Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Lost sight in the right eye; They said it was spinal meningitis/ really bad headache/ Light really hurt the eyes; They said the patient had intercranial hypertension; right eye was hemorrhaging/ left eye had a spot on it and the eye sight was deteriorating; One of the shots, the needle hit the bone; a huge lymph node on the collarbone; This spontaneous case was reported by a patient and describes the occurrence of MENINGITIS (They said it was spinal meningitis/ really bad headache/ Light really hurt the eyes), INTRACRANIAL PRESSURE INCREASED (They said the patient had intercranial hypertension), BLINDNESS (Lost sight in the right eye) and EYE HAEMORRHAGE (right eye was hemorrhaging/ left eye had a spot on it and the eye sight was deteriorating) in a female patient of an unknown age 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 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 August 2021, the patient experienced LYMPHADENOPATHY (a huge lymph node on the collarbone). On 31-Aug-2021, the patient experienced MENINGITIS (They said it was spinal meningitis/ really bad headache/ Light really hurt the eyes) (seriousness criteria hospitalization and medically significant). On 15-Sep-2021, the patient experienced INTRACRANIAL PRESSURE INCREASED (They said the patient had intercranial hypertension) (seriousness criteria hospitalization and medically significant). In September 2021, the patient experienced BLINDNESS (Lost sight in the right eye) (seriousness criteria hospitalization and medically significant). On 28-Sep-2021, the patient experienced EYE HAEMORRHAGE (right eye was hemorrhaging/ left eye had a spot on it and the eye sight was deteriorating) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (One of the shots, the needle hit the bone). The patient was hospitalized from 15-Sep-2021 to 17-Sep-2021 due to INTRACRANIAL PRESSURE INCREASED, and then from 29-Sep-2021 to 09-Oct-2021 due to EYE HAEMORRHAGE. The patient was treated with ACETAZOLAMIDE (DIAMOX [ACETAZOLAMIDE]) for Spots before eyes, at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency and TOPIRAMATE at an unspecified dose and frequency. At the time of the report, MENINGITIS (They said it was spinal meningitis/ really bad headache/ Light really hurt the eyes), INTRACRANIAL PRESSURE INCREASED (They said the patient had intercranial hypertension), BLINDNESS (Lost sight in the right eye), EYE HAEMORRHAGE (right eye was hemorrhaging/ left eye had a spot on it and the eye sight was deteriorating), LYMPHADENOPATHY (a huge lymph node on the collarbone) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (One of the shots, the needle hit the bone) outcome was unknown.            No concomitant medications were reported.  On an unknown date, the patient received booster dose of Moderna COVID-19 Vaccine.  In Aug-2021, the patient had received the Moderna Covid-19 vaccine and got a really bad headache and a huge lymph node on her collarbone. On 31-Aug-2021, she went to urgent care and got Toradol, which did not work. After being admitted to the hospital, they did a spinal tap on the patient and said that it was spinal meningitis. She was discharged 3 days later. They later said the patient had Covid-19, which she did not have. She did not know if they were charging Moderna for all of this, or not. The patient visited the physician for deteriorating eyesight and they prescribed Diamox. On 15-Sep-2021, she had a reaction to Diamox and was admitted to the hospital. She stayed in the hospital for 3 days. They said that she had intercranial hypertension. She saw a neurologist who prescribed to perform eye exams every month. They gave her a prescription for Topiramate. On 28-Sep-2021, the patient saw an ophthalmologist associated with neuro health, who said that her right eye was hemorrhaging. On 29-Sep-2021, she was admitted to the hospital, because her right eye was hemorrhaging. She was there for 11 days. 2 different physicians said that if something happened to her, then the patient would have a 50-50 chance of survival. There were things in her medical records that were not true. The patient stated that she did not know what they were trying to protect for themselves. The reporter appeared to not clearly recall some of the details and appeared to be confused when sharing the number of dates/days of in-patient hospital stays.  Company Comment : This spontaneous case concerns a female patient of unknown age with no medical history information reported who experienced the unexpected, serious (hospitalization, medically significant) adverse event of special interest Meningitis and unexpected, serious (hospitalization, medically significant) events of Intracranial pressure increased, Blindness and Eye hemorrhage which occurred after receiving an unspecified dose number of mRNA-1273. Wrong technique in product usage process was also noted in the case as patient reported unusual technique during vaccine administration. The patient received mRNA-1273 as primary series and booster doses of COVID-19 immunization series. The patient developed severe headache, photophobia, and lymphadenopathy on the same month of mRNA-1273 vaccination. She consulted the emergency room and was given ketorolac which afforded no relief of the condition. A spinal tap was performed but findings were not reported. She was admitted in the hospital for three days with a diagnosis of meningitis. On the next month after vaccination and 7 days after hospital admission for meningitis, she developed visual spots and blurring of vision. Physician consultation was done but diagnosis was not provided. She was prescribed with Acetazolamide but developed an unspecified drug reaction leading to hospital readmission. She stayed in the hospital for three days with a diagnosis of intercranial hypertension. There was information on diagnostic evaluation and treatment provided. Neurologist consultation was also done but no diagnosis was reported. She was prescribed with Topiramate and advised to have monthly eye examination. One month after vaccination, she developed blindness of the right eye. She was admitted in the hospital for 11 days due to eye hemorrhage. The clinical course, diagnostic evaluation and detailed treatment information were not reported. Increased intracranial pressure is a complication of meningitis leading papilledema and loss of vision. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no medical history information reported who experienced the unexpected, serious (hospitalization, medically significant) adverse event of special interest Meningitis and unexpected, serious (hospitalization, medically significant) events of Intracranial pressure increased, Blindness and Eye hemorrhage which occurred after receiving an unspecified dose number of mRNA-1273. Wrong technique in product usage process was also noted in the case as patient reported unusual technique during vaccine administration. The patient received mRNA-1273 as primary series and booster doses of COVID-19 immunization series. The patient developed severe headache, photophobia, and lymphadenopathy on the same month of mRNA-1273 vaccination. She consulted the emergency room and was given ketorolac which afforded no relief of the condition. A spinal tap was performed but findings were not reported. She was admitted in the hospital for three days with a diagnosis of meningitis. On the next month after vaccination and 7 days after hospital admission for meningitis, she developed visual spots and blurring of vision. Physician consultation was done but diagnosis was not provided. She was prescribed with Acetazolamide but developed an unspecified drug reaction leading to hospital readmission. She stayed in the hospital for three days with a diagnosis of intercranial hypertension. There was information on diagnostic evaluation and treatment provided. Neurologist consultation was also done but no diagnosis was reported. She was prescribed with Topiramate and advised to have monthly eye examination. One month after vaccination, she developed blindness of the right eye. She was admitted in the hospital for 11 days due to eye hemorrhage. The clinical course, diagnostic evaluation and detailed treatment information were not reported. Increased intracranial pressure is a complication of meningitis leading papilledema and loss of vision. The benefit-risk relationship of mRNA-1273 is not affected by this report.