chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Antibody test normal, Antinuclear antibody negative, Areflexia, Balance disorder, CSF protein increased
Clinical narrative: This literature report (initial receipt: 16-Apr-2013) concerns a 31-year-old healthy male patient. On an unknown date the patient received an influenza vaccine (brand name, manufacturer and lot number were not reported). Two months (8 weeks) after influenza vaccine, the patient developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability. His symptoms worsened over the following 4 months. At his nadir, numbness affected his hands below the wrists and legs below the knees. Balance was unsteady, especially in the dark. He was not able to run. Walking short distances could be achieved with minimal support, but he used a wheelchair for longer distances. Examination was notable for decreased vibration and pin sensation in his hands and feet, areflexia, and mild weakness of toe extension. Gait was slow and broad based. Serum laboratory studies revealed normal vitamin B12, anti-Ro, anti-La, and serum immunofixation. MAG (myelin-associated glycoprotein) antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). Nerve conduction studies showed prolonged distal latency in median, ulnar, peroneal, and tibial motor nerves (30%-50% above upper limit of normal) and median, ulnar, and sural sensory nerves. The F waves were absent (median) or mildly prolonged. Partial conduction block was present in the right ulnar nerve forearm segment (30% amplitude reduction). Martin-Gruber anastomosis was not present. Limb temperature was more than 32 degrees C. Two grams per kilogram of IVIG (intravenous immunoglobulin) was initiated 4 months after symptom onset. One gram per kilogram of IVIG was repeated every 3 weeks. Over the following 6 months, symptoms and signs improved. He continued to experience mild intermittent paraesthesias in his fingers and toes but numbness resolved. Examination revealed normal perception of vibration and pin in his hands and feet. Reflexes normalized. Gait was narrow, and he could perform tandem gait without difficulty. He was able to resume exercise, and reported running 3 consecutive miles at 8 hours and 30 minutes per mile pace. IVIG was discontinued without relapse in symptoms. Reporter's comment: Vaccine-associated DADS-I (idiopathic distal acquired demyelinating symmetric neuropathy) may suggest a vaccine-triggered immunologic event directed against MAG below detectable concentrations. More likely, we suspect vaccination in our patient triggered an immune response against currently unrecognized antigens and manifested as restricted CIDP in the form of DADS-I. Vaccine-associated CIDP is a rare but poorly characterized event that should not discourage at-risk individuals from being vaccinated. Nonetheless, vaccine safety and public reassurance rely on rapid detection and treatment of adverse outcomes. DADS-I neuropathy can occur after vaccine. We suggest consideration of this diagnosis for patients with new sensory symptoms after vaccination.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Decreased vibratory sense, Demyelinating polyneuropathy, Gait disturbance, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: This literature report (initial receipt: 16-Apr-2013) concerns a 31-year-old healthy male patient. On an unknown date the patient received an influenza vaccine (brand name, manufacturer and lot number were not reported). Two months (8 weeks) after influenza vaccine, the patient developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability. His symptoms worsened over the following 4 months. At his nadir, numbness affected his hands below the wrists and legs below the knees. Balance was unsteady, especially in the dark. He was not able to run. Walking short distances could be achieved with minimal support, but he used a wheelchair for longer distances. Examination was notable for decreased vibration and pin sensation in his hands and feet, areflexia, and mild weakness of toe extension. Gait was slow and broad based. Serum laboratory studies revealed normal vitamin B12, anti-Ro, anti-La, and serum immunofixation. MAG (myelin-associated glycoprotein) antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). Nerve conduction studies showed prolonged distal latency in median, ulnar, peroneal, and tibial motor nerves (30%-50% above upper limit of normal) and median, ulnar, and sural sensory nerves. The F waves were absent (median) or mildly prolonged. Partial conduction block was present in the right ulnar nerve forearm segment (30% amplitude reduction). Martin-Gruber anastomosis was not present. Limb temperature was more than 32 degrees C. Two grams per kilogram of IVIG (intravenous immunoglobulin) was initiated 4 months after symptom onset. One gram per kilogram of IVIG was repeated every 3 weeks. Over the following 6 months, symptoms and signs improved. He continued to experience mild intermittent paraesthesias in his fingers and toes but numbness resolved. Examination revealed normal perception of vibration and pin in his hands and feet. Reflexes normalized. Gait was narrow, and he could perform tandem gait without difficulty. He was able to resume exercise, and reported running 3 consecutive miles at 8 hours and 30 minutes per mile pace. IVIG was discontinued without relapse in symptoms. Reporter's comment: Vaccine-associated DADS-I (idiopathic distal acquired demyelinating symmetric neuropathy) may suggest a vaccine-triggered immunologic event directed against MAG below detectable concentrations. More likely, we suspect vaccination in our patient triggered an immune response against currently unrecognized antigens and manifested as restricted CIDP in the form of DADS-I. Vaccine-associated CIDP is a rare but poorly characterized event that should not discourage at-risk individuals from being vaccinated. Nonetheless, vaccine safety and public reassurance rely on rapid detection and treatment of adverse outcomes. DADS-I neuropathy can occur after vaccine. We suggest consideration of this diagnosis for patients with new sensory symptoms after vaccination.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Immunology test normal, Muscular weakness, Nerve conduction studies abnormal, Paraesthesia, Sensory disturbance
Clinical narrative: This literature report (initial receipt: 16-Apr-2013) concerns a 31-year-old healthy male patient. On an unknown date the patient received an influenza vaccine (brand name, manufacturer and lot number were not reported). Two months (8 weeks) after influenza vaccine, the patient developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability. His symptoms worsened over the following 4 months. At his nadir, numbness affected his hands below the wrists and legs below the knees. Balance was unsteady, especially in the dark. He was not able to run. Walking short distances could be achieved with minimal support, but he used a wheelchair for longer distances. Examination was notable for decreased vibration and pin sensation in his hands and feet, areflexia, and mild weakness of toe extension. Gait was slow and broad based. Serum laboratory studies revealed normal vitamin B12, anti-Ro, anti-La, and serum immunofixation. MAG (myelin-associated glycoprotein) antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). Nerve conduction studies showed prolonged distal latency in median, ulnar, peroneal, and tibial motor nerves (30%-50% above upper limit of normal) and median, ulnar, and sural sensory nerves. The F waves were absent (median) or mildly prolonged. Partial conduction block was present in the right ulnar nerve forearm segment (30% amplitude reduction). Martin-Gruber anastomosis was not present. Limb temperature was more than 32 degrees C. Two grams per kilogram of IVIG (intravenous immunoglobulin) was initiated 4 months after symptom onset. One gram per kilogram of IVIG was repeated every 3 weeks. Over the following 6 months, symptoms and signs improved. He continued to experience mild intermittent paraesthesias in his fingers and toes but numbness resolved. Examination revealed normal perception of vibration and pin in his hands and feet. Reflexes normalized. Gait was narrow, and he could perform tandem gait without difficulty. He was able to resume exercise, and reported running 3 consecutive miles at 8 hours and 30 minutes per mile pace. IVIG was discontinued without relapse in symptoms. Reporter's comment: Vaccine-associated DADS-I (idiopathic distal acquired demyelinating symmetric neuropathy) may suggest a vaccine-triggered immunologic event directed against MAG below detectable concentrations. More likely, we suspect vaccination in our patient triggered an immune response against currently unrecognized antigens and manifested as restricted CIDP in the form of DADS-I. Vaccine-associated CIDP is a rare but poorly characterized event that should not discourage at-risk individuals from being vaccinated. Nonetheless, vaccine safety and public reassurance rely on rapid detection and treatment of adverse outcomes. DADS-I neuropathy can occur after vaccine. We suggest consideration of this diagnosis for patients with new sensory symptoms after vaccination.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Temperature difference of extremities, Vitamin B12 normal, Wheelchair user
Clinical narrative: This literature report (initial receipt: 16-Apr-2013) concerns a 31-year-old healthy male patient. On an unknown date the patient received an influenza vaccine (brand name, manufacturer and lot number were not reported). Two months (8 weeks) after influenza vaccine, the patient developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability. His symptoms worsened over the following 4 months. At his nadir, numbness affected his hands below the wrists and legs below the knees. Balance was unsteady, especially in the dark. He was not able to run. Walking short distances could be achieved with minimal support, but he used a wheelchair for longer distances. Examination was notable for decreased vibration and pin sensation in his hands and feet, areflexia, and mild weakness of toe extension. Gait was slow and broad based. Serum laboratory studies revealed normal vitamin B12, anti-Ro, anti-La, and serum immunofixation. MAG (myelin-associated glycoprotein) antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). Nerve conduction studies showed prolonged distal latency in median, ulnar, peroneal, and tibial motor nerves (30%-50% above upper limit of normal) and median, ulnar, and sural sensory nerves. The F waves were absent (median) or mildly prolonged. Partial conduction block was present in the right ulnar nerve forearm segment (30% amplitude reduction). Martin-Gruber anastomosis was not present. Limb temperature was more than 32 degrees C. Two grams per kilogram of IVIG (intravenous immunoglobulin) was initiated 4 months after symptom onset. One gram per kilogram of IVIG was repeated every 3 weeks. Over the following 6 months, symptoms and signs improved. He continued to experience mild intermittent paraesthesias in his fingers and toes but numbness resolved. Examination revealed normal perception of vibration and pin in his hands and feet. Reflexes normalized. Gait was narrow, and he could perform tandem gait without difficulty. He was able to resume exercise, and reported running 3 consecutive miles at 8 hours and 30 minutes per mile pace. IVIG was discontinued without relapse in symptoms. Reporter's comment: Vaccine-associated DADS-I (idiopathic distal acquired demyelinating symmetric neuropathy) may suggest a vaccine-triggered immunologic event directed against MAG below detectable concentrations. More likely, we suspect vaccination in our patient triggered an immune response against currently unrecognized antigens and manifested as restricted CIDP in the form of DADS-I. Vaccine-associated CIDP is a rare but poorly characterized event that should not discourage at-risk individuals from being vaccinated. Nonetheless, vaccine safety and public reassurance rely on rapid detection and treatment of adverse outcomes. DADS-I neuropathy can occur after vaccine. We suggest consideration of this diagnosis for patients with new sensory symptoms after vaccination.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Mycoplasma infection, Stevens-Johnson syndrome
Clinical narrative: Stevens Johnson syndrome; onset one day after HPV vaccine dose #1.
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Condition aggravated, Systemic lupus erythematosus
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 60 year old patient with lupus. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot number not reported). On an unknown date, the patient experienced "flare-up" of lupus after receiving a dose of PNEUMOVAX23 in the past. The patient was in a remission at the time of report. Upon internal review, a "flare-up" of lupus was considered medically significant. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Death
Clinical narrative: No known reaction to vaccine. Patient passed away 4.21.13.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Grip strength decreased, Impaired driving ability, Injected limb mobility decreased
Clinical narrative: Initial report was received from a consumer on 15 April 2013. A 28-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, lot number C3864 (corresponding Sanofi Pasteur Inc. lot number U3957CA) on 24 November 2012. Following vaccination, the patient experienced diminished function of left arm, was unable to use her left arm and had no grip strength. The patient is left hand dominant and has not been able to use her left arm. She cannot drive and has lost her job. Outcome was not recovered. Documents held by sender: None.
Age: 81.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers: 2013-05188, 2013-005251, 2013-005252, 2013-005254 to 2013-005263, 2013-05268, 2013-05269, 2011-03827, 2006-03086, 1995-00668, 2006-03230, 1995-00224 and 2003-02926. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. Regarding this case which involved a 81-year-old male patient had received I-TYPHOID VACCINE, manufacturer unknown, and HEPATITIS A vaccine, other manufacturer, (lot numbers, routes, sites and dates of administration not reported); and nine days later reported the onset of GBS. No further information was provided. Outcomes were not reported. Documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: DTP
Symptoms: Anti-ganglioside antibody negative, Anti-neuronal antibody negative, Antibody test negative, Antinuclear antibody negative, Areflexia
Clinical narrative: Initial case was retrieved from the scientific literature on 15 April 2013. Verbatim from the report: "A 35-year-old healthy man developed progressive distal symmetric numbness and paraesthesias 2 weeks after diphtheria-tetanus-pertussis vaccination. Paraesthesias initially affected only the distal portions of his hands and feet. Over the following month, sensory loss developed in the same areas. Sensory loss and paraesthesias progressed over the next month to affect the legs below the knees and arms below the elbows. Two months into his disease course, he could walk without assistance but with a slow broad-based gait. Three months into his disease course, he could not ambulate independently. Three months after symptom onset, examination demonstrated severely diminished vibration, distal loss of pin sensation, areflexia, and normal strength. Laboratory studies revealed normal vitamin B12, vitamin B6, HIV, RPR, and serum immunofixation (no monoclonal protein). Antibodies against myelin-associated glycoprotein (MAG), GQ1b, GD1a, GD1b, antinuclear antibody, anti-Ro, anti-La, and anti-Hu were absent. Cerebrospinal fluid (CSF) demonstrated elevated protein (74 mg/dL) without white blood cells. Nerve conduction studies (NCSs) were notable for prolonged distal latencies in median, ulnar, peroneal, and tibial motor nerves (30%-50% above upper limit of normal) and median, ulnar, and sural sensory nerves. Mild conduction velocity slowing was observed in several nerves. The F waves were absent (peroneal) or mildly prolonged. No conduction block or temporal disperson was present. Limb temperature was more than 32 degrees C. Three months after symptom onset, he began 2 g/kg of intravenous immunoglobulin (IVIG; divided) followed by 1 g/kg of intravenous immunoglobulin every 4 weeks. Three months after treatment, initiation examination showed vibration and pin loss only in his feet and fingertips. Reflexes were now present but hypoactive. He could ambulate independently but was unsteady and not able to perform tandem gait. Six months after treatment initiation, only a mild degree of vibration loss remained in his toes. Pin testing and reflexes normalized. Gait was stable, and tandem gait was performed without difficulty. Strength remained normal during the disease course." The reporter for this case is the same as for case 2013-05406. Documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: DTP
Symptoms: Balance disorder, CSF protein increased, CSF white blood cell count negative, Decreased vibratory sense, Electrocardiogram abnormal
Clinical narrative: Initial case was retrieved from the scientific literature on 15 April 2013. Verbatim from the report: "A 35-year-old healthy man developed progressive distal symmetric numbness and paraesthesias 2 weeks after diphtheria-tetanus-pertussis vaccination. Paraesthesias initially affected only the distal portions of his hands and feet. Over the following month, sensory loss developed in the same areas. Sensory loss and paraesthesias progressed over the next month to affect the legs below the knees and arms below the elbows. Two months into his disease course, he could walk without assistance but with a slow broad-based gait. Three months into his disease course, he could not ambulate independently. Three months after symptom onset, examination demonstrated severely diminished vibration, distal loss of pin sensation, areflexia, and normal strength. Laboratory studies revealed normal vitamin B12, vitamin B6, HIV, RPR, and serum immunofixation (no monoclonal protein). Antibodies against myelin-associated glycoprotein (MAG), GQ1b, GD1a, GD1b, antinuclear antibody, anti-Ro, anti-La, and anti-Hu were absent. Cerebrospinal fluid (CSF) demonstrated elevated protein (74 mg/dL) without white blood cells. Nerve conduction studies (NCSs) were notable for prolonged distal latencies in median, ulnar, peroneal, and tibial motor nerves (30%-50% above upper limit of normal) and median, ulnar, and sural sensory nerves. Mild conduction velocity slowing was observed in several nerves. The F waves were absent (peroneal) or mildly prolonged. No conduction block or temporal disperson was present. Limb temperature was more than 32 degrees C. Three months after symptom onset, he began 2 g/kg of intravenous immunoglobulin (IVIG; divided) followed by 1 g/kg of intravenous immunoglobulin every 4 weeks. Three months after treatment, initiation examination showed vibration and pin loss only in his feet and fingertips. Reflexes were now present but hypoactive. He could ambulate independently but was unsteady and not able to perform tandem gait. Six months after treatment initiation, only a mild degree of vibration loss remained in his toes. Pin testing and reflexes normalized. Gait was stable, and tandem gait was performed without difficulty. Strength remained normal during the disease course." The reporter for this case is the same as for case 2013-05406. Documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: DTP
Symptoms: Gait disturbance, HIV test negative, Hypoaesthesia, Hyporeflexia, Immunoglobulin therapy
Clinical narrative: Initial case was retrieved from the scientific literature on 15 April 2013. Verbatim from the report: "A 35-year-old healthy man developed progressive distal symmetric numbness and paraesthesias 2 weeks after diphtheria-tetanus-pertussis vaccination. Paraesthesias initially affected only the distal portions of his hands and feet. Over the following month, sensory loss developed in the same areas. Sensory loss and paraesthesias progressed over the next month to affect the legs below the knees and arms below the elbows. Two months into his disease course, he could walk without assistance but with a slow broad-based gait. Three months into his disease course, he could not ambulate independently. Three months after symptom onset, examination demonstrated severely diminished vibration, distal loss of pin sensation, areflexia, and normal strength. Laboratory studies revealed normal vitamin B12, vitamin B6, HIV, RPR, and serum immunofixation (no monoclonal protein). Antibodies against myelin-associated glycoprotein (MAG), GQ1b, GD1a, GD1b, antinuclear antibody, anti-Ro, anti-La, and anti-Hu were absent. Cerebrospinal fluid (CSF) demonstrated elevated protein (74 mg/dL) without white blood cells. Nerve conduction studies (NCSs) were notable for prolonged distal latencies in median, ulnar, peroneal, and tibial motor nerves (30%-50% above upper limit of normal) and median, ulnar, and sural sensory nerves. Mild conduction velocity slowing was observed in several nerves. The F waves were absent (peroneal) or mildly prolonged. No conduction block or temporal disperson was present. Limb temperature was more than 32 degrees C. Three months after symptom onset, he began 2 g/kg of intravenous immunoglobulin (IVIG; divided) followed by 1 g/kg of intravenous immunoglobulin every 4 weeks. Three months after treatment, initiation examination showed vibration and pin loss only in his feet and fingertips. Reflexes were now present but hypoactive. He could ambulate independently but was unsteady and not able to perform tandem gait. Six months after treatment initiation, only a mild degree of vibration loss remained in his toes. Pin testing and reflexes normalized. Gait was stable, and tandem gait was performed without difficulty. Strength remained normal during the disease course." The reporter for this case is the same as for case 2013-05406. Documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: DTP
Symptoms: Immunology test, Nerve conduction studies abnormal, Paraesthesia, Sensory loss, Tandem gait test abnormal
Clinical narrative: Initial case was retrieved from the scientific literature on 15 April 2013. Verbatim from the report: "A 35-year-old healthy man developed progressive distal symmetric numbness and paraesthesias 2 weeks after diphtheria-tetanus-pertussis vaccination. Paraesthesias initially affected only the distal portions of his hands and feet. Over the following month, sensory loss developed in the same areas. Sensory loss and paraesthesias progressed over the next month to affect the legs below the knees and arms below the elbows. Two months into his disease course, he could walk without assistance but with a slow broad-based gait. Three months into his disease course, he could not ambulate independently. Three months after symptom onset, examination demonstrated severely diminished vibration, distal loss of pin sensation, areflexia, and normal strength. Laboratory studies revealed normal vitamin B12, vitamin B6, HIV, RPR, and serum immunofixation (no monoclonal protein). Antibodies against myelin-associated glycoprotein (MAG), GQ1b, GD1a, GD1b, antinuclear antibody, anti-Ro, anti-La, and anti-Hu were absent. Cerebrospinal fluid (CSF) demonstrated elevated protein (74 mg/dL) without white blood cells. Nerve conduction studies (NCSs) were notable for prolonged distal latencies in median, ulnar, peroneal, and tibial motor nerves (30%-50% above upper limit of normal) and median, ulnar, and sural sensory nerves. Mild conduction velocity slowing was observed in several nerves. The F waves were absent (peroneal) or mildly prolonged. No conduction block or temporal disperson was present. Limb temperature was more than 32 degrees C. Three months after symptom onset, he began 2 g/kg of intravenous immunoglobulin (IVIG; divided) followed by 1 g/kg of intravenous immunoglobulin every 4 weeks. Three months after treatment, initiation examination showed vibration and pin loss only in his feet and fingertips. Reflexes were now present but hypoactive. He could ambulate independently but was unsteady and not able to perform tandem gait. Six months after treatment initiation, only a mild degree of vibration loss remained in his toes. Pin testing and reflexes normalized. Gait was stable, and tandem gait was performed without difficulty. Strength remained normal during the disease course." The reporter for this case is the same as for case 2013-05406. Documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: DTP
Symptoms: Temperature difference of extremities, Treponema test negative, Vitamin B12 normal, Vitamin B6 normal
Clinical narrative: Initial case was retrieved from the scientific literature on 15 April 2013. Verbatim from the report: "A 35-year-old healthy man developed progressive distal symmetric numbness and paraesthesias 2 weeks after diphtheria-tetanus-pertussis vaccination. Paraesthesias initially affected only the distal portions of his hands and feet. Over the following month, sensory loss developed in the same areas. Sensory loss and paraesthesias progressed over the next month to affect the legs below the knees and arms below the elbows. Two months into his disease course, he could walk without assistance but with a slow broad-based gait. Three months into his disease course, he could not ambulate independently. Three months after symptom onset, examination demonstrated severely diminished vibration, distal loss of pin sensation, areflexia, and normal strength. Laboratory studies revealed normal vitamin B12, vitamin B6, HIV, RPR, and serum immunofixation (no monoclonal protein). Antibodies against myelin-associated glycoprotein (MAG), GQ1b, GD1a, GD1b, antinuclear antibody, anti-Ro, anti-La, and anti-Hu were absent. Cerebrospinal fluid (CSF) demonstrated elevated protein (74 mg/dL) without white blood cells. Nerve conduction studies (NCSs) were notable for prolonged distal latencies in median, ulnar, peroneal, and tibial motor nerves (30%-50% above upper limit of normal) and median, ulnar, and sural sensory nerves. Mild conduction velocity slowing was observed in several nerves. The F waves were absent (peroneal) or mildly prolonged. No conduction block or temporal disperson was present. Limb temperature was more than 32 degrees C. Three months after symptom onset, he began 2 g/kg of intravenous immunoglobulin (IVIG; divided) followed by 1 g/kg of intravenous immunoglobulin every 4 weeks. Three months after treatment, initiation examination showed vibration and pin loss only in his feet and fingertips. Reflexes were now present but hypoactive. He could ambulate independently but was unsteady and not able to perform tandem gait. Six months after treatment initiation, only a mild degree of vibration loss remained in his toes. Pin testing and reflexes normalized. Gait was stable, and tandem gait was performed without difficulty. Strength remained normal during the disease course." The reporter for this case is the same as for case 2013-05406. Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site pain, Pain
Clinical narrative: Started with pain at site - bruised (gone now) sorer on 3rd day. Hurts worse if raises arm. Pain hasn't gone away muscle where shot given to elbow painful. No swelling. Better when ices.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient found unresponsive in crib at daycare. Resuscitative efforts unsuccessful.
Age: 68.0
Sex: F
Vaccine: FLUX, IPV, JEVX, PPV
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Tracheostomy
Clinical narrative: 19-JUL-95 follow-up: A "short time" after vaccination with whole virus flu vaccine developed symptoms and was hospitalized. Intubated via tracheostomy. Current status: all symptoms resolved. Follow-up report received via search of the literature on 16 April 2013. Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers: 2013-05188, 2013-005251, 2013-005252, 2013-005254 to 2013-005263, 2013-05268, 2013-05269, 2011-03827, 2006-03086, 1995-00668, 2006-03230 and 2003-02926. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. Regarding this case which involved a 68-year-old female patient who had received TIV, (previously reported as INFLUENZA WHOLE VIRION VACCCINE, manufacturer PMC, lot number unknown, administered on 26 August 1994) and 23-valent PPV-23 (other manufacturer; lot number, route, site and date of administration not reported); and 14 days later reported the onset of GBS. She also received Injectable (killed) IPV and JAPANESE ENCEPHALITIS VACCINE (manufacturers unknown; lot numbers, routes, sites and dates of administration not reported) and 18 days later reported the onset of GBS. No further information was provided. An updated outcome was not provided. The patient remained recovered on an unspecified date. Documents held by sender: none.
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Dyspnoea, Incubator therapy, Intensive care, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report by a contactable physician. This female physician reported on behalf of a female patient, unspecified age and ethnicity, received PREVNAR 13 unknown dose unknown frequency by unknown route unknown dosage form at 10:50am on right thigh and hepatitis A vaccine on left thigh on 16Apr2013. Relevant medical history was none. Relevant concomitant medications were none. Vaccines taken within the last four weeks were none. On 17Apr2013 in the morning while PREVNAR 13 unknown dose unknown frequency she experienced fever. On 19Apr2013 in the morning, she experienced facial swelling, body swelling and difficulty in breathing. In Apr2013, she was hospitalised in Intensive Care Unit and was kept in an incubator in response to facial swelling, body swelling and difficulty breathing. The physician was not sure if there was a causal relationship between the vaccine and the events. Sibling information was unknown. Relevant lab data was none. At the time of the report, she had not recovered from all the above mentioned events.
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Swelling face
Clinical narrative: This is a spontaneous report by a contactable physician. This female physician reported on behalf of a female patient, unspecified age and ethnicity, received PREVNAR 13 unknown dose unknown frequency by unknown route unknown dosage form at 10:50am on right thigh and hepatitis A vaccine on left thigh on 16Apr2013. Relevant medical history was none. Relevant concomitant medications were none. Vaccines taken within the last four weeks were none. On 17Apr2013 in the morning while PREVNAR 13 unknown dose unknown frequency she experienced fever. On 19Apr2013 in the morning, she experienced facial swelling, body swelling and difficulty in breathing. In Apr2013, she was hospitalised in Intensive Care Unit and was kept in an incubator in response to facial swelling, body swelling and difficulty breathing. The physician was not sure if there was a causal relationship between the vaccine and the events. Sibling information was unknown. Relevant lab data was none. At the time of the report, she had not recovered from all the above mentioned events.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Blood creatinine increased, Chest X-ray normal, Dysphagia, Eye discharge
Clinical narrative: 1/18/2013: stomach ache, eye pain, lesions on left arm, lesions in mouth. 1/20/13: eye drainage, swelling. 01/21/13 taken to ER given Rx Acyclovir, Z-pak; 01/22/13 condition worsened unable to swallow, taken to Hospital ER. Admitted to PICU. Hospitalized for 15 days (11 ICU; 4 ward). PICC line, IV TPN. Dx: Stevens Johnson Syndrome.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Intensive care, Mycoplasma test positive, Oral disorder, Skin lesion
Clinical narrative: 1/18/2013: stomach ache, eye pain, lesions on left arm, lesions in mouth. 1/20/13: eye drainage, swelling. 01/21/13 taken to ER given Rx Acyclovir, Z-pak; 01/22/13 condition worsened unable to swallow, taken to Hospital ER. Admitted to PICU. Hospitalized for 15 days (11 ICU; 4 ward). PICC line, IV TPN. Dx: Stevens Johnson Syndrome.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Stevens-Johnson syndrome, Swelling, Varicella virus test negative
Clinical narrative: 1/18/2013: stomach ache, eye pain, lesions on left arm, lesions in mouth. 1/20/13: eye drainage, swelling. 01/21/13 taken to ER given Rx Acyclovir, Z-pak; 01/22/13 condition worsened unable to swallow, taken to Hospital ER. Admitted to PICU. Hospitalized for 15 days (11 ICU; 4 ward). PICC line, IV TPN. Dx: Stevens Johnson Syndrome.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Injection site warmth, Skin exfoliation
Clinical narrative: Pt experienced redness, warmth at injection site, knot at injection site, peeling of the skin around site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Local tissue reaction with area of swelling and erythema.  5 cm x 10 cm . Non tender.
Age: 1.03
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site erythema, Lymphadenopathy, Malaise
Clinical narrative: CHILD DIAGNOSED WITH CELLULITIS AT THE SITE OF VACCINE ADMINISTRATION.  THE SITE WAS RED THEN DEVELOPED A PURPLE CENTER.  CHICKENPOX ALSO DIAGNOSED.  ONE WEEK LATER (04/13/2013) ANTIBIOTICS GIVEN, 3 LYMPH NODES ON NECK WERE SWOLLEN. AS OF 04/22/2013 CHILD WAS STILL ON ANTIBIOTICS. MOTHER SAID THAT CHILD WAS STILL NOT WELL.
Age: 1.03
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Varicella
Clinical narrative: CHILD DIAGNOSED WITH CELLULITIS AT THE SITE OF VACCINE ADMINISTRATION.  THE SITE WAS RED THEN DEVELOPED A PURPLE CENTER.  CHICKENPOX ALSO DIAGNOSED.  ONE WEEK LATER (04/13/2013) ANTIBIOTICS GIVEN, 3 LYMPH NODES ON NECK WERE SWOLLEN. AS OF 04/22/2013 CHILD WAS STILL ON ANTIBIOTICS. MOTHER SAID THAT CHILD WAS STILL NOT WELL.
Age: 1.02
Sex: M
Vaccine: DTAP
Symptoms: Hypersomnia, Narcolepsy, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, narcolepsy.  Had a fever for several hours of 100.5.  It is currently 4/29/13 ay 10:09am and he has been sleeping almost non stop since 4/26/13.  He wakes up to eat, but sometimes throws up shortly after.  He always goes right back to sleep.  Nowhere near typical behavior for my one year old.
Age: 34.0
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Scab
Clinical narrative: Red bump started, then a yellow crust formed at injection spots about an inch large.  Highly unusual reaction.  It's been two months and issue still there.  Possible exposure to unclean or infected office. (can provide photos of reaction)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt said she noticed a baseball sized red mark at injection site, that was hot, red and itchy. Pt is calling Dr to report the event.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Paraesthesia oral, Rash
Clinical narrative: Rash, not painful or pruritic on left chest wall.  Preceded by one day of lip tingling and nausea. No medication prescribed.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Left arm and shoulder pain.
Age: 1.27
Sex: M
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Rash generalised, Rash papular
Clinical narrative: Patient started with fever to 103F.  Developed rash papular on body that began to resolve without treatment in 48 hours.  No fever after 24hours.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: Severe headache, fever lethargy for 24 hours.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Eye pain
Clinical narrative: Complaining of eye pain. Wont open eyes for 20 minutes at a time. Crying because of eye pain.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient informed Pharmacist administrator after the injection that he previously had Zostavax.  He came back into the Pharmacy in over a month later with no adverse reactions to report.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Expired drug administered
Clinical narrative: Administered Menactra U4001AA which expired on 04/28/2013. Re-Vaccinated with U4291AA EXP on 17 OCT 2013.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Large area of redness around injection site. Patient states itchy but not painful.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin infection
Clinical narrative: Left arm red and swollen past elbow.  Saw PCP, mom stated PCP said chld also had skin infection under arm not related to injection.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: About 6 in diameter red area. Warm to touch, itchy, tender.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Condition aggravated, Oedema peripheral, Pyrexia, Skin warm, Urticaria
Clinical narrative: Fever, leg hot and swollen; possible reaction to immunization.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Pruritus, Rash
Clinical narrative: Itchy, bumpy, also patient was feeling "hot".
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Rash
Clinical narrative: Painful rash to R side of neck.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Painful rash to R side of neck.
Age: 32.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Oedema peripheral, Pain, Rash erythematous, Skin warm
Clinical narrative: Arm was swollen and hot with restricted movement d/t swelling and pain.  There was also a red hot rash on the entire upper arm.
Age: 77.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of Right Deltoid.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Localized erythema and swelling to the right deltoid where vaccine was administered.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Feeling of body temperature change, Headache, Pain in extremity
Clinical narrative: At 5:30 PM employee states his arm hurt really bad, he has a bad headache, and feels hot than cold off and on. Employee was visibly in pain. Ice pack applied to left arm and employee took Ibuprofen for headache. Employees symptoms started to improve at 6:30 PM.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Pain in extremity
Clinical narrative: Arm pain, urticaria at site of injection (left deltoid).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 64 year old male patient. On 16-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose unspecified), subcutaneously. No concomitant medications were reported. On 10-APR-2013, the patient was diagnosed with shingles during an office visit. The patient sought medical attention (office visit), It was unspecified if any treatment was provided or if any lab tests were performed. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of patients. The physician reported that improperly stored RECOMBIVAX HB might have been administered to an unknown number of patients for vaccination. Administration date and lot# was unspecified. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous, dosing information was not provided). On an unknown date the patient experienced redness and itching at the injection site, after receiving ZOSTAVAX. The patient sought medical attention by calling the doctor. The physician reported that this was the first for their practice. The outcome of redness at the injection site and itching at the injection site was reported as recovering/resolving. The relatedness of the events was not reported for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Papilloma viral infection
Clinical narrative: This spontaneous report was received from a registered nurse via company representative refers to a female patient of unknown age (reported as early 20s). On an unknown date in 2007, the patient was vaccinated with one dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, after administration of the vaccine the patient was diagnosed with HPV (human papilloma virus). The nurse reported that the patient did not receive subsequent doses after starting the series. The outcome of the reported event was unknown. Additional information is not expected.
Sex: U
Vaccine: HBHEPB
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 23-APR-2013 the patient was vaccinated with a dose of COMVAX (lot# 0807Z/expired date 04-APR-2013). No adverse symptoms reported. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Contusion, Headache, Injection site erythema, Pruritus
Clinical narrative: This spontaneous report as received from a physician refers to a 60 year old patient. The patient had no pertinent medical history and no drug reactions or allergies. On 19-APR-2013 the patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported). Concomitant therapies included cholesterol and heart pressure. On 20-APR-2012 the patient experienced redness around the injection sit, felt the bruising, headache lasting one day and also had the itching sensation. There was no treatment given for adverse events and no diagnostics studies performed. The action taken was not provided at the time of report. The causality and outcome were unknown. The patient did not seek any medical attention. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date and dose was not reported), subcutaneously. On an unknown date, 2 days after injection, the patient had a rash all over the body. The outcome of rash all over the body was unknown. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a female patient of approximately 54 years. On an unknown date in January 2013, the patient was vaccinated with a first dose of RECOMBIVAX HB (Lot number, expiry date, route and dose were not reported). The second dose was given on an unspecified date in 2013. The patient was vaccinated with the third dose early. On an unknown date in 2013 (reported as 2 months after the second dose), the patient was vaccinated with a third dose of RECOMBIVAX HB (Lot number, expiry date, route and dose were not reported) and no adverse effects reported. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. The patient had splenectomy done in the past. On an unknown date in 2013, the patient was vaccinated with a dose 3 of PNEUMOVAX 23, (lot number reported as 51 YOWF or 5LYOWF, expiration date and route was not reported). Concomitant medications were not reported. On an unknown date in 2013, the patient became febrile after she received PNEUMOVAX 23. The patient experienced red, swollen arm. The patient had received a dose of PNEUMOVAX 23 in 2008 at the physicians office as well as possibly one prior to 2008 from another unspecified healthcare provider. The outcome of reported events were unknown. The patient sought medical attention. Additional information has been requested.