chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody, Arthritis, Body temperature increased, Costochondritis, Dizziness
Clinical narrative: Information has been received from a dentist concerning her 21 year old daughter with a medical history of mononucleosis and sulfonamide allergy who in July 2007, was vaccinated with a first dose of GARDASIL (lot # 658094/0524U).  The patient received a second and third dose of GARDASIL (lot # 659439/1267U).  Concomitant therapy included montelukast sodium (MSD), (dose, duration and indication not reported) and NUVARING.  After received all 3 doses the patient experienced arthritis symptoms, tiredness, weight loss, general achy feeling (neck and jaw pain), tingling in her arms and hands, and dizziness.  The reporter also stated that she had inflammation in the cartridge in her chest.  She was at some point diagnosed with labyrinthitis.  Her physician prescribed her some steroids and other non steroidal medication (unspecified which ones) and she felts a little better and was able to go back to school.  The reporter also mentioned that after each dose the patient experienced minor problems like dizziness, nausea and temperature but did not have joint pain until after the third dose.  The patient had blood work, urine tests, thyroid tests, serum antinuclear antibodies tests (ANA), RA and x rays, everything came back normal.  The patient sought unspecified medical attention.  At the time of this report the patient had not recovered.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Haematology test normal, Laboratory test, Labyrinthitis, Nausea
Clinical narrative: Information has been received from a dentist concerning her 21 year old daughter with a medical history of mononucleosis and sulfonamide allergy who in July 2007, was vaccinated with a first dose of GARDASIL (lot # 658094/0524U).  The patient received a second and third dose of GARDASIL (lot # 659439/1267U).  Concomitant therapy included montelukast sodium (MSD), (dose, duration and indication not reported) and NUVARING.  After received all 3 doses the patient experienced arthritis symptoms, tiredness, weight loss, general achy feeling (neck and jaw pain), tingling in her arms and hands, and dizziness.  The reporter also stated that she had inflammation in the cartridge in her chest.  She was at some point diagnosed with labyrinthitis.  Her physician prescribed her some steroids and other non steroidal medication (unspecified which ones) and she felts a little better and was able to go back to school.  The reporter also mentioned that after each dose the patient experienced minor problems like dizziness, nausea and temperature but did not have joint pain until after the third dose.  The patient had blood work, urine tests, thyroid tests, serum antinuclear antibodies tests (ANA), RA and x rays, everything came back normal.  The patient sought unspecified medical attention.  At the time of this report the patient had not recovered.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pain, Pain in jaw, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a dentist concerning her 21 year old daughter with a medical history of mononucleosis and sulfonamide allergy who in July 2007, was vaccinated with a first dose of GARDASIL (lot # 658094/0524U).  The patient received a second and third dose of GARDASIL (lot # 659439/1267U).  Concomitant therapy included montelukast sodium (MSD), (dose, duration and indication not reported) and NUVARING.  After received all 3 doses the patient experienced arthritis symptoms, tiredness, weight loss, general achy feeling (neck and jaw pain), tingling in her arms and hands, and dizziness.  The reporter also stated that she had inflammation in the cartridge in her chest.  She was at some point diagnosed with labyrinthitis.  Her physician prescribed her some steroids and other non steroidal medication (unspecified which ones) and she felts a little better and was able to go back to school.  The reporter also mentioned that after each dose the patient experienced minor problems like dizziness, nausea and temperature but did not have joint pain until after the third dose.  The patient had blood work, urine tests, thyroid tests, serum antinuclear antibodies tests (ANA), RA and x rays, everything came back normal.  The patient sought unspecified medical attention.  At the time of this report the patient had not recovered.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroid function test normal, Urine analysis normal, Weight decreased, X-ray normal
Clinical narrative: Information has been received from a dentist concerning her 21 year old daughter with a medical history of mononucleosis and sulfonamide allergy who in July 2007, was vaccinated with a first dose of GARDASIL (lot # 658094/0524U).  The patient received a second and third dose of GARDASIL (lot # 659439/1267U).  Concomitant therapy included montelukast sodium (MSD), (dose, duration and indication not reported) and NUVARING.  After received all 3 doses the patient experienced arthritis symptoms, tiredness, weight loss, general achy feeling (neck and jaw pain), tingling in her arms and hands, and dizziness.  The reporter also stated that she had inflammation in the cartridge in her chest.  She was at some point diagnosed with labyrinthitis.  Her physician prescribed her some steroids and other non steroidal medication (unspecified which ones) and she felts a little better and was able to go back to school.  The reporter also mentioned that after each dose the patient experienced minor problems like dizziness, nausea and temperature but did not have joint pain until after the third dose.  The patient had blood work, urine tests, thyroid tests, serum antinuclear antibodies tests (ANA), RA and x rays, everything came back normal.  The patient sought unspecified medical attention.  At the time of this report the patient had not recovered.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Blood test, Pain in extremity, X-ray
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 29-MAY-2007 was vaccinated with the first dose of GARDASIL  (Lot # 657736/0389U), on 2-AUG-2007 was vaccinated with the second dose of GARDASIL (Lot # 657868/0523U), on 21-NOV-2007 was vaccinated with the third dose of GARDASIL 0.5ml (Lot # 659437/1266U).  Concomitant therapy included oral contraceptive (manufacture unknown).  Since then the patient had developed rheumatoid arthritis.  The outcome of adverse event was unknown.  It was reported that the patient sought unspecified medical attention.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 29-MAY-2007 was vaccinated with the first dose of GARDASIL  (Lot # 657736/0389U), on 2-AUG-2007 was vaccinated with the second dose of GARDASIL (Lot # 657868/0523U), on 21-NOV-2007 was vaccinated with the third dose of GARDASIL 0.5ml (Lot # 659437/1266U).  Concomitant therapy included oral contraceptive (manufacture unknown).  Since then the patient had developed rheumatoid arthritis.  The outcome of adverse event was unknown.  It was reported that the patient sought unspecified medical attention.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration, Rheumatoid arthritis
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 29-MAY-2007 was vaccinated with the first dose of GARDASIL  (Lot # 657736/0389U), on 2-AUG-2007 was vaccinated with the second dose of GARDASIL (Lot # 657868/0523U), on 21-NOV-2007 was vaccinated with the third dose of GARDASIL 0.5ml (Lot # 659437/1266U).  Concomitant therapy included oral contraceptive (manufacture unknown).  Since then the patient had developed rheumatoid arthritis.  The outcome of adverse event was unknown.  It was reported that the patient sought unspecified medical attention.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cardiac monitoring normal, Neurological examination normal, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  A 15 year old female who on 04-FEB-2008, was vaccinated with a dose of GARDASIL (lot# null).  Concomitant therapy included BIAXIN.  On 28-FEB-2008, 25 days after GARDASIL #3 developed syncopal episodes-recurrent, over course of 6 months.  Neuro and cardio work-ups within normal limits.  The original reporter was not provided.  The VAER ID # 337752.  No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Blood test, Headache, Lumbar puncture, Pain
Clinical narrative: Information has been received from a 20 year old female patient with no pre-existing physician-diagnosed allergies, birth defects or medical conditions who at 10:00 on 20-SEP-2007 was vaccinated with the first dose of GARDASIL in her arm (lot #658558/1061U) after doing extensive research about GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). There was no illness at the time of vaccination. At 11:00 on 20-SEP-2007 ("about an hour later") the patient experienced a fever of 102.2, vomiting and a severe headache, and was hospitalized for two days. Subsequently, the other symptoms went away but the headache persisted. It was an intense headache that lasted 24 hours a day. The patient saw her PCP several times and was referred to a neurologist. On 14-NOV-2007, the patient received the second dose of GARDASIL in her arm (lot # 658560/1062U). In December 2007 the patient went to the emergency room twice. At the first visit, MRI, CT and lumbar puncture were performed. The patient ended back in the ER a few days later for observation. All of the tests were normal, but the pain was unbearable. The patient was given IV morphine which had little effect. Then in December 2007 the patient got an urgent appointment with the neurologist. She noted that her life had been "turned upside down", and the patient had missed work, had to switch jobs and had struggled to finish nursing school. She also indicated that she was 100% healthy prior to the vaccinations. The patient had been on more therapy in the last one year and a half, and has been in the ER three times again "within the past month". The only thing that "took the edge off" was IV DILAUDID. She had tried basic OTC such as ADVIL, TYLEND, ALEVE, EXCEDERIN, nonsteroidal anti-inflammatory drug (unspecified), PREDNISONE, muscle relaxes, anticonvulsants, tricyclic antidepressants, caffeine, antihistamine, narcotic, and just about anything else. Still nothing had worked. The patient's doctor had concluded she had a serious reaction from GARDASIL. A fever of 102.2, vomiting and severe headache were considered to be disabling. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a 20 year old female patient with no pre-existing physician-diagnosed allergies, birth defects or medical conditions who at 10:00 on 20-SEP-2007 was vaccinated with the first dose of GARDASIL in her arm (lot #658558/1061U) after doing extensive research about GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). There was no illness at the time of vaccination. At 11:00 on 20-SEP-2007 ("about an hour later") the patient experienced a fever of 102.2, vomiting and a severe headache, and was hospitalized for two days. Subsequently, the other symptoms went away but the headache persisted. It was an intense headache that lasted 24 hours a day. The patient saw her PCP several times and was referred to a neurologist. On 14-NOV-2007, the patient received the second dose of GARDASIL in her arm (lot # 658560/1062U). In December 2007 the patient went to the emergency room twice. At the first visit, MRI, CT and lumbar puncture were performed. The patient ended back in the ER a few days later for observation. All of the tests were normal, but the pain was unbearable. The patient was given IV morphine which had little effect. Then in December 2007 the patient got an urgent appointment with the neurologist. She noted that her life had been "turned upside down", and the patient had missed work, had to switch jobs and had struggled to finish nursing school. She also indicated that she was 100% healthy prior to the vaccinations. The patient had been on more therapy in the last one year and a half, and has been in the ER three times again "within the past month". The only thing that "took the edge off" was IV DILAUDID. She had tried basic OTC such as ADVIL, TYLEND, ALEVE, EXCEDERIN, nonsteroidal anti-inflammatory drug (unspecified), PREDNISONE, muscle relaxes, anticonvulsants, tricyclic antidepressants, caffeine, antihistamine, narcotic, and just about anything else. Still nothing had worked. The patient's doctor had concluded she had a serious reaction from GARDASIL. A fever of 102.2, vomiting and severe headache were considered to be disabling. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Computerised tomogram normal, Headache, Lumbar puncture, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a 20 year old female patient with no pre-existing physician-diagnosed allergies, birth defects or medical conditions who at 10:00 on 20-SEP-2007 was vaccinated with the first dose of GARDASIL in her arm (lot #658558/1061U) after doing extensive research about GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). There was no illness at the time of vaccination. At 11:00 on 20-SEP-2007 ("about an hour later") the patient experienced a fever of 102.2, vomiting and a severe headache, and was hospitalized for two days. Subsequently, the other symptoms went away but the headache persisted. It was an intense headache that lasted 24 hours a day. The patient saw her PCP several times and was referred to a neurologist. On 14-NOV-2007, the patient received the second dose of GARDASIL in her arm (lot # 658560/1062U). In December 2007 the patient went to the emergency room twice. At the first visit, MRI, CT and lumbar puncture were performed. The patient ended back in the ER a few days later for observation. All of the tests were normal, but the pain was unbearable. The patient was given IV morphine which had little effect. Then in December 2007 the patient got an urgent appointment with the neurologist. She noted that her life had been "turned upside down", and the patient had missed work, had to switch jobs and had struggled to finish nursing school. She also indicated that she was 100% healthy prior to the vaccinations. The patient had been on more therapy in the last one year and a half, and has been in the ER three times again "within the past month". The only thing that "took the edge off" was IV DILAUDID. She had tried basic OTC such as ADVIL, TYLEND, ALEVE, EXCEDERIN, nonsteroidal anti-inflammatory drug (unspecified), PREDNISONE, muscle relaxes, anticonvulsants, tricyclic antidepressants, caffeine, antihistamine, narcotic, and just about anything else. Still nothing had worked. The patient's doctor had concluded she had a serious reaction from GARDASIL. A fever of 102.2, vomiting and severe headache were considered to be disabling. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a 20 year old female patient with no pre-existing physician-diagnosed allergies, birth defects or medical conditions who at 10:00 on 20-SEP-2007 was vaccinated with the first dose of GARDASIL in her arm (lot #658558/1061U) after doing extensive research about GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). There was no illness at the time of vaccination. At 11:00 on 20-SEP-2007 ("about an hour later") the patient experienced a fever of 102.2, vomiting and a severe headache, and was hospitalized for two days. Subsequently, the other symptoms went away but the headache persisted. It was an intense headache that lasted 24 hours a day. The patient saw her PCP several times and was referred to a neurologist. On 14-NOV-2007, the patient received the second dose of GARDASIL in her arm (lot # 658560/1062U). In December 2007 the patient went to the emergency room twice. At the first visit, MRI, CT and lumbar puncture were performed. The patient ended back in the ER a few days later for observation. All of the tests were normal, but the pain was unbearable. The patient was given IV morphine which had little effect. Then in December 2007 the patient got an urgent appointment with the neurologist. She noted that her life had been "turned upside down", and the patient had missed work, had to switch jobs and had struggled to finish nursing school. She also indicated that she was 100% healthy prior to the vaccinations. The patient had been on more therapy in the last one year and a half, and has been in the ER three times again "within the past month". The only thing that "took the edge off" was IV DILAUDID. She had tried basic OTC such as ADVIL, TYLEND, ALEVE, EXCEDERIN, nonsteroidal anti-inflammatory drug (unspecified), PREDNISONE, muscle relaxes, anticonvulsants, tricyclic antidepressants, caffeine, antihistamine, narcotic, and just about anything else. Still nothing had worked. The patient's doctor had concluded she had a serious reaction from GARDASIL. A fever of 102.2, vomiting and severe headache were considered to be disabling. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with drug hypersensitivity to MORPHINE who on 14-AUG-2008 was vaccinated IM with the first dose of GARDASIL 0.5ml (LOT # 659962/1740U).  Concomitant therapy included MENACTRA.  After receiving her first dose of GARDASIL, the patient experienced dizziness and lightheadedness, and slept for a few hours.  The patient also experienced pain in her arm at the injection site.  Subsequently, the patient recovered from adverse events (date unspecified).  It was reported that the patient sought medical attention: phone call.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Dizziness, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with drug hypersensitivity to MORPHINE who on 14-AUG-2008 was vaccinated IM with the first dose of GARDASIL 0.5ml (LOT # 659962/1740U).  Concomitant therapy included MENACTRA.  After receiving her first dose of GARDASIL, the patient experienced dizziness and lightheadedness, and slept for a few hours.  The patient also experienced pain in her arm at the injection site.  Subsequently, the patient recovered from adverse events (date unspecified).  It was reported that the patient sought medical attention: phone call.  Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Acute myeloid leukaemia, Injection site swelling, Neutropenia, Pyrexia
Clinical narrative: This case was initially received from health authority on 03 March 2009 and follow-up was received from the Health Research Center on 05 March 2009. Additional follow-up was received from Health authority on 10 March 2009. A 20 year-old male was diagnosed with acute myelogenous leukemia on 28 January 2009. The patient received SMALLPOX vaccine (manufacturer and lot number not reported) on 23 January 2009. The patient is being treated at a medical center for progressive vaccinia. The vaccination site has failed to heal due to the neutropenia caused by AML. Vaccinia immunoglobulin, procured by the Program, was administered on 04 March 2009. FDA approved the use of ST-246, an experimental oral anti-viral medication, which was started on 05 march 2009. The patient is being considered for a bone marrow transplant pending resolution of the progressive vaccinia. The CDC are coordinating viral load and serologic immune response testing. Physicians from the agency and the CDC are collaborating on the patient's care plan. Although the manufacturer was reported as unknown in this case, ACAM200 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination. List of Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Impaired healing, Myeloid leukaemia, Neutropenia, Vaccinia
Clinical narrative: This case was initially received from health authority on 03 March 2009 and follow-up was received from the Health Research Center on 05 March 2009. Additional follow-up was received from Health authority on 10 March 2009. A 20 year-old male was diagnosed with acute myelogenous leukemia on 28 January 2009. The patient received SMALLPOX vaccine (manufacturer and lot number not reported) on 23 January 2009. The patient is being treated at a medical center for progressive vaccinia. The vaccination site has failed to heal due to the neutropenia caused by AML. Vaccinia immunoglobulin, procured by the Program, was administered on 04 March 2009. FDA approved the use of ST-246, an experimental oral anti-viral medication, which was started on 05 march 2009. The patient is being considered for a bone marrow transplant pending resolution of the progressive vaccinia. The CDC are coordinating viral load and serologic immune response testing. Physicians from the agency and the CDC are collaborating on the patient's care plan. Although the manufacturer was reported as unknown in this case, ACAM200 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination. List of Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Biopsy bone marrow abnormal, Blood product transfusion, Blood test abnormal, Chemotherapy, Clostridial infection
Clinical narrative: This case was initially received from health authority on 03 March 2009 and follow-up was received from the Health Research Center on 05 March 2009. Additional follow-up was received from Health authority on 10 March 2009. A 20 year-old male was diagnosed with acute myelogenous leukemia on 28 January 2009. The patient received SMALLPOX vaccine (manufacturer and lot number not reported) on 23 January 2009. The patient is being treated at a medical center for progressive vaccinia. The vaccination site has failed to heal due to the neutropenia caused by AML. Vaccinia immunoglobulin, procured by the Program, was administered on 04 March 2009. FDA approved the use of ST-246, an experimental oral anti-viral medication, which was started on 05 march 2009. The patient is being considered for a bone marrow transplant pending resolution of the progressive vaccinia. The CDC are coordinating viral load and serologic immune response testing. Physicians from the agency and the CDC are collaborating on the patient's care plan. Although the manufacturer was reported as unknown in this case, ACAM200 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination. List of Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Cow pox, Culture positive, Endotracheal intubation, Gangrene, Haemodialysis
Clinical narrative: This case was initially received from health authority on 03 March 2009 and follow-up was received from the Health Research Center on 05 March 2009. Additional follow-up was received from Health authority on 10 March 2009. A 20 year-old male was diagnosed with acute myelogenous leukemia on 28 January 2009. The patient received SMALLPOX vaccine (manufacturer and lot number not reported) on 23 January 2009. The patient is being treated at a medical center for progressive vaccinia. The vaccination site has failed to heal due to the neutropenia caused by AML. Vaccinia immunoglobulin, procured by the Program, was administered on 04 March 2009. FDA approved the use of ST-246, an experimental oral anti-viral medication, which was started on 05 march 2009. The patient is being considered for a bone marrow transplant pending resolution of the progressive vaccinia. The CDC are coordinating viral load and serologic immune response testing. Physicians from the agency and the CDC are collaborating on the patient's care plan. Although the manufacturer was reported as unknown in this case, ACAM200 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination. List of Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Impaired healing, Injection site erythema, Injection site induration, Injection site scab, Intensive care
Clinical narrative: This case was initially received from health authority on 03 March 2009 and follow-up was received from the Health Research Center on 05 March 2009. Additional follow-up was received from Health authority on 10 March 2009. A 20 year-old male was diagnosed with acute myelogenous leukemia on 28 January 2009. The patient received SMALLPOX vaccine (manufacturer and lot number not reported) on 23 January 2009. The patient is being treated at a medical center for progressive vaccinia. The vaccination site has failed to heal due to the neutropenia caused by AML. Vaccinia immunoglobulin, procured by the Program, was administered on 04 March 2009. FDA approved the use of ST-246, an experimental oral anti-viral medication, which was started on 05 march 2009. The patient is being considered for a bone marrow transplant pending resolution of the progressive vaccinia. The CDC are coordinating viral load and serologic immune response testing. Physicians from the agency and the CDC are collaborating on the patient's care plan. Although the manufacturer was reported as unknown in this case, ACAM200 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination. List of Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Leg amputation, Lung infection pseudomonal, Multi-organ failure, Myeloid leukaemia, Neutropenia
Clinical narrative: This case was initially received from health authority on 03 March 2009 and follow-up was received from the Health Research Center on 05 March 2009. Additional follow-up was received from Health authority on 10 March 2009. A 20 year-old male was diagnosed with acute myelogenous leukemia on 28 January 2009. The patient received SMALLPOX vaccine (manufacturer and lot number not reported) on 23 January 2009. The patient is being treated at a medical center for progressive vaccinia. The vaccination site has failed to heal due to the neutropenia caused by AML. Vaccinia immunoglobulin, procured by the Program, was administered on 04 March 2009. FDA approved the use of ST-246, an experimental oral anti-viral medication, which was started on 05 march 2009. The patient is being considered for a bone marrow transplant pending resolution of the progressive vaccinia. The CDC are coordinating viral load and serologic immune response testing. Physicians from the agency and the CDC are collaborating on the patient's care plan. Although the manufacturer was reported as unknown in this case, ACAM200 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination. List of Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Perirectal abscess, Polymerase chain reaction, Pseudomonal sepsis, Staphylococcal infection, Vaccination complication
Clinical narrative: This case was initially received from health authority on 03 March 2009 and follow-up was received from the Health Research Center on 05 March 2009. Additional follow-up was received from Health authority on 10 March 2009. A 20 year-old male was diagnosed with acute myelogenous leukemia on 28 January 2009. The patient received SMALLPOX vaccine (manufacturer and lot number not reported) on 23 January 2009. The patient is being treated at a medical center for progressive vaccinia. The vaccination site has failed to heal due to the neutropenia caused by AML. Vaccinia immunoglobulin, procured by the Program, was administered on 04 March 2009. FDA approved the use of ST-246, an experimental oral anti-viral medication, which was started on 05 march 2009. The patient is being considered for a bone marrow transplant pending resolution of the progressive vaccinia. The CDC are coordinating viral load and serologic immune response testing. Physicians from the agency and the CDC are collaborating on the patient's care plan. Although the manufacturer was reported as unknown in this case, ACAM200 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination. List of Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Vaccinia
Clinical narrative: This case was initially received from health authority on 03 March 2009 and follow-up was received from the Health Research Center on 05 March 2009. Additional follow-up was received from Health authority on 10 March 2009. A 20 year-old male was diagnosed with acute myelogenous leukemia on 28 January 2009. The patient received SMALLPOX vaccine (manufacturer and lot number not reported) on 23 January 2009. The patient is being treated at a medical center for progressive vaccinia. The vaccination site has failed to heal due to the neutropenia caused by AML. Vaccinia immunoglobulin, procured by the Program, was administered on 04 March 2009. FDA approved the use of ST-246, an experimental oral anti-viral medication, which was started on 05 march 2009. The patient is being considered for a bone marrow transplant pending resolution of the progressive vaccinia. The CDC are coordinating viral load and serologic immune response testing. Physicians from the agency and the CDC are collaborating on the patient's care plan. Although the manufacturer was reported as unknown in this case, ACAM200 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination. List of Documents held by sender: None.
Sex: F
Vaccine: FLUX
Symptoms: Angioedema, Neuropathy peripheral
Clinical narrative: Initial report received from another manufacturer (document number 45214356), who received the report from a health care professional.  A female patient (age not reported) with a history of penicillin allergy, had received an influenza vaccine (manufacturer, lot number, route and site of administration not reported) on an unspecified date in 2004 and an unspecified amount of time later, she developed angioedema and neuropathy.  No further information was provided at the time of the report.  Documents held by sender:  None.
Age: 84.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Abdominal pain upper, Asthenia, Bilirubin urine, Blood bilirubin increased, Blood culture negative
Clinical narrative: Information has been received from a physician concerning an 84 year old male patient with diverticulitis and a history of malaria who on 05-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck), 0.65ml. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, "ECOTIN", LANOXIN and simvastatin (MSD). On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, decreased appetite and pain between his shoulder blades. The patient noted that the symptoms are similar to the symptoms he experienced when he had a malaria infection. The patient underwent urinalysis (results not reported), chest x-ray (results not reported) and complete blood cell count that revealed an elevated white blood cell count. At the time of report on the 16-DEC-2008 the patient was recovering. The patient sought medical attention seen by the physician. Follow up information has been received from a Physician via medical record concerning an 84 (also reported as 85 year old) year old male patient who on 05-DEC-2008 received a dose of ZOSTAVAX (Oka/Merck) (Lot # 662969/1206X) in the arm at AM. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, LANOXIN, simvastatin (MSD), TENORMIN and ECOTRIN. On 05-DEC-2008 the patient experienced fever, sweats, generalized weakness, stomach pain and pain in chest below breasts. On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, chills, decreased appetite, pain between his shoulder blades and fever. On 15-DEC-2008 complete blood cell count was performed and showed high white blood cell count (20.7 K/micro l), low neutrophils (13%), high blood lymphocyte count (84%), high absolute blood lymphocyte count (17.4%) and many atypical lymphocytes. Also blood culture was performed with no growth in 5 days. On 15-DEC-2008 PA and lateral chest were performed and were compared with multiple chest regress date on 09-OCT-2006. The cardiac silhouette was enlarged, but stable. There were persistent postoperative changes of a right upper lobectomy with volume loss on the right, elevation of the minor fissure and sixth rib resection. There was a stable right fifth rib fracture, which was unchanged in appearance. There was mild scarring in the left lung base. There was no local consolidation, effusion, or pneumothorax. There were degenerative changes of the spine. There were no acute cardiopulmonary process identified and stable postoperative changes of a right upper lobectomy. The patient sought medical attention by the physician. On 06-JAN-2009 patient was recovered. Fever, sweats, generalized weakness, stomach pain, pain in chest below breasts, profuse sweating, decreased appetite, chills and pain between his shoulder blades were considered to be disabling. Additional information is not expected. All available medical records will be provided upon request.
Age: 84.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Blood urine absent, Chest X-ray normal, Chest pain, Chills, Decreased appetite
Clinical narrative: Information has been received from a physician concerning an 84 year old male patient with diverticulitis and a history of malaria who on 05-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck), 0.65ml. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, "ECOTIN", LANOXIN and simvastatin (MSD). On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, decreased appetite and pain between his shoulder blades. The patient noted that the symptoms are similar to the symptoms he experienced when he had a malaria infection. The patient underwent urinalysis (results not reported), chest x-ray (results not reported) and complete blood cell count that revealed an elevated white blood cell count. At the time of report on the 16-DEC-2008 the patient was recovering. The patient sought medical attention seen by the physician. Follow up information has been received from a Physician via medical record concerning an 84 (also reported as 85 year old) year old male patient who on 05-DEC-2008 received a dose of ZOSTAVAX (Oka/Merck) (Lot # 662969/1206X) in the arm at AM. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, LANOXIN, simvastatin (MSD), TENORMIN and ECOTRIN. On 05-DEC-2008 the patient experienced fever, sweats, generalized weakness, stomach pain and pain in chest below breasts. On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, chills, decreased appetite, pain between his shoulder blades and fever. On 15-DEC-2008 complete blood cell count was performed and showed high white blood cell count (20.7 K/micro l), low neutrophils (13%), high blood lymphocyte count (84%), high absolute blood lymphocyte count (17.4%) and many atypical lymphocytes. Also blood culture was performed with no growth in 5 days. On 15-DEC-2008 PA and lateral chest were performed and were compared with multiple chest regress date on 09-OCT-2006. The cardiac silhouette was enlarged, but stable. There were persistent postoperative changes of a right upper lobectomy with volume loss on the right, elevation of the minor fissure and sixth rib resection. There was a stable right fifth rib fracture, which was unchanged in appearance. There was mild scarring in the left lung base. There was no local consolidation, effusion, or pneumothorax. There were degenerative changes of the spine. There were no acute cardiopulmonary process identified and stable postoperative changes of a right upper lobectomy. The patient sought medical attention by the physician. On 06-JAN-2009 patient was recovered. Fever, sweats, generalized weakness, stomach pain, pain in chest below breasts, profuse sweating, decreased appetite, chills and pain between his shoulder blades were considered to be disabling. Additional information is not expected. All available medical records will be provided upon request.
Age: 84.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Haematocrit decreased, High density lipoprotein decreased, Hyperhidrosis, Lymphocyte count increased, Lymphocyte percentage increased
Clinical narrative: Information has been received from a physician concerning an 84 year old male patient with diverticulitis and a history of malaria who on 05-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck), 0.65ml. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, "ECOTIN", LANOXIN and simvastatin (MSD). On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, decreased appetite and pain between his shoulder blades. The patient noted that the symptoms are similar to the symptoms he experienced when he had a malaria infection. The patient underwent urinalysis (results not reported), chest x-ray (results not reported) and complete blood cell count that revealed an elevated white blood cell count. At the time of report on the 16-DEC-2008 the patient was recovering. The patient sought medical attention seen by the physician. Follow up information has been received from a Physician via medical record concerning an 84 (also reported as 85 year old) year old male patient who on 05-DEC-2008 received a dose of ZOSTAVAX (Oka/Merck) (Lot # 662969/1206X) in the arm at AM. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, LANOXIN, simvastatin (MSD), TENORMIN and ECOTRIN. On 05-DEC-2008 the patient experienced fever, sweats, generalized weakness, stomach pain and pain in chest below breasts. On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, chills, decreased appetite, pain between his shoulder blades and fever. On 15-DEC-2008 complete blood cell count was performed and showed high white blood cell count (20.7 K/micro l), low neutrophils (13%), high blood lymphocyte count (84%), high absolute blood lymphocyte count (17.4%) and many atypical lymphocytes. Also blood culture was performed with no growth in 5 days. On 15-DEC-2008 PA and lateral chest were performed and were compared with multiple chest regress date on 09-OCT-2006. The cardiac silhouette was enlarged, but stable. There were persistent postoperative changes of a right upper lobectomy with volume loss on the right, elevation of the minor fissure and sixth rib resection. There was a stable right fifth rib fracture, which was unchanged in appearance. There was mild scarring in the left lung base. There was no local consolidation, effusion, or pneumothorax. There were degenerative changes of the spine. There were no acute cardiopulmonary process identified and stable postoperative changes of a right upper lobectomy. The patient sought medical attention by the physician. On 06-JAN-2009 patient was recovered. Fever, sweats, generalized weakness, stomach pain, pain in chest below breasts, profuse sweating, decreased appetite, chills and pain between his shoulder blades were considered to be disabling. Additional information is not expected. All available medical records will be provided upon request.
Age: 84.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Musculoskeletal pain, Neutrophil count decreased, Protein urine absent, Prothrombin time prolonged, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 84 year old male patient with diverticulitis and a history of malaria who on 05-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck), 0.65ml. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, "ECOTIN", LANOXIN and simvastatin (MSD). On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, decreased appetite and pain between his shoulder blades. The patient noted that the symptoms are similar to the symptoms he experienced when he had a malaria infection. The patient underwent urinalysis (results not reported), chest x-ray (results not reported) and complete blood cell count that revealed an elevated white blood cell count. At the time of report on the 16-DEC-2008 the patient was recovering. The patient sought medical attention seen by the physician. Follow up information has been received from a Physician via medical record concerning an 84 (also reported as 85 year old) year old male patient who on 05-DEC-2008 received a dose of ZOSTAVAX (Oka/Merck) (Lot # 662969/1206X) in the arm at AM. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, LANOXIN, simvastatin (MSD), TENORMIN and ECOTRIN. On 05-DEC-2008 the patient experienced fever, sweats, generalized weakness, stomach pain and pain in chest below breasts. On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, chills, decreased appetite, pain between his shoulder blades and fever. On 15-DEC-2008 complete blood cell count was performed and showed high white blood cell count (20.7 K/micro l), low neutrophils (13%), high blood lymphocyte count (84%), high absolute blood lymphocyte count (17.4%) and many atypical lymphocytes. Also blood culture was performed with no growth in 5 days. On 15-DEC-2008 PA and lateral chest were performed and were compared with multiple chest regress date on 09-OCT-2006. The cardiac silhouette was enlarged, but stable. There were persistent postoperative changes of a right upper lobectomy with volume loss on the right, elevation of the minor fissure and sixth rib resection. There was a stable right fifth rib fracture, which was unchanged in appearance. There was mild scarring in the left lung base. There was no local consolidation, effusion, or pneumothorax. There were degenerative changes of the spine. There were no acute cardiopulmonary process identified and stable postoperative changes of a right upper lobectomy. The patient sought medical attention by the physician. On 06-JAN-2009 patient was recovered. Fever, sweats, generalized weakness, stomach pain, pain in chest below breasts, profuse sweating, decreased appetite, chills and pain between his shoulder blades were considered to be disabling. Additional information is not expected. All available medical records will be provided upon request.
Age: 84.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Red cell distribution width increased, Tissue polypeptide antigen, Urine analysis normal, Urine ketone body absent, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning an 84 year old male patient with diverticulitis and a history of malaria who on 05-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck), 0.65ml. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, "ECOTIN", LANOXIN and simvastatin (MSD). On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, decreased appetite and pain between his shoulder blades. The patient noted that the symptoms are similar to the symptoms he experienced when he had a malaria infection. The patient underwent urinalysis (results not reported), chest x-ray (results not reported) and complete blood cell count that revealed an elevated white blood cell count. At the time of report on the 16-DEC-2008 the patient was recovering. The patient sought medical attention seen by the physician. Follow up information has been received from a Physician via medical record concerning an 84 (also reported as 85 year old) year old male patient who on 05-DEC-2008 received a dose of ZOSTAVAX (Oka/Merck) (Lot # 662969/1206X) in the arm at AM. Concomitant therapy included influenza virus vaccine (unspecified), COUMADIN, LANOXIN, simvastatin (MSD), TENORMIN and ECOTRIN. On 05-DEC-2008 the patient experienced fever, sweats, generalized weakness, stomach pain and pain in chest below breasts. On 08-DEC-2008 the patient experienced elevate white blood cell count, profuse sweating, chills, decreased appetite, pain between his shoulder blades and fever. On 15-DEC-2008 complete blood cell count was performed and showed high white blood cell count (20.7 K/micro l), low neutrophils (13%), high blood lymphocyte count (84%), high absolute blood lymphocyte count (17.4%) and many atypical lymphocytes. Also blood culture was performed with no growth in 5 days. On 15-DEC-2008 PA and lateral chest were performed and were compared with multiple chest regress date on 09-OCT-2006. The cardiac silhouette was enlarged, but stable. There were persistent postoperative changes of a right upper lobectomy with volume loss on the right, elevation of the minor fissure and sixth rib resection. There was a stable right fifth rib fracture, which was unchanged in appearance. There was mild scarring in the left lung base. There was no local consolidation, effusion, or pneumothorax. There were degenerative changes of the spine. There were no acute cardiopulmonary process identified and stable postoperative changes of a right upper lobectomy. The patient sought medical attention by the physician. On 06-JAN-2009 patient was recovered. Fever, sweats, generalized weakness, stomach pain, pain in chest below breasts, profuse sweating, decreased appetite, chills and pain between his shoulder blades were considered to be disabling. Additional information is not expected. All available medical records will be provided upon request.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pruritus, Respiratory tract congestion, Wheezing
Clinical narrative: This report was received from GlaxoSmithKline and was assigned manufacturer report number A0769858A for KINRIX.  This case was originally reported by a physician via a sales representative and described the occurrence of itching in a 4-year-old male subject who was vaccinated with combined KINRIX, MMR II and VARIVAX (Oka/Merck).  Concurrent medical conditions included asthma.  On 19-FEB-2009 the subject received unspecified dose of KINRIX, unspecified dose of MMR II and unspecified dose of VARIVAX (Oka/Merck).  On 19-FEB-2009, approximately 5 minutes after vaccination with the 3 vaccines, the subject experienced itching, congestion (unknown) and wheezing.  The subject was treated with BENADRYL, SOLUMEDROL and EPINEPHRINE.  The subject was admitted to the hospital overnight for observation.  At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: MMR
Symptoms: Asperger's disorder
Clinical narrative: Information has been received from a consumer concerning her son who was vaccinated with all the doses of MMR II on unspecified dates.  Subsequently the patient developed asperger syndrome.  No other information provided.  Upon internal review, asperger syndrome was determined to be an other important medical event.  Additional information is not expected.