Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Heart rate, Nasal discomfort, Nasal dryness, Oral discomfort
Clinical narrative: Sore left nostril/rawness around nose; Burning under eyebrows and around eyes /red burning/burning returned/mouth pizza burn very raw; Sore nostril; Rawness around nose and mouth; Essential hypertension; Lips feel funny; Tips of nose has dry area; Itching under eye brows/itching/pruritus/itching returned; Stinging where glasses sit; Tired; Gastro esophageal reflux disease; Degernative joint disease of hand; Dermatomyositis; This spontaneous case was reported by a consumer and describes the occurrence of DERMATOMYOSITIS (Dermatomyositis), NASAL DISCOMFORT (Sore left nostril/rawness around nose), BURNING SENSATION (Burning under eyebrows and around eyes /red burning/burning returned/mouth pizza burn very raw), NASAL DISCOMFORT (Sore nostril) and STOMATITIS (Rawness around nose and mouth) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives, Maxillary sinusitis (Endoscopy Maxillary Sinus) on 23-Dec-2020, Cautery to nose (Nasal Cautery -ENT) on 23-Dec-2020, Esophagogastroduodenoscopy on 16-Sep-2019, Colonoscopy on 30-Sep-2019, Knee surgery NOS (right knee, scope) on 06-May-2014, Orthopedic procedure (right clavical surgery) on 24-Oct-2012, Flexible sigmoidoscopy on 01-Mar-2016, Hysterectomy (THA, Bilateral salpingo, unilateral oophorectomy) on 01-Jun-1990, Colonoscopy on 30-Sep-2014, Ovarian cystectomy (rt ovary removed with Stellation.) on 04-Jun-2021, Appendectomy on 02-Jun-1954, Arthroscopic surgery in January 2005 and Arthroscopic surgery on 16-Aug-2005. Previously administered products included for Product used for unknown indication: Td (TD (ADULT), adsorbed.) on 08-Apr-1997, Influenza (Unspecified formulation) on 08-Oct-1997, Influenza (Unspecified formulation) on 14-Oct-1998, Influenza (Unspecified formulation) on 13-Oct-1999, Influenza (Unspecified formulation) on 29-Nov-2001, Influenza (Unspecified formulation) on 30-Oct-2002, Influenza (Whole) on 16-Oct-2003, Influenza (Seasonal, injectable) on 17-Oct-2006, Influenza (Seasonal, injectable) on 22-Oct-2007, Influenza (Seasonal, injectable) on 23-Oct-2008, pneumococcal (pneumococcal polysaccharide PPV23) on 23-Oct-2008, Influenza (Seasonal, injectable) on 14-Oct-2009, Influenza (Seasonal, injectable) on 20-Oct-2010, Zoster (Zoster live) on 06-Oct-2011, Influenza (Seasonal, injectable) on 06-Oct-2011, Influenza (Seasonal, injectable) on 18-Sep-2012, Influenza (Seasonal, injectable) on 07-Oct-2013, Influenza (Seasonal, injectable) on 18-Oct-2014, Influenza (HIgh dose seasonal,0.5 ml) on 07-Oct-2015, pneumococcal (pneumococcal conjugate PCV 13,0.5 ml) on 21-Mar-2016, Influenza (HIgh dose seasonal,0.5 ml) on 26-Oct-2016, Influenza (HIgh dose seasonal,0.5 ml) on 26-Oct-2016, pneumococcal (pneumococcal polysaccharide PPV23 ,0.5 ml) on 06-Apr-2017, Influenza (HIgh dose seasonal) on 11-Oct-2017, Influenza (HIgh dose seasonal,0.5 ml) on 15-Oct-2018, Td (TD (ADULT), adsorbed, 0.5 ml) on 19-Nov-2018, Influenza (HIgh dose seasonal,0.5 ml,quadrivalent) on 27-Sep-2019, Zoster (Zoster recombinant ,0.5 ml) on 07-Jan-2020, Zoster (Zoster recombinant ,0.5 ml) on 10-Mar-2020, Influenza (injectable ,MDCK, preservative free and quadrivalent) on 14-Oct-2020; for an unreported indication: TDAP on 06-Nov-2000. Family history included Colonoscopy on 24-Sep-2009. Concurrent medical conditions included Blood pressure high since 2018, Drug allergy (Aspirin/ibuprofen; hives), Drug allergy (Keflex/hibiclens; rash), Drug allergy (surgical drape glue; burn), Hypercholesteraemia since 1988, Necrotizing pancreatitis since 15-Apr-2018, Drug allergy (Aluminum Aspirin) since 17-Sep-2009, Drug allergy (Prednisone - Rash) since 16-Dec-2011, Allergy to chemicals (Aminobenzoic acid- Edema) since 19-Jul-2014, Drug allergy (Chlorhexidine - Rash) since 29-Jul-2021, Oil allergy (Lavender oil -Rash) since 29-Apr-2014, Drug allergy (Cephalexin- Rash) since 18-Oct-2016, Iodine allergy (Iodine-Hive), Contrast media allergy (IVP dye allergy), Seasonal allergy (Ragweed and pollen) and Heartburn. Concomitant products included LISINOPRIL for Blood pressure high, PANTOPRAZOLE from an unknown date to 23-May-2021 for Heartburn, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Seasonal allergy, CALCIUM from 15-Jun-2016 to an unknown date, FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE (GLUCOCORTICOID)) from 15-Jun-2016 to an unknown date, VITAMIN B6, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE, MANGANESE ASCORBATE (COSAMIN DS [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE;MANGANESE ASCORBATE]) from 15-Jun-2016 to an unknown date, PSYLLIUM HYDROPHILIC MUCILLOID (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]), CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]), TRIAMCINOLONE ACETONIDE from 20-Apr-2021 to an unknown date, METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) from 20-Apr-2021 to an unknown date and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DERMATOMYOSITIS (Dermatomyositis). On 28-May-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Gastro esophageal reflux disease) and OSTEOARTHRITIS (Degernative joint disease of hand). On an unknown date, the patient experienced NASAL DISCOMFORT (Sore left nostril/rawness around nose), BURNING SENSATION (Burning under eyebrows and around eyes /red burning/burning returned/mouth pizza burn very raw), NASAL DISCOMFORT (Sore nostril), STOMATITIS (Rawness around nose and mouth), ESSENTIAL HYPERTENSION (Essential hypertension), ORAL DISCOMFORT (Lips feel funny), NASAL DRYNESS (Tips of nose has dry area), PRURITUS (Itching under eye brows/itching/pruritus/itching returned), PAIN (Stinging where glasses sit) and FATIGUE (Tired). The patient was treated with PREDNISONE at a dose of 1 dosage form; METHYLPREDNISOLONE from 21-Apr-2021 to 26-Apr-2021 at an unspecified dose and frequency; TRIAMCINOLONE ongoing since an unknown date at a dose of 1 dosage form; DESONIDE ongoing since an unknown date at an unspecified dose and frequency and CLOBETASOL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DERMATOMYOSITIS (Dermatomyositis) had not resolved and NASAL DISCOMFORT (Sore left nostril/rawness around nose), BURNING SENSATION (Burning under eyebrows and around eyes /red burning/burning returned/mouth pizza burn very raw), NASAL DISCOMFORT (Sore nostril), STOMATITIS (Rawness around nose and mouth), ESSENTIAL HYPERTENSION (Essential hypertension), GASTROOESOPHAGEAL REFLUX DISEASE (Gastro esophageal reflux disease), OSTEOARTHRITIS (Degernative joint disease of hand), ORAL DISCOMFORT (Lips feel funny), NASAL DRYNESS (Tips of nose has dry area), PRURITUS (Itching under eye brows/itching/pruritus/itching returned), PAIN (Stinging where glasses sit) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Blood pressure measurement: 130/60 (High) 130/60mm/Hg. On 20-Apr-2021, Heart rate: 80bpm (High) normal range-60-100bpm. On 20-Apr-2021, Respiratory rate: 14 (normal) 14 breaths per minute. On 28-May-2021, Heart rate: 60bpm (Low) normal range-60-100bpm. On 07-Jul-2021, Blood pressure measurement: 156/70 (High) 156/70 mm/Hg. On 07-Jul-2021, Heart rate: 84bpm (High) normal range-60-100bpm.         The patient used 06 day pack steroids and various ointments.   On 27-Apr-2021, the burning and itching had returned.  On unknown date  the patient had an additional test performed that included a CBC (completed blood count), however, the result was not provided.  Patient reported that within two weeks after shot, the patient developed rash on back which was size of orange, itched and burned, inflammation around cuticle , red burning itching below eyebrows and around eyes, dry patches, sore developed around nostrils. sore healed but still has rawness, rash on shoulders, upper chest and up on neck. terrible amount of weakness in shoulders, biceps and sides. The symptoms persisted looked like vaccine kicked immune system and now couldn't calm down and worsening. The patient went to doctor and was diagnosed with rare autoimmune disease dermatomyositis after CBC.  The subject underwent EMG (electromyography) on 06-Jul-2021.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Additional information included allergic condition, historical vaccine, surgical history, concomitant medication and event updated.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.