chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Oxygen supplementation, Pleural effusion, Respiratory arrest, Resuscitation, Upper respiratory tract infection
Clinical narrative: Vaccine administration date 2/12/2007, varicella dose #2 and Gardisil dose #1 administered concurrently. No symptoms until March 4th when in AM noted by mother to have a cold/URI symptoms with cough. Emesis at 11 after soup at 10, napping when mom at home at 3 PM but difficult to arouse. Called 911 and started rescue breathing. Paramedics initially called in stable VS's but required active CPR on gurney by time came into ED.  In disorganized vfib in ER-resusc'd with PALS then consulted cardiology for ECMO.  Cannulated for VA ECMO - on full flow support after 1.5 hours. Heart completely akinetic. Went to cath lab to get biopsies, CAD's and assessment of integrity of heart with very poor tone/strength to heart muscle noted; presumed acute viral myocarditis. Has gotten IVIG. Can't assess neurologic function due to significant drug load. Remains with very disorganized rhythym today; to consider EPS study; also studying family for possible inherited rhythym disturbances. 03/20/07-partial records received from facility, patient remains in hospital. Received ECMO support for cardiac arrest secondary to myocarditis. Endomyocardial biopsy: acute lymphocytic myocarditis with scattered eosinophils.  04/25/07-DC Summary received for DOS 03/04-03/23/07-DC DX: Cardiac arrhythmia. Myocarditis.  Per information received from annual follow up, off all CHF medications; very minimal residual orgainc brain syndrome; responding to PT/OT & counseling.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Ventricular fibrillation, Vomiting
Clinical narrative: Vaccine administration date 2/12/2007, varicella dose #2 and Gardisil dose #1 administered concurrently. No symptoms until March 4th when in AM noted by mother to have a cold/URI symptoms with cough. Emesis at 11 after soup at 10, napping when mom at home at 3 PM but difficult to arouse. Called 911 and started rescue breathing. Paramedics initially called in stable VS's but required active CPR on gurney by time came into ED.  In disorganized vfib in ER-resusc'd with PALS then consulted cardiology for ECMO.  Cannulated for VA ECMO - on full flow support after 1.5 hours. Heart completely akinetic. Went to cath lab to get biopsies, CAD's and assessment of integrity of heart with very poor tone/strength to heart muscle noted; presumed acute viral myocarditis. Has gotten IVIG. Can't assess neurologic function due to significant drug load. Remains with very disorganized rhythym today; to consider EPS study; also studying family for possible inherited rhythym disturbances. 03/20/07-partial records received from facility, patient remains in hospital. Received ECMO support for cardiac arrest secondary to myocarditis. Endomyocardial biopsy: acute lymphocytic myocarditis with scattered eosinophils.  04/25/07-DC Summary received for DOS 03/04-03/23/07-DC DX: Cardiac arrhythmia. Myocarditis.  Per information received from annual follow up, off all CHF medications; very minimal residual orgainc brain syndrome; responding to PT/OT & counseling.
Age: 1.02
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Anorexia, Blood test, Lethargy, Lip swelling, Pyrexia
Clinical narrative: Patient received her vaccine on 2/7/2007 at her 1-year checkup.  On Feb 13th, patient started to have fever of 104F, 105F.  She also developed a runny nose and a scratchy throat.  After administering Tylenol the fever went down to 100, but hung on until Saturday night, Feb 17th. On Thursday night, Feb 15th, we noticed she had a slight rash on her head.  When she woke up the next day (Friday morning, Feb 16th) she was COVERED with a measles-like rash.  The rash covered her head, neck and torso (front and back).  It was really thick around her neck and ears.  As the day progressed on Friday, the rash got worse, and she became very lethargic and didn't want to eat.  That night her cheeks started to swell up as well.  Friday night/early Saturday morning, she was in a very uncomfortable state, she could not sleep and cried from the itchiness of the rash, and then her lips started to swell up too.  That was when we got really scared and took her to the ER.  There at the ER, they ran a lot of tests and told us that it was probably from the MMR vaccine. The rash started to darken on Sunday morning, Feb 18th, in transition of fading away.  We notice that she screams now when she is not happy or frustrated. And, once a while, she seems to scream out of blue.  The rash is still (Mar 5th) visible and itchy once a while since patient still attempts to scratch from time to time.
Age: 1.02
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Rash, Rash morbilliform, Rash pruritic, Rhinorrhoea, Screaming
Clinical narrative: Patient received her vaccine on 2/7/2007 at her 1-year checkup.  On Feb 13th, patient started to have fever of 104F, 105F.  She also developed a runny nose and a scratchy throat.  After administering Tylenol the fever went down to 100, but hung on until Saturday night, Feb 17th. On Thursday night, Feb 15th, we noticed she had a slight rash on her head.  When she woke up the next day (Friday morning, Feb 16th) she was COVERED with a measles-like rash.  The rash covered her head, neck and torso (front and back).  It was really thick around her neck and ears.  As the day progressed on Friday, the rash got worse, and she became very lethargic and didn't want to eat.  That night her cheeks started to swell up as well.  Friday night/early Saturday morning, she was in a very uncomfortable state, she could not sleep and cried from the itchiness of the rash, and then her lips started to swell up too.  That was when we got really scared and took her to the ER.  There at the ER, they ran a lot of tests and told us that it was probably from the MMR vaccine. The rash started to darken on Sunday morning, Feb 18th, in transition of fading away.  We notice that she screams now when she is not happy or frustrated. And, once a while, she seems to scream out of blue.  The rash is still (Mar 5th) visible and itchy once a while since patient still attempts to scratch from time to time.
Age: 1.02
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Sleep disorder, Throat irritation
Clinical narrative: Patient received her vaccine on 2/7/2007 at her 1-year checkup.  On Feb 13th, patient started to have fever of 104F, 105F.  She also developed a runny nose and a scratchy throat.  After administering Tylenol the fever went down to 100, but hung on until Saturday night, Feb 17th. On Thursday night, Feb 15th, we noticed she had a slight rash on her head.  When she woke up the next day (Friday morning, Feb 16th) she was COVERED with a measles-like rash.  The rash covered her head, neck and torso (front and back).  It was really thick around her neck and ears.  As the day progressed on Friday, the rash got worse, and she became very lethargic and didn't want to eat.  That night her cheeks started to swell up as well.  Friday night/early Saturday morning, she was in a very uncomfortable state, she could not sleep and cried from the itchiness of the rash, and then her lips started to swell up too.  That was when we got really scared and took her to the ER.  There at the ER, they ran a lot of tests and told us that it was probably from the MMR vaccine. The rash started to darken on Sunday morning, Feb 18th, in transition of fading away.  We notice that she screams now when she is not happy or frustrated. And, once a while, she seems to scream out of blue.  The rash is still (Mar 5th) visible and itchy once a while since patient still attempts to scratch from time to time.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Patient awakened early 3/2/07 with fever, chills,  nausea and headache.  L arm at injection site was tender and puffy.  Temperatures ranged from 100.8 to 102.0 throughout the day.  3/3/07-c/o nausea, headache and temp of 100.0   3/4/07- c/o headache and stiff neck.  3/5/07-c/o headache
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient awakened early 3/2/07 with fever, chills,  nausea and headache.  L arm at injection site was tender and puffy.  Temperatures ranged from 100.8 to 102.0 throughout the day.  3/3/07-c/o nausea, headache and temp of 100.0   3/4/07- c/o headache and stiff neck.  3/5/07-c/o headache
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Agitation, Crying
Clinical narrative: Parents report baby cried for 4 solid hours with a high pitch cry and then was fussy for another day but then within a day or 2 was back to normal
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Erythema, Injection site nodule, Swelling
Clinical narrative: Skin red and slightly puffy with "knot" under the injection site (right thigh).
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Musculoskeletal pain, Pain
Clinical narrative: The 2nd injection in November nearly caused my daughter to pass out.  She had to lie down & drink some water.  The third injection on Feb. 26 was the most painful, with a burning sensation flowing down her arm toward her hand.  Approximately 5 days after the injection, she began experiencing very sharp pain in the shoulder she received the injection in.  Continues to be in moderate pain, especially with movement of shoulder.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Sudden infant death syndrome
Clinical narrative: Undetermined category II SIDS. 3/20/07 Received Autopsy Report which reveals COD as Undertermined (Category II SIDS).  Following were findings at Autopsy: hx of recent cough hx of cosleeping w/parent bloody fluid about nasal orifices pulmonary congestion & edema No evidence of trauma, natural disease, toxicological findings or metabolic disorder. Patent ductus arteriosus. Meckels diverticulum.
Sex: U
Vaccine: TDAP
Symptoms: Arthralgia, Dizziness, Syncope
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of fainting in a subject of unspecified age and gender who was vaccinated with Boostrix for prophylaxis. On an unspecified ate the subject received unspecified dose of Boostrix (unknown). At an unspecified time after vaccination with Boostrix, the subject experienced fainting, joint pain and dizziness. This case was assessed as medically serious by manufacturer. At the time of reporting the outcome of the events were unspecified.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Cellulitis, Haemoglobin decreased, Injection site cellulitis, Platelet count decreased, White blood cell count normal
Clinical narrative: Left thigh cellulitis for one day. Treated with Nafcillin and Clindamycin.  03/23/2007 MR received for an ER admit for c/o Left thigh redness after receiving vaccines in the Left thigh. PE WNL except redness and swelling noted on the left thigh. No fever, no chills, no discharge.  Impression: Left thigh Cellulitis/Reaction (local) to vaccines. Principal DX:  Cellulitis. Secondary DX:  Adverse reaction to vaccination.
Age: 48.0
Sex: F
Vaccine: FLUN3
Symptoms: Deafness, Ear discomfort, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Ear feeling clogged, hearing loss, constant sinus drainage, sore throat. 4 visits to Dr.
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dysgeusia, Feeling hot, Hyperhidrosis, Myalgia
Clinical narrative: 24 later, patient had all over muscle aches, mildly sweaty/felt warm, bitter taste in mouth, loose stools x 2 days.
Sex: M
Vaccine: HBHEPB, MMRV
Symptoms: Body temperature increased, Erythema, Injection site reaction, Rash, Urticaria
Clinical narrative: A week later patient had 103 temperature (rectal) and was treated with Tylenol and Motrin at bedtime. On Wednesday patient developed large welt at ProQuad injection site. Grew longer and darker red as days progressed. On 3/3 went to doctor and had red spots all over body. Today they are even more around, 20 on face and legs and 30/40 on trunk.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pyrexia
Clinical narrative: 3/1/07: Fever 103, onset in a.m., sib with documented Influenza Type B by rapid Ag test. Treated with Tamiflu x 5 days.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Cough, Influenza, Musculoskeletal stiffness, Nasal congestion
Clinical narrative: 2/26/07 Fever 104 x 1 day, c/o lower abdominal pain, lower back stiffness, nasal congestion, residual cough from previous sinusitis 2/17/07; completed Augmentin 3 days ago; treated with Tamiflu x 5 days.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 2/26/07 Fever 104 x 1 day, c/o lower abdominal pain, lower back stiffness, nasal congestion, residual cough from previous sinusitis 2/17/07; completed Augmentin 3 days ago; treated with Tamiflu x 5 days.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 32.0
Sex: M
Vaccine: MMR, TD
Symptoms: Rash
Clinical narrative: Received MMR and Td on 2/20/07. Developed rash on face 3/4/07 and chest area 3/5/07. Denies shortness of breath or pruritus. Patient given Diphenhydramine HCl 25 mg stg 1 PO every eight hours PRN and referred to facility reported.
Age: 2.0
Sex: M
Vaccine: DT, MMR
Symptoms: Febrile convulsion
Clinical narrative: On 2/25/07 at about 3am febrile seizure lasting about 15 seconds. Paramedics on scene. Went to emergency room and released.
Age: 17.0
Sex: M
Vaccine: MNQ, PPV, MNQ, PPV, MNQ, PPV
Symptoms: Abscess drainage, Culture positive, Inappropriate schedule of drug administration, Staphylococcus test positive, Swelling
Clinical narrative: Patient given 3 cc of PNEUMOVAX IM.   Follow-up information received - (2) Chronic swelling on scar tissue of back - ruptured and drained pus. Started on CIPRO oral 500 mg tab BID X 6 weeks.
Age: 17.0
Sex: M
Vaccine: MNQ, PPV, MNQ, PPV, MNQ, PPV
Symptoms: Abscess drainage, Abscess rupture, Culture positive, Incorrect dose administered, Staphylococcal abscess
Clinical narrative: Patient given 3 cc of PNEUMOVAX IM.   Follow-up information received - (2) Chronic swelling on scar tissue of back - ruptured and drained pus. Started on CIPRO oral 500 mg tab BID X 6 weeks.
Age: 17.0
Sex: M
Vaccine: MNQ, PPV, MNQ, PPV, MNQ, PPV
Symptoms: Abscess drainage, Abscess rupture, Culture positive, Culture wound positive, Staphylococcal abscess
Clinical narrative: Patient given 3 cc of PNEUMOVAX IM.   Follow-up information received - (2) Chronic swelling on scar tissue of back - ruptured and drained pus. Started on CIPRO oral 500 mg tab BID X 6 weeks.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Cellulitis
Clinical narrative: Cellulitis of right thigh.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, UNK
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pain and swelling, left thigh on 2/23/07 and redness advised to apply cool compress.
Age: 20.0
Sex: F
Vaccine: JEV
Symptoms: Pruritus
Clinical narrative: A 20-year-old female patient developed generalized itching within 24 hours of receiving the subcutaneous injection of JE-VAX (dose one) lot number EJN222A (expiry date 13/May/2008) in the right arm on 13/Apr/2006. Per reporter vaccination was received during a travel physical and the patient had no illness at the time. The patient had no rash or hives. Per reporter the patient recovered.
Age: 52.0
Sex: F
Vaccine: JEV
Symptoms: Injection site reaction, Pain in extremity, Urticaria
Clinical narrative: A 52-year-old female patient developed arm achiness lasting for 72 hours after receiving the intramuscular injection with a 5/8" needle of JE-VAX, dose one, lot number JEN222A (expiry date 13/May/2008) in the left deltoid on 20/Apr/2006. Per reporter patient had no illness at the time of vaccination. On 01/May/2006 the patient developed a red welt (nickel size) at the injection site. There was no fever and the area was not painful to touch. No diagnostic tests were performed. On 27/Apr/2006 the patient received the second dose of JE-VAX subcutaneously in the left upper arm. No complaints at that time. Per reporter at the time of this report the patient has not recovered. Follow-up information received on 18/May/2006 from a healthcare provider. The patient was treated with Benadryl, and "the welp went down". The event onset is provided as 01/May/2006. Follow-up information received on 21/Jul/2006. Per the reporter, the patient recovered from these adverse events. The date of recovery was not provided. No further information is expected.
Age: 23.0
Sex: M
Vaccine: JEV
Symptoms: Dizziness, Erythema, Fatigue, Headache, Paraesthesia
Clinical narrative: Initial report received from a healthcare provider on 17/May/2006. A 23 year odl male patient, with no pre existing medicla history, had recieved a subcutaneous, right extremity, second dose injection of JE VAX, lot number EJN221A, on 08/May/02006. On the same day, he developed headache, fatigue, and dizziness which lasted for one to two days. Two days later, he developed a red rash generalized throughout his body and tingling in his hands and feet. The patient ha drecieved prior vaccinations on 01/May/2006 which included a subcutaneous, right extremity, first dose injection of JE VAX, lot number EJN221A, and a second dose injection of Hepatitis A vaccine, lot number AHAVB106. the patient had also recieved the follwoing vaccinations within four weeks of the 08/May/2006 vacciantion (date of these vaccinations was not specified. an injection of YF VAX, lot number UE664AB, and in injection of Typhim VI, lto number Z0479-2. Routes and sites of administration were not provided. At the time of this report, the patient had recovered. Follow up information recieved on 05/Jun/2006 from a health care professional JE VAX (second dose) was adminiastered in the right arm, JE VAX (first dose) was administered in the right arm, YF Vax was administered subcutaneously in the right arm, Typhim VI was administered in the left deltoid, and Hepatitis A vaccine was administered in the right deltoid. Other medications which had included Ataral was amended to Adderall (as needed).
Age: 23.0
Sex: M
Vaccine: JEV
Symptoms: Rash
Clinical narrative: Initial report received from a healthcare provider on 17/May/2006. A 23 year odl male patient, with no pre existing medicla history, had recieved a subcutaneous, right extremity, second dose injection of JE VAX, lot number EJN221A, on 08/May/02006. On the same day, he developed headache, fatigue, and dizziness which lasted for one to two days. Two days later, he developed a red rash generalized throughout his body and tingling in his hands and feet. The patient ha drecieved prior vaccinations on 01/May/2006 which included a subcutaneous, right extremity, first dose injection of JE VAX, lot number EJN221A, and a second dose injection of Hepatitis A vaccine, lot number AHAVB106. the patient had also recieved the follwoing vaccinations within four weeks of the 08/May/2006 vacciantion (date of these vaccinations was not specified. an injection of YF VAX, lot number UE664AB, and in injection of Typhim VI, lto number Z0479-2. Routes and sites of administration were not provided. At the time of this report, the patient had recovered. Follow up information recieved on 05/Jun/2006 from a health care professional JE VAX (second dose) was adminiastered in the right arm, JE VAX (first dose) was administered in the right arm, YF Vax was administered subcutaneously in the right arm, Typhim VI was administered in the left deltoid, and Hepatitis A vaccine was administered in the right deltoid. Other medications which had included Ataral was amended to Adderall (as needed).
Age: 19.0
Sex: M
Vaccine: JEV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from a physician on 24/May/2006. A 16-year-old male student developed a 7cm x 4cm raised, itchy area at the injection site after receiving the second dose of JE-VAX, on an unspecified date. The lot number, route and site of administration was not reported. Per reporting physician the patient had no illness at the time of vaccination. The patient had no systemic signs or symptoms. Per reporter, the patient recovered.
Age: 47.0
Sex: M
Vaccine: JEV
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Initial report received on 06/Jun/2006. A male patient (no age or date of birth reported) received a dose of Je-Vax, lot number unknown, on an unspecified date. The route and site of administration were not reported. An unspecified amount of time post vaccination, the patient developed an injection site reaction consisting of redness, induration and tenderness. The patient's recovery status was reported as unknown. Follow up report received on 13/Jul/2006. Six days later, the patient developed an upset stomach without nausea or vomiting and was tired. The injection site reaction consisted of a 1.5 inch circumference area of redness, slight induration and mild warmth. The patient did not have any tenderness at the injection site (previously reported as injection site tenderness). The patient recovered from the events. Further information is not expected.
Age: 47.0
Sex: M
Vaccine: JEV
Symptoms: Nausea, Stomach discomfort, Vomiting
Clinical narrative: Initial report received on 06/Jun/2006. A male patient (no age or date of birth reported) received a dose of Je-Vax, lot number unknown, on an unspecified date. The route and site of administration were not reported. An unspecified amount of time post vaccination, the patient developed an injection site reaction consisting of redness, induration and tenderness. The patient's recovery status was reported as unknown. Follow up report received on 13/Jul/2006. Six days later, the patient developed an upset stomach without nausea or vomiting and was tired. The injection site reaction consisted of a 1.5 inch circumference area of redness, slight induration and mild warmth. The patient did not have any tenderness at the injection site (previously reported as injection site tenderness). The patient recovered from the events. Further information is not expected.
Age: 45.0
Sex: F
Vaccine: HEPAB, JEV
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: A 45-year-old female with no current illnesses had received a second dose of JE-VAX, lot number EJN222A, in the left deltoid, and a third dose of Twinrix , lot number AHABB058CA, in the left deltoid, on 21/Jul/2006. The patient experienced a half dollar sized area of redness, induration, warmth, and itching at the injections site, with loose stools and nausea five days post immunization, on 26/Jul/2006. Treatment and diagnostic testing were not reported. At the time of this report, the patient had not recovered. The patient had previously received on 14/Jul/2006, a first dose of JE-VAX and a second dose of Twinrix, in the left deltoid with no adverse reaction. The patient also received on 07/JUL/2006, a first dose of Twinrix, a dose of TD vaccine, a dose of Ipol and a dose of MMR vaccine. All of those vaccines were administered in the left deltoid with no reported adverse reactions. Follow up information received on 21/Aug/2006 from a health care professional. As of 15/Aug/2006, the patient was "feeling much better except for residual malaise. Concomitant medications had been added to the record.
Age: 45.0
Sex: F
Vaccine: HEPAB, JEV
Symptoms: Malaise, Nausea
Clinical narrative: A 45-year-old female with no current illnesses had received a second dose of JE-VAX, lot number EJN222A, in the left deltoid, and a third dose of Twinrix , lot number AHABB058CA, in the left deltoid, on 21/Jul/2006. The patient experienced a half dollar sized area of redness, induration, warmth, and itching at the injections site, with loose stools and nausea five days post immunization, on 26/Jul/2006. Treatment and diagnostic testing were not reported. At the time of this report, the patient had not recovered. The patient had previously received on 14/Jul/2006, a first dose of JE-VAX and a second dose of Twinrix, in the left deltoid with no adverse reaction. The patient also received on 07/JUL/2006, a first dose of Twinrix, a dose of TD vaccine, a dose of Ipol and a dose of MMR vaccine. All of those vaccines were administered in the left deltoid with no reported adverse reactions. Follow up information received on 21/Aug/2006 from a health care professional. As of 15/Aug/2006, the patient was "feeling much better except for residual malaise. Concomitant medications had been added to the record.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Abdominal X-ray, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Information has been received concerning a 6 month old male, with no medical history and no allergies, who on 12-DEC-2006, at 1:00 pm, was vaccinated with a third oral dose of Rotateq (lot #653915/0389F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left upper thigh of Daptacel (Lot #C2377A), a third subcutaneous dose in the left upper arm of Ipol (Lot #Y0575), a third intramuscular dose in the left lower thigh of ActHib (Lot # UE709AA), a third intramuscular dose in the right left thigh of Prevnar (Lot B08686), and a third intramuscular dose in the right upper thigh of Recombivax HB (lot #651854/0306R). It was reported that the patient had vomiting and diarrhea for one to two days at the time of vaccination. On 10-JAN-2007, at 6: am, the patient developed intussusception and was hospitalized. The patient had an abdominal X-ray, which was suspicious for intussusception, and abdominal ultrasound of the right upper quadrant which showed colonic intussusception, and an XR enema which successfully reduced the intussusception. It was reported that the patient recovered. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Abdominal X-ray, Enema administration, Feeding disorder of infancy or early childhood, Intussusception, Irritability
Clinical narrative: Information has been received concerning a 6 month old male, with no medical history and no allergies, who on 12-DEC-2006, at 1:00 pm, was vaccinated with a third oral dose of Rotateq (lot #653915/0389F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left upper thigh of Daptacel (Lot #C2377A), a third subcutaneous dose in the left upper arm of Ipol (Lot #Y0575), a third intramuscular dose in the left lower thigh of ActHib (Lot # UE709AA), a third intramuscular dose in the right left thigh of Prevnar (Lot B08686), and a third intramuscular dose in the right upper thigh of Recombivax HB (lot #651854/0306R). It was reported that the patient had vomiting and diarrhea for one to two days at the time of vaccination. On 10-JAN-2007, at 6: am, the patient developed intussusception and was hospitalized. The patient had an abdominal X-ray, which was suspicious for intussusception, and abdominal ultrasound of the right upper quadrant which showed colonic intussusception, and an XR enema which successfully reduced the intussusception. It was reported that the patient recovered. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Ultrasound abdomen, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Information has been received concerning a 6 month old male, with no medical history and no allergies, who on 12-DEC-2006, at 1:00 pm, was vaccinated with a third oral dose of Rotateq (lot #653915/0389F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left upper thigh of Daptacel (Lot #C2377A), a third subcutaneous dose in the left upper arm of Ipol (Lot #Y0575), a third intramuscular dose in the left lower thigh of ActHib (Lot # UE709AA), a third intramuscular dose in the right left thigh of Prevnar (Lot B08686), and a third intramuscular dose in the right upper thigh of Recombivax HB (lot #651854/0306R). It was reported that the patient had vomiting and diarrhea for one to two days at the time of vaccination. On 10-JAN-2007, at 6: am, the patient developed intussusception and was hospitalized. The patient had an abdominal X-ray, which was suspicious for intussusception, and abdominal ultrasound of the right upper quadrant which showed colonic intussusception, and an XR enema which successfully reduced the intussusception. It was reported that the patient recovered. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Abdominal X-ray, Barium enema, Diarrhoea, Enema administration, Intussusception
Clinical narrative: Information has been received concerning a 6 month old male, with no medical history and no allergies, who on 12-DEC-2006, at 1:00 pm, was vaccinated with a third oral dose of Rotateq (lot #653915/0389F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left upper thigh of Daptacel (Lot #C2377A), a third subcutaneous dose in the left upper arm of Ipol (Lot #Y0575), a third intramuscular dose in the left lower thigh of ActHib (Lot # UE709AA), a third intramuscular dose in the right left thigh of Prevnar (Lot B08686), and a third intramuscular dose in the right upper thigh of Recombivax HB (lot #651854/0306R). It was reported that the patient had vomiting and diarrhea for one to two days at the time of vaccination. On 10-JAN-2007, at 6: am, the patient developed intussusception and was hospitalized. The patient had an abdominal X-ray, which was suspicious for intussusception, and abdominal ultrasound of the right upper quadrant which showed colonic intussusception, and an XR enema which successfully reduced the intussusception. It was reported that the patient recovered. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Information has been received concerning a 6 month old male, with no medical history and no allergies, who on 12-DEC-2006, at 1:00 pm, was vaccinated with a third oral dose of Rotateq (lot #653915/0389F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left upper thigh of Daptacel (Lot #C2377A), a third subcutaneous dose in the left upper arm of Ipol (Lot #Y0575), a third intramuscular dose in the left lower thigh of ActHib (Lot # UE709AA), a third intramuscular dose in the right left thigh of Prevnar (Lot B08686), and a third intramuscular dose in the right upper thigh of Recombivax HB (lot #651854/0306R). It was reported that the patient had vomiting and diarrhea for one to two days at the time of vaccination. On 10-JAN-2007, at 6: am, the patient developed intussusception and was hospitalized. The patient had an abdominal X-ray, which was suspicious for intussusception, and abdominal ultrasound of the right upper quadrant which showed colonic intussusception, and an XR enema which successfully reduced the intussusception. It was reported that the patient recovered. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Barium enema, Blood gases abnormal, Diarrhoea, Diet refusal, Intussusception
Clinical narrative: Information has been received concerning a 6 month old male, with no medical history and no allergies, who on 12-DEC-2006, at 1:00 pm, was vaccinated with a third oral dose of Rotateq (lot #653915/0389F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left upper thigh of Daptacel (Lot #C2377A), a third subcutaneous dose in the left upper arm of Ipol (Lot #Y0575), a third intramuscular dose in the left lower thigh of ActHib (Lot # UE709AA), a third intramuscular dose in the right left thigh of Prevnar (Lot B08686), and a third intramuscular dose in the right upper thigh of Recombivax HB (lot #651854/0306R). It was reported that the patient had vomiting and diarrhea for one to two days at the time of vaccination. On 10-JAN-2007, at 6: am, the patient developed intussusception and was hospitalized. The patient had an abdominal X-ray, which was suspicious for intussusception, and abdominal ultrasound of the right upper quadrant which showed colonic intussusception, and an XR enema which successfully reduced the intussusception. It was reported that the patient recovered. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV
Symptoms: Irritability, Pyrexia, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Information has been received concerning a 6 month old male, with no medical history and no allergies, who on 12-DEC-2006, at 1:00 pm, was vaccinated with a third oral dose of Rotateq (lot #653915/0389F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left upper thigh of Daptacel (Lot #C2377A), a third subcutaneous dose in the left upper arm of Ipol (Lot #Y0575), a third intramuscular dose in the left lower thigh of ActHib (Lot # UE709AA), a third intramuscular dose in the right left thigh of Prevnar (Lot B08686), and a third intramuscular dose in the right upper thigh of Recombivax HB (lot #651854/0306R). It was reported that the patient had vomiting and diarrhea for one to two days at the time of vaccination. On 10-JAN-2007, at 6: am, the patient developed intussusception and was hospitalized. The patient had an abdominal X-ray, which was suspicious for intussusception, and abdominal ultrasound of the right upper quadrant which showed colonic intussusception, and an XR enema which successfully reduced the intussusception. It was reported that the patient recovered. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Enema administration, Intussusception, Surgery
Clinical narrative: Information has been received concerning an 18 week old female who on 07-FEB-2007 was vaccinated with an oral dose of Rotateq (lot #656100/1112F). Concomitant vaccines included an intramuscular dose in the right leg of Prevnar (lot #B08670F) and an intramuscular dose in the left leg of Pediarix (lot #AC21B089AA). On 10-FEB-2007 the patient experienced intussusception in two places and was hospitalized for three days. One intussusception required an air enema and the other needed surgical reduction. Subsequently, the patient recovered. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirement and was released. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Barium double contrast, Intussusception, Surgery
Clinical narrative: Information has been received concerning an 18 week old female who on 07-FEB-2007 was vaccinated with an oral dose of Rotateq (lot #656100/1112F). Concomitant vaccines included an intramuscular dose in the right leg of Prevnar (lot #B08670F) and an intramuscular dose in the left leg of Pediarix (lot #AC21B089AA). On 10-FEB-2007 the patient experienced intussusception in two places and was hospitalized for three days. One intussusception required an air enema and the other needed surgical reduction. Subsequently, the patient recovered. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirement and was released. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Constipation, Intussusception, Surgery
Clinical narrative: Vomiting, constipated, abdominal pain. Treatment - surgery for intussusception.  04/16/2007 MR received for 2 night hospitalization 3/3-5/2007 for a 6 day h/o crampy abdominal pain, lack of bowel movement, and vomiting. Partial reduction of the intussusception was completed, however focal intussusception remained in the distal terminal ileum which was surgically reduced via open reduction. Discharge DX:  Intussusception.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound abdomen, Vomiting
Clinical narrative: Vomiting, constipated, abdominal pain. Treatment - surgery for intussusception.  04/16/2007 MR received for 2 night hospitalization 3/3-5/2007 for a 6 day h/o crampy abdominal pain, lack of bowel movement, and vomiting. Partial reduction of the intussusception was completed, however focal intussusception remained in the distal terminal ileum which was surgically reduced via open reduction. Discharge DX:  Intussusception.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Computerised tomogram normal, Convulsion, Drug screen negative, Malaise
Clinical narrative: Information has been received from a physician assistant concerning a 16 year old healthy male with no known medical history who on 14-FEB-2007 was vaccinated IM in the left deltoid with a first dose of Vaqta (lot #656320/1281F). Concomitant vaccination the same day included a dose of Menactra given in the right deltoid. On 17-FEB-2007 the patient wasn't "feeling well" and had malaise. He went to tell his mother how he was feeling and had a seizure. He was taken to the emergency room. The CT scan of his head and urine and drug screen were normal. The patient was sent home He had a second seizure the same day and was taken back to the emergency room and KEPPRA was started. The patient was not hospitalized and was treated and released. The patient was seen for follow up at the doctors office on 19-FEB-2007. He was seen by a Neurologist on 20-FEB-2007 who changed his medication from LEPRRA to TOPAMAX. The patient is scheduled to have a neurology work up including an EEG and MRI. At the time of the report the patient was recovering. There was no product quality complaint involved. Upon internal review the patients seizure was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a female who on 16-NOV-2006 was vaccinated with 2ml oral first dose of Rotateq (lot #655405/1113F). Concomitant vaccination that day included doses of Dtap, Comvax, Poliovirus and Prevnar. On the evening of 16-NOV-2006 the patient developed bloody stool. Unspecified medical attention was sought. The patients present status was unknown. On 21-FEB-2007 the patient did received the second dose of Rotateq. There was no product quality complaint involved. The patients blood in stool was considered to be an other important medical event. Additional information has been requested.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: Barium double contrast, Intussusception
Clinical narrative: Information has been received from a physician concerning a 7 month old female, with no medical history, who was vaccinated with an oral first, second, and third dose of Rotateq, on 19-SEP-2006, 20-NOV-2006, and 16-JAN-2007, respectively. There was no concomitant medication. On 20-FEB-2007, the patient developed intussusception and was admitted to the hospital the morning of 21-FEB-2007. The patient was given an air enema three times before the condition responded. It was reported that the patient would be released from the hospital on 22-FEB-2007. At the time of the report the patient was recovering. No product quality complaint was involved. No other information was provided. The patient's experience was considered to be an other important medical event, immediately life-threatening, and disabling by the reporter. Additional information has been requested.
Age: 0.15
Sex: F
Vaccine: RV5
Symptoms: Colitis, Haematochezia
Clinical narrative: Information has been received from a registered nurse concerning a 12 week old female with a diary allergy and no other medical history who on 14-DEC-2006 was vaccinated with an oral first dose "single-dose tube" of Rotateq. There was no concomitant medication. On 17-JAN-2007, four weeks after vaccination, the patient developed colitis with blood in stool. As of 22-FEB-2007 the patient had not recovered. The physician suspected that the patient's colitis and blood in stool was an allergy to dairy product. There was no product quality complaint involved. Upon internal review the patient's blood in stool was considered to be an other important medical event. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Body temperature increased, Diarrhoea, Haematochezia, Irritability, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 9 week old female with a protein allergy and a milk allergy who was vaccinated with a first and second dose of Rotateq on 20-NOV-2006 and 18-JAN-2007, respectively. On 21-NOV-2006 the patient developed vomiting, irritability, and diarrhea. The patient was taken to the emergency room and had a fever of 100.6. The patient was sent home from the emergency room that day. On 19-JAN-2007, one day after the second dose, the patient developed a low grade fever, blood in stool and diarrhea. These symptoms resolved with a few days. On 18-FEB-2007 the patient went to the emergency room with projectile vomiting with some oral bile discharge. The physician reported on 20-FEB-2007 that the vomiting had resolved, but reported that the patient had periodic diarrhea after both vaccinations had occurred (date and time unspecified). There was no product quality complaint involved. Upon internal review the patient's blood in stool was considered to be an other important medical event. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Similar reaction on previous exposure to drug, Vomiting projectile
Clinical narrative: Information has been received from a physician concerning a 9 week old female with a protein allergy and a milk allergy who was vaccinated with a first and second dose of Rotateq on 20-NOV-2006 and 18-JAN-2007, respectively. On 21-NOV-2006 the patient developed vomiting, irritability, and diarrhea. The patient was taken to the emergency room and had a fever of 100.6. The patient was sent home from the emergency room that day. On 19-JAN-2007, one day after the second dose, the patient developed a low grade fever, blood in stool and diarrhea. These symptoms resolved with a few days. On 18-FEB-2007 the patient went to the emergency room with projectile vomiting with some oral bile discharge. The physician reported on 20-FEB-2007 that the vomiting had resolved, but reported that the patient had periodic diarrhea after both vaccinations had occurred (date and time unspecified). There was no product quality complaint involved. Upon internal review the patient's blood in stool was considered to be an other important medical event. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Respiratory arrest
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a 2 ml PO dose of Rotateq. Subsequently the patient stopped breathing for a short time. The patient was taken to the hospital. It was not reported if the patient was admitted. The patients outcome was not reported. There was no product quality complaint involved. Upon internal review the patient's stopping breathing was considered to be an other important medical event. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Breath holding, Cyanosis, Laboratory test, Pallor, Respiratory arrest
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a 2 ml PO dose of Rotateq. Subsequently the patient stopped breathing for a short time. The patient was taken to the hospital. It was not reported if the patient was admitted. The patients outcome was not reported. There was no product quality complaint involved. Upon internal review the patient's stopping breathing was considered to be an other important medical event. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Skin discolouration
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a 2 ml PO dose of Rotateq. Subsequently the patient stopped breathing for a short time. The patient was taken to the hospital. It was not reported if the patient was admitted. The patients outcome was not reported. There was no product quality complaint involved. Upon internal review the patient's stopping breathing was considered to be an other important medical event. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with the first dose of Rotateq. The physician reported that the patient developed bloody stool roughly 3-4 weeks after being vaccinated. it was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Upon internal review, bloody stool was determined to be an other important medical event. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a health professional concerning a patient under 1 year old who was vaccinated with an oral dose of Rotateq. Subsequently the patient experienced a bloody stool. Unspecified medical attention was sought. No product quality complaint was involved. Upon internal review, the patient's bloody stool was determined to be an other important medical event. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Gastrointestinal disorder, X-ray
Clinical narrative: Information has been received from a registered nurse concerning a 9 week old female who on 05-FEB-2007 was vaccinated with a 2 ml oral first dose of Rotateq. On 12-FEB-2007 the patient experienced signs and symptoms of possible intussusception and was hospitalized. X rays were performed that showed that there was no intussusception and the patient was released on 13-FEB-2007 and was considered to be recovered. There was no product quality complaint involved. Additional information has been requested.