Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cognitive disorder, Headache, Nausea, Visual impairment
Clinical narrative: covid-19 prior to Paxlovid treatment.; Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit; Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit; Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit; Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment.), VISUAL IMPAIRMENT (Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit), COGNITIVE DISORDER (Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit), HEADACHE (Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit) and NAUSEA (Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Stress at work (work stress due to healthcare provider) and Allergy. Concomitant products included SERTRALINE from 01-Aug-2019 to an unknown date for an unknown indication.    On 03-Apr-2022 at 3:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced VISUAL IMPAIRMENT (Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit), COGNITIVE DISORDER (Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit), HEADACHE (Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit) and NAUSEA (Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit). On an unknown date, the patient experienced COVID-19 (covid-19 prior to Paxlovid treatment.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 30-May-2022 to 02-Jun-2022 for COVID-19 treatment, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 03-Jun-2022, COVID-19 (covid-19 prior to Paxlovid treatment.), VISUAL IMPAIRMENT (Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit), COGNITIVE DISORDER (Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit), HEADACHE (Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit) and NAUSEA (Severe headache, worse when bending over, slight visual changes with retrobu bar pressure worse with bending which was new, difficult looking at fast moving screens, slow cognition, nausea, no tinnit) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Race was reported as UNKNOWN  It was reported that slight visual changes with retrobulbar pressure worse with bending which was new. Patient had not experienced tinnitus  Treatment ibuprofen not working, intensity worse closer to timing of dose Device Date 03 Jun 2022  Company Comment: This spontaneous case concerns a 53-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred unspecified days after receiving the fourth dose of mRNA-1273 vaccine and non-serious events of Visual impairment, Cognitive disorder, Headache and Nausea which occurred approximately 1 month after the fourth dose of mRNA-1273 vaccine.  It was reported patient had slight visual changes with worsened retrobulbar pressure while bending, difficulty looking at fast moving screens, slow cognition, and nausea. Patient was treated with Paxlovid from 30 th May to 3 rd June 2022 for Covid-19. Patients using sertraline could be confounding for events headache and nausea. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 53-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred unspecified days after receiving the fourth dose of mRNA-1273 vaccine and non-serious events of Visual impairment, Cognitive disorder, Headache and Nausea which occurred approximately 1 month after the fourth dose of mRNA-1273 vaccine.  It was reported patient had slight visual changes with worsened retrobulbar pressure while bending, difficulty looking at fast moving screens, slow cognition, and nausea. Patient was treated with Paxlovid from 30 th May to 3 rd June 2022 for Covid-19. Patients using sertraline could be confounding for events headache and nausea. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.