chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.1
Sex: M
Vaccine: HEPA, MMR
Symptoms: Rhinorrhoea, Roseola, Wheezing
Clinical narrative: 7 Days after receiving the shot he had a fever for three days of 102.8, on day 10 it was followed by a flat, red, rash over his body and face. It first started on his face, then spread. His eyes were sunken in and his skin turned pastey. He had no appetite for about 2 weeks. He then developed a runny nose and cough. He sounds like he is wheezing at times when he breathes , and his cough is deep and loud, at times choking. He also has been really irritable, which was not like him at all. Everyone that knows him, has remarked how he is not himself for the past few weeks. On the 18th, we went to Urgent Care, where Dr. said that it was Roseola, and not contributed to the shots at all. I called our son's PCP on Monday the 21st, and they said that they got his records from the Urgent Care and that they did not need to see him. I followed up with them again though later that week on June 22nd, he had started coughing really deep in his chest and was running a fever still of 102.4. This had continued off and on since the first onset June 18th. The rash had disappered on the 22nd, though. At the time that we returned on June 27th, I had them send him for immune tests per my request. We are still waiting for the results as of June 3rd. I have called them everyday this week.The office that we visited on the 18th for urgent care with Dr. was Urgent Care Center. In addition, I do not recall ever been given a form to sign about the shots that were given, or given literature on them from Dr.'s office. Their office was not concerned of it being a reaction initially, and then on the 27th said it was possible (Dr. was out, but the female doctor said it had happened to one out of the two of her kids). I don't recall her name, but she is the only female physician there.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope following administration of immunization.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope following administration of immunization.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Gait disturbance, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Mild swelling to right thigh day after administration. Second day after administration, itching sensation to right thigh, which child scratched. There was increased swelling and redness to right thigh. Child's mother adminsitered Tylenol PRN and placed cold compresses to site. At doctor's visit: right thigh swelling, skin tightness, and warmth noted. Temp 98.2F oral. Child walks with guarding and slight limp to right leg. Bactrim antibiotic course for 7 days provided. To take Tylenol PRN for pain. Discussed severe reactions and to go to ED if they occur. Stressed not to scratch right thigh.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activated partial thromboplastin time, Ammonia increased, Antithrombin III increased, Blood lactic acid normal, C-reactive protein increased
Clinical narrative: 14 year old (previously health) (no recent history of URIs or trauma)- History significant for fact that she received Gardasil at clinic on 6/27/08 (2nd dose- first dose in April 2008)- On 6/28/08 patient with acute onset severe headache, left arm pain(paralysis)- leading to parents to call 911- by the time ambulance arrived patient with flaccid paralysis and asystolic event in ambulance requiring atropine IV-- currently in ICU with bilateral upper and lower extremity paralysis and respiratory failure (ventilated)-- diagnosed with : classic transverse myelitis currently of unknown etiology8/28/08-records received-presented to ED on 6/28/08 with acute onset of flaccid paralysis, sudden onset of severe headache on day of presentation followed by arm pain. Shortly thereafter lost tone in all extremities. Intubated in field and went into asystole. Placed on ventilator. Hospital course complicated by right sided pleural effusion and pneumothorax requiring placement of chest tube. DX with aspiration pneumonia. Nasogastric tube insertion. Unable to be extubated. Respiratory alkalosis. Plasmapheresis. PE on 7/7/08 no change since admission. Dyspnea. DX:transverse myelitis of unknown etiology, intubated secondary to respiratory failure with persistent sensation of air hunger. 9/10/08-DC Summary received for DOS 6/28-8/7/08- DX:Transverse myelitis. Plasmapheresis. Etiology of transverse myelitis was negative.  Re-developed temperature and deep touch sensation in extremities, three weeks after event regained deep tendon reflexes and positive Babinski sign bilaterally. Neuropathic pain. Tracheostomy and mechanical ventilation. Asystole of unknown etiology. Transferred to rehabilitation facility.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: CSF culture negative, CSF glucose increased, CSF protein increased, CSF protein normal, Cardiac arrest
Clinical narrative: 14 year old (previously health) (no recent history of URIs or trauma)- History significant for fact that she received Gardasil at clinic on 6/27/08 (2nd dose- first dose in April 2008)- On 6/28/08 patient with acute onset severe headache, left arm pain(paralysis)- leading to parents to call 911- by the time ambulance arrived patient with flaccid paralysis and asystolic event in ambulance requiring atropine IV-- currently in ICU with bilateral upper and lower extremity paralysis and respiratory failure (ventilated)-- diagnosed with : classic transverse myelitis currently of unknown etiology8/28/08-records received-presented to ED on 6/28/08 with acute onset of flaccid paralysis, sudden onset of severe headache on day of presentation followed by arm pain. Shortly thereafter lost tone in all extremities. Intubated in field and went into asystole. Placed on ventilator. Hospital course complicated by right sided pleural effusion and pneumothorax requiring placement of chest tube. DX with aspiration pneumonia. Nasogastric tube insertion. Unable to be extubated. Respiratory alkalosis. Plasmapheresis. PE on 7/7/08 no change since admission. Dyspnea. DX:transverse myelitis of unknown etiology, intubated secondary to respiratory failure with persistent sensation of air hunger. 9/10/08-DC Summary received for DOS 6/28-8/7/08- DX:Transverse myelitis. Plasmapheresis. Etiology of transverse myelitis was negative.  Re-developed temperature and deep touch sensation in extremities, three weeks after event regained deep tendon reflexes and positive Babinski sign bilaterally. Neuropathic pain. Tracheostomy and mechanical ventilation. Asystole of unknown etiology. Transferred to rehabilitation facility.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cold agglutinins, Computerised tomogram normal, Electrocardiogram normal, HIV antibody negative, Headache
Clinical narrative: 14 year old (previously health) (no recent history of URIs or trauma)- History significant for fact that she received Gardasil at clinic on 6/27/08 (2nd dose- first dose in April 2008)- On 6/28/08 patient with acute onset severe headache, left arm pain(paralysis)- leading to parents to call 911- by the time ambulance arrived patient with flaccid paralysis and asystolic event in ambulance requiring atropine IV-- currently in ICU with bilateral upper and lower extremity paralysis and respiratory failure (ventilated)-- diagnosed with : classic transverse myelitis currently of unknown etiology8/28/08-records received-presented to ED on 6/28/08 with acute onset of flaccid paralysis, sudden onset of severe headache on day of presentation followed by arm pain. Shortly thereafter lost tone in all extremities. Intubated in field and went into asystole. Placed on ventilator. Hospital course complicated by right sided pleural effusion and pneumothorax requiring placement of chest tube. DX with aspiration pneumonia. Nasogastric tube insertion. Unable to be extubated. Respiratory alkalosis. Plasmapheresis. PE on 7/7/08 no change since admission. Dyspnea. DX:transverse myelitis of unknown etiology, intubated secondary to respiratory failure with persistent sensation of air hunger. 9/10/08-DC Summary received for DOS 6/28-8/7/08- DX:Transverse myelitis. Plasmapheresis. Etiology of transverse myelitis was negative.  Re-developed temperature and deep touch sensation in extremities, three weeks after event regained deep tendon reflexes and positive Babinski sign bilaterally. Neuropathic pain. Tracheostomy and mechanical ventilation. Asystole of unknown etiology. Transferred to rehabilitation facility.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Intensive care, International normalised ratio, International normalised ratio increased, Mechanical ventilation, Mycoplasma serology
Clinical narrative: 14 year old (previously health) (no recent history of URIs or trauma)- History significant for fact that she received Gardasil at clinic on 6/27/08 (2nd dose- first dose in April 2008)- On 6/28/08 patient with acute onset severe headache, left arm pain(paralysis)- leading to parents to call 911- by the time ambulance arrived patient with flaccid paralysis and asystolic event in ambulance requiring atropine IV-- currently in ICU with bilateral upper and lower extremity paralysis and respiratory failure (ventilated)-- diagnosed with : classic transverse myelitis currently of unknown etiology8/28/08-records received-presented to ED on 6/28/08 with acute onset of flaccid paralysis, sudden onset of severe headache on day of presentation followed by arm pain. Shortly thereafter lost tone in all extremities. Intubated in field and went into asystole. Placed on ventilator. Hospital course complicated by right sided pleural effusion and pneumothorax requiring placement of chest tube. DX with aspiration pneumonia. Nasogastric tube insertion. Unable to be extubated. Respiratory alkalosis. Plasmapheresis. PE on 7/7/08 no change since admission. Dyspnea. DX:transverse myelitis of unknown etiology, intubated secondary to respiratory failure with persistent sensation of air hunger. 9/10/08-DC Summary received for DOS 6/28-8/7/08- DX:Transverse myelitis. Plasmapheresis. Etiology of transverse myelitis was negative.  Re-developed temperature and deep touch sensation in extremities, three weeks after event regained deep tendon reflexes and positive Babinski sign bilaterally. Neuropathic pain. Tracheostomy and mechanical ventilation. Asystole of unknown etiology. Transferred to rehabilitation facility.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myelitis transverse, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain, Pain in extremity, Paralysis
Clinical narrative: 14 year old (previously health) (no recent history of URIs or trauma)- History significant for fact that she received Gardasil at clinic on 6/27/08 (2nd dose- first dose in April 2008)- On 6/28/08 patient with acute onset severe headache, left arm pain(paralysis)- leading to parents to call 911- by the time ambulance arrived patient with flaccid paralysis and asystolic event in ambulance requiring atropine IV-- currently in ICU with bilateral upper and lower extremity paralysis and respiratory failure (ventilated)-- diagnosed with : classic transverse myelitis currently of unknown etiology8/28/08-records received-presented to ED on 6/28/08 with acute onset of flaccid paralysis, sudden onset of severe headache on day of presentation followed by arm pain. Shortly thereafter lost tone in all extremities. Intubated in field and went into asystole. Placed on ventilator. Hospital course complicated by right sided pleural effusion and pneumothorax requiring placement of chest tube. DX with aspiration pneumonia. Nasogastric tube insertion. Unable to be extubated. Respiratory alkalosis. Plasmapheresis. PE on 7/7/08 no change since admission. Dyspnea. DX:transverse myelitis of unknown etiology, intubated secondary to respiratory failure with persistent sensation of air hunger. 9/10/08-DC Summary received for DOS 6/28-8/7/08- DX:Transverse myelitis. Plasmapheresis. Etiology of transverse myelitis was negative.  Re-developed temperature and deep touch sensation in extremities, three weeks after event regained deep tendon reflexes and positive Babinski sign bilaterally. Neuropathic pain. Tracheostomy and mechanical ventilation. Asystole of unknown etiology. Transferred to rehabilitation facility.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paralysis flaccid, Protein S normal, Protein total increased, Red blood cell sedimentation rate decreased, Red blood cells CSF positive
Clinical narrative: 14 year old (previously health) (no recent history of URIs or trauma)- History significant for fact that she received Gardasil at clinic on 6/27/08 (2nd dose- first dose in April 2008)- On 6/28/08 patient with acute onset severe headache, left arm pain(paralysis)- leading to parents to call 911- by the time ambulance arrived patient with flaccid paralysis and asystolic event in ambulance requiring atropine IV-- currently in ICU with bilateral upper and lower extremity paralysis and respiratory failure (ventilated)-- diagnosed with : classic transverse myelitis currently of unknown etiology8/28/08-records received-presented to ED on 6/28/08 with acute onset of flaccid paralysis, sudden onset of severe headache on day of presentation followed by arm pain. Shortly thereafter lost tone in all extremities. Intubated in field and went into asystole. Placed on ventilator. Hospital course complicated by right sided pleural effusion and pneumothorax requiring placement of chest tube. DX with aspiration pneumonia. Nasogastric tube insertion. Unable to be extubated. Respiratory alkalosis. Plasmapheresis. PE on 7/7/08 no change since admission. Dyspnea. DX:transverse myelitis of unknown etiology, intubated secondary to respiratory failure with persistent sensation of air hunger. 9/10/08-DC Summary received for DOS 6/28-8/7/08- DX:Transverse myelitis. Plasmapheresis. Etiology of transverse myelitis was negative.  Re-developed temperature and deep touch sensation in extremities, three weeks after event regained deep tendon reflexes and positive Babinski sign bilaterally. Neuropathic pain. Tracheostomy and mechanical ventilation. Asystole of unknown etiology. Transferred to rehabilitation facility.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Respiratory failure, Scan brain
Clinical narrative: 14 year old (previously health) (no recent history of URIs or trauma)- History significant for fact that she received Gardasil at clinic on 6/27/08 (2nd dose- first dose in April 2008)- On 6/28/08 patient with acute onset severe headache, left arm pain(paralysis)- leading to parents to call 911- by the time ambulance arrived patient with flaccid paralysis and asystolic event in ambulance requiring atropine IV-- currently in ICU with bilateral upper and lower extremity paralysis and respiratory failure (ventilated)-- diagnosed with : classic transverse myelitis currently of unknown etiology8/28/08-records received-presented to ED on 6/28/08 with acute onset of flaccid paralysis, sudden onset of severe headache on day of presentation followed by arm pain. Shortly thereafter lost tone in all extremities. Intubated in field and went into asystole. Placed on ventilator. Hospital course complicated by right sided pleural effusion and pneumothorax requiring placement of chest tube. DX with aspiration pneumonia. Nasogastric tube insertion. Unable to be extubated. Respiratory alkalosis. Plasmapheresis. PE on 7/7/08 no change since admission. Dyspnea. DX:transverse myelitis of unknown etiology, intubated secondary to respiratory failure with persistent sensation of air hunger. 9/10/08-DC Summary received for DOS 6/28-8/7/08- DX:Transverse myelitis. Plasmapheresis. Etiology of transverse myelitis was negative.  Re-developed temperature and deep touch sensation in extremities, three weeks after event regained deep tendon reflexes and positive Babinski sign bilaterally. Neuropathic pain. Tracheostomy and mechanical ventilation. Asystole of unknown etiology. Transferred to rehabilitation facility.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cardiac arrest, Myelitis transverse
Clinical narrative: 14 year old (previously health) (no recent history of URIs or trauma)- History significant for fact that she received Gardasil at clinic on 6/27/08 (2nd dose- first dose in April 2008)- On 6/28/08 patient with acute onset severe headache, left arm pain(paralysis)- leading to parents to call 911- by the time ambulance arrived patient with flaccid paralysis and asystolic event in ambulance requiring atropine IV-- currently in ICU with bilateral upper and lower extremity paralysis and respiratory failure (ventilated)-- diagnosed with : classic transverse myelitis currently of unknown etiology8/28/08-records received-presented to ED on 6/28/08 with acute onset of flaccid paralysis, sudden onset of severe headache on day of presentation followed by arm pain. Shortly thereafter lost tone in all extremities. Intubated in field and went into asystole. Placed on ventilator. Hospital course complicated by right sided pleural effusion and pneumothorax requiring placement of chest tube. DX with aspiration pneumonia. Nasogastric tube insertion. Unable to be extubated. Respiratory alkalosis. Plasmapheresis. PE on 7/7/08 no change since admission. Dyspnea. DX:transverse myelitis of unknown etiology, intubated secondary to respiratory failure with persistent sensation of air hunger. 9/10/08-DC Summary received for DOS 6/28-8/7/08- DX:Transverse myelitis. Plasmapheresis. Etiology of transverse myelitis was negative.  Re-developed temperature and deep touch sensation in extremities, three weeks after event regained deep tendon reflexes and positive Babinski sign bilaterally. Neuropathic pain. Tracheostomy and mechanical ventilation. Asystole of unknown etiology. Transferred to rehabilitation facility.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: The patient came into pharmacy 2 days after vaccination was given and had a bright red, softball sized area of cellulitis.  It was very warm to the touch, and slightly swollen.  She said it began on 7/1/2008 with a small red bump, and then progressively got larger.  She visited her doctor and was given a Cephalexin.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: The patient came into pharmacy 2 days after vaccination was given and had a bright red, softball sized area of cellulitis.  It was very warm to the touch, and slightly swollen.  She said it began on 7/1/2008 with a small red bump, and then progressively got larger.  She visited her doctor and was given a Cephalexin.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Fatigue, Irritability, Muscle twitching
Clinical narrative: Vaccinations given 7/2/08 @ 11:00am. TC from mother 7/3/08 stating  that patient had become fussy and whiney @ 5:00am 7/3/08.  She then suddenly developed a temp of 106 and that her legs and arms began twithching.  Mother gave the infant Tylenol and took her to the ER.  The ER assessed and monitored and then sent home when the temp was back to 98.  Mother states that patient is just really tired now.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, PNC, PPV
Symptoms: Incorrect dose administered
Clinical narrative: Given adult dose from private stock. No reaction noted with observation by physician and parent. Parents informed of error.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Rash erythematous, Rash macular, Screaming, Vomiting
Clinical narrative: Red flat rash noted as last of 4 immunization administered (prevnar). Latex free gloves, and bandaids used as parent reported that she was allergic to latex. Rash noted immediatedly at bandaid sites and on legs, face, L arm and abdomen. Lungs clear bilaterally.  Child alert waving, cooing and making eye contact with staff.  0.05ml Epinephrine given IM in Rt. Vast. Lat. per standing order.  911 called. Child's primary physician called.  Patient & mom tranported to ER.  Mom reports that child vomited in ER, screamed and had a fever of 100.5.  Child had an appointment at primary's office on 7-2-08.  At this time primary physician is awaiting ER report.  As of 7-2 rash had faded almost completely.  Mom reports a little blotchy rash on back remains.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Upper respiratory tract infection
Clinical narrative: Pt reported flu like symptoms and Upper respiratory symptomsafter receiving Gardasil lot#0279x exp10-23-2010
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Appendicectomy, Computerised tomogram abnormal, Explorative laparotomy, Small intestinal obstruction, Vomiting
Clinical narrative: presented to ER on 06/20/2008, admitted for vomiting x 3 days, was previously seen by primary doctor. admitted by our service for IV fluids, was found to have Intussusception via CT scan, had exploratory laparotomy with reduction of intussusceptum, appendectomy and small bowel obsruction.  7/8/08 Reviewed hospital medical records of 6/20-6/25/2008. FINAL DX: no d/c summary available.  Ileocolic intussusception, appendectomy & small bowel obstruction, exp laparotomy, small bowel resection per operative report. Records reveal patient experienced vomiting x 2.5 days, tiredness.  Taken to OR where IS was reduced & small bowel resection done due to ischemic gangrenous appearance.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Pyrexia, Rash, Rash erythematous, Vaccine positive rechallenge
Clinical narrative: Patient developed red dot-like rash on abdomen,chest and back. No rash on arms or legs or face.  States had fever, but is controlling it with Tylenol. Fussiness noted.  No loss of appetite.  Had similar reaction after same vaccines in May, but was not reported. Called physician who advised Benadryl and tylenol, but was not seen.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema
Clinical narrative: LARGE AREA OF REDNESS ON LEFT ARM.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Varicella zoster serology negative
Clinical narrative: On night of the day after administration (about 30 hours after administration), area of injection became red, swollen and itchy.  States at that time area was "larger than a quarter."  Today returned to our site (48 hours after immunization).  The site, which is reddened, swollen and warm to the touch, measures 7cm x 9.5cm.  C/o itching in area.  Denies fever, nausea, pain.  Denies allergies except for hay fever.  Has not taken any medications.  States that as a child she remembers having had chicken pox; however, when varicella titer was drawn for school requirement, titer was "low" and school told her to receive Varicella Vaccine.  We instructed patient to purchase and take benadryl tablets and to SMA if area worsens or if she feels worse in any way.
Age: 77.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Headache, Hypoaesthesia, Lymphadenopathy, Muscular weakness
Clinical narrative: 5/17 Crushing Headache, Fever, Sore Jaw and Neck, Swollen Glands 5/20 Joint Pain, 6/05 Jaw and neck get worse. 6/07 Lower Legs and Arms become numb. Legs become weak and shaky.
Age: 77.0
Sex: F
Vaccine: TD
Symptoms: Neck pain, Pain in jaw, Pyrexia, Tremor
Clinical narrative: 5/17 Crushing Headache, Fever, Sore Jaw and Neck, Swollen Glands 5/20 Joint Pain, 6/05 Jaw and neck get worse. 6/07 Lower Legs and Arms become numb. Legs become weak and shaky.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: 3-4 cm warmth, erythematous mass, burning sensation, pruritic at injection site of varicella.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: Fever, dizzy, "feels weird in her head", nausea, felt tired.  All this started only 1-2 after injection.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose normal, Electrocardiogram normal, Fall, Skin laceration, Suture insertion
Clinical narrative: Syncope after MENACTRA vaccine, fell and had 3 lacerations on face, sent to E.R. for stitches.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Syncope after MENACTRA vaccine, fell and had 3 lacerations on face, sent to E.R. for stitches.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse event. Patient given Tdap. This is only licensed for patients 11-64 yrs. Follow-up Information 22-JUL-2008: She did not have an adverse reaction. She is over the recommended age for this vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Induration, Pyrexia, Urticaria
Clinical narrative: Pt got a whelp associated with the DTaP.  Lt was more indurated on 6-26-08 better today 6-27-08 had some fever.  Eating & drinking well.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Child had MMR, IPV & DTaP in 6/07.  Were given again 6/08.  Parents notified.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Patient received varicella on 2-3-06 & on 6-30-08, diagnosed w/ varicella disease.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: Administered Hep A vaccination #1 on 6/30/08; on 7/01/08 pt mother called pt woke up with chest pain at 9am, the repeated fever at 930 am with possible wheezing per local average Dr advised mother to take pt to Emer RM for further evaluation.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Urine analysis, Wheezing
Clinical narrative: Administered Hep A vaccination #1 on 6/30/08; on 7/01/08 pt mother called pt woke up with chest pain at 9am, the repeated fever at 930 am with possible wheezing per local average Dr advised mother to take pt to Emer RM for further evaluation.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: L arm deltoid area with warmth/erythema and mild swelling.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: 6 3/4 x 3 3/4 area of erythema and redness, warmth treated with Augmentin (600) 6ml PO BID x 10 days.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Amyotrophic lateral sclerosis, Neurological symptom
Clinical narrative: Started with numbness in toes on left foot and then left foot drop in 9/07.  First diagnosed with spinal stenosis and pinched nerve 11/07. Diagnosed with ALS 6/6/08. Left foot is paralyzed.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Amyotrophic lateral sclerosis, Hypoaesthesia, Nerve compression, Paralysis, Peroneal nerve palsy
Clinical narrative: Started with numbness in toes on left foot and then left foot drop in 9/07.  First diagnosed with spinal stenosis and pinched nerve 11/07. Diagnosed with ALS 6/6/08. Left foot is paralyzed.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Spinal column stenosis
Clinical narrative: Started with numbness in toes on left foot and then left foot drop in 9/07.  First diagnosed with spinal stenosis and pinched nerve 11/07. Diagnosed with ALS 6/6/08. Left foot is paralyzed.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test negative, Dizziness, Headache, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Fluid and feeling of pressure in ears; shakiness/trembling; dizziness; tingling/numbness in legs; sudden sharp head pain; nausea; stiff neck. Symptoms are intermittent and unpredictable in their onset. Lasts anywhere from a day to a week. Physician refused to acknowledge that the vaccine could be a potential cause of symptoms, no treatment given.  7/21/2008 MR received from PCP from 7/10/2007 (1st HPV4) through 5/01/2008. No c/o after 1st HPV4. #2 given 11/08/07.  Seen 2/28/08 with c/o recurring URI sx, neck pain, fluid in ears with occ soreness, sinus pressure, feeling tired, lightheaded, nauseous.  Assessment:  Eustachian tube dysfunction.  allergic Rhinitis. Seen again 3/17/08 with improvement in ear plugging and congestion. HPV4 #3 given.  Returned  5/01/08 with c/o L knee pain. Assessment:  Sprained medial and collateral ligaments of L knee.  Acute meniscal tear L knee.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Paraesthesia, Tremor
Clinical narrative: Fluid and feeling of pressure in ears; shakiness/trembling; dizziness; tingling/numbness in legs; sudden sharp head pain; nausea; stiff neck. Symptoms are intermittent and unpredictable in their onset. Lasts anywhere from a day to a week. Physician refused to acknowledge that the vaccine could be a potential cause of symptoms, no treatment given.  7/21/2008 MR received from PCP from 7/10/2007 (1st HPV4) through 5/01/2008. No c/o after 1st HPV4. #2 given 11/08/07.  Seen 2/28/08 with c/o recurring URI sx, neck pain, fluid in ears with occ soreness, sinus pressure, feeling tired, lightheaded, nauseous.  Assessment:  Eustachian tube dysfunction.  allergic Rhinitis. Seen again 3/17/08 with improvement in ear plugging and congestion. HPV4 #3 given.  Returned  5/01/08 with c/o L knee pain. Assessment:  Sprained medial and collateral ligaments of L knee.  Acute meniscal tear L knee.
Age: 26.0
Sex: M
Vaccine: TTOX
Symptoms: Anaphylactic reaction, Anaphylactic shock, Chills, Hyperhidrosis, Pain
Clinical narrative: Patient received treatment of 4 stitches to right forefinger and a 0.5ml Tetanus shot at approximately 6:00PM EST on 07/03/2007 at the emergency room of the given hospital. Patient began showing symptoms of extreme pain and aches throughout the body, fever of above 100 degrees F, chills, sweating, and vomiting once at approximately 12:30AM EST on 07/04/2008. By 11:00AM EST on 07/04/2007 patient's symptoms excluding vomiting have not diminished. A prescribed antibiotic (Kflex 500mg 28ct.) is being filled, patient is drinking fluids and taking Ibuprofen 200mg x 2 every 4 hours. If symptoms persist until 6:00PM EST on 07/04, patient will go back to the emergency room. According to the reportable symptoms chart, patient is exhibiting signs of Anaphylaxis and anaphylactic shock and traces of Brachial neuritis.
Age: 26.0
Sex: M
Vaccine: TTOX
Symptoms: Pyrexia, Radiculitis brachial, Vomiting
Clinical narrative: Patient received treatment of 4 stitches to right forefinger and a 0.5ml Tetanus shot at approximately 6:00PM EST on 07/03/2007 at the emergency room of the given hospital. Patient began showing symptoms of extreme pain and aches throughout the body, fever of above 100 degrees F, chills, sweating, and vomiting once at approximately 12:30AM EST on 07/04/2008. By 11:00AM EST on 07/04/2007 patient's symptoms excluding vomiting have not diminished. A prescribed antibiotic (Kflex 500mg 28ct.) is being filled, patient is drinking fluids and taking Ibuprofen 200mg x 2 every 4 hours. If symptoms persist until 6:00PM EST on 07/04, patient will go back to the emergency room. According to the reportable symptoms chart, patient is exhibiting signs of Anaphylaxis and anaphylactic shock and traces of Brachial neuritis.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Lacrimation increased, Pain, Sinus headache
Clinical narrative: fatigue accompanied by painful cough, wheezing, difficulty producing sputum, sneezing, eye tearing, sinus headache. Symptoms abated after approximately 72 hours.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Sneezing, Sputum retention, Wheezing
Clinical narrative: fatigue accompanied by painful cough, wheezing, difficulty producing sputum, sneezing, eye tearing, sinus headache. Symptoms abated after approximately 72 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Asthenia, Irritability, Pyrexia
Clinical narrative: Fever up to 104 degrees.  Onset 1 week after MMR and DTAP were given.  Fever continued apx. 4 days.  Childrens Motrin was used to keep fever within normal range during this 4 day period.  Child was cranky/irritable and lacked energy during this period.
Age: 76.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Herpes virus infection
Clinical narrative: Patient developed a herpetic lesion on the left medial breast.
Age: 38.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Erythema multiforme, Pain in extremity, Rash
Clinical narrative: Pt received small pox vac 2 wks ago to L arm.  Yesterday he came to see me at ER b/c he had a disseminated erythema multiforme-like rash x 24hs (when he saw me.  He had no fever, no nausea, or weakness.  His only complaint was that his L arm was very, very sore.  The rash initially started on the opposite arm and moved very quickly to his left arm, neck, scalp, and forehead.  I called the CDC to see if VIG was necessary but they said that NSAIDs and Benadryl was warrented in this case as well as daily follow up to see if he develops any worsening events.
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 53 year old female patient who on 22-AUG-2007 at 3:11 pm, was vaccinated IM into the right deltoid with a first 0.5ml dose of PNEUMOVAX 23 (Lot# 656826/0308U). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid administered in a different site. On 22-AUG-2007, the patient developed pain, redness and swelling distal to the injection site of PNEUMOVAX 23. Unspecified medical attention was sought. A few weeks later in September 2007, the patient recovered. No product quality complaint was involved. The reporter considered pain, redness and swelling distal to the injection site to be other important medical events. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 24 year old female employee in the office who on 01-OCT-2007 was vaccinated subcutaneous with a first dose of pneumococcal 23v polysaccharide vaccine lot #657525/0554U. On 01-OCT-2007, after the injection the patient developed immediate itching and redness at the injection site. She still had the red area at the injection site. No other information to report. The patient was recovering. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Anxiety, Fatigue, Neurological examination normal, Syncope
Clinical narrative: Fainted after receiving shot.  Over the next two months, experienced fatigue, loss of appetite, anxiety.  With doctor's agreement, opted not to get the remaining two shots in the series.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Convulsion
Clinical narrative: She had a seizure twice one at home in her crib lasted 5mins the other at the ER in my arms lasted 3mins.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Convulsion, Laboratory test
Clinical narrative: She had a seizure twice one at home in her crib lasted 5mins the other at the ER in my arms lasted 3mins.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: This case was reported by a pharmacist and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR, ACTHIB (Sanofi Pasteur) and ROTATEQ (Merck). On 01 July 2008 at 10:00 the subject received the 2nd dose of PEDIARIX (.5 ml, unknown); the 2nd dose of PREVNAR (unknown); the 2nd dose of ACTHIB (unknown); and the 2nd dose of ROTATEQ (unknown). On 01 July 2008, less than one day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject was taken to the emergency room for unspecified symptoms. At an unspecified time on 01 July 2008, the subject died. It was unknown whether an autopsy was performed. The reporting pharmacist could not provide any further details, as he did not have the subject's medical chart at the time of this report. The pharmacist requested a search to find out if there were any other problems associated with this particular lot of PEDIARIX (Lot # AC21B143AA, expiration date February 2010).
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: This case was reported by a pharmacist and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR, ACTHIB (Sanofi Pasteur) and ROTATEQ (Merck). On 01 July 2008 at 10:00 the subject received the 2nd dose of PEDIARIX (.5 ml, unknown); the 2nd dose of PREVNAR (unknown); the 2nd dose of ACTHIB (unknown); and the 2nd dose of ROTATEQ (unknown). On 01 July 2008, less than one day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject was taken to the emergency room for unspecified symptoms. At an unspecified time on 01 July 2008, the subject died. It was unknown whether an autopsy was performed. The reporting pharmacist could not provide any further details, as he did not have the subject's medical chart at the time of this report. The pharmacist requested a search to find out if there were any other problems associated with this particular lot of PEDIARIX (Lot # AC21B143AA, expiration date February 2010).
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Respiratory arrest
Clinical narrative: This case was reported by a pharmacist and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR, ACTHIB (Sanofi Pasteur) and ROTATEQ (Merck). On 01 July 2008 at 10:00 the subject received the 2nd dose of PEDIARIX (.5 ml, unknown); the 2nd dose of PREVNAR (unknown); the 2nd dose of ACTHIB (unknown); and the 2nd dose of ROTATEQ (unknown). On 01 July 2008, less than one day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject was taken to the emergency room for unspecified symptoms. At an unspecified time on 01 July 2008, the subject died. It was unknown whether an autopsy was performed. The reporting pharmacist could not provide any further details, as he did not have the subject's medical chart at the time of this report. The pharmacist requested a search to find out if there were any other problems associated with this particular lot of PEDIARIX (Lot # AC21B143AA, expiration date February 2010).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin, Drug exposure during pregnancy, Stillbirth, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow up information has been received from a physician's assistant for the Pregnancy Registry for GARDASIL concerning a 14 year old female with no known allergies and attention deficit/hyperactivity disorder who on 15-FEB-2007 was vaccinated with GARDASIL (Lot#655165/1425F).  Concomitant therapy included CONCERTA.  On 15-MAR-2007, a urine pregnancy test revealed the patient was pregnant (LMP & EDD = approximately 28-JAN-2007 & 04-Nov-2007).  On 17-MAR-2007, a quantitative HCG showed 6-7 weeks gestation.  The patient had no symptoms and sought unspecified medical attention.  On 01-JUL-2008 the physician's assistant (PA) was informed by the patient's sister, that the patient delivered a stillborn baby "early."  The PA was given very limited information and did not know the date of delivery or estimated gestational age.  No further information is available.
Age: 23.0
Sex: F
Vaccine: JEV
Symptoms: Headache, Nuclear magnetic resonance imaging abnormal, Paraesthesia, Pituitary enlargement
Clinical narrative: Initial report received from a health care professional on 05 May 2008. A 23-year-old female patient with no known medical history received a subcutaneous injection of JE-Vax, lot number EJN232B, administered in the left arm. Two days later, on 01 May 2008, the patient complained of pins and needles in her left arm that extended to her left leg. She also complained of a headache. She was seen at an employee health center on 04 May 2008, but there were no findings. By the evening of 04 May 2008, all symptoms had resolved and the patient recovered. Follow-up information received on 30 June 2008 from the original reporter. Per the reporter, the patient had no illnesses at the time of the vaccination on 29 April 2008. It was confirmed that at the time of the vaccination the patient was taking concomitant medications of FLOVENT, ALBUTEROL, ZYRTEC, PATANOL, and VERAMYST for spring allergies. The patient had an MRI completed on 06 May 2008 that revealed an enlarged pituitary that will need further study. No demyelinating diagnosis has been made. Per the reporter, the patient did not continue the "series of vaccinations." Per this new information, this case was upgraded to serious.
Sex: F
Vaccine: RAB
Symptoms: Dysuria, Local swelling, Rash, Swelling face, Swollen tongue
Clinical narrative: Initial report received on 25 June 2008 and on 26 June 2008. The original reporter was a physician with a state department of public health. Follow-up information was received on 26 June 2008 from a physician with the state department of public health, and on 27 June 2008 from another physician with the state department of public health that was also added to this case. A female patient (demographics not provided), who is a wildlife worker had physical contact with a bat that landed on her head during the daytime hours. It was uncertain whether the patient was bitten or not. The bat was not tested. An unspecified amount of time later, the patient received one dose of IMOGAM RABIES-HT, and three doses of IMOVAX Rabies vaccine (Lot # A0485-2). The dates of vaccinations, lot number of the IMOGAM RABIES-HT, routes and sites of administration for both the IMOVAX and IMOGAM were not provided. At an unspecified amount of time after receiving the third dose of IMOVAX RABIES vaccine, the patient developed a rash, facial swelling to where she was hardly recognizable, swollen tongue, swollen groin area and genital swelling to the point she could no longer urinate. The patient sought medical evaluation at that time and was treated with oral BENADRYL which was not totally effective. There was no allergist in the patient's area and due to difficulty controlling the patient's adverse events the patient was subsequently taken to the hospital (date not reported) for treatment. Treatments received, and diagnostic tests/laboratory data performed were not provided. At the time of this report, further vaccinations with IMOVAX were being discussed, and other options were being considered. The recovery status of the patient was reported as "not recovered."
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Amniocentesis normal, Caesarean section, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Laboratory test abnormal
Clinical narrative: Information has been received from a 33 year old female physician for the Merck Pregnancy Registry for GARDASIL, with hypothyroidism and no known drug allergies, who on 01-OCT-2007 was vaccinated intramuscularly into the deltoid with a first dose of GARDASIL.  Concomitant medication included SYNTHROID.  The patient reported that her last menstrual period was 18-SEP-2007 and she ovulated and conceived 03-OCT-2007.  The patient sought unspecified medical attention with another physician.  A pregnancy test was performed.  On 17-JAN-2007 amniocentesis performed at 16 weeks reported that cytomegalovirus, enterovirus and Toxoplasma were not detected.  She went into preterm labor at 34 weeks on 18-MAY-2008 and delivered her daughter by cesarean section at 17:02, weight 400 grams.  She reported that she did not experience any other problems with her pregnancy (except an elevated Downs syndrome risk for which she had the amniocentesis).  She does not think that the vaccine had anything to do with her preterm labor.  Placenta pathology report indicates a third trimester placenta at 34 weeks gestation with subchorionic fibrin deposition and less than 5% of placental disc.  Also noted were microcalcifications, intraparenchymal hemorrhage, no acute chorioamnionitis, and a trivascular umbilical cord.  On 19-MAY-2008 the patient recovered.  No product quality complaint was involved.  Upon internal review preterm labor at 34 weeks delivering by cesarean section was considered to be an other important medical event.  Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test, Pregnancy test positive, Premature labour
Clinical narrative: Information has been received from a 33 year old female physician for the Merck Pregnancy Registry for GARDASIL, with hypothyroidism and no known drug allergies, who on 01-OCT-2007 was vaccinated intramuscularly into the deltoid with a first dose of GARDASIL.  Concomitant medication included SYNTHROID.  The patient reported that her last menstrual period was 18-SEP-2007 and she ovulated and conceived 03-OCT-2007.  The patient sought unspecified medical attention with another physician.  A pregnancy test was performed.  On 17-JAN-2007 amniocentesis performed at 16 weeks reported that cytomegalovirus, enterovirus and Toxoplasma were not detected.  She went into preterm labor at 34 weeks on 18-MAY-2008 and delivered her daughter by cesarean section at 17:02, weight 400 grams.  She reported that she did not experience any other problems with her pregnancy (except an elevated Downs syndrome risk for which she had the amniocentesis).  She does not think that the vaccine had anything to do with her preterm labor.  Placenta pathology report indicates a third trimester placenta at 34 weeks gestation with subchorionic fibrin deposition and less than 5% of placental disc.  Also noted were microcalcifications, intraparenchymal hemorrhage, no acute chorioamnionitis, and a trivascular umbilical cord.  On 19-MAY-2008 the patient recovered.  No product quality complaint was involved.  Upon internal review preterm labor at 34 weeks delivering by cesarean section was considered to be an other important medical event.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac operation, Cerebrovascular accident
Clinical narrative: Information has been received from a medical assistant concerning an approximately 15 year old female who in approximately 2007, "about a year ago," was vaccinated with a first dose of GARDASIL. On the same date experienced a stroke with unspecified symptoms. The patient was hospitalized for treatment of the stroke and underwent open heart surgery. The patient suffered a second stroke (date unspecified) subsequent to the open heart surgery. At the time of the report the patient was recovering. Additional information has been requested.  8/08/2008 MR received for DOS 8/22-9/12/2007 with D/C DX: Infective endocarditis 2' to Streptococcus sanguinis infection.  Left sided CVA 2' to embolic stroke from mitral valve thrombus.  Moderate to severe mitral valve regurgitation.  Residual R upper extremity weakness 2' to L sided CVA.   Pt presented to ER with c/o severe H/A as well as right-sided weakness, numbness, vomiting and mental status changes. Pt had had some subjective fever with chest discomfort and palpitations over the past 4 weeks. Pt now with confusion and unintelligable language. PE (+) for 3-4/5 muscle strength on R side. 3/6 holosystolic murmur. R sided toes not downgoing. Dizziness upon standing, poor short-term memory, slurred speech, blurry vision and intermittant R eye esotropia. Admitted  with dx of bacterial endocarditis and septic ebolic stroke of the L posterior cerebral artery. Concern for seizures with normal EEG. Tx with heparin/lovenox and abx via a Broviac cath with partial resolution of neuro sx. By d/c able to ambulate, but somewhat unsteady gait r/t paresthesias on the R side. Lower extremity strength returning with some residual weakness in the upper extremities.