Sex: F
Vaccine: COVID19
Symptoms: Deafness, Head discomfort, Headache, Hypoaesthesia, Immunisation reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (latest thing I have is left foot neuropathy), DEAFNESS (I have sentinel hearing loss in right ear hearing loss is proven by hearing tests) and HEADACHE (band type headaches had to go to doctor for this because it got worse had to be hospitalized twice to treat headache. No treatment has stopped the pressure headaches debilitating band headaches injection in 5 places in the head didn't help the headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient was a healthy person with no issues. In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced HEADACHE (band type headaches had to go to doctor for this because it got worse had to be hospitalized twice to treat headache no treatment has stopped the pressure headaches debilitating band headaches injection in 5 places in the head didn't help the headache) (seriousness criterion hospitalization). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (latest thing I have is left foot neuropathy) (seriousness criterion medically significant), DEAFNESS (I have sentinel hearing loss in right ear hearing loss is proven by hearing tests) (seriousness criterion medically significant), VACCINATION COMPLICATION (it's a year later and I'm no better), TINNITUS (got ringing in my ears tinnitus in right ear as I talk to you my ears are ringing), HEAD DISCOMFORT (feels like my head will explode), PARAESTHESIA (tingling all over my body weird and creepy it doesn't hurt but is unsettling really suffering), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can no longer function daily sit in the chair all day), HEAD DISCOMFORT (head feels heavy and weighted I have to hold my head up it's ridiculous) and HYPOAESTHESIA (foot has gone numb I was a healthy person before, can't feel my left foot). At the time of the report, NEUROPATHY PERIPHERAL (latest thing I have is left foot neuropathy), DEAFNESS (I have sentinel hearing loss in right ear hearing loss is proven by hearing tests), HEADACHE (band type headaches had to go to doctor for this because it got worse had to be hospitalized twice to treat headache no treatment has stopped the pressure headaches debilitating band headaches injection in 5 places in the head didn't help the headache), VACCINATION COMPLICATION (it's a year later and I'm no better), TINNITUS (got ringing in my ears tinnitus in right ear as I talk to you my ears are ringing), HEAD DISCOMFORT (feels like my head will explode), PARAESTHESIA (tingling all over my body weird and creepy it doesn't hurt but is unsettling really suffering), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can no longer function daily sit in the chair all day), HEAD DISCOMFORT (head feels heavy and weighted I have to hold my head up it's ridiculous) and HYPOAESTHESIA (foot has gone numb I was a healthy person before can't feel my left foot) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative and negative (Negative) Negative. The patient got Moderna COVID-19 vax last year. It had been a year of this report and she did not feel any better. She had AE from the vax different than what was expected. She might get band type headaches, began 2 days after 2nd dose of Moderna vax on Apr-2021, also got ringing in her ears. She went to her doctor because her symptoms get worse. She had sentinel hearing loss and tinnitus in her right ear. She was hospitalized twice to treat her headaches. She felt like her head would explode. No treatment at hospital, IV or oral had helped her. She started a new symptom, tingling all over her body, it felt weird and creepy. It did not hurt but felt unsettling. She could no longer function in her day-life and sat in a chair, felt heavy and weighted. The community where she lived did not know how to treat her. She also recently had neuropathy in her left foot, it had become numb. Prior to the vax, she was healthy, it got worse over time and she was scared that it may keep getting even worse. It was going downhill for her since the 2nd shot and it continued to go downhill to that day. One of her doctors thought she had long COVID symptoms but had 3 COVID tests negative. While she was on the phone with agent, she had to hold her head as she was talking, her ears were ringing and she did not feel her left foot. COMPANY COMMENT: This is an spontaneous case concerning an unknown -years-old patient with no clinical history who experienced the unexpected events of HEADACHE, NEUROPATHY PERIPHERAL, DEAFNESS, VACCINATION COMPLICATION, TINNITUS, HEAD DISCOMFORT, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, HEAD DISCOMFORT and other expected events unknown days after 2nd dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided. The case was assessed as serious by the Regulatory Authority´s report due to IME and hospitalization. Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown -years-old patient with no clinical history who experienced the unexpected events of HEADACHE, NEUROPATHY PERIPHERAL, DEAFNESS, VACCINATION COMPLICATION, TINNITUS, HEAD DISCOMFORT, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, HEAD DISCOMFORT and other expected events unknown days after 2nd dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided. The case was assessed as serious by the Regulatory Authority´s report due to  IME and hospitalization.