Age: 55.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19, FLUX
Symptoms: Paraesthesia, Peripheral swelling, Pyrexia, Retching, SARS-CoV-2 antibody test negative
Clinical narrative: I also now have polyneuropathy shoulder, neck, arms and feet; Later that night i was delerious with fever; there are times when i feel such desperate that i have considered suicide; I have a painful streak going up both sides of my neck and those have not went away; my nose started run; Feeling weak/did not have the strength/too weak to find my phone/extremely week; would get back to bed, slowly and start dry heaving; in ability to move then when I need them to move; My back has had some serious tension knots that seemed to be related to my hands/the knots get so painful I can barely take it and they are not normal to be there this long; my ankles are both swelling up daily; have been strugling with depression; would go to the bathroom and had diarrhea; Muscle ache/about an hour later my body started to feel sore and achy; extreme high fever; find myself shivering and violently shaking uncontrolabally/chills; Fatigue; I was holding trash can to puke; i get head aches often; I am scared of my eyes seeing double which happens daily/it happens in episodes/sometimes its long and sometimes it comes and goes; was on disability for broken leg/it was fractured/could bare no weight on my leg/it took my leg 4 long months to heal; was dripping wet my whole bed was drenched/sweating terribly/ had not sweated in years and now I an dripping wet every day all day, everytime I sweat, I would start to dry heave; This spontaneous case was reported by a patient and describes the occurrence of DIPLOPIA (I am scared of my eyes seeing double which happens daily/it happens in episodes/sometimes its long and sometimes it comes and goes), LOWER LIMB FRACTURE (was on disability for broken leg/it was fractured/could bare no weight on my leg/it took my leg 4 long months to heal), POLYNEUROPATHY (I also now have polyneuropathy shoulder, neck, arms and feet), DELIRIUM FEBRILE (Later that night i was delerious with fever) and SUICIDAL IDEATION (there are times when i feel such desperate that i have considered suicide) in a 55-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.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    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 and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced DIPLOPIA (I am scared of my eyes seeing double which happens daily/it happens in episodes/sometimes its long and sometimes it comes and goes) (seriousness criterion disability), LOWER LIMB FRACTURE (was on disability for broken leg/it was fractured/could bare no weight on my leg/it took my leg 4 long months to heal) (seriousness criterion disability), POLYNEUROPATHY (I also now have polyneuropathy shoulder, neck, arms and feet) (seriousness criterion medically significant), DELIRIUM FEBRILE (Later that night i was delerious with fever) (seriousness criterion medically significant), SUICIDAL IDEATION (there are times when i feel such desperate that i have considered suicide) (seriousness criterion medically significant), NECK PAIN (I have a painful streak going up both sides of my neck and those have not went away), RHINORRHOEA (my nose started run), ASTHENIA (Feeling weak/did not have the strength/too weak to find my phone/extremely week), RETCHING (would get back to bed, slowly and start dry heaving), HYPOKINESIA (in ability to move then when I need them to move), MUSCULOSKELETAL DISCOMFORT (My back has had some serious tension knots that seemed to be related to my hands/the knots get so painful I can barely take it and they are not normal to be there this long), JOINT SWELLING (my ankles are both swelling up daily), HYPERHIDROSIS (was dripping wet my whole bed was drenched/sweating terribly/ had not sweated in years and now I an dripping wet every day all day, everytime I sweat, I would start to dry heave), DEPRESSION (have been strugling with depression), DIARRHOEA (would go to the bathroom and had diarrhea), MYALGIA (Muscle ache/about an hour later my body started to feel sore and achy), PYREXIA (extreme high fever), CHILLS (find myself shivering and violently shaking uncontrolabally/chills), FATIGUE (Fatigue), VOMITING (I was holding trash can to puke) and HEADACHE (i get head aches often). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, DIPLOPIA (I am scared of my eyes seeing double which happens daily/it happens in episodes/sometimes its long and sometimes it comes and goes), DELIRIUM FEBRILE (Later that night i was delerious with fever), SUICIDAL IDEATION (there are times when i feel such desperate that i have considered suicide), RHINORRHOEA (my nose started run), ASTHENIA (Feeling weak/did not have the strength/too weak to find my phone/extremely week), RETCHING (would get back to bed, slowly and start dry heaving), HYPOKINESIA (in ability to move then when I need them to move), MUSCULOSKELETAL DISCOMFORT (My back has had some serious tension knots that seemed to be related to my hands/the knots get so painful I can barely take it and they are not normal to be there this long), JOINT SWELLING (my ankles are both swelling up daily), DEPRESSION (have been strugling with depression), MYALGIA (Muscle ache/about an hour later my body started to feel sore and achy), PYREXIA (extreme high fever), CHILLS (find myself shivering and violently shaking uncontrolabally/chills), FATIGUE (Fatigue) and HEADACHE (i get head aches often) outcome was unknown, LOWER LIMB FRACTURE (was on disability for broken leg/it was fractured/could bare no weight on my leg/it took my leg 4 long months to heal), HYPERHIDROSIS (was dripping wet my whole bed was drenched/sweating terribly/ had not sweated in years and now I an dripping wet every day all day, everytime I sweat, I would start to dry heave), DIARRHOEA (would go to the bathroom and had diarrhea) and VOMITING (I was holding trash can to puke) had resolved and POLYNEUROPATHY (I also now have polyneuropathy shoulder, neck, arms and feet) and NECK PAIN (I have a painful streak going up both sides of my neck and those have not went away) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: MRI seemed normal except that one part that said she had white brain matter in her brain.. On an unknown date, Ophthalmological examination: When doctor examined her eyes, after testing he said that the muscles that hold her eyes were not moving in unison, they were moving independently from each other and said the most common cause was stroke.. On an unknown date, SARS-CoV-2 antibody test: Never had the COVID-19 virus.. On an unknown date, SARS-CoV-2 test: (Negative) Negative.         No concomitant medication reported.  Patient got first and second COVID vaccine and booster on a Friday. She took unspecified flu shot in left arm along with booster. After some time, she started sneezing and an hour later body ached. She had horrible shakes which was more than shivers. She was hot to the touch and there was nothing left to puke and stayed liked this through the weekend into Tuesday. Patient was afraid that this was bad, and she could be dying. When she looked at phone or TV, they would separate into two because of which she had to concentrate very hard and if she closes one eye her perspective would get better. Patient was in and out of consciousness. While driving she could see more than one lane and couldn't judge how far the car was Infront of her, after shaking head her vision would get cleared for a moment. She reported that her leg broke because her eyesight was affected, and she needed a case and gave crutches which she could not use. She did not have the strength to take one step, if she takes five steps would sweat profusely, dry heave and after resting for a moment again it happens, and this went on for three months. It was reported as patient had sleepless nights and feelings of unease. Patient reported distorted eyesight, her eye was still jacked, and it got so bad that she cannot drive at night. When she looked something on floor it would appear as floating several inches above the floor and same went with nail or screw which seemed like floating in front of wall but not attached. She could barely grip anything with hands as she drops it. She reported that when her toe was hurt it would take five times the normal amount of time to gain her composure.   It was reported as Involuntary movements, Cramping, feet are often numb, her hands would get so numb that they would be painful and wake her up at night, the nerves in her shoulder are hurt so bad that she afraid to move, might disturb it more that it was already nerve issue, tingly burning, and her arms hurt/nothing can touch her toes without her buckling over in pain. Patient had three MRI and CAT scan. On 28-Jun-2022, she was put on 6 months disability due to visual problems but now she reported that disability was gone. She saw neurologist on 01-Jul-2022. She spends most day applying nerve oil, wrapped up with heating pad and had nerve balm that must put on every half an hour. She had been taking gabapentin which have not gained any relief. Patient had never been suicidal.  Company Comment: This spontaneous case concerns a 55-year-old female patient, with no reported medical history, who experienced the unexpected serious (disability) events of Diplopia and Lower limb fracture, unexpected serious (medically significant) events of Polyneuropathy, Delirium febrile (reported as delirious with fever), and Suicidal ideation after receiving the mRNA-1273 vaccine as 3rd dose and co-suspect drug Influenza vaccine. Onset latency could not be determined as date of vaccination and onset dates of events were not provided. After vaccination, patient experienced high grade fever causing delirium, polyneuropathy on shoulder, neck, upper and lower extremities presented as red hot with tingling ang burning sensation, involuntary movements, pain, cramps, and inability to move, and double vision that led to an accident resulting in leg fracture. Patient sought consult, magnetic resonance imaging was done and showed fracture and cast was applied. Patient also consulted eye specialist and reported that ocular muscles fail to move in unison. Patient was advised referral to neurologist.  Magnetic resonance was done, and report stated that it seemed normal. CT scans done but results not provided. Cast was removed after 4 months. Diplopia still intermittently persisted. The report stated that patient had struggling with depression and suicidal ideations. On an unknown date, SARS-CoV-2 was reported as negative. Patient took gabapentin which offered no relief. On an unknown date, patient received 1st and 2nd doses of COIVID-19 vaccine. It was reported that patient received the flu shot together with the mRNA-1273 vaccine 3rd dose. Co-suspect Influenza vaccine could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness was assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient, with no reported medical history, who experienced the unexpected serious (disability) events of Diplopia and Lower limb fracture, unexpected serious (medically significant) events of Polyneuropathy, Delirium febrile (reported as delirious with fever), and Suicidal ideation after receiving the mRNA-1273 vaccine as 3rd dose and co-suspect drug Influenza vaccine. Onset latency could not be determined as date of vaccination and onset dates of events were not provided. After vaccination, patient experienced high grade fever causing delirium, polyneuropathy on shoulder, neck, upper and lower extremities presented as red hot with tingling ang burning sensation, involuntary movements, pain, cramps, and inability to move, and double vision that led to an accident resulting in leg fracture. Patient sought consult, magnetic resonance imaging was done and showed fracture and cast was applied. Patient also consulted eye specialist and reported that ocular muscles fail to move in unison. Patient was advised referral to neurologist.  Magnetic resonance was done, and report stated that it seemed normal. CT scans done but results not provided. Cast was removed after 4 months. Diplopia still intermittently persisted. The report stated that patient had struggling with depression and suicidal ideations. On an unknown date, SARS-CoV-2 was reported as negative. Patient took gabapentin which offered no relief. On an unknown date, patient received 1st and 2nd doses of COIVID-19 vaccine. It was reported that patient received the flu shot together with the mRNA-1273 vaccine 3rd dose. Co-suspect Influenza vaccine could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness was assessed based on medical judgement.