chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Transfusion, White blood cell count decreased
Clinical narrative: Very fatigued since 2.5.2008. Seen by me, pediatrician on 2.8.08 and 2.11.08. Blood work done 2.12.08 showed occasional blasts and patient had blood marrow done. Now DX to have A.L.L. and chemo Rx started.  2/26/08 Reviewed pcp medical records & vax records. FINAL PCP DX: Acute lymphocytic leukemia (pre B-cell). Received HPV #1 0680U on 9/18/07 at GYN office & Menactra U2385BA on 8/7/07 Fluzone U2451AA on 1/4/2008 at pcp office.  Seen 11/07 for cough, sinus pressure, fever, tight chest, ear ache, HA; sibling w/similar symptoms 10 days prior.  Dx w/sinusitis, otalgia & cough.  Tx w/antibiotics.  Returned to office 1/4/08 w/o complaints for flu shot.  Returned to office 2/8/08 c/o of extreme fatigue beginning approx 2/5/08, stomach pain & intermittent hiccups.  Dx w/malaise & fatigue, r/o mono.  Referred for labs.  Returned to office 2/11/08 w/continued fatigue, pallor, feeling miserable, SOB, nausea, decreased appetite, earache.  Temp 100.7 at that time.  2/13/08 notified by lab of abnormal CBC & referred to hospital.  2/18/08 Received call from parent w/dx of ALL (pre-B cell).  Admitted 2/13-2/23/08.  Placed in study & will receive most tx as outpatient.  3/11/08 Reviewed hospital medical records for admission 2/13-2/23/2008. FINAL DX: acute lymphocytic leukemia Patient experienced extreme fatigue, excessive sleepiness, SOB, low grade fever, abdominal distention w/tenderness, petechiae on LEs, pancytopenia & hepatosplenomegaly.  Consults done by heme/onc.  Transfused x 2. Follow-up: Patient is still being treated for high risk A.L.L. at medical center. Report received from hematooncologist (dated 4.14.08) is attached. Please contact them for further information. I have reported this as part of on going surveillance post-licensure for new vaccines.
Age: 17.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Acute lymphocytic leukaemia, Blast cell count increased, Fatigue, Laboratory test abnormal
Clinical narrative: Very fatigued since 2.5.2008. Seen by me, pediatrician on 2.8.08 and 2.11.08. Blood work done 2.12.08 showed occasional blasts and patient had blood marrow done. Now DX to have A.L.L. and chemo Rx started.  2/26/08 Reviewed pcp medical records & vax records. FINAL PCP DX: Acute lymphocytic leukemia (pre B-cell). Received HPV #1 0680U on 9/18/07 at GYN office & Menactra U2385BA on 8/7/07 Fluzone U2451AA on 1/4/2008 at pcp office.  Seen 11/07 for cough, sinus pressure, fever, tight chest, ear ache, HA; sibling w/similar symptoms 10 days prior.  Dx w/sinusitis, otalgia & cough.  Tx w/antibiotics.  Returned to office 1/4/08 w/o complaints for flu shot.  Returned to office 2/8/08 c/o of extreme fatigue beginning approx 2/5/08, stomach pain & intermittent hiccups.  Dx w/malaise & fatigue, r/o mono.  Referred for labs.  Returned to office 2/11/08 w/continued fatigue, pallor, feeling miserable, SOB, nausea, decreased appetite, earache.  Temp 100.7 at that time.  2/13/08 notified by lab of abnormal CBC & referred to hospital.  2/18/08 Received call from parent w/dx of ALL (pre-B cell).  Admitted 2/13-2/23/08.  Placed in study & will receive most tx as outpatient.  3/11/08 Reviewed hospital medical records for admission 2/13-2/23/2008. FINAL DX: acute lymphocytic leukemia Patient experienced extreme fatigue, excessive sleepiness, SOB, low grade fever, abdominal distention w/tenderness, petechiae on LEs, pancytopenia & hepatosplenomegaly.  Consults done by heme/onc.  Transfused x 2. Follow-up: Patient is still being treated for high risk A.L.L. at medical center. Report received from hematooncologist (dated 4.14.08) is attached. Please contact them for further information. I have reported this as part of on going surveillance post-licensure for new vaccines.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Guillain-Barre syndrome, Muscular weakness, Pain in extremity, Pain in extremity
Clinical narrative: 1/5/08 Legs gave way and she fell several times right together. Legs hurt and didn't have any strength in them. 1/8/08 Diagnosed with Guillain-Barre Syndrome (Admitted to hospital and stayed 5 days. Received intravenous immunoglobulin(s). 2/26/08-records received for DOS 1/8-1/13/08- DC DX: Guillain-Barre syndrome. One week prior became extremely weak and started to fall serveral times per day. On exam found to have areflexic partial lower extremity paraparesis. Ataxic. Treated with 5 days gamma globulin.  02/05/2010 Follow up: She still has pain and tingling in her legs and they are still weak.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, West Nile virus test negative
Clinical narrative: 1/5/08 Legs gave way and she fell several times right together. Legs hurt and didn't have any strength in them. 1/8/08 Diagnosed with Guillain-Barre Syndrome (Admitted to hospital and stayed 5 days. Received intravenous immunoglobulin(s). 2/26/08-records received for DOS 1/8-1/13/08- DC DX: Guillain-Barre syndrome. One week prior became extremely weak and started to fall serveral times per day. On exam found to have areflexic partial lower extremity paraparesis. Ataxic. Treated with 5 days gamma globulin.  02/05/2010 Follow up: She still has pain and tingling in her legs and they are still weak.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Cold sweat, Electrocardiogram normal, Fall, Foaming at mouth
Clinical narrative: Pt received vaccine, took 6 steps, fell to the ground unconscious and had a 60 sec grand mal seizure then regained consciousness.  BP after seizure 60/40 pale clammy skin.  Pt had bit her tongue and had foam around her mouth.  BP raised in 7 mins.  Benadryl at 1500 25mg. 2/25/08-records receivedfor DOS 2/12/08-Impression: Syncopal episode. Presented to ED after experiencing syncopal episode immediately upon injection of vaccine. PE: unremarkable.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion, Heart rate, Laboratory test normal, Loss of consciousness, Pallor
Clinical narrative: Pt received vaccine, took 6 steps, fell to the ground unconscious and had a 60 sec grand mal seizure then regained consciousness.  BP after seizure 60/40 pale clammy skin.  Pt had bit her tongue and had foam around her mouth.  BP raised in 7 mins.  Benadryl at 1500 25mg. 2/25/08-records receivedfor DOS 2/12/08-Impression: Syncopal episode. Presented to ED after experiencing syncopal episode immediately upon injection of vaccine. PE: unremarkable.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Tongue biting
Clinical narrative: Pt received vaccine, took 6 steps, fell to the ground unconscious and had a 60 sec grand mal seizure then regained consciousness.  BP after seizure 60/40 pale clammy skin.  Pt had bit her tongue and had foam around her mouth.  BP raised in 7 mins.  Benadryl at 1500 25mg. 2/25/08-records receivedfor DOS 2/12/08-Impression: Syncopal episode. Presented to ED after experiencing syncopal episode immediately upon injection of vaccine. PE: unremarkable.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Differential white blood cell count, Full blood count, Myalgia, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Woke 2/15/08 c/o L arm pain-pt Tylenol & ibuprofen, iced inj site.  Seen in MD office on 2/19/08-myalgia following HPV.  Labs drawn CBC-D & sed rate.  Given Keflex & Naprosyn.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash
Clinical narrative: Rash on chest, back, and face.
Age: 35.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Dermatitis, Erythema, Injection site erythema, Injection site induration, Lymphadenopathy
Clinical narrative: 35 y/o AD Maj, Staff Cardiologist, returned to clinic today for smallpox vaccine site check.  He received 3 vaccines on 5 FEB 2008: AVA #7, typhoid IM, and primary SPV.  No previous history vaccine reactions.  SM reported development of a large area of redness and induration surrounding his SPV site, with lymph node swelling, and malaise on or about 9 FEB, which resolved.  On 15 FEB he had recurrent malaise along with the development of multiple non-pruitic, non-tender skin eruptions primarily over lower chest, abdomen, trunk, and upper back.  These eruptions peaked on 17 FEB and gradually began to fade the next day.  There were no palmar or mucosal lesions.  Examination of the SPV site left upper arm revealed the expected skin change without satellite lesions, minimal erythema, no induration or regional adenopathy; there were multiple diffusely scattered papulo-macular lesions over his lower chest, abdomen, trunk and fewer over his upper back.  Dx: 1. Nonspecific dermatitis following SPV: Case discussed with He requested derm photos.  VAERS filed.  F/U prn.  2. Major (Robust) Take to SPV.  Symptom: Rash, focal.  Comment: lower chest, abd, trunk, upper back
Age: 35.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Malaise, No reaction on previous exposure to drug, Rash, Rash maculo-papular
Clinical narrative: 35 y/o AD Maj, Staff Cardiologist, returned to clinic today for smallpox vaccine site check.  He received 3 vaccines on 5 FEB 2008: AVA #7, typhoid IM, and primary SPV.  No previous history vaccine reactions.  SM reported development of a large area of redness and induration surrounding his SPV site, with lymph node swelling, and malaise on or about 9 FEB, which resolved.  On 15 FEB he had recurrent malaise along with the development of multiple non-pruitic, non-tender skin eruptions primarily over lower chest, abdomen, trunk, and upper back.  These eruptions peaked on 17 FEB and gradually began to fade the next day.  There were no palmar or mucosal lesions.  Examination of the SPV site left upper arm revealed the expected skin change without satellite lesions, minimal erythema, no induration or regional adenopathy; there were multiple diffusely scattered papulo-macular lesions over his lower chest, abdomen, trunk and fewer over his upper back.  Dx: 1. Nonspecific dermatitis following SPV: Case discussed with He requested derm photos.  VAERS filed.  F/U prn.  2. Major (Robust) Take to SPV.  Symptom: Rash, focal.  Comment: lower chest, abd, trunk, upper back
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, RVX, UNK
Symptoms: Pyrexia
Clinical narrative: High fevers of 104.8.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, RVX, UNK
Symptoms: Blood test, Culture negative, Feeling hot, Full blood count normal, Pyrexia
Clinical narrative: High fevers of 104.8.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, RVX, UNK
Symptoms: Somnolence, Unresponsive to stimuli
Clinical narrative: High fevers of 104.8.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Rash, Rash generalised
Clinical narrative: Rash all over body. Rash also on both cheeks. Face x2d. Patient was initially seen at Peds 2/4/08. Follow up with us on 2/7/08. Dr. Rx'd Triamcinolone for rash, and Tylenol for fever
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: A few hours later got bad headache, nausea, dizzy lasted for several hours, resolved by next day.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Presented at appointment on 02/05/08 with rash on left side of chest. Diagnosed zoster by MD.. Application of emollients recommended for treatment.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Red bumps starting approx 2/17/08. More appearing over time, now in varying stages of varicella. No treatment.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Faeces discoloured, Occult blood negative, Pyrexia
Clinical narrative: Child started with fever around 4:45 pm on 2-18-08. Loose stools with mucous and pink tinged started approx at 7:00pm. Went to emergency room 9:15pm due to fever and loose stools. ER didn't check stool for blood. Sent home no treatment except Tylenol for fever. Seen in our 2-19-08 at 4:00pm. Stool hemocult negative for blood. Abdomen soft. Still having loose stools. No treatment needed other than Tylenol for fever. Instructed to return to office if blood noted in stool and have stool tested.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 2/7/08-4pm-Injection site became red (when mom noticed) - large area of erythema, about 3x3 in. - warm to touch - no fever - Rx with Cephalexin 250 mg tid x5 days.  Area was all clear within couple days.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives throughout body hours after vaccine administered
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pain, Pallor, Pruritus
Clinical narrative: Indurated warm, 4 cm erythematous area with blanched area.  Painful with moderate pressure.  Surrounding area is pruritic.  Afebrile.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm
Clinical narrative: Indurated warm, 4 cm erythematous area with blanched area.  Painful with moderate pressure.  Surrounding area is pruritic.  Afebrile.
Age: 0.4
Sex: M
Vaccine: HIBV
Symptoms: Body temperature increased, Irritability, Medication error
Clinical narrative: Information has been received from a pharmacist concerning a 4 month old male with pertinent medical history and drug reactions/allergies reported as none who on 29-DEC-2006 was vaccinated with PEDVAX HIB (OMPC).  On 29-DEC-2006, the patient was given 2 doses of PEDVAX HIB (OMPC) on the same day.  The pharmacist reported that this was an overdose of PEDVAX HIB (OMPC).  Medical attention was sought.  The infant developed a fever later the same day that persisted for one and a half days.  The infant was given acetominophen (TYLENOL) alternating with ibuprofen for the fever later on in the day on Friday, 29-DEC-2006 through Saturday 30-DEC-2006.  No diagnostic studies were performed.  The infant had no fever on 31-DEC-2006.  The infant has been irritable and there has been a green substance (no mention of what area of the body this has been seen or what date this occurred).  The patient will be seen by the physician on 02-JAN-2007 for these other symptoms.  No further information was available at the time or reporting.  Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Injection site induration, Pain, Swelling
Clinical narrative: Initial and follow-up information has been received from a health professional concerning a 5 month old white male with no past medical history or illness at the time of vaccination who on 29-SEP-2006 was vaccinated IM with one dose of PEDVAX HIB (OMPC) (lot # 652866/0083F).  There was no concomitant medication.  On 30-SEP-2006 the patient developed swelling and hardness at/around the injection site.  The area involved was greater than 2.5 cm.  The patient was treated with acetaminophen (TYLENOL).  Subsequently, the patient recovered from swelling at the injection site and hardness at the injection site.  In follow-up, it was noted that on 25-JAN-2007, the patient was vaccinated intramuscularly with a second dose of PEDVAX HIB (OMPC) (Lot # 653300/0277F) and that, on an unspecified date, the patient developed pain around the injection site.  It was not indicated with which vaccination the pain around the injection site occurred.  The outcome of the pain around the injection site was unknown.  Additional information is not expected.
Sex: F
Vaccine: HIBV
Symptoms: Haematochezia, Insomnia, Irritability
Clinical narrative: Information has been received from the mother of a female child with allergies to soy, milk and eggs.  The mother of the child reported that when the child received the 2 months vaccinations of PEDVAX HIB (OMPC) (manufacturer unknown) and (unspecified) DTaP, she became very fussy, could not sleep, and had blood in her stools.  The child was sought unspecified medical attention.  The patient's mother states that her child had lots of allergies.  It was reported that due to religious reasons the child was not given pork gelatin products.  At the time of the report, it was unknown if the patient recovered.  Additional information has been requested.
Age: 1.8
Sex: M
Vaccine: HIBV, PNC
Symptoms: Gait disturbance, Irritability, Pyrexia, Walking disability, X-ray
Clinical narrative: Information has been received from a licensed practical nurse concerning a 21 month old male who on 28-MAR-2007 was vaccinated intramuscularly into the left thigh with a second dose of PEDVAXHIB (OMPC) (Lot # 655076/1272F).  Concomitant therapy included PREVNAR.  Beginning at night on 28-MAR-2007 the patient developed a "little fever".  By the next morning, the child would not walk and was irritable.  When the patient was seen at the office on 29-MAR-2007, he had bilateral limping and would not readily walk.  The patient was given ibuprofen (MOTRIN).  The patient was scheduled for x-rays.  It was noted that this was the patient's second dose of PEDVAXHIB (OMPC) and that he had no symptoms after the first dose.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  No further information is available.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Serum sickness
Clinical narrative: Information has been received from a physician and the mother of a 24 month old female who was vaccinated with PEDVAXHIB (OMPC).  Subsequently the patient developed serum sickness, reportedly due to the administration.  At the time of the report, it was unknown, if the patient recovered.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: HIBV
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a licensed practical nurse concerning a 7 month old white male (birth weight 7lbs. 2.5oz, no. of siblings was 1) who on 11-DEC-2006 was vaccinated with the first dose of PEDVAXHIB (OMPC), (lot #653525/0279F), IM right.  Concomitant therapy included the first dose of PEDIARIX, (lot #AC21B5H79), IM right and the first dose of PREVNAR, (lot #B08672K), IM left.  Other concomitant medications were not reported.  On 19-FEB-2007, the patient was vaccinated with the second dose of the following medications PEDIARIX, (lot #AC21B071AA), PREVNAR, (lot #B08672K), and ROTATEQ (MSD) (lot #656103/1166F), oral.  On 13-MAR-2007 at 12:35 pm, the patient experienced diarrhea.  The patient was placed on Isomil OF.  On 29-MAR-2007, a stool sample was taken which tested positive for ROTATEQ.  As of 16-APR-2007, the patient still experienced diarrhea.  The patient recovered from the events on an unspecified date.  Additional information is not expected.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Erythema of eyelid, Wheezing
Clinical narrative: Information has been received from a pharmacist concerning a 6 month old male patient who on 26-JAN-2007 was vaccinated IM with a first 0.5 ml dose of PEDVAXHIB (OMPC).  Concomitant therapy on 26-JAN-2007 included doses of ROTATEQ (MSD), PREVNAR and PEDIARIX.  On 28-JAN-2007 the patient developed wheezing and eye erythema.  Details regarding treatment were unknown.  The patient fully recovered.  On 27-MAR-2007 the patient received the second IM 0.5 ml dose of PEDVAXHIB (OMPC).  Concomitant therapy on 27-MAR-2007 included doses of ROTATEQ (MSD), PREVNAR and PEDIARIX.  On 29-MAR-2007 the patient developed eye erythema and wheezing.  Subsequently, the patient fully recovered from wheezing, eye erythema but treatment details were unknown.  Additional information has been requested.
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 2 day old female who on 29-MAR-2007 was vaccinated IM in the right leg with a 0.5 mL dose of PEDVAXHIB (OMPC) (lot #653523/0063U).  Concomitant therapy included MMR (MSD) and PREVNAR.  On approximately 29-MAR-2007, after vaccination, the patient developed an injection site reaction described as red, warm, swollen, and a painful knot (size of knot not reported).  On 06-APR-2007, the patient was examined in the physician's office for an unrelated visit, and the injection site reaction was disclosed at that time.  The physician reported that the injection site reaction had resolved by 06-APR-2007, and that the duration of the injection site reaction was unspecified.  A concern regarding the lot was reported.  Additional information has been requested.  This is one of several reports received from the same source.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of an agency and was released.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 12 month old female who on 29-MAR-2007 was vaccinated intramuscularly, into the right leg, with a 0.5 ml dose of PEDVAXHIB (OMPC) (lot #653523/0063U).  Concomitant suspect vaccination given on 29-MAR-2007 included a dose of MMR (MSD).  Other vaccination given on 29-MAR-2007 included a dose of PREVNAR.  On 29-MAR-2007 the patient developed injection site reaction described as red, warm, swollen and a painful knot the size of a half dollar.  The patient was seen in the physician's office on 30-MAR-2007.  The patient was treated with cephalexin (KEFLEX).  The physician's office requested a lot check.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a male (age not reported) who on an unspecified date was vaccinated with a dose of PEDVAXHIB (OMPC) (lot #653523/0063U).  Subsequently the patient developed an injection site reaction described as red, warm, swollen, painful knot at the injection site.  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  The office requested a lot check to be performed on lot 653523/0063U.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency was released.  This is one of several reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a patient (age and gender not reported) who "within the last 3 months" was vaccinated with a dose of PEDVAXHIB (OMPC).  The patient was given a subcutaneous vaccination instead of intramuscular.  The patient subsequently developed redness and swelling at the injection site.  The outcome was unknown.  No additional information is expected.
Age: 2.0
Sex: U
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Body temperature increased, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 24 month old patient who in May 2007, was vaccinated with PEDVAXHIB (OMPC).  Secondary suspect therapy included PROQUAD (MSD).  Concomitant therapy included DTaP (unspecified) (+) PREVNAR.  On 19-MAY-2007 the patient experienced fever 104 F and leg pain.  The patient's fever 104 F and leg pain persisted.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 0.63
Sex: F
Vaccine: DTP, FLU3, HIBV
Symptoms: Febrile convulsion
Clinical narrative: Information has been received from a nurse concerning a 7 month old female with no pertinent medical history or drug reactions or allergies who on 15-NOV-2007 was vaccinated intramuscularly with a 0.5ml dose of PEDVAXHIB (OMPC) (lot # 654072/1013F).  Concomitant therapy included DAPTACEL and FLUZONE (influenza virus split virion 3v vaccine inactivated), date received was not specified.  On 15-NOV-2007, 12 hours post vaccination, the patient developed a fever and had a febrile seizure.  The patient was taken to the emergency room and later released.  No lab diagnostic test were performed.  The patient recovered on 16-Nov-2007.  Upon internal review, the patient's febrile seizure was considered an other important medical event.  Additional information has been requested. This is in follow-up to reports previously submitted on 2/28/2008. Information has been received from a nurse concerning a 7 month old female with no pertinent medical history or drug reactions, allergies or illness at time of vaccination who on 15-NOV-2007 at 9:00am was vaccinated intramusculary in the right lower thigh with a third 0.5ml dose of Hib conj vaccine (lot # 654072/1013F). The patient was concomitantly vaccinated on the same day with DAPTACEL -lot# C2569AA given intramuscularly in the right upper thigh and FLUZONE - lot# UT2460AA intramusculary in the left thigh. On 15-NOV-2007 at 9:00pm. 12 hours post vaccine the patient developed a fever and had a febrile seizure. The patient was taken to the emergency room and later released. No lab diagnostic test were performed. The patient recovered on 16-NOV-2007. Upon internal review, the patient's febrile seizure was considered an other important medical event. No additional information is expected.
Age: 0.8
Sex: M
Vaccine: HIBV
Symptoms: Diarrhoea, Mucous stools
Clinical narrative: Information has been received from a mother concerning her 10 month old son with no pertinent medical history and no history of drug reactions/allergies who on 28-NOV-2007 was vaccinated with PEDVAXHIB (OMPC).  There was no concomitant medication.  On 29-NOV-2007, the patient experienced diarrhea and mucus.  Unspecified medical attention was sought.  The patient was still having the experience two weeks after the vaccination.  At the time of reporting, the patient had not recovered.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: HIBV
Symptoms: Ear infection, Injection site swelling, Respiratory tract infection, Viral upper respiratory tract infection
Clinical narrative: Information has been received from a father concerning his 10 week old daughter with no medical history who on approximately 28-NOV-2007 was vaccinated into the leg with a first dose of PEDVAXHIB (OMPC).  Concomitant therapy included (therapy unspecified).  On approximately 05-DEC-2007 ("within a week of receiving vaccine") the patient experienced swelling at the injection site, respiratory virus and ear infection.  The patient's swelling at the injection site and respiratory virus and ear infection persisted.  Additional information has been requested.
Age: 0.15
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Muscle twitching
Clinical narrative: Information has been received from a physician concerning a 53 day old male with no past medical history or allergies who on 10-DEC-2007 was vaccinated with a first dose of PEDVAXHIB (OMPC).  Concomitant vaccinations included doses of poliovirus vaccine, pneumococcal conj vaccine (unspecified) and DtAP (unspecified).  On 10-DEC-2007, according to the patient's mother, the patient developed twitching, jerking with facial muscles and arms, low grade temperature and lots of crying.  The patient was seen by the physician who told the mother to "make sure the patient does not have a seizure."  By 6:00 am on 11-DEC-2007, the patient recovered from twitching, jerking with facial muscles and arms, low grade temperature and lots of crying.  Additional information has been requested. 02/18/09 This is in follow-up to report(s) previously submitted on 2/18/2008. Initial and follow up information has been received from two physicians and a mother concerning a 53 day old male patient with no past medical history or allergies who on 10-DEC-2007, at a 2 month check up, was vaccinated with a first dose of Hib conj vaccine (OMPC). Concomitant vaccinations included first doses of poliovirus vaccine, PREVNAR and DTAP 0.5 ml IM x 1 (lot #C2797AA). On 10-DEC-2007, according to the patient's mother, the patient developed twitching right side of face, jerking with facial muscles and arms, low grade temperature, irritability and lots of crying. The mother called within 3-4 hours after child received vaccinations. The patient was seen by the physician who told the mother to "make sure the patient does not have a seizure". The patient was treated with BENADRYL and TYLENOL 80 mg every 4 hours po 10-DEC-2007 until 11-DEC-2007. By 6:00 am on 11-DEC-2007, the patient recovered from twitching, irritability, jerking with facial muscles and arms, low grade temperature and lots of crying. Additional information is not expected.
Age: 0.3
Sex: F
Vaccine: DTPIHI, HEP, HIBV, HIBV, IPV, RV5
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site reaction, Laboratory test
Clinical narrative: Information has been received from a consumer concerning her 4 month old daughter who on 03-APR-2007, was vaccinated with a dose of PEDVAXHIB (OMPC).  Suspect concomitant therapy included ROTATEQ, for the treatment of prophylaxis (duration and dose not reported).  Other concomitant therapy included polio virus vaccine, DTAP (unspecified) Hib conj vaccine (unspecified carrier) and hepatitis B virus vaccine (unspecified).  On 04-APR-2007, the patient developed a huge red bump that was hard to the touch at the injection site.  The physician saw the patient within a week and thought it was a typical injection site reaction that should resolve on it's own.  It was reported that weeks went by and the patient's injection site reaction was still red.  In mid May 2007, the patient was seen by the physician and it was recommended that she start massaging it and hot packing the injection site area and within a week it ended up bursting with green goo coming out.  The reporter took her daughter to the emergency room where they evaluated the injection site and ran some tests.  The patient was then put on a series of antibiotics at that time.  It was reported that shortly thereafter the patient saw a new physician and she was again prescribed more antibiotics for about a month.  It was reported that the patient's leg was lanced to get the infection out.  The patient is now seeing a surgeon because the injection site reaction left a scar on her leg but it's no longer a large bump under the site.  At the time of this report, the patient's abscess is small but still had a red bump that's half the size of a penny.  It was also reported that the patient did not have a reaction from her 2 month immunizations.  No product quality complaint was involved.  Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: HIBV
Symptoms: Culture stool negative, Culture urine negative, Diarrhoea, Laboratory test normal, Pyrexia
Clinical narrative: Initial and follow up information has been received from a licensed pratical nurse and the mother of a 10 week old female infant with no medical history who on 04-DEC-2007 was vaccinated with a dose of PedvaxHIB. There was no concomitant medication. There was no illness at the time of vaccination.. On 05-DEC-2007 the patient developed diarrhea which persisted for 3 weeks. On 10-DEC-2007 the infant was hospitalized for fever and possible urinary tract infection; unspecified urine and blood tests were performed (results not provided). The patient was discharged on 11-DEC-2007. As of the report date, her diarrhea persisted. Additional information has been requested. This is in follow up to report (s) submitted on 2/14/2008. Urine cultures were negative for urinary tract infection. On 12-Dec-2007 laboratory diagnostic test were negative for rotavirus antigen. Urine cultures were negative for urinary tract infection. On 12-Dec-2007 laboratory diagnostic test were negative for rotavirus antigen. On 14-Dec-2007 stool cultures were negative for salmonella, shigella, campylobacto: and bacillus cereus. On 27-Dec-2008 stool cultures were again negative for salmonella, shigelia, campylobactor and giardia, C diff toxins were negative. The patient was discharged after 3 days. The patient recovered on 28-Dec-2007. No further information is available.
Age: 0.19
Sex: F
Vaccine: HIBV
Symptoms: Rotavirus test negative
Clinical narrative: Initial and follow up information has been received from a licensed pratical nurse and the mother of a 10 week old female infant with no medical history who on 04-DEC-2007 was vaccinated with a dose of PedvaxHIB. There was no concomitant medication. There was no illness at the time of vaccination.. On 05-DEC-2007 the patient developed diarrhea which persisted for 3 weeks. On 10-DEC-2007 the infant was hospitalized for fever and possible urinary tract infection; unspecified urine and blood tests were performed (results not provided). The patient was discharged on 11-DEC-2007. As of the report date, her diarrhea persisted. Additional information has been requested. This is in follow up to report (s) submitted on 2/14/2008. Urine cultures were negative for urinary tract infection. On 12-Dec-2007 laboratory diagnostic test were negative for rotavirus antigen. Urine cultures were negative for urinary tract infection. On 12-Dec-2007 laboratory diagnostic test were negative for rotavirus antigen. On 14-Dec-2007 stool cultures were negative for salmonella, shigella, campylobacto: and bacillus cereus. On 27-Dec-2008 stool cultures were again negative for salmonella, shigelia, campylobactor and giardia, C diff toxins were negative. The patient was discharged after 3 days. The patient recovered on 28-Dec-2007. No further information is available.
Age: 0.1
Sex: F
Vaccine: HIBV
Symptoms: Limb reduction defect
Clinical narrative: Information has been received from a consumer concerning her 10 month old daughter, who had no pertinent medical history or drug reactions/allergies and was vaccinated (route and site not reported) in July 2007 (exact date not reported) with PEDVAXHIB (OMPC) (lot # not given).  Concomitant therapy includes unspecified "heart medication".  In July 2007, post vaccination, the patient experienced "absence in both legs".  The patient did receive unspecified medical attention.  No lab diagnostics test were performed.  At the time of this report the patient had not recovered.  No additional information is expected.
Sex: U
Vaccine: HIBV
Symptoms: Irritability
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a patient who was vaccinated with a dose of PEDVAXHIB (OMPC).  The reporter stated that a mother said her child had been "fussy" after receiving the injection.  Medical attention was sought.  The patient's outcome was unknown.  The physician was not convinced symptoms were related to the vaccine.  Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Information has been received from a registered nurse concerning an 8 week old female infant with dermatitis and congestion on the day of vaccination who on 06-DEC-2007 was vaccinated intramuscularly a 0.5 mL dose of with a dose of Hib conj vaccine (OMPC) (lot 657395/0819U). The patient was concomitantly vaccinated with PEDIARIX and PREVNAR. The nurse reported that the patient's mother contacted the office and stated that the patient seemed to cry a lot the third day post vaccination. The nurse did not think that the crying was related to the vaccine. The patient recovered by the following day. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/18/2008. The nurse did not think that the crying was related to the vaccine and reported that the patient did not have any ill effects from the vaccine. No furher information is available.
Age: 0.2
Sex: M
Vaccine: HIBV, IPV, PPV, RV5, TTOX
Symptoms: Diarrhoea, Pallor, Pyrexia
Clinical narrative: Information has been received from a consumer concerning his 8 week old son with no relevant medical history reported who on 12-DEC-2007 was vaccinated with a first dose of PEDVAXHIB (OMPC).  On 12-DEC-2007, the patient was concomitantly vaccinated with a dose of ROTATEQ, tetanus toxoid, poliovirus vaccine, and pneumococcal vaccine (manufacturer unknown).  During the evening of 12-DEC-2007, the patient developed a fever, diarrhea and was pale.  The patient received unspecified medical attention.  At the time of this report, the patient had not recovered.  Additional information has been requested. Additional information was received from a physician who reported that the patient was never seen nor was the office contacted regarding any type of adverse reactons from htis immunization. No additional information is expected.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV, RV5
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: Information has been received from a mother (a medical assistant) concerning her 22 week old daughter who on 05-DEC-2007 was vaccinated with PedvaxHIB (lot # not reported). Concomitant therapy also given on 05-DEC-2007, included DTAP-IPV (manufacturer unknown), IPOL, Pneumovax (manufacturer unknown), and Rotateq. On 05-DEC-2007, her daughter developed at injection site lump, and injection site redness after being vaccinated with PedvaxHIB. The child was seen by a nurse in the office. She also developed a fever. She was treated with warm compresses. At the time of reporting, the patient had not recovered. Additional information has been requested. 02/18/09 This is in follow-up to report(s) previously submitted on 02/18/2008. Follow-up information was received from the physician's practice. "The patient's parent informed that the vaccine had nothing to do with the report because we don't carry that in our office, regular HIB was given only". No additional information is expected.
Age: 0.18
Sex: M
Vaccine: HIBV, PNC
Symptoms: Abnormal behaviour, Blood test, Body temperature increased, Crying, Irritability
Clinical narrative: Information has been received from a consumer, a mother, concerning her 10 month old son who on 10-APR-2007 (at 2 months) was vaccinated with a first dose of Hib conj vaccine (OMPC) (lot#656136/0077U). There was no concomitant medication. The mother reported that her son had several health issues since receiving the Hib conj vaccine (OMPC). On 10-APR-2007 he developed swelling, fever of 103, rash and behavioral issues (crying, irritability, eating things). The baby received a second and third dose of Hib conj vaccine (OMPC) on 01-JUN-2007 (Lot# 654679/1126F) and 27-AUG-2007, (Lot# 654678/1125F) respectively. The mother reported that her son had a blood tests done (no results). At the time of the report he was no recovered. Additional information has been requested. 02/18/09 This is in follow-up to report(s) previously submitted on 2/18/2008. Information has been received from a mother concerning her 10 month old son, and follow up information has been received from a registered nurse concerning the male patient who on 10-APR-2007 (at 2 months) was vaccinated in the left leg with a first dose of Hib conj vaccine (OMPC) (Lot# 654678/1125F) and in the right leg with a first dose of PREVENAR (Lot# B47742B). The mother reported that her son had several health issues since receiving the Hib conj vaccine (OMPC). On 10-APR-2007 he developed swelling, fever of 103, rash and behavorial issues (crying, irritability, eating things). The baby was vaccinated in the left leg with a second dose and third dose of Hib conj vaccine (OMPC) on 01-JUN-2007 (Lot# 654679/1126F) and 27-AUG-2007, (Lot#656136/0077U) respectively. The mother reported that her son had blood tests done (no results). At the time of the report he was not recovered. Follow up information from a registered nurse indicated that on 24-APR-2007, the patient developed a lump on his right leg where PREVENAR was administered. On an unspecified date, the patient recovered from lump on right leg. Additional information is not expected.
Age: 0.18
Sex: M
Vaccine: HIBV, PNC
Symptoms: Laboratory test, Pyrexia, Rash, Swelling
Clinical narrative: Information has been received from a consumer, a mother, concerning her 10 month old son who on 10-APR-2007 (at 2 months) was vaccinated with a first dose of Hib conj vaccine (OMPC) (lot#656136/0077U). There was no concomitant medication. The mother reported that her son had several health issues since receiving the Hib conj vaccine (OMPC). On 10-APR-2007 he developed swelling, fever of 103, rash and behavioral issues (crying, irritability, eating things). The baby received a second and third dose of Hib conj vaccine (OMPC) on 01-JUN-2007 (Lot# 654679/1126F) and 27-AUG-2007, (Lot# 654678/1125F) respectively. The mother reported that her son had a blood tests done (no results). At the time of the report he was no recovered. Additional information has been requested. 02/18/09 This is in follow-up to report(s) previously submitted on 2/18/2008. Information has been received from a mother concerning her 10 month old son, and follow up information has been received from a registered nurse concerning the male patient who on 10-APR-2007 (at 2 months) was vaccinated in the left leg with a first dose of Hib conj vaccine (OMPC) (Lot# 654678/1125F) and in the right leg with a first dose of PREVENAR (Lot# B47742B). The mother reported that her son had several health issues since receiving the Hib conj vaccine (OMPC). On 10-APR-2007 he developed swelling, fever of 103, rash and behavorial issues (crying, irritability, eating things). The baby was vaccinated in the left leg with a second dose and third dose of Hib conj vaccine (OMPC) on 01-JUN-2007 (Lot# 654679/1126F) and 27-AUG-2007, (Lot#656136/0077U) respectively. The mother reported that her son had blood tests done (no results). At the time of the report he was not recovered. Follow up information from a registered nurse indicated that on 24-APR-2007, the patient developed a lump on his right leg where PREVENAR was administered. On an unspecified date, the patient recovered from lump on right leg. Additional information is not expected.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 19 week old male who on 12-DEC-2007 was vaccinated with a dose of PedvaxHIB (Lot# 657387/0995U). Concomitant suspect vaccinations included Rotateq. Other concomitant vaccinations included Prevnar and Pediarix. On 13-DEC-2007 the patient experienced fever and diarrhea. The nurse practitioner's office was contacted. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: HIBV
Symptoms: Injection site induration
Clinical narrative: Information has been received from a consumer concerning her 1 year old daughter with a history of impetigo, cellulitis, contact dermatitis - type rashes several times during 2007, and occasional fevers, who on 30-MAY-2007 was vaccinated with a first dose of PEDVAXHIB (OMPC) (Lot #654070/0071U).  On 10-JUL-2007 the patient was vaccinated with a second dose of PEDVAXHIB (OMPC).  On 27-AUG-2007 the patient was vaccinated with a third dose of PEDVAXHIB (OMPC) (Lot# 655078/1273F).  In the beginning of September 2007, the patient experienced an injection site lump about 1/2 the size of a golf ball.  It was reported that the lump reduced very slowly over the course of two and a half months.  The patient sought unspecified medical attention.  At the time of the report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 18 month old son with mild seasonal allergies, who on 04-DEC-2007 was vaccinated with a first dose of PedvaxHIB (Lot# 654909/1127F). Concomitant vaccinations included DTaP. On 05-DEC-2007 the patient experienced an injection site reaction with swelling, warmth, and redness with a mild fever for a few days post vaccination. It was reported that by "Sunday or Monday" the swelling of the injection site had started to go down, but there was still a 1-2 inch bump located at the injection site. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Nasopharyngitis
Clinical narrative: Information has been received from a consumer concerning their child (age and gender unknown) who, on an unspecified date, was vaccinated with a dose of Hib conj vaccine(OMPC). Subsequently, the patient experienced a cold. The patient did not seek medical attention. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: HIBV, UNK
Symptoms: Inappropriate schedule of drug administration, Rash
Clinical narrative: Information has been received from a consumer concerning his 11 month old son with no medical history and no drug allergies, who on 21-MAR-2007 was vaccinated with a first dose of Hib conj vaccine. Concomitant therapies included an unspecified vaccine.  On 17-JUL-2007 the patient received a second dose of Hib conj vaccine (OMPC). On 25-SEP-2007 the patient received a third dose of Hib conj vaccine (OMPC). It was reported that "about six months ago" in approximately June 2007, the patient experienced rash. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: HIBV
Symptoms: Dysphonia, Pyrexia, Rhinorrhoea
Clinical narrative: Information has been received from a consumer concerning her 4 month old daughter with no medical history and no drug allergies, who on 10-DEC-2007 was vaccinated with a second dose of PEDVAXHIB (OMPC).  There was no concomitant medication.  On 12-DEC-2007 the patient experienced a fever, runny nose, and hoarseness.  The patient did not seek medical attention.  No laboratory diagnostics were performed.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 0.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: This is a follow-up to report(s) previously submitted on 2/18/2008.  Information has been received from a physician and a licensed practival nurse concerning a 2 month old patient with no medical history and no drug allergies, who on 07-DEC-2007 was vaccinated with a first dose of PEDVAXHIB (Lot# 657386/0820U). Concomitant suspect vaccinations included ROTATEQ (Lot# 657671/0902U) administered by mouth. Other concomitant vaccinations included PEDIARIX (Lot# AC218125BB) administered intramuscularly in the left arm and a first dose of PREVNAR (Lot# 854014D) administered intramuscularly in the right arm.  There were no illnesses at the time of the vaccinations.   On 07-DEC-2007 the patient developed a localized reaction and a red mark at the injection site. The patient sought unspecified medical attention. No laboratory diagnostics were performed. No treatment was required. The patient sought unspecified medical attention.  No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a child (age and gender unknown), who, on an unspecified date, was vaccinated with a dose of PEDVAXHIB (OMPC).  Subsequently, the patient experienced diarrhea, vomiting, and a low grade fever.  The physician was contacted by phone.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information has been requested.