Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash papular, Red blood cell count, Red cell distribution width increased
Clinical narrative: Itching; I feel miserable; erythematous evanescent edematous plaques; Dermatitis with papular feature; Parakeratotic scale-crust; scratching and scarring my body, waking up bleeding; Irregular heart rate; Flushing; Feeling hot; Rash started on back and moved to abdomen, chest, at one point from neck to ankles; hives that don't go away/ hives covered my entire back, around body, top of my ankle, even in ears; Bruising; Eczema,Huge patches of eczema/ Spongiotic dermatitis; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Itching) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included BACLOFEN from an unknown date to 09-Feb-2021 for Back pain, HYDROCODONE from an unknown date to 09-Feb-2021 for Neck pain, ESTRADIOL, PROGESTERONE (BIJUVA) from an unknown date to 09-Feb-2021 for Perimenopause.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced CONTUSION (Bruising), ECZEMA (Eczema,Huge patches of eczema/ Spongiotic dermatitis), URTICARIA (hives that don't go away/ hives covered my entire back, around body, top of my ankle, even in ears) and RASH (Rash started on back and moved to abdomen, chest, at one point from neck to ankles). On 09-Feb-2021, the patient experienced PRURITUS (Itching) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING ABNORMAL (I feel miserable), ERYTHEMA (erythematous evanescent edematous plaques), RASH PAPULAR (Dermatitis with papular feature), PARAKERATOSIS (Parakeratotic scale-crust), SKIN HAEMORRHAGE (scratching and scarring my body, waking up bleeding), PALPITATIONS (Irregular heart rate), FLUSHING (Flushing) and FEELING HOT (Feeling hot). The patient was hospitalized on 22-Feb-2021 due to PRURITUS. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing from 09-Feb-2021 at a dose of 1 dosage form; PREDNISOLONE (oral) ongoing from 22-Feb-2021 at a dose of 10 mg; BETAMETHASONE DIPROPIONATE (topical) ongoing from 22-Feb-2021 at a dose of cream; TRIAMCINOLONE ACETONIDE (topical) at a dose of 0.1 % cream; MUPIROCIN (topical) at a dose of 2 % ointment; HYDROXIZINE HCL ongoing since an unknown date at a dose of 25 mg tablet; LEVOFLOXACIN at a dose of 500 mg tablet and OMALIZUMAB (XOLAIR) at a dose of Injection,2. At the time of the report, PRURITUS (Itching), URTICARIA (hives that don't go away/ hives covered my entire back, around body, top of my ankle, even in ears), SKIN HAEMORRHAGE (scratching and scarring my body, waking up bleeding), PALPITATIONS (Irregular heart rate), FLUSHING (Flushing) and FEELING HOT (Feeling hot) had not resolved and CONTUSION (Bruising), ECZEMA (Eczema,Huge patches of eczema/ Spongiotic dermatitis), FEELING ABNORMAL (I feel miserable), ERYTHEMA (erythematous evanescent edematous plaques), RASH PAPULAR (Dermatitis with papular feature), PARAKERATOSIS (Parakeratotic scale-crust) and RASH (Rash started on back and moved to abdomen, chest, at one point from neck to ankles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Alanine aminotransferase (0-32): 19 (normal) 19 joule per litre. On 20-Mar-2021, Albumin globulin ratio (1.2-2.2): 1.8 (normal) Normal. On 20-Mar-2021, Aspartate aminotransferase (0-40): 20 (normal) 20 joule per litre. On 20-Mar-2021, Blood albumin (3.8-4.8): 4.7 (normal) 4.7 g/dL. On 20-Mar-2021, Blood alkaline phosphatase (39-117): 43 (normal) 43 joule per litre. On 20-Mar-2021, Blood bilirubin (0.0-1.2): 0.7 (normal) 0.7mg/dl. On 20-Mar-2021, Blood calcium (8.7-10.2): 10.2 (normal) 10.2mg/dl. On 20-Mar-2021, Blood chloride (96-106): 103 (normal) 103 mmol. On 20-Mar-2021, Blood cholesterol (100-199): 195 (normal) 195 mg/dl. On 20-Mar-2021, Blood creatinine (0.57-1.00): 0.77 (normal) 0.77mg/dl. On 20-Mar-2021, Blood glucose (65-99): 82 (normal) 82 mg/dl. On 20-Mar-2021, Blood potassium (3.5-5.2): 4.2 (normal) 4.2 mmol. On 20-Mar-2021, Blood sodium (134-144): 141 (normal) 141 mmol. On 20-Mar-2021, Blood thyroid stimulating hormone (0.450-4.500): 0.718 (normal) Normal. On 20-Mar-2021, Blood triglycerides (0-149): 55 (normal) 55 mg/dl. On 20-Mar-2021, Blood urea (6-24): 8 (normal) 8 mg/dl. On 20-Mar-2021, Blood urea nitrogen/creatinine ratio (9-23): 10 (normal) Normal. On 20-Mar-2021, Carbon dioxide (20-29): 23 (normal) 23 mmol. On 20-Mar-2021, EGFR status assay: 105 (normal) 105 mL/min (Normal range>59) and 91 (normal) 91 mL/min Normal range>59). On 20-Mar-2021, Globulin (1.5-4.5): 2.6 (normal) 2.6g/dL. On 20-Mar-2021, High density lipoprotein: 73 (normal) 73 mg/dl (Normal range >39). On 20-Mar-2021, Low density lipoprotein (0-99): 112 (High) 112 mg/dl. On 20-Mar-2021, Protein total (6.0-8.5): 7.3 (normal) 7.3g/dL. On 20-Mar-2021, Very low density lipoprotein (5-40): 10 (normal) 10mg/dl. On 07-May-2021, Antinuclear antibody: negative (Negative) Negative. On 07-May-2021, Basophil count (0.00-0.20): 0.07 (normal) Normal and 0.9 (Inconclusive) Inconclusive. On 07-May-2021, Eosinophil count (0.00-0.70): 0.73 (normal) Normal and 2.8 (Inconclusive) Inconclusive. On 07-May-2021, Haematocrit (35.0-48.0): 44.5 (normal) 44.5 %. On 07-May-2021, Haemoglobin (11.5-16.0): 14.9 (normal) 14.9g/dL. On 07-May-2021, Immature granulocyte count (0.00-0.10): 0.04 (normal) Normal and 0.5 (Inconclusive) 0.5 %. On 07-May-2021, Lymphocyte count: 16.2 (Inconclusive) Inconclusive. On 07-May-2021, Mean cell haemoglobin (27.0-34.0): 32.2 (normal) 32.2 pg/ml. On 07-May-2021, Mean cell haemoglobin concentration (31.0-37.0): 33.5 (normal) 33.5 g/dL. On 07-May-2021, Mean cell volume (78.0-100.0): 96.1 (normal) 96.1 fL. On 07-May-2021, Mean platelet volume (7.5-140): 10.7 (normal) 10.7fL. On 07-May-2021, Monocyte count (0.10-1.60): 1.22 (normal) Normal and 9.7 (Inconclusive) Inconclusive. On 07-May-2021, Neutrophil count (1.60-9.30): 5.24 (normal) Normal and 69.5 (Inconclusive) 69.5 %. On 07-May-2021, Platelet count (130-450): 297 (normal) Normal. On 07-May-2021, Red blood cell count (0.0-1.0): red blood cell count (Inconclusive) Red blood cell count and 4.63 (normal) Normal. On 07-May-2021, Red cell distribution width increased (11.0-15.0 percent): 13.2 percent (normal) Normal and 46.5 (normal) 46.5fL. On 07-May-2021, White blood cell count (4.0-11.0): 7.5 (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported she taken woman's multivitamin always by oral route as concomitant medication.  Patient diagnosis as left posterior shoulder biopsy and represented a popular eczematous dermatitis.  Action taken with mRNA-1273 in response to the events was not Applicable.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Patient details, other relevant history as asthma, lab data, concomitant medications, treatment medications, event and outcome, even prolonged hospitalization has been updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.