Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Viral test
Clinical narrative: Delta-wave Infection; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (Delta-wave Infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.      No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 COVID-19 (Delta-wave Infection) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Delta-wave Infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: SARS-CoV-2 infection with delta variant. In 2021, Viral test: SARS-CoV-2 infection with delta variant.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (Delta-wave Infection) to be related.    Concomitant and treatment medications were not reported.  Sanger sequencing was done to identify the variant as delta variant.  Patient age range was provided as 22-87 years. Median age was reported as 60 years.  Plasma samples were collected 3 days after ICU admission for 18 Delta-wave patient. Sample Collection Window between Aug 2021 and Dec 2021. Days post 2nd dose for Recipients of two doses was 12.  Booster vaccination provided sufficient neutralizing- antibody titers against the BA.4/5 and BA.2.12.1 subvariants, albeit to a lower extent than against BA.1 and BA.2.4,5 These findings underscore the importance of booster vaccination for protection against emerging variants.  Company comment: This literature non-study case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected serious (hospitalization) AESI COVID-19 after receiving the mRNA-1273 vaccine as 3rd dose on an unknown date. The onset date of COVID-19 delta variant was not reported. The event was confirmed by viral RNA extraction on nasal swab followed by RT-PCR. Clinical course of event and hospitalization and treatment details were not reported. The outcome of event was reported as unknown. It was reported that patient who received three doses of the mRNA-1273 vaccine had dramatically increased neutralizing-antibody titers overall. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness was assessed as per medical judgement.   This case was linked to MOD-2022-610666 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2022: Follow up received by safety on 22-Jul-2022 has Email with full text article and contains significant information: Reporter information, literature information, lab data, dose information and event details were updated.; Sender's Comments: This literature non-study case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected serious (hospitalization) AESI COVID-19 after receiving the mRNA-1273 vaccine as 3rd dose on an unknown date. The onset date of COVID-19 delta variant was not reported. The event was confirmed by viral RNA extraction on nasal swab followed by RT-PCR. Clinical course of event and hospitalization and treatment details were not reported. The outcome of event was reported as unknown. It was reported that patient who received three doses of the mRNA-1273 vaccine had dramatically increased neutralizing-antibody titers overall. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness was assessed as per medical judgement. MOD-2022-610666:This case refers to 4 patients who developed Omicron-wave Infection