Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Atelectasis, COVID-19, Chest X-ray, Coma scale, Computerised tomogram head
Clinical narrative: Cryptococcal meningitis; embolic showers/thromboembolic phenomena/embolic phenomena; atelectasis; Grade I diastolic dysfunction; positive for COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of MENINGITIS CRYPTOCOCCAL (Cryptococcal meningitis) and MICROEMBOLISM (embolic showers/thromboembolic phenomena/embolic phenomena) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   Previously administered products included for Product used for unknown indication: influenza (Patient had been vaccinated against and influenza by admission). Past adverse reactions to the above products included No adverse event with influenza. Concurrent medical conditions included Hypertension.   In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2022, the patient experienced COVID-19 (positive for COVID-19). On an unknown date, the patient experienced MENINGITIS CRYPTOCOCCAL (Cryptococcal meningitis) (seriousness criteria hospitalization and medically significant), MICROEMBOLISM (embolic showers/thromboembolic phenomena/embolic phenomena) (seriousness criterion medically significant), ATELECTASIS (atelectasis) and DIASTOLIC DYSFUNCTION (Grade I diastolic dysfunction). The patient was hospitalized from 11-Feb-2022 to 25-Feb-2022 due to MENINGITIS CRYPTOCOCCAL. The patient was treated with AMPHOTERICIN B at an unspecified dose and frequency and FLUCYTOSINE at an unspecified dose and frequency. At the time of the report, MENINGITIS CRYPTOCOCCAL (Cryptococcal meningitis) had not resolved and MICROEMBOLISM (embolic showers/thromboembolic phenomena/embolic phenomena), COVID-19 (positive for COVID-19), ATELECTASIS (atelectasis) and DIASTOLIC DYSFUNCTION (Grade I diastolic dysfunction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2022, SARS-CoV-2 test: (Positive) tested positive for COVID-19 from the referral facility and no need for treatment had been established. On an unknown date, Chest X-ray: showed patchy bibasilar opacities, likely atelectasis, with a low likelihood of pneumonia along the diaphragmatic margins. On an unknown date, Coma scale: remained below 8 by patient's discharge to palliative care. On an unknown date, Computerised tomogram head: demonstrated evidence of thromboembolic phenomena with areas of hypo-perfusion suggestive of a stroke. On an unknown date, Echocardiogram: Transthoracic echo showed a hyperdynamic left ventricular ejection fraction of 70% and a grade I diastolic dysfunction with no noted valvulopathies. On an unknown date, Ejection fraction: 70 %. On an unknown date, Magnetic resonance imaging: leptomeningeal enhancement on MRI and imaging findings showed bilateral diffuse emboli in multiple cerebellar territories on MRI, were not characteristic of the thromboembolism caused by the organism, Cryptococcus. On an unknown date, Polymerase chain reaction: was subsequently diagnosed with Cryptococcal meningitis by CSF PCR. On an unknown date, Ultrasound Doppler: Bilateral carotid artery dopplers showed no significant stenosis. On an unknown date, Vital signs measurement: stable on arrival.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient was admitted to the hospital on February 11, 2022, with an altered mental status. Patient's main presentation was decreased responsiveness, with waxing and waning levels of consciousness.  Initial evaluation by the neurology team was that though the diagnosis of Cryptococcal meningitis had been rightly made (supported by leptomeningeal enhancement on MRI) and could substantively account in part for the clinical presentation, her imaging findings of bilateral diffuse emboli in multiple cerebellar territories on MRI, were not characteristic of the thromboembolism caused by the organism, Cryptococcus.  There was an initial move to go further with a transesophageal echocardiogram, with the view to exposing potential valvular lesions-this required cardiology input at this point. Though agreeing with the assertions of their neurology counterparts, the cardiology consult opted to hold back on the more invasive approach, citing, amongst other things, her COVID-19 positivity status as a limiting factor. The patient was started on anticoagulation, and further evaluation was deferred.  This patient went on to experience deleterious CNS sequelae of the presumptive diagnosis of Cryptococcal meningitis, requiring several lumbar punctures, antifungal treatment later showing no recovery of baseline neurological status. Patient was discharged on February 25 to a nursing home.  On discharge, it was unknown whether her entire presentation was due to a single disease process or if there were overlapping conditions, including COVID-19-related embolic phenomena. Her prognosis remained guarded at the time of discharge.  The evaluation of the patient for valvulopathy, abscess, or endocardial compromise may have pointed to an alternate line of treatment besides anticoagulation. She may have developed an abscess or vegetation not picked up on the transthoracic echo.  Company Comment: This literature-non-study case concerns a female patient aged 65 years with relevant medical history of Hypertension reported, who experienced the unexpected serious (medically significant/Hospitalization) event of Meningitis cryptococcal, unexpected serious (medically significant) AESI event of Microembolism (reported as embolic showers/thromboembolic phenomena/ embolic phenomena) after second dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date nor event onset date was disclosed. Patient also experienced non serious events of COVID-19 (about 3 months after vaccination), Atelectasis, Diastolic dysfunction. Patient was hospitalized with an history of altered mental status and no cardiovascular or respiratory symptoms. She was tested positive for COVID-19 about 8 days prior and no need for treatment had been established. Her main presentation was decreased responsiveness, with waxing and waning levels of consciousness. She had been vaccinated for influenza by admission. Her vital signs were stable on arrival. Initial work-up showed thromboembolic phenomena as evidenced on head CT, with areas of hypoperfusion suggestive of a stroke, and was subsequently diagnosed with Cryptococcal meningitis by CSF PCR. Initial evaluation by the neurology team was that though the diagnosis of Cryptococcal meningitis had been rightly made (supported by leptomeningeal enhancement on MRI) and could substantively account in part for the clinical presentation, her imaging findings of bilateral diffuse emboli in multiple cerebellar territories on MRI, were not characteristic of the thromboembolism caused by the organism, Cryptococcus. Another cause of her embolic event had to be investigated. A chest x-ray showed patchy bibasilar opacities, likely atelectasis, with a low likelihood of pneumonia. Bilateral carotid artery dopplers showed no significant stenosis. A transthoracic echo proved unrevealing, showing a hyperdynamic left ventricular ejection fraction of 70% and a grade I diastolic dysfunction with no noted valvulopathies, and a transesophageal echocardiogram with the view to find out potential valvular lesions was needed. The patient was started on anticoagulation, and further evaluation was deferred. This patient went on to experience deleterious CNS sequelae of the presumptive diagnosis of Cryptococcal meningitis, requiring several lumbar punctures, antifungal treatment with Amphotericin B and flucytosine, later showing no recovery of baseline neurological status. Her GCS remained below 8 by her discharge to palliative care. She was discharged after 14 days of hospitalization to a nursing home. On discharge, it was unknown whether her entire presentation was due to a single disease process or if there were overlapping conditions, including COVID-19-related embolic phenomena. Her prognosis remained guarded at the time of discharge. Outcome of the events was unknown at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature-non-study case concerns a female patient aged 65 years with relevant medical history of Hypertension reported, who experienced the unexpected serious (medically significant/Hospitalization) event of Meningitis cryptococcal, unexpected serious (medically significant) AESI event of Microembolism (reported as embolic showers/thromboembolic phenomena/ embolic phenomena) after second dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date nor event onset date was disclosed. Patient also experienced non serious events of COVID-19 (about 3 months after vaccination), Atelectasis, Diastolic dysfunction. Patient was hospitalized with an history of altered mental status and no cardiovascular or respiratory symptoms. She was tested positive for COVID-19 about 8 days prior and no need for treatment had been established. Her main presentation was decreased responsiveness, with waxing and waning levels of consciousness. She had been vaccinated for influenza by admission. Her vital signs were stable on arrival. Initial work-up showed thromboembolic phenomena as evidenced on head CT, with areas of hypoperfusion suggestive of a stroke, and was subsequently diagnosed with Cryptococcal meningitis by CSF PCR. Initial evaluation by the neurology team was that though the diagnosis of Cryptococcal meningitis had been rightly made (supported by leptomeningeal enhancement on MRI) and could substantively account in part for the clinical presentation, her imaging findings of bilateral diffuse emboli in multiple cerebellar territories on MRI, were not characteristic of the thromboembolism caused by the organism, Cryptococcus. Another cause of her embolic event had to be investigated. A chest x-ray showed patchy bibasilar opacities, likely atelectasis, with a low likelihood of pneumonia. Bilateral carotid artery dopplers showed no significant stenosis. A transthoracic echo proved unrevealing, showing a hyperdynamic left ventricular ejection fraction of 70% and a grade I diastolic dysfunction with no noted valvulopathies, and a transesophageal echocardiogram with the view to find out potential valvular lesions was needed. The patient was started on anticoagulation, and further evaluation was deferred. This patient went on to experience deleterious CNS sequelae of the presumptive diagnosis of Cryptococcal meningitis, requiring several lumbar punctures, antifungal treatment with Amphotericin B and flucytosine, later showing no recovery of baseline neurological status. Her GCS remained below 8 by her discharge to palliative care. She was discharged after 14 days of hospitalization to a nursing home. On discharge, it was unknown whether her entire presentation was due to a single disease process or if there were overlapping conditions, including COVID-19-related embolic phenomena. Her prognosis remained guarded at the time of discharge. Outcome of the events was unknown at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report