Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Albumin globulin ratio, Anosmia, Aspartate aminotransferase, Blood albumin
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over her body, 4 inches in size), ANOSMIA (lost sense of smell and taste), DIZZINESS (dizzy), ERYTHEMA (Redness/erythema) and PRURITUS (Itching/pruritus generalised/Sunlight on hives increased itching) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Previously administered products included for Product used for unknown indication: Pneumonia vaccine. Past adverse reactions to the above products included Anaphylactic shock with Pneumonia vaccine. Concurrent medical conditions included Diabetes mellitus, Hypersensitivity, Allergy to antibiotic (Macrolide causes rash &shortness of breath), Iodine allergy (Causes rash and swelling with direct contact), Allergy to antibiotic (Ciclopirox Olamine  0.77% cream causes rash groin & under belly areas hives), Drug allergy (Metformin causes hearing loss), Latex allergy (Rash, swelling with direct contact), Allergy to antibiotic (Levofloxacin causes nausea, hives, vomiting), Allergy to antibiotic (Polymyxin B Sulfate Trimethoprim causes eye swelling to size of golf ball) and Allergy to chemicals (Titanium causes rash, swelling (MRI tremors)). Concomitant products included WELLNESS FORMULA for Immune disorder (NOS), SPIRONOLACTONE from 14-May-2018 to an unknown date and HCTZ for Lymphedema, INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN N) from 18-Jan-2021 to an unknown date, CANAGLIFLOZIN from 28-Jan-2021 to 03-Apr-2021, GLIPIZIDE (GLUCOTROL XL) from 17-Mar-2017 to an unknown date and EMPAGLIFLOZIN (JARDIANCE) from 04-Apr-2021 to 17-May-2021 for an unknown indication. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (dizzy). On 05-Jun-2021, the patient experienced URTICARIA (hives all over her body, 4 inches in size), VACCINATION SITE PRURITUS (Injection sight swell and itch) and VACCINATION SITE SWELLING (Injection sight swell and itch). On an unknown date, the patient experienced ANOSMIA (lost sense of smell and taste), ERYTHEMA (Redness/erythema), PRURITUS (Itching/pruritus generalised/Sunlight on hives increased itching), PHARYNGEAL SWELLING (Swelling of upper airway), TASTE DISORDER (Unusual taste), PARAESTHESIA (Prickling/Tingling Sensation), FEELING HOT (Feeling hot), RASH (Generalised rash) and FATIGUE (felt sick and tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) on 05-Jun-2021 at a dose of 1 UNK and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) at a dose of 1 dosage form once a day. On 20-Jun-2021, URTICARIA (hives all over her body, 4 inches in size), ANOSMIA (lost sense of smell and taste), DIZZINESS (dizzy), ERYTHEMA (Redness/erythema), PRURITUS (Itching/pruritus generalised/Sunlight on hives increased itching), PHARYNGEAL SWELLING (Swelling of upper airway), TASTE DISORDER (Unusual taste), FEELING HOT (Feeling hot), VACCINATION SITE PRURITUS (Injection sight swell and itch) and VACCINATION SITE SWELLING (Injection sight swell and itch) had resolved. At the time of the report, PARAESTHESIA (Prickling/Tingling Sensation), RASH (Generalised rash) and FATIGUE (felt sick and tired) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2021, Alanine aminotransferase (7-40): 47 (High) 47 U/L. On 05-Jun-2021, Albumin globulin ratio: 1.6 (Inconclusive) Unknown. On 05-Jun-2021, Aspartate aminotransferase (13-40): 42 (High) 42 U/L. On 05-Jun-2021, Blood albumin (3.2-4.8): 4.6 (normal) 4.6 g/dl. On 05-Jun-2021, Blood alkaline phosphatase (46-116): 63 (normal) unknown. On 05-Jun-2021, Blood bilirubin (0-1.2): 1.1 (normal) 1.1 mg/dl. On 05-Jun-2021, Blood creatinine (0.5-0.8): 0.52 (normal) 0.52 mg/dl. On 05-Jun-2021, Blood glucose (76-106): 317 (High) 317 mg/dl. On 05-Jun-2021, Blood osmolarity (275-295): 284 (normal) unknown. On 05-Jun-2021, Blood potassium (3.5-5.1): 4.1 (normal) 4.1 mmol/L. On 05-Jun-2021, Blood pressure measurement: 159/84 mmHg (Inconclusive) unknown. On 05-Jun-2021, Blood sodium (136-145): 135 (Low) 135 mmol/L. On 05-Jun-2021, Blood urea (9-23): 19 (normal) 19 mg/dl. On 05-Jun-2021, Blood urea nitrogen/creatinine ratio (7-24): 37 (High) high. On 05-Jun-2021, Body temperature: 97.9 (Inconclusive) 97.9F.On 05-Jun-2021, Carbon dioxide (20-31): 24 (normal) unknown. On 05-Jun-2021, Globulin (1.8-3.5): 2.8 (normal) 2.8 g/dL. On 05-Jun-2021, Glomerular filtration rate: >90 (Inconclusive) >90 ml/min. On 05-Jun-2021, Haematocrit (34-46): 47 (High) unknown. On 05-Jun-2021, Haemolysis: slight (Inconclusive) unknown. On 05-Jun-2021, Respiratory rate: 18 (Inconclusive) 19 bpm. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered URTICARIA (hives all over her body, 4 inches in size), ANOSMIA (lost sense of smell and taste), DIZZINESS (dizzy), ERYTHEMA (Redness/erythema), PRURITUS (Itching/pruritus generalised/Sunlight on hives increased itching), PHARYNGEAL SWELLING (Swelling of upper airway), TASTE DISORDER (Unusual taste), PARAESTHESIA (Prickling/Tingling Sensation), FEELING HOT (Feeling hot), RASH (Generalised rash), VACCINATION SITE PRURITUS (Injection sight swell and itch), VACCINATION SITE SWELLING (Injection sight swell and itch) and FATIGUE (felt sick and tired) to be related. The hives left dark marks on body. Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow up received on 20-JUN-2021 contains Patient demographic details, medical history of hypersensitivity, Laboratory data, Treatment with Zyrtec, additional events include Swelling of upper air way, Tingling, Feeling hot, Rash local, erythema. The outcome of the event updated to Recovered and stop date as 20-JUN-2021. The causality is given as yes.