery (Neck surgery that had repercussion on her arm.) in September 2020. Previously administered products included for Varicella zoster: SHINGRIX (When she had the shingle´s vaccine, some years ago, she had a really bad reaction with the 1st dose and but did not last that long.). Past adverse reactions to the above products included Reaction allergic (NOS) with SHINGRIX. Concurrent medical conditions included Drug allergy (Pregabalin), Blood pressure high, Cholesterol, Heart disease, unspecified and Allergy (Some allergies).   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore/ extremely sore) and CHILLS (Chills). On 18-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm was extremely swollen), INDURATION (Arm is hard), SKIN WARM (Arm Feverish), PRURITUS (Its itchy/itchiness is in any part of her body that comes and goes away), INJECTED LIMB MOBILITY DECREASED (Can barely lift the right arm) and ERYTHEMA (Arm really red). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 17-Feb-2021 at a dose of every 5 to 6 hours and PARACETAMOL (TYLENOL) on 17-Feb-2021 at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Right arm was sore/ extremely sore), PERIPHERAL SWELLING (Arm was extremely swollen), DYSPNOEA (Shortness of breath) and ERYTHEMA (Arm really red) had resolved and INDURATION (Arm is hard), SKIN WARM (Arm Feverish), PRURITUS (Its itchy/itchiness is in any part of her body that comes and goes away), INJECTED LIMB MOBILITY DECREASED (Can barely lift the right arm) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: increased (High) Her blood pressure was high. In February 2021, Heart rate: high (High) Fast heart beat.         Concomitant medications included blood pressure medication, cholesterol medication and heart medication.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-020473 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Relevant medical history was updated, event outcomes was changed for right arm was sore, arm is really red and arm is swollen from unknown to recovered/resolved. On 12-Jul-2021: No significant information was reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020473:Same patient, 1st dose