Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site scar, SARS-CoV-2 test
Clinical narrative: I have been on disability; COVID-19; I still have spots on both of my arms, in the upper part where they give me the injection; holes in my arms with little stabs over them; Pain at the injection site and I still having the pain at of them, at both of my upper arms; Itchy at the shot injection site; This spontaneous case was reported by a patient and describes the occurrence of DISABILITY (I have been on disability) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Sleep apnea. Concurrent medical conditions included Blood pressure high, Irritable bowel syndrome, Type 2 diabetes mellitus, Asthma, Bladder disorder NOS (Bladder issue) and Heart disease, unspecified (Heart issues).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2023, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular use) 1 dosage form. In 2021, the patient experienced INJECTION SITE SCAR (I still have spots on both of my arms, in the upper part where they give me the injection), INJECTION SITE INDENTATION (holes in my arms with little stabs over them), INJECTION SITE PAIN (Pain at the injection site and I still having the pain at of them, at both of my upper arms) and INJECTION SITE PRURITUS (Itchy at the shot injection site). On 15-Jan-2024, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DISABILITY (I have been on disability) (seriousness criterion medically significant). The patient was treated with AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISABILITY (I have been on disability), INJECTION SITE SCAR (I still have spots on both of my arms, in the upper part where they give me the injection), INJECTION SITE INDENTATION (holes in my arms with little stabs over them) and INJECTION SITE PAIN (Pain at the injection site and I still having the pain at of them, at both of my upper arms) had not resolved and COVID-19 (COVID-19) and INJECTION SITE PRURITUS (Itchy at the shot injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2024, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. It was reported that all of patient vaccines were with Moderna except last Pfizer dose. The patient had the problems since getting the Moderna ones. The patient was given Pfizer vaccine to find out if the patient was developing an allergy to Moderna vaccines. All the doses received were adult doses. Patient still had spots on both of her arms, in the upper part where they gave her the injection and she also have pain there still. She was supposed to get another shot that coming Monday. Patient can see the holes in her arms with little stabs over them on arms wherever it been almost 3 years. Patient had been on disability.  Company Comment: This is a Spontaneous case concerning an adult female patient on her sixties with medical history of Blood pressure high, Irritable bowel syndrome, Type 2 diabetes mellitus, Asthma, Bladder disorder NOS (Bladder issue) and Heart disease, who experienced the serious (per medically significant) unexpected event of Disability (reported as "I have been on disability") which occurred on an unknown onset latency with a dose of mRNA-1273 received as the first dose for COVID-19 Vaccination. It was reported that the patient still had spots on both of her arms, in the upper part where they gave her the injection and she also still have pain there. And that she can see the holes in her arms with little stabs over them on arms wherever it been almost 3 years. The mentioned medical history could remain as confounders for the mentioned disability. No further clinical information or diagnostic tests results were disclosed for analysis. The patient also received Tozinameran dose. No concomitant medication or treatment information was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.