chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Oral herpes, Pain, Pain in extremity, Paraesthesia, Photophobia
Clinical narrative: First week June 2007-Fourth week July 2007: Achy body, mostly in thighs; Very tired; Feeling weak; Foggy thought process, confused; Fever feeling (burning on forehead, back of neck and behind the eyes). Diagnosis: Lyme disease (never a positive test). Last week in May 2008-Third week of August: Diarrhea for the first two days before I got other symptoms; Achy body (mostly in the thighs); Fever feeling (burning on forehead, back of neck and behind the eyes); Fatigue; Chest pains (sharp and random spells. Feelings in the upper chest area, under breasts, all of the way to the back); Bones cracking a lot; Loss of appetite (easily full and chest would hurt if I ate too much); Sensitive skin.  Diagnosis: Fibromyalgia. March 29th 2009-Last week in July 2009: Diarrhea for the four days before I got other symptoms; Achy body all over; Fever feeling worse than the years previous (burning on forehead, back of neck and behind the eyes); Fatigue; Chest pains (sharp and random feelings in the upper chest area, under breasts); Bones cracking a lot; Loss of appetite (easily full and chest would hurt if I ate too much); Sensitive skin especially under arms. Diagnosis: Fibromyalgia. January 1st to Current (Seemed to get worse first week of May): Flu like feeling all over body-especially intense in legs (thighs and calves); Sore feeling all over body (like after working out)- especially intense in legs (thighs and calves); Shooting/sharp pain in legs (knees, thighs, calves, behind the legs); Constipation and diarrhea; Fever felling all over body (Never have a fever but I feel hot all over body, especially on forehead, back of neck and behind eyes); Headache- behind the eyes and on the side of the head; Loss of appetite and then very hungry feeling; Nausea and vomiting; Fatigue; Bouts of extreme exhaustion to the point of feeling like passing out; Bouts of extreme exhaustion after eating, feeling worse after eating (eating anything, in any amount); Chest pains- sharp pains in chest, under breast all the way to the back; Sharp pains in arms, under arm pits; Achy body all over; Sensitive skin-especially on arms and legs; Pain on butt tissue; Bruise easy-not sure if this has anything to do with Fibro; Very sensitive to noise-does not hurt ears but I feel sharp pain in arms, legs, chest when a loud noise occurs; Mildly sensitive to a quick burst of light; Shaking and feeling swollen in fingers/face and knees; Stuttering when speaking, having a hard time getting out what I want to say; Breaking out of face cold sores or pimples; Bones cracking a lot; Arms, fingers and toes feeling numb and tingly; Not sleeping during the night-waking up because of extreme sweating to the point where I wake up soaking wet from head to toes, waking up because of sharp pains in legs and achy feeling all over body; Weakness in legs and arms, takes so much effort to move and speak. Diagnosis: Fibromyalgia.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Sleep disorder, Speech disorder, Swelling face, Tremor, Vomiting
Clinical narrative: First week June 2007-Fourth week July 2007: Achy body, mostly in thighs; Very tired; Feeling weak; Foggy thought process, confused; Fever feeling (burning on forehead, back of neck and behind the eyes). Diagnosis: Lyme disease (never a positive test). Last week in May 2008-Third week of August: Diarrhea for the first two days before I got other symptoms; Achy body (mostly in the thighs); Fever feeling (burning on forehead, back of neck and behind the eyes); Fatigue; Chest pains (sharp and random spells. Feelings in the upper chest area, under breasts, all of the way to the back); Bones cracking a lot; Loss of appetite (easily full and chest would hurt if I ate too much); Sensitive skin.  Diagnosis: Fibromyalgia. March 29th 2009-Last week in July 2009: Diarrhea for the four days before I got other symptoms; Achy body all over; Fever feeling worse than the years previous (burning on forehead, back of neck and behind the eyes); Fatigue; Chest pains (sharp and random feelings in the upper chest area, under breasts); Bones cracking a lot; Loss of appetite (easily full and chest would hurt if I ate too much); Sensitive skin especially under arms. Diagnosis: Fibromyalgia. January 1st to Current (Seemed to get worse first week of May): Flu like feeling all over body-especially intense in legs (thighs and calves); Sore feeling all over body (like after working out)- especially intense in legs (thighs and calves); Shooting/sharp pain in legs (knees, thighs, calves, behind the legs); Constipation and diarrhea; Fever felling all over body (Never have a fever but I feel hot all over body, especially on forehead, back of neck and behind eyes); Headache- behind the eyes and on the side of the head; Loss of appetite and then very hungry feeling; Nausea and vomiting; Fatigue; Bouts of extreme exhaustion to the point of feeling like passing out; Bouts of extreme exhaustion after eating, feeling worse after eating (eating anything, in any amount); Chest pains- sharp pains in chest, under breast all the way to the back; Sharp pains in arms, under arm pits; Achy body all over; Sensitive skin-especially on arms and legs; Pain on butt tissue; Bruise easy-not sure if this has anything to do with Fibro; Very sensitive to noise-does not hurt ears but I feel sharp pain in arms, legs, chest when a loud noise occurs; Mildly sensitive to a quick burst of light; Shaking and feeling swollen in fingers/face and knees; Stuttering when speaking, having a hard time getting out what I want to say; Breaking out of face cold sores or pimples; Bones cracking a lot; Arms, fingers and toes feeling numb and tingly; Not sleeping during the night-waking up because of extreme sweating to the point where I wake up soaking wet from head to toes, waking up because of sharp pains in legs and achy feeling all over body; Weakness in legs and arms, takes so much effort to move and speak. Diagnosis: Fibromyalgia.
Age: 38.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Blister, Papule, Pyrexia
Clinical narrative: Reported low grade fever 1 wk after immunization. Followed by discreet papules & vesicles on neck, chest & upper arm.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Pyrexia, Respiratory rate increased, Vomiting
Clinical narrative: Patient was given the DTaP vaccine on 10-13-2010 at around 4:00pm. At around 1:00am on 10-14-2010 he woke up with a fever of 103 and the shivers. He also vomited 3 times and had 47 breaths per minute. Due to his fast breathing and his pre-existing asthma the nurse advised to bring him in to emergency where he was seen.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Approximately 24 hrs after vaccine administered, pt went to ER with redness, swelling, hardness around injection site. Pt was treated with prednisone & released.
Age: 37.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling at injection site of ADACEL vaccine. Client states Dr gave her an antibiotic for reaction.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Influenza virus test positive, Seroconversion test positive
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (seasonal influenza vaccine, manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 5, 20, 10, and 1280 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had more than 4 fold increase in titer value and also tested positive for seroconversion of A/H3N2 strain. Therefore this patient was considered as a LCI case of Influenza A/H3N2. The outcome was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Influenza virus test positive, Polymerase chain reaction, Seroconversion test negative
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with influenza virus vaccine 2007/2008 (manufacturer unknown, batch number; unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody at titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 5, 20, 10 and 5 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient did not have 4-fold increase in titer value and tested negative for seroconversion of A/H3N2 strain but PCR (polymer chain reaction) tested positive. Therefore this patient was considered as an LCI case of Influenza A/H3N2. The outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza virus test positive, Seroconversion test positive
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (seasonal influenza vaccine, manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 5, 80, 320, and 320 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had more than 4 fold increase in titer value and also tested positive for seroconversion of A/H3N2 strain. Therefore this patient was considered as a LCI case of Influenza A/H3N2. The outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza virus test positive, Respiratory disorder, Seroconversion test positive
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlated of protection against influenza following vaccination in older adults. The patients were vaccinated with INFLUENZA (manufacturer unknown, batch number unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient was exposed to a H3N2 LCI case and had acute respiratory illness. This patient had an antibody titer value of 40, 113, and 320 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. But the patient was not available for nasopharyngeal swab at the time of illness. The patient had 4-fold increase in titer value and tested positive for seroconversion of A/H3N2 strain. Therefore this patient was considered as an LCI case of INFLUENZA A/JH3N2. The outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza like illness, Influenza virus test positive, Seroconversion test positive
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both criteria and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 5, 10, 5, and 20 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had 4-fold increase in titer value and tested positive for seroconversion of A/H3N2 strain. Therefore this patient was considered as an LCI case of Influenza A/H3N2. The outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza virus test positive, Seroconversion test positive
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with FLUVIRIN 2007/2008 (manufacturer unknown, batch number unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swab or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 160, 320, 320, and 2560 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had 4-fold increase in titer value and tested positive for seroconversion of A/H3N2 strain. Therefore this patient was considered as an LCI case of Influenza A/H3N2. The outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza virus test positive, Polymerase chain reaction, Seroconversion test negative
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza. This patient had an antibody titer value of 5, 20, 10, and 10 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient did not have 4-fold increase in titer value and tested negative for seroconversion of strain but PCR tested positive. Therefore this patient was considered as an case of Influenza A/H3N2. The outcome was not reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Abdominal tenderness, Asthenia, Blood amylase normal, CSF glucose increased
Clinical narrative: Initial literature report received on 18 Oct 2010: Authors presented two adult cases of neurologic complications occur after administration of the influenza vaccine. This patient (second case: 64 year old female) was vaccinated with Influenza virus vaccine (manufacturer and batch number unknown). Eighteen days after the vaccination, the patient presented with paraplegia and a diagnosis of acute idiopathic demyelinating polyradiculopathy (Guillain-Barre syndrome) was made. The patient was given treatment with intravenous immunoglobulin therapy but response was poor. Authors concluded that the rare occurrence of neurological complications after influenza vaccine should not discourage against the vaccination. Follow up information received on 01 Nov 2010: The patient had medical history of coronary artery disease, diabetes mellitus, asthma, severe diabetic neuropathy and chronic low back pain. This patient initially had complaint of epigastric pain, 18 days after vaccination on unknown date. On physical examination the patient had tenderness to palpation on the epigastric, left and right upper quadrants of abdomen for which she was admitted to hospital. Initial laboratory workup including amylase and lipase levels came back within normal limits. An upper endoscopy revealed gastritis and esophagitis. The patient was neurologically intact. Three days later the patient had developed generalized weakness and shortness of breath. Physical examination at the time showed deep tendon reflexes +1 in upper extremity. The strength was symmetrically decreased 2/5 in all four extremities. Electromyogram was performed which showed denervation of extremities due to 80% axonal loss. Lumbar puncture yielded a cerebro spinal fluid with 268.2 mg/dL of proteins, 172 mg/dL of glucose and 1 white blood cell (WBC). The diagnosis of Guillain Barre Syndrome was established and intravenous immunoglobulin therapy was started. The patient's condition continued to deteriorate and progressed to quadriplegia and respiratory failure requiring mechanical ventilation. The patient was negative for C. jejuni Ab and stool for Shigella, Salmonella and E.coli and also titres of EBV, Influenza A&B, Enterovirus, Parainfluenza I, II, III and Echovirus were negative. The patient remained dependant on mechanical ventilation with minimal motor improvement. The patient was discharged with same condition on unspecified date.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: CSF protein increased, CSF white blood cell count negative, Denervation atrophy, Dyspnoea, Echovirus test negative
Clinical narrative: Initial literature report received on 18 Oct 2010: Authors presented two adult cases of neurologic complications occur after administration of the influenza vaccine. This patient (second case: 64 year old female) was vaccinated with Influenza virus vaccine (manufacturer and batch number unknown). Eighteen days after the vaccination, the patient presented with paraplegia and a diagnosis of acute idiopathic demyelinating polyradiculopathy (Guillain-Barre syndrome) was made. The patient was given treatment with intravenous immunoglobulin therapy but response was poor. Authors concluded that the rare occurrence of neurological complications after influenza vaccine should not discourage against the vaccination. Follow up information received on 01 Nov 2010: The patient had medical history of coronary artery disease, diabetes mellitus, asthma, severe diabetic neuropathy and chronic low back pain. This patient initially had complaint of epigastric pain, 18 days after vaccination on unknown date. On physical examination the patient had tenderness to palpation on the epigastric, left and right upper quadrants of abdomen for which she was admitted to hospital. Initial laboratory workup including amylase and lipase levels came back within normal limits. An upper endoscopy revealed gastritis and esophagitis. The patient was neurologically intact. Three days later the patient had developed generalized weakness and shortness of breath. Physical examination at the time showed deep tendon reflexes +1 in upper extremity. The strength was symmetrically decreased 2/5 in all four extremities. Electromyogram was performed which showed denervation of extremities due to 80% axonal loss. Lumbar puncture yielded a cerebro spinal fluid with 268.2 mg/dL of proteins, 172 mg/dL of glucose and 1 white blood cell (WBC). The diagnosis of Guillain Barre Syndrome was established and intravenous immunoglobulin therapy was started. The patient's condition continued to deteriorate and progressed to quadriplegia and respiratory failure requiring mechanical ventilation. The patient was negative for C. jejuni Ab and stool for Shigella, Salmonella and E.coli and also titres of EBV, Influenza A&B, Enterovirus, Parainfluenza I, II, III and Echovirus were negative. The patient remained dependant on mechanical ventilation with minimal motor improvement. The patient was discharged with same condition on unspecified date.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Endoscopy upper gastrointestinal tract abnormal, Enterovirus test negative, Gastritis, General physical health deterioration
Clinical narrative: Initial literature report received on 18 Oct 2010: Authors presented two adult cases of neurologic complications occur after administration of the influenza vaccine. This patient (second case: 64 year old female) was vaccinated with Influenza virus vaccine (manufacturer and batch number unknown). Eighteen days after the vaccination, the patient presented with paraplegia and a diagnosis of acute idiopathic demyelinating polyradiculopathy (Guillain-Barre syndrome) was made. The patient was given treatment with intravenous immunoglobulin therapy but response was poor. Authors concluded that the rare occurrence of neurological complications after influenza vaccine should not discourage against the vaccination. Follow up information received on 01 Nov 2010: The patient had medical history of coronary artery disease, diabetes mellitus, asthma, severe diabetic neuropathy and chronic low back pain. This patient initially had complaint of epigastric pain, 18 days after vaccination on unknown date. On physical examination the patient had tenderness to palpation on the epigastric, left and right upper quadrants of abdomen for which she was admitted to hospital. Initial laboratory workup including amylase and lipase levels came back within normal limits. An upper endoscopy revealed gastritis and esophagitis. The patient was neurologically intact. Three days later the patient had developed generalized weakness and shortness of breath. Physical examination at the time showed deep tendon reflexes +1 in upper extremity. The strength was symmetrically decreased 2/5 in all four extremities. Electromyogram was performed which showed denervation of extremities due to 80% axonal loss. Lumbar puncture yielded a cerebro spinal fluid with 268.2 mg/dL of proteins, 172 mg/dL of glucose and 1 white blood cell (WBC). The diagnosis of Guillain Barre Syndrome was established and intravenous immunoglobulin therapy was started. The patient's condition continued to deteriorate and progressed to quadriplegia and respiratory failure requiring mechanical ventilation. The patient was negative for C. jejuni Ab and stool for Shigella, Salmonella and E.coli and also titres of EBV, Influenza A&B, Enterovirus, Parainfluenza I, II, III and Echovirus were negative. The patient remained dependant on mechanical ventilation with minimal motor improvement. The patient was discharged with same condition on unspecified date.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Influenza virus test negative, Lipase normal, Lumbar puncture abnormal
Clinical narrative: Initial literature report received on 18 Oct 2010: Authors presented two adult cases of neurologic complications occur after administration of the influenza vaccine. This patient (second case: 64 year old female) was vaccinated with Influenza virus vaccine (manufacturer and batch number unknown). Eighteen days after the vaccination, the patient presented with paraplegia and a diagnosis of acute idiopathic demyelinating polyradiculopathy (Guillain-Barre syndrome) was made. The patient was given treatment with intravenous immunoglobulin therapy but response was poor. Authors concluded that the rare occurrence of neurological complications after influenza vaccine should not discourage against the vaccination. Follow up information received on 01 Nov 2010: The patient had medical history of coronary artery disease, diabetes mellitus, asthma, severe diabetic neuropathy and chronic low back pain. This patient initially had complaint of epigastric pain, 18 days after vaccination on unknown date. On physical examination the patient had tenderness to palpation on the epigastric, left and right upper quadrants of abdomen for which she was admitted to hospital. Initial laboratory workup including amylase and lipase levels came back within normal limits. An upper endoscopy revealed gastritis and esophagitis. The patient was neurologically intact. Three days later the patient had developed generalized weakness and shortness of breath. Physical examination at the time showed deep tendon reflexes +1 in upper extremity. The strength was symmetrically decreased 2/5 in all four extremities. Electromyogram was performed which showed denervation of extremities due to 80% axonal loss. Lumbar puncture yielded a cerebro spinal fluid with 268.2 mg/dL of proteins, 172 mg/dL of glucose and 1 white blood cell (WBC). The diagnosis of Guillain Barre Syndrome was established and intravenous immunoglobulin therapy was started. The patient's condition continued to deteriorate and progressed to quadriplegia and respiratory failure requiring mechanical ventilation. The patient was negative for C. jejuni Ab and stool for Shigella, Salmonella and E.coli and also titres of EBV, Influenza A&B, Enterovirus, Parainfluenza I, II, III and Echovirus were negative. The patient remained dependant on mechanical ventilation with minimal motor improvement. The patient was discharged with same condition on unspecified date.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Mechanical ventilation, Neurological examination normal, Oesophagitis, Paraplegia, Quadriplegia
Clinical narrative: Initial literature report received on 18 Oct 2010: Authors presented two adult cases of neurologic complications occur after administration of the influenza vaccine. This patient (second case: 64 year old female) was vaccinated with Influenza virus vaccine (manufacturer and batch number unknown). Eighteen days after the vaccination, the patient presented with paraplegia and a diagnosis of acute idiopathic demyelinating polyradiculopathy (Guillain-Barre syndrome) was made. The patient was given treatment with intravenous immunoglobulin therapy but response was poor. Authors concluded that the rare occurrence of neurological complications after influenza vaccine should not discourage against the vaccination. Follow up information received on 01 Nov 2010: The patient had medical history of coronary artery disease, diabetes mellitus, asthma, severe diabetic neuropathy and chronic low back pain. This patient initially had complaint of epigastric pain, 18 days after vaccination on unknown date. On physical examination the patient had tenderness to palpation on the epigastric, left and right upper quadrants of abdomen for which she was admitted to hospital. Initial laboratory workup including amylase and lipase levels came back within normal limits. An upper endoscopy revealed gastritis and esophagitis. The patient was neurologically intact. Three days later the patient had developed generalized weakness and shortness of breath. Physical examination at the time showed deep tendon reflexes +1 in upper extremity. The strength was symmetrically decreased 2/5 in all four extremities. Electromyogram was performed which showed denervation of extremities due to 80% axonal loss. Lumbar puncture yielded a cerebro spinal fluid with 268.2 mg/dL of proteins, 172 mg/dL of glucose and 1 white blood cell (WBC). The diagnosis of Guillain Barre Syndrome was established and intravenous immunoglobulin therapy was started. The patient's condition continued to deteriorate and progressed to quadriplegia and respiratory failure requiring mechanical ventilation. The patient was negative for C. jejuni Ab and stool for Shigella, Salmonella and E.coli and also titres of EBV, Influenza A&B, Enterovirus, Parainfluenza I, II, III and Echovirus were negative. The patient remained dependant on mechanical ventilation with minimal motor improvement. The patient was discharged with same condition on unspecified date.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory failure
Clinical narrative: Initial literature report received on 18 Oct 2010: Authors presented two adult cases of neurologic complications occur after administration of the influenza vaccine. This patient (second case: 64 year old female) was vaccinated with Influenza virus vaccine (manufacturer and batch number unknown). Eighteen days after the vaccination, the patient presented with paraplegia and a diagnosis of acute idiopathic demyelinating polyradiculopathy (Guillain-Barre syndrome) was made. The patient was given treatment with intravenous immunoglobulin therapy but response was poor. Authors concluded that the rare occurrence of neurological complications after influenza vaccine should not discourage against the vaccination. Follow up information received on 01 Nov 2010: The patient had medical history of coronary artery disease, diabetes mellitus, asthma, severe diabetic neuropathy and chronic low back pain. This patient initially had complaint of epigastric pain, 18 days after vaccination on unknown date. On physical examination the patient had tenderness to palpation on the epigastric, left and right upper quadrants of abdomen for which she was admitted to hospital. Initial laboratory workup including amylase and lipase levels came back within normal limits. An upper endoscopy revealed gastritis and esophagitis. The patient was neurologically intact. Three days later the patient had developed generalized weakness and shortness of breath. Physical examination at the time showed deep tendon reflexes +1 in upper extremity. The strength was symmetrically decreased 2/5 in all four extremities. Electromyogram was performed which showed denervation of extremities due to 80% axonal loss. Lumbar puncture yielded a cerebro spinal fluid with 268.2 mg/dL of proteins, 172 mg/dL of glucose and 1 white blood cell (WBC). The diagnosis of Guillain Barre Syndrome was established and intravenous immunoglobulin therapy was started. The patient's condition continued to deteriorate and progressed to quadriplegia and respiratory failure requiring mechanical ventilation. The patient was negative for C. jejuni Ab and stool for Shigella, Salmonella and E.coli and also titres of EBV, Influenza A&B, Enterovirus, Parainfluenza I, II, III and Echovirus were negative. The patient remained dependant on mechanical ventilation with minimal motor improvement. The patient was discharged with same condition on unspecified date.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza virus test positive, Polymerase chain reaction, Seroconversion test positive
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (seasonal influenza vaccine, manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both  clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCL). This patient had an antibody titer value of 40, 40, 40, and 160 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had 4-fold increase in titer value and tested positive for seroconversion of A/H3N2 strain. Therefore this patient was considered as an LCI case of Influenza A/H3N2. The outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza virus test positive, Polymerase chain reaction, Seroconversion test negative
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with influenza virus vaccine 2007/2008 (manufacturer unknown, batch number; unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody at titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 5, 20, 10 and 5 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient did not have 4-fold increase in titer value and tested negative for seroconversion of A/H1N1 strain but PCR (polymer chain reaction) tested positive. Therefore this patient was considered as an LCI case of Influenza A/H1N1. The outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza virus test positive, Polymerase chain reaction, Seroconversion test negative
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 113, 160, 160, and 160 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient did not have 4-fold increase in titer value and tested negative for seroconversion of A/H3N2 strain but PCR (polymer chain reaction) tested positive. Therefore this patient was considered as an LCI case of Influenza A/H3N2. The outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive, Influenza like illness, Polymerase chain reaction, Seroconversion test positive
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with FLUVIRIN 2007/2008 (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza Surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient tested positive for seroconversion of A/H32 strain (antibody titer values not provided). Therefore this patient was considered as an LCI case of influenza A/H3N2. The outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Antibody test positive, Influenza, Influenza B virus test positive, Polymerase chain reaction, Seroconversion test negative
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (seasonal influenza vaccine, manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 40, 160, 80, and 160 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had more than 4 fold increase in titer value and also tested negative for seroconversion of B strain but tested positive for PCR of B strain. Therefore this patient was considered as a LCI case of Influenza B. The outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza virus test positive, Polymerase chain reaction, Seroconversion test positive
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza. This patient had an antibody titer value of 5, 20, 20, and 80 after 0 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had 4-fold increase in titer value and tested positive for seroconversion of B strain. Therefore this patient was considered as an LCI case of Influenza B. The outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza virus test positive, Seroconversion test positive
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient with a medical history of heart failure participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient, who had a history of heart failure, had an antibody titer value of 20, 40, 40, and 640 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectfully. The patient had 4-fold increase in titer value and tested positive for seroconversion of B strain. Therefore this patient was considered as an LCI case of Influenza B. The outcome was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza virus test positive, Seroconversion test positive
Clinical narrative: Initial literature report received on 01 Nov 2010: This patient with a medical history of heart failure participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza. This patient who had a history of heart failure had an antibody titer value of 10, 20, 20, and 160 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had 4-fold increase in titer value and tested positive for seroconversion of A/H3N2 strain. Therefore this patient was considered as an LCI case of Influenza A/H3N2. The outcome was not reported.