chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: X-ray limb
Clinical narrative: On 12/07/2006 I received the first shot for the three shot vaccine Gardasil, however, some of the vaccine was discharged and sprayed out of the syringe. For a month later I felt tired and dizzy. On 01/05/2007 I woke to chest pain and a racing heart and was transported by ambulance to the hospital with later discharge. On 01/09/2007 I passed out at my work place and again was transported by ambulance to the hospital they kept me from 01/09/2007 to 01/12/2007. While in the hospital I fainted again. They did the tilt table test and an EPS. Later that month I fainted again. Feb 12, 2007 I fainted, hitting my head and Feb 13, 2007 I fainted again. March 5, 2007 I fainted again injuring my head again and was sent to the ER and had a CT scan and X-Ray of my shoulder. March 14, 2007 fainted again resulting in a black eye. March 15th to the 20th of 2007 I was hospitalized. April 3, 2007, April 17, 2007, April 27, 2007 I fainted again. May 10, 2007 I visited a neurologist at the clinic. As well as May 14 and 15 of 2007. May 19, 2007 fainted again.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool negative, Gastrointestinal haemorrhage, Haematochezia, Occult blood negative, Parasite stool test negative
Clinical narrative: Information has been received from a physician concerning an 18-week-old female with no pertinent medical history who on 20-FEB-2007 was vaccinated with the first dose of Rotateq. On 27-APR-2007, the patient was vaccinated PO with the second 2.0 mL dose of Rotateq (Lot #655406/1114F). Concomitant vaccinations administered on 27-APR-2007 included a dose of PEDIARIX, a dose of PREVNAR and a dose of PedvaxHIB. There was no other concomitant drug therapy. On the morning of 30-APR-2007, the patient developed bloody stools. The patient was seen by the physician on that same day. A rectal examination found that the hematochezia had resolved. Stool and parasite cultures were negative x 3. At the time of this report, the patient was considered to be recovered and there had been no recurrence. Upon internal review, bloody stools was determined to be an other important medical event. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool negative, Haematochezia, Rectal examination
Clinical narrative: Information has been received from a physician concerning an 18-week-old female with no pertinent medical history who on 20-FEB-2007 was vaccinated with the first dose of Rotateq. On 27-APR-2007, the patient was vaccinated PO with the second 2.0 mL dose of Rotateq (Lot #655406/1114F). Concomitant vaccinations administered on 27-APR-2007 included a dose of PEDIARIX, a dose of PREVNAR and a dose of PedvaxHIB. There was no other concomitant drug therapy. On the morning of 30-APR-2007, the patient developed bloody stools. The patient was seen by the physician on that same day. A rectal examination found that the hematochezia had resolved. Stool and parasite cultures were negative x 3. At the time of this report, the patient was considered to be recovered and there had been no recurrence. Upon internal review, bloody stools was determined to be an other important medical event. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Influenza like illness, Urine output decreased, Viral infection, Vomiting
Clinical narrative: Vomiting; decrease urine output (adverse event) "flu-like symptoms" Versus viral infection
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Marked erythema, pain, swelling from R side of neck to just below elbow.
Age: 0.83
Sex: F
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Inappropriate schedule of drug administration, Rotavirus test positive, Vaccination failure
Clinical narrative: Information has been received from a nurse concerning a 10-month-old female who on 14-SEP-2006, 17-NOV-2006 and 22-JAN-2007 was vaccinated PO with the first (Lot #654422/0607F), second (Lot #654663/0942F) and third (Lot #655406/1114F) doses, respectively, of Rotateq. The nurse reported that on 17-MAY-2007, the patient was admitted to the hospital and tested positive for rotavirus. The patient was treated with hydration therapy. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a 2 month old male, with no medical history and no allergies, who, 'about a month ago," on approximately 16-APAR-2007, was vaccinated with a dose of Rotateq. There was no concomitant medication. "About one month ago," on approximately 16-APR-2007, the patient developed a bloody stool. The patient's bloody stool lasted overnight and was considered to be recovered by the reporter. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Upon internal review, the patient's bloody stool considered to be an other important medical event. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 6 month old female, with no medical history and no allergies, who was vaccinated with a first, second, and third oral dose of Rotateq (Lot# "1116D," 656188/1238F, and 656194/0024U) on 17-JAN-2007, 02-MAR-2007, and 15-MAY-2007, respectively. There was no concomitant medication. On 26-APR-2007 the patient was treated at the emergency room for intussusception and then released. No other symptoms were noted. Subsequently, the patient recovered. No product quality complaint was involved. the patient's intussusception was considered to be an other important medical event by the reporter. A lot check has been requested. Additional ifnormation has been requested.  06/11/2007 MR received from CDC. Hospital record for ER admit on 4/25-27/2007 for c/o vomiting x6 which began the night prior. No stool noted that day.  Also c/o fussiness and  drinking less.  PE: revealed an alert but mildly fussy infant with sunken eyes and dry mucus membranes.  HR in the 140's.  Abdomen tender with guarding. pallor noted.  Ped. surgery note 4/27 reveals infant tolerating po, voiding well, no blood noted in stools, abdomen soft and round. D/C to home. DX:  Intussusception- Air enema reduced.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dyskinesia, Heart rate decreased, Heart rate increased, Hypotension
Clinical narrative: Information has been received from a health professional, concerning a 14 year old female student, with no known drug allergies, who on 14-MAY-2007, at 3:00pm, was vaccinated IM in the left arm, with the third dose of Gardasil (Lot #657622/0388U). There was no illness at the time of vaccination. The reporter indicated that immediately after vaccination, at 3:00pm, on 14-MAY-2007 the patient "passed out and started jerking all over the shot was given" (duration of symptoms and treatment were not reported). The patient's vital signs included a blood pressure of 72/48mmHg, and a pulse of 38bpm. The reporter confirmed that the patient recovered on the same day, 14-MAY-2007. The reporter stated that the events of passed out, jerking all over, pulse very low and blood pressure very low, required medical intervention to prevent serious criteria, and were considered as an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a health professional, concerning a 14 year old female student, with no known drug allergies, who on 14-MAY-2007, at 3:00pm, was vaccinated IM in the left arm, with the third dose of Gardasil (Lot #657622/0388U). There was no illness at the time of vaccination. The reporter indicated that immediately after vaccination, at 3:00pm, on 14-MAY-2007 the patient "passed out and started jerking all over the shot was given" (duration of symptoms and treatment were not reported). The patient's vital signs included a blood pressure of 72/48mmHg, and a pulse of 38bpm. The reporter confirmed that the patient recovered on the same day, 14-MAY-2007. The reporter stated that the events of passed out, jerking all over, pulse very low and blood pressure very low, required medical intervention to prevent serious criteria, and were considered as an other important medical event. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Chest X-ray, Cough, Cyanosis, Dyskinesia, Flushing
Clinical narrative: Found sleeping with movements of extremities-Awoke and became stiff with some peripheral cyanosis-regained spont. breathing and became very flushed in the face with congested sound and vomited up mucus.  07/02/2007 MR received for 2 night admit 4/26-28/2007 for an episode apnea with color change and stiffening.  Parents noted large amt. of mucus in child's mouth.  PE WNL. On apnea and cardiac monitors during admission with no alarms.  Impression: ALTE: workup (-) so far.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Full blood count, Musculoskeletal stiffness, Vomiting
Clinical narrative: Found sleeping with movements of extremities-Awoke and became stiff with some peripheral cyanosis-regained spont. breathing and became very flushed in the face with congested sound and vomited up mucus.  07/02/2007 MR received for 2 night admit 4/26-28/2007 for an episode apnea with color change and stiffening.  Parents noted large amt. of mucus in child's mouth.  PE WNL. On apnea and cardiac monitors during admission with no alarms.  Impression: ALTE: workup (-) so far.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anaemia, Feeling abnormal, Leukocytosis, Thrombocythaemia, Transfusion
Clinical narrative: Fuzzy, leukocytosis, severe anemia, requiring hospitalization with RBC transfusion. Rotavirus, Pedvax, HIB and Prevnar given on 4/26/07 or 4/28/07 pm pts symptomatic with leukocytosis, anemia, thrombocytosis which gradually increased and pt finally hosp on 5/3/07.  06/04/2007 MR recieved for 4 day hospitalization 5/3-7/2007 for c/o vomiting x 3 days, watery diarrhea and decreased po intake. Seen in Ped. MD office where infant appeared weak and lethargic and a CBC revealed severe anemia.  Admitted for eval. and tx.  Required several days of IV fluids due to poor po intake and continued watery stools.  PE: c/w dehydration.  D/C DX:  Rotavirus Gastroenteritis.  Dehydration.  Anemia-improved.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Orbital oedema, Oxygen saturation normal, Skin discolouration, Wheezing
Clinical narrative: 5 minutes after Hep A And Varivax, Patient developed infra orbital edema, discoloration, and acute wheezing, with O2 sat 88%. Child given nebuliZed albuterol (2.5 mg x 2), SQ epi, nebulized pulmicort (.5mg) and po Zyrtec. Child had gradual improvement with decreased wheezing and rise in O2 sat to 96%. Child transported to local hospital by ground EMS for further care.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema and erythema in left thigh after receiving injection there. At time if follow up, left thigh was 3 " larger in circumference than right.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Injection site cellulitis, Oedema peripheral, Skin warm
Clinical narrative: Redenned swollen area, warm to touch of lower right arm just below injection site of Proquad.  "pre-cellutitis" per MD
Age: 1.0
Sex: F
Vaccine: DTPHIB, HEPA, MMRV, PNC
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Trihibit given, DTaP too soon. No reactions noted.
Age: 44.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Medication error, Pruritus, Rash, Wrong drug administered
Clinical narrative: Large pinkish-red rash--itches.  Started 24 hrs. afater injection.  Instructed to take oral benadryl and use benadryl cream.
Age: 1.58
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Pyrexia, Rash generalised, Urticaria, Vomiting
Clinical narrative: RECIEVED SHOT ON MAY 17, ON MAY 25TH STARTED TO BREAK-OUT IN RED BUMPS OVER ENTIRE BODY. GOT WORSE ON SATURDAY MAY 26 - HAD FEVER AND THREW UP. ON MAY 29TH BETTER, BUT STILL HAS RASH( RIVES OVER ENTIRE BODY. MOM TO TAKE TO DR TODAY. NO FEVER TODAY
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Anorexia, Computerised tomogram normal, Dizziness, Fatigue, Feeling hot and cold
Clinical narrative: Pt woke up on May 18th with severe headache. No improvement with Motrin. Also had nausea. Had lightheadedness when standing.  Had photophobia. Headache described as squeezing on top of head/band around head. No blurry vision. Lasted for 4 days. Went to the ER around 3AM the day after it started. Diagnosed with tension headache and sinusitis. Had negative Head CT. Was given a Z-pak and some "headache medicine" which sounded like vicodin or other narcotic. The meds helped but he required the pain med for the 4 days. He had anorexia. The smell of food made him vomit. Pain worse with sitting up. Was essentially incapacitated for 4 days. Had some hot and cold spells and sweats. Never got temperature reading. No diarrhea. No sore throat, no myalgias or arthralgias. Had fatigue. Feels totally fine now (5/29/07).
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Hyperhidrosis, Nausea, Photophobia, Sinusitis
Clinical narrative: Pt woke up on May 18th with severe headache. No improvement with Motrin. Also had nausea. Had lightheadedness when standing.  Had photophobia. Headache described as squeezing on top of head/band around head. No blurry vision. Lasted for 4 days. Went to the ER around 3AM the day after it started. Diagnosed with tension headache and sinusitis. Had negative Head CT. Was given a Z-pak and some "headache medicine" which sounded like vicodin or other narcotic. The meds helped but he required the pain med for the 4 days. He had anorexia. The smell of food made him vomit. Pain worse with sitting up. Was essentially incapacitated for 4 days. Had some hot and cold spells and sweats. Never got temperature reading. No diarrhea. No sore throat, no myalgias or arthralgias. Had fatigue. Feels totally fine now (5/29/07).
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Tension headache, Vomiting
Clinical narrative: Pt woke up on May 18th with severe headache. No improvement with Motrin. Also had nausea. Had lightheadedness when standing.  Had photophobia. Headache described as squeezing on top of head/band around head. No blurry vision. Lasted for 4 days. Went to the ER around 3AM the day after it started. Diagnosed with tension headache and sinusitis. Had negative Head CT. Was given a Z-pak and some "headache medicine" which sounded like vicodin or other narcotic. The meds helped but he required the pain med for the 4 days. He had anorexia. The smell of food made him vomit. Pain worse with sitting up. Was essentially incapacitated for 4 days. Had some hot and cold spells and sweats. Never got temperature reading. No diarrhea. No sore throat, no myalgias or arthralgias. Had fatigue. Feels totally fine now (5/29/07).
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: New chicken pox case, 38 year old male. Both children recieved the varicella immunization on May 15, 2007.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Oedema peripheral, Pain in extremity
Clinical narrative: Patient reports to LHD today with mild edema in ankles and feet.States that edema is greatly improved since initial onset on evening of vaccine administration.Vaccine was given between 4:30-5 pm.Patient states acute onset of edema noticed at bedtime.States swelling was enough to make legs and feet hurt.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Abasia, Blood creatine phosphokinase increased, Computerised tomogram abnormal, Cough, Demyelinating polyneuropathy
Clinical narrative: About 1 week prior to admission, patient had c/o gradually progressive neuropathy of his feet and hands along with ascending paralysis (More specifically, patient unable to ambulate, move hand, arms, and shoulders, or complete activities of daily living) following Pneumovax administration two weeks prior to admission.  Five weeks prior to admission, the patient had visited the hospital.  Upon presentation to the ED, the patient had a BP of 145/83, HR 85, Temp 98 degrees F, and pulse ox of 96% (room air).  Patient had a normal physical exam except for left upper extremity strength of 3-4/5, left/right lower extremity strength of 3/5.  The patient also had (+) neuropathy to the microfilament test.  Patient was admitted on 4/7/2007 to a general medical floor where he stayed until 4/10/2007 when he was found to have a vital capacity of 550, an extremely weak cough and paradoxical breathing.  The patient was electively intubated and transferred to the ICU for further management.  The patient treated with IVIG 35gm/day (400mg/kg) b/w 4/9/2007 and 4/13/2007 without improvement.  A short trial of corticosteroids (dexamethasone 6mg IV q6h, 4/10/2007 - 4-16/2007) was also used without improvement.  An NG tube was also placed during the patient's hospital stay.  Because the patient was not improving with the IVIG and steroid treatment regimen, the medical team transferred him on 4/19/2007 to the MICU for plasmapheresis (x 5 cycles) with a diagnosis of acute inflammatory demyelinating polyneuropathy. 7/11/07-records received from transferring facility for DOS 4/7-4/19/07- DC DX: Acute inflammatory demyelinating plymneuropathy. Transferred for plasmapheresis therapy. Essential tremor, endocarditis, status post mechanical aortic valve replacement 2000. One week history of progressively worsening neuropathy and ascending paralysis following a pneumovax two weeks prior to presentation. Elective intubation secondary to severe respiratory muscle weakness. No improvement after IVIG. Treated for pneumonia and pseudohyponatremia. 7/25/07-recods received from receiving facility for DOS 4/19-5/15/07-DC DX: Guillain Barre syndrome. Ventilatory dependent failure. Ventilator associated pneumonia. Staphylococcus communis bacteremia. Pseudomonas urinary tract infection. Depression. Atrioventricular nodal reentrant tachycardia. Chronic obstructive pulmonary disease.  Ascending paralysis treated with IVIG and high dose steroids with minimal improvement. Intubated and trached. Treated with plasmapheresis with some improvement. Discharged to long term rehabilitation facility with tube feed diet
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Electromyogram abnormal, Full blood count normal, Guillain-Barre syndrome, Immunoglobulins
Clinical narrative: About 1 week prior to admission, patient had c/o gradually progressive neuropathy of his feet and hands along with ascending paralysis (More specifically, patient unable to ambulate, move hand, arms, and shoulders, or complete activities of daily living) following Pneumovax administration two weeks prior to admission.  Five weeks prior to admission, the patient had visited the hospital.  Upon presentation to the ED, the patient had a BP of 145/83, HR 85, Temp 98 degrees F, and pulse ox of 96% (room air).  Patient had a normal physical exam except for left upper extremity strength of 3-4/5, left/right lower extremity strength of 3/5.  The patient also had (+) neuropathy to the microfilament test.  Patient was admitted on 4/7/2007 to a general medical floor where he stayed until 4/10/2007 when he was found to have a vital capacity of 550, an extremely weak cough and paradoxical breathing.  The patient was electively intubated and transferred to the ICU for further management.  The patient treated with IVIG 35gm/day (400mg/kg) b/w 4/9/2007 and 4/13/2007 without improvement.  A short trial of corticosteroids (dexamethasone 6mg IV q6h, 4/10/2007 - 4-16/2007) was also used without improvement.  An NG tube was also placed during the patient's hospital stay.  Because the patient was not improving with the IVIG and steroid treatment regimen, the medical team transferred him on 4/19/2007 to the MICU for plasmapheresis (x 5 cycles) with a diagnosis of acute inflammatory demyelinating polyneuropathy. 7/11/07-records received from transferring facility for DOS 4/7-4/19/07- DC DX: Acute inflammatory demyelinating plymneuropathy. Transferred for plasmapheresis therapy. Essential tremor, endocarditis, status post mechanical aortic valve replacement 2000. One week history of progressively worsening neuropathy and ascending paralysis following a pneumovax two weeks prior to presentation. Elective intubation secondary to severe respiratory muscle weakness. No improvement after IVIG. Treated for pneumonia and pseudohyponatremia. 7/25/07-recods received from receiving facility for DOS 4/19-5/15/07-DC DX: Guillain Barre syndrome. Ventilatory dependent failure. Ventilator associated pneumonia. Staphylococcus communis bacteremia. Pseudomonas urinary tract infection. Depression. Atrioventricular nodal reentrant tachycardia. Chronic obstructive pulmonary disease.  Ascending paralysis treated with IVIG and high dose steroids with minimal improvement. Intubated and trached. Treated with plasmapheresis with some improvement. Discharged to long term rehabilitation facility with tube feed diet
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Intensive care, International normalised ratio increased, Intubation, Lumbar puncture abnormal, Lumbar puncture normal
Clinical narrative: About 1 week prior to admission, patient had c/o gradually progressive neuropathy of his feet and hands along with ascending paralysis (More specifically, patient unable to ambulate, move hand, arms, and shoulders, or complete activities of daily living) following Pneumovax administration two weeks prior to admission.  Five weeks prior to admission, the patient had visited the hospital.  Upon presentation to the ED, the patient had a BP of 145/83, HR 85, Temp 98 degrees F, and pulse ox of 96% (room air).  Patient had a normal physical exam except for left upper extremity strength of 3-4/5, left/right lower extremity strength of 3/5.  The patient also had (+) neuropathy to the microfilament test.  Patient was admitted on 4/7/2007 to a general medical floor where he stayed until 4/10/2007 when he was found to have a vital capacity of 550, an extremely weak cough and paradoxical breathing.  The patient was electively intubated and transferred to the ICU for further management.  The patient treated with IVIG 35gm/day (400mg/kg) b/w 4/9/2007 and 4/13/2007 without improvement.  A short trial of corticosteroids (dexamethasone 6mg IV q6h, 4/10/2007 - 4-16/2007) was also used without improvement.  An NG tube was also placed during the patient's hospital stay.  Because the patient was not improving with the IVIG and steroid treatment regimen, the medical team transferred him on 4/19/2007 to the MICU for plasmapheresis (x 5 cycles) with a diagnosis of acute inflammatory demyelinating polyneuropathy. 7/11/07-records received from transferring facility for DOS 4/7-4/19/07- DC DX: Acute inflammatory demyelinating plymneuropathy. Transferred for plasmapheresis therapy. Essential tremor, endocarditis, status post mechanical aortic valve replacement 2000. One week history of progressively worsening neuropathy and ascending paralysis following a pneumovax two weeks prior to presentation. Elective intubation secondary to severe respiratory muscle weakness. No improvement after IVIG. Treated for pneumonia and pseudohyponatremia. 7/25/07-recods received from receiving facility for DOS 4/19-5/15/07-DC DX: Guillain Barre syndrome. Ventilatory dependent failure. Ventilator associated pneumonia. Staphylococcus communis bacteremia. Pseudomonas urinary tract infection. Depression. Atrioventricular nodal reentrant tachycardia. Chronic obstructive pulmonary disease.  Ascending paralysis treated with IVIG and high dose steroids with minimal improvement. Intubated and trached. Treated with plasmapheresis with some improvement. Discharged to long term rehabilitation facility with tube feed diet
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Mechanical ventilation, Metabolic function test normal, Nuclear magnetic resonance imaging abnormal, Paralysis, Plasmapheresis
Clinical narrative: About 1 week prior to admission, patient had c/o gradually progressive neuropathy of his feet and hands along with ascending paralysis (More specifically, patient unable to ambulate, move hand, arms, and shoulders, or complete activities of daily living) following Pneumovax administration two weeks prior to admission.  Five weeks prior to admission, the patient had visited the hospital.  Upon presentation to the ED, the patient had a BP of 145/83, HR 85, Temp 98 degrees F, and pulse ox of 96% (room air).  Patient had a normal physical exam except for left upper extremity strength of 3-4/5, left/right lower extremity strength of 3/5.  The patient also had (+) neuropathy to the microfilament test.  Patient was admitted on 4/7/2007 to a general medical floor where he stayed until 4/10/2007 when he was found to have a vital capacity of 550, an extremely weak cough and paradoxical breathing.  The patient was electively intubated and transferred to the ICU for further management.  The patient treated with IVIG 35gm/day (400mg/kg) b/w 4/9/2007 and 4/13/2007 without improvement.  A short trial of corticosteroids (dexamethasone 6mg IV q6h, 4/10/2007 - 4-16/2007) was also used without improvement.  An NG tube was also placed during the patient's hospital stay.  Because the patient was not improving with the IVIG and steroid treatment regimen, the medical team transferred him on 4/19/2007 to the MICU for plasmapheresis (x 5 cycles) with a diagnosis of acute inflammatory demyelinating polyneuropathy. 7/11/07-records received from transferring facility for DOS 4/7-4/19/07- DC DX: Acute inflammatory demyelinating plymneuropathy. Transferred for plasmapheresis therapy. Essential tremor, endocarditis, status post mechanical aortic valve replacement 2000. One week history of progressively worsening neuropathy and ascending paralysis following a pneumovax two weeks prior to presentation. Elective intubation secondary to severe respiratory muscle weakness. No improvement after IVIG. Treated for pneumonia and pseudohyponatremia. 7/25/07-recods received from receiving facility for DOS 4/19-5/15/07-DC DX: Guillain Barre syndrome. Ventilatory dependent failure. Ventilator associated pneumonia. Staphylococcus communis bacteremia. Pseudomonas urinary tract infection. Depression. Atrioventricular nodal reentrant tachycardia. Chronic obstructive pulmonary disease.  Ascending paralysis treated with IVIG and high dose steroids with minimal improvement. Intubated and trached. Treated with plasmapheresis with some improvement. Discharged to long term rehabilitation facility with tube feed diet
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Urine analysis abnormal, Vital capacity decreased
Clinical narrative: About 1 week prior to admission, patient had c/o gradually progressive neuropathy of his feet and hands along with ascending paralysis (More specifically, patient unable to ambulate, move hand, arms, and shoulders, or complete activities of daily living) following Pneumovax administration two weeks prior to admission.  Five weeks prior to admission, the patient had visited the hospital.  Upon presentation to the ED, the patient had a BP of 145/83, HR 85, Temp 98 degrees F, and pulse ox of 96% (room air).  Patient had a normal physical exam except for left upper extremity strength of 3-4/5, left/right lower extremity strength of 3/5.  The patient also had (+) neuropathy to the microfilament test.  Patient was admitted on 4/7/2007 to a general medical floor where he stayed until 4/10/2007 when he was found to have a vital capacity of 550, an extremely weak cough and paradoxical breathing.  The patient was electively intubated and transferred to the ICU for further management.  The patient treated with IVIG 35gm/day (400mg/kg) b/w 4/9/2007 and 4/13/2007 without improvement.  A short trial of corticosteroids (dexamethasone 6mg IV q6h, 4/10/2007 - 4-16/2007) was also used without improvement.  An NG tube was also placed during the patient's hospital stay.  Because the patient was not improving with the IVIG and steroid treatment regimen, the medical team transferred him on 4/19/2007 to the MICU for plasmapheresis (x 5 cycles) with a diagnosis of acute inflammatory demyelinating polyneuropathy. 7/11/07-records received from transferring facility for DOS 4/7-4/19/07- DC DX: Acute inflammatory demyelinating plymneuropathy. Transferred for plasmapheresis therapy. Essential tremor, endocarditis, status post mechanical aortic valve replacement 2000. One week history of progressively worsening neuropathy and ascending paralysis following a pneumovax two weeks prior to presentation. Elective intubation secondary to severe respiratory muscle weakness. No improvement after IVIG. Treated for pneumonia and pseudohyponatremia. 7/25/07-recods received from receiving facility for DOS 4/19-5/15/07-DC DX: Guillain Barre syndrome. Ventilatory dependent failure. Ventilator associated pneumonia. Staphylococcus communis bacteremia. Pseudomonas urinary tract infection. Depression. Atrioventricular nodal reentrant tachycardia. Chronic obstructive pulmonary disease.  Ascending paralysis treated with IVIG and high dose steroids with minimal improvement. Intubated and trached. Treated with plasmapheresis with some improvement. Discharged to long term rehabilitation facility with tube feed diet
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Oedema peripheral
Clinical narrative: L arm swollen 3 inches above elbow. Blister area about size of 50 cent. Instructed cold/warm compresses. Benadry prn
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Feeling hot, Loss of consciousness
Clinical narrative: Patient presented to office for dose of Tetanus Diptheria vaccine. Dose was administered intramuscularly into the left deltoid. Approximately 5 minutes post administration, patient complained of being hot to MOC, then proceeded to black out. Nurse responded immediately to find pateint in a supine position on the ground. LOC lasted 10-15 seconds. Patient was placed in the recovery position and a blood pressure was recorded as 90/44, and again 5 minutes later as 100/50. Pt recovered in office for about 30 minutes. A nurse escorted patient's mother and patient to their vehicle without incident.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Injection site pain, Nausea, Vision blurred
Clinical narrative: Patient had blurry vision and dizziness initially. Patient's BP was stable throughout. Patient continued wtih dizziness and also developed nausea, nausea, and pain at the shot site for 3-4 hours after shot given. Patient reported no symptoms after that time.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness/pain/swelling/itching at injection site 5 days after injection. Instructed to take Benadryl, apply cool compress & see PCP in am if no improvement. Manufacturer (Aventis)unable to enter in section 13.
Age: 41.0
Sex: U
Vaccine: HEPAB
Symptoms: Haemorrhage, Joint stiffness, Pain in extremity, Similar reaction on previous exposure to drug, Syncope
Clinical narrative: When the patient was contacted to come back for another dose of Hep A due to the use of single antigen and combination vaccine, she complained of having a reaction to the last shot and did not want to go through that again.  When asked about the reaction, she stated "I felt very faint and had to lay down for 4-5 minutes and I bled for 2 days after the shot and my arm was very stiff and sore for those two days also."  She went on to say she had to change the bandaid on her arm several times the next 2 days.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient received Gardasil dose #1 Friday(5/25/07) and developed pinpoint, intensely pruritic rash on thighs to knees. Did not extend up onto trunk, did not extend below knees. Presented to clinic this afternoon (first day open after holiday) with concern.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site discolouration, Musculoskeletal stiffness, Oedema peripheral, Pain in extremity
Clinical narrative: Egg sized swelling accoompanied by soreness and stiffness of upper arm. Skin over the site became black and blue. This persisted for 5 weeks although the swelling and soreness decreased over time
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity, Pain in jaw
Clinical narrative: SHE GETS A SHARP PAIN IN DIFFERENT AREAS OF HER BODY VERY SHARP LIKE A NEEDLE  IN HER LOWER JAW AND THE ARM HER SHOT WAS IN AND HER FOOT AND HER LEG DIFFERENT TIMES OF THE DAY 5 TIMES IT HAPPEN TODAY
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: 5-26-07 Tdap administered in ED. Later that day arm sore. 5-27-07 nausea, vomiting, chills, fatigue, headache 5-28-07 same symptoms. 5-29-07 fatigue headache only - feels a little better.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: 5-26-07 Tdap administered in ED. Later that day arm sore. 5-27-07 nausea, vomiting, chills, fatigue, headache 5-28-07 same symptoms. 5-29-07 fatigue headache only - feels a little better.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Rash papular
Clinical narrative: Papular rash on right hip, thorax and L inner arm since Friday (4 days) Claritin or OTC antihistamine PRN recheck if not better in one week
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling 6cm x 12cm.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Food allergy, Urticaria
Clinical narrative: On 5/22/07 rec'd vaccine. On 5/24/07 when at work and mixing cappuccino from powder (powder became aerosolized) Pt started with hives and SOB. Seen in ES and rec'd Benadryl. Pt told by allergist had "small allergy to nuts" of skin testing at cappuccino powder has nuts.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Headache
Clinical narrative: Severe HA x 24 hrs.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure decreased, Dizziness, Vision blurred
Clinical narrative: Pt c/o feeling dizzy within 5 min of being vaccinated with MCV4, pt c/o seeing blurry pt stayed on office 30 min
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Rt arm area where varicella vaccine given warm and redness noted fever of 102.2
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Sensory loss
Clinical narrative: Pain, swelling at site (R arm) and loss of sensation of fingers of R hand. Symptoms Resolved.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Lt arm were varicella vaccine given warm and redness no fever.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Rt arm area were varicella vaccine given warm and redness noted. 11cm x 7cm no fever seen by physician and antibiotics given
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 1 y/o given DTaP (IM) and ProQuad (SQ) in upper (r) arm on 5/1/07. Presents 2 d late with 9 x9 cm area of warm tender redness at vaccination site
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Induration, Pruritus, Skin warm
Clinical narrative: L arm developed large area of warm hard itchy (intense) induration
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Rt arm swollen, tender and erythematous from shoulder to elbow.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Received Tdap vaccine 5/2/07 IM into (L) arm. Woke on 5/22/07 with hives on back, chest, stomach and thigh. Resolved with Benadryl ->evaluated in office after developed hives under her eye. No fever or s/s illness. Possible reaction to Tdap. No resp distress or swelling anywhere
Age: 1.08
Sex: M
Vaccine: IPV, MMRV, PNC
Symptoms: Body temperature increased, Rash, Urticaria
Clinical narrative: Rash started on (L) leg and rapidly progressed-Parent took patient to  urgent care center-patient was given steroid injection and Benadryl. Also given 1 tsp of prednisolone x 2 doses Q 6 hr after visit. Patient also with temp 101 deg last noc. seen in office today-Dx with urticaria and prescribed Orapred 15 mg/5 ml-3ml BID x 5 days and Benadryl
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: (R) Deltoid 4 1/2 x 4 1/4 cm erythema, induration, pain onset 5/23/07 AM (L) upper arm 1 x 1 cm area mild erythema, no pain
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: 26 hr after receiving varicella vaccine at our clinic pt. c/o Red hive like reaction at injections site-very itchy, given oral Benadryl-calamine to hive like rash with some relief-to continue this until gone or if worse refer to private provider. 5-22-07 parent reports 1 hive like rash-itchy remains at injection site
Age: 0.73
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: I gave Tdap/Boostrix, when I should've given the patient Pediarix.
Age: 1.5
Sex: F
Vaccine: FLU3, HEPA, MMRV, PNC
Symptoms: Localised infection, Nodule, Rash papular, Vaccination failure, Varicella
Clinical narrative: Pt came to clinic 5-14-07 with scattered papules in different stages of progression from small papules on an erythematous base to crusted ulcerated lesions Addendum: Pt came to clinic 5-22-07 with a superinfected chicken pox lesion on (L) shoulder 2.5 x 2.5 cm firm eryth. nodule
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site warmth, Rash macular
Clinical narrative: Received Menactra 5/23/07. (R) Arm with raised Blotchy Bumps-Warm to touch
Age: 0.67
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Febrile convulsion, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Fever became 105.7 within 41 hours of shot fever (lowered) lasted a total of 3 days. Febrile seizures began with fever 33 hours after shot and repeated several times over next 2 days.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Viral DNA test positive
Clinical narrative: Pt. seen in our office on 5-22-07 and diagnosed with shingles to (R) lower extremity. Pt has numerous raised lesions to (R) LE
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Nausea, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Swollen arm, body aches, fever, nausea/vomiting and painful (Temp 101.8 deg)
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Swollen arm, body aches, fever, nausea/vomiting and painful (Temp 101.8 deg)
Age: 51.0
Sex: F
Vaccine: JEV
Symptoms: Chest discomfort, Injection site erythema, Injection site swelling, Injection site urticaria, Lip swelling
Clinical narrative: 5/10/07 Pt called with c/o chest tightness and a local reaction the size of a goose egg from her JE shot. The injection site was 'red w/a wheel in the center. Pt was referred to ER/PCP. 5/16/07 pt called to F/u stating she went to the ICC on 5/10/07 and received an epi and cortisone shot along with a breathing treatment and for Bronchospasms. Pt was also finishing a steroid dose pack and taking Zyrtec. Pt stated she had lip swelling on 5/11/07 and got injected with epi pen.
Age: 51.0
Sex: F
Vaccine: JEV
Symptoms: Local reaction
Clinical narrative: 5/10/07 Pt called with c/o chest tightness and a local reaction the size of a goose egg from her JE shot. The injection site was 'red w/a wheel in the center. Pt was referred to ER/PCP. 5/16/07 pt called to F/u stating she went to the ICC on 5/10/07 and received an epi and cortisone shot along with a breathing treatment and for Bronchospasms. Pt was also finishing a steroid dose pack and taking Zyrtec. Pt stated she had lip swelling on 5/11/07 and got injected with epi pen.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Asthma, Malaise
Clinical narrative: 1-2 weeks after vaccination patient began having multiple joint pain and exacerbation of asthma. Continues to have these problems and does not feel well at all.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Neuralgia, Pain, Swelling
Clinical narrative: MMR 12/21/06 one week later, pain, swelling. Describes - neuralgia with pain radiating distally has residual muscle defect at injection site. No medical intervention.
Age: 52.0
Sex: F
Vaccine: MU
Symptoms: Malaise, Pain, Pharyngolaryngeal pain, Pyrexia, Swelling
Clinical narrative: Fever 100, generalized aching, bilateral swelling posture cervical ncxecr el - cheelic el - complain of sore throat, malaise.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Rash generalised, Rash pruritic, Skin warm
Clinical narrative: Patient started having head to toe pruritic rash - 2 days after Hepatitis A vaccine. Follicular red papules, blanching on exam and heated in leg area genital area but where body involvement. Improved with Benadryl, no wheals. Placed patient on short course of steroids and Benadryl due to pruritis. History of eczema - mom says different.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Left arm with localize redness, swelling, tenderness feet -- shins, hands itchy, red, swollen approximately 6 hours after immunization. No SOB, seizure, fever.
Age: 1.3
Sex: M
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever up to 103 x 2 days, facial rash 2 days after time onset
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Agitation, Body temperature increased
Clinical narrative: Temperature 104.7 (oral); fussiness resolved over next 3 days nonfocal examination.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Dysaesthesia, Erythema, Oedema, Paraesthesia
Clinical narrative: Erythema/ Edema/ Paresthesia/ Dysesthesia of entire right arm. At exam erythema 31cm x 5-8cm
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever within 8 hours temperature max. 104
Age: 6.0
Sex: M
Vaccine: DTAP, HIBV, PPV, VARCEL
Symptoms: Varicella
Clinical narrative: Child developed Varicella (chickenpox) received vaccination 9-26-02
Age: 3.0
Sex: F
Vaccine: HEPA, HIBV, PPV
Symptoms: Feeling hot, Urticaria
Clinical narrative: 5/12/07 Approximately 9am, child was felt warm and was given Ibuprofen. 9PM child developed urticaria and was taken to ER medical center where she was treated with steroid and antihistamine.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Body temperature increased, Rash
Clinical narrative: Rash (dots on back and chest), increase temperature (102)
Age: 6.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Varicella vaccine given 2 days ago - today there is red, induration measuring 19 x 19cm (r) upper arm - no pain, but pruritic.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Agitation, Crying, Enema administration, Faeces hard, Haematochezia
Clinical narrative: Information has been received concerning a 21-week-old female with a history of an apnea monitor she was a full term pregnancy - mom had fever and was on antibiotics) who on 15-JAN-2007 was vaccinated PO with a first dose of Rotateq. Concomitant therapy that day included a first dose of PEDIARIX (Lot # AC21B066AA) administered IM in the left leg, a dose of ACTHIB (Lot #Z0467/2, Batch #UE972AA) administered IM in the left arm, and a dose of PREVNAR (Lot # B08657F) administered IM in the right arm. At the time of vaccination, the patient had rhinitis. On 12-MAR-2007, 56 days post vaccination, the child was brought to the office with hard stool and was fussy and crying with blood in stool. She was brought back to the office in the PM with 2 diapers blood stained. The diaper tested positive for blood. An xray was obtained. Intussusception could not be reduced by enema and was surgically reduced bowel viable. She was hospitalized for one day. The outcome was recovered. Follow up information received indicated that hospital medical records revealed that the patient experienced bloody stools, vomiting, lethargy, and fever. She was transferred from an outlying hospital for a higher level of car from 12-MAR-2007 through 17-MAR-2007. Laboratory data included: WBC=18.1, segs=62; lymphs=2; bands=2; barium enema confirmed IT through descending colon - able to reduce to ileocecal valve only. She was given IM fluids and antibiotics, and was taken to the operating room for an exploratory laparoscopy and reduction of intussusception and appendectomy. The patient progressed well and was discharged to home on 17-MAR-2007. No discharge summary was available. The final diagnosis was ileocecal intussusception, surgically reduced. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Surgery, X-ray
Clinical narrative: Information has been received concerning a 21-week-old female with a history of an apnea monitor she was a full term pregnancy - mom had fever and was on antibiotics) who on 15-JAN-2007 was vaccinated PO with a first dose of Rotateq. Concomitant therapy that day included a first dose of PEDIARIX (Lot # AC21B066AA) administered IM in the left leg, a dose of ACTHIB (Lot #Z0467/2, Batch #UE972AA) administered IM in the left arm, and a dose of PREVNAR (Lot # B08657F) administered IM in the right arm. At the time of vaccination, the patient had rhinitis. On 12-MAR-2007, 56 days post vaccination, the child was brought to the office with hard stool and was fussy and crying with blood in stool. She was brought back to the office in the PM with 2 diapers blood stained. The diaper tested positive for blood. An xray was obtained. Intussusception could not be reduced by enema and was surgically reduced bowel viable. She was hospitalized for one day. The outcome was recovered. Follow up information received indicated that hospital medical records revealed that the patient experienced bloody stools, vomiting, lethargy, and fever. She was transferred from an outlying hospital for a higher level of car from 12-MAR-2007 through 17-MAR-2007. Laboratory data included: WBC=18.1, segs=62; lymphs=2; bands=2; barium enema confirmed IT through descending colon - able to reduce to ileocecal valve only. She was given IM fluids and antibiotics, and was taken to the operating room for an exploratory laparoscopy and reduction of intussusception and appendectomy. The patient progressed well and was discharged to home on 17-MAR-2007. No discharge summary was available. The final diagnosis was ileocecal intussusception, surgically reduced. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.