Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Muscle tightness, Rash, Urticaria
Clinical narrative: neck stays red and real tight \ red area next to the injection site/ another red area next to the injection site; neck stays red and real tight; arm broke out with both shots \  woke up with rash on neck, chest and arms/ rash on neck, chest and arms; red area on arm at injection site; Hypersensitivity reaction; broke hives out on the neck and chest/ Hives continue with mild breakout; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke hives out on the neck and chest/ Hives continue with mild breakout), ERYTHEMA (neck stays red and real tight \ red area next to the injection site/ another red area next to the injection site), MUSCLE TIGHTNESS (neck stays red and real tight), HYPERSENSITIVITY (Hypersensitivity reaction) and RASH (arm broke out with both shots \  woke up with rash on neck, chest and arms/ rash on neck, chest and arms) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (Hives, treated with Benadryl (diphenhydramine hydrochloride)) and Cholesterol. Concomitant products included LOVASTATIN for an unknown indication.   On 23-Feb-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced URTICARIA (broke hives out on the neck and chest/ Hives continue with mild breakout) and HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced ERYTHEMA (neck stays red and real tight \ red area next to the injection site/ another red area next to the injection site), MUSCLE TIGHTNESS (neck stays red and real tight), RASH (arm broke out with both shots \  woke up with rash on neck, chest and arms/ rash on neck, chest and arms) and INJECTION SITE ERYTHEMA (red area on arm at injection site). The patient was treated with PREDNISONE from 27-Mar-2021 to 12-May-2021 for Rash, at a dose of UNK UNK, qd; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 09-Apr-2021 for Rash, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) on 09-Apr-2021 for Rash, at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) on 09-Apr-2021 for Rash, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 22-Apr-2021 at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEK) on 22-Apr-2021 at an unspecified dose and frequency and MONTELUKAST SODIUM (SINGULAIR) on 22-Apr-2021 at an unspecified dose and frequency. At the time of the report, URTICARIA (broke hives out on the neck and chest/ Hives continue with mild breakout), HYPERSENSITIVITY (Hypersensitivity reaction) and RASH (arm broke out with both shots \  woke up with rash on neck, chest and arms/ rash on neck, chest and arms) had not resolved and ERYTHEMA (neck stays red and real tight \ red area next to the injection site/ another red area next to the injection site), MUSCLE TIGHTNESS (neck stays red and real tight) and INJECTION SITE ERYTHEMA (red area on arm at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Blood pressure measurement: 175-98 mmHg (High) 175-98. On 27-Mar-2021, Body temperature: 97.8 (normal) 97.8. On 27-Mar-2021, Heart rate: 86 (normal) 86.         On 22-APR-2021, mast cell tryptase was checked and results not provided. On 21-Jul-2021, hives continue with mild breakout, patient continued taking Allegra, Zyrtek and Sinulair   This case was linked to MODERNATX, INC.-MOD-2021-076423 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow-up information received on 26-JUN-2021 contains significant information patient demographics, lab data, concomitant drug,  treatment drug and new events were added On 21-Jul-2021: Follow-up information received, contains non significant information; Sender's Comments:  MODERNATX, INC.-MOD-2021-076423:Cross link with Dose 1