Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Investigation, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume
Clinical narrative: Itching; 1st dose - 11 Oct 2021, lot number 025C21A, 2nd dose - 02 Dec 2021, lot number 045J21A; Rash all over her body; Welts at random places on her body/ welts on her back arms lower extremities chest abdomen/Urticarial rash; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itching), RASH (Rash all over her body), URTICARIA (Welts at random places on her body/ welts on her back arms lower extremities chest abdomen/Urticarial rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 11 Oct 2021, lot number 025C21A, 2nd dose - 02 Dec 2021, lot number 045J21A) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A and 025C21A) for COVID-19 prophylaxis.     Patient had no parental vaccine exposure. It was unknown if patient had acute illnesses at the time of and up to one month before vaccination. Patient's blood pressure was well controlled. Patient denied a family history of any autoimmune disease.  The patient's past medical history included COVID-19 (Was sick in the hospital with COVID infection) on 30-Jul-2021, Clot blood, Bursitis on 11-Sep-2018, Encephalopathy acute on 30-Jul-2021, Finger injury (Left ring finger) in 2018, Finger injury on 25-Jul-2018, Fracture on 02-May-2018, Compression fracture on 13-May-2016, Headache, Substance abuse (Quit (09-2006)) in September 2006, Tinea corporis on 01-Jun-2015, Varicella zoster on 11-Sep-2018, Smoker (16.2 years since quitting) from 11-May-1978 to 04-Sep-2006, Knee replacement on 23-Jun-2015, Blood transfusion in October 1987, Knee operation (Bilateral knees) in May 2016, Kyphoplasty in May 2016, Nasal operation, Vertebral cementoplasty (T-12 with Anesthesia) on 27-May-2016, Ovary removal in 2013, Knee arthroplasty on 07-Sep-2015 and Tubal ligation in December 1984. Previously administered products included for Drug use for unknown indication: Hepatitis B (3 dose (adult)) on 26-Dec-2008, Hepatitis B (3 dose (adult)) on 09-Jul-2009, INFLUENZA on 09-Dec-2016, Tetanus-Diphtheria on 14-Apr-2017, Pneumococcal polysaccharide 23 valent on 25-May-2017, INFLUENZA on 26-Sep-2018 and INFLUENZA on 07-Oct-2019; for Nausea: Imodium (Takes Imodium and her symptoms get better); for COVID-19: Cetirizine (Stopped after her hospital stay). Past adverse reactions to the above products included No adverse event with Cetirizine, Hepatitis B, Hepatitis B, INFLUENZA, INFLUENZA, INFLUENZA, Imodium, Pneumococcal polysaccharide 23 valent and Tetanus-Diphtheria. Family history included Arthritis (Mother), Diabetes (Father), Blood pressure high (Father), High cholesterol (Father), Mental disorder (Daughter and Son), Alcoholism (Children with alcoholism- Daughter and Son), Substance abuse (Maternal grandmother, Maternal grandfather, Sister, daughter and Son), Depression (Sister and brother) and Depression since 11-May-2015. Concurrent medical conditions included Hypertension (Episode of hypertension) since 26-Sep-2015, Type 2 diabetes mellitus (With diabetic neuropathy, long term  current use of insulin (HCC)) since 01-Jun-2015, Hyperlipidaemia since 11-May-2015, Hypothyroidism since 26-Sep-2018, Asthma since 13-Dec-2019, Drug allergy (GI upset), Drug allergy (Cough), Adhesive tape allergy, Drug allergy (Intolerance to medication, suicidal ideation), Allergy to metals, Drug allergy (Anxiety), Chronic insomnia since 11-May-2015, GERD since 11-May-2015, Cystic acne (Treated with spironolactone by dermatology) since 01-Jun-2015, Osteoarthritis knees (Other bilateral secondary osteoarthritis of knee) since 23-Jun-2015, Sciatica (Left sided) since 23-Jun-2015, Postmenopausal bleeding since 20-Oct-1201, Cramp since 20-Jan-2016, Generalized anxiety disorder since 20-Jan-2016, Thoracic vertebral fracture T12 since 16-May-2016, Foot callus since 31-May-2016, Restless legs syndrome since 14-Jun-2016, Cheek swelling since 12-Jul-2016, Psoriasis of scalp since 31-Jan-2018, Shoulder pain since 26-Sep-2018, Hypothyroidism (Due to acquired atrophy of thyroid) since 26-Sep-2018, Dyspnea exertional since 13-Dec-2019, Cat bite since 07-Jan-2020, Stable angina pectoris since 19-Feb-2020, Major depressive disorder (Current moderate episode) since 14-Jul-2020, Chronic kidney disease stage 3 (Unspecified whether stage 3a or 3b CKD) since 24-Mar-2022, Muscle spasms, Allergy, Anxiety since 11-May-2015, Insomnia, Chest pain, Nausea (History of chronic nausea for many years), Vomiting, Leg cramps, Arthritis, Chronic fatigue, Allergy and Obstructive sleep apnea syndrome. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Allergic reaction, CETIRIZINE HYDROCHLORIDE (ZYRTEC R) from 26-Jan-2022 to an unknown date for Allergy, CLONAZEPAM (KLONOPIN) from 07-Oct-2022 to an unknown date for Anxiety, GLYCERYL TRINITRATE (NITROSTAT) for Chest pain, DULAGLUTIDE (TRULICITY) from 15-Nov-2022 to an unknown date and METFORMIN from 30-Jun-2022 to an unknown date for Diabetes mellitus, MELATONIN for Insomnia, TIZANIDINE HYDROCHLORIDE (ZANAFLEX) from 04-Aug-2022 to an unknown date for Leg cramps, BACLOFEN (LIORESAL) from 03-Jan-2023 to an unknown date for Muscle spasm, ONDANSETRON (ZOFRAN [ONDANSETRON]) from 13-Oct-2022 to an unknown date for Nausea and Vomiting, MONTELUKAST SODIUM (SINGULAIR), AMLODIPINE BESILATE (NORVASC) from 02-Nov-2022 to an unknown date, ATORVASTATIN CALCIUM (LIPITOR) from 17-Feb-2022 to an unknown date, CARVEDILOL (COREG) from 07-Oct-2022 to an unknown date, FAMOTIDINE (PEPCID AC) from 30-Sep-2022 to an unknown date, LEVOTHYROXINE SODIUM (SYNTHROID) from 17-Feb-2022 to an unknown date, LOSARTAN POTASSIUM (COZAAR) from 19-Sep-2022 to an unknown date, NAPROXEN (NAPROSYN [NAPROXEN]) from 11-Jan-2022 to an unknown date, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) from 25-Apr-2022 to an unknown date, RIVAROXABAN (XARELTO) from 17-Feb-2022 to an unknown date, TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) from 09-Sep-2022 to an unknown date and USTEKINUMAB (STELARA) for an unknown indication.   On 11-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced URTICARIA (Welts at random places on her body/ welts on her back arms lower extremities chest abdomen/Urticarial rash). On 26-Jan-2022, the patient experienced RASH (Rash all over her body). On an unknown date, the patient experienced PRURITUS (Itching) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 11 Oct 2021, lot number 025C21A, 2nd dose - 02 Dec 2021, lot number 045J21A). The patient was treated with HYDROXYZINE (ATARAX [HYDROXYZINE]) (oral) ongoing from 04-Aug-2022 for Itching, at a dose of 25 milligram, 3 tablet nightly as needed. At the time of the report, PRURITUS (Itching) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 11 Oct 2021, lot number 025C21A, 2nd dose - 02 Dec 2021, lot number 045J21A) outcome was unknown and RASH (Rash all over her body) and URTICARIA (Welts at random places on her body/ welts on her back arms lower extremities chest abdomen/Urticarial rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Oct-2021, Blood albumin: 3.8. On 13-Oct-2021, Blood bilirubin: 0.3. On 13-Oct-2021, Electrophoresis protein: 2.3 and 1.7. On 13-Oct-2021, Protein total: 6.1. On 14-Oct-2021, Anion gap: 10. On 14-Oct-2021, Blood glucagon: 172 (H). On 18-Jan-2022, Cardiac stress test: Positive. On 19-Jul-2022, Antibody test: Less than 20. On 19-Jul-2022, Antinuclear antibody: Less than 1:40 and Less than 20. On 19-Jul-2022, C-reactive protein: 8. On 19-Jul-2022, Red blood cell sedimentation rate: 22. On 19-Jul-2022, Rheumatoid factor: Less than 14. On 30-Sep-2022, Antinuclear antibody: Negative. On 30-Sep-2022, Double stranded DNA antibody: Less than 1. On 30-Sep-2022, Protein total: 149 and 23. On 10-Nov-2022, Alanine aminotransferase: 77 (H). On 10-Nov-2022, Antibody test: 2.0. On 10-Nov-2022, Aspartate aminotransferase: 50 (H). On 10-Nov-2022, Basophil count: 0 and 0.0. On 10-Nov-2022, Blood alkaline phosphatase: 102. On 10-Nov-2022, Blood bilirubin: 0.3. On 10-Nov-2022, Blood calcium: 9.8. On 10-Nov-2022, Blood chloride: 101. On 10-Nov-2022, Blood creatine: 0.74. On 10-Nov-2022, Blood potassium: 4.3. On 10-Nov-2022, Blood sodium: 142. On 10-Nov-2022, Blood urea: 15. On 10-Nov-2022, Blood urea nitrogen/creatinine ratio: 20. On 10-Nov-2022, Carbon dioxide: 25. On 10-Nov-2022, Eosinophil count: 6 and 0.4. On 10-Nov-2022, Haematocrit: 40.8. On 10-Nov-2022, Investigation: 4.3. On 10-Nov-2022, Mean cell haemoglobin: 28.3. On 10-Nov-2022, Mean cell haemoglobin concentration: 32.8. On 10-Nov-2022, Mean cell volume: 86. On 10-Nov-2022, Monocyte count: 6 and 0.4. On 10-Nov-2022, Neutrophil count: 61 and 4.4. On 10-Nov-2022, Platelet count: 185. On 10-Nov-2022, Protein total normal: 6.7. On 10-Nov-2022, Red cell distribution width: 15.8 (H). On 10-Nov-2022, White blood cell count: 7.2. On an unknown date, Antinuclear antibody: Positive. On an unknown date, Eosinophil count: very high. On an unknown date, Haemoglobin: 7.1. On an unknown date, Physical examination: Vitals: Virtual visit only, appears to be in no acute distress   Eyes: PERRL, no eyelid swelling, or deformity noted on virtual exam of patient.   HENT: Atraumatic, external ears appear normal, normal visual appears of external facial structures and nose   Respiratory: No observed respiratory distress or coughing by virtual exam   Musculoskeletal: No deformity of extremities viewed by virtual exam, no observed rashes or skin deformities by virtual exam, did not observe actual welts   Neurologic: Alert & oriented x 3, no observed neurologic deficits by virtual exam   Psychiatric: Speech, behavior appears well, pleasant mood.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RASH (Rash all over her body) to have an unknown relationship. No further causality assessments were provided for PRURITUS (Itching), URTICARIA (Welts at random places on her body/ welts on her back arms lower extremities chest abdomen/Urticarial rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 11 Oct 2021, lot number 025C21A, 2nd dose - 02 Dec 2021, lot number 045J21A).    It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient  started getting welts a week after the second dose, the welts come and go.   The patient was taking Zyrtec 2x a day, Hydroxyzine 75mg at bedtime and Singulair once a  day.  It was reported that, vaccine was not administered at the clinic, manufacturer and lot number not available.It was reported that patient did labs for autoimmune disease and the rheumatologist does not think that it was autoimmune.  Patient took multiple antiallergic which helps stabilizes the rashes despite taking so many antiallergic's patient was having rashes. Even though patient did not had any muscle weakness the CK levels would be checked by the HCP. The HCP discussed with the patient that this rash looked more urticarial rather than any rash related to connective tissue disease. The HCP wanted the patient to see a dermatologist for biopsy. The biopsy of the rash would give more information on what type of rash improves.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2023: Follow-up document received on 18-Jan-2023 wherein medical history, patient's information, lab data, date of first vaccination, concomitant drugs, treatment drug, Event and I-narrative supplement updated.