Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Rash erythematous
Clinical narrative: Going to pass out; Bright red rash/redness/rash on hands; Arm was swollen/hand was swollen/left hand swelling; Knees became swollen/swelling on both knees; Dry mouth; Metal taste/unusual taste; Felt dizzy/dizziness; Blood pressure high; Irregular heart rate/palpitations; Blood sugar high; Irregular heart rate/palpitations; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Going to pass out), RASH ERYTHEMATOUS (Bright red rash/redness/rash on hands), PERIPHERAL SWELLING (Arm was swollen/hand was swollen/left hand swelling), JOINT SWELLING (Knees became swollen/swelling on both knees) and DRY MOUTH (Dry mouth) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included D & C (Miscarriages with D & C and polyp removal), Hysterectomy in 1984, Tonsillectomy in 1988, Cholecystectomy in 1988, Cervical discectomy (Discectomy c 4/5 at Graduate hospital) on 05-Aug-1992, Sinus antrostomy (Sinus surgery maxulary polyp and sist) in 1994, Bunionectomy (Modified austin bunionectomy left) on 25-Sep-1998, Sinuplasty (Sinuplasti left mass removal from Fmoid sinus) on 30-Apr-2008, Bunionectomy (Bunionectomy, bone plug, left foot) on 25-May-2011, Epidural injection (Epidurals L2 to L5) on 17-Feb-2017, Polyp removal (Upper endoscopy and colonoscopy with removal of polyps) on 23-Feb-2006 and Polyp removal (Colonoscopy with polyp removal) on 23-Feb-2009. Previously administered products included for Product used for unknown indication: Shingrix vaccine (Shingrix vaccine) on 14-Jul-2018, Shingrix vaccine (Shingrix vaccine) on 22-Jan-2019, Pnuemonia booster (Pnuemonia booster) on 13-Jun-2019, Clonidine HCl (Tabs) from 17-Apr-2021 to 15-Jul-2021, Hydralazine (75 mg) from 21-Jul-2021 to 18-Aug-2021, Acebutolo (Acebutolo 200 mg) until 26-Jul-2019, Aspirin (81 mg) until 13-Sep-2019, Amlodipine besylate (5 mg) until 13-Sep-2019, Linzess (Caps 30's) until 05-May-2020 and Nitroglycerin (0.4 mg) until 13-Sep-2019. Past adverse reactions to the above products included Adverse drug reaction with Hydralazine. Concurrent medical conditions included Allergic reaction to analgesics (Allergic to percodan; had vomiting as a reaction), Allergic reaction to drug (Allergic to benzoyl peroxide; had blisters as a reaction), Allergic reaction to antibiotics (Had hives as allergic reaction to augmentin and blisters with neomycin & bacitracin), Food allergy (Allergic to tyramine; had migraines as a reaction), Reaction to food additive (Allergic to MSG; had migraines as a reaction), Latex allergy (Had blisters as a reaction), Adhesive tape allergy, Gout, Asthma, Hives, Hypersensitivity reaction, Eye disorder, Hypertension (High blood pressure), Hypercholesterolaemia, Hypertriglyceridemia, Renal insufficiency (Renal deficiency), Sciatica (Acute), Chronic sinusitis, Type 2 diabetes mellitus, Intervertebral disc bulging (Bulging disc pain/bone on bone lumbar area), Goitre nontoxic, Hypothyroidism, Irritable bowel syndrome (IBS constipation), Hair loss, Vitamin D deficiency, Chronic kidney disease stage 3, Spinal stenosis (Severe), Carpal tunnel syndrome (Advanced), Aortic valve insufficiency (Aortic insufficiency), Mitral valve prolapse and Heart murmur (Murmur). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma, IPRATROPIUM BROMIDE from 16-Sep-2000 to an unknown date for Chronic sinusitis, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for Eye disorder, LEVOTHYROXINE SODIUM (SYNTHROID) from 18-Nov-2018 to an unknown date for Goitre nontoxic and Hypothyroidism, ALLOPURINOL (ZYLOPRIM) for Gout, SILICON DIOXIDE (VIVISCAL [SILICON DIOXIDE]) from 01-Feb-2019 to an unknown date for Hair loss, EZETIMIBE, SIMVASTATIN (VYTORIN) and EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) from 18-Jun-2018 to an unknown date for Hypercholesterolaemia, CHOLINE FENOFIBRATE (TRILIPIX) for Hypercholesterolaemia and Hypertriglyceridemia, DOXAZOSIN from 22-Feb-2021 to an unknown date, LOSARTAN from 19-Aug-2021 to an unknown date and VERAPAMIL from 13-Sep-2019 to an unknown date for Hypertension, NABUMETONE (RELAFEN) for Intervertebral disc bulging, PLECANATIDE (TRULANCE) from 06-May-2020 to an unknown date for Irritable bowel syndrome, CYANOCOBALAMIN, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE (FOLBEE) from 21-Feb-2021 to an unknown date for Renal insufficiency, GABAPENTIN (NEURONTIN) from 16-Jan-2016 to an unknown date for Sciatica, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET XR) from 17-Sep-2017 to an unknown date for Type 2 diabetes mellitus, VITAMIN D3 from 21-Jan-2021 to an unknown date for Vitamin D deficiency, VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PRESYNCOPE (Going to pass out), RASH ERYTHEMATOUS (Bright red rash/redness/rash on hands), PERIPHERAL SWELLING (Arm was swollen/hand was swollen/left hand swelling), JOINT SWELLING (Knees became swollen/swelling on both knees), DRY MOUTH (Dry mouth), DYSGEUSIA (Metal taste/unusual taste), DIZZINESS (Felt dizzy/dizziness), HYPERTENSION (Blood pressure high), PALPITATIONS (Irregular heart rate/palpitations), BLOOD GLUCOSE INCREASED (Blood sugar high), HEART RATE IRREGULAR (Irregular heart rate/palpitations), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, PRESYNCOPE (Going to pass out), RASH ERYTHEMATOUS (Bright red rash/redness/rash on hands), PERIPHERAL SWELLING (Arm was swollen/hand was swollen/left hand swelling), JOINT SWELLING (Knees became swollen/swelling on both knees), DRY MOUTH (Dry mouth), DYSGEUSIA (Metal taste/unusual taste), DIZZINESS (Felt dizzy/dizziness), HYPERTENSION (Blood pressure high), PALPITATIONS (Irregular heart rate/palpitations), BLOOD GLUCOSE INCREASED (Blood sugar high), HEART RATE IRREGULAR (Irregular heart rate/palpitations), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood glucose: high (High) Blood sugar was high post vaccination. In February 2021, Blood pressure measurement: 201/91 (High) 201/91 and high (High) Blood pressure was high post vaccination. In February 2021, Heart rate: 98 (normal) 98 and irregular (abnormal) Heart rate was irregular.         Patient was unaware if she had a history of anaphylaxis or hay fever. Allergies also included allergy to propolis; had blisters as a reaction.  On 22-Feb-2021, doxazosin 2 mg at night was taken; on 15-Jul-2021, the dose was increased to 4 mg at night and on 19-Aug-2021, the dose was again increased to 8 mg at night. On 21-Jul-2021, hydralazine 25 mg was taken at morning and night; on 5-Aug-2021, dose was increased to 50 mg morning and night; on 14-Aug-2021, dose was again increased to 75 mg in the morning when she had a bad reaction; again had a bad reaction when she tried taking it on 15-Aug-2021; finally on 19-Aug-2021 hydralazine was discontinued. Dose of verapamil was increased on 15-Jul-2021.  Treatment information was not provided.  Patient underwent arteriogram in 1978; laparoscopy in 1987; full open exploratory with lysis of adhesions in 1988; mammotome (right breast tumor) on 31-Aug-2002 and 03-Sep-2004;  heart catherization on 13-Dec-2004 and 02-Sep-2019; surgery for gross hematuria on 04-Jun-2005; stress test on 19-Apr-2011; nuclear stress test on 05-Aug-2013 and 14-Aug-2019; holter on 21-Aug-2021; back MRIs at Princeston radiology on 01-Sep-2018; partial nail abrasion right toe on 26-Feb-2019 and 14-Jan-2020; colonoscopy on 17-Jun-2019; blood work on 14-Jan-2021, 15-Apr-2021 and 09-Jul-2021; eye exam and transcranial doppler on 09-Aug-2021; PAP on 03-Aug-2020; mammogram and thyroid scan on 16-Aug-2021; skin cancer screening on 28-09-2020 and teeth cleaning with x-rays on 21-Jan-2021.  Patient had seen her doctor for heart issues on 18-Aug-2021, primary doctor on 22-Apr-2021 and 22-Jul-2021, doctor for bone issues on 11-Aug-2020, gastroenterologist on 25-Mar-2019 and nephrologist on 12-Jul-2021. Patient will have blood work done on 01-Oct-2021 and will see her cardiologist on 14-Oct-2021.   This case was linked to MOD-2021-280047 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Updated reporter details, patient details, medical history details, lab details, route of administration, facility information, new events were added and additional information was added in the I-narrative supplement.