Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Swelling in my brain / vacular leaking and swelling; Lossing my vision/ deteriorating vision loss; Bilateral hearing loss; Constant headaches; Got COVID even after the vaccine; Got covid, it was not even effective; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN OEDEMA (Swelling in my brain / vacular leaking and swelling), BLINDNESS (Lossing my vision/ deteriorating vision loss) and DEAFNESS BILATERAL (Bilateral hearing loss) in a 39-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.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BRAIN OEDEMA (Swelling in my brain / vacular leaking and swelling) (seriousness criterion medically significant), BLINDNESS (Lossing my vision/ deteriorating vision loss) (seriousness criterion medically significant), DEAFNESS BILATERAL (Bilateral hearing loss) (seriousness criterion medically significant), HEADACHE (Constant headaches), COVID-19 (Got COVID even after the vaccine) and VACCINATION FAILURE (Got covid, it was not even effective). At the time of the report, BRAIN OEDEMA (Swelling in my brain / vacular leaking and swelling), BLINDNESS (Lossing my vision/ deteriorating vision loss), DEAFNESS BILATERAL (Bilateral hearing loss) and HEADACHE (Constant headaches) had not resolved and COVID-19 (Got COVID even after the vaccine) and VACCINATION FAILURE (Got covid, it was not even effective) outcome was unknown.            No concomitant medications were reported. It was reported that patient was completely healthy, active and felt better than in whole life before the vaccine. Patient was hesitant to get the vaccine initially but later felt to keep son and mother safe as they have severe medical issues went a head and got the vaccine doses in May/June of 2021.   It was reported that patient have been battling every day with debiliating side effects after the vaccine. It was reported that patient had undergone many tests by multiple hospitals and facilities and was refered to numerous specialists. Patient also underwent numerous MRI's, spinal taps, blood testing, brain scan, angiogram and more. During these tests patient was found that vision loss was deteriorating and had to receive injections every four weeks. Patient had swelling in brain, vascular leaking and swelling, bilateral hearing loss which was diminished in both ears, and there were many other issues. It was reported that brain swelling is the most frightening as there was no way to monitor personally on day-to-day basis. The constant headaches were difficult to manage.  It was reported that patient was taking 15 pills per day, just to keep thing stable and have to take more when flare-ups and have to fight to get things back under control. The vision on the right eye which was dominant eye and has almost completely lost on multiple occasions, but the retinologist had been able to fight the deterioration off as long as he could.  Ther was no help from the people in the cuurent situation, there was no releif and no treatment options being provided and spoke with many doctors about the reactions but do not know what to do with reactions they were seeing. Patient was regularly travelling to seven medical facilities in two states for the appointments.  Company Comment: This is a spontaneous case concerning a 39-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of brain oedema, blindness, and deafness bilateral among other non-serious events. Vaccination failure was also reported in this case. The events occurred unknown days after the second dose of mRNA-1273 vaccine. It was reported that patient undergo numerus of blood test, MRIs, spinal taps, brain scans, angiograms and more but no results were reported. She had to take injections every four weeks. No further information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the events was not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as reported.; Sender's Comments: This is a spontaneous case concerning a 39-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of brain oedema, blindness, and deafness bilateral among other non-serious events. Vaccination failure was also reported in this case. The events occurred unknown days after the second dose of mRNA-1273 vaccine. It was reported that patient undergo numerus of blood test, MRIs, spinal taps, brain scans, angiograms and more but no results were reported. She had to take injections every four weeks. No further information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the events was not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as reported.