chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Intubation, Intussusception, Laparotomy, Sepsis, Ultrasound abdomen abnormal
Clinical narrative: Patient developed GI symptoms (vomiting) on 2/3/2007  (31 days after receiving 3rd Rotateq).  Was diagnosed with intussception on 2/7/2007.  Suffered perforation of intestine during attempt to reduce by Barium enema, requiring emergent laparotomy and reanastomosis of small bowel.  Suffered a 2nd bowel perforation on 2/12/2007.  Illness resulted in ICU admission, intubation, probable sepsis.  3/15/07 Received partial medical records from hospital which reveal patient admitted 2/7/07 after experienced +IS s/p perforation x 2 w/OR repair who developed fever, elevated WBC, increasing discomfort & irritability.  Returned to OR on 2/15 for transverse colon perforation. FINAL DX: none at present as patient still hospitalized.  Peritonitis, either resistant bacteria such as MRSA or fungal were considered likely. T/C to hospital to determine D/C status of patient & to request D/C Summary if available.  Patient d/c to home 3/14.  No D/C Summary dictated yet.  Will request later. 4/10/07 Received D/C summary from hospital which reveals patient admitted from 2/7/07-3/14/07.  Admitted w/abdominal pain & emesis x approx 5 days w/lethargy & dehydration.  Treated at outlying hospital w/IVF prior to transfer for surgery on 2/7/07 was exp lap w/ileocecectomy w/primary anastomosis; then, lysis of adhesions & repair of transverse colon perforation on 2/12/07.  Condition was critical & worsened prior to second surgry w/patient remaining intubated & in PICU.  After second surgery & continued IVF, antibiotics & TPN, had gradual improvement & was successfully extubated.  Despite treatment, continued to have intermittent fevers & multiple w/ups were done, all were neg for source of infection.  Transitioned from TPN to NJ feeds & was transferred to regular peds floor.  Gradually, oral feeds were introduced & tolerated & NJ feeds were d/c.  Patient had become accustomed to MSO4 pain med & had extensive wean w/ativan & methadone.  Bowel function had returned to normal by d/c to home w/f/u w/PCP & surgery. FINAL DX: Intussusception complicated by small bowel perforation & transverse colon perforation. Per information received from the annual follow up patient did have the complication of intestinal perforation twice after diagnosis of intussusception, was hospitalized for greater than 1 month.
Age: 0.13
Sex: F
Vaccine: DTAPH, HEP, IPV, PPV, RVX
Symptoms: Somnolence
Clinical narrative: PATIENT RECIVED THE DATP, IPV, PREVNAR, ROTATEG #1,AND HEPB AT 7 WEEKS OLD. AFTER THE VACCINA  TION SHE WAS SLEEPY FOR 7 DAYS. HER APPOTITE WAS NOT CHANGED BUT I HAD TO WAKE HER UP FOR HER BOTTLE. AFTER EXACTLY 7 DAYS SHE CAME BACK TO NORMAL R0UTINE. I THINK SHE HADE A ABNORMAL REACTION THAT CALLED "MARKED INCREASE IN SLEEPING TIME"
Age: 0.47
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Intussussception. 3/20/07 Received medical records from hospital which reveal patient experienced vomiting & bloody stools for 1 day.  Seen at outlying ER on 2/16 & tx w/air contrast enema for +IS then transferred for higher level of care.  Admitted to hospital 2/17-2/24/07.  Air contrast enema from outlying ER successful but f/u US of abdomen revealed IS had recurred.  Repeat air contrast enema reduced IS but again recurred & was so was taken to OR.  Stayed in PICU for several days observation & treated w/antibiotics & TPN.  Transitioned to oral feeds & antibiotics d/c 2 days prior to d/c home w/o further complication. FINAL DX: Intussusception, RLQ in cecum, adjacent to eleocecal valve.  Surgically reduced after failure of air contrast enemas x 2.  Exp lap; segmental resection of IS, ileal; & enteroenterostomy.
Age: 0.47
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Diarrhoea haemorrhagic, Intussusception, Surgery, Ultrasound abdomen, Vomiting
Clinical narrative: Intussussception. 3/20/07 Received medical records from hospital which reveal patient experienced vomiting & bloody stools for 1 day.  Seen at outlying ER on 2/16 & tx w/air contrast enema for +IS then transferred for higher level of care.  Admitted to hospital 2/17-2/24/07.  Air contrast enema from outlying ER successful but f/u US of abdomen revealed IS had recurred.  Repeat air contrast enema reduced IS but again recurred & was so was taken to OR.  Stayed in PICU for several days observation & treated w/antibiotics & TPN.  Transitioned to oral feeds & antibiotics d/c 2 days prior to d/c home w/o further complication. FINAL DX: Intussusception, RLQ in cecum, adjacent to eleocecal valve.  Surgically reduced after failure of air contrast enemas x 2.  Exp lap; segmental resection of IS, ileal; & enteroenterostomy.
Age: 0.47
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Intussussception. 3/20/07 Received medical records from hospital which reveal patient experienced vomiting & bloody stools for 1 day.  Seen at outlying ER on 2/16 & tx w/air contrast enema for +IS then transferred for higher level of care.  Admitted to hospital 2/17-2/24/07.  Air contrast enema from outlying ER successful but f/u US of abdomen revealed IS had recurred.  Repeat air contrast enema reduced IS but again recurred & was so was taken to OR.  Stayed in PICU for several days observation & treated w/antibiotics & TPN.  Transitioned to oral feeds & antibiotics d/c 2 days prior to d/c home w/o further complication. FINAL DX: Intussusception, RLQ in cecum, adjacent to eleocecal valve.  Surgically reduced after failure of air contrast enemas x 2.  Exp lap; segmental resection of IS, ileal; & enteroenterostomy.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR
Symptoms: Blood immunoglobulin E, Radioallergosorbent test negative, Skin test negative, Urticaria, Vaccination complication
Clinical narrative: hives on face and hairline
Age: 0.2
Sex: M
Vaccine: DTAPH, HEP, IPV
Symptoms: Pyrexia, Screaming
Clinical narrative: Patient had high-pitched, inconsolable screaming that lasted about 5 hours.  Also had low-grade fever of about 101 degrees
Age: 25.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Pain, Pregnancy test positive
Clinical narrative: Initial report received on 19 January 2007 from a health care professional.  A 25-year-old female patient, who had no concurrent illnesses and no pre-existing medical conditions, but who did have a positive pregnancy test on 17 January 2007, had received a first dose, left arm, subcutaneous injection of YF-VAX, lot number UE913AA, and a first oral dose of Vivotif, manufacturer reported, lot number 3001139, on 16 January 2007 at 11:30 am. The following day, at 15:00 pm, the patient experienced body pain, abdominal pain, vomiting, dizziness, fever (temperature not reported), and diarrhea. She was taken to the emergency room and a pregnancy test was positive. Treatment received and other diagnostic testings performed were not reported. It was reported that the patient had not experienced any adverse events with prior vaccinations. The date of the patient's last menstrual period and the expected date of delivery were not reported. The recovery status of the patient was unknown at the time of this report. Follow-up information received on 12 February 2007 from a health care professional. The patient reported she was menstruating at the time of the vaccinations on 16 January 2007, and the following day, contracted the reporter by phone stating she had a spontaneous abortion. Reportedly, the patient fully recovered. No diagnostic test's were performed as far as this reporter knew.
Age: 25.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Pyrexia, Vomiting
Clinical narrative: Initial report received on 19 January 2007 from a health care professional.  A 25-year-old female patient, who had no concurrent illnesses and no pre-existing medical conditions, but who did have a positive pregnancy test on 17 January 2007, had received a first dose, left arm, subcutaneous injection of YF-VAX, lot number UE913AA, and a first oral dose of Vivotif, manufacturer reported, lot number 3001139, on 16 January 2007 at 11:30 am. The following day, at 15:00 pm, the patient experienced body pain, abdominal pain, vomiting, dizziness, fever (temperature not reported), and diarrhea. She was taken to the emergency room and a pregnancy test was positive. Treatment received and other diagnostic testings performed were not reported. It was reported that the patient had not experienced any adverse events with prior vaccinations. The date of the patient's last menstrual period and the expected date of delivery were not reported. The recovery status of the patient was unknown at the time of this report. Follow-up information received on 12 February 2007 from a health care professional. The patient reported she was menstruating at the time of the vaccinations on 16 January 2007, and the following day, contracted the reporter by phone stating she had a spontaneous abortion. Reportedly, the patient fully recovered. No diagnostic test's were performed as far as this reporter knew.
Age: 25.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Abdominal pain, Abortion spontaneous, Diarrhoea, Dizziness, Drug exposure during pregnancy
Clinical narrative: Initial report received on 19 January 2007 from a health care professional.  A 25-year-old female patient, who had no concurrent illnesses and no pre-existing medical conditions, but who did have a positive pregnancy test on 17 January 2007, had received a first dose, left arm, subcutaneous injection of YF-VAX, lot number UE913AA, and a first oral dose of Vivotif, manufacturer reported, lot number 3001139, on 16 January 2007 at 11:30 am. The following day, at 15:00 pm, the patient experienced body pain, abdominal pain, vomiting, dizziness, fever (temperature not reported), and diarrhea. She was taken to the emergency room and a pregnancy test was positive. Treatment received and other diagnostic testings performed were not reported. It was reported that the patient had not experienced any adverse events with prior vaccinations. The date of the patient's last menstrual period and the expected date of delivery were not reported. The recovery status of the patient was unknown at the time of this report. Follow-up information received on 12 February 2007 from a health care professional. The patient reported she was menstruating at the time of the vaccinations on 16 January 2007, and the following day, contracted the reporter by phone stating she had a spontaneous abortion. Reportedly, the patient fully recovered. No diagnostic test's were performed as far as this reporter knew.
Age: 25.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Pain, Pregnancy test positive, Pyrexia, Vomiting
Clinical narrative: Initial report received on 19 January 2007 from a health care professional.  A 25-year-old female patient, who had no concurrent illnesses and no pre-existing medical conditions, but who did have a positive pregnancy test on 17 January 2007, had received a first dose, left arm, subcutaneous injection of YF-VAX, lot number UE913AA, and a first oral dose of Vivotif, manufacturer reported, lot number 3001139, on 16 January 2007 at 11:30 am. The following day, at 15:00 pm, the patient experienced body pain, abdominal pain, vomiting, dizziness, fever (temperature not reported), and diarrhea. She was taken to the emergency room and a pregnancy test was positive. Treatment received and other diagnostic testings performed were not reported. It was reported that the patient had not experienced any adverse events with prior vaccinations. The date of the patient's last menstrual period and the expected date of delivery were not reported. The recovery status of the patient was unknown at the time of this report. Follow-up information received on 12 February 2007 from a health care professional. The patient reported she was menstruating at the time of the vaccinations on 16 January 2007, and the following day, contracted the reporter by phone stating she had a spontaneous abortion. Reportedly, the patient fully recovered. No diagnostic test's were performed as far as this reporter knew.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Dyspnoea, Swelling face
Clinical narrative: Initial report received on 07 February 2007, from other manufacturer (under the reference number WAES0701USA04412). Initial information had been received by the other manufacturer from a nurse (R.N.). A 4 year-old male patient with no pertinent medical history or allergies, received on 23 January 2007 fourth intra-muscular dose of IPOL (lot number unknown), 0.5 ml subcutaneous first dose of ProQuad (lot number 655752/1122F), fifth intra-muscular dose of Tripedia (U1813AB). There was no illness at the time of vaccination. On 23 January 2007, the patient remained in the department for 30-45 minutes following vaccination then went home. On the way home (also reported as fifteen minutes after the vaccination), the patient complained of a slight cough, difficulty breathing and throat pain. His mother noted facial swelling. He was returned to the clinic and was given epinephrine and Solu Medrol. He was taken to the emergency room and was discharged at 9 AM on January 2007 when he was free of symptoms. The patient went home on Benadryl and Epipen. The patient was scheduled to be seen in the allergy clinic on 26 January 2007. He recovered. It was reported that prior vaccinations with ProQuad and IPOL have been well tolerated with no adverse symptoms. The reporter considered the patient's adverse experience to be life threatening and other important medical events.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Cough, Dyspnoea, Pharyngolaryngeal pain, Swelling face
Clinical narrative: Initial report received on 07 February 2007, from other manufacturer (under the reference number WAES0701USA04412). Initial information had been received by the other manufacturer from a nurse (R.N.). A 4 year-old male patient with no pertinent medical history or allergies, received on 23 January 2007 fourth intra-muscular dose of IPOL (lot number unknown), 0.5 ml subcutaneous first dose of ProQuad (lot number 655752/1122F), fifth intra-muscular dose of Tripedia (U1813AB). There was no illness at the time of vaccination. On 23 January 2007, the patient remained in the department for 30-45 minutes following vaccination then went home. On the way home (also reported as fifteen minutes after the vaccination), the patient complained of a slight cough, difficulty breathing and throat pain. His mother noted facial swelling. He was returned to the clinic and was given epinephrine and Solu Medrol. He was taken to the emergency room and was discharged at 9 AM on January 2007 when he was free of symptoms. The patient went home on Benadryl and Epipen. The patient was scheduled to be seen in the allergy clinic on 26 January 2007. He recovered. It was reported that prior vaccinations with ProQuad and IPOL have been well tolerated with no adverse symptoms. The reporter considered the patient's adverse experience to be life threatening and other important medical events.
Sex: M
Vaccine: RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Intussusception, Rash, Vomiting
Clinical narrative: None Stated
Sex: M
Vaccine: RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: None Stated
Sex: M
Vaccine: RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Intussusception, Rash, Surgery, Vomiting
Clinical narrative: None Stated
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: LOCAL REACTION TO L DELTOID: EDEMATOUS, ERYTHEMATOUS, PRURITIS WITH TENDERNESS & WARMTH TO TOUCH X 7 DAYS. NO LAD, AFEBRILE, DECREASED ROM SEC. TO PAIN, NEURO IS INTACT. RA SIZE:23MM, LA-36MM. GIVEN BENADRYL PO Q6H, MOTRIN 800 MG  TID, WARM COMPRESS APPLY TO THE AREA.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: LOCAL REACTION TO L DELTOID: EDEMATOUS, ERYTHEMATOUS, PRURITIS WITH TENDERNESS & WARMTH TO TOUCH X 7 DAYS. NO LAD, AFEBRILE, DECREASED ROM SEC. TO PAIN, NEURO IS INTACT. RA SIZE:23MM, LA-36MM. GIVEN BENADRYL PO Q6H, MOTRIN 800 MG  TID, WARM COMPRESS APPLY TO THE AREA.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of sore arm in an 80-year-old female subject who was vaccinated with FluLaval for prophylaxis. The subject had no adverse events following receipt of prior immunizations. On 24 October 2006 the subject received unspecified dose of FluLaval in the right arm. Within approximately 3 months after vaccination with FluLaval, on an unspecified date on or after 24 October 2006 and before 16 February 2007, the subject experienced a sore right arm and was unable to lift the right arm. The subject was seen at a physician's office. The pharmacist considered the events were disabling. the outcome of the events was not reported.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Agitation, Blood test, Discomfort, Ear infection, Emotional distress
Clinical narrative: Monday 11/6/06 shots were given at doctor's office around 5:30pm. Wednesday 11/8/06 patient was becoming increasingly irritable and not sleeping well. Thursday 11/9/06 started treating patient for a suspected ear infection due to brother's cold earlier in the week and a supposed yeast infection on his penis. He was not sleeping well and only nursed for comfort. Friday 11/10/06 returned to doctor's office to verify ear infection to which we discovered both ears were clear. Decided to try a new course of treat supposed yeast infection due to uncharacteristic screaming during diaper changes. Patient continued to be inconsolable and very uncomfortable. Saturday 11/11/06 returned to doctor's office because patient continued to be inconsolable and very uncomfortable. While waiting to see the doctor I discovered patient would not put any weight on his legs and kept his legs curled in a fetal position if picked up. Upon removing his pants and diaper, we discovered his right thigh had swelled to twice the size of his left thigh and was hot to touch. Patient screamed in pain if you tried to move the right leg and we were immediately sent to the ER for a spinal tap to rule out infection. While in the ER, patient had a blood draw for a preliminary diagnosis, 4 spinal tap attempts and ultrasounds on his legs. All blood work came back negative for any infection. Concerned about the swelling cutting of circulation, patient was admitted for observation. Doctors were thinking about possibly draining the mass in his leg to help reduce the swelling and scheduled another round of ultrasounds for the morning. Patient was given Tylenol with codeine to help his sleep. Sunday 11/12/06 ultrasounds at 7am showed no fluid in the mass so drainage was possible. Patient was discharged around noon with directions to administer the Tylenol with codeine for pain management, keep warm compresses on the leg and have warm baths during which we should try to move the leg to improve circulation. After about 6 weeks the swelling and pain was completely gone but there are still issues with movement and flexibility. Doctors don't think this will continue to be a problem.  6/22/07 Received hospital med recs which reveal patient seen in ER & kept overnight for treatment/observation right thigh abscess & swelling.  Had received vax 6 days prior & fussiness/irritability persisted.  Did not develop right leg swelling w/hard tender mass until day of admission & had been seen in PCP office 1-2 x over the 6 day period.  In ER, full septic w/u done which was WNL. FINAL DX: right thigh myositis.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Fungal infection, Irritability, Lumbar puncture, Pain, Poor peripheral circulation
Clinical narrative: Monday 11/6/06 shots were given at doctor's office around 5:30pm. Wednesday 11/8/06 patient was becoming increasingly irritable and not sleeping well. Thursday 11/9/06 started treating patient for a suspected ear infection due to brother's cold earlier in the week and a supposed yeast infection on his penis. He was not sleeping well and only nursed for comfort. Friday 11/10/06 returned to doctor's office to verify ear infection to which we discovered both ears were clear. Decided to try a new course of treat supposed yeast infection due to uncharacteristic screaming during diaper changes. Patient continued to be inconsolable and very uncomfortable. Saturday 11/11/06 returned to doctor's office because patient continued to be inconsolable and very uncomfortable. While waiting to see the doctor I discovered patient would not put any weight on his legs and kept his legs curled in a fetal position if picked up. Upon removing his pants and diaper, we discovered his right thigh had swelled to twice the size of his left thigh and was hot to touch. Patient screamed in pain if you tried to move the right leg and we were immediately sent to the ER for a spinal tap to rule out infection. While in the ER, patient had a blood draw for a preliminary diagnosis, 4 spinal tap attempts and ultrasounds on his legs. All blood work came back negative for any infection. Concerned about the swelling cutting of circulation, patient was admitted for observation. Doctors were thinking about possibly draining the mass in his leg to help reduce the swelling and scheduled another round of ultrasounds for the morning. Patient was given Tylenol with codeine to help his sleep. Sunday 11/12/06 ultrasounds at 7am showed no fluid in the mass so drainage was possible. Patient was discharged around noon with directions to administer the Tylenol with codeine for pain management, keep warm compresses on the leg and have warm baths during which we should try to move the leg to improve circulation. After about 6 weeks the swelling and pain was completely gone but there are still issues with movement and flexibility. Doctors don't think this will continue to be a problem.  6/22/07 Received hospital med recs which reveal patient seen in ER & kept overnight for treatment/observation right thigh abscess & swelling.  Had received vax 6 days prior & fussiness/irritability persisted.  Did not develop right leg swelling w/hard tender mass until day of admission & had been seen in PCP office 1-2 x over the 6 day period.  In ER, full septic w/u done which was WNL. FINAL DX: right thigh myositis.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Screaming, Skin warm, Sleep disorder, Ultrasound scan, Weight bearing difficulty
Clinical narrative: Monday 11/6/06 shots were given at doctor's office around 5:30pm. Wednesday 11/8/06 patient was becoming increasingly irritable and not sleeping well. Thursday 11/9/06 started treating patient for a suspected ear infection due to brother's cold earlier in the week and a supposed yeast infection on his penis. He was not sleeping well and only nursed for comfort. Friday 11/10/06 returned to doctor's office to verify ear infection to which we discovered both ears were clear. Decided to try a new course of treat supposed yeast infection due to uncharacteristic screaming during diaper changes. Patient continued to be inconsolable and very uncomfortable. Saturday 11/11/06 returned to doctor's office because patient continued to be inconsolable and very uncomfortable. While waiting to see the doctor I discovered patient would not put any weight on his legs and kept his legs curled in a fetal position if picked up. Upon removing his pants and diaper, we discovered his right thigh had swelled to twice the size of his left thigh and was hot to touch. Patient screamed in pain if you tried to move the right leg and we were immediately sent to the ER for a spinal tap to rule out infection. While in the ER, patient had a blood draw for a preliminary diagnosis, 4 spinal tap attempts and ultrasounds on his legs. All blood work came back negative for any infection. Concerned about the swelling cutting of circulation, patient was admitted for observation. Doctors were thinking about possibly draining the mass in his leg to help reduce the swelling and scheduled another round of ultrasounds for the morning. Patient was given Tylenol with codeine to help his sleep. Sunday 11/12/06 ultrasounds at 7am showed no fluid in the mass so drainage was possible. Patient was discharged around noon with directions to administer the Tylenol with codeine for pain management, keep warm compresses on the leg and have warm baths during which we should try to move the leg to improve circulation. After about 6 weeks the swelling and pain was completely gone but there are still issues with movement and flexibility. Doctors don't think this will continue to be a problem.  6/22/07 Received hospital med recs which reveal patient seen in ER & kept overnight for treatment/observation right thigh abscess & swelling.  Had received vax 6 days prior & fussiness/irritability persisted.  Did not develop right leg swelling w/hard tender mass until day of admission & had been seen in PCP office 1-2 x over the 6 day period.  In ER, full septic w/u done which was WNL. FINAL DX: right thigh myositis.
Age: 0.24
Sex: F
Vaccine: RV5
Symptoms: Bacteraemia, Biopsy, Differential white blood cell count, Full blood count, Nuclear magnetic resonance imaging
Clinical narrative: Rt humerous osteomyelitis, strep pneumococcus bacteremia.  3/22/07 Received medical records from PCP which were vax record, labs & d/c summary from hospital. 3/22/07 Received medical records from hospital which reveal patient experienced pain & decreased ROM of right shoulder.  Seen by PCP & referred to Ortho.  Seen in ER for MRI & labs & then d/c to home.  Returned to ER for repeat MRI on 2/7/07 & was admitted.  No fever.  Nasal congestion & rhinorrhea x 1 wk prior to admit.  PICC line placed for long term antibiotics at home & was to receive serial MRIs & ESRs.  Ortho performed a glenohumeral joint aspiration, c/s pending. FINAL DX: Osteomyelitis of right shoulder; joint effusion right shoulder; synovitis; & lymph node enlargement; & strep pneumoniae bacteremia.
Age: 0.24
Sex: F
Vaccine: RV5
Symptoms: Osteomyelitis, Pneumonia streptococcal, X-ray
Clinical narrative: Rt humerous osteomyelitis, strep pneumococcus bacteremia.  3/22/07 Received medical records from PCP which were vax record, labs & d/c summary from hospital. 3/22/07 Received medical records from hospital which reveal patient experienced pain & decreased ROM of right shoulder.  Seen by PCP & referred to Ortho.  Seen in ER for MRI & labs & then d/c to home.  Returned to ER for repeat MRI on 2/7/07 & was admitted.  No fever.  Nasal congestion & rhinorrhea x 1 wk prior to admit.  PICC line placed for long term antibiotics at home & was to receive serial MRIs & ESRs.  Ortho performed a glenohumeral joint aspiration, c/s pending. FINAL DX: Osteomyelitis of right shoulder; joint effusion right shoulder; synovitis; & lymph node enlargement; & strep pneumoniae bacteremia.
Age: 1.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Hypotension, Rash, Sepsis, Varicella, Virus culture
Clinical narrative: Disseminated varicella, rash, hypotension, Hospitalized 45 days treated with Acyclovir, Foscarnet, as well as Tobramycin and vancomycin and cuspofungim for septic episodes.  Verified AE onset date (box 11) as 10/10/2006 (not 2007). 03/06/2007 Extensive MR received for a 45 day hospitalization for disseminated varicella following vaccination.  The child was also experiencing a septic-like episode with poor color, poor perfusion and low blood pressure on the day of admission. PE: Listless with weak cry, perfusion improved from earlier with BP of 110s/70s. However peripheral perfusion remains poor with cap refill of 7-8 seconds. Intraoral varicella lesions with oral candidiasis on her tongue and buccal mucosa. Intra-auditory canal varicella lesions. Diffuse scattered varicella lesions which appear to have a mild superinfection.  GJ tube insertion has mild erythema. Liver and spleen enlarged. Otherwise, the child appears ill, but exam is grossly non-focal. She was admitted to the PICU and treated with Tobramycin, Vancomycin, Acyclovir, Foscarnet, and Caspofungin. Pain control was also initiated with a ketamine and benzodiazapine drip. She initially responded to the Acyclovir but began developing new lesions again on 11/08/2006.  Hypertension developed early on in the hospitalization without known cause, and treated with multiple anti-hypertensives. She was discharged after 45 days with frequent F/U in the heme/onc clinic with occasional varicella eruptions.  Chemotherapy was resumed on 2/1/07. Assessment:  Disseminated varicella, status post vaccination in an immunocompromised host.  Langerhans cell histiocytosis.  Chemotherapy-currently on hold.  Malnutrition, requiring gastrostomy tube feeds. Hypertension of unknown etiology.  History of developmental delay.  Narcotic and benzodiazapine wean.  History of gram (-) spectrum beta lactamase blood cultures.  Stable hepatosplenomegaly.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Culture stool, Haematochezia
Clinical narrative: Rotateq oral vaccine given 2/13/07 at well child exam.  Blood stool passed this a.m. 2/17/07 x 1 stool.
Age: 1.08
Sex: F
Vaccine: FLU3, MMR, PNC
Symptoms: Varicella
Clinical narrative: was diagnosed with chicken pox a month after getting Proquad
Age: 0.35
Sex: M
Vaccine: DTAP, HEP, OPV, PPV
Symptoms: Crying, Discomfort, Pyrexia, Vomiting
Clinical narrative: Vaccinations adminstered Friday morning at approx. 10:30am.  For the following 12 hours, patient experienced discomfort and moderately high temperatures (100 - 101 deg.).  However throughout the weekend and into Monday morning, patient had crying fits for 1.5 - 2 hours at a time, high fevers, generally 101-102 deg (high of 103.5 at one point), and he began vomitting his bottle after each feeding.  We have remianed in contact with a Nurse, as well as a physician from the pediatricians office.
Age: 15.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Blood glucose, Fall, Grand mal convulsion, Injury, Oxygen supplementation
Clinical narrative: Immediately following vaccination at 0840, patient walked out to nursing station to receive vaccination record, when she fainted, hitting her forehead on the counter and falling to the floor. She exhibited appoximately 15 seconds of generalized tonic-clonic seizure activity, then became responsive within the next 15 seconds. Face mask O2 was administered, despite an O2 saturation of 94%, HR 70. She remained supine while a blood glucose was obtained with difficulty due to vasoconstriction of peripheral extremities. Glucose approximately 10 minutes post-event of 88g/dL. VS 15 minutes post-event in sitting position: T 98.0, BP 104/64, P75, O2 sat 97%. Electrolyte solution offered PO. 45 minutes post-event, patient discharged in stable condition.
Age: 15.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Immediately following vaccination at 0840, patient walked out to nursing station to receive vaccination record, when she fainted, hitting her forehead on the counter and falling to the floor. She exhibited appoximately 15 seconds of generalized tonic-clonic seizure activity, then became responsive within the next 15 seconds. Face mask O2 was administered, despite an O2 saturation of 94%, HR 70. She remained supine while a blood glucose was obtained with difficulty due to vasoconstriction of peripheral extremities. Glucose approximately 10 minutes post-event of 88g/dL. VS 15 minutes post-event in sitting position: T 98.0, BP 104/64, P75, O2 sat 97%. Electrolyte solution offered PO. 45 minutes post-event, patient discharged in stable condition.
Age: 72.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Finished ral typhoid on Tuesday. Became feverish and achy on Thursday, with "violent chills". Symptoms subsided on Sunday.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Oedema
Clinical narrative: Patient complained of pain where vaccine administered.  Site assessed and noted to be edematous (size of tennis ball per nurse).  Ice compress applied and Darvocet N 100 given for pain. Physician was informed and a picture of the reaction was taken
Age: 61.0
Sex: M
Vaccine: MNQ, PPV, TD
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: No adverse event occurred.  Patient given Menactra out of age limit.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain, Physiotherapy, X-ray
Clinical narrative: Pt was vaccinated on right arm for pneumovax (Mecrk) and left arm for FLUARIX on 10/25/06. She presented to clinic on 1/4/07 c/o right shoulder pain that she claimed to have persisted since date of immunization. She subsequently followed up with her physician for imaging/xrays. She is now attending physical therapy for the arm as ordered by her physician, she reports.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP
Symptoms: Vaginal haemorrhage
Clinical narrative: pt recieved HPV #1 on 1/25/07 since vaccine has had period for past 22 days. has not had issues with vaginal bleeding between period before vaccine.
Age: 5.0
Sex: F
Vaccine: PNC
Symptoms: Headache, Pyrexia
Clinical narrative: Patient developed headaches and fever after 24 hours of receiving meningococcal vaccine.  I took her to the doctor on 2/16/07.  today is monday 2/19/07. She still has Fever and she is congested. We have gave her motrin for the fever.  But the fever comes back. 100.3F.on monday 2/19/07. time 06:30pm. I call the doctor.  She denies that the fever is a side effect from the vaccine.The doctor Suggests to take her to the ER depto. Or come back and see her the next day.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Musculoskeletal pain, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: On 2/1/07, complained of right upper arm being sore and slightly red. On 2/2 complained of increased redness, swelling and itching to right upper arm.  T-97.7.  Took ibuprofen 800mg and applied ice to the area.  Began Benadryl 50 mg at bedtime and Levaquin 50 mg daily x 10 days. On 2/12 stopped ibuprofen and started Naprosyn 500 mg and physical therapy for shoulder pain.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Disturbance in attention, Dysphemia, Electrocardiogram, Nuclear magnetic resonance imaging, Postictal state
Clinical narrative: Day after receiving immunizations patient had 3 episodes of syncope, one of which having post ictal like state.  Patient has also experienced stuttering and word finding episodes. 02/27/07-records received and reviewed for DOS 2/15/07- Assessment:3 episodes of syncope followed by 12 hour period of neurologic deficits consisting of word finding and stuttering. Differential diagnosis is board, concerned about a cardiac arrhythmia versus some sort of neurologic event. Shortness of breath is a concern for a cardiac origin or may be due to her asthma. To see cardiologist.  Previous fainting spell six month ago. Day after vaccines fainted 3 times, nauseated prior to fainting, sat a table not responding then fainted again, face white, lips blue.   C/O shortness of breath on exertion over past several months and now short of breath climbing stairs.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Syncope, Urine analysis
Clinical narrative: Day after receiving immunizations patient had 3 episodes of syncope, one of which having post ictal like state.  Patient has also experienced stuttering and word finding episodes. 02/27/07-records received and reviewed for DOS 2/15/07- Assessment:3 episodes of syncope followed by 12 hour period of neurologic deficits consisting of word finding and stuttering. Differential diagnosis is board, concerned about a cardiac arrhythmia versus some sort of neurologic event. Shortness of breath is a concern for a cardiac origin or may be due to her asthma. To see cardiologist.  Previous fainting spell six month ago. Day after vaccines fainted 3 times, nauseated prior to fainting, sat a table not responding then fainted again, face white, lips blue.   C/O shortness of breath on exertion over past several months and now short of breath climbing stairs.
Age: 1.09
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Patient was born in Venezuela.  We do not know where she rec'd varicella vaccine.  No fever, mild break-through disease-11 lesions.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: LA red, pain and itching, mild swelling
Age: 1.5
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, IPV, PNC
Symptoms: C-reactive protein increased, Haemoglobin normal, Oedema peripheral, Pyrexia, Rash erythematous
Clinical narrative: Patient developed fever 101-102 F erythematous skin rash and swelling of the face, the hands and the legs.
Age: 1.5
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, IPV, PNC
Symptoms: Swelling face, Virus serology test, White blood cell count
Clinical narrative: Patient developed fever 101-102 F erythematous skin rash and swelling of the face, the hands and the legs.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Apnoeic attack, Death, Livedo reticularis, Lividity, Loss of consciousness
Clinical narrative: Information has been received concerning a 2-month-old female with no medical history who on 10-JAN-2007, at approximately 10:30, was vaccinated PO with the first dose of Rotateq (Lot #655082/0779F). Concomitant vaccinations administered on that same day ant time included the first IM dose in the lower right thigh of Comvax (lot #654424/0268F), the first IM dose in the left thigh of Tripedia (Lot #U1965BA), the first SC dose in the left arm of Ipol (lot Y1032) and the first IM dose in the right upper thigh of Prevnar (lot #B08658F). There was no illness or other concomitant drug therapy at the time of vaccination. On 13-JAN-2007, at approximately 0500, the patient was dead on arrival at the Emergency Room. Additional information via medical records concerning a 9 week old female revealed the EMS responded to a call from the patients aunt indication that she was pulseless and apneic. The patient's aunt noted that the patient was on her stomach and that a small amount of milk was coming from the mouth. Upon arrival EMS noted that the patient was wrapped in a blanket and was unconscious, unresponsive, pulseless and apneic. Her pupils were fixed and dilated with rigidity and lividity of her extremities. There was also mottling of her skin and blood pooling noted. There was no sign of obvious trauma or injury. The patient was transported to the ER for pronouncement. The cause of death was unknown. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Muscle rigidity, Mydriasis, Pulse absent, Pupil fixed, Unresponsive to stimuli
Clinical narrative: Information has been received concerning a 2-month-old female with no medical history who on 10-JAN-2007, at approximately 10:30, was vaccinated PO with the first dose of Rotateq (Lot #655082/0779F). Concomitant vaccinations administered on that same day ant time included the first IM dose in the lower right thigh of Comvax (lot #654424/0268F), the first IM dose in the left thigh of Tripedia (Lot #U1965BA), the first SC dose in the left arm of Ipol (lot Y1032) and the first IM dose in the right upper thigh of Prevnar (lot #B08658F). There was no illness or other concomitant drug therapy at the time of vaccination. On 13-JAN-2007, at approximately 0500, the patient was dead on arrival at the Emergency Room. Additional information via medical records concerning a 9 week old female revealed the EMS responded to a call from the patients aunt indication that she was pulseless and apneic. The patient's aunt noted that the patient was on her stomach and that a small amount of milk was coming from the mouth. Upon arrival EMS noted that the patient was wrapped in a blanket and was unconscious, unresponsive, pulseless and apneic. Her pupils were fixed and dilated with rigidity and lividity of her extremities. There was also mottling of her skin and blood pooling noted. There was no sign of obvious trauma or injury. The patient was transported to the ER for pronouncement. The cause of death was unknown. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Apnoea, Death, Livedo reticularis, Lividity, Loss of consciousness
Clinical narrative: Information has been received concerning a 2-month-old female with no medical history who on 10-JAN-2007, at approximately 10:30, was vaccinated PO with the first dose of Rotateq (Lot #655082/0779F). Concomitant vaccinations administered on that same day ant time included the first IM dose in the lower right thigh of Comvax (lot #654424/0268F), the first IM dose in the left thigh of Tripedia (Lot #U1965BA), the first SC dose in the left arm of Ipol (lot Y1032) and the first IM dose in the right upper thigh of Prevnar (lot #B08658F). There was no illness or other concomitant drug therapy at the time of vaccination. On 13-JAN-2007, at approximately 0500, the patient was dead on arrival at the Emergency Room. Additional information via medical records concerning a 9 week old female revealed the EMS responded to a call from the patients aunt indication that she was pulseless and apneic. The patient's aunt noted that the patient was on her stomach and that a small amount of milk was coming from the mouth. Upon arrival EMS noted that the patient was wrapped in a blanket and was unconscious, unresponsive, pulseless and apneic. Her pupils were fixed and dilated with rigidity and lividity of her extremities. There was also mottling of her skin and blood pooling noted. There was no sign of obvious trauma or injury. The patient was transported to the ER for pronouncement. The cause of death was unknown. No further information is available.
Age: 56.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Blood test, Cellulitis, Erythema, Myalgia, Oedema peripheral
Clinical narrative: Muscle aches, red, swollen arm and face. Treated empirically as cellulitis.  See CN for details.
Age: 56.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Swelling face
Clinical narrative: Muscle aches, red, swollen arm and face. Treated empirically as cellulitis.  See CN for details.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Haemorrhage, Rectal haemorrhage
Clinical narrative: Information has been received from a health professional concerning her 13 year old female cousin with pertinent medical history and drug reactions/allergies not specified who in approximately February 2007, was vaccinated with Gardasil (Lot # not reported) 0.5 ml. Concomitant therapy was unspecified. In approximately February 2007, the patient experienced "internal bleeding throughout her body" after being vaccinated with Gardasil. The bleeding presented initially as bruising and most recently as rectal bleeding. Medical attention was sought. On an unspecified date, the patient was hospitalized. At the time of reporting, the patient had not recovered. The patient's internal bleeding, bruising, and rectal bleeding were reported as immediately life threatening and disabling events No further information was available at the tiem of reporting. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Bronchiolitis, Herpes zoster, Rash, Respiratory syncytial virus infection
Clinical narrative: Information has been received from a nurse practitioner reporting that on 01-SEP-2006 a 12 month old male was vaccinated with Varivax (lot #653964/0590F). The patient was also given Comvax. Approximately three months later in approximately December 2006, the patient developed a shingles-like rash on the right leg. Also, the patient was diagnosed with bronchiolitis. The patient was prescribed ACYCLOVIR for the rash. The patient sought unspecified medical attention. The patient was reported to be recovering. There was no product quality complaint. Follow-up information was obtained from the nurse practitioner who indicated that the patient (infant male weighting 22.1 lbs and 30.25 inches in height) came in for a 15 month check up. On 24-JAN-2007, the patient developed a rash on his right leg. The reporter said that the rash was consistent with shingles on right leg. It was reported that the patient is a healthy 15 month old with bronchiolitis. The patient is on therapy with Albuterol. The patient was recently hospitalized for bronchiolitis-RSV. The patient recovered. Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus
Clinical narrative: Information has been received from a physician concerning an approximately 9 month old male who was vaccinated with a first, second, and third dose of Rotateq on 08-JUN-2006, 25-AUG-2006 and 20-OCT-2006, respectively. Concomitant unspecified vaccines were given at the same time. "About a week ago," on approximately 02-FEB-2007 the patient experienced rotavirus and was hospitalized. The time frame of the hospitalization was unspecified. It was reported that the patient's father also came down with rotavirus, but did not have to be hospitalized. No product quality complaint was involved. No other information was provided. The patient's twin sister experienced rotavirus following vaccination with Rotateq (WAES0702USA02548). Additional information has been requested.
Age: 0.92
Sex: U
Vaccine: HIBV
Symptoms: Haemophilus infection, Meningitis, Vaccination failure
Clinical narrative: It was reported in a published article, title as stated above that  a 10.5 month-old patient who was born prematurely, had a true vaccination failure (TVF) developed invasive Hib disease, also referred as meningitis, only 11 days after receipt of vaccine. The patient had been vaccinated with a first dose of PEDVAXHIB (manufacturer unknown) at 1.4 months of age, the patient was given a second dose of Hib conj vaccine (manufacturer unknown) at 5.4 months of age and a third dose of Hib conj vaccine (manufacturer unknown) was given 11 days before the illness. No further information was available at the time of this report. No outcome information was reported. upon internal review, invasive Hib disease/meningitis was determined to be an other important medical event. Additional information has been requested.
Age: 0.42
Sex: U
Vaccine: HIBV
Symptoms: Haemophilus infection, Meningitis, Vaccination failure
Clinical narrative: It was reported in a published article, title as stated above that a 4.6 month old patient who was born prematurely, had a total vaccination failure and developed invasive Hib disease, also referred to as meningitis, only 11 days after receipt of a second dose of PedvaxHib (manufacturer unknown) at 1.5 months of age. No further information was available at the time of this report. No outcome information was reported. Upon internal review, invasive Hib disease/meningitis has been determined to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Haemophilus infection, Meningitis, Vaccination failure
Clinical narrative: It was reported in a published article, title as stated above that 6 children experienced true vaccination failure and developed invasive Hib disease, also referred to as meningitis, despite completing the primary series and receiving a booster dose of PedvaxHib (manufacturer unknown) after one year of age. None of the patients had any risk factors. No further information was available at the time of this report. No outcome information was reported. Upon internal review, invasive Hib disease/meningitis was determined to be an other important medical event. Additional information has been requested.