Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Wrong technique in device usage process
Clinical narrative: PEG (polyethylene glycol) allergy; Rash; Became hot; Flushed; Dizzy; Bulls eye redness at the injection site - left arm/a drip mark of redness - it left a red mark, just like the injection site; May not have gotten the full dose; Redness; Swelling; Syringe may have been removed too soon; "something run down my arm" and it was cold/ Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (May not have gotten the full dose), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Syringe may have been removed too soon), VACCINATION COMPLICATION ("something run down my arm" and it was cold/ Adverse event), ERYTHEMA (Redness) and SWELLING (Swelling) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Drug allergy, Drug allergy (Loratadine allergy), Caffeine allergy, Hypertension since June 1988, Hypothyroidism since June 1990, Obesity since February 1960 and GERD since July 1980. Concomitant products included ATENOLOL from June 1998 to an unknown date, QUINAPRIL from 2000 to an unknown date and HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE) from 1988 to an unknown date for Blood pressure management, FAMOTIDINE (PEPCID [FAMOTIDINE]) from 2017 to an unknown date for GERD, LEVOTHYROXINE from 1990 to an unknown date for Hypothyroidism, MACROGOL 3350 (MIRALAX) from 02-Jun-2021 to an unknown date for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Syringe may have been removed too soon) and VACCINATION COMPLICATION ("something run down my arm" and it was cold/ Adverse event). On 12-Mar-2021, the patient experienced UNDERDOSE (May not have gotten the full dose), ERYTHEMA (Redness), SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Bulls eye redness at the injection site - left arm/a drip mark of redness - it left a red mark, just like the injection site). On 02-Jun-2021, the patient experienced FEELING HOT (Became hot), FLUSHING (Flushed), DIZZINESS (Dizzy) and RASH (Rash). On an unknown date, the patient experienced HYPERSENSITIVITY (PEG (polyethylene glycol) allergy). On 11-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Syringe may have been removed too soon) had resolved. On 25-Mar-2021, ERYTHEMA (Redness) and SWELLING (Swelling) had resolved. At the time of the report, UNDERDOSE (May not have gotten the full dose), VACCINATION COMPLICATION ("something run down my arm" and it was cold/ Adverse event), FEELING HOT (Became hot), FLUSHING (Flushed), DIZZINESS (Dizzy), HYPERSENSITIVITY (PEG (polyethylene glycol) allergy), RASH (Rash) and VACCINATION SITE ERYTHEMA (Bulls eye redness at the injection site - left arm/a drip mark of redness - it left a red mark, just like the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2001, Blood pressure measurement: 198/99 (High) 198/99. On 12-Mar-2021, Blood pressure measurement: 197/88 (High) 197/88.         Treatment medication included electrolytes and quinapril.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2021: Follow-up received included patient demographic details which included race, ethnicity, weight and height; relevant medical history which included codeine allergy, hydrocodone allergy, loratadine allergy, caffeine sensitivity, obesity, hypertension, hypothyroid and GERD (Gastroesophageal reflux disease); concomitant medication details included atenolol, quinapril, levothyroxine, dyazide and Pepcid; suspect vaccine details were received and co-suspect product miralax was received; new adverse events included vaccination adverse reaction, redness, swelling, hot, flushed, dizzy and rash; laboratory investigations included blood pressure measurement; treatment medication included electrolytes and quinapril.