Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test
Clinical narrative: Postvaccination COVID-19 Breakthrough; This literature-non-study case was reported in a literature article and describes the occurrence of BREAKTHROUGH COVID-19 (Postvaccination COVID-19 Breakthrough) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:      Concurrent medical conditions included AIDS.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BREAKTHROUGH COVID-19 (Postvaccination COVID-19 Breakthrough) (seriousness criterion hospitalization). At the time of the report, BREAKTHROUGH COVID-19 (Postvaccination COVID-19 Breakthrough) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  This study included patients with age more than or equal to 18 years with HIV who were receiving care and were fully vaccinated by 30-Jun-2021, along with patients without HIV matched according to date fully vaccinated. Those patients with postvaccination COVID-19 breakthrough before 31-Dec-2021, were eligible.  The risk of severe illness higher for people with HIV (PWH). PWH were identified using HIV registries or HIV diagnosis codes. It was reported that the greater proportion of those with obesity, diabetes, hypertension, or ESKD at the date fully vaccinated in PWoH compared with PWH persisted among those who were hospitalized.  Company comment: This literature-non-study case report concerns a patient of an unknown age and gender with medical history of HIV infection, who experienced serious (due to hospitalization) unexpected event of Breakthrough COVID-19 infection. The event occurred after the patient had received the booster (third dose) of mRNA-1273 vaccine. The event required hospitalization, however, no additional details regarding clinical course of the event was available at the time of this report. The patient's underlying medical history of HIV infection, as well as ongoing pandemic are considered as risk factors for the reported event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-661404.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2022: Live Follow up received by safety on 20-Oct-2022 has email with full text article received and contains significant information: Reporter information added, citation details updated, lab data added, product details added.; Sender's Comments: This literature-non-study case report concerns a patient of an unknown age and gender with medical history of HIV infection, who experienced serious (due to hospitalization) unexpected event of Breakthrough COVID-19 infection. The event occurred after the patient had received the booster (third dose) of mRNA-1273 vaccine. The event required hospitalization, however, no additional details regarding clinical course of the event was available at the time of this report. The patient's underlying medical history of HIV infection, as well as ongoing pandemic are considered as risk factors for the reported event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. MOD-2022-661404:Cluster case