chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.8
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Injection site oedema
Clinical narrative: The mother, took pt to ER on Sunday 9/17/06. PT right thigh became swollen. He was treated with ice pack plus Benadryl. Today the swelling has improved and pt is back to baseline.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Skin ulcer, Viral infection
Clinical narrative: Varicella lesions.
Age: 0.87
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Agitation, Cough, Crying, Wheezing
Clinical narrative: Pt started, crying, coughing and audible wheezing after vaccines given.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female with no pertinent medical history or drug allergies, who on 8/14/06 was vaccinated IM in the right deltoid with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5ml (lot 653937/0637F). There was no concomitant medication. On 8/19/06 the pt notified her physicians office stating that she had developed a rash on both legs and torso. The pt did not experienced a fever . Unspecified medical attention was sought. Treatment advised was an antihistamine. Subsequently, the pt recovered. Additional information has been requested. 01/05/2007 Initial and follow-up information has been received from a nurse practitioner concerning a 25 year old female with no pertinent medical history or drug allergies, who on 14-AUG-2006 was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (0.5 ml) (lot # 653537/0537F). There was no concomitant medication and no illness at time of vaccination. On 17-AUG-2006 the patient developed a rash on both legs and torso. The patient also experienced itching. The patient did not experience a fever. Treatment advised was an antihistamine and the patient was seen by a dermatologist. Subsequently, the patient recovered from the rash and itching. No further information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female with no pertinent medical history or drug allergies, who on 8/14/06 was vaccinated IM in the right deltoid with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5ml (lot 653937/0637F). There was no concomitant medication. On 8/19/06 the pt notified her physicians office stating that she had developed a rash on both legs and torso. The pt did not experienced a fever . Unspecified medical attention was sought. Treatment advised was an antihistamine. Subsequently, the pt recovered. Additional information has been requested. 01/05/2007 Initial and follow-up information has been received from a nurse practitioner concerning a 25 year old female with no pertinent medical history or drug allergies, who on 14-AUG-2006 was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (0.5 ml) (lot # 653537/0537F). There was no concomitant medication and no illness at time of vaccination. On 17-AUG-2006 the patient developed a rash on both legs and torso. The patient also experienced itching. The patient did not experience a fever. Treatment advised was an antihistamine and the patient was seen by a dermatologist. Subsequently, the patient recovered from the rash and itching. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injury, Loss of consciousness, Syncope, Syncope vasovagal, Tremor
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated intramuscularly with the first dose of 0.5 ml of HPV rLi 6 11 16 18 VLP vaccine (yeast).  The patient "fainted after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast)".  The patient "fainted after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast).  It was reported that the patient fell over and hit her head when she fainted. The patient developed a concussion. The patient was observed in the office for 3 to 4 hours and was sent home. The patient underwent a computed axial tomography (CT) scan , done the next day and the results were "fine" per the physician (date unknown). It was preiously reported that the patient had not eaten anything. At the time of this report, the patient had recovered from the events (date unknown). The physician assesed the events as non-serious and reported that she was "unsure of the causality of the events". No further information is available. This is in follow-up to report (s) previously submitted on 9/14/2006; 10/6/2006.  Initial and follow up information has been received from a physician and a nursing supervisor concerning a 16 (previously reported as a 15 year old) female with no pre-existing medical condition.  On 25-JUL-2006, in the AM, the patient was vaccinated intramuscularly in the right deltoid with the first dose of 0.5 mL of GARDASIL (Lot #653937/0637F).  There were no illnesses noted at the time of vaccination.  The vaccine was given after a physical.  Subsequently, the patient fainted reported as vasovagal.  It was reported that the patient fell over and hit her head on a carpeted cement floor.  The patient did have a loss of consciousness (previously reported developed a concussion).  It was reported that for 1 minute the patient had tonic posturing of the right hand only some shaking that was considered to be a "seizure-type reaction".  The patient was observed in the office for 3 to 4 hours and was sent home.  On 26-JUL-2006, in the AM, the patient underwent an magnetic resonance imaging (MRI) (previously reported as the patient underwent a computed axial tomography (CT) scan, done the next day, and the results were "fine" per the physician).  It was previously reported that the patient had not eaten anything.  At the time of this report, the patient had recovered completely from the events (date unknow).  The physician assessed the events as non-serious and reported that she was "unsure of the causality of the events".  Upon internal review, the event of tonic posturing of the right hand only some shaking that was considered to be a "seizure-type reaction" was an other important medical event.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Concussion, Fall, Head injury, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated intramuscularly with the first dose of 0.5 ml of HPV rLi 6 11 16 18 VLP vaccine (yeast).  The patient "fainted after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast)".  The patient "fainted after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast).  It was reported that the patient fell over and hit her head when she fainted. The patient developed a concussion. The patient was observed in the office for 3 to 4 hours and was sent home. The patient underwent a computed axial tomography (CT) scan , done the next day and the results were "fine" per the physician (date unknown). It was preiously reported that the patient had not eaten anything. At the time of this report, the patient had recovered from the events (date unknown). The physician assesed the events as non-serious and reported that she was "unsure of the causality of the events". No further information is available. This is in follow-up to report (s) previously submitted on 9/14/2006; 10/6/2006.  Initial and follow up information has been received from a physician and a nursing supervisor concerning a 16 (previously reported as a 15 year old) female with no pre-existing medical condition.  On 25-JUL-2006, in the AM, the patient was vaccinated intramuscularly in the right deltoid with the first dose of 0.5 mL of GARDASIL (Lot #653937/0637F).  There were no illnesses noted at the time of vaccination.  The vaccine was given after a physical.  Subsequently, the patient fainted reported as vasovagal.  It was reported that the patient fell over and hit her head on a carpeted cement floor.  The patient did have a loss of consciousness (previously reported developed a concussion).  It was reported that for 1 minute the patient had tonic posturing of the right hand only some shaking that was considered to be a "seizure-type reaction".  The patient was observed in the office for 3 to 4 hours and was sent home.  On 26-JUL-2006, in the AM, the patient underwent an magnetic resonance imaging (MRI) (previously reported as the patient underwent a computed axial tomography (CT) scan, done the next day, and the results were "fine" per the physician).  It was previously reported that the patient had not eaten anything.  At the time of this report, the patient had recovered completely from the events (date unknow).  The physician assessed the events as non-serious and reported that she was "unsure of the causality of the events".  Upon internal review, the event of tonic posturing of the right hand only some shaking that was considered to be a "seizure-type reaction" was an other important medical event.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated intramuscularly with the first dose of 0.5 ml of HPV rLi 6 11 16 18 VLP vaccine (yeast).  The patient "fainted after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast)".  The patient "fainted after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast).  It was reported that the patient fell over and hit her head when she fainted. The patient developed a concussion. The patient was observed in the office for 3 to 4 hours and was sent home. The patient underwent a computed axial tomography (CT) scan , done the next day and the results were "fine" per the physician (date unknown). It was preiously reported that the patient had not eaten anything. At the time of this report, the patient had recovered from the events (date unknown). The physician assesed the events as non-serious and reported that she was "unsure of the causality of the events". No further information is available. This is in follow-up to report (s) previously submitted on 9/14/2006; 10/6/2006.  Initial and follow up information has been received from a physician and a nursing supervisor concerning a 16 (previously reported as a 15 year old) female with no pre-existing medical condition.  On 25-JUL-2006, in the AM, the patient was vaccinated intramuscularly in the right deltoid with the first dose of 0.5 mL of GARDASIL (Lot #653937/0637F).  There were no illnesses noted at the time of vaccination.  The vaccine was given after a physical.  Subsequently, the patient fainted reported as vasovagal.  It was reported that the patient fell over and hit her head on a carpeted cement floor.  The patient did have a loss of consciousness (previously reported developed a concussion).  It was reported that for 1 minute the patient had tonic posturing of the right hand only some shaking that was considered to be a "seizure-type reaction".  The patient was observed in the office for 3 to 4 hours and was sent home.  On 26-JUL-2006, in the AM, the patient underwent an magnetic resonance imaging (MRI) (previously reported as the patient underwent a computed axial tomography (CT) scan, done the next day, and the results were "fine" per the physician).  It was previously reported that the patient had not eaten anything.  At the time of this report, the patient had recovered completely from the events (date unknow).  The physician assessed the events as non-serious and reported that she was "unsure of the causality of the events".  Upon internal review, the event of tonic posturing of the right hand only some shaking that was considered to be a "seizure-type reaction" was an other important medical event.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Blood glucose increased, Diabetes mellitus, Increased appetite, Pollakiuria, Thirst
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male with a history of wheezing episode in November 2005, no drug allergies or reactions and a family history of diabetes (father diagnosed at 9 year old) who on 26-JUL-2006 was vaccinated with a 0.5 ml subcutaneously dose of measles virus vaccine live (+) mumps virus vaccine (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#652681/1134R).  Concomitant therapy included sodium fluoride (+) vitamins (unspecified) (POLY-VI-FLOR DROPS) and vitamins (unspecified).  On 07-SEP-2006 the patient had since been discharged from the hospital.  The patient was to be seen by an endocrinologist.  A urinalysis result was 4 plus glucose and a fasting sugar result was 259 with a home blood glucose machine.  The patient's condition was considered to be immediately life threatening because :if the condition is left untreated the patient could go into diabetic coma".  At the time of the report the patient had not recovered.  The patient's diabetes was considered to be an important medical event.  Additional information has been requested. (OMIC)
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Blood glucose increased, Diabetes mellitus
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male with a history of wheezing episode in November 2005, no drug allergies or reactions and a family history of diabetes (father diagnosed at 9 year old) who on 26-JUL-2006 was vaccinated with a 0.5 ml subcutaneously dose of measles virus vaccine live (+) mumps virus vaccine (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#652681/1134R).  Concomitant therapy included sodium fluoride (+) vitamins (unspecified) (POLY-VI-FLOR DROPS) and vitamins (unspecified).  On 07-SEP-2006 the patient had since been discharged from the hospital.  The patient was to be seen by an endocrinologist.  A urinalysis result was 4 plus glucose and a fasting sugar result was 259 with a home blood glucose machine.  The patient's condition was considered to be immediately life threatening because :if the condition is left untreated the patient could go into diabetic coma".  At the time of the report the patient had not recovered.  The patient's diabetes was considered to be an important medical event.  Additional information has been requested. (OMIC)
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Blood glucose increased, Diabetes mellitus, Glucose urine, Increased appetite, Pollakiuria
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male with a history of wheezing episode in November 2005, no drug allergies or reactions and a family history of diabetes (father diagnosed at 9 year old) who on 26-JUL-2006 was vaccinated with a 0.5 ml subcutaneously dose of measles virus vaccine live (+) mumps virus vaccine (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#652681/1134R).  Concomitant therapy included sodium fluoride (+) vitamins (unspecified) (POLY-VI-FLOR DROPS) and vitamins (unspecified).  On 07-SEP-2006 the patient had since been discharged from the hospital.  The patient was to be seen by an endocrinologist.  A urinalysis result was 4 plus glucose and a fasting sugar result was 259 with a home blood glucose machine.  The patient's condition was considered to be immediately life threatening because :if the condition is left untreated the patient could go into diabetic coma".  At the time of the report the patient had not recovered.  The patient's diabetes was considered to be an important medical event.  Additional information has been requested. (OMIC)
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Thirst, Urine analysis
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male with a history of wheezing episode in November 2005, no drug allergies or reactions and a family history of diabetes (father diagnosed at 9 year old) who on 26-JUL-2006 was vaccinated with a 0.5 ml subcutaneously dose of measles virus vaccine live (+) mumps virus vaccine (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#652681/1134R).  Concomitant therapy included sodium fluoride (+) vitamins (unspecified) (POLY-VI-FLOR DROPS) and vitamins (unspecified).  On 07-SEP-2006 the patient had since been discharged from the hospital.  The patient was to be seen by an endocrinologist.  A urinalysis result was 4 plus glucose and a fasting sugar result was 259 with a home blood glucose machine.  The patient's condition was considered to be immediately life threatening because :if the condition is left untreated the patient could go into diabetic coma".  At the time of the report the patient had not recovered.  The patient's diabetes was considered to be an important medical event.  Additional information has been requested. (OMIC)
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Blood glucose increased, Diabetes mellitus, Increased appetite, Thirst, Urinary retention
Clinical narrative: Information has been received from two registered nurses concerning a 5 year old male with no pertinent medical history and an allergy to amoxicillin + clavulanate potassium (Augmentin), who on 6/27/06 was vaccinated with a 0.5ml dose of MMR II/Varicella (lot 652681/1134F). Concomitant therapy included sodium fluoride + vitamins unspecified (Poly Vi Flor Tablets). On 9/7/06 the pt was seen in a physicians office and a urinalysis was performed. The results showed positive for glucose that was too high to get a reading. He was admitted to the hospital on 9/7/06 and followed by an endocrinologist. At the time of this report, the pt was not recovered. The reporter considered diabetes to be an other important medical event (OMIC) and also noted that the condition was life threatening because if the condition was left untreated the pt could go into a diabetic coma. Additional information has been requested. 02/01/2010 Patient was diagnosed with diabetes this is a life-long illness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Weight decreased
Clinical narrative: Information has been received from two registered nurses concerning a 5 year old male with no pertinent medical history and an allergy to amoxicillin + clavulanate potassium (Augmentin), who on 6/27/06 was vaccinated with a 0.5ml dose of MMR II/Varicella (lot 652681/1134F). Concomitant therapy included sodium fluoride + vitamins unspecified (Poly Vi Flor Tablets). On 9/7/06 the pt was seen in a physicians office and a urinalysis was performed. The results showed positive for glucose that was too high to get a reading. He was admitted to the hospital on 9/7/06 and followed by an endocrinologist. At the time of this report, the pt was not recovered. The reporter considered diabetes to be an other important medical event (OMIC) and also noted that the condition was life threatening because if the condition was left untreated the pt could go into a diabetic coma. Additional information has been requested. 02/01/2010 Patient was diagnosed with diabetes this is a life-long illness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Blood glucose increased, Diabetes mellitus, Urine analysis abnormal
Clinical narrative: Information has been received from two registered nurses concerning a 5 year old male with no pertinent medical history and an allergy to amoxicillin + clavulanate potassium (Augmentin), who on 6/27/06 was vaccinated with a 0.5ml dose of MMR II/Varicella (lot 652681/1134F). Concomitant therapy included sodium fluoride + vitamins unspecified (Poly Vi Flor Tablets). On 9/7/06 the pt was seen in a physicians office and a urinalysis was performed. The results showed positive for glucose that was too high to get a reading. He was admitted to the hospital on 9/7/06 and followed by an endocrinologist. At the time of this report, the pt was not recovered. The reporter considered diabetes to be an other important medical event (OMIC) and also noted that the condition was life threatening because if the condition was left untreated the pt could go into a diabetic coma. Additional information has been requested. 02/01/2010 Patient was diagnosed with diabetes this is a life-long illness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Blood glucose increased, Diabetes mellitus, Increased appetite, Pollakiuria, Thirst
Clinical narrative: Information has been received from two registered nurses concerning a 5 year old male with no pertinent medical history and an allergy to amoxicillin + clavulanate potassium (Augmentin), who on 6/27/06 was vaccinated with a 0.5ml dose of MMR II/Varicella (lot 652681/1134F). Concomitant therapy included sodium fluoride + vitamins unspecified (Poly Vi Flor Tablets). On 9/7/06 the pt was seen in a physicians office and a urinalysis was performed. The results showed positive for glucose that was too high to get a reading. He was admitted to the hospital on 9/7/06 and followed by an endocrinologist. At the time of this report, the pt was not recovered. The reporter considered diabetes to be an other important medical event (OMIC) and also noted that the condition was life threatening because if the condition was left untreated the pt could go into a diabetic coma. Additional information has been requested. 02/01/2010 Patient was diagnosed with diabetes this is a life-long illness.
Age: 40.0
Sex: M
Vaccine: UNK, HEP
Symptoms: Dizziness, Fatigue, Hepatic enzyme abnormal, Injection site oedema, Irritability
Clinical narrative: Information has been received from a 40 year old male pharmacist with a history of pernicious anaemia and no drug reaction/allergies who on 7/3/06 was vaccinated IM in the left deltoid with a first dose of hepatitis B virus vaccine rHBsAg (yeast). Concomitant therapy included monthly cyanocobalamin injections. On 7/13/06, 10 days post vaccination, the pt experienced vertigo, dizziness, nausea, vomited twice, pain in his left shoulder, and stiffness in his neck. On 8/19/06 the pt had a negative titer. On 8/23/06 blood work showed elevated liver enzymes (AST and ALT). Subsequently, on approximately 9/2/06, the pt recovered from the pain in his left shoulder and the stiffness in his neck. The pharmacist indicated that the week of 9/5/06 he was feeling better for about 5-6 days, but on 9/8/06, the dizziness, vertigo, and nausea had reoccurred. On 9/9/06, he went to the ER and blood work found that 1 of the 2 liver enzymes (specific enzyme not mentioned) was back to normal, but the other was still high. The pharmacist was seen by an eye doctor who found the pharmacist eyes to be fine. No further information was available. The pts vertigo and dizziness and nausea and vomiting and elevated liver enzymes persisted. There was no product quality complaint. The events were considered to be disabling by the pt because it affected his school work. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: UNK, HEP
Symptoms: Malaise, Musculoskeletal stiffness, Nausea, Neck pain, Shoulder pain
Clinical narrative: Information has been received from a 40 year old male pharmacist with a history of pernicious anaemia and no drug reaction/allergies who on 7/3/06 was vaccinated IM in the left deltoid with a first dose of hepatitis B virus vaccine rHBsAg (yeast). Concomitant therapy included monthly cyanocobalamin injections. On 7/13/06, 10 days post vaccination, the pt experienced vertigo, dizziness, nausea, vomited twice, pain in his left shoulder, and stiffness in his neck. On 8/19/06 the pt had a negative titer. On 8/23/06 blood work showed elevated liver enzymes (AST and ALT). Subsequently, on approximately 9/2/06, the pt recovered from the pain in his left shoulder and the stiffness in his neck. The pharmacist indicated that the week of 9/5/06 he was feeling better for about 5-6 days, but on 9/8/06, the dizziness, vertigo, and nausea had reoccurred. On 9/9/06, he went to the ER and blood work found that 1 of the 2 liver enzymes (specific enzyme not mentioned) was back to normal, but the other was still high. The pharmacist was seen by an eye doctor who found the pharmacist eyes to be fine. No further information was available. The pts vertigo and dizziness and nausea and vomiting and elevated liver enzymes persisted. There was no product quality complaint. The events were considered to be disabling by the pt because it affected his school work. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: UNK, HEP
Symptoms: Vertigo, Vomiting
Clinical narrative: Information has been received from a 40 year old male pharmacist with a history of pernicious anaemia and no drug reaction/allergies who on 7/3/06 was vaccinated IM in the left deltoid with a first dose of hepatitis B virus vaccine rHBsAg (yeast). Concomitant therapy included monthly cyanocobalamin injections. On 7/13/06, 10 days post vaccination, the pt experienced vertigo, dizziness, nausea, vomited twice, pain in his left shoulder, and stiffness in his neck. On 8/19/06 the pt had a negative titer. On 8/23/06 blood work showed elevated liver enzymes (AST and ALT). Subsequently, on approximately 9/2/06, the pt recovered from the pain in his left shoulder and the stiffness in his neck. The pharmacist indicated that the week of 9/5/06 he was feeling better for about 5-6 days, but on 9/8/06, the dizziness, vertigo, and nausea had reoccurred. On 9/9/06, he went to the ER and blood work found that 1 of the 2 liver enzymes (specific enzyme not mentioned) was back to normal, but the other was still high. The pharmacist was seen by an eye doctor who found the pharmacist eyes to be fine. No further information was available. The pts vertigo and dizziness and nausea and vomiting and elevated liver enzymes persisted. There was no product quality complaint. The events were considered to be disabling by the pt because it affected his school work. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: UNK, HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Dizziness, Hepatic enzyme abnormal, Laboratory test abnormal
Clinical narrative: Information has been received from a 40 year old male pharmacist with a history of pernicious anaemia and no drug reaction/allergies who on 7/3/06 was vaccinated IM in the left deltoid with a first dose of hepatitis B virus vaccine rHBsAg (yeast). Concomitant therapy included monthly cyanocobalamin injections. On 7/13/06, 10 days post vaccination, the pt experienced vertigo, dizziness, nausea, vomited twice, pain in his left shoulder, and stiffness in his neck. On 8/19/06 the pt had a negative titer. On 8/23/06 blood work showed elevated liver enzymes (AST and ALT). Subsequently, on approximately 9/2/06, the pt recovered from the pain in his left shoulder and the stiffness in his neck. The pharmacist indicated that the week of 9/5/06 he was feeling better for about 5-6 days, but on 9/8/06, the dizziness, vertigo, and nausea had reoccurred. On 9/9/06, he went to the ER and blood work found that 1 of the 2 liver enzymes (specific enzyme not mentioned) was back to normal, but the other was still high. The pharmacist was seen by an eye doctor who found the pharmacist eyes to be fine. No further information was available. The pts vertigo and dizziness and nausea and vomiting and elevated liver enzymes persisted. There was no product quality complaint. The events were considered to be disabling by the pt because it affected his school work. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: UNK, HEP
Symptoms: Musculoskeletal stiffness, Nausea, Shoulder pain, Vertigo, Vomiting
Clinical narrative: Information has been received from a 40 year old male pharmacist with a history of pernicious anaemia and no drug reaction/allergies who on 7/3/06 was vaccinated IM in the left deltoid with a first dose of hepatitis B virus vaccine rHBsAg (yeast). Concomitant therapy included monthly cyanocobalamin injections. On 7/13/06, 10 days post vaccination, the pt experienced vertigo, dizziness, nausea, vomited twice, pain in his left shoulder, and stiffness in his neck. On 8/19/06 the pt had a negative titer. On 8/23/06 blood work showed elevated liver enzymes (AST and ALT). Subsequently, on approximately 9/2/06, the pt recovered from the pain in his left shoulder and the stiffness in his neck. The pharmacist indicated that the week of 9/5/06 he was feeling better for about 5-6 days, but on 9/8/06, the dizziness, vertigo, and nausea had reoccurred. On 9/9/06, he went to the ER and blood work found that 1 of the 2 liver enzymes (specific enzyme not mentioned) was back to normal, but the other was still high. The pharmacist was seen by an eye doctor who found the pharmacist eyes to be fine. No further information was available. The pts vertigo and dizziness and nausea and vomiting and elevated liver enzymes persisted. There was no product quality complaint. The events were considered to be disabling by the pt because it affected his school work. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: Fever as high as 107 degree on 9/12/06, rash on hand, forehead, that progressed to torso, rash pruritic; seen in urgent care on 9/17/06 for rash and given antihistamine.  Called mom 9/18/06 still with rash, no fevers, slight RN.
Age: 23.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Cold sweat, Erythema, Heart rate irregular, Hypertension, Injection site rash
Clinical narrative: Pt given both vaccines left deltoid. 15-30 sec after 2nd vaccine, yellow fever, pt became pale. She said she felt fine. She was clammy and damp to touch. Head was reclined BP 122/90, P72. Nose running, face red and blotchy. BP 140/100, P 56. Physician called to room at 1110. BP at 11:15 142/100, P 70. Pt transported to urgent care in house for monitoring. Minimal pink rash at yellow fever injection site. Pt monitored until 11:50. VS returned to NL at 11:20. No progression of symptoms thereafter.
Age: 23.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Injection site reaction, Pallor, Rash macular, Rhinorrhoea
Clinical narrative: Pt given both vaccines left deltoid. 15-30 sec after 2nd vaccine, yellow fever, pt became pale. She said she felt fine. She was clammy and damp to touch. Head was reclined BP 122/90, P72. Nose running, face red and blotchy. BP 140/100, P 56. Physician called to room at 1110. BP at 11:15 142/100, P 70. Pt transported to urgent care in house for monitoring. Minimal pink rash at yellow fever injection site. Pt monitored until 11:50. VS returned to NL at 11:20. No progression of symptoms thereafter.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Death, Hepatitis B
Clinical narrative: Hepatitis B 3/16/07 Received copy of Death Certificate from reporter which states COD as cirrhosis & fatty metamorphosis of liver with pulmonary emphysema as contributing factor.  Also noted corrected DOB & DOD. Immediate cause disease or condition resulting in death. Cirrhosis and fatty metomorphsis of liver. Cancer to liver. Pulmonary emphysemo. He die of pulmonary emphysome and the vaccine cause to get worse.
Sex: F
Vaccine: PER
Clinical narrative: Pertussis (Whooping cough). 4/20/07 Received copy of Death Certificate from patients son which reveals COD as advanced metastatic cancer lungs, ribs and vagina and squamous cell carcinoma of cervix.
Age: 36.0
Sex: M
Vaccine: PER
Symptoms: Bacterial infection
Clinical narrative: Pertussis (Whooping Cough)
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Anaemia, Apnoea, Choking, Febrile convulsion, Gastroenteritis
Clinical narrative: 4 days after MMR and Varivax and Pediarix Hib, Prevnar had apnea and was hospitalized.  No etiology found but 2 episodes of apnea is suspicious. 1. DOS 9/4/-9/5/06 DC DX: Gastroenterities, choking episodes with apnea. Episodes of choking and stopped breathing. Temp 100 2. DOX 10/13-10/15/06 DC DX: fever no source (resolved, cultures negative), febrile seizure, beta thalassemia trait, neutropenia (likely viral suppression).  On second day of hospitalization, able to eat but continued temp 102.4.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Neutropenia, Pyrexia
Clinical narrative: 4 days after MMR and Varivax and Pediarix Hib, Prevnar had apnea and was hospitalized.  No etiology found but 2 episodes of apnea is suspicious. 1. DOS 9/4/-9/5/06 DC DX: Gastroenterities, choking episodes with apnea. Episodes of choking and stopped breathing. Temp 100 2. DOX 10/13-10/15/06 DC DX: fever no source (resolved, cultures negative), febrile seizure, beta thalassemia trait, neutropenia (likely viral suppression).  On second day of hospitalization, able to eat but continued temp 102.4.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Blood creatine phosphokinase increased, Eosinophilia, Myalgia, Pain
Clinical narrative: 1 day after vaccine given developed bilat popliteal pain, now with bilateral anterior thigh pain and muscle tenderness, and bilat hip pain.
Age: 49.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt had 2 vaccines 8/30/06 on left deltoid. 3 days after noticed increasing redness, soreness and area of shot warm to touch. Saw 2 different Drs on separate occasion and was started on antibiotics. Pt diagnosed with cellulitis.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Received vaccine 8/30/06. Next day started with swelling, soreness, and redness that increased in size. Seen in office 9/5/06 swelling, erythema with some bruising at injection site of upper arm (Left).
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Alopecia, Amnesia, Blindness, Bone pain, Diarrhoea
Clinical narrative: Diarrhea, bone sore, blood stool, skin rash in all body, loss hair, vision loss, high blood pressure, loss memory, cramps on arms, Sexual impotent.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Erectile dysfunction, Haematochezia, Hypertension, Muscle spasms, Rash
Clinical narrative: Diarrhea, bone sore, blood stool, skin rash in all body, loss hair, vision loss, high blood pressure, loss memory, cramps on arms, Sexual impotent.
Age: 0.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic
Clinical narrative: Got Immunization 9/8/06 developed water diarrhea on  9/11/06, and on 9/12/06 blood noticed with diarrhea, stool culture sent 9/12/06.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Large Erythematous, circular area on right lateral thigh. Approx 8cm in diameters.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash
Clinical narrative: Mild local rash (immediately after Tdap inoculation) at injection site left upper arm. No raised hives. TX ice pack to arm.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site oedema, Injection site rash, Pruritus, Tinnitus
Clinical narrative: 2 hours after vaccine had ringing in ears, 12/15 hours after vaccine given had arm swelling around injection site, bumps around injection site and itching. Mother called 9/6/06 discussed with provider. Treat with Benadryl and fluids. Unable to reach mother 9/8/06. On 9/11/06 contacted mother. She stated symptoms clearing.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Skin ulcer
Clinical narrative: Pt came in with about 15 red lesions.
Age: 0.14
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Haematochezia, Laboratory test abnormal
Clinical narrative: Had vaccinations, Dtap, IPV, Comvax, Prevnar, Rotateq on Wed 9/6/06. Parent noticed what appeared to be blood in stool Thurs 9/7/06. On 9/9/6 + hemocult in office. Baby exclusively BF Dr to monitor condition at this time. Mom to monitor conditions at this time. Mom to monitor dairy intake, IE milk allergy baby.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Injection site reaction, Nail discolouration, Pyrexia, Rash papular
Clinical narrative: Surrounding erythema about 10cm with streaking into axilla, subjective fever x 1 day, multiple (30-40) small papules (about 1-3 mm diam each), whitish in color (containing pus) surrounding vaccine site, but not touching it, 4 purulent papules on upper forehead (likely auto inoculation), treated with IV Ancef and Clindamycin x 24 hours, then oral Keflex and clindamycin x 10 days.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pustular
Clinical narrative: Surrounding erythema about 10cm with streaking into axilla, subjective fever x 1 day, multiple (30-40) small papules (about 1-3 mm diam each), whitish in color (containing pus) surrounding vaccine site, but not touching it, 4 purulent papules on upper forehead (likely auto inoculation), treated with IV Ancef and Clindamycin x 24 hours, then oral Keflex and clindamycin x 10 days.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Joint swelling, Rheumatoid arthritis
Clinical narrative: Mother states that one week after influenza vaccine on 10/31/05 (given in right thigh he began having swelling and redness to right knee, subsequently diagnoses with JRA by DR (as a out PT) (of note a older sib subsequently diagnosed with JRA a few months later.)
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Dizziness, Headache, Pain, Pruritus
Clinical narrative: Pain in hands and knee joints, headache, itching in different parts of the body and dizziness.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Hypotonia, Lethargy, Somnolence
Clinical narrative: Toward end of dose pt went limp and became lethargic. no choking. Pt had been alert prior to vaccine and was sleepy after the episode, observed for 30 minutes. Pt was sleeping comfortable, but aroused. The rest of his vaccines were differed to another time.
Age: 36.0
Sex: F
Vaccine: FLUN3, MMR, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Lymphadenopathy, Pyrexia
Clinical narrative: Arm where Tdap given red, swollen, warm to touch, temperature 100.2, lymph nodes in neck swollen. Swelling on arm and lymph nodes swelled 24 hours after injection. Treatment with steroids.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia
Clinical narrative: 2 hours after Gardasil Administration pt developed inability to swallow. Advised to take Benadryl by covering physician and go to ER. In ER not given EPI but Solumedrol to take for 5 days.
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Dermatitis bullous
Clinical narrative: Varicella like rash.
Age: 44.0
Sex: U
Vaccine: ANTH
Symptoms: Abdominal pain, Muscle spasms, Skin nodule
Clinical narrative: When I has my first shot of Anthrax three days later I developed a lump like a birth mark in my left arm over the years I have three more on my left leg and I am suffering from constant abdominal pain and frequent muscle cramps.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration
Clinical narrative: Induration 7x9 cm lasting 10 days.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Oedema
Clinical narrative: Extreme swelling, redness and very warm to touch noted in both arms. Right arm swollen to neck knots in left arm and skin discolored. Red streaks, noted in both arms, Started on Bactrim and Keflex. Right arm improved by 9/10/06. Left arm is still improving.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Skin discolouration
Clinical narrative: Extreme swelling, redness and very warm to touch noted in both arms. Right arm swollen to neck knots in left arm and skin discolored. Red streaks, noted in both arms, Started on Bactrim and Keflex. Right arm improved by 9/10/06. Left arm is still improving.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Hypokinesia, Injection site erythema, Injection site warmth, Tenderness
Clinical narrative: Right deltoid erythema 6x7 cm + warm and tender. Unable to move right shoulder above head.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Erythema, Swelling
Clinical narrative: History left thigh swelling, redness after vaccination, evaluated 2 days after vaccination given, improved, no erythema, 1cm by 1cm firmness.
Age: 1.28
Sex: M
Vaccine: DTAPH, FLUX, MMR
Symptoms: Dermatitis bullous
Clinical narrative: Started to show symptoms of chicken pox-spots September 13, 2006.  No hospitalization.  Treatments for itchiness and other symptoms.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Spoke with doctor's office whom mother reported to that client reported to her on 08/23/06 in the am that the night before when he was at a friend's house he had when he woke up around midnight dizziness and difficulty breathing did not seek medical attention in the am had temperature 101 and a headache felt under the weather.  Reported 8-24-06 left for college in no apparent distress.  Spoke with mother.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Eye swelling, Injection site pain, Rash
Clinical narrative: Received Tdap at 445 pm awoke at 900 pm with swollen eye, lips, difficulty breathing pain at site of injection with skin rash at site.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Vomiting
Clinical narrative: Dizziness, vomiting for 6 times today (8/24/2006)
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Back pain, Eye swelling, Fatigue
Clinical narrative: Left arm swelling redness, soreness at injection site, joint swelling, pain both knees, hips, elbows, shoulders, neck pain in neck and back, muscle aches, loss of stamina, weakness, oral temperature 100.1, swollen eyes, face skin eruptions on face and chest, general malaise, fatigue-symptoms improved but recurrent.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Joint swelling, Malaise, Myalgia
Clinical narrative: Left arm swelling redness, soreness at injection site, joint swelling, pain both knees, hips, elbows, shoulders, neck pain in neck and back, muscle aches, loss of stamina, weakness, oral temperature 100.1, swollen eyes, face skin eruptions on face and chest, general malaise, fatigue-symptoms improved but recurrent.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pyrexia, Rash
Clinical narrative: Left arm swelling redness, soreness at injection site, joint swelling, pain both knees, hips, elbows, shoulders, neck pain in neck and back, muscle aches, loss of stamina, weakness, oral temperature 100.1, swollen eyes, face skin eruptions on face and chest, general malaise, fatigue-symptoms improved but recurrent.
Age: 39.0
Sex: M
Vaccine: ANTH, TD
Symptoms: Alopecia, Amnesia, Anxiety, Blood cholesterol increased, Delirium
Clinical narrative: High cholesterol, alopecia (hair loss), mood anxiety, cold and flu symptoms, concentration difficulty, depression, delirium episodes, fatigue and pain hemorrhoids, memory loss, trouble finding words, weight loss, speech disorder.
Age: 39.0
Sex: M
Vaccine: ANTH, TD
Symptoms: Depression, Fatigue, Influenza like illness, Mental impairment, Speech disorder
Clinical narrative: High cholesterol, alopecia (hair loss), mood anxiety, cold and flu symptoms, concentration difficulty, depression, delirium episodes, fatigue and pain hemorrhoids, memory loss, trouble finding words, weight loss, speech disorder.
Age: 39.0
Sex: M
Vaccine: ANTH, TD
Symptoms: Weight decreased
Clinical narrative: High cholesterol, alopecia (hair loss), mood anxiety, cold and flu symptoms, concentration difficulty, depression, delirium episodes, fatigue and pain hemorrhoids, memory loss, trouble finding words, weight loss, speech disorder.
Age: 54.0
Sex: M
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: see attachment at shots record
Sex: M
Vaccine: ANTH
Symptoms: Abdominal distension, Rash, Swelling
Clinical narrative: Second dose in right arm had a week of a rash, abdomen soreness, swelling for a week from injection.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning her daughter who on approximately 25-JUL-2006 was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast).  On approximately 25-JUL-2006 the patient experienced soreness at the injection site that lasted approximately one week and at the time of this report had not resolved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female who on 02-AUG-2006 was vaccinated with the first dose of HPV rLi 3 11 16 18 VLP vaccine (yeast).  It was reported that the patient fainted "shortly after receiving the vaccination".  The nurse did not feel the experience was vaccine related and stated "the patient was very uneasy with the idea of an injection".  The patient subsequently recovered "shortly after fainting".  Unspecified medical attention was sought.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash, Rash papular, Skin burning sensation, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with seasonal allergies who was exposed to roseola on 25-JUL-2006 and had a fever on 02-AUG-2006.  On 03-AUG-2006, the patient was vaccinated intramuscularly with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F).  Concomitant therapy included loratadine (CLARITIN) and vitamins (unspecified).  On 04-AUG-2006, the patient developed an extensive rash.  The patient discovered the rash at 7 am on the back of her legs.  It was reported that the rash spread to her back and shoulders and had started to spread to her abdomen.  The rash consisted of non vesicular papular single lesions that were slightly larger than a pinpoint and too numerous to count.  The lesions were described as "burning and itchy".  Unspecified medical attention was sought.  At the time of the report, the patient's rash persisted.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Information has been received form a physician concerning a 29 year old female with no pertinent medical history and no history of drug reactions allergies who on 8/9/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653937/0637F) inappropriate schedule of vaccina administration. There was no concomitant medication. On 8/9/06 the pt experienced a fever, nausea, body aches, joint pains and experienced flu like symptoms. Unspecified medical attention was sought. At the time of this report, the pt was recovering from the fever, nausea, body aches, joint pains and flu like symptoms.