Sex: F
Vaccine: COVID19, COVID19-2, COVID19-2
Symptoms: Breakthrough COVID-19, Fatigue, Injection site pain, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: slight soreness on arm/local injection site soreness on day of vaccination; fatigue at 24 hr/at 24th or so hr., got really tired; Home RAT for covid-19 on 31-Jan-2023, Result Positive; This spontaneous case was reported by a physician and describes the occurrence of BREAKTHROUGH COVID-19 (Home RAT for covid-19 on 31-Jan-2023, Result Positive), INJECTION SITE PAIN (slight soreness on arm/local injection site soreness on day of vaccination) and FATIGUE (fatigue at 24 hr/at 24th or so hr., got really tired) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (COMIRNATY) for an unknown indication and RAXTOZINAMERAN (COMIRNATY OMICRON XBB.1.5) for an unknown indication.    Concurrent medical conditions included Smoker (Active smoking of cigarettes (50+ packs in a year)), COPD (COPD with intermittent O2 use), Alcohol use disorder (Etoh use disorder (sober for 8 years)) and Bronchitis (3 times).   On 26-Feb-2021, the patient received first dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Sep-2023, the patient received sixth dose of RAXTOZINAMERAN (COMIRNATY OMICRON XBB.1.5) (unknown route) 1 dosage form. On 13-Mar-2024, received seventh dose of RAXTOZINAMERAN (COMIRNATY OMICRON XBB.1.5) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2023, the patient experienced BREAKTHROUGH COVID-19 (Home RAT for covid-19 on 31-Jan-2023, Result Positive). On an unknown date, the patient experienced INJECTION SITE PAIN (slight soreness on arm/local injection site soreness on day of vaccination) and FATIGUE (fatigue at 24 hr/at 24th or so hr., got really tired). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 01-Feb-2023 for COVID-19, at a dose of UNK, bid for 5 days; NIRMATRELVIR, RITONAVIR (PAXLOVID) on 11-Nov-2023 for COVID-19, at a dose of UNK, bid for 5 days; NIRMATRELVIR, RITONAVIR (PAXLOVID) on 28-Apr-2024 for COVID-19, at a dose of UNK, bid for 5 days and PREDNISONE at a dose of 40 milligram once a day. At the time of the report, BREAKTHROUGH COVID-19 (Home RAT for covid-19 on 31-Jan-2023, Result Positive) had resolved and INJECTION SITE PAIN (slight soreness on arm/local injection site soreness on day of vaccination) and FATIGUE (fatigue at 24 hr/at 24th or so hr., got really tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2023, SARS-CoV-2 test: Positive. On 11-Nov-2023, SARS-CoV-2 test: Positive. On 28-Apr-2024, SARS-CoV-2 test: Positive. On an unknown date, Oxygen saturation: <90%.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received Pfizer vaccines at the hospital and pharmacy/drug store via intramuscular use and did not receive any other vaccines on the same date as the Pfizer vaccine. It was unknown if the patient had SARS-CoV2 antibodies at diagnosis. No culture was performed. The patient took extensional precautions during the pandemic including remaining at home, limiting visits to occasional visits by her children and used N95 masks. Her illnesses occurred after minimal or unknown exposure. The patient was not hospitalized and was not admitted to an ICU. The patient had home O2 at 2L/min. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient had worsening of baseline dyspnea requiring increased use of supplemental home oxygen. After COVID-19 illness, had respiratory issues.  The patient had used steroid inhaler and albuterol inhaler routinely prior to the event being reported. It was unknown if any pre-existing disease worsened during the SARS-CoV2 infection. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient had metallic taste on day 2 of Paxlovid.