chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Client has shooting pain down arm and hand gets numb at times.  Seen nurse practitioner at health care.  Took Methy/Pred for six days (started it on 7-8-08).  Went back to health care on 7-15-08 and seen nurse practitioner and is currently taking Naproxen, Skelaxin and BUT/APAP/CFSO.  If she skips a dose, her arm still has shooting pain.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Abdominal pain upper, Flushing, Pruritus, Sneezing, Upper respiratory tract congestion
Clinical narrative: Within minutes pt. complained of stomach ache, then vomiting, flushing, sneezing, congestion, facial (cheeks) hives, pruritis.  Pt. was given BENADRYL, placed on monitor, observation.  Given BENADRYL to take x48 hrs directions.  Referred to allergy dept.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Urticaria, Vomiting
Clinical narrative: Within minutes pt. complained of stomach ache, then vomiting, flushing, sneezing, congestion, facial (cheeks) hives, pruritis.  Pt. was given BENADRYL, placed on monitor, observation.  Given BENADRYL to take x48 hrs directions.  Referred to allergy dept.
Age: 50.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: Rabies booster shots (2)- day 0=6/17/08, Day 3= 6/20/08 booster. Peripheral neuropathy- hands, feet, arms, legs-tingling and numbness commenced 6/28/08. Increased symptoms until about 7/17/08 when symptoms began to lessen. Currently minor numbness and tingling remaining.
Age: 0.92
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt. was given Hep A vaccine #1 on 6/24/08, which was 1 month prior to her first birthday.  No adverse reactions were reported.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Fever, swelling at site of injection R upper arm.
Age: 1.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Cellulitis
Clinical narrative: Cellulitis.  Tx with BACTROBAN - SEPTRA.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Pain, Skin warm
Clinical narrative: Redness about 1 1/2 in around vaccine area. Warm to touch, soreness to area, painful to touch.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: L arm red/warm to touch.
Age: 4.0
Sex: M
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Vaccine administered 5/6/08- Parent reports shot he broke out into chickenpox soon after- Patient doing fine 7/22/08
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Cerebellar ataxia, Fall, Gait disturbance
Clinical narrative: Acute cerebellar ataxia - pt noted to have falling, abnl gait 2 days after vaccinations given - lasted ~3 wks.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site swelling, Rash, Swelling, Urticaria
Clinical narrative: Face red swollen rash and hives quarter size swelling at injection site within 4 hours after immunizations.
Age: 53.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt. received hep. B and Typhoid vaccines at a drill weekend.  Became nauseous, and started vomiting about 1 1/2 hours after immunizations.  Also had a fever and headache.  He laid down at event and rested for a couple of hours.  No problem since and back to baseline.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: DTaP given to R deltoid; area red, swollen, & hard to touch (hot); given MOTRIN, KEFLEX, and BENADRYL by PCM.  Area had a prior scratch to skin from furniture per father.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling abnormal, Injection site erythema, Injection site induration, Injection site pain, Pruritus
Clinical narrative: Mother reports that client c/o pain with redness at injection site 6/20/08 night.  Says that child told her that it hurt when she received the injection & was itching & "felt funny" but she didn't tell anymore.  Mother put cortisone cream & ice but still hurt to touch & area was hard but not red.
Age: 7.0
Sex: F
Vaccine: HEPA, IPV, MMR, TD, VARCEL
Symptoms: Blood pressure, Eye swelling, Heart rate normal, Oxygen saturation normal, Throat irritation
Clinical narrative: At 1500 hours puffy eyes.  Child states, "my throat is itching."  Called EMS - 911 at 1502. At 1502 hours administered diphenhydramine 25mg IM left deltoid.  At 1503 B/P 90/60 pulse 80/min.  Dr satellite check breathing freq of wheezing.  1508 hours B/P 90/60 pulse 80/min. At 1512 O2 at pulse oximeter at 100% sat.  B/P at 1514 hour 90/60.  At 1517 hour EMS at scene and assess client.  At 1525 hour child transport to hospital with grandmother.  Mom at clinic during transport.
Age: 17.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Cardiac monitoring, Cardiac stress test, Hypersensitivity, Palpitations
Clinical narrative: Mother & pt report that 20 days after receiving vaccines pt had palpitations, racing heart beat, was followed up by his physician & a cardiologist all workup done, outcome was normal & only thing doctors could find was that pt had allergic reaction to the Oral Typhoid & not be surprised if it occurs again with other vaccinations.
Age: 18.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Deafness, Temporomandibular joint syndrome
Clinical narrative: Mother states that in mid-May pt's girlfriend noticed "he was not hearing her" - took pt to Dr., ENT, on 06-30-08.  Mother states hearing test showed severe hearing loss - was also dx with TMJ - has return appt 07-30-08.  Mother states she was told by a friend that hearing loss could be a side effect of vaccines.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pt denied pregnancy at time of vaccine on 6/19/08 and 6/23/08.  Came to clinic 7/1/08 and had positive pregnancy test.   Report made to Merck Pregnancy Registry.  Patient also reported to OB MD.
Age: 38.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Erythema, Local reaction, Skin nodule, Swelling, Tenderness
Clinical narrative: Local reaction within few days following anthrax vaccine (red, tender, swollen sub-q knot).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness, itching to site on 7-26-08. Family gave BENADRYL. Improved. Smaller area and no c/o itching today.
Age: 9.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Dizziness, Headache, Laboratory test, Pyrexia
Clinical narrative: Received 7/15/08, around 2 pm (Hep A #2) (Pneumovax). next day 7/16/08, felt dizziness and headache. Seen for f/u 7/17/08 (had fever 102), recommended to be seen at ER in a hospital. Symptomatic treatment recommended.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local reaction-redness and swelling at site. Parents using TYLENOL and ice for comfort
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Pt's mom called clinic on 7/24/08. Stated pt's arm where DTaP was given was red, not pink, red, from deltoid to elbow and swollen up - painful to touch. Had fever noted at 101. I told Mom to bring pt to doctor.
Age: 20.0
Sex: U
Vaccine: PNC
Symptoms: Injection site mass
Clinical narrative: knot at injection site.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Intussusception, Surgery, X-ray abnormal
Clinical narrative: information has been received on request from the FDA under the Freedom of Information Act regarding a 3-month-old female with diarrhoea who on 21-DEC-2006 was vaccinated with the first dose of ROTATEQ (Lot # 653661/0077F). There was no concomitant medication. On 26-DEC-2006 the patient experienced haematochezia (complete red) like sauce, small intestine intussusception and surgery and was hospitalized. The X-ray showed sigmoid dilation, "Champagne cup." There was no gas reported on rectum surgery. It was reported that today the patient is ok. Haematochezia, intussusception and surgery were considered to be life-threatening. The original reporting source was not provided. Lot check results; A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal mass, Abdominal pain, Computerised tomogram abnormal
Clinical narrative: Information has been received from an agency concerning a 4-month old male who on 23-JUL-2007 was vaccinated with ROTATEQ, oral, (Lot # 656393/0240U). Concomitant therapy included polio vaccine, SC, left leg, (Lot #Z0548) (Sanofi Pasteur); diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, IM, left leg, (Lot # U1986AA) (Sanofi Pasteur); Hib conj vaccine (unspecified carrier), IM, right leg, (Lot # UF0TTAA) (Sanofi Pasteur); and pneumococcal vaccine (unspecified) IM, right leg, (Lot # B08692C) (Wyeth). On 10-SEP-2007 the patient experienced intussusception, abdominal distension, abdominal mass, abdominal pain, explorative laparotomy, fontanelle depressed, gastrointestinal sounds abnormal, high-pitched crying, intestinal perforation, opisthotonus, rectal hemorrhage, surgery and vomiting and was hospitalized. All adverse events were considered to be immediately life-threatening. The patient had abdominal pain, vomiting on 10-SEP-2007, was seen in the emergency room, was transferred to another hospital where surgery was performed, and dismissed on 24-SEP-2007. The infant presented to the local ER with 5-7 episodes of greenish yellow emesis, high-pitched crying, and back arching. He had a sunken fontanelle, decreased BS, and (+) rectal bleeding. He was transferred to current facility to r/o intussusception vs bowel obstruction. PE was (+) for palpable mass in the mid upper abdomen and currant jelly stool. The child was taken to the OR for laparoscopic reduction of incarcerated intussusception which was reduced. However, post-op, the patient developed increasing abdominal distention and pain. He was taken again to the OR for a diagnostic laparoscopy with exploratory lap and resection of an intestinal perforation with primary anastamosis of the ileum. On 10-SEP-207, an abdominal x-ray was (+) for air in the small bowel but showed no evidence of obstruction or perforation. On 12-SEP-2007, a CT of the abdomen and pelvis showed bowel gas pattern c/w small bowel obstruction. Abdominal X-rays of 15-SEP-2007 and 16-SEP-2007 were c/w SBO. KUB X-ray was done on 17-SEP-2007; results not reported. Reporting source was not provided. The VAERS ID # is 292384. Lot check has been requested. Lot check results as follows: A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information available.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Explorative laparotomy, Fontanelle depressed, Gastrointestinal sounds abnormal, High-pitched crying, Intestinal anastomosis
Clinical narrative: Information has been received from an agency concerning a 4-month old male who on 23-JUL-2007 was vaccinated with ROTATEQ, oral, (Lot # 656393/0240U). Concomitant therapy included polio vaccine, SC, left leg, (Lot #Z0548) (Sanofi Pasteur); diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, IM, left leg, (Lot # U1986AA) (Sanofi Pasteur); Hib conj vaccine (unspecified carrier), IM, right leg, (Lot # UF0TTAA) (Sanofi Pasteur); and pneumococcal vaccine (unspecified) IM, right leg, (Lot # B08692C) (Wyeth). On 10-SEP-2007 the patient experienced intussusception, abdominal distension, abdominal mass, abdominal pain, explorative laparotomy, fontanelle depressed, gastrointestinal sounds abnormal, high-pitched crying, intestinal perforation, opisthotonus, rectal hemorrhage, surgery and vomiting and was hospitalized. All adverse events were considered to be immediately life-threatening. The patient had abdominal pain, vomiting on 10-SEP-2007, was seen in the emergency room, was transferred to another hospital where surgery was performed, and dismissed on 24-SEP-2007. The infant presented to the local ER with 5-7 episodes of greenish yellow emesis, high-pitched crying, and back arching. He had a sunken fontanelle, decreased BS, and (+) rectal bleeding. He was transferred to current facility to r/o intussusception vs bowel obstruction. PE was (+) for palpable mass in the mid upper abdomen and currant jelly stool. The child was taken to the OR for laparoscopic reduction of incarcerated intussusception which was reduced. However, post-op, the patient developed increasing abdominal distention and pain. He was taken again to the OR for a diagnostic laparoscopy with exploratory lap and resection of an intestinal perforation with primary anastamosis of the ileum. On 10-SEP-207, an abdominal x-ray was (+) for air in the small bowel but showed no evidence of obstruction or perforation. On 12-SEP-2007, a CT of the abdomen and pelvis showed bowel gas pattern c/w small bowel obstruction. Abdominal X-rays of 15-SEP-2007 and 16-SEP-2007 were c/w SBO. KUB X-ray was done on 17-SEP-2007; results not reported. Reporting source was not provided. The VAERS ID # is 292384. Lot check has been requested. Lot check results as follows: A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information available.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intestinal perforation, Intussusception, Mucous stools, Opisthotonus, Rectal haemorrhage
Clinical narrative: Information has been received from an agency concerning a 4-month old male who on 23-JUL-2007 was vaccinated with ROTATEQ, oral, (Lot # 656393/0240U). Concomitant therapy included polio vaccine, SC, left leg, (Lot #Z0548) (Sanofi Pasteur); diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, IM, left leg, (Lot # U1986AA) (Sanofi Pasteur); Hib conj vaccine (unspecified carrier), IM, right leg, (Lot # UF0TTAA) (Sanofi Pasteur); and pneumococcal vaccine (unspecified) IM, right leg, (Lot # B08692C) (Wyeth). On 10-SEP-2007 the patient experienced intussusception, abdominal distension, abdominal mass, abdominal pain, explorative laparotomy, fontanelle depressed, gastrointestinal sounds abnormal, high-pitched crying, intestinal perforation, opisthotonus, rectal hemorrhage, surgery and vomiting and was hospitalized. All adverse events were considered to be immediately life-threatening. The patient had abdominal pain, vomiting on 10-SEP-2007, was seen in the emergency room, was transferred to another hospital where surgery was performed, and dismissed on 24-SEP-2007. The infant presented to the local ER with 5-7 episodes of greenish yellow emesis, high-pitched crying, and back arching. He had a sunken fontanelle, decreased BS, and (+) rectal bleeding. He was transferred to current facility to r/o intussusception vs bowel obstruction. PE was (+) for palpable mass in the mid upper abdomen and currant jelly stool. The child was taken to the OR for laparoscopic reduction of incarcerated intussusception which was reduced. However, post-op, the patient developed increasing abdominal distention and pain. He was taken again to the OR for a diagnostic laparoscopy with exploratory lap and resection of an intestinal perforation with primary anastamosis of the ileum. On 10-SEP-207, an abdominal x-ray was (+) for air in the small bowel but showed no evidence of obstruction or perforation. On 12-SEP-2007, a CT of the abdomen and pelvis showed bowel gas pattern c/w small bowel obstruction. Abdominal X-rays of 15-SEP-2007 and 16-SEP-2007 were c/w SBO. KUB X-ray was done on 17-SEP-2007; results not reported. Reporting source was not provided. The VAERS ID # is 292384. Lot check has been requested. Lot check results as follows: A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information available.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Surgery, Urinary system X-ray, Vomiting, X-ray abnormal
Clinical narrative: Information has been received from an agency concerning a 4-month old male who on 23-JUL-2007 was vaccinated with ROTATEQ, oral, (Lot # 656393/0240U). Concomitant therapy included polio vaccine, SC, left leg, (Lot #Z0548) (Sanofi Pasteur); diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, IM, left leg, (Lot # U1986AA) (Sanofi Pasteur); Hib conj vaccine (unspecified carrier), IM, right leg, (Lot # UF0TTAA) (Sanofi Pasteur); and pneumococcal vaccine (unspecified) IM, right leg, (Lot # B08692C) (Wyeth). On 10-SEP-2007 the patient experienced intussusception, abdominal distension, abdominal mass, abdominal pain, explorative laparotomy, fontanelle depressed, gastrointestinal sounds abnormal, high-pitched crying, intestinal perforation, opisthotonus, rectal hemorrhage, surgery and vomiting and was hospitalized. All adverse events were considered to be immediately life-threatening. The patient had abdominal pain, vomiting on 10-SEP-2007, was seen in the emergency room, was transferred to another hospital where surgery was performed, and dismissed on 24-SEP-2007. The infant presented to the local ER with 5-7 episodes of greenish yellow emesis, high-pitched crying, and back arching. He had a sunken fontanelle, decreased BS, and (+) rectal bleeding. He was transferred to current facility to r/o intussusception vs bowel obstruction. PE was (+) for palpable mass in the mid upper abdomen and currant jelly stool. The child was taken to the OR for laparoscopic reduction of incarcerated intussusception which was reduced. However, post-op, the patient developed increasing abdominal distention and pain. He was taken again to the OR for a diagnostic laparoscopy with exploratory lap and resection of an intestinal perforation with primary anastamosis of the ileum. On 10-SEP-207, an abdominal x-ray was (+) for air in the small bowel but showed no evidence of obstruction or perforation. On 12-SEP-2007, a CT of the abdomen and pelvis showed bowel gas pattern c/w small bowel obstruction. Abdominal X-rays of 15-SEP-2007 and 16-SEP-2007 were c/w SBO. KUB X-ray was done on 17-SEP-2007; results not reported. Reporting source was not provided. The VAERS ID # is 292384. Lot check has been requested. Lot check results as follows: A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information available.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Explorative laparotomy, Haematochezia, Intensive care, Intestinal resection
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 3-month-old female with twin born at 37 weeks who on 31-OCT-2007 was vaccinated with the second dose of ROTATEQ (Lot # 656836/0876U). Suspect therapy included the second dose of Hib conj vaccine (Lot # 657178/0676U), IM in the left leg. Concomitant therapy included the second dose of PEDIARIX (Lot # AC21B194AA), IM in the right leg and the second dose of PREVNAR (Lot # B50007A), IM in the left leg. 12-Nov-2007 Received vax record from PCP which confirms RO  dose and lot # as reported. 04-Dec-2007 Reviewed hospital medical records which revealed that the patient experienced irritability, fever, vomiting, pallor, cold extremities and bloody stools x 3 day. On 06-NOV-2007 the patient experienced explorative laparotomy, haematochezia, intensive care, intestinal resection, intussusception, irritability, pallor, peripheral coldness, pyrexia, surgery and vomiting and was hospitalized from 06-Nov-2007 to 14-Nov-2007. An abdominal x-ray revealed dilated loops and an ultrasound of the abdomen revealed IS. The patient was taken to the OR for explorative laparotomy and ileocolic resection when unable to reduce in radiology. The patient was placed on TPN postoperatively in the PICU. She progressed well and was discharged to home. Final diagnosis included intussusception, surgically reduced (8 days after second doses of vaccinations). Explorative laparotomy, haematochezia, intensive care, intestinal resection, intussusception, irritability, pallor, peripheral coldness, pyrexia, surgery and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 296290. Lot check results requested. Lot check results reported: A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Irritability, Pallor, Peripheral coldness, Pyrexia
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 3-month-old female with twin born at 37 weeks who on 31-OCT-2007 was vaccinated with the second dose of ROTATEQ (Lot # 656836/0876U). Suspect therapy included the second dose of Hib conj vaccine (Lot # 657178/0676U), IM in the left leg. Concomitant therapy included the second dose of PEDIARIX (Lot # AC21B194AA), IM in the right leg and the second dose of PREVNAR (Lot # B50007A), IM in the left leg. 12-Nov-2007 Received vax record from PCP which confirms RO  dose and lot # as reported. 04-Dec-2007 Reviewed hospital medical records which revealed that the patient experienced irritability, fever, vomiting, pallor, cold extremities and bloody stools x 3 day. On 06-NOV-2007 the patient experienced explorative laparotomy, haematochezia, intensive care, intestinal resection, intussusception, irritability, pallor, peripheral coldness, pyrexia, surgery and vomiting and was hospitalized from 06-Nov-2007 to 14-Nov-2007. An abdominal x-ray revealed dilated loops and an ultrasound of the abdomen revealed IS. The patient was taken to the OR for explorative laparotomy and ileocolic resection when unable to reduce in radiology. The patient was placed on TPN postoperatively in the PICU. She progressed well and was discharged to home. Final diagnosis included intussusception, surgically reduced (8 days after second doses of vaccinations). Explorative laparotomy, haematochezia, intensive care, intestinal resection, intussusception, irritability, pallor, peripheral coldness, pyrexia, surgery and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 296290. Lot check results requested. Lot check results reported: A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 3-month-old female with twin born at 37 weeks who on 31-OCT-2007 was vaccinated with the second dose of ROTATEQ (Lot # 656836/0876U). Suspect therapy included the second dose of Hib conj vaccine (Lot # 657178/0676U), IM in the left leg. Concomitant therapy included the second dose of PEDIARIX (Lot # AC21B194AA), IM in the right leg and the second dose of PREVNAR (Lot # B50007A), IM in the left leg. 12-Nov-2007 Received vax record from PCP which confirms RO  dose and lot # as reported. 04-Dec-2007 Reviewed hospital medical records which revealed that the patient experienced irritability, fever, vomiting, pallor, cold extremities and bloody stools x 3 day. On 06-NOV-2007 the patient experienced explorative laparotomy, haematochezia, intensive care, intestinal resection, intussusception, irritability, pallor, peripheral coldness, pyrexia, surgery and vomiting and was hospitalized from 06-Nov-2007 to 14-Nov-2007. An abdominal x-ray revealed dilated loops and an ultrasound of the abdomen revealed IS. The patient was taken to the OR for explorative laparotomy and ileocolic resection when unable to reduce in radiology. The patient was placed on TPN postoperatively in the PICU. She progressed well and was discharged to home. Final diagnosis included intussusception, surgically reduced (8 days after second doses of vaccinations). Explorative laparotomy, haematochezia, intensive care, intestinal resection, intussusception, irritability, pallor, peripheral coldness, pyrexia, surgery and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 296290. Lot check results requested. Lot check results reported: A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Computerised tomogram, Convulsion, Dizziness, Fatigue
Clinical narrative: SYNCOPE, NAUSE, DIZZINESS AT TIME OF INJECTION. FATIGUE, "BRAIN FOG", IRRITABILITY AND MUSCLE ACHES AND SORENESS IN JOINTS WITHIN HOURS OF INJECTION AND CONTINUING TO DATE. SEIZURES, WITH NO PREVIOUS HISTORY, WITHIN MONTHS OF VACCINE, NO EXPLANATION AND CONTINUE TO DATE.  PATIENT IS ON MEDICATIONS TO CONTROL SEIZURES AT THIS TIME.  PATIENT REQUIRED TO EMERGENCY ROOM VISITS AT TIME OF BOTH GRAND MAL SEIZURES.  9/22/2008 Office records received from Neuro consult beginning 11/27/07. Pt presented after 1st generalized seizure on 11/24/07. Seizure lasted ~45 minutes with post ictal sleepines, then confusion, combativeness and tearfulness.  Seen 12/7/07 following 2nd similar seizure, again during sleep. Placed on lamictal. Pt continued to have brief complex partial seizures.  Report from 2nd neurologist also included. Seen 1/2/2008. DX:  New onset epilepsy.  10/29/2008 MR received for ER visit 12/2/2007 with DX: seizure. Pt presented after 2nd seizure. Found unresponsive, shaking all over. Pain 4-10/10. D/C on Cerebyx.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Full blood count, Grand mal convulsion, Immediate post-injection reaction, Irritability
Clinical narrative: SYNCOPE, NAUSE, DIZZINESS AT TIME OF INJECTION. FATIGUE, "BRAIN FOG", IRRITABILITY AND MUSCLE ACHES AND SORENESS IN JOINTS WITHIN HOURS OF INJECTION AND CONTINUING TO DATE. SEIZURES, WITH NO PREVIOUS HISTORY, WITHIN MONTHS OF VACCINE, NO EXPLANATION AND CONTINUE TO DATE.  PATIENT IS ON MEDICATIONS TO CONTROL SEIZURES AT THIS TIME.  PATIENT REQUIRED TO EMERGENCY ROOM VISITS AT TIME OF BOTH GRAND MAL SEIZURES.  9/22/2008 Office records received from Neuro consult beginning 11/27/07. Pt presented after 1st generalized seizure on 11/24/07. Seizure lasted ~45 minutes with post ictal sleepines, then confusion, combativeness and tearfulness.  Seen 12/7/07 following 2nd similar seizure, again during sleep. Placed on lamictal. Pt continued to have brief complex partial seizures.  Report from 2nd neurologist also included. Seen 1/2/2008. DX:  New onset epilepsy.  10/29/2008 MR received for ER visit 12/2/2007 with DX: seizure. Pt presented after 2nd seizure. Found unresponsive, shaking all over. Pain 4-10/10. D/C on Cerebyx.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nausea, Syncope, Toxicologic test
Clinical narrative: SYNCOPE, NAUSE, DIZZINESS AT TIME OF INJECTION. FATIGUE, "BRAIN FOG", IRRITABILITY AND MUSCLE ACHES AND SORENESS IN JOINTS WITHIN HOURS OF INJECTION AND CONTINUING TO DATE. SEIZURES, WITH NO PREVIOUS HISTORY, WITHIN MONTHS OF VACCINE, NO EXPLANATION AND CONTINUE TO DATE.  PATIENT IS ON MEDICATIONS TO CONTROL SEIZURES AT THIS TIME.  PATIENT REQUIRED TO EMERGENCY ROOM VISITS AT TIME OF BOTH GRAND MAL SEIZURES.  9/22/2008 Office records received from Neuro consult beginning 11/27/07. Pt presented after 1st generalized seizure on 11/24/07. Seizure lasted ~45 minutes with post ictal sleepines, then confusion, combativeness and tearfulness.  Seen 12/7/07 following 2nd similar seizure, again during sleep. Placed on lamictal. Pt continued to have brief complex partial seizures.  Report from 2nd neurologist also included. Seen 1/2/2008. DX:  New onset epilepsy.  10/29/2008 MR received for ER visit 12/2/2007 with DX: seizure. Pt presented after 2nd seizure. Found unresponsive, shaking all over. Pain 4-10/10. D/C on Cerebyx.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 2 month old female with diaper rash who on 01-NOV-2007 was vaccinated with the first dose of ROTATEQ (lot # reported as 656379/0505U). Concomitant suspect therapy included the first doses of PEDIARIX (lot # reported as AC21B124BA) in the right leg, PREVNAR (Lot # reported as B47300B) and ACTHIB (lot # reported as VF163AA). This case was reported by a physician and described the occurrence of intussusception. ON 08-NOV-2007 in the morning, 7 days after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ the subject experienced intussusception. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). On 09-NOV-2007 the event was resolved. The physician considered the event was possibly related to vaccination with ACTHIB, PREVNAR, PEDIARIX and ROTATEQ. The original reporting source was not provided. The VAERS ID is 303219. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound scan abnormal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 2 month old female with diaper rash who on 01-NOV-2007 was vaccinated with the first dose of ROTATEQ (lot # reported as 656379/0505U). Concomitant suspect therapy included the first doses of PEDIARIX (lot # reported as AC21B124BA) in the right leg, PREVNAR (Lot # reported as B47300B) and ACTHIB (lot # reported as VF163AA). This case was reported by a physician and described the occurrence of intussusception. ON 08-NOV-2007 in the morning, 7 days after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ the subject experienced intussusception. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). On 09-NOV-2007 the event was resolved. The physician considered the event was possibly related to vaccination with ACTHIB, PREVNAR, PEDIARIX and ROTATEQ. The original reporting source was not provided. The VAERS ID is 303219. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 2 month old female with diaper rash who on 01-NOV-2007 was vaccinated with the first dose of ROTATEQ (lot # reported as 656379/0505U). Concomitant suspect therapy included the first doses of PEDIARIX (lot # reported as AC21B124BA) in the right leg, PREVNAR (Lot # reported as B47300B) and ACTHIB (lot # reported as VF163AA). This case was reported by a physician and described the occurrence of intussusception. ON 08-NOV-2007 in the morning, 7 days after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ the subject experienced intussusception. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). On 09-NOV-2007 the event was resolved. The physician considered the event was possibly related to vaccination with ACTHIB, PREVNAR, PEDIARIX and ROTATEQ. The original reporting source was not provided. The VAERS ID is 303219. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.1
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Barium enema, Colectomy, Intestinal anastomosis, Intussusception, Surgery
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 2 month old female with no medical history who on 11-FEB-2008 was vaccinated po with the first dose of ROTATEQ (lot # reported as 657667/1392U). Concomitant suspect vaccine includes the first dose of COMVAX (lot # reported as 653783/0012F) in the right leg. Other concomitant vaccines included are the first doses of poliovirus vaccine (unspecified) (Sanofi Pasteur) (lot # reported as A0474PK) in the left leg, PREVNAR (Wyeth Pharmaceuticals) (lot # reported as C49271) in the right leg and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown)  (lot # reported as C2607AB) in the left leg. Records revealed on 15-FEZB-2008 a patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output and rectal bleeding times one day. Patient was seen at outlying ER where ultrasound of abdomen confirmed intussusception. Hydrostatic reduction was unsuccessful and taken to the operating room. Surgical findings included compound ileocolic colocolic intussusception involving entire large bowel to level of sigmoid colon. Unable to manually reduce and terminal ileum and ascending colon were resected. Patient was admitted to the pediatric intensive care unit post operatively. Progressed well and discharged to home with surgery clinic follow-up. Final diagnosis gangrenous ileocolic, colocolic compound intussusception, laparotomy; right hemicolectomy with ileocolic anastomosis. It was reported that abdominal mass, abdominal pain, crying, diet refusal, intestinal gangrene, intussusception, lethargy, rectal hemorrhage, urine output decreased and vomiting was considered life threatening and serious. The original reporting source was not reported The VAERS ID $# is 305057. Other related VAERS reports include 305057-2 and 305057-3. A standard lot check investigations were performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologic Evaluation and Research and was released. No further information is available.
Age: 0.1
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Colectomy, Intussusception, Surgery, Ultrasound abdomen abnormal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 2 month old female with no medical history who on 11-FEB-2008 was vaccinated po with the first dose of ROTATEQ (lot # reported as 657667/1392U). Concomitant suspect vaccine includes the first dose of COMVAX (lot # reported as 653783/0012F) in the right leg. Other concomitant vaccines included are the first doses of poliovirus vaccine (unspecified) (Sanofi Pasteur) (lot # reported as A0474PK) in the left leg, PREVNAR (Wyeth Pharmaceuticals) (lot # reported as C49271) in the right leg and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown)  (lot # reported as C2607AB) in the left leg. Records revealed on 15-FEZB-2008 a patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output and rectal bleeding times one day. Patient was seen at outlying ER where ultrasound of abdomen confirmed intussusception. Hydrostatic reduction was unsuccessful and taken to the operating room. Surgical findings included compound ileocolic colocolic intussusception involving entire large bowel to level of sigmoid colon. Unable to manually reduce and terminal ileum and ascending colon were resected. Patient was admitted to the pediatric intensive care unit post operatively. Progressed well and discharged to home with surgery clinic follow-up. Final diagnosis gangrenous ileocolic, colocolic compound intussusception, laparotomy; right hemicolectomy with ileocolic anastomosis. It was reported that abdominal mass, abdominal pain, crying, diet refusal, intestinal gangrene, intussusception, lethargy, rectal hemorrhage, urine output decreased and vomiting was considered life threatening and serious. The original reporting source was not reported The VAERS ID $# is 305057. Other related VAERS reports include 305057-2 and 305057-3. A standard lot check investigations were performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologic Evaluation and Research and was released. No further information is available.
Age: 0.1
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Gastrointestinal oedema, Intussusception, Rectal haemorrhage, Surgery, Ultrasound scan abnormal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 2 month old female with no medical history who on 11-FEB-2008 was vaccinated po with the first dose of ROTATEQ (lot # reported as 657667/1392U). Concomitant suspect vaccine includes the first dose of COMVAX (lot # reported as 653783/0012F) in the right leg. Other concomitant vaccines included are the first doses of poliovirus vaccine (unspecified) (Sanofi Pasteur) (lot # reported as A0474PK) in the left leg, PREVNAR (Wyeth Pharmaceuticals) (lot # reported as C49271) in the right leg and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown)  (lot # reported as C2607AB) in the left leg. Records revealed on 15-FEZB-2008 a patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output and rectal bleeding times one day. Patient was seen at outlying ER where ultrasound of abdomen confirmed intussusception. Hydrostatic reduction was unsuccessful and taken to the operating room. Surgical findings included compound ileocolic colocolic intussusception involving entire large bowel to level of sigmoid colon. Unable to manually reduce and terminal ileum and ascending colon were resected. Patient was admitted to the pediatric intensive care unit post operatively. Progressed well and discharged to home with surgery clinic follow-up. Final diagnosis gangrenous ileocolic, colocolic compound intussusception, laparotomy; right hemicolectomy with ileocolic anastomosis. It was reported that abdominal mass, abdominal pain, crying, diet refusal, intestinal gangrene, intussusception, lethargy, rectal hemorrhage, urine output decreased and vomiting was considered life threatening and serious. The original reporting source was not reported The VAERS ID $# is 305057. Other related VAERS reports include 305057-2 and 305057-3. A standard lot check investigations were performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologic Evaluation and Research and was released. No further information is available.
Age: 0.1
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal mass, Abdominal pain, Barium enema abnormal, Blood culture
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 2 month old female with no medical history who on 11-FEB-2008 was vaccinated po with the first dose of ROTATEQ (lot # reported as 657667/1392U). Concomitant suspect vaccine includes the first dose of COMVAX (lot # reported as 653783/0012F) in the right leg. Other concomitant vaccines included are the first doses of poliovirus vaccine (unspecified) (Sanofi Pasteur) (lot # reported as A0474PK) in the left leg, PREVNAR (Wyeth Pharmaceuticals) (lot # reported as C49271) in the right leg and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown)  (lot # reported as C2607AB) in the left leg. Records revealed on 15-FEZB-2008 a patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output and rectal bleeding times one day. Patient was seen at outlying ER where ultrasound of abdomen confirmed intussusception. Hydrostatic reduction was unsuccessful and taken to the operating room. Surgical findings included compound ileocolic colocolic intussusception involving entire large bowel to level of sigmoid colon. Unable to manually reduce and terminal ileum and ascending colon were resected. Patient was admitted to the pediatric intensive care unit post operatively. Progressed well and discharged to home with surgery clinic follow-up. Final diagnosis gangrenous ileocolic, colocolic compound intussusception, laparotomy; right hemicolectomy with ileocolic anastomosis. It was reported that abdominal mass, abdominal pain, crying, diet refusal, intestinal gangrene, intussusception, lethargy, rectal hemorrhage, urine output decreased and vomiting was considered life threatening and serious. The original reporting source was not reported The VAERS ID $# is 305057. Other related VAERS reports include 305057-2 and 305057-3. A standard lot check investigations were performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologic Evaluation and Research and was released. No further information is available.
Age: 0.1
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Blood test normal, Colectomy, Crying, Diet refusal, Enema administration
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 2 month old female with no medical history who on 11-FEB-2008 was vaccinated po with the first dose of ROTATEQ (lot # reported as 657667/1392U). Concomitant suspect vaccine includes the first dose of COMVAX (lot # reported as 653783/0012F) in the right leg. Other concomitant vaccines included are the first doses of poliovirus vaccine (unspecified) (Sanofi Pasteur) (lot # reported as A0474PK) in the left leg, PREVNAR (Wyeth Pharmaceuticals) (lot # reported as C49271) in the right leg and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown)  (lot # reported as C2607AB) in the left leg. Records revealed on 15-FEZB-2008 a patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output and rectal bleeding times one day. Patient was seen at outlying ER where ultrasound of abdomen confirmed intussusception. Hydrostatic reduction was unsuccessful and taken to the operating room. Surgical findings included compound ileocolic colocolic intussusception involving entire large bowel to level of sigmoid colon. Unable to manually reduce and terminal ileum and ascending colon were resected. Patient was admitted to the pediatric intensive care unit post operatively. Progressed well and discharged to home with surgery clinic follow-up. Final diagnosis gangrenous ileocolic, colocolic compound intussusception, laparotomy; right hemicolectomy with ileocolic anastomosis. It was reported that abdominal mass, abdominal pain, crying, diet refusal, intestinal gangrene, intussusception, lethargy, rectal hemorrhage, urine output decreased and vomiting was considered life threatening and serious. The original reporting source was not reported The VAERS ID $# is 305057. Other related VAERS reports include 305057-2 and 305057-3. A standard lot check investigations were performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologic Evaluation and Research and was released. No further information is available.