chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 80 year old male patient. On 07-MAY-2014 the patient was vaccinated with ZOSTAVAX (lot # J007208, expiration date: 20-SEP-2014, strength and dose not reported), subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown), PRILOSEC, ZOCOR and hydrochlorothiazide. On 07-MAY-2014, the patient experienced rash and pain in his back. The patient sought unspecified medical attention. On 13-MAY-2014, the patient came to the pharmacy to get a prescription filled for VALTREX for the rash that he stated he developed on the middle portion of his back after getting ZOSTAVAX. The patient was also treated with TYLENOL and codeine. Therapy with ZOSTAVAX was not reintroduced. The outcome of pain in his back and rash was reported as recovering/resolving. The reporter considered rash and pain in back to be significant disability. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 80 year old male patient. On 07-MAY-2014 the patient was vaccinated with ZOSTAVAX (lot # J007208, expiration date: 20-SEP-2014, strength and dose not reported), subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown), PRILOSEC, ZOCOR and hydrochlorothiazide. On 07-MAY-2014, the patient experienced rash and pain in his back. The patient sought unspecified medical attention. On 13-MAY-2014, the patient came to the pharmacy to get a prescription filled for VALTREX for the rash that he stated he developed on the middle portion of his back after getting ZOSTAVAX. The patient was also treated with TYLENOL and codeine. Therapy with ZOSTAVAX was not reintroduced. The outcome of pain in his back and rash was reported as recovering/resolving. The reporter considered rash and pain in back to be significant disability. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: RED, SWOLLEN, AND SORE ARM.
Age: 1.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Crying, Decreased appetite, Poor quality sleep, Pyrexia, Screaming
Clinical narrative: Fever over 103 degrees - measured by rectal thermometer.  Temperature went on for 3-4 days.  Even after fever ceased, it has been 5 days now, her temperament has not returned to what it was.  Patient will scream and cry randomly which is not at all typical behavior for her.  She has not been sleeping well as she wakes constantly and is very difficult to put back down.  Again, this is all new since she received her vaccinations.  She will only take fluids if she is nursed and is still does not have much of an appetite, although it has increased slightly.  She has not been around anyone with a virus.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Back pain, Herpes zoster, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient developed a case of shingles after the second varicella shot. Symptoms included rash and pain on one side of body, back, neck & arm areas. Doctor was notified and medicine was given to her to lessen symptoms. Also of note - she had a mild case of chicken pox at the age of 4 months that she caught from her older sister. Her pediatrician at that time (1996) said this was the equivalent of having the vaccine and she would have immunity to the chicken pox. It was discovered at a check-up when she was 17 years old that she did not have the antibodies in her blood & should therefore get the varicella vaccine. She did not have an adverse reaction to the 1st shot which was given on 1/7/2014, but then got shingles after the second shot.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Patient developed a case of shingles after the second varicella shot. Symptoms included rash and pain on one side of body, back, neck & arm areas. Doctor was notified and medicine was given to her to lessen symptoms. Also of note - she had a mild case of chicken pox at the age of 4 months that she caught from her older sister. Her pediatrician at that time (1996) said this was the equivalent of having the vaccine and she would have immunity to the chicken pox. It was discovered at a check-up when she was 17 years old that she did not have the antibodies in her blood & should therefore get the varicella vaccine. She did not have an adverse reaction to the 1st shot which was given on 1/7/2014, but then got shingles after the second shot.
Age: 1.55
Sex: F
Vaccine: DTAPH, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: First day had hives and welts forming on back and chest, then the next day covered her entire body from head to toe. Was not allowed into daycare until I received a doctor's note.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Allodynia, Antibody test negative, Ataxia, Blindness, Blindness unilateral
Clinical narrative: Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: CSF cell count increased, CSF culture negative, CSF glucose normal, CSF lymphocyte count normal, CSF monocyte count negative
Clinical narrative: Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: CSF oligoclonal band absent, CSF polymorphonuclear cell count increased, CSF pressure increased, CSF protein increased, CSF white blood cell count increased
Clinical narrative: Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Central nervous system lesion, Constipation, Demyelination, Diarrhoea, Diplopia
Clinical narrative: Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dysuria, Encephalopathy, Enterovirus test negative, Eyelid ptosis, Headache
Clinical narrative: Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Herpes simplex serology negative, Hyperaesthesia, Hypersomnia, Influenza, Irritability
Clinical narrative: Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Laboratory test normal, Lymphocyte percentage, Malaise, Middle insomnia, Migraine
Clinical narrative: Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Monocyte percentage increased, Mycoplasma test, Myelitis transverse, Nausea, Neurological examination abnormal
Clinical narrative: Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Neuromyelitis optica, Neutrophil percentage decreased, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Optic neuritis
Clinical narrative: Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Oropharyngeal pain, Pleocytosis, Polymerase chain reaction, Pruritus, Pupillary reflex impaired
Clinical narrative: Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Red blood cells CSF positive, Residual urine volume increased, Somnolence, Urinary retention
Clinical narrative: Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Viral test negative, Vision blurred, Visual acuity reduced, Vomiting, Weight decreased
Clinical narrative: Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: Developed neuromyelitis optica (bilateral optic neuritis and longitudinally extensive transverse myelitis plus encephalopathy).  Prior Demyelinating Events and Treatments Dec 5, 2013: immunizations given by PMD (varicella #2, Tdap, Meningococcal). Dec 19, 2013:  Fever, sore throat, didn't feel well, diagnosed with Flu (type unknown) on 12/22/2013; improved a little, then Dec 25-27, return of fever to 101, more headache; vomiting on Dec 27; severe emesis Dec 28; went to ED; so was admitted to Peds Group; admitted for 4 days; slept >4 days, awake <30 minutes per day but was appropriate when awakened.  Discharged from MC on 1/1 (WBC still 18K, but trending down).  Continued sleeping a lot with severe headache.  On Jan 3, LP obtained at MC which showed CSF pleocytosis with elevated opening pressure (30 cm CSF) but negative cultures;  also HR in 40's.  She was transferred to another hospital 1/5-1/8; treated as migraine. A little better but on day of discharge patient had diarrhea and emesis.  Patient had a lot of throwing up on the way home.  At home, she slept most of the time; no more vomiting but occasional nausea; low grade fevers (<100.5)   Weight loss of 10-11 lbs. On 1/13/2013 she developed blurry vision, horizontal diplopia; was waking up in the middle of the night, felt like she had to go to the bathroom but couldn't go; Also severe constipation, no stools since discharge on 1/8/2014; parents also noted sleepiness, irritability and bilateral ptosis then horizontal diplopia. Developed allodynia and paroxysmal itching.  No hiccups, dysphagia, dysarthria, focal weakness.  Acute loss of left eye vision on 1/16/2014 without painful eye movement; readmitted to hospital on 1/17 where exam documented visual acuity 20/100 OD, no light perception OS with left APD. No focal weakness but diffuse hypersensitivity to touch and mild ataxia bilaterally. She was also somnolent and very irritable. She had urinary post-void residuals of >200 ml. MRI brain showed optic nerve swelling; medullar lesion. Treated with methylprednisolone 1 g x 6 days followed by slow prednisone taper x 8 weeks. Visual acuity and remainder of neuro exam returned to baseline.
Age: 23.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Malaise, Sinus tachycardia, Supraventricular tachycardia, Tachycardia, Valsalva maneuver
Clinical narrative: Patient reported "not feeling well" after vaccine administration. Vitals were checked - patient in SVT at 177 with BP of 129/78. Valsalva maneuver abated SVT and patient returned to Sinus Tach. Patient a few minutes later began having tachycardia into the 170's and with use of Valsalva maneuver and metoprolol returned to a normal sinus rate in the 70's.
Age: 23.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Heart rate increased, Malaise, Supraventricular tachycardia
Clinical narrative: Patient reported "not feeling well" after vaccine administration. Vitals were checked - patient in SVT at 177 with BP of 129/78. Valsalva maneuver abated SVT and patient returned to Sinus Tach. Patient a few minutes later began having tachycardia into the 170's and with use of Valsalva maneuver and metoprolol returned to a normal sinus rate in the 70's.
Age: 1.02
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Audiogram abnormal, Brain stem auditory evoked response abnormal, Deafness bilateral, Deafness neurosensory, Otoacoustic emissions test abnormal
Clinical narrative: Patient stopped responding to name and verbal commands, stopped making baby talk, and started making high pitch sounds.
Age: 1.02
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Speech disorder, Speech disorder developmental, Tympanometry normal, Unresponsive to stimuli
Clinical narrative: Patient stopped responding to name and verbal commands, stopped making baby talk, and started making high pitch sounds.
Age: 31.0
Sex: F
Vaccine: IPV, MEN, PPV, TYP
Symptoms: Abdominal pain, Arthralgia, Chills, Decreased appetite, Dizziness
Clinical narrative: It started with soreness at injection site. By late evening fatigue, swollen/sore joints, chills, low grade fever, headache, dizziness, nausea, abdominal pain, and dizziness set in. The injection site on right arm developed redness and swelling on Saturday morning and has worsened through Sunday. Nausea and decreased appetite has increased to Sunday night.
Age: 31.0
Sex: F
Vaccine: IPV, MEN, PPV, TYP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: It started with soreness at injection site. By late evening fatigue, swollen/sore joints, chills, low grade fever, headache, dizziness, nausea, abdominal pain, and dizziness set in. The injection site on right arm developed redness and swelling on Saturday morning and has worsened through Sunday. Nausea and decreased appetite has increased to Sunday night.
Age: 31.0
Sex: F
Vaccine: IPV, MEN, PPV, TYP
Symptoms: Joint swelling, Nausea, Pyrexia
Clinical narrative: It started with soreness at injection site. By late evening fatigue, swollen/sore joints, chills, low grade fever, headache, dizziness, nausea, abdominal pain, and dizziness set in. The injection site on right arm developed redness and swelling on Saturday morning and has worsened through Sunday. Nausea and decreased appetite has increased to Sunday night.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced redness, swelling, and fever around the injection site. Pt was given AUGMENTIN 875-125 mg.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported large swelling at site of injection. Warm to touch and slightly tender.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Pharmacist reported that on 13-MAY-2014 the patient received injection of ZOSTAVAX which expired on 11-APR-2014 and Lot number J000444. Pharmacist reported that no adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with no pertinent medical history and drug reactions/allergies. On 10-MAY-2014 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot#J011828/Exp date 12/26/2014) subcutaneous for prevention of shingles. Injection location was not reported. On 10-MAY-2014, the patient experienced a red, swollen, and oval shaped reaction (about three inches in diameter) around the injection site after receiving ZOSTAVAX. Pharmacist reported that patient did not experience any itching or irritation at injection site. The patient saw pharmacist for medical attention. The outcome of the event was unknown. The causality of the event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 6 months old patient. On 05-MAY-2014 the patient was inadvertently vaccinated with  GARDASIL (lot# not reported), 0.5 ml, intramuscularly. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Abdominal discomfort, Activities of daily living impaired, Adverse drug reaction, Computerised tomogram head normal, Diplopia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age (not pregnant, no other medical history provided). On an unknown date, the physician administered GARDASIL dose 1, intramuscularly (lot#, expiration date and dose unknown) to a patient. No concomitant therapy was reported. On an unknown date, after the first dosage of vaccine, the patient experienced developed migraines and she was also getting breakthrough menstrual bleeding every two weeks. The patient sought medical attention and received the treatment by another physician. No laboratory results were provided. The outcome of events was unknown. The relatedness between events and GARDASIL was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Disturbance in attention, Dizziness, Electrocardiogram abnormal, Fatigue, Hyperacusis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age (not pregnant, no other medical history provided). On an unknown date, the physician administered GARDASIL dose 1, intramuscularly (lot#, expiration date and dose unknown) to a patient. No concomitant therapy was reported. On an unknown date, after the first dosage of vaccine, the patient experienced developed migraines and she was also getting breakthrough menstrual bleeding every two weeks. The patient sought medical attention and received the treatment by another physician. No laboratory results were provided. The outcome of events was unknown. The relatedness between events and GARDASIL was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Hyperthyroidism, Hypotension, Malaise, Migraine, Nausea
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age (not pregnant, no other medical history provided). On an unknown date, the physician administered GARDASIL dose 1, intramuscularly (lot#, expiration date and dose unknown) to a patient. No concomitant therapy was reported. On an unknown date, after the first dosage of vaccine, the patient experienced developed migraines and she was also getting breakthrough menstrual bleeding every two weeks. The patient sought medical attention and received the treatment by another physician. No laboratory results were provided. The outcome of events was unknown. The relatedness between events and GARDASIL was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Neck pain, Photophobia, Polymenorrhoea, Premature menopause, Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age (not pregnant, no other medical history provided). On an unknown date, the physician administered GARDASIL dose 1, intramuscularly (lot#, expiration date and dose unknown) to a patient. No concomitant therapy was reported. On an unknown date, after the first dosage of vaccine, the patient experienced developed migraines and she was also getting breakthrough menstrual bleeding every two weeks. The patient sought medical attention and received the treatment by another physician. No laboratory results were provided. The outcome of events was unknown. The relatedness between events and GARDASIL was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Metrorrhagia, Migraine
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age (not pregnant, no other medical history provided). On an unknown date, the physician administered GARDASIL dose 1, intramuscularly (lot#, expiration date and dose unknown) to a patient. No concomitant therapy was reported. On an unknown date, after the first dosage of vaccine, the patient experienced developed migraines and she was also getting breakthrough menstrual bleeding every two weeks. The patient sought medical attention and received the treatment by another physician. No laboratory results were provided. The outcome of events was unknown. The relatedness between events and GARDASIL was not reported. Additional information is not expected.
Age: 0.33
Sex: F
Vaccine: RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Blood in stool, fussiness and discomfort.
Age: 0.33
Sex: F
Vaccine: RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Culture stool, Differential white blood cell count, Discomfort, Escherichia test, Full blood count
Clinical narrative: Blood in stool, fussiness and discomfort.
Age: 0.33
Sex: F
Vaccine: RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Haematochezia, Irritability, Occult blood, Red blood cell sedimentation rate
Clinical narrative: Blood in stool, fussiness and discomfort.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report was received from a Nurse refers to a 16 year old female patient. On 21-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J009165, 0.5 ml, subcutaneous. On 22-APR-2014, 2 days after onset of therapy the patient experienced redness and induration at the injection site (which measured 5 inches by 4.5 inches). The patient did not sought medical attention. The nurse reported that this was reported to VAERS and physician was not documented on the report. The patient was treated with BENADRYL. On an unknown date in 2014, the patient recovered from redness and induration at the injection site. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case 1405USA003423 and 1405USA003445 (same reporter link). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Eye swelling, Productive cough, Rhinorrhoea, Trichomoniasis, Wheezing
Clinical narrative: Almost immediately patient started with profuse drainage from nose and wet cough.  Cough began to progress in severity with stridor and wheezing.  Eyes noted to have some swelling. One teaspoon of Benadryl orally and patient sent to ER.  5/14/14 f/u with mom who stated that @ ER child was given Epinephrine.  States child also started to break out in whelps in ER. For return appointment with primary MD on 5/15/14.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Eye swelling, Productive cough, Rhinorrhoea, Stridor, Urticaria
Clinical narrative: Almost immediately patient started with profuse drainage from nose and wet cough.  Cough began to progress in severity with stridor and wheezing.  Eyes noted to have some swelling. One teaspoon of Benadryl orally and patient sent to ER.  5/14/14 f/u with mom who stated that @ ER child was given Epinephrine.  States child also started to break out in whelps in ER. For return appointment with primary MD on 5/15/14.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Almost immediately patient started with profuse drainage from nose and wet cough.  Cough began to progress in severity with stridor and wheezing.  Eyes noted to have some swelling. One teaspoon of Benadryl orally and patient sent to ER.  5/14/14 f/u with mom who stated that @ ER child was given Epinephrine.  States child also started to break out in whelps in ER. For return appointment with primary MD on 5/15/14.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Blood test normal, Dyspnoea, Heart rate increased, Lethargy, Palpitations
Clinical narrative: Fever, swelling, couldn't breathe, lethargy, racing heart.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Scan abnormal, Swelling
Clinical narrative: Fever, swelling, couldn't breathe, lethargy, racing heart.