Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Body temperature, Chromaturia, Chronic pigmented purpura
Clinical narrative: Peculiar rolling sensation and painful one beginning with her scalp and going to the tips of her toes and then back to her scalp several times; Feel very hot; flash fevers; Blurry vision; Brown spots, burning sensation on her skin; Mysterious aches and pains; Mentally exhausted; Nausea; Skin in upper back and neck rapidly started to burn; Stomach upset; Temperature 100.5 F, on and off for weeks alternating with chills; Fatigue; Weird sensation and pressure; Night sweating; Skin eruptions, "breaking out" big boils; Stomach upset and diarrhea; Urine come a brownish 24 hours that berry, yellow, than return to normal; Lost weight; Lessions; deep dark circle under eye; Schamberg's disease on leg; scarring everywhere; Joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Weird sensation and pressure), NIGHT SWEATS (Night sweating), FURUNCLE (Skin eruptions, "breaking out" big boils), DIARRHOEA (Stomach upset and diarrhea) and CHROMATURIA (Urine come a brownish 24 hours that berry, yellow, than return to normal) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Egg allergy (egg yolk), Dust allergy (dust mites), Allergy to antibiotic (allergy to 2 antibiotics (unspecified)) and Fruit allergy (Oranges). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) from 01-Jan-2010 to an unknown date for Blood disorder NOS, ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]) from 01-Jan-2014 to an unknown date for Eye disorder, IRON for Iron supplementation, CALCIUM, COLECALCIFEROL (D3) from 01-Oct-2020 to an unknown date, ZINC from 01-Oct-2020 to an unknown date and BIOTIN from 01-Jan-2014 to an unknown date for Supplementation therapy.   On 10-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced SKIN LESION (Lessions). 10-Mar-2021, the patient experienced DARK CIRCLES UNDER EYES (deep dark circle under eye), CHRONIC PIGMENTED PURPURA (Schamberg's disease on leg), SCAR (scarring everywhere), ARTHRALGIA (Joint pain) and MYALGIA (muscle pain). On 12-Mar-2021, the patient experienced FEELING ABNORMAL (Weird sensation and pressure), NIGHT SWEATS (Night sweating), FURUNCLE (Skin eruptions, "breaking out" big boils), DIARRHOEA (Stomach upset and diarrhea), CHROMATURIA (Urine come a brownish 24 hours that berry, yellow, than return to normal), WEIGHT DECREASED (Lost weight), ABDOMINAL DISCOMFORT (Stomach upset), PYREXIA (Temperature 100.5 F, on and off for weeks alternating with chills) and FATIGUE (Fatigue). On 30-Mar-2021, the patient experienced SKIN BURNING SENSATION (Skin in upper back and neck rapidly started to burn). On an unknown date, the patient experienced PAIN OF SKIN (Peculiar rolling sensation and painful one beginning with her scalp and going to the tips of her toes and then back to her scalp several times), HOT FLUSH (Feel very hot; flash fevers), VISION BLURRED (Blurry vision), PIGMENTATION DISORDER (Brown spots, burning sensation on her skin), PAIN (Mysterious aches and pains), MENTAL FATIGUE (Mentally exhausted) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form; TRIAMCINOLONE for Adverse event, at a dose of 1 dosage form and HYDROXYZINE for Adverse event, at a dose of 1 dosage form. On 17-Mar-2021, FEELING ABNORMAL (Weird sensation and pressure) and NIGHT SWEATS (Night sweating) had resolved. On 24-Jun-2021, WEIGHT DECREASED (Lost weight) and DARK CIRCLES UNDER EYES (deep dark circle under eye) had resolved. At the time of the report, FURUNCLE (Skin eruptions, "breaking out" big boils), DIARRHOEA (Stomach upset and diarrhea), SKIN BURNING SENSATION (Skin in upper back and neck rapidly started to burn), PAIN OF SKIN (Peculiar rolling sensation and painful one beginning with her scalp and going to the tips of her toes and then back to her scalp several times), HOT FLUSH (Feel very hot; flash fevers), VISION BLURRED (Blurry vision), PIGMENTATION DISORDER (Brown spots, burning sensation on her skin), PAIN (Mysterious aches and pains), SKIN LESION (Lessions), MENTAL FATIGUE (Mentally exhausted), CHRONIC PIGMENTED PURPURA (Schamberg's disease on leg), SCAR (scarring everywhere), ARTHRALGIA (Joint pain), MYALGIA (muscle pain), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved, CHROMATURIA (Urine come a brownish 24 hours that berry, yellow, than return to normal) had resolved, ABDOMINAL DISCOMFORT (Stomach upset) outcome was unknown and PYREXIA (Temperature 100.5 F, on and off for weeks alternating with chills) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 100.5 (High) Fever 100.5F. On 12-Mar-2021, Heart rate: high (High) High.         The patient had an appointment with dermatologist who diagnosed her with Schaumberg's disease. She had a biopsy on one lesion on  her torso, but the results were not reported.  The patient reported: "My body has settled into a new routine: I have an upset stomach, a flash fever, then I feel lesions pushing up through my dermis and epidermis. Then I have muscle and joint pains."  The patient reported that the events go away, then reappear a few days later.   This case was linked to US-MODERNATX, INC.-MOD-2021-076568 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Added reporter's address, updated patient initials, added other relevant history, concomitant medications, additional events of pain of skin, hot flush, pyrexia, nausea, vision blurred, weight decreased, pain, pigmentation disorder. updated outcome of the events. On 22-Jul-2021: Follow up received: New events added and event information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076568:Dose 1 case