chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Full blood count, Irritability, Laboratory test, Laboratory test normal, Leukocytosis
Clinical narrative: Baby became very pale, white lips 3 brief seizures (2) hospitalizations - for decrease appetite, increase irritability poor eye contact, loss of verbal coo / 8 only - on day 4 after event - resolving symptoms. Seen in ER awake, alert, PE WNL. labs negative. CSF negative. Blood culture leukocytosis. MRI normal. EEG normal.  5/25/07-no DC summary only progress note available for short stay. received progress note Impression. new onset seizure times three without recurrence. question abnormal behavior, not seen here.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Nuclear magnetic resonance imaging normal, Pallor
Clinical narrative: Baby became very pale, white lips 3 brief seizures (2) hospitalizations - for decrease appetite, increase irritability poor eye contact, loss of verbal coo / 8 only - on day 4 after event - resolving symptoms. Seen in ER awake, alert, PE WNL. labs negative. CSF negative. Blood culture leukocytosis. MRI normal. EEG normal.  5/25/07-no DC summary only progress note available for short stay. received progress note Impression. new onset seizure times three without recurrence. question abnormal behavior, not seen here.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: At one month post injection pt was having continued pain at injection site. At two months, not much improvement.  Difficulty moving arm. Refused 2nd and 3rd injection because of this reaction.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Rash
Clinical narrative: rash-small spots broke out day 10
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, TD
Symptoms: Injection site erythema, Injection site haemorrhage
Clinical narrative: Some bleeding at the site with slight redness-no temp. Bandaid applied. Mother called and advised-no swelling noted by mother.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Varicella
Clinical narrative: Vaccine induced eruption (mild) after recommended varicella vaccine. One lesion on left arm, right leg, left neck, 3 mm and minor itch.
Age: 48.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Pt received Hep A and Tdap in the right arm. Six days later, pt developed redness, warmth, pain and hard area at the point of Tdap and down to elbow, approx 20 cm. Pt used ice and ibuprofen. Pt seen on day 7 improved.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: Within 15 minutes of injection patient developed urticaria, swelling, redness, pain, diaphoresis, headache, and nausea. Patient was given Benadryl 50mg and Motrin 800mg within 30 mins of the injection. The patient received a steroid pack with rapid improvement.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling, Urticaria
Clinical narrative: Within 15 minutes of injection patient developed urticaria, swelling, redness, pain, diaphoresis, headache, and nausea. Patient was given Benadryl 50mg and Motrin 800mg within 30 mins of the injection. The patient received a steroid pack with rapid improvement.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Injection site bruising, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: 2/27-sore, redness 3x3", bruise at injection site-AM rash, itching, burning, hurts, difficulty moving arm, cannot raise arm. 2/28-returned to ER, PA said it was a reaction. In future, may need to avoid shot. That evening fever (102 deg), swelling from shoulder to elbow. Rash grew bubbles. 3/2 felt like bugs running inside and bees stinging.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Rash, Skin burning sensation, Swelling
Clinical narrative: 2/27-sore, redness 3x3", bruise at injection site-AM rash, itching, burning, hurts, difficulty moving arm, cannot raise arm. 2/28-returned to ER, PA said it was a reaction. In future, may need to avoid shot. That evening fever (102 deg), swelling from shoulder to elbow. Rash grew bubbles. 3/2 felt like bugs running inside and bees stinging.
Age: 1.48
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: FIRST TIME SEIZURE LATER IN SAME DAY FOLLOWING INJECTION 03/16/07-records received from facility for DOS 03/05/07 Seen by PCP with cold like picture, began amoxicillin, and received flu immunization. Expereienced a shaking spell for 5-10 seconds, unresponsive, limp. Seen in ER somnolent and irritable. VS unremarkable. Temp99.  Impression:febrile convulsion or adverse reaction to immunization of flu vaccine. Bronchitis.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL, VARCEL
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Erythema - 12 cm and Induration - 4 cm around injection site.  No fever.  Started evening after administration.  Measured 2 days after administration 02/11/2010 Initial and follow up information has been received from a physician concerning a 7 year old male with no known allergies or pertinet medical history, wha on the morning of 05-MAR-2007 was vaccinated SC in the left thigh with second dose of VARIVAX (lot # 654526/1141P). Concomitant vaccineation included a first dose of VAQTA (lot # 656497/1213F) given IM in the left vastus lateralis. THere was no illness at the time of vaccination. Subsequently, that evening, the patient developed a local site reaction 12 x 12 cm erythema and 4 x 4 cm induration around the VARIVAX (lot # 654526/1141P) injection site (also reported to be a fairly large local reaction ). There were no lab test performed. The patietn was treated with KEFLEX. The signs and symptomas resolved "in a few days." THe patient was considered recovered. In follow-up, it was reported the reaction resolved repidly. The patient had no adverse events following prior vaccination. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Erythema - 12 cm and Induration - 4 cm around injection site.  No fever.  Started evening after administration.  Measured 2 days after administration 02/11/2010 Initial and follow up information has been received from a physician concerning a 7 year old male with no known allergies or pertinet medical history, wha on the morning of 05-MAR-2007 was vaccinated SC in the left thigh with second dose of VARIVAX (lot # 654526/1141P). Concomitant vaccineation included a first dose of VAQTA (lot # 656497/1213F) given IM in the left vastus lateralis. THere was no illness at the time of vaccination. Subsequently, that evening, the patient developed a local site reaction 12 x 12 cm erythema and 4 x 4 cm induration around the VARIVAX (lot # 654526/1141P) injection site (also reported to be a fairly large local reaction ). There were no lab test performed. The patietn was treated with KEFLEX. The signs and symptomas resolved "in a few days." THe patient was considered recovered. In follow-up, it was reported the reaction resolved repidly. The patient had no adverse events following prior vaccination. Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Arthralgia, Back pain, Musculoskeletal pain, Oedema peripheral, Pain in extremity
Clinical narrative: Client states that she started having soreness in her left arm the evening of 1-25-07.  She continues to have soreness in her left arm.     She also has pain in her left shoulder, left elbow, left inner arm (near elbow), and left lower back.  Client states that she also had fluid on her knees and in her legs that started the third day after the injections.  Client states that she went to her physician on 2-22-07 for routine labs (cholesterol, etc.) but did not receive any treatment for her left arm and shoulder.  Client returned to physician on 2-28-07.  Client received a flu shot on 11-2-06.  States no other injections between 11-2-06 and 1-25-07.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLU3, HPV4
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: First seizure 10 days after first gardasil vaccine.  Two months later, second seizure episode 16 days after second gardasil.  08/22/2008 MR received from Neuro consult dated 12/22/06 (as well as some past hx.) Assessment: 1st Seizure.  Most likely a complex partial seizure with secondary generalization. Pt was trying to speak but unable to do so, then had a 30-40 sec grand mal seizure which may have begun in the legs. Neuro exam WNL. 9/11/2008 2 ER recs received dated 12/21/2006 and 6/16/2007 with DX: 1st seizure and seizure.  Pt 1st presented 12/21/06 following 30-40 sec seizure.  Seen 6/17/07 after 2 episodes of lip quivering and feeling of throat closing which was a similar aura with last grand mal seizure. C/o headache after.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLU3, HPV4
Symptoms: Convulsion, Vaccine positive rechallenge
Clinical narrative: First seizure 10 days after first gardasil vaccine.  Two months later, second seizure episode 16 days after second gardasil.  08/22/2008 MR received from Neuro consult dated 12/22/06 (as well as some past hx.) Assessment: 1st Seizure.  Most likely a complex partial seizure with secondary generalization. Pt was trying to speak but unable to do so, then had a 30-40 sec grand mal seizure which may have begun in the legs. Neuro exam WNL. 9/11/2008 2 ER recs received dated 12/21/2006 and 6/16/2007 with DX: 1st seizure and seizure.  Pt 1st presented 12/21/06 following 30-40 sec seizure.  Seen 6/17/07 after 2 episodes of lip quivering and feeling of throat closing which was a similar aura with last grand mal seizure. C/o headache after.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLU3, HPV4
Symptoms: Convulsion, Electroencephalogram normal, Gaze palsy, Laboratory test, Loss of consciousness
Clinical narrative: First seizure 10 days after first gardasil vaccine.  Two months later, second seizure episode 16 days after second gardasil.  08/22/2008 MR received from Neuro consult dated 12/22/06 (as well as some past hx.) Assessment: 1st Seizure.  Most likely a complex partial seizure with secondary generalization. Pt was trying to speak but unable to do so, then had a 30-40 sec grand mal seizure which may have begun in the legs. Neuro exam WNL. 9/11/2008 2 ER recs received dated 12/21/2006 and 6/16/2007 with DX: 1st seizure and seizure.  Pt 1st presented 12/21/06 following 30-40 sec seizure.  Seen 6/17/07 after 2 episodes of lip quivering and feeling of throat closing which was a similar aura with last grand mal seizure. C/o headache after.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLU3, HPV4
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: First seizure 10 days after first gardasil vaccine.  Two months later, second seizure episode 16 days after second gardasil.  08/22/2008 MR received from Neuro consult dated 12/22/06 (as well as some past hx.) Assessment: 1st Seizure.  Most likely a complex partial seizure with secondary generalization. Pt was trying to speak but unable to do so, then had a 30-40 sec grand mal seizure which may have begun in the legs. Neuro exam WNL. 9/11/2008 2 ER recs received dated 12/21/2006 and 6/16/2007 with DX: 1st seizure and seizure.  Pt 1st presented 12/21/06 following 30-40 sec seizure.  Seen 6/17/07 after 2 episodes of lip quivering and feeling of throat closing which was a similar aura with last grand mal seizure. C/o headache after.
Age: 45.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: 12/28/06 Td given in left deltoid, influenza given in right deltoid. Email from patient (coworker)to county nurse on 2/15/07 stating, "Right after I got the tetanus shot, the arm I got it in got really sore which I expected.  Unfortunately, the pain hasn't gone away and I'm having problems straightening my arm out.  I know I didn't injure the elbow or strain it but I just can't get rid of the pain in the elbow and now the wrist is starting to bug me." We referred the individual to her primary care physician. pc to patient on 3/5/07 found that patient did not seek medical attention. She states now she occasionally needs to pick her left arm up with her right one to move it.
Age: 0.48
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Explorative laparotomy, Intussusception, Laparotomy
Clinical narrative: Intussusception with exploratory laparotomy with right hemicolectomy and partial ileectomy. 03/15/07-records received from facility for DOS 2/3-2/10/07 DC DX: Intussusception status post right hemicolectomy.  Previously healthy infant developed emesis and bloody mucoid stools PE:WNL except for abdomen large palpable mass in mid left which was mobile, somewhat tender to palpation and firm.  Right hemicolectomy 2/4/07-
Age: 0.48
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal mass, Barium enema, Colectomy, Haematochezia, Intussusception
Clinical narrative: Intussusception with exploratory laparotomy with right hemicolectomy and partial ileectomy. 03/15/07-records received from facility for DOS 2/3-2/10/07 DC DX: Intussusception status post right hemicolectomy.  Previously healthy infant developed emesis and bloody mucoid stools PE:WNL except for abdomen large palpable mass in mid left which was mobile, somewhat tender to palpation and firm.  Right hemicolectomy 2/4/07-
Age: 0.48
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laparotomy, Mucous stools, Surgery, Tenderness, Ultrasound abdomen abnormal
Clinical narrative: Intussusception with exploratory laparotomy with right hemicolectomy and partial ileectomy. 03/15/07-records received from facility for DOS 2/3-2/10/07 DC DX: Intussusception status post right hemicolectomy.  Previously healthy infant developed emesis and bloody mucoid stools PE:WNL except for abdomen large palpable mass in mid left which was mobile, somewhat tender to palpation and firm.  Right hemicolectomy 2/4/07-
Age: 0.48
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Intussusception with exploratory laparotomy with right hemicolectomy and partial ileectomy. 03/15/07-records received from facility for DOS 2/3-2/10/07 DC DX: Intussusception status post right hemicolectomy.  Previously healthy infant developed emesis and bloody mucoid stools PE:WNL except for abdomen large palpable mass in mid left which was mobile, somewhat tender to palpation and firm.  Right hemicolectomy 2/4/07-
Age: 0.48
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laparotomy, Surgery, Tenderness, Vomiting
Clinical narrative: Intussusception with exploratory laparotomy with right hemicolectomy and partial ileectomy. 03/15/07-records received from facility for DOS 2/3-2/10/07 DC DX: Intussusception status post right hemicolectomy.  Previously healthy infant developed emesis and bloody mucoid stools PE:WNL except for abdomen large palpable mass in mid left which was mobile, somewhat tender to palpation and firm.  Right hemicolectomy 2/4/07-
Age: 88.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: PT WAS ADMITTED TO HOSPITAL FOR THE FOLLOWING SX'S; FEVER, CHILLS, NAUSEA, SWELLING, REDNESS AND WARMTH AT INJECTION SITE. 03/12/07-records received from facility- Admitted with fevers and cough, decreased appetite and nausea. No shortness of breath.
Age: 88.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: PT WAS ADMITTED TO HOSPITAL FOR THE FOLLOWING SX'S; FEVER, CHILLS, NAUSEA, SWELLING, REDNESS AND WARMTH AT INJECTION SITE. 03/12/07-records received from facility- Admitted with fevers and cough, decreased appetite and nausea. No shortness of breath.
Age: 83.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Nausea, Oedema peripheral, Skin irritation, Skin warm
Clinical narrative: 83 YO FEMALE C/O NAUSEA,REDNESS, SWELLING, IRRITATION AND WARMTH LEFT DELTOID
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Joint stiffness, Musculoskeletal stiffness
Clinical narrative: RECEIVED HEPATITIS B VACCINE ON 03/05/07 AND WITHIN A DAY HAD SYMPTOMS OF STIFF NECK AND STIFF ARM.
Age: 44.0
Sex: U
Vaccine: ANTH
Symptoms: Flushing, Hyperhidrosis, Injection site reaction, Vasoconstriction, Vertigo
Clinical narrative: Third in series, caused full body flushing, diaphoresis, vertigo, full arm vasoconstriction, 6-8cm tissue "puckering" at injection site which later sloughed off/scaled for about 2-3 mos.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Pain
Clinical narrative: Local site L deltoid upper region 2" diameter induration; redness.  No fluctuation.  No axillary nodes.  Pain+
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Blood glucose increased, Diabetes mellitus, Type 1 diabetes mellitus
Clinical narrative: Diagnosed with diabetes January 2006, started on oral meds.  Found GAD65 antibodies around June 2006, indicating autoimmune-induced diabetes and thereafter taking injected insulin.  Tests showed lots FAV038 and FAV041 contained squalene adjuvant. 7/18/07-records received from patient. 1/10/06 seen in ED with DX of new onset Diabetes. C/O polydypsia, polyuria and loss of vision. Followup 3/30/2010. Insulin-dependent diabete, expected to continue for life.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Client delayed reporting adverse reaction.  The day after receiving influenza, client reports severe hives.  Client notified PMD and was prescribed 5 days of steroids which resolved symptoms.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Inguinal hernia, Surgery
Clinical narrative: Initial report received on 28 February 2007 from another manufacturer, report number WAES0701USA03736. This manufacturer received the original report from two different health care professionals. Verbatim from report: "This is in follow up to report (s) previously submitted on 1/31/2007. Information has been received from a physician and a registered nurse (RN) concerning a 9 week old male with no known allergies who on the morning of 05-DEC-2006 was vaccinated PO with the first 2.0 mL dose of Rotateq (lot # 655082/0779F). Concomitant vaccinations administered on that same day and time included the first IM dose of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid (lot # C2521AA), the first SC dose of poliovirus vaccine inactivated (Lot # 20457), the first IM dose of hepatitis B virus vaccine (+) Hib conjugate vaccine (lot # 654908/0999F), and the first IM dose of Prevnar (lot # B08646H). There was no illness at the time of vaccination. On the evening of 05-DEC-2006 (previously reported as 06-DEC-2006), the patient began crying during a diaper change. The patient's mother noted his right testicle to be edematous, hard and "purple". The patient was seen in the ER. He was subsequently hospitalized and underwent surgery fro bilateral inguinal hernias. On 06-DEC-2006, the patient was considered to be recovered as he was noted to be fine. The RN also considered the bilateral inguinal hernias to be another important medical event (OMIC). Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Inguinal hernia, Surgery, Testicular disorder, Testicular swelling
Clinical narrative: Initial report received on 28 February 2007 from another manufacturer, report number WAES0701USA03736. This manufacturer received the original report from two different health care professionals. Verbatim from report: "This is in follow up to report (s) previously submitted on 1/31/2007. Information has been received from a physician and a registered nurse (RN) concerning a 9 week old male with no known allergies who on the morning of 05-DEC-2006 was vaccinated PO with the first 2.0 mL dose of Rotateq (lot # 655082/0779F). Concomitant vaccinations administered on that same day and time included the first IM dose of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid (lot # C2521AA), the first SC dose of poliovirus vaccine inactivated (Lot # 20457), the first IM dose of hepatitis B virus vaccine (+) Hib conjugate vaccine (lot # 654908/0999F), and the first IM dose of Prevnar (lot # B08646H). There was no illness at the time of vaccination. On the evening of 05-DEC-2006 (previously reported as 06-DEC-2006), the patient began crying during a diaper change. The patient's mother noted his right testicle to be edematous, hard and "purple". The patient was seen in the ER. He was subsequently hospitalized and underwent surgery fro bilateral inguinal hernias. On 06-DEC-2006, the patient was considered to be recovered as he was noted to be fine. The RN also considered the bilateral inguinal hernias to be another important medical event (OMIC). Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Diarrhoea, Intussusception, Ultrasound scan, Vomiting
Clinical narrative: Information received on 28 February 2007 from another manufacturer, report # WAES0702USA03318. The initial reporter to this manufacturer had been the FDA. Verbatim from the report: "Information has been received from the FDA through the CDC concerning a 6 month old male with eczema and recurrent wheezing and a history of respiratory syncytial virus bronchiolitis who on 29-Jan-2007 was vaccinated PO with a second dose of Rotateq (lot # 654663/0942F). Concomitant vaccination administered that day included a IM second dose of Pediarix (lot # AC21B097AB), an IM first dose of Fluzone (lot # UT2191KA) and an IM second dose of Prevnar (lot # B08691A). There were no other medications. The patient developed explosive diarrhea and emesis shortly after the vaccines were given. On 06-Feb-2007 the patient was admitted to the hospital for worsening vomiting. On the morning of 07-Feb-2007, he was found to have intussusception. A stool culture and viral studies were to be done. An ultrasound showed ileocolic intussusception and the patient was transferred. The patient's outcome was not known. The patient's adverse events were considered to be life threatening. Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Intussusception, Ultrasound scan abnormal, Vomiting
Clinical narrative: Information received on 28 February 2007 from another manufacturer, report # WAES0702USA03318. The initial reporter to this manufacturer had been the FDA. Verbatim from the report: "Information has been received from the FDA through the CDC concerning a 6 month old male with eczema and recurrent wheezing and a history of respiratory syncytial virus bronchiolitis who on 29-Jan-2007 was vaccinated PO with a second dose of Rotateq (lot # 654663/0942F). Concomitant vaccination administered that day included a IM second dose of Pediarix (lot # AC21B097AB), an IM first dose of Fluzone (lot # UT2191KA) and an IM second dose of Prevnar (lot # B08691A). There were no other medications. The patient developed explosive diarrhea and emesis shortly after the vaccines were given. On 06-Feb-2007 the patient was admitted to the hospital for worsening vomiting. On the morning of 07-Feb-2007, he was found to have intussusception. A stool culture and viral studies were to be done. An ultrasound showed ileocolic intussusception and the patient was transferred. The patient's outcome was not known. The patient's adverse events were considered to be life threatening. Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Barium enema, Diarrhoea, Intussusception, Ultrasound scan, Ultrasound scan abnormal
Clinical narrative: Information received on 28 February 2007 from another manufacturer, report # WAES0702USA03318. The initial reporter to this manufacturer had been the FDA. Verbatim from the report: "Information has been received from the FDA through the CDC concerning a 6 month old male with eczema and recurrent wheezing and a history of respiratory syncytial virus bronchiolitis who on 29-Jan-2007 was vaccinated PO with a second dose of Rotateq (lot # 654663/0942F). Concomitant vaccination administered that day included a IM second dose of Pediarix (lot # AC21B097AB), an IM first dose of Fluzone (lot # UT2191KA) and an IM second dose of Prevnar (lot # B08691A). There were no other medications. The patient developed explosive diarrhea and emesis shortly after the vaccines were given. On 06-Feb-2007 the patient was admitted to the hospital for worsening vomiting. On the morning of 07-Feb-2007, he was found to have intussusception. A stool culture and viral studies were to be done. An ultrasound showed ileocolic intussusception and the patient was transferred. The patient's outcome was not known. The patient's adverse events were considered to be life threatening. Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information received on 28 February 2007 from another manufacturer, report # WAES0702USA03318. The initial reporter to this manufacturer had been the FDA. Verbatim from the report: "Information has been received from the FDA through the CDC concerning a 6 month old male with eczema and recurrent wheezing and a history of respiratory syncytial virus bronchiolitis who on 29-Jan-2007 was vaccinated PO with a second dose of Rotateq (lot # 654663/0942F). Concomitant vaccination administered that day included a IM second dose of Pediarix (lot # AC21B097AB), an IM first dose of Fluzone (lot # UT2191KA) and an IM second dose of Prevnar (lot # B08691A). There were no other medications. The patient developed explosive diarrhea and emesis shortly after the vaccines were given. On 06-Feb-2007 the patient was admitted to the hospital for worsening vomiting. On the morning of 07-Feb-2007, he was found to have intussusception. A stool culture and viral studies were to be done. An ultrasound showed ileocolic intussusception and the patient was transferred. The patient's outcome was not known. The patient's adverse events were considered to be life threatening. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Haematochezia, Intussusception, Irritability, Laparotomy
Clinical narrative: Initial report received on 28 February 2007 from another manufacturer, report # WAES0702USA02696. 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 24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (lot # 655175/0849F and 655296/0979F, respectively), on 20-Oct-2006, and 19-Dec-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (lot # AC2113089AA), on 20-Oct-2006 and 19-Dec-2006, respectively, a first and second intramuscular dose in the right leg of Act-HIB (lot # UE867AA), on 20-Oct-2006 and 19-Dec-2006, respectively, and a first and second intramuscular dose in the right leg of Prevnar (lot # B08646F), on 20-Oct-2006 and 19-Dec-2006, respectively. Five days prior to the onset of intussusception, on 04-Feb-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-Feb-2007, at 6:00 AM, the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception and was admitted to the hospital. A barium enema was able to partially reduce the intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-Feb-2007. The physician indicated that the patient was doing well and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening, and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Initial report received on 28 February 2007 from another manufacturer, report # WAES0702USA02696. 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 24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (lot # 655175/0849F and 655296/0979F, respectively), on 20-Oct-2006, and 19-Dec-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (lot # AC2113089AA), on 20-Oct-2006 and 19-Dec-2006, respectively, a first and second intramuscular dose in the right leg of Act-HIB (lot # UE867AA), on 20-Oct-2006 and 19-Dec-2006, respectively, and a first and second intramuscular dose in the right leg of Prevnar (lot # B08646F), on 20-Oct-2006 and 19-Dec-2006, respectively. Five days prior to the onset of intussusception, on 04-Feb-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-Feb-2007, at 6:00 AM, the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception and was admitted to the hospital. A barium enema was able to partially reduce the intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-Feb-2007. The physician indicated that the patient was doing well and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening, and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Ear infection, Gastrointestinal necrosis, Haematochezia, Intussusception
Clinical narrative: Initial report received on 28 February 2007 from another manufacturer, report # WAES0702USA02696. 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 24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (lot # 655175/0849F and 655296/0979F, respectively), on 20-Oct-2006, and 19-Dec-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (lot # AC2113089AA), on 20-Oct-2006 and 19-Dec-2006, respectively, a first and second intramuscular dose in the right leg of Act-HIB (lot # UE867AA), on 20-Oct-2006 and 19-Dec-2006, respectively, and a first and second intramuscular dose in the right leg of Prevnar (lot # B08646F), on 20-Oct-2006 and 19-Dec-2006, respectively. Five days prior to the onset of intussusception, on 04-Feb-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-Feb-2007, at 6:00 AM, the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception and was admitted to the hospital. A barium enema was able to partially reduce the intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-Feb-2007. The physician indicated that the patient was doing well and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening, and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Laparotomy, Nasopharyngitis, Small intestinal resection, Surgery
Clinical narrative: Initial report received on 28 February 2007 from another manufacturer, report # WAES0702USA02696. 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 24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (lot # 655175/0849F and 655296/0979F, respectively), on 20-Oct-2006, and 19-Dec-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (lot # AC2113089AA), on 20-Oct-2006 and 19-Dec-2006, respectively, a first and second intramuscular dose in the right leg of Act-HIB (lot # UE867AA), on 20-Oct-2006 and 19-Dec-2006, respectively, and a first and second intramuscular dose in the right leg of Prevnar (lot # B08646F), on 20-Oct-2006 and 19-Dec-2006, respectively. Five days prior to the onset of intussusception, on 04-Feb-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-Feb-2007, at 6:00 AM, the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception and was admitted to the hospital. A barium enema was able to partially reduce the intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-Feb-2007. The physician indicated that the patient was doing well and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening, and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting, X-ray
Clinical narrative: Initial report received on 28 February 2007 from another manufacturer, report # WAES0702USA02696. 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 24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (lot # 655175/0849F and 655296/0979F, respectively), on 20-Oct-2006, and 19-Dec-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (lot # AC2113089AA), on 20-Oct-2006 and 19-Dec-2006, respectively, a first and second intramuscular dose in the right leg of Act-HIB (lot # UE867AA), on 20-Oct-2006 and 19-Dec-2006, respectively, and a first and second intramuscular dose in the right leg of Prevnar (lot # B08646F), on 20-Oct-2006 and 19-Dec-2006, respectively. Five days prior to the onset of intussusception, on 04-Feb-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-Feb-2007, at 6:00 AM, the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception and was admitted to the hospital. A barium enema was able to partially reduce the intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-Feb-2007. The physician indicated that the patient was doing well and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening, and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Ear infection, Haematochezia, Intussusception, Irritability
Clinical narrative: Initial report received on 28 February 2007 from another manufacturer, report # WAES0702USA02696. 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 24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (lot # 655175/0849F and 655296/0979F, respectively), on 20-Oct-2006, and 19-Dec-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (lot # AC2113089AA), on 20-Oct-2006 and 19-Dec-2006, respectively, a first and second intramuscular dose in the right leg of Act-HIB (lot # UE867AA), on 20-Oct-2006 and 19-Dec-2006, respectively, and a first and second intramuscular dose in the right leg of Prevnar (lot # B08646F), on 20-Oct-2006 and 19-Dec-2006, respectively. Five days prior to the onset of intussusception, on 04-Feb-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-Feb-2007, at 6:00 AM, the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception and was admitted to the hospital. A barium enema was able to partially reduce the intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-Feb-2007. The physician indicated that the patient was doing well and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening, and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laparotomy, Nasopharyngitis, Small intestinal resection, Vomiting, X-ray
Clinical narrative: Initial report received on 28 February 2007 from another manufacturer, report # WAES0702USA02696. 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 24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (lot # 655175/0849F and 655296/0979F, respectively), on 20-Oct-2006, and 19-Dec-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (lot # AC2113089AA), on 20-Oct-2006 and 19-Dec-2006, respectively, a first and second intramuscular dose in the right leg of Act-HIB (lot # UE867AA), on 20-Oct-2006 and 19-Dec-2006, respectively, and a first and second intramuscular dose in the right leg of Prevnar (lot # B08646F), on 20-Oct-2006 and 19-Dec-2006, respectively. Five days prior to the onset of intussusception, on 04-Feb-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-Feb-2007, at 6:00 AM, the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception and was admitted to the hospital. A barium enema was able to partially reduce the intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-Feb-2007. The physician indicated that the patient was doing well and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening, and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Death
Clinical narrative: Information has been received from the FDA through the CDC concerning a 2 month old male who had hydronephrosis at birth who on 13-FEB-2007 was vaccinated with an oral first dose of Rotateq (lot # 653661/0146F). Concomitant vaccination administered that day included an IM first dose in the left thigh of Daptacel (lot # C2630AA), an IM first dose in the right thigh of HIB conj-hepatitis B Vaccine (lot # 654904/0757F), an IM first dose in the right thigh of Prevnar (lot # B36258A) and a SC first dose in the left thigh of IPOL (Lot # B0240). There were no other concomitant medications. On 14-FEB-2007 the patient was found dead of an unknown cause. It was reported that the patient was sleeping in bed with his mom. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning an 18 week old female who on 21-FEB-2007 was vaccinated PO with a 2 ml first dose of Rotateq (lot 656103/1166F). There was no concomitant medication. On 24-FEB-2007, the patient experienced blood in the stool. Unspecified medical attention was sought. Upon internal review, blood in the stool was considered an other important medical event. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Haematochezia, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning an 18 week old female who on 21-FEB-2007 was vaccinated PO with a 2 ml first dose of Rotateq (lot 656103/1166F). There was no concomitant medication. On 24-FEB-2007, the patient experienced blood in the stool. Unspecified medical attention was sought. Upon internal review, blood in the stool was considered an other important medical event. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Dark circles under eyes, Drug ineffective, Skin discolouration
Clinical narrative: Patient is receiving hepB series again due to negative titer.  Had initial series in 2005.  About 1 week after injection developed dark spots on face and dark circles under eyes - patient called them "burns".  Areas were not tender or sore and patient experienced no itching.  She now recalls that this happened after each HepB injection she received in 2005, but did not make the connection at the time.  Areas are resolving now.
Age: 0.52
Sex: F
Vaccine: RV5
Symptoms: Barium double contrast, Intussusception
Clinical narrative: Information has been received from a physician concerning a 9 month old white female patient who was vaccinated with a first, second and third oral dose of Rotateq on 01-JUL-2006 (Lot # 653754/0139F), 11-SEP-2006 (Lot # 654248/0577F), and 14-NOV-2006 (Lot# 654248/0577F). Medical history and drug allergies were reported as unknown. Concomitant therapy was unknown. On 21-FEB-2007 the patient was diagnosed with intussusception. Patient was admitted to hospital on 21-FEB-2007. The patient underwent 2 air enemas and the intussusception reversed. On 22-FEB-2007, the patient was discharged from the hospital. Outcome reported as recovered. there was no product quality complaint involved. Additional information has been requested.
Age: 0.61
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning an 8 month old white female patient who was vaccinated with a first, second and third oral dose of Rotateq on 28-JUL-2006 (Lot # 654504/0695F), 28-AUG-2006 (Lot # 654504/0695F), and 25-OCT-2006 (654665/1017F). the patient had no medical history, no known drug allergies and was not on any concomitant medication. On 17-NOV-2006 the patient was seen in the doctors office and was diagnosed with intussusception. The patient was admitted to hospital that same day, where she underwent emergency surgery. On 22-NOV-2006, the patient was discharged from the hospital. on 07-DEC-2007, the patient was seen in the doctors office for a well-visit and was considered recovered from the intussusception. There was no product quality complaint involved. Additional information has been requested.  3/22/07 Received medical records from hospital which reveal patient experienced intermittent abdominal pain associated w/vomiting approx 24 hours prior to admit on 11/17/06-11/22/06.  Seen by PCP who noted bloody stool & tender abdomen.  Barium enema performed at outlying facility but failed to reduce IS noted in mid transverse colon near splenic flexure.  Then transferred to higher level of care where air reduction enema was also unsuccessful.  Peds Surg consult obtained.  Taken to OR where ileocolic resection w/primary anastomosis was performed.  Progressed slowly but steadily, oral diet tolerated by d/c to home w/o further complication except for oral thrush which was treated. FINAL DX: Ileocecal intussusception w/necrotic bowel, surgically reduced w/bowel resection.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Infectious mononucleosis
Clinical narrative: Information has been received from the mother of a 18 year old female consumer who in late December 2006, was vaccinated 0.5 mL IM with her first dose of Gardasil. The patient came down with mononucleosis on 15-FEB-2007. Unspecified Blood work was performed. The patient was reported as recovered on 19-FEB-2007. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Contusion, Idiopathic thrombocytopenic purpura, Infectious mononucleosis, Injection site haematoma
Clinical narrative: Information has been received from a physician at health conference, concerning her 15 year old daughter with a history of bleeding gums (attributed to orthodontic braces) previous 7 days, menstruation heavier 7 days earlier, slight sore throat approximately 1 week prior, and infectious mononucleosis showed possible acute infection, but seroconversion did not occur until 05-FEB-2007, possibly delayed by prolonged steroid treatment.  On 03-OCT-2006, the patient was vaccinated with first dose of HPV vaccine. No reaction occurred. On 24-NOV-2006, the patient was vaccinated with second dose of HPV vaccine (lot # not reported), one month after the first dose. No reaction occurred.  On 12-DEC-2006, poliovirus vaccine boosterix injection was given. A 5cm bruise developed within 4 hours. On 12-DEC-2006, the patient was hospitalized with a platelet count greater than 5. Signs included: 4 cm hematoma at the site of immunization left upper arm, few petechiae on lower abdomen, no hepato-splenomegaly. Provisional diagnosis of immune thrombocytopenia (ITP) was made. The patient was treated with Prednisone 75 mg stat, 3 weeks of 50 mg Prednisone, followed by decreasing dose over the next month. By 29-JAN-2007, the patient's platelet count slowly returned to normal.  The physician commented: "This is case of ITP, probably due to infectious mononucleosis, but diagnosed 18 days after the second dose of HPV vaccine (symptoms started approximately 10 days after the vaccine). I am hopeful it was due to Glandular fever but an interesting co-incidence and an unusual presentation of "IW." Additional information has been requested.