chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: CSF protein increased, Electrocardiogram abnormal, Gait disturbance, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Initial case was retrieved from the scientific literature on 15 April 2013. Verbatim from the report: "A 31-year-old healthy man developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability 2 months after influenza vaccine. 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 antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). NCS 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 33 degrees C. Two grams per kilogram of IVIG 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 paresthesias 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." The reporter for this case is the same as for case 2013-05405. Documents held by sender: none.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Immunology test normal, Muscular weakness, Nerve conduction studies abnormal, Nerve injury, Paraesthesia
Clinical narrative: Initial case was retrieved from the scientific literature on 15 April 2013. Verbatim from the report: "A 31-year-old healthy man developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability 2 months after influenza vaccine. 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 antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). NCS 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 33 degrees C. Two grams per kilogram of IVIG 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 paresthesias 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." The reporter for this case is the same as for case 2013-05405. Documents held by sender: none.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Sensory disturbance, Skin warm, Vitamin B12 normal, Wheelchair user
Clinical narrative: Initial case was retrieved from the scientific literature on 15 April 2013. Verbatim from the report: "A 31-year-old healthy man developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability 2 months after influenza vaccine. 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 antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). NCS 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 33 degrees C. Two grams per kilogram of IVIG 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 paresthesias 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." The reporter for this case is the same as for case 2013-05405. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLUX
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, 2013-005252 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 65-year-old female patient who had received Trivalent inactivated influenza vaccine (manufacturer unknown; lot number, route, site and date of administration not reported) and three days later reported the onset of GBS. No further information was provided. Outcomes were not reported. Documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: FLUX
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, 2013-05251-05254, 2013-05256-05263, 2013-05268-05269, 2006-03230, 1995-00224, 2003-02926, 2011-03827, 2006-03086 and 1995-00668. 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 65-year-old male patient who had received Trivalent inactivated influenza vaccine (manufacturer unknown; lot number, route, site and date of administration not reported) and 14 days later reported the onset of GBS. No further information was provided. Outcomes were not reported. Documents held by sender: none.
Age: 87.0
Sex: M
Vaccine: FLUX
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, 2013-05251-05256, 2013- 05258-05263, 2013-05268-05269, 2006-03230, 1995-00224, 2003-02926, 2011-03827, 2006-03086 and 1995-00668. 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 an 87 year-old male patient who had received Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and 18 days later reported the onset of GBS. No further information was provided. Outcome were not reported. Documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: FLUX
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 1995-00224, 2003-02926, 2006-03086, 2006-03230, 2011-03827, 2013-02288, 2013-05188, 2013-05251-05259 and 2013-05261-05263 and 2013-05268-05269. 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. This case involved a 76-year-old female patient who had received Trivalent inactivated influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and 35 days later reported the onset of GBS. No further information was provided. Outcome was not reported. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: FLUX
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, 2013-05251-05257, 2013-05259-05263, 2013-05268-05269, 2006-03230, 1995-00224, 2003-02926, 2011-03827, 2006-03086 and 1995-00668. 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 37-year-old female patient who had received Trivalent inactivated influenza vaccine (manufacturer unknown; lot number, route, site and date of administration not reported) and 21 days later reported the onset of GBS. No further information was provided. Outcomes were not reported. Documents held by sender: none.
Age: 28.0
Sex: M
Vaccine: FLUX
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 2013-005251 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 28-year-old male patient who had received Trivalent inactivated influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and one day later reported the onset of GBS. No further information was provided. Outcomes were not reported. Documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: FLUX
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, 2013-05251-05255, 2013-05257-05263, 2013-05268-05269, 2006-03230, 1995-00224, 2003-02926, 2011-03827, 2006-03086 and 1995-00668. 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 hospitalized 65 year-old male patient who had received Influenza vaccine (manufacturer name, lot number, route, site and date of administration not reported) and 14 days later reported the onset of GBS. No further information was provided. Outcome not reported. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLUX
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 1995-00224, 2003-02926, 2006-03086, 2006-03230, 2011-03827, 2013-02288, 2013-05188, 2013-05251-05261, 2013-05263 and 2013-05268-05269. 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. This case involved a 57-year-old male patient who had received Trivalent inactivated influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and 21 days later reported the onset of GBS. No further information was provided. Outcome was not reported. Documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLUX
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, 2013-05251-05258, 2013-05260-05263, 2013-05268-05269, 2006-03230, 1995-00224, 2003-02926, 2011-03827, 2006-03086 and 1995-00668. 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 74-year-old male patient who had received Trivalent inactivated influenza vaccine (manufacturer unknown; lot number, route, site and date of administration not reported) and 25 days later reported the onset of GBS. No further information was provided. Outcomes were not reported. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: FLUX, TD
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, 2013-005253, 2013-005255 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 62-year-old female patient who had received Combination tetanus and reduced diphtheria vaccine and Trivalent inactivated influenza vaccine, (manufacturers unknown; lot numbers, routes, sites and dates of administration not reported); and 12 days later reported the onset of GBS. No further information was provided. Outcomes were not reported. Documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLUX
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 1995-00224, 2003-02926, 2006-03086, 2006-03230, 2011-03827, 2013-02288, 2013-05188, 2013-05251-05260 and 2013-05262-05263 and 2013-05268-05269. 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. This case involved a 66-year-old male patient who had received Trivalent inactivated influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and 36 days later reported the onset of GBS. No further information was provided. Outcome was not reported. Documents held by sender: None.
Age: 59.0
Sex: M
Vaccine: FLUX
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 1995-00224, 2003-02926, 2006-03086, 2006-03230, 2011-03827, 2013-02288, 2013-05188, 2013-05251-05263 and 2013-05268. 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. This case involved a 59-year-old male patient who had received Trivalent inactivated influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and 24 days later reported the onset of GBS. No further information was provided. Outcome was not reported. Documents held by sender: none.
Age: 59.0
Sex: M
Vaccine: FLUX
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 1995-00224, 2003-02926, 2006-03086, 2006-03230, 2011-03827, 2013-02288, 2013-05188, 2013-05251-05263 and 2013-05269. 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. This case which involved a 59-year-old male patient who had received Trivalent inactivated influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and 31 days later reported the onset of GBS. No further information was provided. Outcome was not reported. Documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a female patient of unknown age who is allergic to LEVAQUIN, allergic to ZITHROMAX, has varied sensitivities and allergy to synthetic fibers like nylon. The patient's medical history included gets pneumonia routinely during specific seasons. On an unknown date in October 2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date were not reported) 0.65 milliliter (reported as standard dose), subcutaneously. Concomitant therapies included amoxicillin and PRILOSEC. The patient reported that after receiving ZOSTAVAX in October 2012, she developed a bad reaction on her arm where the injection site became red and itchy and then spread over a larger area in the arm. The patient also developed a pins and needles sensation around her neck and top of her back that occurred in January 2013 after the vaccination, on the same side of her body that the shot was given and eventually subsided approximately in January 2013 (reported as after 2 weeks). The patient explained that when she received the vaccine on an unknown date in October 2012, it felt slightly itchy and burned during administration and resolved on an unknown date in October 2012. After the painful administration on an unknown date in October 2012, the arm became swollen and developed a mark that lasted almost 4 months in decreasing severity and was recovering at the time of report. Diagnostic test was not performed. The patient sought medical attention (spoke to the doctor). No treatment was provided. The outcome of the events the injection site became red and itchy and then spread over a larger area in the arm was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Paraesthesia, Pruritus
Clinical narrative: This spontaneous report as received from a female patient of unknown age who is allergic to LEVAQUIN, allergic to ZITHROMAX, has varied sensitivities and allergy to synthetic fibers like nylon. The patient's medical history included gets pneumonia routinely during specific seasons. On an unknown date in October 2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date were not reported) 0.65 milliliter (reported as standard dose), subcutaneously. Concomitant therapies included amoxicillin and PRILOSEC. The patient reported that after receiving ZOSTAVAX in October 2012, she developed a bad reaction on her arm where the injection site became red and itchy and then spread over a larger area in the arm. The patient also developed a pins and needles sensation around her neck and top of her back that occurred in January 2013 after the vaccination, on the same side of her body that the shot was given and eventually subsided approximately in January 2013 (reported as after 2 weeks). The patient explained that when she received the vaccine on an unknown date in October 2012, it felt slightly itchy and burned during administration and resolved on an unknown date in October 2012. After the painful administration on an unknown date in October 2012, the arm became swollen and developed a mark that lasted almost 4 months in decreasing severity and was recovering at the time of report. Diagnostic test was not performed. The patient sought medical attention (spoke to the doctor). No treatment was provided. The outcome of the events the injection site became red and itchy and then spread over a larger area in the arm was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TD, HPV4, MNQ, TDAP
Symptoms: Computerised tomogram head, Head injury, Headache, Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 year old female patient with no drug reactions or allergies and with no pertinent medical history and do not pregnant at the time of reporting. On 24-APR-2013 the patient was vaccinated with a dose of GARDASIL (lot number: H012643, expiration date: 30-MAR-2015) (dose and route of administration were not reported). At the same date patient was vaccinated with MENACTRA and diphtheria toxoid (+) tetanus toxoid. There was not more concomitant medication. After receiving the vaccines on 24-APR-2013 the patient immediately fainted. When the patient fainted she bumped her head and then quickly developed an extremely painful headache. On 24-APR-2013, after leaving physician's office the patient was sent for Computed Tomography Scan at an unspecified site. The results of the diagnostic procedure was not reported. on 25-APR-2013 the patient was fully recovered. The patient sought unspecified medical attention. The relatedness between faint after receiving the vaccine and extremely painful headache and GARDASIL was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TD, HPV4, MNQ, TDAP
Symptoms: Computerised tomogram head, Fall, Head injury, Headache, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 year old female patient with no drug reactions or allergies and with no pertinent medical history and do not pregnant at the time of reporting. On 24-APR-2013 the patient was vaccinated with a dose of GARDASIL (lot number: H012643, expiration date: 30-MAR-2015) (dose and route of administration were not reported). At the same date patient was vaccinated with MENACTRA and diphtheria toxoid (+) tetanus toxoid. There was not more concomitant medication. After receiving the vaccines on 24-APR-2013 the patient immediately fainted. When the patient fainted she bumped her head and then quickly developed an extremely painful headache. On 24-APR-2013, after leaving physician's office the patient was sent for Computed Tomography Scan at an unspecified site. The results of the diagnostic procedure was not reported. on 25-APR-2013 the patient was fully recovered. The patient sought unspecified medical attention. The relatedness between faint after receiving the vaccine and extremely painful headache and GARDASIL was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TD, HPV4, MNQ, TDAP
Symptoms: Loss of consciousness, Miosis, Muscle rigidity, Syncope, Tremor
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 year old female patient with no drug reactions or allergies and with no pertinent medical history and do not pregnant at the time of reporting. On 24-APR-2013 the patient was vaccinated with a dose of GARDASIL (lot number: H012643, expiration date: 30-MAR-2015) (dose and route of administration were not reported). At the same date patient was vaccinated with MENACTRA and diphtheria toxoid (+) tetanus toxoid. There was not more concomitant medication. After receiving the vaccines on 24-APR-2013 the patient immediately fainted. When the patient fainted she bumped her head and then quickly developed an extremely painful headache. On 24-APR-2013, after leaving physician's office the patient was sent for Computed Tomography Scan at an unspecified site. The results of the diagnostic procedure was not reported. on 25-APR-2013 the patient was fully recovered. The patient sought unspecified medical attention. The relatedness between faint after receiving the vaccine and extremely painful headache and GARDASIL was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TD, HPV4, MNQ, TDAP
Symptoms: Computerised tomogram head, Head injury, Headache, Immediate post-injection reaction, Syncope
Clinical narrative: Pt fainted while HPV vaccine was being administered. Pt's eyes were open, pinpoint pupils, fell back onto table from sitting. Hit head on metal table. Body stiff and shaking for approx 3-5 seconds then pt came to. Severe H/A.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TD, HPV4, MNQ, TDAP
Symptoms: Computerised tomogram head, Fall, Head injury, Headache, Immediate post-injection reaction
Clinical narrative: Pt fainted while HPV vaccine was being administered. Pt's eyes were open, pinpoint pupils, fell back onto table from sitting. Hit head on metal table. Body stiff and shaking for approx 3-5 seconds then pt came to. Severe H/A.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TD, HPV4, MNQ, TDAP
Symptoms: Loss of consciousness, Miosis, Muscle rigidity, Syncope, Tremor
Clinical narrative: Pt fainted while HPV vaccine was being administered. Pt's eyes were open, pinpoint pupils, fell back onto table from sitting. Hit head on metal table. Body stiff and shaking for approx 3-5 seconds then pt came to. Severe H/A.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Pallor, Posture abnormal
Clinical narrative: Patient became pale after receiving shot. She stood up and pitched forward and was caught by her dad and lower to the floor. She was responsive. Her pulse was strong and steady. After 10 minutes we helped her to the chair where she sat for another 5 minutes then said she was feeling woozy again so we laid her on the floor for another 20 minutes. After sitting for about 5 min she was ready to leave. I cautioned dad to hold on to her as they exited. He refused a call to 911.
Age: 60.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Gait disturbance
Clinical narrative: Severe pain at site, general malaise, which developed later in the night to chills, nausea, epigastric pain. Headaches, arthalgias, myalgis especially hip, shoulder and knee pain with pain and tenderness of gluteal, thigh and calf muscle, profound fatigue, difficulty going up stairs due to pain and walking, even driving painful on legs, fever of 100.2 - 100.6, chills, very scary. At present pain at site decreased but arthralgias/myalgis and tiredness still present and the headache and GI upset.
Age: 60.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Injection site pain, Malaise, Myalgia, Nausea
Clinical narrative: Severe pain at site, general malaise, which developed later in the night to chills, nausea, epigastric pain. Headaches, arthalgias, myalgis especially hip, shoulder and knee pain with pain and tenderness of gluteal, thigh and calf muscle, profound fatigue, difficulty going up stairs due to pain and walking, even driving painful on legs, fever of 100.2 - 100.6, chills, very scary. At present pain at site decreased but arthralgias/myalgis and tiredness still present and the headache and GI upset.
Age: 60.0
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Severe pain at site, general malaise, which developed later in the night to chills, nausea, epigastric pain. Headaches, arthalgias, myalgis especially hip, shoulder and knee pain with pain and tenderness of gluteal, thigh and calf muscle, profound fatigue, difficulty going up stairs due to pain and walking, even driving painful on legs, fever of 100.2 - 100.6, chills, very scary. At present pain at site decreased but arthralgias/myalgis and tiredness still present and the headache and GI upset.
Age: 37.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Left outer arm started swelling and turning red.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain in left shoulder and numbness in left arm.  Severe loss of mobility in left shoulder and arm.  The pain and immobility increased over the next few days and has remained fairly constant through the present time (over 2 weeks later).  Regularly took ibuprofen (for c-section recovery) and applied heat packs to shoulder.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient who is allergic to DEMEROL and DARVIN. Pertinent medical history was none. On 20-APR-2013 the patient was vaccinated with ZOSTAVAX (Lot number and expiry date was not reported), 0.65 milliliter (ml), subcutaneously. Concomitant medication was none. On 22-APR-2013, the patient developed 3 bumps on their forehead after receiving ZOSTAVAX. Diagnostic test performed was none. The patient sought medical attention (called the pharmacist) and no treatment was provided. The outcome of 3 bumps on their forehead was reported as not recovered/not resolved. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Erythema, Herpes zoster, Local swelling
Clinical narrative: This spontaneous report was received from a 66 year old male patient. On an unknown date in 2006, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose unspecified), subcutaneously. No concomitant medications were reported. On 23-APR-2013, the patient was diagnosed with shingles outbreak red and swollen on his neck, on the right side under his ear. It was painful to his ear. The patient did not seek any medical attention. He was treated with acyclovir, a herpes viral inhibitor. It was unspecified if any lab tests were performed. The outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number was reported as J000447, expiry date 11-APR-2014, route and dose were not reported). On an unknown date, the patient experienced swelling at the injection site after receiving ZOSTAVAX. The outcome of swelling at the injection site was unknown. This is one of the several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients with unknown demographics. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). On an unknown date, the patients experienced swelling at the injection site after receiving ZOSTAVAX. The outcome of swelling at the injection site was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000433, expiry date 10-APR-2014, route and dose were not reported). On an unknown date, the patient experienced swelling at the injection site after receiving ZOSTAVAX. Patient was treated with KEFLEX. The outcome of swelling at the injection site was unknown. This is one of the several reports received from the same reporter. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Pain in extremity
Clinical narrative: Sore arm, which she felt was normal, then back pain starting the morning after vaccine, still lasting on and off the full week after.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen in area of immunization.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Pt. noticed a red spot at injection site, about the size of her palm. It was somewhat swollen and felt like a knot under neath. Pt. self-treated with ice and BENADRYL, and it got progressively better. She says it is completely resolved as of this morning (4/19/13).
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Campylobacter test positive, Dehydration, Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: Diarrhea 2 days after vaccine was given, then worsening by emesis admitted for dehydration.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a male patient of unknown age who on 21-JUN-2012 was vaccinated with the first dose of PNEUMOVAX 23 (dose/frequency, route and lot # not provided). On 16-APR-2013, the patient received a second dose of PNEUMOVAX 23 (dose/frequency, route and lot # not provided). No adverse effects were reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site reaction, Pain, Swelling
Clinical narrative: 60 min erythema. Pain and swelling. Tdap given on 4/24/2013 at 1030 am. Swelling noted on 4/24/13 at 1700. Area noted worse on 4/26/13 in AM (R) deltoid.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Bumps on back and Rt shoulder and spreading.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Lymph node pain, Lymphadenitis
Clinical narrative: Lymphadenitis. PE indicates 3 tender, lymph nodes of (L) supraclavicular and periclavicular chain.