chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: FLUN3, HEPA, MMR
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging thoracic abnormal, Paraesthesia, Paraesthesia, Protein total normal
Clinical narrative: Service member was a basic trainee and received multiple vaccines at the end of September 2008 and then developed lower extremity weakness and paresthesias in late October-early November 2008 time-frame. First noted tingling in bilateral great toes which then progressed to calves and thighs. SM was admitted in November 2008 and treated with steroids. He was then discharged to Inpatient Rehab x 8 days with ongoing lower extremity weakness and ataxia. He currently is experiencing ongoing lower extremity weakness and paresthesias. He is pending a medical board. Diagnosed as ADEM. 4/2/09-records received for DOS 11/8-11/17/08- DC DX:Acute transverse myelitis versus ADEM. Ataxia secondary to 1st diagnosis. urinary retention resolving. Received immunizations 3 weeks prior and had 1 week of progressive muscle weakness with mostly lower limb involvement and urinary retention. Began with tingling sensation of big toes progressing to legs buckling and no longer able to walk.Transferred to rehabiliation.  Follow up 5/11/10 Last clinical not visible to VHC-April 2009; last contact with patient, 4/30/09 placed on TDRL status with 70% disability.
Age: 24.0
Sex: M
Vaccine: FLUN3, HEPA, MMR
Symptoms: Red blood cell sedimentation rate normal, Spinal X-ray abnormal
Clinical narrative: Service member was a basic trainee and received multiple vaccines at the end of September 2008 and then developed lower extremity weakness and paresthesias in late October-early November 2008 time-frame. First noted tingling in bilateral great toes which then progressed to calves and thighs. SM was admitted in November 2008 and treated with steroids. He was then discharged to Inpatient Rehab x 8 days with ongoing lower extremity weakness and ataxia. He currently is experiencing ongoing lower extremity weakness and paresthesias. He is pending a medical board. Diagnosed as ADEM. 4/2/09-records received for DOS 11/8-11/17/08- DC DX:Acute transverse myelitis versus ADEM. Ataxia secondary to 1st diagnosis. urinary retention resolving. Received immunizations 3 weeks prior and had 1 week of progressive muscle weakness with mostly lower limb involvement and urinary retention. Began with tingling sensation of big toes progressing to legs buckling and no longer able to walk.Transferred to rehabiliation.  Follow up 5/11/10 Last clinical not visible to VHC-April 2009; last contact with patient, 4/30/09 placed on TDRL status with 70% disability.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Nausea, Dizzy, Weak
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, DTAPIPV, MMR, DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 3/10 2pm - immunization administered. 3/11/09 Am - increased redness, swelling at injection sites, ice applied, TYLENOL given. 3/12/09 6pm - seen by MD in office for increased pain, worsening redness and swelling at injection site. Had both KINRIX and MMR boosters put in left arm. On Wednesday started with the swelling which has progressively gotten worse. Mom gave TYLENOL and put ice on it but did not give anything else. Not itchy. No history of adverse reactions before.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, DTAPIPV, MMR, DTAPIPV, MMR
Symptoms: Injection site swelling
Clinical narrative: 3/10 2pm - immunization administered. 3/11/09 Am - increased redness, swelling at injection sites, ice applied, TYLENOL given. 3/12/09 6pm - seen by MD in office for increased pain, worsening redness and swelling at injection site. Had both KINRIX and MMR boosters put in left arm. On Wednesday started with the swelling which has progressively gotten worse. Mom gave TYLENOL and put ice on it but did not give anything else. Not itchy. No history of adverse reactions before.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, DTAPIPV, MMR, DTAPIPV, MMR
Symptoms: Cellulitis, Inflammation, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 3/10 2pm - immunization administered. 3/11/09 Am - increased redness, swelling at injection sites, ice applied, TYLENOL given. 3/12/09 6pm - seen by MD in office for increased pain, worsening redness and swelling at injection site. Had both KINRIX and MMR boosters put in left arm. On Wednesday started with the swelling which has progressively gotten worse. Mom gave TYLENOL and put ice on it but did not give anything else. Not itchy. No history of adverse reactions before.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, DTAPIPV, MMR, DTAPIPV, MMR
Symptoms: Injection site swelling, No reaction on previous exposure to drug, Skin swelling
Clinical narrative: 3/10 2pm - immunization administered. 3/11/09 Am - increased redness, swelling at injection sites, ice applied, TYLENOL given. 3/12/09 6pm - seen by MD in office for increased pain, worsening redness and swelling at injection site. Had both KINRIX and MMR boosters put in left arm. On Wednesday started with the swelling which has progressively gotten worse. Mom gave TYLENOL and put ice on it but did not give anything else. Not itchy. No history of adverse reactions before.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Abscess
Clinical narrative: Sterile abscess left thigh.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intestinal resection, Intussusception
Clinical narrative: Intussusception (ileo-cecal) requiring bowel resection. 5/19/09-records received for DOS 1/2/09 and 3/5/09 -clinic notes for follow-up-3/13/09-seen in clinic after presenting to ED with large bloody stools times 2 days, developed respiratory distress. Transfusions. Intubated. PICU. Impression: rectal bleeding, DIC, leukocytosis.  5/21/09-operative report received for DOS 3/13/09-exploratory laparotomy with right hemicolectomy and ileocolostomy. DX: Intussusception. Presented with C/O abdominal tenderness and distended abdomen, rectal bleeding.  Post operatively developed ARDS, ventialtor dependent. Subsequent surgery 5/7/09 Median sternotomy,  PDA ligation, pulmonary artery banding, insertion of right femoral arterial line. 5/12/09-subsequent surgery for closure of sternal wound. Failure to wean from ventilator.   8/11/09 Hospital DC summary, ICD-9 codes received DOS 3/11/09 to 7/5/09. Assessment: Intussusception status post bowel resection, ischemic colitis - septic shock, multi organ system dysfunction. Additional clinical data abstracted: 5/28/09 Continued fever. Signs of sepsis. Parental decision to withdraw care on 7/5/09. Patient expired on 7/5/09.  ICD-9 Codes: 786.05 Shortness of breath,  560.0 Intussusception,  286.6 Defibrination syndrome,  557.0 Acute vascular insufficiency of intestine,  785.52 Septic shock,  569.83 Perforation of intestine,  038.49 Septicemia due to gram-negative organism,  038.43 Septicemia due to Pseudomonas,  518.5 Pulmonary insufficiency following trauma and surgery,  745.69 Endocardial cushion defect,  747.0 Patent ductus arteriousus,  238.79 Neoplasm of uncertain behavior of other lymphatic and hematopoietic tissue,  995.92 Severe sepsis,  599.0 Urinary tract infection site not specified,  758.0 Down's syndrome,  427.5 Cardiac arrest.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Dermal infiltrate L anterior thigh: indurated, reddened, not tender.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Auricular swelling, Dysphagia, Lip swelling, Pruritus, Swelling face
Clinical narrative: Approximately 30min after receiving MMR vaccine Pt's lips + face + ears started swelling, face + head pruritic +mild difficulty swallowing. No resp. distress.
Age: 23.0
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Infection, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient was given pneumococcal vaccine in L Deltoid on 3/14/09 @ 1722. Patient noted that her arm was very sore. On 3/15/09 @ 2038 RN noted that "deltoid areas of arms painful. L deltoid erythematous." Patient's L arm is red, swollen hot and itchy from L deltoid to 2-3" below L elbow. Patient received blood transfusions during the day shift on 3/15/09 through R arm. Applying BENADYL cream to arm for itch. Patient started on rifampin and BACTRIM DS for infection/cellulitis precaution b/c of Hx. of heart valve replacement.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Transfusion
Clinical narrative: Patient was given pneumococcal vaccine in L Deltoid on 3/14/09 @ 1722. Patient noted that her arm was very sore. On 3/15/09 @ 2038 RN noted that "deltoid areas of arms painful. L deltoid erythematous." Patient's L arm is red, swollen hot and itchy from L deltoid to 2-3" below L elbow. Patient received blood transfusions during the day shift on 3/15/09 through R arm. Applying BENADYL cream to arm for itch. Patient started on rifampin and BACTRIM DS for infection/cellulitis precaution b/c of Hx. of heart valve replacement.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Axillary mass, Axillary pain, Fatigue, Mass
Clinical narrative: Patient reports developing a pruritic rash on her face, fatigue and joint pain within 2 hours of vaccine administration.  She subsequently developed painful swelling in axillary region which resolved spontaneously in about 4-5 days.  She noted a "lump" in upper chest 6 days after vaccine.  She went to ED & received IV SOLUMEDROL & VICODIN with improvement.  Now on PREDNISONE & BENADRYL.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic, Swelling
Clinical narrative: Patient reports developing a pruritic rash on her face, fatigue and joint pain within 2 hours of vaccine administration.  She subsequently developed painful swelling in axillary region which resolved spontaneously in about 4-5 days.  She noted a "lump" in upper chest 6 days after vaccine.  She went to ED & received IV SOLUMEDROL & VICODIN with improvement.  Now on PREDNISONE & BENADRYL.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Bronchitis, Chest X-ray abnormal, Febrile convulsion
Clinical narrative: Febrile seizure - ER visit treated with MOTRIN and TYLENOL.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue, severe muscle aches all over body - sore muscles with touch. 3/20/09 Note received from PCP. Pt has not been seen at all since DOV. TC from parent 3/16/09 reporting fatigue, muscle aches-especially in arms since 3rd Gardasil in 12/2008. Will f/u PRN.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash generalised, Streptococcal identification test negative
Clinical narrative: High fever - up to 103- March 13-14-2009 Full body rash- March 15-16-17-2009 MMR-given 3-02-09
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Varicella
Clinical narrative: Dx with chicken pox.
Sex: F
Vaccine: HEP
Symptoms: Autoimmune hepatitis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age not reported) with acne who on an unspecified date was vaccinated with RECOMBIVAX HB.  Concomitant therapy included MINOCYCLINE.  Subsequently the patient experienced autoimmune hepatitis.  The patient alleged that the hepatitis B vaccine had caused the autoimmune hepatitis.  The rulling was that "a preponderance of the evidence established that the hepatitis B virus does not cause autoimmune hepatitis."  The patient's physician withdrew the molecular mimicry theory primarily because no evidence showed a homology between parts of the hepatitis B vaccine and liver cells that were attacked by autoimmune hepatitis.  In follow up it was noted that the patient did not have autoimmune hepatitis, but instead she had was taking MINOCYCLINE, an antibiotic used to treat acne, which was prescribed in 1991, when she was 28 year old.  The reporter felt that autoimmune hepatitis was not related to therapy with RECOMBIVAX HB.  This is one of several  reports received from the same source.  No further information is available.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Hepatic steatosis
Clinical narrative: Information has been received from lawyer regarding a case in litigation concerning an approximately 47 year old male with non-alcoholic steatohepatitis (February 1994) who on an unspecified date was vaccinated with RECOMBIVAX HB.  Subsequently the patient experienced autoimmune hepatitis.  The patient alleged that the hepatitis B vaccine had caused the autoimmune hepatitis.  The ruling was that "a preponderance of the evidence established that the hepatitis B virus does not cause autoimmune hepatitis."  The patient's physician withdrew the molecular mimicry theory primarily because no evidence showed a homology between parts of the hepatitis B vaccine and liver cells that were attacked by autoimmune hepatitis.  In follow up it was noted that the patient did not have autoimmune hepatitis, but instead had nonalcoholic steatohepatitis.  His liver problems predated his hepatitis B vaccinations, which began in February 1994.  The reporter felt that autoimmune hepatitis was not related to therapy with RECOMBIVAX HB.  This is one of several reports received from the same source.  No further information available.
Sex: M
Vaccine: HEP
Symptoms: Bilirubin conjugated increased, Blood bilirubin increased, Candidiasis, Cough, Dermatitis diaper
Clinical narrative: Information has been received from a medical record concerning a 7 month old male with no known drug allergies, who on 03-APR-2008 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) and on 23-MAY-2006 with a dose of RECOMBIVAX HB (657605/1069U) administered IM in the right thigh.  Concomitant suspect vaccination administered on 23-MAY-2008 and 04-SEP-2008 orally included ROTATEQ (660547/0207X) and (660845/0289X).  Other concomitant vaccinations administered on 23-MAY-2008 and 04-SEP-2008 included PREVNAR (C57537) and (C57542) both administered IM in the right thigh, DTaP (C2950AA) and (C2953AA) both administered IM in the left thigh, POLIOVIRUS vaccine (A0805) and (A0492) both administered IM in the right thigh, and HIB CONJ vaccine (unspecified carrier) (UF355AA) and (UF362AA) both administered IM in the left thigh.  On 06-APR-2008 the patient developed jaundice at 4 days old.  Laboratory diagnostics were performed and the results can be found in the laboratory section.  On 05-MAY-2008 the patient presented with a cough, heavy breathing, and a rash.  The patient was diagnosed with a cough and an upper respiratory infection.  The patient was afebrile and did not experience a change in appetite.  The care for the patient's symptoms was discussed and the patient was advised to return to the clinic if the symptoms worsened.  On 23-MAY-2008 the patient presented with a white coating in his mouth, diaper rash, was spitting more, and was cranky.  On 03-JUN-2008 the patient was seen and it was reported that the patient had been exposed to lead at home.  On 04-SEP-2008 the patient presented with congestion, cough, sneezing, and a runny nose with green discharge.  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Infantile spitting up, Irritability, Jaundice, Rash
Clinical narrative: Information has been received from a medical record concerning a 7 month old male with no known drug allergies, who on 03-APR-2008 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) and on 23-MAY-2006 with a dose of RECOMBIVAX HB (657605/1069U) administered IM in the right thigh.  Concomitant suspect vaccination administered on 23-MAY-2008 and 04-SEP-2008 orally included ROTATEQ (660547/0207X) and (660845/0289X).  Other concomitant vaccinations administered on 23-MAY-2008 and 04-SEP-2008 included PREVNAR (C57537) and (C57542) both administered IM in the right thigh, DTaP (C2950AA) and (C2953AA) both administered IM in the left thigh, POLIOVIRUS vaccine (A0805) and (A0492) both administered IM in the right thigh, and HIB CONJ vaccine (unspecified carrier) (UF355AA) and (UF362AA) both administered IM in the left thigh.  On 06-APR-2008 the patient developed jaundice at 4 days old.  Laboratory diagnostics were performed and the results can be found in the laboratory section.  On 05-MAY-2008 the patient presented with a cough, heavy breathing, and a rash.  The patient was diagnosed with a cough and an upper respiratory infection.  The patient was afebrile and did not experience a change in appetite.  The care for the patient's symptoms was discussed and the patient was advised to return to the clinic if the symptoms worsened.  On 23-MAY-2008 the patient presented with a white coating in his mouth, diaper rash, was spitting more, and was cranky.  On 03-JUN-2008 the patient was seen and it was reported that the patient had been exposed to lead at home.  On 04-SEP-2008 the patient presented with congestion, cough, sneezing, and a runny nose with green discharge.  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Rhinorrhoea, Sneezing, Upper respiratory tract infection
Clinical narrative: Information has been received from a medical record concerning a 7 month old male with no known drug allergies, who on 03-APR-2008 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) and on 23-MAY-2006 with a dose of RECOMBIVAX HB (657605/1069U) administered IM in the right thigh.  Concomitant suspect vaccination administered on 23-MAY-2008 and 04-SEP-2008 orally included ROTATEQ (660547/0207X) and (660845/0289X).  Other concomitant vaccinations administered on 23-MAY-2008 and 04-SEP-2008 included PREVNAR (C57537) and (C57542) both administered IM in the right thigh, DTaP (C2950AA) and (C2953AA) both administered IM in the left thigh, POLIOVIRUS vaccine (A0805) and (A0492) both administered IM in the right thigh, and HIB CONJ vaccine (unspecified carrier) (UF355AA) and (UF362AA) both administered IM in the left thigh.  On 06-APR-2008 the patient developed jaundice at 4 days old.  Laboratory diagnostics were performed and the results can be found in the laboratory section.  On 05-MAY-2008 the patient presented with a cough, heavy breathing, and a rash.  The patient was diagnosed with a cough and an upper respiratory infection.  The patient was afebrile and did not experience a change in appetite.  The care for the patient's symptoms was discussed and the patient was advised to return to the clinic if the symptoms worsened.  On 23-MAY-2008 the patient presented with a white coating in his mouth, diaper rash, was spitting more, and was cranky.  On 03-JUN-2008 the patient was seen and it was reported that the patient had been exposed to lead at home.  On 04-SEP-2008 the patient presented with congestion, cough, sneezing, and a runny nose with green discharge.  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Facial pain, Headache, Memory impairment, Pain in jaw
Clinical narrative: Information has been received for a case in litigation who in June 1992, was vaccinated with a dose of RECOMBIVAX HB.  Concomitant medication was not reported.  Subsequently in June 1992, the patient experienced jaw and facial pain, headaches, confusion, memory and other problems.  The reporter felt that jaw pain, facial pain, headaches, confusion, memory problems and other problems were related to therapy with RECOMBIVAX.  The outcome of the events were not reported.  Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Autoimmune disorder, Demyelination, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Optic neuritis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation, which was reported concerning a 52 year old female who on 03-FEB-1998 was vaccinated with RECOMBIVAX HB (lot # not reported). Subsequently, three weeks after receiving a RECOMBIVAX HB (24-FEB-1998), the patient was diagnosed with optic neuritis. Her condition continued to deteriorate, and on 19-JUN-1998, a physician discovered that an MRI revealed an "active demyelinating plaque secondary to multiple sclerosis (MS). It was concluded that the RECOMBIVAX HB was responsible for the patient's optic neuritis and multiple sclerosis (MS). The reporter concluded that the lapse of three weeks between the administration of the RECOMBIVAX HB and the development of symptoms is consistent with an immune response. Regarding autoimmune disease: "the basis of a (physician's) opinion is that it is biologically plausible for RECOMBIVAX HB to cause demyelination because it is composed of antigens that are made of organic compounds of viral origin,". "If petitioner has antigens sharing a homology with the vaccine's antigens, the petitioner's immune response to the vaccine will also be directed at her own antigens, leading to an autoimmune response" The patient's outcome was not reported. Upon internal review, the patient's multiple sclerosis was considered to be an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Erythema nodosum, Headache, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a consumer concerning his 14 year old granddaughter with a history of migraine who in September 2008, was vaccinated with a dose of GARDASIL. In October 2008 (on an unspecified time after vaccination), the patient experienced abdominal pain and headaches. Her symptoms had been getting more pronounced and more frequent. Since December 2008, the patient had spent more time out of school than in school. On approximately 18-FEB-2009 ("three weeks ago") the patient was doing homework and was feeling well. Then she began to look unwell and laid down on the couch. As her grandparents watched, the patient's body started to "draw up", her hands became claws, and she developed numbness in her legs and hands. Then she developed extreme shortness of breath and coughing. Her head rolled back, her eyes crossed, she passed out and stopped breathing. Paramedics were called and she was taken to a hospital. This was about the seventh time the patient had gone to the ER in the last two months. Oxygen was given in the ambulance. By the time she reached the hospital the patient was responding. After this episode the patient lost her memory for a week and only recognized a few people. The patient was later released from the ER. In the last 2.5 months the patient had spent two nights in the hospital. While at a hospital for testing, the patient fainted and was admitted for testing for one week. The patient had had migraines lasting as long as a month. Numerous MRIs and CAT scans were performed. On 10-MAR-2009 (" Last night") the patient went to the ER. All tests had come up with no diagnosis. Unknown medications had not worked. At the time of reporting, the adverse events persisted. Additional information has been requested.  4/10/09-records received for DOT 9/7/08-consult for evaluation of syncope. Initial syncopal episode 1-2 years ago however this past week epxperienced 3-4 episodes with 1st episode ocurring 9/3/08 when running for about half an hour and started feeling dizzy and passed out, continued to feel dizzy and following day passed out twice while walking and also at rest. During last episode dizzy with blurred vision then lost consciousness and might have hit head during fall. Heartrate showed atrial flutter. Assessment: history of syncope most likely partly due to orthostatic hypotension and vasovagal. 9/6/08-admitted with 3 day history of syncopal episode.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mass, Neurological examination normal, Pyrexia
Clinical narrative: Information has been received from a consumer concerning his 14 year old granddaughter with a history of migraine who in September 2008, was vaccinated with a dose of GARDASIL. In October 2008 (on an unspecified time after vaccination), the patient experienced abdominal pain and headaches. Her symptoms had been getting more pronounced and more frequent. Since December 2008, the patient had spent more time out of school than in school. On approximately 18-FEB-2009 ("three weeks ago") the patient was doing homework and was feeling well. Then she began to look unwell and laid down on the couch. As her grandparents watched, the patient's body started to "draw up", her hands became claws, and she developed numbness in her legs and hands. Then she developed extreme shortness of breath and coughing. Her head rolled back, her eyes crossed, she passed out and stopped breathing. Paramedics were called and she was taken to a hospital. This was about the seventh time the patient had gone to the ER in the last two months. Oxygen was given in the ambulance. By the time she reached the hospital the patient was responding. After this episode the patient lost her memory for a week and only recognized a few people. The patient was later released from the ER. In the last 2.5 months the patient had spent two nights in the hospital. While at a hospital for testing, the patient fainted and was admitted for testing for one week. The patient had had migraines lasting as long as a month. Numerous MRIs and CAT scans were performed. On 10-MAR-2009 (" Last night") the patient went to the ER. All tests had come up with no diagnosis. Unknown medications had not worked. At the time of reporting, the adverse events persisted. Additional information has been requested.  4/10/09-records received for DOT 9/7/08-consult for evaluation of syncope. Initial syncopal episode 1-2 years ago however this past week epxperienced 3-4 episodes with 1st episode ocurring 9/3/08 when running for about half an hour and started feeling dizzy and passed out, continued to feel dizzy and following day passed out twice while walking and also at rest. During last episode dizzy with blurred vision then lost consciousness and might have hit head during fall. Heartrate showed atrial flutter. Assessment: history of syncope most likely partly due to orthostatic hypotension and vasovagal. 9/6/08-admitted with 3 day history of syncopal episode.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Activities of daily living impaired, Amnesia, Apnoea, Cough
Clinical narrative: Information has been received from a consumer concerning his 14 year old granddaughter with a history of migraine who in September 2008, was vaccinated with a dose of GARDASIL. In October 2008 (on an unspecified time after vaccination), the patient experienced abdominal pain and headaches. Her symptoms had been getting more pronounced and more frequent. Since December 2008, the patient had spent more time out of school than in school. On approximately 18-FEB-2009 ("three weeks ago") the patient was doing homework and was feeling well. Then she began to look unwell and laid down on the couch. As her grandparents watched, the patient's body started to "draw up", her hands became claws, and she developed numbness in her legs and hands. Then she developed extreme shortness of breath and coughing. Her head rolled back, her eyes crossed, she passed out and stopped breathing. Paramedics were called and she was taken to a hospital. This was about the seventh time the patient had gone to the ER in the last two months. Oxygen was given in the ambulance. By the time she reached the hospital the patient was responding. After this episode the patient lost her memory for a week and only recognized a few people. The patient was later released from the ER. In the last 2.5 months the patient had spent two nights in the hospital. While at a hospital for testing, the patient fainted and was admitted for testing for one week. The patient had had migraines lasting as long as a month. Numerous MRIs and CAT scans were performed. On 10-MAR-2009 (" Last night") the patient went to the ER. All tests had come up with no diagnosis. Unknown medications had not worked. At the time of reporting, the adverse events persisted. Additional information has been requested.  4/10/09-records received for DOT 9/7/08-consult for evaluation of syncope. Initial syncopal episode 1-2 years ago however this past week epxperienced 3-4 episodes with 1st episode ocurring 9/3/08 when running for about half an hour and started feeling dizzy and passed out, continued to feel dizzy and following day passed out twice while walking and also at rest. During last episode dizzy with blurred vision then lost consciousness and might have hit head during fall. Heartrate showed atrial flutter. Assessment: history of syncope most likely partly due to orthostatic hypotension and vasovagal. 9/6/08-admitted with 3 day history of syncopal episode.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Gaze palsy, Headache, Hypoaesthesia, Loss of consciousness
Clinical narrative: Information has been received from a consumer concerning his 14 year old granddaughter with a history of migraine who in September 2008, was vaccinated with a dose of GARDASIL. In October 2008 (on an unspecified time after vaccination), the patient experienced abdominal pain and headaches. Her symptoms had been getting more pronounced and more frequent. Since December 2008, the patient had spent more time out of school than in school. On approximately 18-FEB-2009 ("three weeks ago") the patient was doing homework and was feeling well. Then she began to look unwell and laid down on the couch. As her grandparents watched, the patient's body started to "draw up", her hands became claws, and she developed numbness in her legs and hands. Then she developed extreme shortness of breath and coughing. Her head rolled back, her eyes crossed, she passed out and stopped breathing. Paramedics were called and she was taken to a hospital. This was about the seventh time the patient had gone to the ER in the last two months. Oxygen was given in the ambulance. By the time she reached the hospital the patient was responding. After this episode the patient lost her memory for a week and only recognized a few people. The patient was later released from the ER. In the last 2.5 months the patient had spent two nights in the hospital. While at a hospital for testing, the patient fainted and was admitted for testing for one week. The patient had had migraines lasting as long as a month. Numerous MRIs and CAT scans were performed. On 10-MAR-2009 (" Last night") the patient went to the ER. All tests had come up with no diagnosis. Unknown medications had not worked. At the time of reporting, the adverse events persisted. Additional information has been requested.  4/10/09-records received for DOT 9/7/08-consult for evaluation of syncope. Initial syncopal episode 1-2 years ago however this past week epxperienced 3-4 episodes with 1st episode ocurring 9/3/08 when running for about half an hour and started feeling dizzy and passed out, continued to feel dizzy and following day passed out twice while walking and also at rest. During last episode dizzy with blurred vision then lost consciousness and might have hit head during fall. Heartrate showed atrial flutter. Assessment: history of syncope most likely partly due to orthostatic hypotension and vasovagal. 9/6/08-admitted with 3 day history of syncopal episode.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Malaise, Migraine, Posture abnormal, Syncope
Clinical narrative: Information has been received from a consumer concerning his 14 year old granddaughter with a history of migraine who in September 2008, was vaccinated with a dose of GARDASIL. In October 2008 (on an unspecified time after vaccination), the patient experienced abdominal pain and headaches. Her symptoms had been getting more pronounced and more frequent. Since December 2008, the patient had spent more time out of school than in school. On approximately 18-FEB-2009 ("three weeks ago") the patient was doing homework and was feeling well. Then she began to look unwell and laid down on the couch. As her grandparents watched, the patient's body started to "draw up", her hands became claws, and she developed numbness in her legs and hands. Then she developed extreme shortness of breath and coughing. Her head rolled back, her eyes crossed, she passed out and stopped breathing. Paramedics were called and she was taken to a hospital. This was about the seventh time the patient had gone to the ER in the last two months. Oxygen was given in the ambulance. By the time she reached the hospital the patient was responding. After this episode the patient lost her memory for a week and only recognized a few people. The patient was later released from the ER. In the last 2.5 months the patient had spent two nights in the hospital. While at a hospital for testing, the patient fainted and was admitted for testing for one week. The patient had had migraines lasting as long as a month. Numerous MRIs and CAT scans were performed. On 10-MAR-2009 (" Last night") the patient went to the ER. All tests had come up with no diagnosis. Unknown medications had not worked. At the time of reporting, the adverse events persisted. Additional information has been requested.  4/10/09-records received for DOT 9/7/08-consult for evaluation of syncope. Initial syncopal episode 1-2 years ago however this past week epxperienced 3-4 episodes with 1st episode ocurring 9/3/08 when running for about half an hour and started feeling dizzy and passed out, continued to feel dizzy and following day passed out twice while walking and also at rest. During last episode dizzy with blurred vision then lost consciousness and might have hit head during fall. Heartrate showed atrial flutter. Assessment: history of syncope most likely partly due to orthostatic hypotension and vasovagal. 9/6/08-admitted with 3 day history of syncopal episode.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her son who on 27-DEC-2001 was vaccinated with the first dose of MMR II (Lot # 638702/0253L) albumin status HSA. The reporter stated that her son developed autism after getting the first dose of measles vaccine. At the time of reporting, the patient had not recovered. The patient sought unspecified medical attention. Upon internal review, autism was determined to be an other important medical event. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Information has been received from a health professional concerning a 21 year old female with no pertinent medical history, drug reactions or allergies who on 14-JAN-2008 at 0955 was vaccinated intramuscularly into the left deltoid with a 1.0 ml second dose of RECOMBIVAX HB (lot # 655566/0659U). There was no concomitant medication. On 15-JAN-2008, the patient developed a flat, red rash on her feet, legs and stomach. No erythema or edema noted at the injection site. No respiratory symptoms were noted. On 16-JAN-2008, the patient was seen with a macular erythematous lesion on lower extremities. Maculose erythematous pinpoint lesions to dilated arms and stomach. The patient was treated with BENADRYL. The patient was diagnosed with a rash. No lab diagnostic studies were performed. On 19-JAN-2008, the rash was gone and the patient recovered. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a 33 year old female consumer with no pertinent medical history and with an allergy/drug reaction to latex, CODEINE, HYDROCODONE and BUSPAR who on 03-SEP-2008 was vaccinated with RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included ALPRAZOLAM and MOTRIN.  On 03-SEP-2008 the patient experienced a rash down both of her arms after she received the RECOMBIVAX HB (manufacturer unknown).  The consumer reported that she believed that the reaction was due to her latex allergy.  The consumer sought medical attention in clinic.  On 13-SEP-2008, the consumer recovered from the rash.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Heart rate increased, Palpitations
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of heart palpitation in a 25-year-old female subject who was vaccinated with HAVRIX and ADACEL. On 2 April 2008 at 09:30 the subject received 1st dose of HAVRIX (.5ml, unknown, right arm). On 2 April 2008 the subject received booster dose of ADACEL (.5 ml, unknown, left arm). At an unspecified time after vaccination with HAVRIX, the subject experienced a nonspecific reaction. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 14 October 2008, via healthcare professional, who reported concurrent medical conditions included upper respiratory infection. On 2 April 2008, 12 hours after vaccination with HAVRIX and ADACEL, the subject experienced heart palpitation and high resting heart rate. The reporting healthcare professional stated the palpitations and resting heart rate of 150's on 2 April 2008 was brief. On 2 April 2008, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with HAVRIX and ADACEL.
Sex: F
Vaccine: MNQ
Symptoms: Blood culture positive, Meningitis meningococcal, Meningococcal infection, Vaccination failure
Clinical narrative: Information was initially provided from the Centers for Disease Control which concerned a total of 13 cases of MENACTRA vaccine failure from January 2005 to September 2008. No individual case information or patient identifiers were provided. This information was entered into case reference number 2008-04011. It was determined that five of these cases came from the VAERS database and had previously been entered in the Sanofi Pasteur Pharmacovigilance database (Sanofi Pasteur case reference numbers 2007-03425, 2007-03383, 2008-00038, 2008-00531, and 2008-02355. On 05 January 2009, additional information was provided for seven patients. This information included specific patient identifiers. The information for these case is contained in cases 2009-00012, 2009-00013, 2009-00014, 2009-00015, 2009-00016, 2009-00017 and 2009-00018. This serious report was received from the Centers for Disease Control and Prevention on 05 January 2009, under VAERS number 335760. A female patient, born in 1987 and with no reported medical history, received an injection of MENACTRA (lot number U1766AA) on 16 August 2005. The patient developed meningococcal disease on 06 July 2006, and blood culture was positive for Neisseria meningitidis serogroup C. The patient was hospitalized for three days, and subsequently recovered. Documents held by sender: None.
Sex: U
Vaccine: SMALL
Symptoms: Hypersensitivity, Myocarditis, Troponin increased
Clinical narrative: This case was considered medically important. Information regarding DRYVAX was received from a literature source regarding a participant enrolled in a prospective immunogenetics study who developed myocarditis after receiving a dose on an unspecified date. The patient was enrolled in a prospective immunogenetics study with measurement of cardiac muscle, specific troponin-1, prior to and 5-21 days after immunization. On an unspecified date following vaccination with DRYVAX, the patient developed myocarditis. Treatment and patient outcome were not reported. The authors concluded that myocarditis is a hypersensitivity reaction to vaccinia immunization, regardless of product used (calf lymph derived or cell cultured derived) or number of punctures (3 versus 15 for eLDVac), and that it appears to be far more common than predicted by passive and epidemiologic safety surveillance methods. The natural history of myocarditis, clinical or subclinical, remains to be defined. See attached literature abstract. The assessments of the investigator(s) and medical monitor(s) for myocarditis were unknown. No additional information was available at the time of this report.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Antisocial behaviour, Autism, Childhood disintegrative disorder, Disturbance in attention, Haematology test
Clinical narrative: Information has been received from a consumer concerning her son, who received the routine vaccines (names and manufacturer unspecified) at five or six months old and subsequently started to deteriorate. Then after the patient's first birthday, in May 2002, he received the first dose of MMR II (Lot number not reported) and right after receiving MMR II the patient completely regressed. The patient lost eye contact, did not complete his words, and lacked in communication and socialization skills and was diagnosed with autism. At the time of the report, the mother stated that her son, now 8 years old, had gotten better due to intervention treatments but he still had some problems. Upon internal review, autism was considered to be an Other Important Medical Event. No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Speech disorder
Clinical narrative: Information has been received from a consumer concerning her son, who received the routine vaccines (names and manufacturer unspecified) at five or six months old and subsequently started to deteriorate. Then after the patient's first birthday, in May 2002, he received the first dose of MMR II (Lot number not reported) and right after receiving MMR II the patient completely regressed. The patient lost eye contact, did not complete his words, and lacked in communication and socialization skills and was diagnosed with autism. At the time of the report, the mother stated that her son, now 8 years old, had gotten better due to intervention treatments but he still had some problems. Upon internal review, autism was considered to be an Other Important Medical Event. No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism, Autoimmune disorder, Diarrhoea, Enterocolitis viral, Irritability
Clinical narrative: Information has been received from a consumer concerning her 12 month old son who on 21-AUG-2002 was vaccinated with an only first dose of MMR II (Lot # 641020/1483L). Concomitant therapy included VARIVAX. On 22-AUG-2002, the next day, the patient had fever of 104 degrees and cranky behavior. On 27-AUG-2002, the patient started throwing up with diarrhea whole week and next week diarrhea changed to large chunk tissue coming out from his stool. On 28-AUG-2002, the patient was hospitalized and stayed there for 3 days; the patient was diagnosed with viral colitis of unknown origin. A week later, the patient was diagnosed with autism, chronic pain and autoimmune response, which were ongoing at the time of reporting. Upon internal review, autism was considered to be an other important medical event. No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 12 month old son who on 21-AUG-2002 was vaccinated with an only first dose of MMR II (Lot # 641020/1483L). Concomitant therapy included VARIVAX. On 22-AUG-2002, the next day, the patient had fever of 104 degrees and cranky behavior. On 27-AUG-2002, the patient started throwing up with diarrhea whole week and next week diarrhea changed to large chunk tissue coming out from his stool. On 28-AUG-2002, the patient was hospitalized and stayed there for 3 days; the patient was diagnosed with viral colitis of unknown origin. A week later, the patient was diagnosed with autism, chronic pain and autoimmune response, which were ongoing at the time of reporting. Upon internal review, autism was considered to be an other important medical event. No further information is available.
Age: 1.4
Sex: M
Vaccine: MMR
Symptoms: Autism, Gastrointestinal infection, Immune system disorder
Clinical narrative: It was reported in a published report, title stated above regarding a case in litigation concerning an approximately 17 month old male who on 23-APR-1998 (age at time of vaccination was 16 months) was vaccinated with a dose of MMR II (manufacturer unknown). The patient's family brought a petition alleging that thimerosol caused immune dysfunction that allowed the MMR II (mfr. unknown) to establish a chronic infection in the gastrointestinal tract, causing autism. The patient had developed normally as an infant but regressed after receiving the vaccine. The patient's medical records up to the point of vaccination at 16 months of age do not list the words that the patient was using. However, family videos show possible developmental problems before administration of the vaccinations that the parents blame for the autism. Upon internal review autism was considered to be an other important medical event. This is one of two reports from the same source. No further information was available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Migraine, Nausea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female who on 09-JAN-2009 and 09-MAR-2009 was vaccinated with her first (lot number 661764/0650X) and second (lot number 661952/1129X) dose of GARDASIL 0.5ml IM into her deltoid respectively. Concomitant therapy included NUVARING. The patient did not have any reactions after the 1st dose of GARDASIL. On 09-MAR-2009, 2 hours after the vaccination the patient developed nausea. On 10-MAR-2009, one day after the vaccination the patient experienced a severe headache. Unspecified time the patient experienced migraine. The nurse practitioner felt an intervention to prevent serious criteria was "the patient received NSAIDs". The patient sought medical attention by phone and an office visit. The patient's outcome was recovering. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Gastrointestinal tube insertion, Impaired gastric emptying
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with no pertinent medical history, no drug reactions/allergies, who on 16-AUG-2007 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. On 11-OCT-2007, the patient was vaccinated intramuscularly with the second 0.5 mL dose of GARDASIL. There was no concomitant medication. On 10-JAN-2008 the patient was diagnosed with gastroparesis and was having abdominal pain. The patient had been hospitalized (dates of admission were not known by the reporter). On 11-FEB-2008, the patient was vaccinated intramuscularly with the third 0.5 mL dose of GARDASIL. The patient had had a nasogastric tube placed since the spring to Summer of 2008 for nutritional support. The reporter stated that the physicians were unable to determine the etiology of the diagnosis. At the time of the reporting, the patient had not recovered. Additional information has been requested. 3/27/09-records received for DOS 4/30-5/4/08-DC DX: Crohns Disease. Presented with 2 month history of abdominal cramping, bloody diarrhea and 28  pound weight loss. 3 month history of diarrhea, weight loss and intermittant abdominal pain. Records-DC DX for 7/28-7/30/08 gastroparesis. DC DX: 8/7-8/15/08-Chronic gastroparesis. Presented with malaise, anorexia and weight loss and NJ feeds. Severe abdominal pain one day prior to admission. DC DX:10/29-11/1/08-Gastroparesis, nausea and vomiting. C/O 2 days of abdominal pain and feeding intolerance. NJ feeding problems. Dizziness and feeling not like herself with shortness of breath and chest pains over past month when exerting. February 2008 onset of diarrhea nausea and vomiting.  DC DX: 12/11-12/18/08-Neck pain. Colitis, gastroparesis, GERD, NJ tube, ashtma.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Brain death, Tracheostomy
Clinical narrative: Information has been received from a registered nurse concerning an adolescent female between 14 and 17 who was vaccinated with GARDASIL. The patient had an AE to GARDASIL that required the nurse to be trached. The patient was basically "brain dead". It was not reported whether the patients sought medical attention. Upon internal review brain dead and required to be trached were determined to be other important medical events. Additional information has been requested.