Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Felt kind of funny; Knot at the injection site/knot was not going away; Felt like being stung by a bee; Arm was sore/ killed her if she raised the arm/could not lay on the left arm; Knot was hard; Area itched; If the area was touched would go through the ceiling / the area could not be touched; Feel queasy in her stomach; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt kind of funny), VACCINATION SITE SWELLING (Knot at the injection site/knot was not going away), PAIN (Felt like being stung by a bee), PAIN IN EXTREMITY (Arm was sore/ killed her if she raised the arm/could not lay on the left arm) and VACCINATION SITE INDURATION (Knot was hard) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and INSULIN GLARGINE (TOUJEO MAX SOLOSTAR) for Diabetes, LOSARTAN, MELOXICAM, GABAPENTIN, CLONIDINE, METOPROLOL, OXYBUTYNIN, TRAZODONE and VITAMIN D NOS for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced FEELING ABNORMAL (Felt kind of funny), VACCINATION SITE SWELLING (Knot at the injection site/knot was not going away), PAIN (Felt like being stung by a bee), PAIN IN EXTREMITY (Arm was sore/ killed her if she raised the arm/could not lay on the left arm), VACCINATION SITE INDURATION (Knot was hard), VACCINATION SITE PRURITUS (Area itched), VACCINATION SITE PAIN (If the area was touched would go through the ceiling / the area could not be touched) and NAUSEA (Feel queasy in her stomach). At the time of the report, FEELING ABNORMAL (Felt kind of funny), VACCINATION SITE SWELLING (Knot at the injection site/knot was not going away), PAIN (Felt like being stung by a bee), PAIN IN EXTREMITY (Arm was sore/ killed her if she raised the arm/could not lay on the left arm), VACCINATION SITE INDURATION (Knot was hard), VACCINATION SITE PRURITUS (Area itched), VACCINATION SITE PAIN (If the area was touched would go through the ceiling / the area could not be touched) and NAUSEA (Feel queasy in her stomach) had resolved. Not Provided          Relevant concomitant medications also included victo (verified). The patient did not take any treatment medication.  Action taken with mRNA-1273 in response to the events was not applicable.  Since the knot was not going away, she called the ER last night, 09 May 2021, to get advice and the healthcare professional referred her to Moderna medical information. The healthcare professional said that it could possibly a reaction to the Moderna COVID-19 Vaccine.   This case was linked to MOD-2021-116629 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up was received on 10-Jun-2021 added outcome of the events was resolved.