Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Biopsy, Burning sensation, Rash erythematous, Rash pruritic
Clinical narrative: itchy rash at the injection site/itchy rash at the injection site; itchy rash (looked like prickly heat) on her lower back/itchy rash on her shoulder blades; red rash (looked like prickly heat) on her lower back; lower back pain/sharp pain in her lower back; itchy rash at the injection site; rash on lower back that itched and burned; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (rash on lower back that itched and burned), RASH PRURITIC (itchy rash (looked like prickly heat) on her lower back/itchy rash on her shoulder blades), RASH ERYTHEMATOUS (red rash (looked like prickly heat) on her lower back), BACK PAIN (lower back pain/sharp pain in her lower back) and VACCINATION SITE PRURITUS (itchy rash at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives. Concurrent medical conditions included Shellfish allergy (patient experienced diarrhea for shellfish allergy).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BURNING SENSATION (rash on lower back that itched and burned). On 13-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy rash at the injection site). On 14-Mar-2021, the patient experienced RASH PRURITIC (itchy rash (looked like prickly heat) on her lower back/itchy rash on her shoulder blades), RASH ERYTHEMATOUS (red rash (looked like prickly heat) on her lower back) and BACK PAIN (lower back pain/sharp pain in her lower back). On an unknown date, the patient experienced VACCINATION SITE RASH (itchy rash at the injection site/itchy rash at the injection site). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Itching, at a dose of 5 milligram; BETAMETHASONE DIPROPIONATE (topical) for Rash, at an unspecified dose and frequency; CLOBETASOL PROPIONATE ongoing from 24-Mar-2021 for Rash, at an unspecified dose and frequency; MONOLAURIN [GLYCERINE MONOLAURATE] for Shingles, at an unspecified dose and frequency; L-LYSINE [LYSINE] for Shingles, at an unspecified dose and frequency; PREDNISONE (oral) for Adverse event, at a dose of methyl prednisone and Physical therapy for Back pain. At the time of the report, BURNING SENSATION (rash on lower back that itched and burned), RASH PRURITIC (itchy rash (looked like prickly heat) on her lower back/itchy rash on her shoulder blades), RASH ERYTHEMATOUS (red rash (looked like prickly heat) on her lower back), VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE RASH (itchy rash at the injection site/itchy rash at the injection site) was resolving and BACK PAIN (lower back pain/sharp pain in her lower back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Biopsy: negative for shingles (Negative) negative for shingles.         Patient concomitant medication included natrol biotin at a dose of 5000 microgram from 2019 On 05/Oct/2021, a consumer reported that she had a severe reaction to bug bites and had a high immunoglobulin level. She took no medications On 15-Mar-2021, the patient went to chiropractor, who did an adjustment which worked, but did not help. On an unknown date, the patient went to orthopedic and they did not find anything wrong. The patient was given steroid shot (methyl prednisone) and physical therapy three times a week. The patient was not pregnant.   This case was linked to MOD-2021-343345 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow up received contains no new clinically significant information. On 08-Oct-2021: significant follow up received.patient demography updated. patient allergy added. patient medical history added. lab data updated. concomitant product received.treatment information updated. event burning sensation added. event assessment updated. outcome of event back pain changed from unknown to not recovered. outcome of remaining events changed from unknown to recovering