Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Off label use, Oxygen saturation, Pain assessment, Respiratory rate
Clinical narrative: First dose of vaccine on 25-JAN-2021, second dose of vaccine received on 09-MAR-2021 as the doctor instructed not to take the second shot; Cellulitis right upper limb; Allergic reaction to drug; Itchy; Swollen; Arm is red, it´s a 3 inch circle; Some soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis right upper limb) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Depressive disorder (Including post partum) on 12-Nov-2020, Osteoporosis on 01-Feb-2018, Acute stress disorder, Urinary incontinence (Medications did not help) on 12-Nov-2020, Incontinence of feces on 26-Aug-2020, Hiatal hernia on 27-Aug-2020, Osteopenia (Mild) on 12-Nov-2020, Gastroesophageal reflux disease (Without esophagitis) on 27-Aug-2020, Cataract operation (Bilateral), Tubal ligation (Ligation of fallopian tube), Varicose veins stripping (Stripping of vein), Uterine dilation and curettage, Back surgery, Cholecystectomy on 06-Nov-2018, Esophagogastroduodenoscopy (EGD) on 03-May-2018, Colonoscopy on 01-Jan-2015, Bladder tack on 01-Jan-1995, Total hysterectomy on 01-Jan-1995, Mammogram on 14-Jul-2020, Bone densitometry on 02-Jul-2019 and PAP smear on 01-Jan-2017. Previously administered products included for an unreported indication: TDAP on 11-Aug-2011, VARICELLA ZOSTER VACCINE (Zoster recombinant) on 01-Jan-2018, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) on 02-Jul-2019 and INFLUENZA VACCINE POLYVALENT (Injectable quadrivalent) on 01-Sep-2020. Family history included Hyperlipidemia since 12-Nov-2020 and Family history of cancer (Family history of colon cancer- Parental uncle, Maternal Aunt, first cousin) since 26-Aug-2020. Concurrent medical conditions included Hypothyroidism since 12-Nov-2020, Gastroesophageal reflux disease since 10-Apr-2018, Alcoholic (Occasional) and Seasonal allergic rhinitis since 12-Nov-2020. Concomitant products included FAMOTIDINE from 12-Nov-2020 to an unknown date for Reflux esophagitis, SIMVASTATIN from 01-Jan-2021 to an unknown date, LEVOTHYROXINE from 01-Jan-2021 to an unknown date, VITAMIN B12 NOS from 12-Nov-2020 to an unknown date, VITAMIN D3 from 27-Aug-2020 to an unknown date, DL-ALPHA TOCOPHERYL ACETATE, TOCOPHEROL (VITAMIN E MIXED TOCOPHEROLS) from 26-Aug-2020 to an unknown date, CALCIUM FRUCTOBORATE, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE, HYALURONIC ACID (MOVE FREE JOINT HEALTH), LORATADINE (CLARITIN [LORATADINE]) from 26-Aug-2020 to an unknown date, CENTRUM SILVER WOMEN 50+ from 27-Aug-2020 to an unknown date, BIOTIN, CALCIUM CARBONATE (TUMS ANTACID) and PARACETAMOL (ARTHRITIS PAIN RELIEF [PARACETAMOL]) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced DRUG HYPERSENSITIVITY (Allergic reaction to drug), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Swollen), INJECTION SITE ERYTHEMA (Arm is red, it´s a 3 inch circle) and VACCINATION SITE PAIN (Some soreness). On 03-Feb-2021, the patient experienced CELLULITIS (Cellulitis right upper limb) (seriousness criterion medically significant). On 09-Mar-2021, the patient experienced OFF LABEL USE (First dose of vaccine on 25-JAN-2021, second dose of vaccine received on 09-MAR-2021 as the doctor instructed not to take the second shot). On 10-Feb-2021, CELLULITIS (Cellulitis right upper limb) had resolved. On 09-Mar-2021, OFF LABEL USE (First dose of vaccine on 25-JAN-2021, second dose of vaccine received on 09-MAR-2021 as the doctor instructed not to take the second shot) had resolved. At the time of the report, DRUG HYPERSENSITIVITY (Allergic reaction to drug), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Swollen), INJECTION SITE ERYTHEMA (Arm is red, it´s a 3 inch circle) and VACCINATION SITE PAIN (Some soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Blood pressure measurement: 118/74 (Inconclusive) Sitting Left arm. On 03-Feb-2021, Body temperature: 99.3 (Inconclusive) 99.3 Degree Fahrenheit temporal artery. On 03-Feb-2021, Heart rate: 64 (Inconclusive) 64 bpm. On 03-Feb-2021, Oxygen saturation: 9 percent (Inconclusive) Room air at rest. On 03-Feb-2021, Pain assessment: 0 Inconclusive. On 03-Feb-2021, Respiratory rate: 16 Inconclusive. On 10-Feb-2021, Blood pressure measurement: 118/70 (Inconclusive) Sitting Left arm. On 10-Feb-2021, Body temperature: 98 (Inconclusive) 98 Degree Fahrenheit temporal artery. On 10-Feb-2021, Heart rate: 67 (Inconclusive) 67 bpm. On 10-Feb-2021, Oxygen saturation: 98 percent (Inconclusive) Room air at rest. On 10-Feb-2021, Pain assessment: 4 Inconclusive. On 10-Feb-2021, Respiratory rate: 16 Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CELLULITIS (Cellulitis right upper limb) to be related. No further causality assessments were provided for DRUG HYPERSENSITIVITY (Allergic reaction to drug), OFF LABEL USE (First dose of vaccine on 25-JAN-2021, second dose of vaccine received on 09-MAR-2021 as the doctor instructed not to take the second shot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Swollen), INJECTION SITE ERYTHEMA (Arm is red, it´s a 3 inch circle) and VACCINATION SITE PAIN (Some soreness).    Family history of the patient also included: Father: Heart disease (died age 86), malignant melanoma, hypertensive disorder, hyperlipidemia, benign neoplasm of stomach. Mother: suspected brain tumor (died age 86). Brother: Myocardial infarction. Paternal aunt: Malignant tumor of pancreas.  Treatment was reported as the patient took diphenhydramine cream initially. On 03 Feb 2021 the doctor prescribed Augmentin 500 mg-125mg 1 tablet every 12 hours by oral route for 7 days. On 10 Feb 2021, upon followup the doctor instructed to take diphenhydramine 25 mg 1 pill every 6 hours. Stop Claritin. Take famotidine 20 mg 1 pill twice a day. Also instructed not to take COVID-19 second shot. Concomitant medication also included over-the-counter (OTC) Arthritis Pain Relief (unspecified).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Patient's demographics, history and lab details updated. Product details updated and second dose added. Concomitant medications updated. Events updated.; Sender's Comments: This case concerns a 73-year-old female with a serious unexpected event of cellulitis, and nonserious unexpected hypersensitivity, and off label use and expected vaccination site pruritus, vaccination site swelling, injection site erythema and vaccination site pain. Latency 10 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.