chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dysstasia, Gait inability, Immunoglobulin therapy, Injury, Magnetic resonance imaging
Clinical narrative: inability to stand; myelitis; Pain; Urinary retention; constipation; This case was reported by a consumer via call center representative and described the occurrence of myelitis in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 72L29, expiry date 30th June 2020) for prophylaxis.   On 29th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 1st November 2019, 3 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced myelitis (serious criteria hospitalization and GSK medically significant), pain (serious criteria hospitalization), urinary retention (serious criteria hospitalization and GSK medically significant) and constipation (serious criteria hospitalization). On an unknown date, the patient experienced difficulty in standing (serious criteria hospitalization). On an unknown date, the outcome of the myelitis, pain, urinary retention, constipation and difficulty in standing were not recovered/not resolved.   It was unknown if the reporter considered the myelitis, pain, urinary retention, constipation and difficulty in standing to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The reporter was patient's son. The patient received vaccine in left deltoid. The patient the patient developed pain and became bedridden. The patient also developed urinary retention and constipation. The patient could not stand on her own and had magnetic resonance imaging that showed myelitis in T2 of her spine. As a result, the patient was hospitalized for 32 days and was currently in rehabilitation center. The emergency room visit was required. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Magnetic resonance imaging spinal abnormal, Mobility decreased, Muscular weakness, Myelitis, Pain
Clinical narrative: inability to stand; myelitis; Pain; Urinary retention; constipation; This case was reported by a consumer via call center representative and described the occurrence of myelitis in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 72L29, expiry date 30th June 2020) for prophylaxis.   On 29th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 1st November 2019, 3 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced myelitis (serious criteria hospitalization and GSK medically significant), pain (serious criteria hospitalization), urinary retention (serious criteria hospitalization and GSK medically significant) and constipation (serious criteria hospitalization). On an unknown date, the patient experienced difficulty in standing (serious criteria hospitalization). On an unknown date, the outcome of the myelitis, pain, urinary retention, constipation and difficulty in standing were not recovered/not resolved.   It was unknown if the reporter considered the myelitis, pain, urinary retention, constipation and difficulty in standing to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The reporter was patient's son. The patient received vaccine in left deltoid. The patient the patient developed pain and became bedridden. The patient also developed urinary retention and constipation. The patient could not stand on her own and had magnetic resonance imaging that showed myelitis in T2 of her spine. As a result, the patient was hospitalized for 32 days and was currently in rehabilitation center. The emergency room visit was required. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Plasmapheresis, Sensory loss, Urinary retention, Urinary tract infection
Clinical narrative: inability to stand; myelitis; Pain; Urinary retention; constipation; This case was reported by a consumer via call center representative and described the occurrence of myelitis in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 72L29, expiry date 30th June 2020) for prophylaxis.   On 29th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 1st November 2019, 3 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced myelitis (serious criteria hospitalization and GSK medically significant), pain (serious criteria hospitalization), urinary retention (serious criteria hospitalization and GSK medically significant) and constipation (serious criteria hospitalization). On an unknown date, the patient experienced difficulty in standing (serious criteria hospitalization). On an unknown date, the outcome of the myelitis, pain, urinary retention, constipation and difficulty in standing were not recovered/not resolved.   It was unknown if the reporter considered the myelitis, pain, urinary retention, constipation and difficulty in standing to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The reporter was patient's son. The patient received vaccine in left deltoid. The patient the patient developed pain and became bedridden. The patient also developed urinary retention and constipation. The patient could not stand on her own and had magnetic resonance imaging that showed myelitis in T2 of her spine. As a result, the patient was hospitalized for 32 days and was currently in rehabilitation center. The emergency room visit was required. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: X-ray
Clinical narrative: inability to stand; myelitis; Pain; Urinary retention; constipation; This case was reported by a consumer via call center representative and described the occurrence of myelitis in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 72L29, expiry date 30th June 2020) for prophylaxis.   On 29th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 1st November 2019, 3 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced myelitis (serious criteria hospitalization and GSK medically significant), pain (serious criteria hospitalization), urinary retention (serious criteria hospitalization and GSK medically significant) and constipation (serious criteria hospitalization). On an unknown date, the patient experienced difficulty in standing (serious criteria hospitalization). On an unknown date, the outcome of the myelitis, pain, urinary retention, constipation and difficulty in standing were not recovered/not resolved.   It was unknown if the reporter considered the myelitis, pain, urinary retention, constipation and difficulty in standing to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The reporter was patient's son. The patient received vaccine in left deltoid. The patient the patient developed pain and became bedridden. The patient also developed urinary retention and constipation. The patient could not stand on her own and had magnetic resonance imaging that showed myelitis in T2 of her spine. As a result, the patient was hospitalized for 32 days and was currently in rehabilitation center. The emergency room visit was required. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bedridden, Constipation, Dysstasia, Magnetic resonance imaging spinal abnormal, Myelitis
Clinical narrative: inability to stand; myelitis; Pain; Urinary retention; constipation; This case was reported by a consumer via call center representative and described the occurrence of myelitis in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 72L29, expiry date 30th June 2020) for prophylaxis.   On 29th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 1st November 2019, 3 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced myelitis (serious criteria hospitalization and GSK medically significant), pain (serious criteria hospitalization), urinary retention (serious criteria hospitalization and GSK medically significant) and constipation (serious criteria hospitalization). On an unknown date, the patient experienced difficulty in standing (serious criteria hospitalization). On an unknown date, the outcome of the myelitis, pain, urinary retention, constipation and difficulty in standing were not recovered/not resolved.   It was unknown if the reporter considered the myelitis, pain, urinary retention, constipation and difficulty in standing to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The reporter was patient's son. The patient received vaccine in left deltoid. The patient the patient developed pain and became bedridden. The patient also developed urinary retention and constipation. The patient could not stand on her own and had magnetic resonance imaging that showed myelitis in T2 of her spine. As a result, the patient was hospitalized for 32 days and was currently in rehabilitation center. The emergency room visit was required. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Urinary retention
Clinical narrative: inability to stand; myelitis; Pain; Urinary retention; constipation; This case was reported by a consumer via call center representative and described the occurrence of myelitis in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 72L29, expiry date 30th June 2020) for prophylaxis.   On 29th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 1st November 2019, 3 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced myelitis (serious criteria hospitalization and GSK medically significant), pain (serious criteria hospitalization), urinary retention (serious criteria hospitalization and GSK medically significant) and constipation (serious criteria hospitalization). On an unknown date, the patient experienced difficulty in standing (serious criteria hospitalization). On an unknown date, the outcome of the myelitis, pain, urinary retention, constipation and difficulty in standing were not recovered/not resolved.   It was unknown if the reporter considered the myelitis, pain, urinary retention, constipation and difficulty in standing to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The reporter was patient's son. The patient received vaccine in left deltoid. The patient the patient developed pain and became bedridden. The patient also developed urinary retention and constipation. The patient could not stand on her own and had magnetic resonance imaging that showed myelitis in T2 of her spine. As a result, the patient was hospitalized for 32 days and was currently in rehabilitation center. The emergency room visit was required. The reporter consented to follow up.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: ACTH stimulation test normal, Amino acid level normal, Anti-thyroid antibody positive, Antinuclear antibody negative, Blood catecholamines
Clinical narrative: Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Blood catecholamines normal, Blood corticotrophin decreased, Blood creatine phosphokinase normal, Blood follicle stimulating hormone normal, Blood homocysteine normal
Clinical narrative: Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Blood iron normal, Blood luteinising hormone normal, Blood magnesium normal, Blood oestrogen normal, Blood testosterone decreased
Clinical narrative: Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Cognitive disorder, Complement factor C3, Complement factor C4, Complement factor normal, Condition aggravated
Clinical narrative: Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Cortisol decreased, Cortisol normal, Cytogenetic analysis normal, Ehlers-Danlos syndrome, Electrocardiogram normal
Clinical narrative: Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Electrophoresis protein, Epstein-Barr virus test positive, Fatigue, Full blood count normal, Gastric emptying study
Clinical narrative: Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: General physical health deterioration, Glycosylated haemoglobin normal, Histamine normal, Hypermobility syndrome, Impaired gastric emptying
Clinical narrative: Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Inflammation, Insulin-like growth factor, Interleukin level, Iron binding capacity total normal
Clinical narrative: Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test normal, Loss of personal independence in daily activities, Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal normal, Malaise
Clinical narrative: Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Neurological examination abnormal, Pain, Postural orthostatic tachycardia syndrome, Presyncope, Progesterone normal
Clinical narrative: Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Rheumatoid factor negative, Serum ferritin normal, Sleep study normal, Small fibre neuropathy, Sweat test abnormal
Clinical narrative: Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Thyroid function test normal, Tilt table test positive, Tryptase, Ultrasound scan normal, Urine analysis
Clinical narrative: Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Urine analysis normal, Urine copper, Vitamin A normal, Vitamin B12 normal, Vitamin D
Clinical narrative: Pre-syncopal episode following day. Had to go home early from work. Felt extremely tired and achy. Saw PCP May 18 who referred me to neurology and rheumatology due to concerning symptoms and abnormal neuro exam. Continued to get worse over about a week until I could no longer work. Continued to get worse, until called a neurologist friend who gave me steroids to get me to my appointment with a neurologist. Felt much better after week of steroids, neurologist saw me at that time and wasn't concerned due to resolution of symptoms, but within a few days of stopping steroids started to decline again and symptoms slowly became severe. This happened in about 3 monthly cycles of steroids and decline until none of my doctors were comfortable giving me high dose steroids any longer. I continued to decline and take medical leave on and off for extreme POTS exacerbations (or so I thought). Continued with neurologists and cardiologists with no diagnosis or help. In March/April 2018 found a chronic fatigue specialist and treated with much improvement in condition overall. Diagnosed with Chronic pain and malaise, and Chronic Pain Syndrome 6/20/18 by original drs. I can now work part time, but become exhausted, inflammed and in pain, and have cognitive disfunction if I push too hard. I tried to work full time in 9/18 unsuccessfully and was too sick to work at all again after about 5 weeks. Recovered after a couple weeks. Started working in January 2019 2 days per week. Up to 3. I don't think I will ever make 5 days again. I know have to take 17 medications and tons of supplements daily to function at all. I can't miss most without symptoms within hours to days
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; A dose of improperly stored Varivax administered to patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information regarding the patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not provided. On 04-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (strength, dose #, schedule, route of administration were not reported) lot # S002735 expiration date reported as 28-JAN-2021 for prophylaxis (product storage error) reconstituted with properly stored sterile diluent. No additional adverse effects reported. The vaccine underwent temperature excursion of 16.9 Fahrenheit for a duration of 8 hours and 38 minutes. There were no previous temperature excursions. Digital data logger was involved. No product quality complaint.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: a patient who was in the pharmacy was administered a dose of PREVNAR 13 on an unspecified date 2 years ago. Patient is in the pharmacy and will be administered the PNEUMOVAX 23 vaccine on 06-JAN-2020; no adverse event; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date in 2018 (reported as 2 years ago), the patient was vaccinated with pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) for prophylaxis (dose, route, lot# and expiration date were not reported).  On 06-JAN-2020, the patient was in the pharmacy and would be vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route, lot# and expiration date were not reported) (information capable of leading to medication error). No adverse event was reported. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from an attorney regarding a case in litigation, concerning a female patient of unspecified age. Information about her past drug and medical history, concurrent medical conditions, illnesses at vaccination, and concomitant medications was not provided.  In 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider in a hospital, for the long-term prevention of shingles and/or zoster-related conditions (concentration; administered dose, dose number, frequency in vaccination scheme; route and anatomical location of vaccination; lot number and expiration date were not reported).  On an unspecified subsequent date, the patient was treated by a physician for shingles. Her outcome from shingles was not reported; however, it was stated that as a direct and proximate result of her use of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future; therefore, the reporter's causality assessment between shingles occurrence and zoster vaccine live (ZOSTAVAX) administration was considered related.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event; The pharmacist reported a dose of poperly stored Varivax was given intramuscular injection instead of subcutaneous injection; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies.  On 09-JAN-2020, the patient was vaccinated with a properly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 1 injection, intramuscular instead of subcutaneously (incorrect route of product administration), lot number S024368, expiration date 06-AUG-2021 for prophylaxis (anatomical location was not reported). The vaccine was reconstituted with diluent MRK (lot number and expiration date were not reported).   No adverse event was reported.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, UNK
Symptoms: Dizziness, Loss of consciousness, Pallor, Syncope, Vomiting
Clinical narrative: BP (Blood pressure) 188/70 (units not provided); BR (Breathig rate) 25 (units not provided); loss of consciousness; Patient fainted as she was walking out; felt dizzy; Thrown up chocolate; Pale; This spontaneous report was received from a health professional concerning an 11 year old female patient. There was no information about the patient's medical history or concurrent conditions Concomitant vaccines given on the same day included meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid,pertussis acellular vaccine (unspecified), tetanus toxoid(TDAP).  On 08-MAY-2019 at 10:45am, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) lot number R00816A, via intramuscular route in the right thigh for prophylaxis (dose and frequency were not provided). On the same date, at 11:00am, the patient fainted as she was walking out (syncope), felt dizzy (dizziness), pale and thrown up chocolate (vomiting) and lost consciousness. Later, at 11:10am, the patient's BP (Blood pressure) was 188/70 (units not provided) (blood pressure abnormal), BR (breathing rate) 25 (units not provided) (respiration abnormal) and HR (Heart rate) 80 (units not provided). The patient received treatment at doctor's office and felt better in supine position. At the reporting time, the patient recovered from the adverse events. The causality assessment between therapy with the suspect therapies and the aforementioned events was not provided.  Upon internal review, the events syncope and loss of consciousness were determined to be medically significant events.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Immediate post-injection reaction, Rash
Clinical narrative: Persistent rashes and blisters immediately following vaccination; Persistent rashes and blisters immediately following vaccination; This initial spontaneous report was received on 09-JAN-2020, from a lawyer regarding a case in litigation referring to an approximately 70-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 29-NOV-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen information was not reported) for the long-term prevention of shingles and zoster-related conditions. Then, the patient suffered the following injuries and was diagnosed on the following dates as a result of the vaccination: persistent rashes and blisters immediately following vaccination. At the time of the report, the outcome of rash and blister was unknown. The reporter considered rash and blister to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number 2K9T2, expiry date 9th April 2022) for prophylaxis.   On 20th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and paracetamol (Tylenol). On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: The patient experienced pain for 10 days following the injection. It has resolved. She called complained of pain about 3-4 days after and the pharmacist told her to use ice and Tylenol and then she called again asking he report it to the manufacturer.  The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pain, Pain in extremity, Pruritus
Clinical narrative: itching; slept most of the day; swellling; redness; exhausted; pain; arm tenderness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received Shingrix. On 3rd January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 4th January 2020, the patient experienced swelling, erythema, exhaustion, pain and sleepiness. On 5th January 2020, the patient experienced pruritus. On an unknown date, the outcome of the pain in arm, swelling, erythema, exhaustion, pain, pruritus and sleepiness were recovering/resolving.   It was unknown if the reporter considered the pain in arm, swelling, erythema, exhaustion, pain, pruritus and sleepiness to be related to Shingrix.  Additional case details were reported as follows: On Saturday, the patient was exhausted and slept most of the day but she spent 2 hours at the gym and felt great. The outcome of pain in arm, swelling, erythema, exhaustion, pain and pruritus were reported as recovring/resolving in the database however in source document, it was mentioned as Fatal.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Swelling
Clinical narrative: itching; slept most of the day; swellling; redness; exhausted; pain; arm tenderness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received Shingrix. On 3rd January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 4th January 2020, the patient experienced swelling, erythema, exhaustion, pain and sleepiness. On 5th January 2020, the patient experienced pruritus. On an unknown date, the outcome of the pain in arm, swelling, erythema, exhaustion, pain, pruritus and sleepiness were recovering/resolving.   It was unknown if the reporter considered the pain in arm, swelling, erythema, exhaustion, pain, pruritus and sleepiness to be related to Shingrix.  Additional case details were reported as follows: On Saturday, the patient was exhausted and slept most of the day but she spent 2 hours at the gym and felt great. The outcome of pain in arm, swelling, erythema, exhaustion, pain and pruritus were reported as recovring/resolving in the database however in source document, it was mentioned as Fatal.