Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hyperaesthesia, Incorrect route of product administration, Pain, Pain in extremity
Clinical narrative: Arm hurt for days; Arm was sensitive to touch; Fever in the area of the vaccine; Knot in the area of the vaccine; Horrible rash in the area of vaccine; FIrst vaccine in the back of arm in the subcutaneous fat; Redness; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (FIrst vaccine in the back of arm in the subcutaneous fat), ERYTHEMA (Redness), PAIN (Soreness), PAIN IN EXTREMITY (Arm hurt for days) and HYPERAESTHESIA (Arm was sensitive to touch) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 0043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 09-Jan-1985, Polycystic ovarian syndrome in 1997, GERD, Blood pressure and Insulin resistant diabetes. Concomitant products included ATORVASTATIN for Blood pressure, INSULIN LISPRO (HUMALOG) for Diabetes, ESOMEPRAZOLE for GERD, SEMAGLUTIDE (OZEMPIC) for Insulin resistant diabetes, SPIRONOLACTONE for Polycystic ovarian syndrome, VITAMIN D NOS, BUPROPION, CURCUMIN (TURMERIC MERIVA), VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) and BIOTIN for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2020, the patient experienced PAIN (Soreness). On 29-Dec-2020, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (FIrst vaccine in the back of arm in the subcutaneous fat), ERYTHEMA (Redness), PAIN IN EXTREMITY (Arm hurt for days), HYPERAESTHESIA (Arm was sensitive to touch), VACCINATION SITE WARMTH (Fever in the area of the vaccine), VACCINATION SITE INDURATION (Knot in the area of the vaccine) and VACCINATION SITE RASH (Horrible rash in the area of vaccine). On 29-Dec-2020, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (FIrst vaccine in the back of arm in the subcutaneous fat) had resolved. At the time of the report, ERYTHEMA (Redness) and PAIN (Soreness) was resolving and PAIN IN EXTREMITY (Arm hurt for days), HYPERAESTHESIA (Arm was sensitive to touch), VACCINATION SITE WARMTH (Fever in the area of the vaccine), VACCINATION SITE INDURATION (Knot in the area of the vaccine) and VACCINATION SITE RASH (Horrible rash in the area of vaccine) outcome was unknown.            Height of the patient was, 5' 2".  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.  Patient reported that she got antibodies tested twice and did not had any antibodies both the times.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow up was received on 08 Apr 2021, includes, email , height, weight and race of the patient.Date of first dose of vaccination  updated from 28 Dec 2020 to 29 Dec 2020. Route of first dose of vaccination updated to subcutaneous.New adverse events mentioned, which occurred after the first dose, rash, knot and fever at vaccination site, arm hurts for days and sensitive to touch.Many concomitant medications addedPCOS added as current condition..For diabetes(current condition), date of onset added in the follow up.