chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: JEV
Symptoms: Abdominal pain upper, Burning sensation, Headache, Pain in extremity
Clinical narrative: The patient states she's had constant pain over her entire left arm with radiation to the upper left torso and a left sided headache since approximately 6 hours after receiving her third Japanese Encephalitis vaccine in her left arm in my office 4 days ago. She describes the pain as a constant burning sensation that seems to have worsened with time. She denies hives, rashes, erythemia, edema, sore throat or shortness of breath. She has an appointment scheduled with her family physician in a few hours and states she will get back to me after the appointment.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT RECIEVED ROUTINE 4 YEAR OLD SHOTS ON FRIDAY APRIL 25, 2008. ON MONDAY APRIL 28 MOTHER BROUGHT CHILD WITH LEFT SWOLLEN LEG.  SHE STATED THAT THE LEG WAS NOTICED SWOLLEN, WARM, AND RED AS OF SATURDAY EVENING.  CHILD HAD NO COMPLAINTS OF PAIN AND WAS HIMSELF ALL WEEKEND.  LEFT LEG IS STILL SWOLLEN BUT NOT RED OR WARM TO TOUCH.  DR. WHO WAS THE DOCTOR IN CLINIC AT THE TIME EXAMINED THE PATIENT AND CLEARED THE PATIENT AS BEING OK.  NO FURTHER TREATMENT OR MEDICATIONS WERE NEEDED AT THE TIME. DR STATED THE DTaP WAS PROBABLY THE CAUSE OF IT.
Age: 11.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling, Rash, Rash erythematous, Swelling face
Clinical narrative: Client recieved Varicella vaccine on 04/26/08 @2:00pm. On 04/27/08 client woke up with a slight red rash under left eye and mother applied Benadryl cream to area. By the pm of 04/27/08 the rash had spread to right side of face and by 04/28/08 the rash and swelling became apparent at injection site. Client back in clinic today 04/29/08 with increased swelling and redness to face accompanied with extreme itching. Client has been taking Benadryl by mouth since yesterday without any improvement.
Age: 1.01
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Balance disorder, Blood glucose decreased, Disorientation, Fatigue, Hyperinsulinism
Clinical narrative: Within 24hrs of receiving Hepatitis B and Varicella vaccinations, my son displayed extreme fatigue and lethargy, loss of balance, pale complexion, had a glazed look in his eyes and was disoriented. The symptoms would occur intermittently and would subside immediately after he ate food. However, within an hour or so after eating, the symptoms would reappear. The pediatrician examined patient by the second day of these unusual symptoms but was not able to pinpoint what was wrong with my son. Three days later I felt the symptoms appeared to be more severe and occurring more frequently so I rushed him to Hospital and he was immediately admitted and put on I.V. after discovering his glucose level at 30ct. Patient was transported to hospital the following day for 1 week and remained on IV along with days and days of blood tests before the doctors could find a way to stabilize his fatally low glucose levels.  He was diagnosed with Hyperinsulinism. When put on a moderate dose of Diazoxide his glucose stabilized. He was released from the hospital and remained on this medication for 2 yrs. As of 6/07 patient's glucose levels have been at a safe level without medication. His diet has some restrictions, but overall he appears to have out grown the Hyperinsulinism condition. Please note: Prior to this adverse reaction patient was completely healthy.  05/08/2008 MR received for DOS 5/15-21/2005 with D/C Dx: Protein Sensitive Hyperinsulinism.  Pt presented to local hospital with ataxia, irritability and lethargy. Found to be hypoglycemic (BS 27) and transfered to current facility for eval. PE WNL.  Pt had bouts of hypoglycemia throughout hospitalization, which resolved with D10. Pt tx with Diazoxide.
Age: 1.01
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Lethargy, Pallor
Clinical narrative: Within 24hrs of receiving Hepatitis B and Varicella vaccinations, my son displayed extreme fatigue and lethargy, loss of balance, pale complexion, had a glazed look in his eyes and was disoriented. The symptoms would occur intermittently and would subside immediately after he ate food. However, within an hour or so after eating, the symptoms would reappear. The pediatrician examined patient by the second day of these unusual symptoms but was not able to pinpoint what was wrong with my son. Three days later I felt the symptoms appeared to be more severe and occurring more frequently so I rushed him to Hospital and he was immediately admitted and put on I.V. after discovering his glucose level at 30ct. Patient was transported to hospital the following day for 1 week and remained on IV along with days and days of blood tests before the doctors could find a way to stabilize his fatally low glucose levels.  He was diagnosed with Hyperinsulinism. When put on a moderate dose of Diazoxide his glucose stabilized. He was released from the hospital and remained on this medication for 2 yrs. As of 6/07 patient's glucose levels have been at a safe level without medication. His diet has some restrictions, but overall he appears to have out grown the Hyperinsulinism condition. Please note: Prior to this adverse reaction patient was completely healthy.  05/08/2008 MR received for DOS 5/15-21/2005 with D/C Dx: Protein Sensitive Hyperinsulinism.  Pt presented to local hospital with ataxia, irritability and lethargy. Found to be hypoglycemic (BS 27) and transfered to current facility for eval. PE WNL.  Pt had bouts of hypoglycemia throughout hospitalization, which resolved with D10. Pt tx with Diazoxide.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: PATIENT WAS DIAGNOSED WITH INTUSSUSCEPTION ON 4/28/08.  6/06/2008 MR received for DOS 4/29-30/2008 with d/C DX: Intussusception.  Rotavirus. Infant presented to local ER with 1 week hx of diarrhea and recent onset of vomiting as well as irritability and abdominal tenderness.  Transferred to current facility due to concern for IS.  In ER had bloody stool.  US confirmed IS and pt taken for Air Contrast Barium Enema reduction which was only partially successful x 2 attempts.  To OR for Laparoscopic reduction of IS. Taking po well post-op and D/c next day.  F/U 5/6/08-doing well with well healed incision.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal tenderness, Barium double contrast abnormal, Barium enema abnormal, Culture stool negative
Clinical narrative: PATIENT WAS DIAGNOSED WITH INTUSSUSCEPTION ON 4/28/08.  6/06/2008 MR received for DOS 4/29-30/2008 with d/C DX: Intussusception.  Rotavirus. Infant presented to local ER with 1 week hx of diarrhea and recent onset of vomiting as well as irritability and abdominal tenderness.  Transferred to current facility due to concern for IS.  In ER had bloody stool.  US confirmed IS and pt taken for Air Contrast Barium Enema reduction which was only partially successful x 2 attempts.  To OR for Laparoscopic reduction of IS. Taking po well post-op and D/c next day.  F/U 5/6/08-doing well with well healed incision.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Culture urine negative, Diarrhoea, Haematochezia, Intussusception, Irritability
Clinical narrative: PATIENT WAS DIAGNOSED WITH INTUSSUSCEPTION ON 4/28/08.  6/06/2008 MR received for DOS 4/29-30/2008 with d/C DX: Intussusception.  Rotavirus. Infant presented to local ER with 1 week hx of diarrhea and recent onset of vomiting as well as irritability and abdominal tenderness.  Transferred to current facility due to concern for IS.  In ER had bloody stool.  US confirmed IS and pt taken for Air Contrast Barium Enema reduction which was only partially successful x 2 attempts.  To OR for Laparoscopic reduction of IS. Taking po well post-op and D/c next day.  F/U 5/6/08-doing well with well healed incision.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Laparoscopy, Large intestinal obstruction reduction, Rotavirus infection, Rotavirus test positive, Surgery
Clinical narrative: PATIENT WAS DIAGNOSED WITH INTUSSUSCEPTION ON 4/28/08.  6/06/2008 MR received for DOS 4/29-30/2008 with d/C DX: Intussusception.  Rotavirus. Infant presented to local ER with 1 week hx of diarrhea and recent onset of vomiting as well as irritability and abdominal tenderness.  Transferred to current facility due to concern for IS.  In ER had bloody stool.  US confirmed IS and pt taken for Air Contrast Barium Enema reduction which was only partially successful x 2 attempts.  To OR for Laparoscopic reduction of IS. Taking po well post-op and D/c next day.  F/U 5/6/08-doing well with well healed incision.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: PATIENT WAS DIAGNOSED WITH INTUSSUSCEPTION ON 4/28/08.  6/06/2008 MR received for DOS 4/29-30/2008 with d/C DX: Intussusception.  Rotavirus. Infant presented to local ER with 1 week hx of diarrhea and recent onset of vomiting as well as irritability and abdominal tenderness.  Transferred to current facility due to concern for IS.  In ER had bloody stool.  US confirmed IS and pt taken for Air Contrast Barium Enema reduction which was only partially successful x 2 attempts.  To OR for Laparoscopic reduction of IS. Taking po well post-op and D/c next day.  F/U 5/6/08-doing well with well healed incision.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: Developed bodywide joint pains 48 hours after vaccination.  This lasted for three days.  Pain was relieved with Excedrine.  Has history of arthralgia with certain medications, but not vaccinations.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Pt received pneumococcal vaccine at Dr's office in AM of 3/13/2008 in Tricep area. Pt experienced reaction and went to emergency room at Hospital approx 7pm (1900 hrs) later that day.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Nausea
Clinical narrative: Mother called, patient had nausea and abdominal pain x 2 days after recieving injection.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunology test, Rash vesicular
Clinical narrative: Vesicular rash one week after Zostavax.
Age: 1.19
Sex: F
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Varicella Disease diagnosed on 4/29/08. Presented with no fevers.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Allergy to vaccine, Apnoea, Loss of consciousness
Clinical narrative: Excessive crying, followed by two episodes of loss of consciousness, and not breathing. 5/19/08-records received for DOS 6/1/07-Presented to ED after fussy screaming after awakening from nap. Inconsolable. Pale, eyes not making eye contact, tone limp. Did not respond to stimuli. Fifteen minutes before returned to baseline. No fever.  Impression: Apneic spells.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Pain in extremity
Clinical narrative: Arm pain (not at injection site) within minutes of injection, decreasing but still persisting 8 days later.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Dehydration, Diarrhoea haemorrhagic, Enema administration, Haematochezia, Intussusception
Clinical narrative: Mother called the clinic on 3/12/08, baby started vomiting x 24 hours and just had a diarrhea stool that was bloody.  She was instructed to bring him in to the clinic and arrived within the hour with more episodes of bloody stools.  IV fluids were administered for treatment of dehydration.  Child was admitted to the hospital for treatment after being diagnosed with Intussusception. Hydrostatic Reduction attempts were made but unsuccessful.  Child was then taken to surgery for manual reduction of the intussusception. 5/2/08-ED records received-presented to ED with on and off abdominal pain times 1 week, vomiting with bouts of crying. DX: intussusception. Transferred.  6/2/08-records received for DOS 3/12-3/15/08-DC DX: Intussusception, status post manual reduction and incidental appendectomy. Gastrographin enema. 24 hour period of emesis starting on 3/11/08-became yellow green and developed intermittent colicky episodic abdominal pain with knees posterior to chest or stiffening. Listlessness. Bright red blood in diaper. On 2/27/08 fussy and x-ray of abdomen did not reveal foreign body.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Surgery, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Mother called the clinic on 3/12/08, baby started vomiting x 24 hours and just had a diarrhea stool that was bloody.  She was instructed to bring him in to the clinic and arrived within the hour with more episodes of bloody stools.  IV fluids were administered for treatment of dehydration.  Child was admitted to the hospital for treatment after being diagnosed with Intussusception. Hydrostatic Reduction attempts were made but unsuccessful.  Child was then taken to surgery for manual reduction of the intussusception. 5/2/08-ED records received-presented to ED with on and off abdominal pain times 1 week, vomiting with bouts of crying. DX: intussusception. Transferred.  6/2/08-records received for DOS 3/12-3/15/08-DC DX: Intussusception, status post manual reduction and incidental appendectomy. Gastrographin enema. 24 hour period of emesis starting on 3/11/08-became yellow green and developed intermittent colicky episodic abdominal pain with knees posterior to chest or stiffening. Listlessness. Bright red blood in diaper. On 2/27/08 fussy and x-ray of abdomen did not reveal foreign body.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Abdominal pain, Appendicectomy, Barium enema abnormal, Crying, Dehydration
Clinical narrative: Mother called the clinic on 3/12/08, baby started vomiting x 24 hours and just had a diarrhea stool that was bloody.  She was instructed to bring him in to the clinic and arrived within the hour with more episodes of bloody stools.  IV fluids were administered for treatment of dehydration.  Child was admitted to the hospital for treatment after being diagnosed with Intussusception. Hydrostatic Reduction attempts were made but unsuccessful.  Child was then taken to surgery for manual reduction of the intussusception. 5/2/08-ED records received-presented to ED with on and off abdominal pain times 1 week, vomiting with bouts of crying. DX: intussusception. Transferred.  6/2/08-records received for DOS 3/12-3/15/08-DC DX: Intussusception, status post manual reduction and incidental appendectomy. Gastrographin enema. 24 hour period of emesis starting on 3/11/08-became yellow green and developed intermittent colicky episodic abdominal pain with knees posterior to chest or stiffening. Listlessness. Bright red blood in diaper. On 2/27/08 fussy and x-ray of abdomen did not reveal foreign body.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Enema administration, Intussusception, Irritability, Listless
Clinical narrative: Mother called the clinic on 3/12/08, baby started vomiting x 24 hours and just had a diarrhea stool that was bloody.  She was instructed to bring him in to the clinic and arrived within the hour with more episodes of bloody stools.  IV fluids were administered for treatment of dehydration.  Child was admitted to the hospital for treatment after being diagnosed with Intussusception. Hydrostatic Reduction attempts were made but unsuccessful.  Child was then taken to surgery for manual reduction of the intussusception. 5/2/08-ED records received-presented to ED with on and off abdominal pain times 1 week, vomiting with bouts of crying. DX: intussusception. Transferred.  6/2/08-records received for DOS 3/12-3/15/08-DC DX: Intussusception, status post manual reduction and incidental appendectomy. Gastrographin enema. 24 hour period of emesis starting on 3/11/08-became yellow green and developed intermittent colicky episodic abdominal pain with knees posterior to chest or stiffening. Listlessness. Bright red blood in diaper. On 2/27/08 fussy and x-ray of abdomen did not reveal foreign body.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Musculoskeletal stiffness, Surgery, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Mother called the clinic on 3/12/08, baby started vomiting x 24 hours and just had a diarrhea stool that was bloody.  She was instructed to bring him in to the clinic and arrived within the hour with more episodes of bloody stools.  IV fluids were administered for treatment of dehydration.  Child was admitted to the hospital for treatment after being diagnosed with Intussusception. Hydrostatic Reduction attempts were made but unsuccessful.  Child was then taken to surgery for manual reduction of the intussusception. 5/2/08-ED records received-presented to ED with on and off abdominal pain times 1 week, vomiting with bouts of crying. DX: intussusception. Transferred.  6/2/08-records received for DOS 3/12-3/15/08-DC DX: Intussusception, status post manual reduction and incidental appendectomy. Gastrographin enema. 24 hour period of emesis starting on 3/11/08-became yellow green and developed intermittent colicky episodic abdominal pain with knees posterior to chest or stiffening. Listlessness. Bright red blood in diaper. On 2/27/08 fussy and x-ray of abdomen did not reveal foreign body.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Burning sensation, Inflammation, Injected limb mobility decreased
Clinical narrative: On Tuesday 4/22/08 I went in for a routine physical and PA suggested getting a tetanus booster vaccine. I received the vaccine by a med. assistant student around 2:15 pm and since then I have had excruciating continuous pain radiating from my upper arm to my elbow. I have been unable to complete personal care activities or work. On Tuesday 4/22/08 I called the practice and spoke to the triage nurse re: the excruciating pain (not soreness) and inability to move or lift my left arm. She advised me to alternate between Tylenol and Motrin; as well as apply a heat compress to the arm and call the service back in AM if worsens. I called back in the AM and the nurse advised me to come in to see PA again. Upon examination PA stated had inflamed muscles and I was having muscle spasms as a result of the vaccine. She stated that she had never seen this happen before. She prescribed Flexeril and Motrin Q8 hrs PRN pain. My condition (L arm) never got any better; in fact my (L) upper arm swelled even more and I began to have more pain (burning, sharp, shooting pain from my upper arm radiating to my elbow ). I called the practice back on Friday and Saturday and the triage nurse finally called me back and stated that PA will call in a prescription for LORTAB 1-2 tablets on Sunday. Well, I went to the office and stated that I feel they should report this reaction to the CDC since they stated that this never happens. The nurse just gave me the VAERS form and a MD note for work. I have missed (4) days of work and I still have pain and I still need assistance to perform regular activities. I am concerned that this batch of vaccine was tainted or the IM administration technique was performed incorrectly by the MA student. Please follow up with this.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: On Tuesday 4/22/08 I went in for a routine physical and PA suggested getting a tetanus booster vaccine. I received the vaccine by a med. assistant student around 2:15 pm and since then I have had excruciating continuous pain radiating from my upper arm to my elbow. I have been unable to complete personal care activities or work. On Tuesday 4/22/08 I called the practice and spoke to the triage nurse re: the excruciating pain (not soreness) and inability to move or lift my left arm. She advised me to alternate between Tylenol and Motrin; as well as apply a heat compress to the arm and call the service back in AM if worsens. I called back in the AM and the nurse advised me to come in to see PA again. Upon examination PA stated had inflamed muscles and I was having muscle spasms as a result of the vaccine. She stated that she had never seen this happen before. She prescribed Flexeril and Motrin Q8 hrs PRN pain. My condition (L arm) never got any better; in fact my (L) upper arm swelled even more and I began to have more pain (burning, sharp, shooting pain from my upper arm radiating to my elbow ). I called the practice back on Friday and Saturday and the triage nurse finally called me back and stated that PA will call in a prescription for LORTAB 1-2 tablets on Sunday. Well, I went to the office and stated that I feel they should report this reaction to the CDC since they stated that this never happens. The nurse just gave me the VAERS form and a MD note for work. I have missed (4) days of work and I still have pain and I still need assistance to perform regular activities. I am concerned that this batch of vaccine was tainted or the IM administration technique was performed incorrectly by the MA student. Please follow up with this.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Headache, Nausea, Oedema peripheral
Clinical narrative: 4/36/08 - Patient received in left arm Tdap Boostrix AC52B021AA 5/09 and MCV4 U539AA 3/13/09 - There is redness and swelling in left arm from bicep to tricep staring 2" below the deltoid - when looking for injection sites clearly below the deltoid muscle - vaccines were given in site to same. Patient also feels nauseated with headaches since Saturday 4/26/08
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Abnormal dreams, Dizziness, Headache
Clinical narrative: Patient complained of dizziness, vivid dreams, and headache.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vaccine positive rechallenge, Vomiting
Clinical narrative: On 4/25/08 patient received GARDASIL #2. Within 50 minutes - onset of vomiting x 6 hours and fever 102. Twin sister - same symptoms. On 2/18/08 - Gardasil #1. Onset of vomiting, fever 3 days later.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy, Pyrexia, Vaccine positive rechallenge, Vomiting
Clinical narrative: On 4/25/08 - patient received GARDASIL #2. Within 50 minutes - onset of vomiting x 6 hours. Also developed fever 102, lethargy. Similar sxs - 3 days after GARDASIL #1 (2/18/08).
Age: 35.0
Sex: U
Vaccine: TD
Symptoms: Mass, Pain in extremity, Weight bearing difficulty
Clinical narrative: I got a nail in my hand and it cut me open so they gave me a tetanus shot after that, about 2 to 3 weeks my arm hurts like I can't hold anything in that arm the lump from the shot finally went away but my arm is still hurting and I told the nurse and they didn't do nothing for me. What can I do because I still hurt.
Age: 6.0
Sex: M
Vaccine: HIBV, PNC
Symptoms: Hypokinesia, Wrong drug administered
Clinical narrative: Patient unable to lift right arm where HIB inj. was given. Pt received wrong immunizations. Pt is a 6 y/o male.
Age: 1.6
Sex: M
Vaccine: MMR
Symptoms: Rash generalised, Rash papular
Clinical narrative: Fine papular rash all over body. Rash started on the trunk and spread to the extremities. H/O MMR 10 days prior. No fever.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Feeling abnormal, Full blood count normal, Hypoaesthesia, Vomiting
Clinical narrative: Within 2 minutes of getting shot, pt began to feel funny. Left arm felt numb, became light-headed, dizzy. After 1 hour vomited. No loss of consciousness or airway impairment. Wife picked him up from work and was seen in ER. Given fluids, Benadryl.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: (L) acromion pain radiates to (L) biceps.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site vesicles
Clinical narrative: Induration, vesicular eruption 4x4cm at site of vaccine within 48 hours of administration.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Torticollis
Clinical narrative: Torticollis to left less than 24 hours post vaccination.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: nausea and vomiting face rash
Age: 0.2
Sex: M
Vaccine: RV5, DTPHIB, HEP, HIBV, PNC, RV5
Symptoms: Respiratory syncytial virus infection, Vomiting
Clinical narrative: Initial report received on 21 April 2008 from another manufacturer, report# WAES 0804USA01346. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 2 month old male who was vaccinated PO with his first 2.0 ml dose of ROTATEQ on 12-MAR-2008. On 13-MAR-2008, the day after the vaccine was administered, the patient experienced vomiting. On 14-MAR-2008 the patient was diagnosed with RSV and was hospitalized for approximately 1 week. The outcome was unknown. There was no product quality complaint. Follow-up information from the physician's office concerning a 9 week old male with pertinent medical history who was vaccinated PO with his first 2.0 ml dose of ROTATEQ (lot# 659680/0018X) on 12-MAR-2008. Suspect vaccination included a dose of hepatitis B vaccine rHBsAg (lot# 655566/0659U), a dose of PREVNAR, a dose of ACTHIB and a dose of Diphtheria Toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. ON 13-MAR-2008 the patient experienced vomiting. The patient was admitted to the hospital on 15-MAR-2008 for 7 days. The patient was started on antibiotics which were discontinued after a septic workup was negative. The patient was treated with caffeine for three days. The patient had three self-limiting periods of apnea. After several days in the ICU, the patient was transferred to the floor on 2 liters of oxygen. The patient was discharged from the hospital on 31-MAR-2008. On 10-APR-2008 the patient was seen in the physician's office with same symptoms. It was reported that the patient was not recovered. RSV and vomiting were also considered to be other important medical events by the physician. Additional information has been requested."
Age: 0.2
Sex: M
Vaccine: RV5, DTPHIB, HEP, HIBV, PNC, RV5
Symptoms: Apnoea, Caffeine consumption, Intensive care, Laboratory test normal, Oxygen supplementation
Clinical narrative: Initial report received on 21 April 2008 from another manufacturer, report# WAES 0804USA01346. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 2 month old male who was vaccinated PO with his first 2.0 ml dose of ROTATEQ on 12-MAR-2008. On 13-MAR-2008, the day after the vaccine was administered, the patient experienced vomiting. On 14-MAR-2008 the patient was diagnosed with RSV and was hospitalized for approximately 1 week. The outcome was unknown. There was no product quality complaint. Follow-up information from the physician's office concerning a 9 week old male with pertinent medical history who was vaccinated PO with his first 2.0 ml dose of ROTATEQ (lot# 659680/0018X) on 12-MAR-2008. Suspect vaccination included a dose of hepatitis B vaccine rHBsAg (lot# 655566/0659U), a dose of PREVNAR, a dose of ACTHIB and a dose of Diphtheria Toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. ON 13-MAR-2008 the patient experienced vomiting. The patient was admitted to the hospital on 15-MAR-2008 for 7 days. The patient was started on antibiotics which were discontinued after a septic workup was negative. The patient was treated with caffeine for three days. The patient had three self-limiting periods of apnea. After several days in the ICU, the patient was transferred to the floor on 2 liters of oxygen. The patient was discharged from the hospital on 31-MAR-2008. On 10-APR-2008 the patient was seen in the physician's office with same symptoms. It was reported that the patient was not recovered. RSV and vomiting were also considered to be other important medical events by the physician. Additional information has been requested."
Age: 0.1
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Frequent bowel movements, Haematochezia, Laboratory test abnormal, Occult blood positive
Clinical narrative: Information has been received from a registered nurse concerning a 6 week old female with no drug allergies who on 07-APR-2008 was vaccinated PO with a dose of Rotateq (lot# 659913/1702U). On 14-APR-2008 the patient experienced diarrhea and had 5 watery bowel movements within 20 hours. The patient sought medical attention through an office visit. In April 2008, laboratory diagnostics studies revealed a positive results for blood in the stool. Subsequently, the symptoms have since resolved and the patient was recovered on 21-APR-2008. There was no product quality complaint. Upon internal review, positive for blood in stool was determined to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Ileus
Clinical narrative: Information has been received from a physician concerning a female with diarrhea for 4 days prior to vaccination who on 31-MAR-2008 was vaccinated PO with her second dose of Rotateq (lot# 660289/188U). On 01-APR-2008 the patient experienced severe abdominal pain and was subsequently hospitalized for "several days." During hospitalization it was determined that she had ileus which resolved spontaneously, and then she was released from the hospital. No labs or diagnostic studies were performed. On 04-APR-2008 the patient recovered. No further information was available. There was no product quality complaint. Ileus was considered to be immediately life-threatening by the physician. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Laboratory test abnormal, Mucous stools, Surgery, Vomiting
Clinical narrative: Information has been received from a Post-Marketing evaluation program for Rotateq concerning a 5 month old male who was vaccinated PO with her first dose of Rotateq.  Subsequently 36 days post dose, the patient was admitted to the hospital with a 3 day history of intractable vomiting and no diarrhea and remained hospitalized for 6 days.  Films were performed which showed a positive result for currant jelly stool and intussusception requiring resection.  The patient recovered and was discharged on day 6.  Intussusception was also considered to be an other important medical event by the reporter.  Additional information has been requested.
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: Barium enema abnormal, Bloody discharge, Enema administration, Explorative laparotomy, Gastrointestinal necrosis
Clinical narrative: Information has been received from a Post-Marketing evaluation program for Rotateq concerning a 5 month old female who was vaccinated PO with her second dose of Rotateq. Subsequently 53 days post dose, the patient was admitted to the hospital with a 24 hour history of emesis and bloody mucous per rectum and remained hospitalized for 3 days. An air contrast enema demonstrated ileocolic intussusception to the level of the sigmoid. An exploratory laparotomy showed a necrotic cecum as well. The intussusception was reduced and an ileocecotomy was performed. The patient was discharged on day 3. The outcome was unknown. Intussusception was also considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Intussusception, Mucous stools, Surgery, Vomiting
Clinical narrative: Information has been received from a Post-Marketing evaluation program for Rotateq concerning a 5 month old female who was vaccinated PO with her second dose of Rotateq. Subsequently 53 days post dose, the patient was admitted to the hospital with a 24 hour history of emesis and bloody mucous per rectum and remained hospitalized for 3 days. An air contrast enema demonstrated ileocolic intussusception to the level of the sigmoid. An exploratory laparotomy showed a necrotic cecum as well. The intussusception was reduced and an ileocecotomy was performed. The patient was discharged on day 3. The outcome was unknown. Intussusception was also considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Enema administration, Haematochezia, Inappropriate schedule of drug administration, Intussusception, Laboratory test abnormal
Clinical narrative: Information has been received from a Post-Marketing evaluation program for ROTATEQ concerning a 5-month-old female who was vaccinated PO with her first dose of ROTATEQ. Subsequently 6 days post dose, the patient was admitted to the hospital with bloody stools and to rule out gastroenteritis and was hospitalized for more than 2 days. Radiological decompression was unsuccessful. The patient experienced ileocolic intussusception midway up the ascending colon which was surgically reduced. Peyer's patches appeared to be the cause of the problem. There were multiple lymph nodes; no Meckel's diverticulum noted. The outcome was unknown. Intussusception was also considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Surgery
Clinical narrative: Information has been received from a Post-Marketing evaluation program for ROTATEQ concerning a 5-month-old female who was vaccinated PO with her first dose of ROTATEQ. Subsequently 6 days post dose, the patient was admitted to the hospital with bloody stools and to rule out gastroenteritis and was hospitalized for more than 2 days. Radiological decompression was unsuccessful. The patient experienced ileocolic intussusception midway up the ascending colon which was surgically reduced. Peyer's patches appeared to be the cause of the problem. There were multiple lymph nodes; no Meckel's diverticulum noted. The outcome was unknown. Intussusception was also considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Biopsy, Biopsy skin, Cardiac arrest, Cardiac pacemaker insertion
Clinical narrative: Information has been received from a medical assistant concerning a 76 year old female consumer with coronary artery disease, hypertension, hypercholesterolemia, gastrooesophageal reflux disease, osteoporosis, sulfonamide and codeine allergies and an autoimmune disorder and a history of cerebrovascular accident who on 03-DEC-2007 was vaccinated SQ with a first dose of ZOSTAVAX (Oka/Merck). It was reported the patient had a rash at the shoulder area prior to vaccination. Concomitant therapy included TOPROL XL TABLETS, PROTONIX, aspirin, COUMADIN, multiple vitamins, PRAVACHOL, alendronate sodium (MSD), ASTELIN, enalapril maleate (MSD), "dil" and "omacor." Subsequently, on approximately 04-DEC-2007 the patient's rash progressed to all over her body since vaccination. The rash was biopsied and found to be caused by an autoimmune disease (unknown type) and needed to be treated. It was suspected that the vaccination exacerbated her conditions. On 28-DEC-2007 the patient was hospitalized for cardiac arrest, increased INR, and looked like she had sepsis and shock. This was due to electrolyte abnormalities. The patient experienced ventricular tachycardia and went into cardiac arrest. A defibrillator was implanted into her. On 02-JAN-2008 the patient was hospitalized again. According to the "cath report," the patient was admitted for "severe native 2 vessel disease with occluded OM2 and LAD." The patient also experienced severe pulmonary hypertension. It was also reported that early in April 2007 the patient reported malaise and not feeling well. On 16-APR-2008 the patient developed swelling all over her body, physical impairment from the rash and no desire to get up move around. At the time of the report the patient had not recovered. Her cardiovascular condition was reported as stable. There was no product quality complaint involved. The reporter considered the events to be disabling, life threatening, and other important medical events. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardioversion, Catheterisation cardiac, Condition aggravated, Coronary artery occlusion, Electrolyte imbalance
Clinical narrative: Information has been received from a medical assistant concerning a 76 year old female consumer with coronary artery disease, hypertension, hypercholesterolemia, gastrooesophageal reflux disease, osteoporosis, sulfonamide and codeine allergies and an autoimmune disorder and a history of cerebrovascular accident who on 03-DEC-2007 was vaccinated SQ with a first dose of ZOSTAVAX (Oka/Merck). It was reported the patient had a rash at the shoulder area prior to vaccination. Concomitant therapy included TOPROL XL TABLETS, PROTONIX, aspirin, COUMADIN, multiple vitamins, PRAVACHOL, alendronate sodium (MSD), ASTELIN, enalapril maleate (MSD), "dil" and "omacor." Subsequently, on approximately 04-DEC-2007 the patient's rash progressed to all over her body since vaccination. The rash was biopsied and found to be caused by an autoimmune disease (unknown type) and needed to be treated. It was suspected that the vaccination exacerbated her conditions. On 28-DEC-2007 the patient was hospitalized for cardiac arrest, increased INR, and looked like she had sepsis and shock. This was due to electrolyte abnormalities. The patient experienced ventricular tachycardia and went into cardiac arrest. A defibrillator was implanted into her. On 02-JAN-2008 the patient was hospitalized again. According to the "cath report," the patient was admitted for "severe native 2 vessel disease with occluded OM2 and LAD." The patient also experienced severe pulmonary hypertension. It was also reported that early in April 2007 the patient reported malaise and not feeling well. On 16-APR-2008 the patient developed swelling all over her body, physical impairment from the rash and no desire to get up move around. At the time of the report the patient had not recovered. Her cardiovascular condition was reported as stable. There was no product quality complaint involved. The reporter considered the events to be disabling, life threatening, and other important medical events. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: International normalised ratio increased, Malaise, Physical disability, Pulmonary hypertension, Rash generalised
Clinical narrative: Information has been received from a medical assistant concerning a 76 year old female consumer with coronary artery disease, hypertension, hypercholesterolemia, gastrooesophageal reflux disease, osteoporosis, sulfonamide and codeine allergies and an autoimmune disorder and a history of cerebrovascular accident who on 03-DEC-2007 was vaccinated SQ with a first dose of ZOSTAVAX (Oka/Merck). It was reported the patient had a rash at the shoulder area prior to vaccination. Concomitant therapy included TOPROL XL TABLETS, PROTONIX, aspirin, COUMADIN, multiple vitamins, PRAVACHOL, alendronate sodium (MSD), ASTELIN, enalapril maleate (MSD), "dil" and "omacor." Subsequently, on approximately 04-DEC-2007 the patient's rash progressed to all over her body since vaccination. The rash was biopsied and found to be caused by an autoimmune disease (unknown type) and needed to be treated. It was suspected that the vaccination exacerbated her conditions. On 28-DEC-2007 the patient was hospitalized for cardiac arrest, increased INR, and looked like she had sepsis and shock. This was due to electrolyte abnormalities. The patient experienced ventricular tachycardia and went into cardiac arrest. A defibrillator was implanted into her. On 02-JAN-2008 the patient was hospitalized again. According to the "cath report," the patient was admitted for "severe native 2 vessel disease with occluded OM2 and LAD." The patient also experienced severe pulmonary hypertension. It was also reported that early in April 2007 the patient reported malaise and not feeling well. On 16-APR-2008 the patient developed swelling all over her body, physical impairment from the rash and no desire to get up move around. At the time of the report the patient had not recovered. Her cardiovascular condition was reported as stable. There was no product quality complaint involved. The reporter considered the events to be disabling, life threatening, and other important medical events. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Sepsis, Shock, Swelling, Ventricular tachycardia
Clinical narrative: Information has been received from a medical assistant concerning a 76 year old female consumer with coronary artery disease, hypertension, hypercholesterolemia, gastrooesophageal reflux disease, osteoporosis, sulfonamide and codeine allergies and an autoimmune disorder and a history of cerebrovascular accident who on 03-DEC-2007 was vaccinated SQ with a first dose of ZOSTAVAX (Oka/Merck). It was reported the patient had a rash at the shoulder area prior to vaccination. Concomitant therapy included TOPROL XL TABLETS, PROTONIX, aspirin, COUMADIN, multiple vitamins, PRAVACHOL, alendronate sodium (MSD), ASTELIN, enalapril maleate (MSD), "dil" and "omacor." Subsequently, on approximately 04-DEC-2007 the patient's rash progressed to all over her body since vaccination. The rash was biopsied and found to be caused by an autoimmune disease (unknown type) and needed to be treated. It was suspected that the vaccination exacerbated her conditions. On 28-DEC-2007 the patient was hospitalized for cardiac arrest, increased INR, and looked like she had sepsis and shock. This was due to electrolyte abnormalities. The patient experienced ventricular tachycardia and went into cardiac arrest. A defibrillator was implanted into her. On 02-JAN-2008 the patient was hospitalized again. According to the "cath report," the patient was admitted for "severe native 2 vessel disease with occluded OM2 and LAD." The patient also experienced severe pulmonary hypertension. It was also reported that early in April 2007 the patient reported malaise and not feeling well. On 16-APR-2008 the patient developed swelling all over her body, physical impairment from the rash and no desire to get up move around. At the time of the report the patient had not recovered. Her cardiovascular condition was reported as stable. There was no product quality complaint involved. The reporter considered the events to be disabling, life threatening, and other important medical events. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Amino acid level normal, Autism spectrum disorder, Blood heavy metal increased, Blood test, Gene mutation identification test
Clinical narrative: Information has been received from a father concerning his 4 year old daughter with milk and casein allergies and no other medical history who on 15-NOV-2004 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number 647263/1136N), 0.5 ml in right arm.  Concomitant therapy included poliovirus vaccine (ELPV-3) on 15-NOV-2004.  The consumer mentioned his daughter received MMR (Enders-Edmonston) (MSD, HSA, lot number 648470/0317P) and VARIVAX (Oka/Merck) and at 18 or 20 months he noticed she stopped talking, regressed socially and was non-responsive.  The daughter was diagnosed with PDDNOS (Pervasive Developmental Disorder).  At the time of reporting, the patient was recovering.  On unknown date, the patient sought medical attention by the physician.  The daughter cannot get rid of metals that are in her body.  The daughter was also given 0.5 ml of MMR (Enders-Edmonston) (MSD, HSA) in left arm on 14-FEB-2005 concomitantly with Hib conj vaccine (OMPC) (manufacturer unknown).  The daughter is currently able to understand some of what is said and respond.  The daughter is also able to sign for what she wants to do but she is still not talking.  The consumer was not saying MMR (Enders-Edmonston) (MSD, HSA) or VARIVAX (Oka/Merck) caused the metals that have accumulated in his daughter's body, he was just trying to find out more information about the vaccines.  Upon internal review, it was determined that PDDNOS (Pervasive Developmental Disorder) was serious as other important medical event.  No further information is available.
Age: 4.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Metal poisoning, Social avoidant behaviour, Speech disorder developmental, Stool analysis, Unresponsive to stimuli
Clinical narrative: Information has been received from a father concerning his 4 year old daughter with milk and casein allergies and no other medical history who on 15-NOV-2004 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number 647263/1136N), 0.5 ml in right arm.  Concomitant therapy included poliovirus vaccine (ELPV-3) on 15-NOV-2004.  The consumer mentioned his daughter received MMR (Enders-Edmonston) (MSD, HSA, lot number 648470/0317P) and VARIVAX (Oka/Merck) and at 18 or 20 months he noticed she stopped talking, regressed socially and was non-responsive.  The daughter was diagnosed with PDDNOS (Pervasive Developmental Disorder).  At the time of reporting, the patient was recovering.  On unknown date, the patient sought medical attention by the physician.  The daughter cannot get rid of metals that are in her body.  The daughter was also given 0.5 ml of MMR (Enders-Edmonston) (MSD, HSA) in left arm on 14-FEB-2005 concomitantly with Hib conj vaccine (OMPC) (manufacturer unknown).  The daughter is currently able to understand some of what is said and respond.  The daughter is also able to sign for what she wants to do but she is still not talking.  The consumer was not saying MMR (Enders-Edmonston) (MSD, HSA) or VARIVAX (Oka/Merck) caused the metals that have accumulated in his daughter's body, he was just trying to find out more information about the vaccines.  Upon internal review, it was determined that PDDNOS (Pervasive Developmental Disorder) was serious as other important medical event.  No further information is available.
Age: 4.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Urine analysis
Clinical narrative: Information has been received from a father concerning his 4 year old daughter with milk and casein allergies and no other medical history who on 15-NOV-2004 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number 647263/1136N), 0.5 ml in right arm.  Concomitant therapy included poliovirus vaccine (ELPV-3) on 15-NOV-2004.  The consumer mentioned his daughter received MMR (Enders-Edmonston) (MSD, HSA, lot number 648470/0317P) and VARIVAX (Oka/Merck) and at 18 or 20 months he noticed she stopped talking, regressed socially and was non-responsive.  The daughter was diagnosed with PDDNOS (Pervasive Developmental Disorder).  At the time of reporting, the patient was recovering.  On unknown date, the patient sought medical attention by the physician.  The daughter cannot get rid of metals that are in her body.  The daughter was also given 0.5 ml of MMR (Enders-Edmonston) (MSD, HSA) in left arm on 14-FEB-2005 concomitantly with Hib conj vaccine (OMPC) (manufacturer unknown).  The daughter is currently able to understand some of what is said and respond.  The daughter is also able to sign for what she wants to do but she is still not talking.  The consumer was not saying MMR (Enders-Edmonston) (MSD, HSA) or VARIVAX (Oka/Merck) caused the metals that have accumulated in his daughter's body, he was just trying to find out more information about the vaccines.  Upon internal review, it was determined that PDDNOS (Pervasive Developmental Disorder) was serious as other important medical event.  No further information is available.