chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HPV4, MNQ, HPV4, MNQ
Symptoms: Subarachnoid haemorrhage, Syncope, Unresponsive to stimuli
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 13 year old female patient with a history or vasovagal response to vaccine who on 02-APR-2007 was vaccinated with a first dose 0.5 mL of Gardasil. Concomitant therapy included Menactra. On 02-APR-2007 the patient felt dizziness and fell on the ground. The patient was hospitalized in intensive care for head injury but did not require any surgery. At the time of this report patient was still in the hospital and had not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Fall, Head injury, Intensive care
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 13 year old female patient with a history or vasovagal response to vaccine who on 02-APR-2007 was vaccinated with a first dose 0.5 mL of Gardasil. Concomitant therapy included Menactra. On 02-APR-2007 the patient felt dizziness and fell on the ground. The patient was hospitalized in intensive care for head injury but did not require any surgery. At the time of this report patient was still in the hospital and had not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 13 year old female patient with a history or vasovagal response to vaccine who on 02-APR-2007 was vaccinated with a first dose 0.5 mL of Gardasil. Concomitant therapy included Menactra. On 02-APR-2007 the patient felt dizziness and fell on the ground. The patient was hospitalized in intensive care for head injury but did not require any surgery. At the time of this report patient was still in the hospital and had not recovered. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Diabetes mellitus insulin-dependent
Clinical narrative: Type I diabetes diagnosed on July 6, 2004.  My son has been on insulin for type I diabetes since then. 05/23/07-records received-note dor DOS 6/10/04-parent concerned regarding wet diapers and diabetes history in family. Hospital records for DOS 07/06/04-DX: New onset diabetes. servere diabetic ketoacidiosis resolved. Seen for increased labored breasthing. Respiratory rate in ED 58,HX ear infections last occurring beginning of June. After measles vaccine on 6/22/04-broke out in rash and parent felt breathing faster. 1/5/10 Patient still has type 1 diabetes.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Diplegia, Guillain-Barre syndrome, Pain
Clinical narrative: Information has been received from a pediatric physician concerning a 14 year old female who was vaccinated with a dose of GARDASIL. Subsequently the patient developed Guillain-Barre syndrome which he thought was "pain and paralysis in the legs" or a "nerve-related syndrome that can last between 6 months to a year." Unspecified medical attention was sought. The patient's outcome was unknown. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Dizziness, Fatigue, Headache, Hypoaesthesia, Injection site pain
Clinical narrative: 3-27-07: Parent called dr's office to report patient had the following symptoms for 2 days: "wakign with really, bad headache", "numbness and tingling down one arm, then the other arm, intermittently", "neck hurts, constantly tired, sometimes dizzy", soreness at injection site
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Neck pain, Paraesthesia
Clinical narrative: 3-27-07: Parent called dr's office to report patient had the following symptoms for 2 days: "wakign with really, bad headache", "numbness and tingling down one arm, then the other arm, intermittently", "neck hurts, constantly tired, sometimes dizzy", soreness at injection site
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Body temperature increased
Clinical narrative: Temp elevation from 1130pm 4-11-07 to 10:00pm 4-12-07. Highest temp 105 deg.
Age: 59.0
Sex: M
Vaccine: TD
Symptoms: Paraesthesia
Clinical narrative: Tingling L shoulder at site of injection started one month after shot. Tingling happens at night a few times a week. Neg swelling and no other pain.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Angioedema, Dyspnoea, Rash, Urticaria
Clinical narrative: Patient developed severe urticaria and angioedema starting about 24-48 hours after getting HPV vaccine (First dose). Patient had two E.R. visits. Needs high dose steroids to control angioedema of throat. Problem lasted ten days.  5/1/07 Received med records from ER visit which reveals patient experienced rash on hip area which spread to extremities. Exam revealed urticarial rash on extemities & trunk.  Initially had mild SOB & tightening of throat.  Pt had recent DepoProvera injection as well as Gardisil.  Tx w/antihistamine & prednisone & d/c to home. ALLERGIES: Augmentin & sulfa FINAL DX: Urticaria.
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Hypoaesthesia, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Onset 1800 3/24 numbness radial side of L arm no weakness, tingling 3/25 0600 radial 8100 L arm 8100 L arm tingle numb, 10000 R side of face numb, 1300 L arm/shoulder numb, 3/26 Facial numbness resolved 3/27 numbness shed to hypersensitive.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: pt states she had fever, nausea, vomiting and diarrhea for one and half days.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness 12-15 cm circular area. Next day after immunizations, Painful red. Seen 5 days later, redness diminished  Instr. Benadryl for comfort
Age: 38.0
Sex: F
Vaccine: SMALL
Symptoms: Antinuclear antibody positive, Blood thyroid stimulating hormone, Dysphagia, Fatigue, Full blood count
Clinical narrative: Developed fevers and left shoulder pain (innoculated L deltoid). Progressed to headache-(evaluated in ER with spinal tap) and then generalized muscle aches, claims of lumps developing over various places on body, tenderness in those palces. Severe fatigue and soreness transient nausea. Difficulty swallowing due to thyroid module/cyst.
Age: 38.0
Sex: F
Vaccine: SMALL
Symptoms: Headache, Lumbar puncture, Metabolic function test, Musculoskeletal pain, Myalgia
Clinical narrative: Developed fevers and left shoulder pain (innoculated L deltoid). Progressed to headache-(evaluated in ER with spinal tap) and then generalized muscle aches, claims of lumps developing over various places on body, tenderness in those palces. Severe fatigue and soreness transient nausea. Difficulty swallowing due to thyroid module/cyst.
Age: 38.0
Sex: F
Vaccine: SMALL
Symptoms: Nausea, Pyrexia, Red blood cell sedimentation rate, Swelling, Tenderness
Clinical narrative: Developed fevers and left shoulder pain (innoculated L deltoid). Progressed to headache-(evaluated in ER with spinal tap) and then generalized muscle aches, claims of lumps developing over various places on body, tenderness in those palces. Severe fatigue and soreness transient nausea. Difficulty swallowing due to thyroid module/cyst.
Age: 38.0
Sex: F
Vaccine: SMALL
Symptoms: Thyroid cyst, Thyroid neoplasm, Urine analysis
Clinical narrative: Developed fevers and left shoulder pain (innoculated L deltoid). Progressed to headache-(evaluated in ER with spinal tap) and then generalized muscle aches, claims of lumps developing over various places on body, tenderness in those palces. Severe fatigue and soreness transient nausea. Difficulty swallowing due to thyroid module/cyst.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Hypersomnia, Pain
Clinical narrative: 4-3-07 a few hrs after shot given-soreness got worse-Thursday 4-5 she felt very tired-slept 9 hrs when laid down for nap. Friday-redness and pain about 5: in diam. Reported on Mon 4-9 and states it is getting better. Not as painful or swollen did not seek treatment
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Injection site erythema
Clinical narrative: Patient received Zostavax vaccine SQ in left upper arm 3-21-07. On 3-23-07 patient stopped in and showed us arm where injection was given. Large red area 2 1/4" x 1 1/2". No itching, burning or irritation. No trouble breathing. Next day it had increased in size to 4" x 4" and another red spot developed on that same arm. Patient visited Dr and concluded it was ADR from vaccine but no further evaluation needed (no treatment)
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm red, swollen and warm to touch. Erythematous area 3 cm diameter in location of vaccine
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Asthenia, Body temperature increased, Cold sweat, Diarrhoea, Injection site erythema
Clinical narrative: Mom reports via telephone that pt received Hep A vaccine on 3/28/07 and last night (3/29) started vomiting. This am diarrhea began. Child very weak and pale. T 96, clammy. Also received DTap and IPV. Mom denies poss. that symptoms are caused by GI virus. Right arm was red and swollen but is better now. Hep a given in LA.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site swelling, Pallor, Vomiting
Clinical narrative: Mom reports via telephone that pt received Hep A vaccine on 3/28/07 and last night (3/29) started vomiting. This am diarrhea began. Child very weak and pale. T 96, clammy. Also received DTap and IPV. Mom denies poss. that symptoms are caused by GI virus. Right arm was red and swollen but is better now. Hep a given in LA.
Age: 9.0
Sex: M
Vaccine: BCG, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Redness, swelling of injection site, "welt-like" bump, hot to touch. Dx: cellulitis Tx: Augmentin x 10d
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Rash pruritic, Skin lesion, Vaccination failure, Varicella
Clinical narrative: appr 2 weeks after vaccination pt broke out in very itchy papulovesicular rash approx 70-100 lesions on face/trunk/extremities. 11 yr old sibling (who had lateral varcella at 1 yr of age) also woke up in same rash.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cold compress therapy, Erythema, Local reaction, Skin warm, Urticaria
Clinical narrative: Had 4 yo booster 4/3/07 DTaP, MMR, Ipol 4/5/07 red welt warm to touch 4/6 seen in our office dx with local vaccine reaction Rec Benadryl and cool compress
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: 11 X 8 cm erythematous area 3 nodule at injection site right deltoid with pruritus and warmth observed 4/9/07. Treated with Elocon cream qd, Zyrtec 10 mg qhs with improvement in 24 hrs.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Dizziness, Erythema, Injection site swelling, Myalgia
Clinical narrative: Menactra given 04/04/2007. Later that evening the patient devvelped a temp of 101, had nausea and felt lightheaded.  Left arm was red and swollen and he states that every muscle in his body hurt.  On 4/5/07 patient was seen by family physician.  Was given Rx of Keflex and continued on routine medications, Allegra and Singular.  Continued with lightheadedness and muscle aches until 4/8/07.  On 4/9/07 muscle aches did decrease.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Nausea, Pain, Swelling
Clinical narrative: Menactra given 04/04/2007. Later that evening the patient devvelped a temp of 101, had nausea and felt lightheaded.  Left arm was red and swollen and he states that every muscle in his body hurt.  On 4/5/07 patient was seen by family physician.  Was given Rx of Keflex and continued on routine medications, Allegra and Singular.  Continued with lightheadedness and muscle aches until 4/8/07.  On 4/9/07 muscle aches did decrease.
Age: 1.0
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Abnormal behaviour, Aphasia, Balance disorder, Coordination abnormal, Personality change
Clinical narrative: Patient was developing normally, and was babbling and had formed some basic word sounds. After 1 yr shots he went completely silent within a day or two. A few days after his 18 month shots he had a huge personality shift, stared into space for minutes, laughed as though drunk, lost all balence and coordination, started chasing and biting parents.  Please see VAERS case # 276280 for continuation.  04/24/2007 MR received from PCP.  OV 4/27/04 for rash DX: Heat rash. OV 5/21/04 for c/o walking with feet in. DX: Normal gait variation. OV 6/14/04 for developmental concerns-stopped babbling, stopped talking. DX: hearing loss vs. speech delay.   Neuro eval 7/1/04 for developmental concerns. Impression: Mild delay of language acquisition with normal gross  and  fine motor dev.  Suspected Seizures manifested by staring and altered responsiveness.  DX: Absence epilepsy.  OV 9/16/04 with concerns re: off balance/clumsy walking, food preferences, waking at night screaming, gasping, hand flapping. Impression: probable sleep disorder. possible behavioral eating disorder, possible dev delay. Neuro consult 10/5/04 with dx:  Developmental apraxia of speech.  Mild ataxia. Case continues with VAERS 276280.  1/01/10 follow up - serious regression after vaccinations. now diagnosed with autism.
Age: 1.0
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Speech disorder, Staring
Clinical narrative: Patient was developing normally, and was babbling and had formed some basic word sounds. After 1 yr shots he went completely silent within a day or two. A few days after his 18 month shots he had a huge personality shift, stared into space for minutes, laughed as though drunk, lost all balence and coordination, started chasing and biting parents.  Please see VAERS case # 276280 for continuation.  04/24/2007 MR received from PCP.  OV 4/27/04 for rash DX: Heat rash. OV 5/21/04 for c/o walking with feet in. DX: Normal gait variation. OV 6/14/04 for developmental concerns-stopped babbling, stopped talking. DX: hearing loss vs. speech delay.   Neuro eval 7/1/04 for developmental concerns. Impression: Mild delay of language acquisition with normal gross  and  fine motor dev.  Suspected Seizures manifested by staring and altered responsiveness.  DX: Absence epilepsy.  OV 9/16/04 with concerns re: off balance/clumsy walking, food preferences, waking at night screaming, gasping, hand flapping. Impression: probable sleep disorder. possible behavioral eating disorder, possible dev delay. Neuro consult 10/5/04 with dx:  Developmental apraxia of speech.  Mild ataxia. Case continues with VAERS 276280.  1/01/10 follow up - serious regression after vaccinations. now diagnosed with autism.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Employee received varicella vaccine on 03/29/07. and on 4/12/07 developed fever of 103.1, chills, and rash.  Injection site red, swollen and tender.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Employee received varicella vaccine on 03/29/07. and on 4/12/07 developed fever of 103.1, chills, and rash.  Injection site red, swollen and tender.
Age: 1.53
Sex: M
Vaccine: DTAP, FLUX, MMR, PNC
Symptoms: Abnormal behaviour, Autism, Balance disorder, Immediate post-injection reaction, Oropharyngeal swelling
Clinical narrative: Patient had a major personality change a day or two after 18 month shots and flu shot. He acted as though intoxicated, had no balence, started chasing and biting parents. He started staring off into space and could not be redirected back to his surroundings. He was later diagnosed with Autism. All of this happened immediatel after these vaccinations.  04/24/2007 MR received from PCP.  12 month well child check on 4/16/2004 with  normal exam and normal growth and development.  See VAERS case # 276278. 18 month check on 10/26/2004 with noted developmental delays.  OV 11/5/04 for fever, congestion and restlessness. PE showed mild oropharyngeal edema and small benign cervical nodes.Assessment:  Pharygitis.  Possible MMR reaction. OV 4/18/2005 for developmental concerns and allergies. Impression: Delayed language skills and socialization.  Possible autism. DX with Autism -moderate degree 8/23/2005 per child development clinic.  04/19/2007 Child Development evaluation for concerns of dev. delays and stereotypical behaviors. DX: Autism/Autistic disorder.  Child meets 8/12 diagnostic criteria.  F/U Neuropsych visit confirms DX of Autism. 1/4/2010 Serious regression after vaccinations. New diagnosed with Autism.
Age: 1.53
Sex: M
Vaccine: DTAP, FLUX, MMR, PNC
Symptoms: Personality change, Pyrexia, Regressive behaviour, Respiratory tract congestion, Restlessness
Clinical narrative: Patient had a major personality change a day or two after 18 month shots and flu shot. He acted as though intoxicated, had no balence, started chasing and biting parents. He started staring off into space and could not be redirected back to his surroundings. He was later diagnosed with Autism. All of this happened immediatel after these vaccinations.  04/24/2007 MR received from PCP.  12 month well child check on 4/16/2004 with  normal exam and normal growth and development.  See VAERS case # 276278. 18 month check on 10/26/2004 with noted developmental delays.  OV 11/5/04 for fever, congestion and restlessness. PE showed mild oropharyngeal edema and small benign cervical nodes.Assessment:  Pharygitis.  Possible MMR reaction. OV 4/18/2005 for developmental concerns and allergies. Impression: Delayed language skills and socialization.  Possible autism. DX with Autism -moderate degree 8/23/2005 per child development clinic.  04/19/2007 Child Development evaluation for concerns of dev. delays and stereotypical behaviors. DX: Autism/Autistic disorder.  Child meets 8/12 diagnostic criteria.  F/U Neuropsych visit confirms DX of Autism. 1/4/2010 Serious regression after vaccinations. New diagnosed with Autism.
Age: 1.53
Sex: M
Vaccine: DTAP, FLUX, MMR, PNC
Symptoms: Staring
Clinical narrative: Patient had a major personality change a day or two after 18 month shots and flu shot. He acted as though intoxicated, had no balence, started chasing and biting parents. He started staring off into space and could not be redirected back to his surroundings. He was later diagnosed with Autism. All of this happened immediatel after these vaccinations.  04/24/2007 MR received from PCP.  12 month well child check on 4/16/2004 with  normal exam and normal growth and development.  See VAERS case # 276278. 18 month check on 10/26/2004 with noted developmental delays.  OV 11/5/04 for fever, congestion and restlessness. PE showed mild oropharyngeal edema and small benign cervical nodes.Assessment:  Pharygitis.  Possible MMR reaction. OV 4/18/2005 for developmental concerns and allergies. Impression: Delayed language skills and socialization.  Possible autism. DX with Autism -moderate degree 8/23/2005 per child development clinic.  04/19/2007 Child Development evaluation for concerns of dev. delays and stereotypical behaviors. DX: Autism/Autistic disorder.  Child meets 8/12 diagnostic criteria.  F/U Neuropsych visit confirms DX of Autism. 1/4/2010 Serious regression after vaccinations. New diagnosed with Autism.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Right arm Redness, arm hot to the touch, itching
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Fontanelle bulging
Clinical narrative: On March 27,2007, patient woke up from his nap around 3 pm with a bulging fontanel. He was happy, alert, and not fussing in any way, nor had he been. His fontanel remained large for around 3 hours then started to go down. It has not happened since.
Age: 0.96
Sex: M
Vaccine: DTPHIB, MMR, OPV
Symptoms: Attention deficit/hyperactivity disorder, Autism spectrum disorder, Fat atrophy, Maternal condition affecting foetus, Muscle atrophy
Clinical narrative: Former 33 week premie with RDS. Maternal HELLP syndrome, gest DM. Baby was breech, delivered by c-section. Mechanical ventilation for 5 days. Also received survanta. Was D/C at 3 weeks of age.  He received HIB/DPT(as tetramune),OPV,MMR on 01-04-2000. Developed significant muscle and fatty atrophy initially. Saw Orthopedics initially. Area of deformation now resolved. Howver child has been diagnosed with Autism Spectrum Disorder and ADD.Unclear if prenatal and antenatal history are likely more causative or the severe reaction to shots.  05/01/2007 MR received from PCP dated from Jan 4, 2000 to May 10, 2005. Pt. developed R leg muscle atrophy/wasting of the thigh first noted 5/2000. March 2002 pt. had Speech and Language Eval due to concerns that much of  child's language is not understandable.  Severe Communication Deficit, Reduced auditory attention skills and ? auditory processing skills. Reduced articulation skills. Developmental eval. 4/19/2002:  Mixed Language Disorder.  Macrocephaly.  Behavior Issues. Left OM.  R/O static encephalopathy.  Psych eval 11/03/2003: Attention problems, Autisitic Traits, Mild defecits.  Developmental eval 5/10/2005: high functioning Autism, making progress. 1/4/10 Autism Spectum Disorder.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site swelling, Oedema peripheral
Clinical narrative: L arm red and swollen
Age: 1.01
Sex: M
Vaccine: HEP, HIBV, MMR, MNQ, PNC, TTOX, HIBV, MMR, PPV, VARCEL
Symptoms: Haematocrit normal, Haemoglobin normal, Idiopathic thrombocytopenic purpura, Inappropriate schedule of drug administration, Platelet count decreased
Clinical narrative: On 20 March 2007, he received the booster dose of Hib-MenCY-TT (IM R upper thigh). MMR II (SC L upper arm), VARIVAX (SC R upper arm) and Prevnar (IM L upper thigh). On 03 April 2007, 14 days after the 4th dose of Hib-MenCY-TT, 14 days after the 1st dose of MMR II vaccine, 14 days after the 1st dose of Varivax, 14 days after the 4th dose of Prevnar, 14 days after the unknown dose of Hepatitis B vaccine, this 13-month-old subject developed idiopathic thrombocytopenia purpura. On that day, the subject was hospitalized. Relevant test results included complete blood count : white blood cells (1030 mm3), hemoglobin (11.8 g/dl), hematocrit (34.6%) and platelet count (2300). On review, platelet count was 16000. Subject received immunoglobulin. On 04 April 2007, the subject as discharged. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the idiopathic thrombocytopenia purpura may have been caused by Hib-MenCY-TT, Varivax, pneumococcal vaccines but considered the ITP either to be viral associated or associated to MMR II and/or Hepatitis B vaccination.
Age: 1.01
Sex: M
Vaccine: HEP, HIBV, MMR, MNQ, PNC, TTOX, HIBV, MMR, PPV, VARCEL
Symptoms: White blood cell count normal
Clinical narrative: On 20 March 2007, he received the booster dose of Hib-MenCY-TT (IM R upper thigh). MMR II (SC L upper arm), VARIVAX (SC R upper arm) and Prevnar (IM L upper thigh). On 03 April 2007, 14 days after the 4th dose of Hib-MenCY-TT, 14 days after the 1st dose of MMR II vaccine, 14 days after the 1st dose of Varivax, 14 days after the 4th dose of Prevnar, 14 days after the unknown dose of Hepatitis B vaccine, this 13-month-old subject developed idiopathic thrombocytopenia purpura. On that day, the subject was hospitalized. Relevant test results included complete blood count : white blood cells (1030 mm3), hemoglobin (11.8 g/dl), hematocrit (34.6%) and platelet count (2300). On review, platelet count was 16000. Subject received immunoglobulin. On 04 April 2007, the subject as discharged. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the idiopathic thrombocytopenia purpura may have been caused by Hib-MenCY-TT, Varivax, pneumococcal vaccines but considered the ITP either to be viral associated or associated to MMR II and/or Hepatitis B vaccination.
Age: 1.01
Sex: M
Vaccine: HEP, HIBV, MMR, MNQ, PNC, TTOX, HIBV, MMR, PPV, VARCEL
Symptoms: Blood lactate dehydrogenase increased, Blood phosphorus increased, Body temperature increased, C-reactive protein increased, Contusion
Clinical narrative: On 20 March 2007, he received the booster dose of Hib-MenCY-TT (IM R upper thigh). MMR II (SC L upper arm), VARIVAX (SC R upper arm) and Prevnar (IM L upper thigh). On 03 April 2007, 14 days after the 4th dose of Hib-MenCY-TT, 14 days after the 1st dose of MMR II vaccine, 14 days after the 1st dose of Varivax, 14 days after the 4th dose of Prevnar, 14 days after the unknown dose of Hepatitis B vaccine, this 13-month-old subject developed idiopathic thrombocytopenia purpura. On that day, the subject was hospitalized. Relevant test results included complete blood count : white blood cells (1030 mm3), hemoglobin (11.8 g/dl), hematocrit (34.6%) and platelet count (2300). On review, platelet count was 16000. Subject received immunoglobulin. On 04 April 2007, the subject as discharged. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the idiopathic thrombocytopenia purpura may have been caused by Hib-MenCY-TT, Varivax, pneumococcal vaccines but considered the ITP either to be viral associated or associated to MMR II and/or Hepatitis B vaccination.
Age: 1.01
Sex: M
Vaccine: HEP, HIBV, MMR, MNQ, PNC, TTOX, HIBV, MMR, PPV, VARCEL
Symptoms: Haematocrit decreased, Haemoglobin normal, Idiopathic thrombocytopenic purpura, Inappropriate schedule of drug administration, Laboratory test abnormal
Clinical narrative: On 20 March 2007, he received the booster dose of Hib-MenCY-TT (IM R upper thigh). MMR II (SC L upper arm), VARIVAX (SC R upper arm) and Prevnar (IM L upper thigh). On 03 April 2007, 14 days after the 4th dose of Hib-MenCY-TT, 14 days after the 1st dose of MMR II vaccine, 14 days after the 1st dose of Varivax, 14 days after the 4th dose of Prevnar, 14 days after the unknown dose of Hepatitis B vaccine, this 13-month-old subject developed idiopathic thrombocytopenia purpura. On that day, the subject was hospitalized. Relevant test results included complete blood count : white blood cells (1030 mm3), hemoglobin (11.8 g/dl), hematocrit (34.6%) and platelet count (2300). On review, platelet count was 16000. Subject received immunoglobulin. On 04 April 2007, the subject as discharged. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the idiopathic thrombocytopenia purpura may have been caused by Hib-MenCY-TT, Varivax, pneumococcal vaccines but considered the ITP either to be viral associated or associated to MMR II and/or Hepatitis B vaccination.
Age: 1.01
Sex: M
Vaccine: HEP, HIBV, MMR, MNQ, PNC, TTOX, HIBV, MMR, PPV, VARCEL
Symptoms: Lymphocyte count increased, Neutrophil count, Petechiae, Platelet count decreased, Protein albumin ratio
Clinical narrative: On 20 March 2007, he received the booster dose of Hib-MenCY-TT (IM R upper thigh). MMR II (SC L upper arm), VARIVAX (SC R upper arm) and Prevnar (IM L upper thigh). On 03 April 2007, 14 days after the 4th dose of Hib-MenCY-TT, 14 days after the 1st dose of MMR II vaccine, 14 days after the 1st dose of Varivax, 14 days after the 4th dose of Prevnar, 14 days after the unknown dose of Hepatitis B vaccine, this 13-month-old subject developed idiopathic thrombocytopenia purpura. On that day, the subject was hospitalized. Relevant test results included complete blood count : white blood cells (1030 mm3), hemoglobin (11.8 g/dl), hematocrit (34.6%) and platelet count (2300). On review, platelet count was 16000. Subject received immunoglobulin. On 04 April 2007, the subject as discharged. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the idiopathic thrombocytopenia purpura may have been caused by Hib-MenCY-TT, Varivax, pneumococcal vaccines but considered the ITP either to be viral associated or associated to MMR II and/or Hepatitis B vaccination.
Age: 1.01
Sex: M
Vaccine: HEP, HIBV, MMR, MNQ, PNC, TTOX, HIBV, MMR, PPV, VARCEL
Symptoms: Protein total increased, Pyrexia, Red blood cell scan, Red cell distribution width increased, Respiratory rate
Clinical narrative: On 20 March 2007, he received the booster dose of Hib-MenCY-TT (IM R upper thigh). MMR II (SC L upper arm), VARIVAX (SC R upper arm) and Prevnar (IM L upper thigh). On 03 April 2007, 14 days after the 4th dose of Hib-MenCY-TT, 14 days after the 1st dose of MMR II vaccine, 14 days after the 1st dose of Varivax, 14 days after the 4th dose of Prevnar, 14 days after the unknown dose of Hepatitis B vaccine, this 13-month-old subject developed idiopathic thrombocytopenia purpura. On that day, the subject was hospitalized. Relevant test results included complete blood count : white blood cells (1030 mm3), hemoglobin (11.8 g/dl), hematocrit (34.6%) and platelet count (2300). On review, platelet count was 16000. Subject received immunoglobulin. On 04 April 2007, the subject as discharged. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the idiopathic thrombocytopenia purpura may have been caused by Hib-MenCY-TT, Varivax, pneumococcal vaccines but considered the ITP either to be viral associated or associated to MMR II and/or Hepatitis B vaccination.
Age: 1.01
Sex: M
Vaccine: HEP, HIBV, MMR, MNQ, PNC, TTOX, HIBV, MMR, PPV, VARCEL
Symptoms: Rhinorrhoea, Upper respiratory tract infection, Viral infection, Weight, White blood cell count
Clinical narrative: On 20 March 2007, he received the booster dose of Hib-MenCY-TT (IM R upper thigh). MMR II (SC L upper arm), VARIVAX (SC R upper arm) and Prevnar (IM L upper thigh). On 03 April 2007, 14 days after the 4th dose of Hib-MenCY-TT, 14 days after the 1st dose of MMR II vaccine, 14 days after the 1st dose of Varivax, 14 days after the 4th dose of Prevnar, 14 days after the unknown dose of Hepatitis B vaccine, this 13-month-old subject developed idiopathic thrombocytopenia purpura. On that day, the subject was hospitalized. Relevant test results included complete blood count : white blood cells (1030 mm3), hemoglobin (11.8 g/dl), hematocrit (34.6%) and platelet count (2300). On review, platelet count was 16000. Subject received immunoglobulin. On 04 April 2007, the subject as discharged. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the idiopathic thrombocytopenia purpura may have been caused by Hib-MenCY-TT, Varivax, pneumococcal vaccines but considered the ITP either to be viral associated or associated to MMR II and/or Hepatitis B vaccination.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: c/o soreness in arm since injection on 3/15/07. Pt came in 4/13/07 with above symptoms not note to us before this date
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: c/o soreness in arm since injection on 3/15/07. Pt came in 4/13/07 with above symptoms not note to us before this date
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Blood culture, Body temperature increased, Full blood count, Injection site vesicles, Pyrexia
Clinical narrative: 10 days intermittent fever Tm 102; localized vesicular rash at injection site x 10 D; symptoms beginning 8D after injection.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: 10 days intermittent fever Tm 102; localized vesicular rash at injection site x 10 D; symptoms beginning 8D after injection.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Body temperature increased, Headache, Physical examination, Vomiting
Clinical narrative: approx 1 hour after vaccine pt reported headache with temp (had tem 99 deg) per pt mom tem up to 102 approx 4 hour after I 25-vomiting approx 2 hour after I 25
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Right thigh celllulitis within 24 hrs of injection, resulting in oral and IM IV antibiotics
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis
Clinical narrative: Proquad given right thigh 4/9/07 cellulitis developed 4/10/07 office visit 4/11/07 IM Rocephin 1 gram po Augmentin to began 4/12/07 am
Age: 54.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized reaction described as red, 4-5 inches around site of injection, swollen, and warm to the touch and received antibiotic from MD for cellulitis.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chest X-ray normal, Cough, Pain, Pneumonia, Wheezing
Clinical narrative: 2-3 days after the 1st vaccine developed a deep unproductive cough with subsequent wheezing. Dr dx pneumonia and gave her Levaquin, Prednisone; 5 days later no better. 5 more days Levaquin with Albuterol. CXR was neg. Achiness missed 2 wks of work. Symptoms gone 4-9-07.
Age: 1.33
Sex: F
Vaccine: TDAP
Symptoms: Angioedema, Cough, Eye swelling, Oxygen saturation decreased, Urticaria
Clinical narrative: eyes, welts, coughing, wheezing, Pulse Ox=90% RA- Angioedema-DTaP ordered-pt inadvertantly given Tdap
Age: 1.33
Sex: F
Vaccine: TDAP
Symptoms: Wheezing, Wrong drug administered
Clinical narrative: eyes, welts, coughing, wheezing, Pulse Ox=90% RA- Angioedema-DTaP ordered-pt inadvertantly given Tdap
Age: 27.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Within a "couple hours" of receiving vaccine (by 1500), arm was swollen to "2x" its normal size. At that point, noticed hives from shoulder to wrist on RUE only. Gradually subsided over 3-4 d and then resolved. Used cocoa butter lotion and ice.
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: Screaming RxN on 2/12/07 after immun. Mom states lasted 1 hr and 45 mins
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Hypersensitivity, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Rash, Pain, swelling at injection site starting after 24 hrs. Seen by MD 4-12-07 dx'd allergic rxn. treated with Benadryl, Ice packs
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site irritation, Throat irritation
Clinical narrative: Information has been received from a nurse concerning a 27 year old female (inappropriate age) who on 15-MAR-2007 was vaccinated with HPV. On 15-MAR-2007, the patient experienced burning in her arm near the injection site as well as burning in her throat after receiving HPV. The patient sought unspecified medical attention. On 15-MAR-2007, the patient recovered from burning in her arm near the injection site and burning in her throat. Additional information has been requested.
Age: 0.79
Sex: F
Vaccine: OPV
Symptoms: Body temperature increased, Somnolence, Staring
Clinical narrative: 1/24/06 - polio shot at 2:40 pm at Health Department.  4:00pm acting very sleepy, temp started rising up to 104.7, just stared into space, not moving much or making noise. Called Dr at 9pm he said to give acedamediphin and it could last 72 hours.  Treated with acedamediphin and temp dropped to 100 range at 2 am. 1/25/07 - temp 100 range during day, temp rose to 104.7 around 6 pm, very sleepy, just stared into space, not moving much or making noise. Treated with acedamediphin and temp dropped to 100 range at 3 am.  1/26/07 - temp 100 range during day, temp rose to 104 around 6 pm, very sleepy, just stared into space, not moving much or making noise. Treated with acedamediphin and temp dropped to 100 range at 2 am.  1/27/07 - temp 102.5 during day.  Saw Dr , said she had a Vax reaction and should get over it soon.  He said he was not reporting it.  Temp went to normal at 3pm.
Age: 0.42
Sex: F
Vaccine: PNC
Symptoms: Body temperature decreased, Body temperature increased, Injection site warmth, Moaning, Screaming
Clinical narrative: 9/11/06 screamed high pitched for 3-4 hours, inconsolable, moaning/whining, temp up to 103.6, warmth at injection site.  Temp went down at 4am.  Dr said would not report.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Erythema, Hypersensitivity, Skin warm, Swelling
Clinical narrative: Local swelling, redness, warmth of arm started several hours after injection - swelling of upper arm, elbow, proximal forearm.  Seen in ER - dx with cellulitis vs. allergic rxn and treated with keflex and orapred
Age: 1.78
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Aplastic anaemia, Biopsy bone marrow, Blood count, Blood count abnormal, Bone marrow transplant
Clinical narrative: 2 months after vaccines, symptoms of low blood counts were apparant.  Bruising, petechia and bleeding gums.  Aplastic anemia was diagnosed on Feb 14th 2005.  Went through drug treament in hospital for a month.  Continuing drug treatment currently.  Was considered in remission at one point after treatment for a year and once the drugs were stopped the condition relapsed.  It took 2mos again for counts to be low like they were at diagnosis and it became obvious it was something that had occurred about 2mos prior to his initial diagnosis that had to have triggered this disease process to occur.  Vaccines were the only thing he had.  Unfortunately a bone marrow transplant is likely in his future.  04/27/2007 MR received for several hospitalizations (3/6-11/2005, 3/14-21/2005, 3/23-26/2005 & 10/5-6/2006) for management of fevers and neutropenia due to recent dx of severe Aplastic Anemia. Initially presented with 8 day hx. of bruising,  petechia, and fevers in February.    Infusaport placed 2/23/2005 for Immunosupressive therapy and potential Bone Marrow Transplant in future. Currently presents (3/6/05)with fever and rhinorrhea. Txd with Abx, Anti-virals, cyclosporine, and transfusions as needed. Final DX: Severe Aplastic Anemia. 1/4/10 Patient is still undergoing Immunosuppresive medication and hopefully will nto relapse again as the medication is slowly being decreased.
Age: 1.78
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Contusion, Gingival bleeding, Mouth haemorrhage, Petechiae
Clinical narrative: 2 months after vaccines, symptoms of low blood counts were apparant.  Bruising, petechia and bleeding gums.  Aplastic anemia was diagnosed on Feb 14th 2005.  Went through drug treament in hospital for a month.  Continuing drug treatment currently.  Was considered in remission at one point after treatment for a year and once the drugs were stopped the condition relapsed.  It took 2mos again for counts to be low like they were at diagnosis and it became obvious it was something that had occurred about 2mos prior to his initial diagnosis that had to have triggered this disease process to occur.  Vaccines were the only thing he had.  Unfortunately a bone marrow transplant is likely in his future.  04/27/2007 MR received for several hospitalizations (3/6-11/2005, 3/14-21/2005, 3/23-26/2005 & 10/5-6/2006) for management of fevers and neutropenia due to recent dx of severe Aplastic Anemia. Initially presented with 8 day hx. of bruising,  petechia, and fevers in February.    Infusaport placed 2/23/2005 for Immunosupressive therapy and potential Bone Marrow Transplant in future. Currently presents (3/6/05)with fever and rhinorrhea. Txd with Abx, Anti-virals, cyclosporine, and transfusions as needed. Final DX: Severe Aplastic Anemia. 1/4/10 Patient is still undergoing Immunosuppresive medication and hopefully will nto relapse again as the medication is slowly being decreased.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Muscle spasms, Pain, Pelvic pain
Clinical narrative: 4/11/07 @3:10pm - patient went to the doctor for pain in stomache, diagnosed as Acid Reflux. We were given a flyer fo HPV, and we all agreed that patient needed to recieve the vaccine. Approximately 3 hours after that, patient complained of cramping in her pelvic area (right, left, and middle of her pany-line area). She took 1-600mg Ibuprophin, which eased the pain. She still complains of pain in that area today. I called the nurse who gave the vaccine, and she said this was not a symptom. Just thought I'd write what we have experienced after recieving the HPV vaccine.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Breast pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm where shot was given became very warm, swollen, experienced alot of pain and arm was very red.  Upper part above the left breast had pain like when a person becomes upset.  Had the shot on Friday 3/23/07 and did not go into work the following Monday, still experiencing pain and weakness, more pain at the elbow area, cannot lean it on the desk without the soft gel pad under my arm.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Left arm where shot was given became very warm, swollen, experienced alot of pain and arm was very red.  Upper part above the left breast had pain like when a person becomes upset.  Had the shot on Friday 3/23/07 and did not go into work the following Monday, still experiencing pain and weakness, more pain at the elbow area, cannot lean it on the desk without the soft gel pad under my arm.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Acne, Allergy test, Biopsy skin, Pruritus, Rash
Clinical narrative: I was administered my 3rd Anthrax injection and after a few days I started to get these little what looked like pimples on my right arm. They were there for a day or two. I had noticed they had popped and had this watery substance in them and the area started to itch pretty severely. This all was in Feb. 2001. This went on for a few months I notice it had moved to my hands and then to my upper thighs and calves and also my other arm. In May. 2001 I had gone to the doctor a couple of times and they had ruled out almost all skin rashes such as scabies, eczema, etc. I was referred to a dermatologist. I was given steroid shots and steroid pills for about 3 to 4 months and had they had no effect on my problem. In Aug 2001 I was referred to dermatology at hospital where they took a skin biopsy. They gave no diagnosis of the biopsy. I was seen then by other doctors and was told it might have been heat rash. Diagnosis went on for a year to 2 years. In Mid 2004 I was then referred to an allergist and was administer an allergy test where I had a variety of pricks on my back to see what kind of allergies I had. No diagnosis was given. In Dec. 2005 I PCSed and was seen at the dermatology here and a skin biopsy was taken and the results were the skin was severely inflamed and he prescribed a very strong topical cream named Cloetasol Propionate Cream. Once it was given to me it was the same thing I was given at my last base and it had no effect on my skin. So since Jan. 2001 I have had this skin rash starting out all over my arms and legs and neck to now its sporadic and break out when it wants to. My home remedy to get rid of the itch and pain is to run warm to hot water on the infected area for 5 to 10 minutes then dry it off and rub rubbing alcohol on it to really dry it out.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Cough, Decreased appetite, Dysphonia, Eye discharge
Clinical narrative: immediately following to current: soreness at shot;  following day: headache, Loss of appetite; two days after: high fever, low energy, hoarse cough, runny eyes and nose; Treatment: Infants Tylenol
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Headache, Injection site pain, Pyrexia, Rhinorrhoea
Clinical narrative: immediately following to current: soreness at shot;  following day: headache, Loss of appetite; two days after: high fever, low energy, hoarse cough, runny eyes and nose; Treatment: Infants Tylenol
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Chills, Injection site pain, Nausea, Pain
Clinical narrative: Pain at the injection site for one week, had to takes aleve twice a day.  For 24 hrs had chills, body aches, sore joints, and nausea.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: intermittent numbness/pain on injection arm.  started after the first vaccine 12/15/06, increased in intensity and frequency after 2nd injection 2/27/07.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of Gardasil. Two days after the injection, the patient developed rash at injection site. Her outcome was unknown. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Follow up information has been received from a health professional concerning a 17 year old female with a sensitivity to latex who on 21-FEB-2007 was vaccinated IM with her first and last dose of GARDASIL, lot #654741/0013U. Concomitant therapy included SEASONALE, FLOVENT and albuterol. The patient complained of bumpy red rash starting the day after injection. The rash started on front of torso and spread to back. On 03-MAR-2007 she was seen by a dermatologist. The diagnosis was "Drug exanthem post first dose of GARDASIL". She was treated with ZYRTEC 10 mg 1 tab PO daily and clobetasol cream BID for 1-2 weeks. On 10-MAR-2007 the patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site rash, Rash papular
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of Gardasil. Two days after the injection, the patient developed rash at injection site. Her outcome was unknown. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Follow up information has been received from a health professional concerning a 17 year old female with a sensitivity to latex who on 21-FEB-2007 was vaccinated IM with her first and last dose of GARDASIL, lot #654741/0013U. Concomitant therapy included SEASONALE, FLOVENT and albuterol. The patient complained of bumpy red rash starting the day after injection. The rash started on front of torso and spread to back. On 03-MAR-2007 she was seen by a dermatologist. The diagnosis was "Drug exanthem post first dose of GARDASIL". She was treated with ZYRTEC 10 mg 1 tab PO daily and clobetasol cream BID for 1-2 weeks. On 10-MAR-2007 the patient recovered. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a 0.65 ml dose of Zostavax. Subsequently the patient experienced redness and soreness around the injection site and small shingles rash on his arm. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a 0.65 ml dose of Zostavax. Subsequently the patient experienced redness and soreness around the injection site and small shingles rash on his arm. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007.