chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.61
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Culture, Dyskinesia, Electroencephalogram, Full blood count
Clinical narrative: Flu vaccine given 12-9-05, seen in ER 12-21-05 for seizures - staring and jerking which mom now realizes started shortly after flu vaccine given. Has been followed by Neuro. Test reveal no cause for delay and hypotonia.    02/21/2007 MR received from PCP. PMH:  Well baby exam of 09/26/2005 all WNL. Developmental delays noted at 6 month check 11/09/2005. Not feeding self, no transfers, not holding bottle, not using sippy cup. DTap and IPV given.  Flu shot 12/09/2005-reportedly doing well.  OV on 12/16/2005 for c/o strange eye movements and jerking lasting a minute or so, 1-2 times/day.  Assessment: R/O seizures. Developmental delay. 03/20/2007 MR received for initial hospital visit for seizure activity on 12/18/05.  Following her Flu vax. mother reported that the child was having  episodes where her eyes would move up in her head, eyelids would flutter, and jerking.  No prior history of fever, but ER temp was 100.8'F. Treated with Ativan and Cerebyx with no further seizures.  Discharge after a 2 night stay.  PE WNL except for: microcephaly-head circumference 39.7cm which is <5th percentile.  Anterior fontanelle only admits tip of finger. No social interaction noted.  No visual tracking.  No response to loud noise.  upon pull to sit, child does not try to maintain position or use hands for support. Final Diagnoses:  Infantile Spasms.  Seizure Disorder.  Developmental Delay. F/U for ER visit on 12/21/2005 for seizures. Now on Topamax. 9 month check(02/10/2006) with Assessment:  Developmental Delay, Seizure disorder. Weight loss noted at 12 month check (4/21/06).  Has not met any developmental milestones. Head lag.  Hypotonia.  Additional Assessment:  Failure to Thrive. Two consultations sent with medical record.  06/06/2006: Child was seen for evaluation of poor weight gain in the context of seizure disorder and severe developmental delay. Marked regression since onset of seizures in 12/2005. Impression:  Severe developmental delay with history of developmental regression after severe seizure at 7 months of age.  Swallowing dysfunction.  Failure to Thrive, likely due to swallowing dysfunction or to underlying metabolic disorder. Nourishment via NG tube.  PE shows fluctuating tone in all extremities. Diagnoses: 1) Feeding dysfunction. 2) Microcephaly. 3) Seizures. 4) Delayed milestones./pc 03/08/2007 Hospital record received for 4 day inpatient stay 06/12/2006-06/16/2006 for admission DX of: 1) Failure to thrive.  2) Severe global developmental delay.  3)  Seizure disorder.  4) Hypotonia.  5)  Microcephaly. Pt. was admitted for further evaluation of the above disorders due to no weight gain over a 3 month period. Genetics consult felt that the patient's condition was highly suggestive of an inborn error of metabolism, however parents declined any further testing and a DNR was signed and the child placed under hospice care. Discharge DX same as admission. Consult in Developmental Pediatrics 01/05/2007.  Improvement noted.
Age: 0.61
Sex: F
Vaccine: FLU3
Symptoms: Hypotonia, Metabolic function test, Nuclear magnetic resonance imaging, Staring
Clinical narrative: Flu vaccine given 12-9-05, seen in ER 12-21-05 for seizures - staring and jerking which mom now realizes started shortly after flu vaccine given. Has been followed by Neuro. Test reveal no cause for delay and hypotonia.    02/21/2007 MR received from PCP. PMH:  Well baby exam of 09/26/2005 all WNL. Developmental delays noted at 6 month check 11/09/2005. Not feeding self, no transfers, not holding bottle, not using sippy cup. DTap and IPV given.  Flu shot 12/09/2005-reportedly doing well.  OV on 12/16/2005 for c/o strange eye movements and jerking lasting a minute or so, 1-2 times/day.  Assessment: R/O seizures. Developmental delay. 03/20/2007 MR received for initial hospital visit for seizure activity on 12/18/05.  Following her Flu vax. mother reported that the child was having  episodes where her eyes would move up in her head, eyelids would flutter, and jerking.  No prior history of fever, but ER temp was 100.8'F. Treated with Ativan and Cerebyx with no further seizures.  Discharge after a 2 night stay.  PE WNL except for: microcephaly-head circumference 39.7cm which is <5th percentile.  Anterior fontanelle only admits tip of finger. No social interaction noted.  No visual tracking.  No response to loud noise.  upon pull to sit, child does not try to maintain position or use hands for support. Final Diagnoses:  Infantile Spasms.  Seizure Disorder.  Developmental Delay. F/U for ER visit on 12/21/2005 for seizures. Now on Topamax. 9 month check(02/10/2006) with Assessment:  Developmental Delay, Seizure disorder. Weight loss noted at 12 month check (4/21/06).  Has not met any developmental milestones. Head lag.  Hypotonia.  Additional Assessment:  Failure to Thrive. Two consultations sent with medical record.  06/06/2006: Child was seen for evaluation of poor weight gain in the context of seizure disorder and severe developmental delay. Marked regression since onset of seizures in 12/2005. Impression:  Severe developmental delay with history of developmental regression after severe seizure at 7 months of age.  Swallowing dysfunction.  Failure to Thrive, likely due to swallowing dysfunction or to underlying metabolic disorder. Nourishment via NG tube.  PE shows fluctuating tone in all extremities. Diagnoses: 1) Feeding dysfunction. 2) Microcephaly. 3) Seizures. 4) Delayed milestones./pc 03/08/2007 Hospital record received for 4 day inpatient stay 06/12/2006-06/16/2006 for admission DX of: 1) Failure to thrive.  2) Severe global developmental delay.  3)  Seizure disorder.  4) Hypotonia.  5)  Microcephaly. Pt. was admitted for further evaluation of the above disorders due to no weight gain over a 3 month period. Genetics consult felt that the patient's condition was highly suggestive of an inborn error of metabolism, however parents declined any further testing and a DNR was signed and the child placed under hospice care. Discharge DX same as admission. Consult in Developmental Pediatrics 01/05/2007.  Improvement noted.
Age: 1.02
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Full blood count, Idiopathic thrombocytopenic purpura, Platelet count decreased, Thrombocytopenia
Clinical narrative: MMR-V Proquad is given on 10/4/06 with Hib. After one month, he developed thromboycytopenia treated for idiopathic thrombocytopenia purpura. Due to persisted thrombocytopenia most likely reason is vaccine associated thrombocytopenia.  02/06/2007: MR received from 2 hospital admissions for easy bruising related to low platelets which had been occuring for approximately 2 weeks.  No epistaxis or other bleeding noted. Sent to ER from Pediatrician's office where platelet count was found to be 7000.  He was admitted and treated with Rhogam.  Two weeks later he was re-admitted for increased bruising again and treated with IgG.  PE: WNL except multiple areas of ecchymosis of lower extremities, chest, forearms, and face on both admissions. Petechia noted on face, arms, legs, and buttocks on 11/16/06. Discharge DX on 11/18/2006: Idiopathic thrombocytopenic purpura. Discharge DX on 11/29/2006: 1) Thrombocytopenia IgG  2) Anemia.  02/19/2007: MR received from PCP.  Infant in for 1 yr. check-up on 10/04/2006 with c/o sores in mouth and recurrent rash x several days.  Fever for 2 days noted, now doing well. Child with DX: of Herpangina given Proquad and Pedvax. Seen again 10/25/2006 for cold sx. and conjunctivitis. Several hospital F/Us for ITP with repeated labs. DX: ITP.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Blood culture negative, Culture urine negative, Irritability, Lumbar puncture, Pyrexia
Clinical narrative: 11-16-06 developed fever 103, irritability, fussiness seen in ER, admitted to Pediatrics for studies and IV antibiotics. 02/06/07-records received and reviewed for DOS 11/16-11/18/06 DC DX: fever  PMH:ureteral strictures requiring surgery immediately following birth. Amoxicillin daily prophylaxis. Seen in ER with temperature of 103 degrees and after admission 102.9 (r)
Age: 0.15
Sex: F
Vaccine: RV5, RV5
Symptoms: Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: pt was given Rotateq at 1 pm-later that evening pt started having vomiting and diarrhea-went to ER
Age: 0.15
Sex: F
Vaccine: RV5, RV5
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: pt was given Rotateq at 1 pm-later that evening pt started having vomiting and diarrhea-went to ER
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Daughter called 12-20-06 claims mother complained of pain in left arm.  Spoke with nurse practitioner who told her to use cold compressions and motrin on 1-4-06, also to come by after to check site. Husband claims pt is in therapy for shoulder pain.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Inflammation, Injection site erythema, Injection site induration
Clinical narrative: Beginning one day after injection profusive erythema and induration around injection site. Spreading to shoulder and neck. Admitted to hospital. At consult-not cellulitis, probable inflammatory reaction. Antibiotics. Discharged home on 1/22/07. 02/15/07-records received and reviewed for DOS 01/20-01/22/07 DC DX: Cellulitis at injection site right arm In ER Swelling at injection site positive axillary lymphnodes. No fever, itching or chills. Consultation exam:Right arm swollen and firm with faint erythema in the upper half extending to the upper lateral chest wall. Slight tenderness, no axillary or epitrochlear lymphandenopathy. Impression cellulitis versus allergic phenomenon. Narrow to vancomycin.
Age: 21.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Enanthema
Clinical narrative: Viral enanthem See attached office notes.  Follow up information received March 30, 2007 - Date of vaccination 01/05/2007 at 16:21 - Adverse event onset 01/07/2007 at 09:00.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site warmth, Tenderness
Clinical narrative: 2"x2" red raised area right upper arm, area warm to touch, area tender
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Axillary mass, Cellulitis, Injection site swelling, Vaccination complication
Clinical narrative: Swelling at injection site-right arm. traveled to axillia, and onto chest (right)
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: site hot, red swelling, size of 4cmx4cm tennis ball, left arm upper noticed. 1/25/07 seen in office 1/26/07
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pruritus
Clinical narrative: Began within 3 hours, redness, swelling, knotty & itchy at the injection site
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Flushing, Hypersensitivity, Rash macular
Clinical narrative: blotching red itchy urticaric rash, flushed cheeks, puffy, warm ears (w/o other known cause for allergic like response)
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Urticaria
Clinical narrative: blotching red itchy urticaric rash, flushed cheeks, puffy, warm ears (w/o other known cause for allergic like response)
Age: 17.0
Sex: M
Vaccine: MMR, MNQ, TDAP
Symptoms: Erythema, Feeling hot, Pain, Skin discolouration, Swelling
Clinical narrative: Erythema, warmth, swelling, pain. Measured 15cm x 17cm pink and swelling on 1/23/07 gives history of having pertussis disease 2 yrs ago.  Follow-up states - MMR II vaccine lot number actually 0862F. Record updated.
Age: 5.0
Sex: F
Vaccine: FLU3, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: vaccine administered 1/23/07-no initial reaction.  Today 1/25/07 RA red, swollen, warm to touch, itchy down to elbow.
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Dehydration, Diarrhoea, Necrosis, Pyrexia, Rash erythematous
Clinical narrative: Developed diarrhea and dehydration (3 days later) became febrile (next day) Developed raised erythematous lesions with central necrosis/sepsis and admitted to PICU (6 days later). 02/21/07-records reviewed for 1/27/07-2/3/07- Admitted with complaints of fever of 102, copious diarrhea. Developed erythematous elevated lesions. WBC 2.7. PE:skin, erythematous elevated lesions on right face, left upper extremity above antecubital fossa, indurated with central grayish discoloration and induration, right calf erythematous and discoloration right wrist lesions and right thigh lesion. Subsequently in hospital developed blisters and swelling over right leg septic with Pseudomonas cultures, intubated, sedated and on pressors. No compressible right upper extremity, left upper extremity and left lower extremity, right lower extremity is rock hard to palpation. Immunological studies results caused by a response to a severe infection.Emergent fasciotomy performed.  05/30/07-DC Summary received for DOS 1/23-3/31/07-DC DX: Pseudomonas aeurginosa sepsis. Ecthyma gangrenosum, secondary to pseudomonas septic emboli. Status post debridement and allograft. Compartment syndrome status post fasciotomy
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Sepsis
Clinical narrative: Developed diarrhea and dehydration (3 days later) became febrile (next day) Developed raised erythematous lesions with central necrosis/sepsis and admitted to PICU (6 days later). 02/21/07-records reviewed for 1/27/07-2/3/07- Admitted with complaints of fever of 102, copious diarrhea. Developed erythematous elevated lesions. WBC 2.7. PE:skin, erythematous elevated lesions on right face, left upper extremity above antecubital fossa, indurated with central grayish discoloration and induration, right calf erythematous and discoloration right wrist lesions and right thigh lesion. Subsequently in hospital developed blisters and swelling over right leg septic with Pseudomonas cultures, intubated, sedated and on pressors. No compressible right upper extremity, left upper extremity and left lower extremity, right lower extremity is rock hard to palpation. Immunological studies results caused by a response to a severe infection.Emergent fasciotomy performed.  05/30/07-DC Summary received for DOS 1/23-3/31/07-DC DX: Pseudomonas aeurginosa sepsis. Ecthyma gangrenosum, secondary to pseudomonas septic emboli. Status post debridement and allograft. Compartment syndrome status post fasciotomy
Age: 23.0
Sex: M
Vaccine: FLU3, HEPAB, IPV, MMR, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Received call from instructors , found patient lying on ground, assessed airway, given 2 doses of Epi-pen, given IV, stayed with patient. Until EMS arrived. 01/31/07-records received and reviewed. Patient seen in follow-up to ER visit, no records available. Received 7 immunizations day prior to visit. HX of treatment at ER, did not receive epinepherine but some other type of IV medication. Allergic to PCN, zithromax. No complaints at the time of office visit. Did not take Benadryl, slept all night.  PE:WNL.  Assessment:other specified adverse effects not elsewhere classified. Patient had 7 immunizations unknown which was offending agent.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella
Clinical narrative: After vaccines was given 3/24/99 he developed chickenpox varicella.  Follow-up received from doctor's office states patient unknown to our practice.
Age: 1.86
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Chest X-ray normal, Computerised tomogram, Disorientation, Full blood count normal, Irritability
Clinical narrative: Extreme fussiness. Refused to bear weight. Seemed disoriented to parents 48 hours after vaccine. No fevers, positive cold like symptoms-on medication.
Age: 1.86
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Laboratory test normal, Nasopharyngitis, Sinus disorder, Weight bearing difficulty
Clinical narrative: Extreme fussiness. Refused to bear weight. Seemed disoriented to parents 48 hours after vaccine. No fevers, positive cold like symptoms-on medication.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Approximately 30 minutes following HBV injection patient became very weak, diaphoretic, pale and dizzy. Symptoms continued approximately 45 minutes when he was transported to home by wife. To ER on 1/28/07 due to continuing symptoms.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Cough, Dyspnoea, Eye swelling, Wheezing
Clinical narrative: Patient received Varicella and Hep A (Havrix) at 12:45 PM. He started having puffy eyes, coughing, difficulty breathing and wheezing at 2pm. He was brought back to my office at 3:20pm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling, redness and some fever at the injection site on her left thigh.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Scattered Varicella lesions
Age: 16.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Feeling hot, Hyperhidrosis, Syncope
Clinical narrative: Immunization given and immediately following reports being hot. Becomes diaphoretic to forehead and extremities. Has syncopal episode lasting 10-15 seconds and remains in chair for 5 minutes and reports feeling "good, fine". Diaphoresis stops patient able to stand without dizziness.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Fatigue, Hypoaesthesia facial
Clinical narrative: Went outside smoked, came back in with fatigue, numbness to right side of face had some anxiety. Approximately 5 minutes passed from immunization. Patient vitals obtained and layed down 163/103, pulse 111 ice compresses to left arm where immunization administered. Face numbness went away after 20 minutes
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Injection site erythema, Injection site rash, Pain, Pruritus
Clinical narrative: 10 cm red, raised with bulls eye in center left mid arm at site of varicella vaccine. Occurred 24 hours after vaccination itches and burns with some pain. Given Benadryl, ice pack and Tylenol for pain.
Age: 47.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Chest pain, Cough, Sinus congestion, Sputum discoloured
Clinical narrative: Acute chest pain, cough and sinus congestion which began 3-4 days after MMR and Hep A vaccine administration. Cough is gaggingly persistent at bedtime and intervals during the day. Sputum production range from yellow, green, to dry. There is no wheezing or LR inflammation detectable.
Age: 45.0
Sex: M
Vaccine: UNK
Symptoms: Burning sensation, Oedema peripheral, Paraesthesia, Tongue oedema
Clinical narrative: Tongue, feet swollen and burning from 0100-0600 today (1-17-07) hands, feet tingly. No vomiting or SOB. Patient received vaccine PM of 1-16-07 from "clinic" whereabouts undetermined.
Age: 1.19
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Swelling, redness and some fever at the injection site on his left thigh.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Client's mother reported to clerk redness and swelling in left arm. Told apply clean, cool, wet washcloth over area for comfort. To call or come to health office if concerned. Client never returned to office.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Local erythema, hot and indurated left anterior thigh.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pyrexia, Tremor
Clinical narrative: Very shaky, fever (tactile)
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Skin lesion, Varicella
Clinical narrative: Varicella vaccine breakthrough. Diagnosed with chickenpox on 1-23-07. Had 50-100 lesions. No fever.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site infection, Swelling
Clinical narrative: 12/12/06 mother stated patient went to emergency room and had infection in his left arm where he received vaccine. 12/13/06 mother called to say that MD said reaction was not from immunization but was an infection. Mother was asked to bring child to health department. Agreed to bring him 12/14/06. 12/14/06 Mother said MD said swelling going away and MD said was a reaction to immunization. Asked mother to sign release of information to obtain MMR recovery. Mother did not come to health department nor did she bring child. 12/15 mother said arm was fine.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pharyngolaryngeal pain, Pyrexia, Rash macular, Skin lesion, Varicella
Clinical narrative: Multiple dew drop lesions, some ruptured on trunk, face. Red macules on extremities after 24 hours. Fever 102 about a day ago, sore throat, chicken pox at school. Diagnosis-post vaccination Varicella.
Age: 1.72
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had localized reaction to Dtap and Hib vaccine. Mother elected to have child evaluated at Hospital ER. Patient evaluated, treated and released. Complained of redness, swelling, warmth at injection site.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Skin lesion
Clinical narrative: About 20 lesions with low grade fever.
Age: 1.34
Sex: M
Vaccine: DTAP, IPV
Symptoms: No adverse effect
Clinical narrative: No adverse reactions noted. Patient checked on at 1440 per foster mother. Patient doing "great", "happy/playing".
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Vaccination around 3pm. Mom noticed hives around 7pm. Gave Benadryl, hives were completely gone by next morning.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Viral infection
Clinical narrative: Initial report received on 18 January 2007 from another manufacturer, reference number WAES0701USA00623. The other manufacturer had originally received the report from a physician and a health professional concerning a 13-week-old male, with no medical history and no allergies, who on 29 November 2006 was vaccinated with a first 2ml oral dose of Rotateq vaccine (human-bovine) (lot#9887/7/1032F). Concomitant vaccines administered on the same day included a dose of IPOL, a dose of HIB conj-hepatitis B vaccine, a dose of Prevnar and a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient  developed diarrhea on an unknown date and was seen in th emergency room. The patient was not hospitalized. At three months of age, on 03 January 2007, the patient tested positive for rotavirus. The reporter was not sure which rotavirus test was performed. The reporter did not have any additional information at the time of the report. Follow-up information received by the other manufacturer from a health professional indicated that the patient experienced rotavirus gastroenteritis. Subsequently the patient recovered.  The patient's rotavirus was considered to be another important medical event by the reporter. Additional information has been requested by the other manufacturer.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive
Clinical narrative: Initial report received on 18 January 2007 from another manufacturer, reference number WAES0701USA00623. The other manufacturer had originally received the report from a physician and a health professional concerning a 13-week-old male, with no medical history and no allergies, who on 29 November 2006 was vaccinated with a first 2ml oral dose of Rotateq vaccine (human-bovine) (lot#9887/7/1032F). Concomitant vaccines administered on the same day included a dose of IPOL, a dose of HIB conj-hepatitis B vaccine, a dose of Prevnar and a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient  developed diarrhea on an unknown date and was seen in th emergency room. The patient was not hospitalized. At three months of age, on 03 January 2007, the patient tested positive for rotavirus. The reporter was not sure which rotavirus test was performed. The reporter did not have any additional information at the time of the report. Follow-up information received by the other manufacturer from a health professional indicated that the patient experienced rotavirus gastroenteritis. Subsequently the patient recovered.  The patient's rotavirus was considered to be another important medical event by the reporter. Additional information has been requested by the other manufacturer.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: I began to itch 3 days after my vaccination shot. At first, I thought it was my eczema acting up, but then I began to itch and scratch all over my arms, underarms, legs, and on my hip bones. Hives have appeared on these areas. i applied flucinonide on the itchy areas, but they still remain itchy. I will see the doctor tomorrow, but I do not believe I can see the doctor who recommended the vaccination.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: 1/16/07 6 pm sore arm left deltoid. 1/17/06 early morning-redness, soreness left deltoid felt tired all day. 1/18/07 early morning-felt sweating, cold, chills. Notice 3 red spots 1- 1 1/2 inch and the other 2- 1inx1in. Warm to touch and tender under arm in arm. 1/19/07 arm feels better left arm is sore.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nasopharyngitis, Skin warm, Tenderness
Clinical narrative: 1/16/07 6 pm sore arm left deltoid. 1/17/06 early morning-redness, soreness left deltoid felt tired all day. 1/18/07 early morning-felt sweating, cold, chills. Notice 3 red spots 1- 1 1/2 inch and the other 2- 1inx1in. Warm to touch and tender under arm in arm. 1/19/07 arm feels better left arm is sore.
Age: 42.0
Sex: F
Vaccine: FLU3, MUR
Symptoms: Body temperature increased, Chills, Decreased appetite, Dizziness, Erythema
Clinical narrative: 1/16/07 6 pm arm sore. 1/16/07 7pm felt sick, chills, light headed, no appetite, "could not get warm". Chills, Temp 102F, drank tea began sweating. 1/17/07 went to hospital early morning. 1/17/07 observed red patch 3.5x2 inch warm to touch, tender when touch.
Age: 42.0
Sex: F
Vaccine: FLU3, MUR
Symptoms: Malaise, Pain in extremity, Tenderness
Clinical narrative: 1/16/07 6 pm arm sore. 1/16/07 7pm felt sick, chills, light headed, no appetite, "could not get warm". Chills, Temp 102F, drank tea began sweating. 1/17/07 went to hospital early morning. 1/17/07 observed red patch 3.5x2 inch warm to touch, tender when touch.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Urticaria
Clinical narrative: Hives. Zyrtec, Epi.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Dyspnoea, Electrocardiogram, Heart rate irregular, Hypoventilation
Clinical narrative: 6 month old into ER, via aunts arms gasping for breath then becoming unresponsive approximately 15 minutes prior to arrival. On admit to ER, patient lethargic with slow shallow respiration weak, crying effort, reported vomiting at home. EKG reported ventricular hypertrophy, rapid irregular rate with PVCS. Patient transferred to a location. Patient coded/died in route to hospital.  2/8/07 Received medical records from hospital which reveal patient brought to ER on 1/22/07 day of vax after experiencing vomiting, SOB then becoming unresponsive w/eyes rolling back in head.  Patient was lethargic w/shallow slow breathing & weak cry on admit to ER.   Patient transferred to higher level care hospital but expired en route.  6/15/07 Received Autopsy Report which reveal COD as: Changes consistent w/vaccination related death.  Pathologic findings: cerebral encephalopathy; thymic enlargement; & visceral congestion.  Manner of death: consistent w/accidental.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Laboratory test, Lethargy, Respiratory rate increased, Unresponsive to stimuli, Ventricular hypertrophy
Clinical narrative: 6 month old into ER, via aunts arms gasping for breath then becoming unresponsive approximately 15 minutes prior to arrival. On admit to ER, patient lethargic with slow shallow respiration weak, crying effort, reported vomiting at home. EKG reported ventricular hypertrophy, rapid irregular rate with PVCS. Patient transferred to a location. Patient coded/died in route to hospital.  2/8/07 Received medical records from hospital which reveal patient brought to ER on 1/22/07 day of vax after experiencing vomiting, SOB then becoming unresponsive w/eyes rolling back in head.  Patient was lethargic w/shallow slow breathing & weak cry on admit to ER.   Patient transferred to higher level care hospital but expired en route.  6/15/07 Received Autopsy Report which reveal COD as: Changes consistent w/vaccination related death.  Pathologic findings: cerebral encephalopathy; thymic enlargement; & visceral congestion.  Manner of death: consistent w/accidental.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: 6 month old into ER, via aunts arms gasping for breath then becoming unresponsive approximately 15 minutes prior to arrival. On admit to ER, patient lethargic with slow shallow respiration weak, crying effort, reported vomiting at home. EKG reported ventricular hypertrophy, rapid irregular rate with PVCS. Patient transferred to a location. Patient coded/died in route to hospital.  2/8/07 Received medical records from hospital which reveal patient brought to ER on 1/22/07 day of vax after experiencing vomiting, SOB then becoming unresponsive w/eyes rolling back in head.  Patient was lethargic w/shallow slow breathing & weak cry on admit to ER.   Patient transferred to higher level care hospital but expired en route.  6/15/07 Received Autopsy Report which reveal COD as: Changes consistent w/vaccination related death.  Pathologic findings: cerebral encephalopathy; thymic enlargement; & visceral congestion.  Manner of death: consistent w/accidental.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a registered nurse (also reported as a physician) concerning a female who was vaccinated  with her first dose of Gardasil vaccine (yeast) 0.5 ml. Subsequently the patient had a seizure. Subsequently, the patient recovered from the seizure. Therapy with Gardasil vaccine (yeast) will not be reintroduced. Upon internal review, seizure was considered an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Hypersensitivity, Oxygen saturation normal
Clinical narrative: Information has been received from a LPN concerning a 17 year old female with asthma who on 16-JAN-2007 was vaccinated with a first dose of Gardasil vaccine (yeast). On 16-JAN-2007 the patient experienced burning in her chest and lungs. The patient was seen at an Urgent Care facility and her lungs were found to be clear and her oxygen saturation was within normal limits. The Urgent Care physician's impression was that the patient experienced some type of allergic reaction. The patient was treated with Tylenol and Benadryl and instructed to come back if the symptoms did not improve or if they exacerbated. The LPN felt that there was a possibility of hospitalization at the time, however, at the time of this report, the patient was recovering and improving on treatment. No product quality complaint was involved. The reporter felt that allergic reaction was an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Joint stiffness, Rash, Rheumatoid arthritis, Swelling
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female who on 03-MAY-1998 was vaccinated with a second dose of Recombivax HB vaccine (yeast). Within hours, she developed a rash on her abdomen. Several days later, her ailments increased to include stiff and painful joints. The patient's condition was described as rheumatoid arthritis. It was reported that the patient "continues to suffer from this permanent condition (disabling), taking daily medication to keep the pain, swelling and stiffness under control". It was reported that the patient's physician decided that she should not receive the third dose of Recombivax HB vaccine (yeast). The doctors attributed her rheumatoid arthritis to her vaccination with Recombivax HB vaccine (yeast). Additional information is not expected.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Abnormal loss of weight, Arthralgia, Blindness unilateral, Blood test
Clinical narrative: The next morning fingers swelled and pain on arm of shot, went across chest into other arm. Starting to effect severe pain and swelling every muscle and  joint in body. Unable to walk or pick up any object with arms. Low fever.  2/2/07 Received medical records from PCP which reveal patient seen 1/17/07 for diffuse muscle pain.  Had been evaluated in early Nov for complaints of leg pain & dx then with arthritis of hips & lumbar spine.  Started PT but got progressively worse with pain extending to arms with severe muscle pain & stiffness of neck, shoulders, arms & lower legs, esp worse in mornings.  Patient had unexplained weight loss of about 5 #.  Exam revealed diffuse muscle tenderness to palpation and unsteady gait requiring use of assistive device.  Tx w/steroids & if no improvement was to be referred to rheumatology.  Daughter related that patient received flu shot at pharmacy which reported to daughter they had 15-17 cases of serum sickness reaction from same lot. FINAL DX: possible serum sickness reaction; although polymyalgia rheumatica type syndrome was felt to be more likely. Per information received from the annual follow up: Unable to walk, hospitalized 3 times for a week or more each time, High Sed Rate, inflamation over entire body. Blind one eye from inflamation ever since flu shot. Yes, I believe this company that made this vaccine should be shut down or prohibited from making any more vaccines. There were other people this happened too. My mother is dying from their mistake and carelessness. She was active, driving a car, doing laundry, cleaning, perfect state of mind, cooking. 48 hours after flu shot this all started and just keep getting worse. She will die from vaccine. My mother's age had nothing to do with this. I received papers from other people in the 40's, 50's, 60's, that had a severe reaction from this company's vaccine. You go get the flu shot to protect you from getting the flu and the shot itself kills you from this company, that is still making vaccine and not brought to justice. What they put in that lot no. vaccine, no one will ever know and it cause such pain and agony and sickness in a person is horrifying. It discusses and hurts me to know this company is still in business. This started 48 hrs after that flu shot and just getting worse. My mother was completely healthy before that shot.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Body temperature decreased, Hypokinesia, Injection site pain, Joint swelling, Muscle swelling
Clinical narrative: The next morning fingers swelled and pain on arm of shot, went across chest into other arm. Starting to effect severe pain and swelling every muscle and  joint in body. Unable to walk or pick up any object with arms. Low fever.  2/2/07 Received medical records from PCP which reveal patient seen 1/17/07 for diffuse muscle pain.  Had been evaluated in early Nov for complaints of leg pain & dx then with arthritis of hips & lumbar spine.  Started PT but got progressively worse with pain extending to arms with severe muscle pain & stiffness of neck, shoulders, arms & lower legs, esp worse in mornings.  Patient had unexplained weight loss of about 5 #.  Exam revealed diffuse muscle tenderness to palpation and unsteady gait requiring use of assistive device.  Tx w/steroids & if no improvement was to be referred to rheumatology.  Daughter related that patient received flu shot at pharmacy which reported to daughter they had 15-17 cases of serum sickness reaction from same lot. FINAL DX: possible serum sickness reaction; although polymyalgia rheumatica type syndrome was felt to be more likely. Per information received from the annual follow up: Unable to walk, hospitalized 3 times for a week or more each time, High Sed Rate, inflamation over entire body. Blind one eye from inflamation ever since flu shot. Yes, I believe this company that made this vaccine should be shut down or prohibited from making any more vaccines. There were other people this happened too. My mother is dying from their mistake and carelessness. She was active, driving a car, doing laundry, cleaning, perfect state of mind, cooking. 48 hours after flu shot this all started and just keep getting worse. She will die from vaccine. My mother's age had nothing to do with this. I received papers from other people in the 40's, 50's, 60's, that had a severe reaction from this company's vaccine. You go get the flu shot to protect you from getting the flu and the shot itself kills you from this company, that is still making vaccine and not brought to justice. What they put in that lot no. vaccine, no one will ever know and it cause such pain and agony and sickness in a person is horrifying. It discusses and hurts me to know this company is still in business. This started 48 hrs after that flu shot and just getting worse. My mother was completely healthy before that shot.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Oedema peripheral, Pain in extremity, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: The next morning fingers swelled and pain on arm of shot, went across chest into other arm. Starting to effect severe pain and swelling every muscle and  joint in body. Unable to walk or pick up any object with arms. Low fever.  2/2/07 Received medical records from PCP which reveal patient seen 1/17/07 for diffuse muscle pain.  Had been evaluated in early Nov for complaints of leg pain & dx then with arthritis of hips & lumbar spine.  Started PT but got progressively worse with pain extending to arms with severe muscle pain & stiffness of neck, shoulders, arms & lower legs, esp worse in mornings.  Patient had unexplained weight loss of about 5 #.  Exam revealed diffuse muscle tenderness to palpation and unsteady gait requiring use of assistive device.  Tx w/steroids & if no improvement was to be referred to rheumatology.  Daughter related that patient received flu shot at pharmacy which reported to daughter they had 15-17 cases of serum sickness reaction from same lot. FINAL DX: possible serum sickness reaction; although polymyalgia rheumatica type syndrome was felt to be more likely. Per information received from the annual follow up: Unable to walk, hospitalized 3 times for a week or more each time, High Sed Rate, inflamation over entire body. Blind one eye from inflamation ever since flu shot. Yes, I believe this company that made this vaccine should be shut down or prohibited from making any more vaccines. There were other people this happened too. My mother is dying from their mistake and carelessness. She was active, driving a car, doing laundry, cleaning, perfect state of mind, cooking. 48 hours after flu shot this all started and just keep getting worse. She will die from vaccine. My mother's age had nothing to do with this. I received papers from other people in the 40's, 50's, 60's, that had a severe reaction from this company's vaccine. You go get the flu shot to protect you from getting the flu and the shot itself kills you from this company, that is still making vaccine and not brought to justice. What they put in that lot no. vaccine, no one will ever know and it cause such pain and agony and sickness in a person is horrifying. It discusses and hurts me to know this company is still in business. This started 48 hrs after that flu shot and just getting worse. My mother was completely healthy before that shot.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, C-reactive protein increased, Musculoskeletal stiffness, Myalgia, Osteoarthritis
Clinical narrative: The next morning fingers swelled and pain on arm of shot, went across chest into other arm. Starting to effect severe pain and swelling every muscle and  joint in body. Unable to walk or pick up any object with arms. Low fever.  2/2/07 Received medical records from PCP which reveal patient seen 1/17/07 for diffuse muscle pain.  Had been evaluated in early Nov for complaints of leg pain & dx then with arthritis of hips & lumbar spine.  Started PT but got progressively worse with pain extending to arms with severe muscle pain & stiffness of neck, shoulders, arms & lower legs, esp worse in mornings.  Patient had unexplained weight loss of about 5 #.  Exam revealed diffuse muscle tenderness to palpation and unsteady gait requiring use of assistive device.  Tx w/steroids & if no improvement was to be referred to rheumatology.  Daughter related that patient received flu shot at pharmacy which reported to daughter they had 15-17 cases of serum sickness reaction from same lot. FINAL DX: possible serum sickness reaction; although polymyalgia rheumatica type syndrome was felt to be more likely. Per information received from the annual follow up: Unable to walk, hospitalized 3 times for a week or more each time, High Sed Rate, inflamation over entire body. Blind one eye from inflamation ever since flu shot. Yes, I believe this company that made this vaccine should be shut down or prohibited from making any more vaccines. There were other people this happened too. My mother is dying from their mistake and carelessness. She was active, driving a car, doing laundry, cleaning, perfect state of mind, cooking. 48 hours after flu shot this all started and just keep getting worse. She will die from vaccine. My mother's age had nothing to do with this. I received papers from other people in the 40's, 50's, 60's, that had a severe reaction from this company's vaccine. You go get the flu shot to protect you from getting the flu and the shot itself kills you from this company, that is still making vaccine and not brought to justice. What they put in that lot no. vaccine, no one will ever know and it cause such pain and agony and sickness in a person is horrifying. It discusses and hurts me to know this company is still in business. This started 48 hrs after that flu shot and just getting worse. My mother was completely healthy before that shot.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: The next morning fingers swelled and pain on arm of shot, went across chest into other arm. Starting to effect severe pain and swelling every muscle and  joint in body. Unable to walk or pick up any object with arms. Low fever.  2/2/07 Received medical records from PCP which reveal patient seen 1/17/07 for diffuse muscle pain.  Had been evaluated in early Nov for complaints of leg pain & dx then with arthritis of hips & lumbar spine.  Started PT but got progressively worse with pain extending to arms with severe muscle pain & stiffness of neck, shoulders, arms & lower legs, esp worse in mornings.  Patient had unexplained weight loss of about 5 #.  Exam revealed diffuse muscle tenderness to palpation and unsteady gait requiring use of assistive device.  Tx w/steroids & if no improvement was to be referred to rheumatology.  Daughter related that patient received flu shot at pharmacy which reported to daughter they had 15-17 cases of serum sickness reaction from same lot. FINAL DX: possible serum sickness reaction; although polymyalgia rheumatica type syndrome was felt to be more likely. Per information received from the annual follow up: Unable to walk, hospitalized 3 times for a week or more each time, High Sed Rate, inflamation over entire body. Blind one eye from inflamation ever since flu shot. Yes, I believe this company that made this vaccine should be shut down or prohibited from making any more vaccines. There were other people this happened too. My mother is dying from their mistake and carelessness. She was active, driving a car, doing laundry, cleaning, perfect state of mind, cooking. 48 hours after flu shot this all started and just keep getting worse. She will die from vaccine. My mother's age had nothing to do with this. I received papers from other people in the 40's, 50's, 60's, that had a severe reaction from this company's vaccine. You go get the flu shot to protect you from getting the flu and the shot itself kills you from this company, that is still making vaccine and not brought to justice. What they put in that lot no. vaccine, no one will ever know and it cause such pain and agony and sickness in a person is horrifying. It discusses and hurts me to know this company is still in business. This started 48 hrs after that flu shot and just getting worse. My mother was completely healthy before that shot.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure - occurred 9 days after vaccine administered.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Presyncope, Trendelenburg position
Clinical narrative: Information has been received from a nurse concerning a 12 year old femmale who on 25-JAN-2007 was vaccinated with GARDISIL, lot # 653735/0688P in the left arm (second dose). On 25-JAN-2007 after receiving vaccine and getting off table felt dizzy walked to appointment desk and became very "oozy" almost fainted mom caught her put in trendelenberg position, given orange juice quickly felt better. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: Information has been received from a nurse concerning a 12 year old femmale who on 25-JAN-2007 was vaccinated with GARDISIL, lot # 653735/0688P in the left arm (second dose). On 25-JAN-2007 after receiving vaccine and getting off table felt dizzy walked to appointment desk and became very "oozy" almost fainted mom caught her put in trendelenberg position, given orange juice quickly felt better. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Rash pruritic
Clinical narrative: pinpoint itchy rash on stomach,back,arms and thighs. Not on face. No temperature, no problems breathing. Saw private Dr. on 1/29/07, benadryl prescribed. 1/31/07 rash is improving.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Rash generalised
Clinical narrative: 7 DAYS AFTER MMR VACCINE, PATIENT SPIKED A FEVER OF 102 AND IT REMAINED HIGH FOR 5 DAYS.   WENT UP TO 104 A FEW TIMES.   KEPT COMFORTABLE WITH MOTRIN.  SHOWED NO OTHER SIGHNS OF COLD/FLU BUT REAL FUSSY AND IRRITABLE.   AFTER FEVER BROKE A RASH APPEARED ALL OVER TRUNK AND ARMS.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Blood urea increased, Dehydration, Diarrhoea haemorrhagic, Hyponatraemia, Screaming
Clinical narrative: Healthy 2 month old received RotaTeq on 1/22/07.  Within 48 hours developed frequent diarrhea (bloody), screaming, weight loss of 1/2 pound and was admitted to hospital with BUN 80.Diagnosed with hyponatremic dehydration.  2/15/07 Received medical records from hospital which reveal patient experienced repeat hospitalizations on 1/25-1/29/07 for cough/fever/vomiting/diarrhea.  IS was ruled out at that time.   Readmitted on 1/30-2/3/07 for decreased appetite despite slight weight gain overnight.  Liver & kidney function deteriorated.  MD unsure if due to rotateq vax.  Consults by peds GI & developmental team.  FINAL DX: Acute renal failure secondary to volume depletion
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Weight decreased
Clinical narrative: Healthy 2 month old received RotaTeq on 1/22/07.  Within 48 hours developed frequent diarrhea (bloody), screaming, weight loss of 1/2 pound and was admitted to hospital with BUN 80.Diagnosed with hyponatremic dehydration.  2/15/07 Received medical records from hospital which reveal patient experienced repeat hospitalizations on 1/25-1/29/07 for cough/fever/vomiting/diarrhea.  IS was ruled out at that time.   Readmitted on 1/30-2/3/07 for decreased appetite despite slight weight gain overnight.  Liver & kidney function deteriorated.  MD unsure if due to rotateq vax.  Consults by peds GI & developmental team.  FINAL DX: Acute renal failure secondary to volume depletion