Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fear of falling, Feeling abnormal, Gait disturbance, Insomnia
Clinical narrative: Their hands are shaky, they even thought they may have Parkinson's disease, due to the tremors in their hands, they are really shaky; Diabetes has gotten out of control, values are very high, they are now diabetic; Dyspnea; feeling bad,they feel really really bad; a lot of pain from their hairs to their toes, intense pain all over their body, in their arms, their legs, their back, pain all over their body/cannot stand the pain, cannot handle the pain; it hurts to walk, afraid of walking for fear of falling; afraid of walking for fear of falling; constant pain in their left arm, it is bad; Cannot sleep at night, cannot stand being in their side; when they walk even a little they are short of breath; Tachycardia; They are forgetting things; pain in their elbow that got more acute after the booster; hard for the patient to even wash their hair/cannot write, cannot pour themselves a glass of water nor hold it, cannot dress themselves/diabetes is so strong and they cannot do exercise; hard for the patient to even wash their hair/cannot write, cannot pour themselves a glass of water nor hold it, cannot dress themselves/diabetes is so strong and they cannot do exercise; Heavy tong; Dry mouth; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Their hands are shaky, they even thought they may have Parkinson's disease, due to the tremors in their hands, they are really shaky), DIABETES MELLITUS INADEQUATE CONTROL (Diabetes has gotten out of control, values are very high, they are now diabetic), DYSPNOEA (Dyspnea), FEELING ABNORMAL (feeling bad,they feel really really bad), PAIN (a lot of pain from their hairs to their toes, intense pain all over their body, in their arms, their legs, their back, pain all over their body/cannot stand the pain, cannot handle the pain), GAIT DISTURBANCE (it hurts to walk, afraid of walking for fear of falling), FEAR OF FALLING (afraid of walking for fear of falling), PAIN IN EXTREMITY (constant pain in their left arm, it is bad), INSOMNIA (Cannot sleep at night, cannot stand being in their side), DYSPNOEA EXERTIONAL (when they walk even a little they are short of breath), TACHYCARDIA (Tachycardia), MEMORY IMPAIRMENT (They are forgetting things), ARTHRALGIA (pain in their elbow that got more acute after the booster), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard for the patient to even wash their hair/cannot write, cannot pour themselves a glass of water nor hold it, cannot dress themselves/diabetes is so strong and they cannot do exercise) and MUSCULAR WEAKNESS (hard for the patient to even wash their hair/cannot write, cannot pour themselves a glass of water nor hold it, cannot dress themselves/diabetes is so strong and they cannot do exercise) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pre-diabetic (controlling it with diet and exercise), Blood pressure high (High blood pressure pills), Allergy (allergy medication) and Pain in elbow. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced TREMOR (Their hands are shaky, they even thought they may have Parkinson's disease, due to the tremors in their hands, they are really shaky) (seriousness criterion medically significant), DIABETES MELLITUS INADEQUATE CONTROL (Diabetes has gotten out of control, values are very high, they are now diabetic) (seriousness criterion medically significant), DYSPNOEA (Dyspnea) (seriousness criterion medically significant), FEELING ABNORMAL (feeling bad,they feel really really bad) (seriousness criterion medically significant), PAIN (a lot of pain from their hairs to their toes, intense pain all over their body, in their arms, their legs, their back, pain all over their body/cannot stand the pain, cannot handle the pain) (seriousness criterion medically significant), GAIT DISTURBANCE (it hurts to walk, afraid of walking for fear of falling) (seriousness criterion medically significant), FEAR OF FALLING (afraid of walking for fear of falling) (seriousness criterion medically significant), PAIN IN EXTREMITY (constant pain in their left arm, it is bad) (seriousness criterion medically significant), INSOMNIA (Cannot sleep at night, cannot stand being in their side) (seriousness criterion medically significant), DYSPNOEA EXERTIONAL (when they walk even a little they are short of breath) (seriousness criterion medically significant), TACHYCARDIA (Tachycardia) (seriousness criterion medically significant), MEMORY IMPAIRMENT (They are forgetting things) (seriousness criterion medically significant), ARTHRALGIA (pain in their elbow that got more acute after the booster) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard for the patient to even wash their hair/cannot write, cannot pour themselves a glass of water nor hold it, cannot dress themselves/diabetes is so strong and they cannot do exercise) (seriousness criterion medically significant), MUSCULAR WEAKNESS (hard for the patient to even wash their hair/cannot write, cannot pour themselves a glass of water nor hold it, cannot dress themselves/diabetes is so strong and they cannot do exercise) (seriousness criterion medically significant), TONGUE DISCOMFORT (Heavy tong), DRY MOUTH (Dry mouth) and FATIGUE (Extreme fatigue). The patient was treated with PARACETAMOL (PANADOL) for Adverse event, at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency; NAPROXEN for Adverse event, at an unspecified dose and frequency and GABAPENTIN (NEURONTIN) for Adverse event, at a dose of Neurontin 100. At the time of the report, TREMOR (Their hands are shaky, they even thought they may have Parkinson's disease, due to the tremors in their hands, they are really shaky), DIABETES MELLITUS INADEQUATE CONTROL (Diabetes has gotten out of control, values are very high, they are now diabetic), DYSPNOEA (Dyspnea), FEELING ABNORMAL (feeling bad,they feel really really bad), PAIN (a lot of pain from their hairs to their toes, intense pain all over their body, in their arms, their legs, their back, pain all over their body/cannot stand the pain, cannot handle the pain), GAIT DISTURBANCE (it hurts to walk, afraid of walking for fear of falling), FEAR OF FALLING (afraid of walking for fear of falling), PAIN IN EXTREMITY (constant pain in their left arm, it is bad), INSOMNIA (Cannot sleep at night, cannot stand being in their side), DYSPNOEA EXERTIONAL (when they walk even a little they are short of breath), TACHYCARDIA (Tachycardia), MEMORY IMPAIRMENT (They are forgetting things), ARTHRALGIA (pain in their elbow that got more acute after the booster), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard for the patient to even wash their hair/cannot write, cannot pour themselves a glass of water nor hold it, cannot dress themselves/diabetes is so strong and they cannot do exercise), MUSCULAR WEAKNESS (hard for the patient to even wash their hair/cannot write, cannot pour themselves a glass of water nor hold it, cannot dress themselves/diabetes is so strong and they cannot do exercise), TONGUE DISCOMFORT (Heavy tong), DRY MOUTH (Dry mouth) and FATIGUE (Extreme fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: high (High) values are very high and they are now diabetic. On an unknown date, X-ray: normal (normal) ok.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had been feeling bad since mid Nov-2021. Today she had an appointment with HCP. She had Booster dose was on 09-Nov-2021, on the right arm. After the second dose it was strange, they developed pain in the left arm, as if they had taken the vaccine in that arm. The pain came and went, they, after a few month they developed pain in their elbow and that got more acute after the booster shot. She stated that since mid Nov-2021 they felt very bad and that their body changed completely. She had extreme fatigue, a lot of pain from their hairs to their toes, it hurts to walk, they have intense pain all over their body, in their arms, their legs, their back. She was afraid of walking for fear of falling. they have pain all over their body and it has put them in bed. She had constant pain in their left arm, it is bad, they can not move it. Had some x-rays that were ok. It was hard for the patient to even wash their hair. Since she was lefthanded she cannot write, cannot pour themselves a glass of water nor hold it, cannot dress themselves. She cannot sleep at night, because she cannot stand being in their side. She get asphyxiated going from the bedroom to the bathroom, when she walk even a little she gets short of breath, it was too much. She had tachycardia. She stated that she cannot stand the pain, cannot handle the pain, felt really really bad. She was even forgetting things. She had taken medication but that has not helped. She stated they are not like this. Her HCP indicated to do an Eco-sonogram and use a Holter. She was pre-diabetic and were controlling it with diet and exercise. Now it has gotten out of control, their values are very high and they are now diabetic. She first noticed she had dry mouth and heavy tong, and now her diabetes was so strong and she cannot do exercise.  Company comment- This spontaneous case concerns a 52 year old female with relevant medical history of Pre DM ( controlled with diet and exercise ) , hypertension who experienced serious ( Medically significant ) unexpected events of Diabetes Mellitus inadequate control,  dyspnea exertional  , dyspnea, tremors, feeling abnormal , pain , fear of falling , gait disturbance , pain in extremity , insomnia, tachycardia  , memory impairment , loss of personal independence in daily activities , muscle weakness ,  arthralgia and non-serious , unexpected events of dry mouth , tongue discomfort   and non-serious , expected event of fatigue which occurred on an unknown date in Nov, 2021 after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . This patient was treated with paracetamol , naproxen sodium and Gabapentin. The re-challenge for this case is not applicable since the events outcome was reported as not resolved and also the events occurred after the 3rd dose and no additional doses will be given. The history of Pre Diabetes  and hypertension may be considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2022-460666 (Patient Link).; Sender's Comments: This spontaneous case concerns a 52 year old female with relevant medical history of Pre DM ( controlled with diet and exercise ) , hypertension who experienced serious ( Medically significant ) unexpected events of Diabetes Mellitus inadequate control,  dyspnea exertional  , dyspnea, tremors, feeling abnormal , pain , fear of falling , gait disturbance , pain in extremity , insomnia, tachycardia  , memory impairment , loss of personal independence in daily activities , muscle weakness ,  arthralgia and non-serious , unexpected events of dry mouth , tongue discomfort   and non-serious , expected event of fatigue which occurred on an unknown date in Nov, 2021 after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . This patient was treated with paracetamol , naproxen sodium and Gabapentin. The re-challenge for this case is not applicable since the events outcome was reported as not resolved and also the events occurred after the 3rd dose and no additional doses will be given. The history of Pre Diabetes  and hypertension may be considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.