chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death, Meningitis
Clinical narrative: Information has been received from a nurse practitioner, concerning an infant (gender and specific age not reported) who on an unknown date was vaccinated with a dose of PedvaxHIB (lot # not reported) and the day after vaccination died in the hospital, from meningitis (no details available). The NP stated there were "rumors in the community" that the death was related to PedvaxHIB. She felt it was possibly related to the vaccine recall, and had received "no definitive information." No further details were provided. Additional information has been requested.  12/28/07 No autopsy done per Decedant Affairs rep at hospital./pc 12/31/2007 Vax record and WCC of 12/04/2007 received from CDC.   No concerns at this time. Temp 99.1'F. PE WNL. 01/04/2008  Death Cert received. COD: meningitis. 01/22/2008 MR received from hospital for DOS 12/11-12/2008.  Child presented to ER after transfer from local hospital with DX: Meningitis and altered mental status.  Initially seen by PCP on 12/7/07 for fever/vomiting.  Pt has several 2-3 min seizure-like episodes: eyes rolling back and spacing out x 1 minute. No T-C activity.  (+) irritability. Presented again to local hospital 12/9/07 with increasing irritability, emesis with nuchal rigidity. Pt admitted to ICU with (+) eye rolling, responsive only to painful stimuli.  Pt had further seizures.  Transferred following head CT showing large bi-hemispheric strokes. Intubated and sedated. Externalized ventricular shunt placed for CSF drainage. Neuro condition deteriorated progressively (posturing, not responsive to any stimuli) to brain death. Pt was extubated and care withdrawn per parent request. Pt expired at 1712. Assessment:  Polybacterial meningitis, Hydrocephalus. 01/29/2008 D/C summary received for above hospitalization.  Principal Final DX:  Escherichia coli meningitis.  Additional DX:  Bilateral cerbral infarcts and hydrocephalus with increased intracranial pressure and seizures.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Movement disorder
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 05-DEC-2007 was vaccinated intramuscularly (site not reported) with the 1st 0.5ml dose of Gardasil (lot# 659437/1266U). On 19-DEC-2007, post vaccination the patient was not able to move her head, hands and legs and was taken to the emergency room and then hospitalized. At the time of this report the patient had not recovered. The patient not being able to move her head, hands and legs was considered to be immediately life-threatening and disabling by the nurse. Additional information has been requested.  1/18/08 Reviewed hospital medical records which reveal patient experienced HA, lethargy, muscle weakness, difficult to arouse, altered speech, difficulty walking.  Admitted 12/18-12/19/2007.  Discussed w/Neuro.  Vax record included w/hospital records.  Admitted for observation & improved to baseline by d/c.  Psychogenic source considered. FINAL DX: muscle weakness.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Abasia, Feeling abnormal, Hypoaesthesia, Laboratory test, Lumbar puncture
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 05-DEC-2007 was vaccinated intramuscularly (site not reported) with the 1st 0.5ml dose of Gardasil (lot# 659437/1266U). On 19-DEC-2007, post vaccination the patient was not able to move her head, hands and legs and was taken to the emergency room and then hospitalized. At the time of this report the patient had not recovered. The patient not being able to move her head, hands and legs was considered to be immediately life-threatening and disabling by the nurse. Additional information has been requested.  1/18/08 Reviewed hospital medical records which reveal patient experienced HA, lethargy, muscle weakness, difficult to arouse, altered speech, difficulty walking.  Admitted 12/18-12/19/2007.  Discussed w/Neuro.  Vax record included w/hospital records.  Admitted for observation & improved to baseline by d/c.  Psychogenic source considered. FINAL DX: muscle weakness.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Mental disorder, Movement disorder, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 05-DEC-2007 was vaccinated intramuscularly (site not reported) with the 1st 0.5ml dose of Gardasil (lot# 659437/1266U). On 19-DEC-2007, post vaccination the patient was not able to move her head, hands and legs and was taken to the emergency room and then hospitalized. At the time of this report the patient had not recovered. The patient not being able to move her head, hands and legs was considered to be immediately life-threatening and disabling by the nurse. Additional information has been requested.  1/18/08 Reviewed hospital medical records which reveal patient experienced HA, lethargy, muscle weakness, difficult to arouse, altered speech, difficulty walking.  Admitted 12/18-12/19/2007.  Discussed w/Neuro.  Vax record included w/hospital records.  Admitted for observation & improved to baseline by d/c.  Psychogenic source considered. FINAL DX: muscle weakness.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a nurse concerning a 19 year old female with a "history of seizures when in pain" who on 21-NOV-2007 was vaccinated with a third dose of Gardasil (lot# 655154/1210U) 0.5 mL IM. Therapy with Gardasil started on an unspecified date "6 months ago'. There was no concomitant medication. On 21-NOV-2007 the patient experienced a seizure after receiving her third dose of Gardasil. Medical attention was sought. On an unspecified date a magnetic resonance imaging (MRI), computed axial tomography (CT SCAN) and an electroencephalography (EEG) was performed. The results were unknown. On an unspecified date the patient had recovered. The reporter felt seizure was considered to be immediately life-threatening, other medical event (OME) and disabling. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Arrhythmia, Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a health professional concerning approximately 20 patients who were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #658673/0990U).  Subsequently, the patient's experienced swelling and pain at the injection site, fever, chills and severe arrhythmia.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  A lot check has been requested.  Swelling at injection site, pain at injection site, fever, chills and severe arrhythmia were considered to be disabling.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Arrhythmia, Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a health professional concerning approximately 20 patients who were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #659148/1382U).  Subsequently, the patient's experienced swelling and pain at the injection site, fever, chills and severe arrhythmia.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  A lot check has been requested.  Swelling at injection site, pain at injection site, fever, chills and severe arrhythmia were considered to be disabling.  Additional information has been requested.
Sex: F
Vaccine: HIBV
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Information has been received from a consumer concerning his daughter (age not given) who a month ago (exact date not reported), was vaccinated (route and site not reported) with Hib conj vaccine (OMPC) (lot # not reported).  The patient's father reported that a day after receiving the vaccine the patient developed a high fever and could not breathe.  The patient was admitted to the hospital and stayed there for 2 weeks.  The father reported that the patient now has to do many treatments for breathing.  The patient's father did not want to answer any other questions and disconnected from the phone call.  At the time of reporting the patient's outcome was not reported.  Additional information has been requested.
Age: 1.29
Sex: F
Vaccine: FLU3, HIBV, PNC
Symptoms: Bronchoscopy, Coma, Computerised tomogram head, Convulsion, Cyanosis
Clinical narrative: Information has been received from a physician concerning a 15 month old female with no pertinent medical history or drug reactions/allergies who on 23-OCT-2006 was vaccinated with a first dose of Hib conj vaccine (OMPC). On 18-DEC-2006, the patient was vaccinated with a second dose of ACTHIB. On 02-MAR-2007, the patient was vaccinated with a third dose of Hib conj vaccine (OMPC). Following the first three doses, the patient had no adverse side effects. On 13-DEC-2007, the patient was vaccinated with a fourth dose of PedvaxHIB (lot# 657387/0995U). Concomitant therapy included influenza virus vaccine (unspecified) and Prevnar. On 13-DEC-2007 after receiving the three vaccines the patient did not have any problems or adverse side effects. Later that same day, at approximately 6:30 PM, the father saw the child chewing on a glass Christmas ornament. He removed the ornament from the child's mouth. As he did so, he saw glass fragments in the child's mouth and he reported that he believes that he removed all of these fragments. The child then took a nap. When the child woke up, her lips were blue but then the lips turned back to a normal pink. Subsequently, the family took a trip by car. With the child in a car seat, the child began drooling and her eyes began to roll. The child appeared to be having a seizure. The child was taken to the emergency department of a local hospital and subsequently transported to a regional hospital. The child continued to have seizures. The child was incubated on a respirator and medically sedated. Presently, the child is still hospitalized in the ICU in a medically induced coma. Some blood was found in the child's stomach. Many tests have been done. This included a CAT scan of the head, blood tests, lumbar puncture, endoscopy and bronchoscopy. To date the test results have been negative. The reporter felt that lips turned blue, inappropriate schedule, seizure, medically induced coma, blood in the stomach all required hospitalization and were considered to be life threatening, disabling and an other medical event (OME). Additional information has been requested. 4/9/08-records received for DOS 12/13-12/14/07-presented after possibly ingesting a crystal ornament at home. Day of vaccination began with tonic-clonic seizure febrile, eyes deviated, drooling, tremulousness of hand. Intubated.
Age: 1.29
Sex: F
Vaccine: FLU3, HIBV, PNC
Symptoms: Drooling, Endoscopy, Gastrointestinal haemorrhage, Gaze palsy, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 15 month old female with no pertinent medical history or drug reactions/allergies who on 23-OCT-2006 was vaccinated with a first dose of Hib conj vaccine (OMPC). On 18-DEC-2006, the patient was vaccinated with a second dose of ACTHIB. On 02-MAR-2007, the patient was vaccinated with a third dose of Hib conj vaccine (OMPC). Following the first three doses, the patient had no adverse side effects. On 13-DEC-2007, the patient was vaccinated with a fourth dose of PedvaxHIB (lot# 657387/0995U). Concomitant therapy included influenza virus vaccine (unspecified) and Prevnar. On 13-DEC-2007 after receiving the three vaccines the patient did not have any problems or adverse side effects. Later that same day, at approximately 6:30 PM, the father saw the child chewing on a glass Christmas ornament. He removed the ornament from the child's mouth. As he did so, he saw glass fragments in the child's mouth and he reported that he believes that he removed all of these fragments. The child then took a nap. When the child woke up, her lips were blue but then the lips turned back to a normal pink. Subsequently, the family took a trip by car. With the child in a car seat, the child began drooling and her eyes began to roll. The child appeared to be having a seizure. The child was taken to the emergency department of a local hospital and subsequently transported to a regional hospital. The child continued to have seizures. The child was incubated on a respirator and medically sedated. Presently, the child is still hospitalized in the ICU in a medically induced coma. Some blood was found in the child's stomach. Many tests have been done. This included a CAT scan of the head, blood tests, lumbar puncture, endoscopy and bronchoscopy. To date the test results have been negative. The reporter felt that lips turned blue, inappropriate schedule, seizure, medically induced coma, blood in the stomach all required hospitalization and were considered to be life threatening, disabling and an other medical event (OME). Additional information has been requested. 4/9/08-records received for DOS 12/13-12/14/07-presented after possibly ingesting a crystal ornament at home. Day of vaccination began with tonic-clonic seizure febrile, eyes deviated, drooling, tremulousness of hand. Intubated.
Age: 1.29
Sex: F
Vaccine: FLU3, HIBV, PNC
Symptoms: Laboratory test, Lumbar puncture
Clinical narrative: Information has been received from a physician concerning a 15 month old female with no pertinent medical history or drug reactions/allergies who on 23-OCT-2006 was vaccinated with a first dose of Hib conj vaccine (OMPC). On 18-DEC-2006, the patient was vaccinated with a second dose of ACTHIB. On 02-MAR-2007, the patient was vaccinated with a third dose of Hib conj vaccine (OMPC). Following the first three doses, the patient had no adverse side effects. On 13-DEC-2007, the patient was vaccinated with a fourth dose of PedvaxHIB (lot# 657387/0995U). Concomitant therapy included influenza virus vaccine (unspecified) and Prevnar. On 13-DEC-2007 after receiving the three vaccines the patient did not have any problems or adverse side effects. Later that same day, at approximately 6:30 PM, the father saw the child chewing on a glass Christmas ornament. He removed the ornament from the child's mouth. As he did so, he saw glass fragments in the child's mouth and he reported that he believes that he removed all of these fragments. The child then took a nap. When the child woke up, her lips were blue but then the lips turned back to a normal pink. Subsequently, the family took a trip by car. With the child in a car seat, the child began drooling and her eyes began to roll. The child appeared to be having a seizure. The child was taken to the emergency department of a local hospital and subsequently transported to a regional hospital. The child continued to have seizures. The child was incubated on a respirator and medically sedated. Presently, the child is still hospitalized in the ICU in a medically induced coma. Some blood was found in the child's stomach. Many tests have been done. This included a CAT scan of the head, blood tests, lumbar puncture, endoscopy and bronchoscopy. To date the test results have been negative. The reporter felt that lips turned blue, inappropriate schedule, seizure, medically induced coma, blood in the stomach all required hospitalization and were considered to be life threatening, disabling and an other medical event (OME). Additional information has been requested. 4/9/08-records received for DOS 12/13-12/14/07-presented after possibly ingesting a crystal ornament at home. Day of vaccination began with tonic-clonic seizure febrile, eyes deviated, drooling, tremulousness of hand. Intubated.
Age: 1.6
Sex: M
Vaccine: HIBV
Symptoms: Musculoskeletal stiffness, Pyrexia, Rash generalised, X-ray
Clinical narrative: Information has been received from the father of a 19 month old male with no medical history and no known allergies who on 10-NOV-2007 was vaccinated with a dose of PedvaxHIB (Lot# 656519/0259U). On 27-NOV-2007, 17 days post vaccination the patient experienced a stiff neck, high fever and developed rashes all over his body. The patient was admitted to the hospital for one day but the physicians did not determine what caused the sickness. On 28-NOV-2007 the patient was discharged from the hospital. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.  12/28/07 Reviewed hospital ER medical records of 12/05/2007 which reveal patient experienced fever & irritability x 2 days.  Saw pcp who found patient unable to extend neck.  Sent to ER to r/o retropharyngeal abscess due to tonsillar & oropharynx erythema.    Tx w/oral antibiotics. FINAL ER DX: fever & otitis media.
Sex: M
Vaccine: HEP
Symptoms: Demyelination, Eye pain, Familial risk factor, Gene mutation identification test positive, HLA marker study
Clinical narrative: Information has been received regarding a case in litigation concerning a male who was vaccinated with hepatitis B virus vaccine rHBsAg (yeast).  Within weeks of a vaccination with hepatitis B virus vaccine rHBsAg (yeast) the patient developed numbness of his right thigh which was reported to be the signaling of the onset of multiple sclerosis (MS), "placing the timing within what was considered accepted for causation of a demyelinating injury".  It was reported that, at an undisclosed time, the patient had undergone human leukocyte antigen (HLA) typing which noted that he was prone to developing MS.  It was reported that the patient had two types of genetic problems making him susceptible to developing MS, Tr at 91.  In addition the patient's mother has had autoimmune diseases, thyroid and psoriasis.  The patient was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) on 11 MAR 1997, and subsequent doses on 09 APR 1997, and 08 AUG 1997.  On 18 APR 1997 the patient complained of a swollen lymph node (unspecified location).  On 3 NOV 1997 the patient was seen by a physician regarding complaints of diminished vision in his left eye associated with pain when moving the eye.  The patient was diagnosed with mild optic retrobulbar neuritis.  On 4 NOV 1997 the patient underwent an evaluation at the division of neuro ophthalmology, and the MRI of the brain was consistent with a demyelinating process.  On 16 JUN 1998 the patient reported the thigh numbness to a neurologist.  Further information is expected.
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Lymphadenopathy, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Optic neuritis retrobulbar
Clinical narrative: Information has been received regarding a case in litigation concerning a male who was vaccinated with hepatitis B virus vaccine rHBsAg (yeast).  Within weeks of a vaccination with hepatitis B virus vaccine rHBsAg (yeast) the patient developed numbness of his right thigh which was reported to be the signaling of the onset of multiple sclerosis (MS), "placing the timing within what was considered accepted for causation of a demyelinating injury".  It was reported that, at an undisclosed time, the patient had undergone human leukocyte antigen (HLA) typing which noted that he was prone to developing MS.  It was reported that the patient had two types of genetic problems making him susceptible to developing MS, Tr at 91.  In addition the patient's mother has had autoimmune diseases, thyroid and psoriasis.  The patient was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) on 11 MAR 1997, and subsequent doses on 09 APR 1997, and 08 AUG 1997.  On 18 APR 1997 the patient complained of a swollen lymph node (unspecified location).  On 3 NOV 1997 the patient was seen by a physician regarding complaints of diminished vision in his left eye associated with pain when moving the eye.  The patient was diagnosed with mild optic retrobulbar neuritis.  On 4 NOV 1997 the patient underwent an evaluation at the division of neuro ophthalmology, and the MRI of the brain was consistent with a demyelinating process.  On 16 JUN 1998 the patient reported the thigh numbness to a neurologist.  Further information is expected.
Sex: M
Vaccine: HEP
Symptoms: Visual acuity reduced
Clinical narrative: Information has been received regarding a case in litigation concerning a male who was vaccinated with hepatitis B virus vaccine rHBsAg (yeast).  Within weeks of a vaccination with hepatitis B virus vaccine rHBsAg (yeast) the patient developed numbness of his right thigh which was reported to be the signaling of the onset of multiple sclerosis (MS), "placing the timing within what was considered accepted for causation of a demyelinating injury".  It was reported that, at an undisclosed time, the patient had undergone human leukocyte antigen (HLA) typing which noted that he was prone to developing MS.  It was reported that the patient had two types of genetic problems making him susceptible to developing MS, Tr at 91.  In addition the patient's mother has had autoimmune diseases, thyroid and psoriasis.  The patient was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) on 11 MAR 1997, and subsequent doses on 09 APR 1997, and 08 AUG 1997.  On 18 APR 1997 the patient complained of a swollen lymph node (unspecified location).  On 3 NOV 1997 the patient was seen by a physician regarding complaints of diminished vision in his left eye associated with pain when moving the eye.  The patient was diagnosed with mild optic retrobulbar neuritis.  On 4 NOV 1997 the patient underwent an evaluation at the division of neuro ophthalmology, and the MRI of the brain was consistent with a demyelinating process.  On 16 JUN 1998 the patient reported the thigh numbness to a neurologist.  Further information is expected.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus generalised, Urticaria
Clinical narrative: broke out in hives, itchness all over body, redness, swelling and warmth at site of shot.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: Intussception; reduced radiologicaly.  12/28/07 Reviewed hospital medical records which reveal patient experienced bloody stool, reduced oral intake & vomiting.  Admitted 12/25-12/26/2007.   FINAL DX: Ileocecal intussusception, enema reduced. 1/22/08 Reviewed vax record which confirms RO dose & lot as reported.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site mass, Skin nodule, Swelling, Tenderness
Clinical narrative: Severe large lump approximately 3 inches in full 360 circle on the arm. Red in color and raised approximately 1 inch. Tender to touch but very lumpy. I still to this day have a ball in the injection area. It hurts. I had hives for a few days but I took benadryl. two weeks later I called the doctor and she wanted to see me.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Complaints of severe deltoid/biceps muscle pain and c/o severe, deep pain when extending left arm laterally and above shoulder level. States Tylenol does not help pain.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Death, Pulse absent, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: At 10:30, patient assessed for contraindications for vaccine.  No contraindications, consent signed, vaccine given.  No s/d of reaction.  13:50, patient found by staff, unresponsive, no pulse, no respiration's.  MD notified.  Stated patient expired due to disease and secondary diagnosis.  6/3/08 Death certificate states COD as cardiac arrhythmia R/T atherosclerosis, atrial fibrillation, CHF & cerebrovascular disease.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Diarrhoea, Melaena, Vomiting
Clinical narrative: vomiting started after vaccine no fever for 2 days-soft stools tarry oral hydration done at hosp with Pedialyte 1/7/08-records received for DOS 12/23/07-Presented to ED with cardiac arrest. The patient was found by family in cardiac arrest, unresponsive, abdomen distended. Vomiting day before. 3/28/08-COD:Complications of a small bowel obstruction. Extensive small bowel adhesions involving the spleen, pancreas, stomach, liver and large bowel. Exucdate in patchy distribution over the surface of the small bowel, liver and retroperitoneal fat. Small bowel luminal narrowing and serosal congestion and hemorrhage. Bilateral cystic dilation of kidneys and ureters.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain lower, Agitation, Anaemia, Anxiety, Asthenia
Clinical narrative: 11/28 - pt. agitated, mental changes. 11/30 - wheezing noted in lungs, anxious, shortness of breath. 12/2 - patient moved to Critical Care unit. 12/28/07 Reviewed partial hospital medical records which reveal patient experienced lower abdominal pain x 1 mo & rectal bleed x 2 wks. Admitted 11/26- Developed cough, wheezing & SOB & dx w/hospital acquired bronchopneumonia.  Tx w/IV antibiotics.  Developed (+) c. difficele.  Later in hospitalization dx w/GBS & intubated.  Developed mild acute pancreatitis & ileus. FINAL DX: Guillain Barre syndrome. 2/11/08 Reviewed hospital medical records.  No D/C summary available. Admitted 11/26/2007-2/2/2008 when transferred to inpatient rehab.  Originally admitted for lower abdominal pain & GI bleed & was to have hemicolectomy.  Received flu shot while hospitalized then developed generalized weakness & respiratory distress. Intubated & transferred to ICU.  LE reflexes absent.  Tx w/IVIG x 2 w/some improvement.  Trach done & weaned from vent. FINAL DX: no d/c summary available but transfer H&P states: debility & Guillian Barre syndrome, recovering; hypertensive cardiovascular disese; recent acute respiratory failure s/p trach & ventilation treatment; c. diff, resolved; hypothyroidism; COPD; & generalized anxiety disorder. Patient admitted in Acute Rehab at medical center for physical and occupational therapy. Patient is still very weak. She needs assistance/supervision with walking, grooming, using bedside commode. 1/20/2010 Left with chronic disability. She needs 24 hour care/assistance. She can walk with walker but is very weak. She needs assitance bathing, cleaning, and grooming. She is on PRN Oxygen.  02/03/2010 Patient admitted in rehab for physical and occupationa therapy.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Colectomy, Dyspnoea, Endotracheal intubation, Gastrointestinal haemorrhage, Mental status changes
Clinical narrative: 11/28 - pt. agitated, mental changes. 11/30 - wheezing noted in lungs, anxious, shortness of breath. 12/2 - patient moved to Critical Care unit. 12/28/07 Reviewed partial hospital medical records which reveal patient experienced lower abdominal pain x 1 mo & rectal bleed x 2 wks. Admitted 11/26- Developed cough, wheezing & SOB & dx w/hospital acquired bronchopneumonia.  Tx w/IV antibiotics.  Developed (+) c. difficele.  Later in hospitalization dx w/GBS & intubated.  Developed mild acute pancreatitis & ileus. FINAL DX: Guillain Barre syndrome. 2/11/08 Reviewed hospital medical records.  No D/C summary available. Admitted 11/26/2007-2/2/2008 when transferred to inpatient rehab.  Originally admitted for lower abdominal pain & GI bleed & was to have hemicolectomy.  Received flu shot while hospitalized then developed generalized weakness & respiratory distress. Intubated & transferred to ICU.  LE reflexes absent.  Tx w/IVIG x 2 w/some improvement.  Trach done & weaned from vent. FINAL DX: no d/c summary available but transfer H&P states: debility & Guillian Barre syndrome, recovering; hypertensive cardiovascular disese; recent acute respiratory failure s/p trach & ventilation treatment; c. diff, resolved; hypothyroidism; COPD; & generalized anxiety disorder. Patient admitted in Acute Rehab at medical center for physical and occupational therapy. Patient is still very weak. She needs assistance/supervision with walking, grooming, using bedside commode. 1/20/2010 Left with chronic disability. She needs 24 hour care/assistance. She can walk with walker but is very weak. She needs assitance bathing, cleaning, and grooming. She is on PRN Oxygen.  02/03/2010 Patient admitted in rehab for physical and occupationa therapy.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Occupational therapy, Physical disability, Physiotherapy, Rectosigmoid cancer, Wean from ventilator
Clinical narrative: 11/28 - pt. agitated, mental changes. 11/30 - wheezing noted in lungs, anxious, shortness of breath. 12/2 - patient moved to Critical Care unit. 12/28/07 Reviewed partial hospital medical records which reveal patient experienced lower abdominal pain x 1 mo & rectal bleed x 2 wks. Admitted 11/26- Developed cough, wheezing & SOB & dx w/hospital acquired bronchopneumonia.  Tx w/IV antibiotics.  Developed (+) c. difficele.  Later in hospitalization dx w/GBS & intubated.  Developed mild acute pancreatitis & ileus. FINAL DX: Guillain Barre syndrome. 2/11/08 Reviewed hospital medical records.  No D/C summary available. Admitted 11/26/2007-2/2/2008 when transferred to inpatient rehab.  Originally admitted for lower abdominal pain & GI bleed & was to have hemicolectomy.  Received flu shot while hospitalized then developed generalized weakness & respiratory distress. Intubated & transferred to ICU.  LE reflexes absent.  Tx w/IVIG x 2 w/some improvement.  Trach done & weaned from vent. FINAL DX: no d/c summary available but transfer H&P states: debility & Guillian Barre syndrome, recovering; hypertensive cardiovascular disese; recent acute respiratory failure s/p trach & ventilation treatment; c. diff, resolved; hypothyroidism; COPD; & generalized anxiety disorder. Patient admitted in Acute Rehab at medical center for physical and occupational therapy. Patient is still very weak. She needs assistance/supervision with walking, grooming, using bedside commode. 1/20/2010 Left with chronic disability. She needs 24 hour care/assistance. She can walk with walker but is very weak. She needs assitance bathing, cleaning, and grooming. She is on PRN Oxygen.  02/03/2010 Patient admitted in rehab for physical and occupationa therapy.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: 11/28 - pt. agitated, mental changes. 11/30 - wheezing noted in lungs, anxious, shortness of breath. 12/2 - patient moved to Critical Care unit. 12/28/07 Reviewed partial hospital medical records which reveal patient experienced lower abdominal pain x 1 mo & rectal bleed x 2 wks. Admitted 11/26- Developed cough, wheezing & SOB & dx w/hospital acquired bronchopneumonia.  Tx w/IV antibiotics.  Developed (+) c. difficele.  Later in hospitalization dx w/GBS & intubated.  Developed mild acute pancreatitis & ileus. FINAL DX: Guillain Barre syndrome. 2/11/08 Reviewed hospital medical records.  No D/C summary available. Admitted 11/26/2007-2/2/2008 when transferred to inpatient rehab.  Originally admitted for lower abdominal pain & GI bleed & was to have hemicolectomy.  Received flu shot while hospitalized then developed generalized weakness & respiratory distress. Intubated & transferred to ICU.  LE reflexes absent.  Tx w/IVIG x 2 w/some improvement.  Trach done & weaned from vent. FINAL DX: no d/c summary available but transfer H&P states: debility & Guillian Barre syndrome, recovering; hypertensive cardiovascular disese; recent acute respiratory failure s/p trach & ventilation treatment; c. diff, resolved; hypothyroidism; COPD; & generalized anxiety disorder. Patient admitted in Acute Rehab at medical center for physical and occupational therapy. Patient is still very weak. She needs assistance/supervision with walking, grooming, using bedside commode. 1/20/2010 Left with chronic disability. She needs 24 hour care/assistance. She can walk with walker but is very weak. She needs assitance bathing, cleaning, and grooming. She is on PRN Oxygen.  02/03/2010 Patient admitted in rehab for physical and occupationa therapy.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Blood creatine phosphokinase increased, Blood urea increased, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms: myalgia, fever beginning 3-4 days after vaccine.  Diffuse muscle aches to presentation 12 days after vaccine. Follow-up Information 17-JAN-2008: Pt was diagnosed with salmonella sepsis
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Salmonella sepsis, White blood cell count increased
Clinical narrative: Flu like symptoms: myalgia, fever beginning 3-4 days after vaccine.  Diffuse muscle aches to presentation 12 days after vaccine. Follow-up Information 17-JAN-2008: Pt was diagnosed with salmonella sepsis
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Diarrhoea, Stool analysis normal, Ultrasound abdomen
Clinical narrative: Extreme fussiness, diarrhea.  IV fluids, abdominal U/S. 1/16/08-records received for DOS 12/2/07-Seen in ED for C/O fussy, frequent small stools since 11/28/07 however on 12/2/07 only 1 stool moderate mucous yellow accompanied by screaming unconsolably. Five day HX of colicky abdominal pain. Straining with stools, constipated. Hellow like stools no heatochezia. Hyper active bowel sounds. Admitted overnight for observation
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea, Photophobia, Vomiting
Clinical narrative: Nausea, vomiting, dizziness within 1 hour of receiving hepatitis B vaccine.  Also headache, light sensitive.  Symptoms lasted approximately 24 hrs.  1/4/08 Reviewed hospital medical records which reveal patient experienced nausea, vomiting & dizziness within an hour of receiving vax.  Was on antibiotic for URI at time of vax.  TMs were clear.  Admitted 12/17-12/18/2007.  Improved w/IVF.  Had mild dizziness & nystagmus  w/moving head to the right.  D/C home w/antivert.   FINAL DX: acute labyrinthitis & adverse reaction to Hep B immunization.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 10/26/07 - Patient reports left arm "aches awful" where "flu shot was given 10 days ago."  No home intervention for pain.  No redness, swelling or discharge.  Advised ice and Tylenol as needed.  Seen by M.D. 11/1/07 for persistent pain.
Age: 2.0
Sex: F
Vaccine: DTP, HIBV, MMR, VARCEL
Symptoms: Abnormal behaviour, Aggression, Body temperature increased, Erythema, Swelling
Clinical narrative: Within 48 hours - temp 104 - behavioral changes - extremely combative - i.e. biting, hitting, yelling. (R) outer thigh - local reaction - extremely swollen, red.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Haematocrit normal, Haemoglobin normal, Injection site pain, White blood cell count normal
Clinical narrative: On 10/29/07 pt reported to PCP office left arm very sore after receiving flu & pneumonia vaccines 10/25/07.  Was seen in ER at hospital 10/27/07 for symptoms.  Pain improving 10/29/07.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Haematocrit normal, Haemoglobin normal, Pain in extremity, White blood cell count
Clinical narrative: Severe pain started in right arm the night vaccine was given.  Could not sleep.  Pain described as "in agony".  Missed work the following day.  Seen in emergency room 10/27/07 for pain, office visit 10/29/07 for pain and 11/07/07.  Interventions included ice to affected area.  Tylenol, Motrin, Percocet and Vicodin for pain.  None helped.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: X-ray limb abnormal
Clinical narrative: Severe pain started in right arm the night vaccine was given.  Could not sleep.  Pain described as "in agony".  Missed work the following day.  Seen in emergency room 10/27/07 for pain, office visit 10/29/07 for pain and 11/07/07.  Interventions included ice to affected area.  Tylenol, Motrin, Percocet and Vicodin for pain.  None helped.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Incorrect dose administered, Medication error
Clinical narrative: No symptoms or problems but client received 2 influenza vaccines, 2 separate arms at same time during vaccination clinic by 2 nurses.  Vaccines were marked correctly but 1 flu vaccine was set up for sibling.  Both nurses grabbed flu shot, gave at same time.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Eosinophil count abnormal, Eye swelling, Headache, Myalgia, Pallor
Clinical narrative: About 36 hr after injection, felt feverish, myalgias, headache.  Had exam 12/6/07.  Red, blanching macular rash & facial/periorbital swelling started 12/9/07 & hives.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Pyrexia, Rash erythematous, Rash macular, Swelling face, Urticaria
Clinical narrative: About 36 hr after injection, felt feverish, myalgias, headache.  Had exam 12/6/07.  Red, blanching macular rash & facial/periorbital swelling started 12/9/07 & hives.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: White blood cell count normal
Clinical narrative: About 36 hr after injection, felt feverish, myalgias, headache.  Had exam 12/6/07.  Red, blanching macular rash & facial/periorbital swelling started 12/9/07 & hives.
Age: 19.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Erythema, Local reaction, Oedema peripheral, Pain in extremity
Clinical narrative: Injection arm became swollen, red and painful in the upper section of the arm.  Patient went to her physician and the emergency room on 12/13/07.  Discharged with diagnosis:  "Local reaction".
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Crying, Injection site erythema, Injection site mass, Insomnia, Irritability
Clinical narrative: Crying almost nonstop, easily startled which sets off crying, very little sleep.  Knot noted in both legs, moreso in the left with small redness, no "fever' in leg noted.  Also teething without help from Orajel.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Myalgia, Pain in extremity, Weight bearing difficulty
Clinical narrative: Ibuprofen for 6 days in diminishing amounts. Very Sore muscles in shoulders and arms then in back, then legs. Within one week I was limping and unable to bear weight on left leg upon waking. Recovery 1 month
Age: 0.5
Sex: F
Vaccine: DTAP, FLU3, MMRV
Symptoms: Eye swelling, Medication error, Swelling face
Clinical narrative: Facial and eye swelling, treated with antihistamines.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site infection, Methicillin-resistant staphylococcal aureus test negative, White blood cell count
Clinical narrative: LOCAL REDNESS GREATER THAN PUNCTURE SITE WITH DISTAL STREAKING > 50 MM OBVIOUS INFECTION, SECONDARY CELLULITIS TX: SEPTRA 05, RIFAMPIN 300mg, RESOLVING
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Chills, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: Chills, felt hot, then cold - did break a sweat felt "run down", weak no fever detected (had no thermometer available) by hand on forhead 12/14/07-12/15/07 (Lasted approx. 30 hours)
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local reaction, Urticaria
Clinical narrative: Local reaction to vaccine with development of hives requiring ER visit.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Mild urticaria  Negative respiratory symptoms.  No edema. Treatment - Benadryl by mouth.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site streaking
Clinical narrative: Patient called, return call to her at 1:30pm.  No fever.  c/o bright red streak from injection site & near armpit.  Advice-take temp, 2 Tylenol & cool compress.  I returned phone call at 3:45pm, no change.  Patient did talk to her MD office, same advice given.  She was told to call me if no improvement.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule
Clinical narrative: Client stated that after receiving Tdap on 11/29/07 she developed a large, red lump on her arm.  She came into city clinic on 12/7/07 to show the lump to a nurse.  At that time the nodule was observed to be approximately 6 mm in size and located one inch below axillary notch and one inch posterior from the midline.  She stated the lump was resolving on its own.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Condition aggravated, Migraine, Vision blurred
Clinical narrative: History of migraines years ago.  After 1st HPV she had more migraines.  Some with left eye blurriness.  Not sure if related to the vaccine.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site pain, Pain
Clinical narrative: Shortly after injection, had flu like symptoms - chills, aching, fever 103 later that evening.  This morning, feels well - temperature 99.7 - area of redness at injection site 7cm x 5cm - tender to the touch.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Shortly after injection, had flu like symptoms - chills, aching, fever 103 later that evening.  This morning, feels well - temperature 99.7 - area of redness at injection site 7cm x 5cm - tender to the touch.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: 1/4" round pimple like rash at injection site occurring on 10/17/07 no pain, no fever, no drainage, no swelling.  Pt. applied antibiotic cr. & took Benadryl 25 mg at  on 10/24.  Saw Dr. on 10/26/07, Dr. reported the rash was prob from the flu vaccine.
Age: 55.0
Sex: F
Vaccine: FLU3, HEPA, TDAP, YF
Symptoms: Pain in extremity, Ultrasound abdomen, Ultrasound scan, White blood cell count
Clinical narrative: Left arm pain radiating to fingers, especially painful when raising arm over head.  Onset in 48 hours, after injections; continues to persist 1 month later.  Physical exam 1 week later - no redness, no swelling at site.  Temperature 98.4.  Patient declined f/u visit at this time (reports continued symptoms by phone).  Has been applying moist heat, massage and gentle exercise.  Still has left arm pain. Telephone follow-up to patient.  She reports pain in Left arm was completely resolved by mid-January, 2008.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: Was given 1/2 dose of Fluzone at 5 1/2 months vs 6 months.
Age: 1.4
Sex: M
Vaccine: DTAP, FLU3, PNC
Symptoms: Febrile convulsion, Full blood count, Influenza
Clinical narrative: Febrile seizure.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pt stated that she was pregnant at the time of her last set of immunizations but had not realized it at the time.  She stated after receiving the vaccines, she took a pregnancy test and learned she was "a few weeks pregnant."  She reported that she had then miscarried at 9 weeks.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cellulitis, Oedema peripheral
Clinical narrative: SWELLING IN BOTH ARMS.  MODERATE CELLULITIS IN LEFT ARM.  PRESCRIBED STEROIDS FOR TREATMENT
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthma, Chest X-ray abnormal, Cough, Ear infection, Nasopharyngitis
Clinical narrative: A cold started one day after the vaccine was given. It turned into a fever and so forth. It has been a roller coaster ride since then. She has been falling sick a number of times after that.(Fevers/ear infections probably due to school) But associated with these fevers are cough and cold. The cough stays on for a long time and does not go away. First time it stayed for 7-10 days and now it has been almost a week. Paediatrician now put her on steroids for lungs(symbicort,xopenex) and today diagnosed it as asthma. My daughter never had asthma before and she never got this cough before even in the last winter. The flumist was given on oct 8 but at that time my daughter was not diagnosed with asthma. One of the warnings on flumist handout is to avoid giving it to kids with asthma. My daughter also has eczema and food allergies. I regret getting flumist now with all these warnings abt asthma and 24 months(she was 5 months over but the warning says increased risk of wheezing for kids <24 mo) and feel that this coughing might be due to that.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A cold started one day after the vaccine was given. It turned into a fever and so forth. It has been a roller coaster ride since then. She has been falling sick a number of times after that.(Fevers/ear infections probably due to school) But associated with these fevers are cough and cold. The cough stays on for a long time and does not go away. First time it stayed for 7-10 days and now it has been almost a week. Paediatrician now put her on steroids for lungs(symbicort,xopenex) and today diagnosed it as asthma. My daughter never had asthma before and she never got this cough before even in the last winter. The flumist was given on oct 8 but at that time my daughter was not diagnosed with asthma. One of the warnings on flumist handout is to avoid giving it to kids with asthma. My daughter also has eczema and food allergies. I regret getting flumist now with all these warnings abt asthma and 24 months(she was 5 months over but the warning says increased risk of wheezing for kids <24 mo) and feel that this coughing might be due to that.
Age: 1.03
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Pt went to hospital after receiving 1 yr. vaccines possibly from DTaP vaccine given on 6/19/07. Has fever up to 105, had seizures. 2/11/08-records received for DOS 6/21/07-DX: Cough. Seen in ED presented with 3 day H/O fevers and runny nose and emesis times 1. Temp 38.2 (R). Follow-up: Have repeatedly called the nurse and she has been unsucessful in reaching the mother of the patient. The one time the nurse was able to talk to the mother, the mother didn't have the papers to give the nurse the information.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Dermatitis, Rash papular
Clinical narrative: Patient had small patch of papulosquemous dermatitis in left parascapular area of skin over back.  On 7/6/07 had Tdap vaccine and within days, localized dermatitis became wide spread over entire trunk persisting for weeks.
Age: 0.35
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Mom noticed injection area looked like a "spider bite" and advised the doctor of this.  The redness lasted approximately 10 days.  There was also a lump under the skin at the site, noticed 10/27/07.  It has resolved somewhat but a slight lump still remains. 1/8/08-reported injection site reaction occurred on the right leg.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Onset of redness, swelling at injection site 10/30/2007.  Fever 24 hours.  Redness, swelling lasted one month.  Slight "lump" remains at injection site. The reported injection site reaction occurred on the right leg.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Haematocrit decreased, Haemoglobin decreased, Lymphocyte count increased, Neutrophil percentage decreased
Clinical narrative: Patient screamed inconsolably for 3 1/2 hours starting 2 hours after vaccination.  M.D. rev. - normal exam.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Occult blood negative, Platelet count increased, White blood cell count increased
Clinical narrative: Patient screamed inconsolably for 3 1/2 hours starting 2 hours after vaccination.  M.D. rev. - normal exam.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Wrong drug administered
Clinical narrative: IM influenza vaccine was mistaken for Flumist and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Injection site induration
Clinical narrative: At site of immunization (R deltoid), 5 cm area induration, no erythema.  (Examined 12/19/2007, reaction began evening of immunization 12/17/07).
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Decreased appetite, Diarrhoea haemorrhagic, Stool analysis normal
Clinical narrative: Developed diarrhea within 1-2 of Rotateq.  Mom noted flecks of blood at home but hemeoccult done on different stools all negative.  Diarrhea persisted 2 wk with initial poor appetite but resolved without sequelae.