Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Wrong technique in device usage process
Clinical narrative: There is also some minor bruising now; the swollen area also itched occasionally; it stung / the swollen area was painful to the touch; redness and swelling starting about a half an inch out from the injection site; redness and swelling starting about a half an inch out from the injection site; put the needle in at a 45 or less in my arm; vaccine was administered subcutaneously rather than intramuscularly; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (put the needle in at a 45 or less in my arm), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was administered subcutaneously rather than intramuscularly), VACCINATION SITE BRUISING (There is also some minor bruising now), VACCINATION SITE PRURITUS (the swollen area also itched occasionally) and VACCINATION SITE PAIN (it stung / the swollen area was painful to the touch) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ill-defined disorder (chronic health problems.).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (put the needle in at a 45 or less in my arm), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was administered subcutaneously rather than intramuscularly), VACCINATION SITE PAIN (it stung / the swollen area was painful to the touch), VACCINATION SITE ERYTHEMA (redness and swelling starting about a half an inch out from the injection site) and VACCINATION SITE SWELLING (redness and swelling starting about a half an inch out from the injection site). On an unknown date, the patient experienced VACCINATION SITE BRUISING (There is also some minor bruising now). an unknown date, the patient experienced VACCINATION SITE PRURITUS (the swollen area also itched occasionally). On 06-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (put the needle in at a 45 or less in my arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was administered subcutaneously rather than intramuscularly) had resolved. At the time of the report, VACCINATION SITE BRUISING (There is also some minor bruising now) outcome was unknown, VACCINATION SITE PRURITUS (the swollen area also itched occasionally) had not resolved, VACCINATION SITE PAIN (it stung / the swollen area was painful to the touch) had resolved and VACCINATION SITE ERYTHEMA (redness and swelling starting about a half an inch out from the injection site) and VACCINATION SITE SWELLING (redness and swelling starting about a half an inch out from the injection site) was resolving.            No relevant concomitant medications were reported.  It was reported that redness and swelling was in line with trajectory of the needle and they continued to worse for next three days. The swelling was like someone had cut a half boiled egg in half and inserted it under her skin. The redness grew up to 5 to 6 inches in diameter, larger than swollen area. The patient saw the doctor and she had no idea what should be done. No treatment information were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-045006 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Follow up was received on 02-APR-2021 contains no new information.; Sender's Comments: This report refers to a case of wrong technique in device usage and inappropriate route of vaccination for mRNA-1273, lot # unknown with associated AEs vaccination site pain, erythema, bruising, swelling and pruritis . Based on the 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