chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA, PPV
Symptoms: Vomiting
Clinical narrative: Right leg pain, fever, vomiting, perioral- rash, Itching (scalp) > -acetaminophen (rectal) - warm compresses - ZYRTEC
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Starting on Tues eve (2/3) pat experienced itching woke up w/blistering rash on waist, under breast & arm pits - itchy & red
Age: 1.3
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Febrile convulsion, Influenza serology positive
Clinical narrative: Received vaccine 1/23/09.  Febrile seizure 1/30/09
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased
Clinical narrative: Temp 102 degree F the day after Tdap vaccination. No other symptoms.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Received ZOSTAVAX vaccine approx. 1pm 1/22/09 went to bed approx. 1030 pm that night-had bout of very fast,hard, heart palpitations lasting approx, 15 min. Resolved with no medical treatment. No residual problems. No HX of anxiety or heart palpitations.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Pyrexia, Rash, Upper respiratory tract infection
Clinical narrative: Fever, headaches, rash prior to immunization documented by doctor at medical center.  Not resulted from MENACTRA.  Student did not report any symptom to N.P. at time of immunization.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Myalgia, Paraesthesia
Clinical narrative: Myalgia beginning w/; 24 hrs- fatigue.  Panesthesia hands on 2/4/09.
Age: 10.0
Sex: M
Vaccine: DTAP, HEP, HEPA, MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None (patient was given DTap at 10 years of age).
Age: 1.3
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Erythematous maculopapular spots on torso, legs and arms. Not itchy. Occurred about 5 days after vaccination. Resolved without treatment. No fever.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Screaming
Clinical narrative: Given Dtap, Hep A at well child cheek 1/7.  Screamed all night and again next night.  No fever.  No other source.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Culture stool, Diarrhoea
Clinical narrative: Mucoid diarrhea for 1 month.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: 1/23/09 1:30 p.m. I administered MMR and Varicella IM rather than sub q.  There were no adverse reactions while client here.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Autopsy, Death, Pyrexia, Unresponsive to stimuli
Clinical narrative: Patient had fever within 24 hours of vaccine administration.  Patient was found unresponsive the next morning.  Patient had a history of febrile seizures. 2/17/09-records received-COD died from complications of a seizure disorder. Seizure disorder, clinical history of febrile seizures. Asthma Clinical history of mild asthma. histologic changes in large airways consistent with mild asthma.
Age: 56.0
Sex: U
Vaccine: PPV
Symptoms: Hyperhidrosis, Injection site mass
Clinical narrative: Large lump on arm at site of administration.  Pt also diaphoretic and sweating all night
Age: 0.17
Sex: F
Vaccine: HIBV, RV1
Symptoms: Crying, Irritability
Clinical narrative: Irritability and crying for more than 3 hours.
Age: 1.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Rash
Clinical narrative: Received MMR and Varivax on 1/30/09. Came to the office on 2/3/09 with a flat pinkish rash on chest and legs with a temperature of 103.8.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Myalgia
Clinical narrative: Pt. reported headache, upper torso myalgia approx. 6 hours after vaccine. Symptoms lasted approx 48 hours.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Blood culture negative, Culture wound negative, Debridement, Injection site necrosis, Necrotising fasciitis
Clinical narrative: Patient underwent surgical debridement of necrotizing faciitis at the site of immunizations.  Discharge to home today on oral antibiotics.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: Patient underwent surgical debridement of necrotizing faciitis at the site of immunizations.  Discharge to home today on oral antibiotics.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Necrotising fasciitis, Pyrexia
Clinical narrative: Patient underwent surgical debridement of necrotizing faciitis at the site of immunizations.  Discharge to home today on oral antibiotics.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Surgery, White blood cell count increased
Clinical narrative: Patient underwent surgical debridement of necrotizing faciitis at the site of immunizations.  Discharge to home today on oral antibiotics.
Age: 1.25
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Developed vomitting, diarrhea, and low grade temp withiin 12 hours of vaccine
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Axonal neuropathy, Blood creatine phosphokinase increased, CSF protein increased, Demyelinating polyneuropathy, Electromyogram abnormal
Clinical narrative: Progressive weakness and muscle atrophy in lower extremities, L>R with intermittent parathesias.  3rd vaccine given around Sept. 9 and unusual gait noticed shortly after. 2/23/09-records received-presented on 11/25/08-with C/O left lower extremity tightness, tingling and leg cramps. Limping. Fainted prior to 12/23/08, weak spells, left leg continue to have tingling. PE developing cavus deformity of foot and muscle wasting of left calf. initial complaint 9/12/08.  Now blance difficulties. Neurolgoy consult 1/20/09-presented with C/O foot weakness and 4 month history of balance problems. Gait changes, waddling. C/O loss of sensation at left big toe, increasing clumisness while walking, including tripping and rolling her ankle. Episode of numbness and tingling of hands when rock climbing, muscle cramps in legs. PE: revealed heel cord tightening, left foot drop.Treated with IVIG. 2/11/09-neurolgoy follow-up, decreased DTRs, positive Babinksi and heel cord tightening.  Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms. Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms.  2/11/09-follow-up visit-over last 2 months has shown no progressive weakness no change in symptoms, wearing ankle-foot orthotics. Feeling well able to walk easier not running. PE: decreased DTRs, positive Babinski and evidence of hell cord tightening. IVIG treatments monthly. Office 3/4/09-Holter monitor showed episode of asymptomatic tachycardia. Impression acquired immune neuropathy versus genetic diseases.  4/13/09 CDC staff, FDA staff and UCSF neurologists reviewed VAERS # 339034 and have concurred that their patient originally diagnosed as CIDP is really juvenile ALS.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Gait disturbance, Muscle atrophy, Paraesthesia
Clinical narrative: Progressive weakness and muscle atrophy in lower extremities, L>R with intermittent parathesias.  3rd vaccine given around Sept. 9 and unusual gait noticed shortly after. 2/23/09-records received-presented on 11/25/08-with C/O left lower extremity tightness, tingling and leg cramps. Limping. Fainted prior to 12/23/08, weak spells, left leg continue to have tingling. PE developing cavus deformity of foot and muscle wasting of left calf. initial complaint 9/12/08.  Now blance difficulties. Neurolgoy consult 1/20/09-presented with C/O foot weakness and 4 month history of balance problems. Gait changes, waddling. C/O loss of sensation at left big toe, increasing clumisness while walking, including tripping and rolling her ankle. Episode of numbness and tingling of hands when rock climbing, muscle cramps in legs. PE: revealed heel cord tightening, left foot drop.Treated with IVIG. 2/11/09-neurolgoy follow-up, decreased DTRs, positive Babinksi and heel cord tightening.  Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms. Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms.  2/11/09-follow-up visit-over last 2 months has shown no progressive weakness no change in symptoms, wearing ankle-foot orthotics. Feeling well able to walk easier not running. PE: decreased DTRs, positive Babinski and evidence of hell cord tightening. IVIG treatments monthly. Office 3/4/09-Holter monitor showed episode of asymptomatic tachycardia. Impression acquired immune neuropathy versus genetic diseases.  4/13/09 CDC staff, FDA staff and UCSF neurologists reviewed VAERS # 339034 and have concurred that their patient originally diagnosed as CIDP is really juvenile ALS.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Gait disturbance, Mobility decreased, Neuromyopathy, Orthosis user, Walking aid user
Clinical narrative: Progressive weakness and muscle atrophy in lower extremities, L>R with intermittent parathesias.  3rd vaccine given around Sept. 9 and unusual gait noticed shortly after. 2/23/09-records received-presented on 11/25/08-with C/O left lower extremity tightness, tingling and leg cramps. Limping. Fainted prior to 12/23/08, weak spells, left leg continue to have tingling. PE developing cavus deformity of foot and muscle wasting of left calf. initial complaint 9/12/08.  Now blance difficulties. Neurolgoy consult 1/20/09-presented with C/O foot weakness and 4 month history of balance problems. Gait changes, waddling. C/O loss of sensation at left big toe, increasing clumisness while walking, including tripping and rolling her ankle. Episode of numbness and tingling of hands when rock climbing, muscle cramps in legs. PE: revealed heel cord tightening, left foot drop.Treated with IVIG. 2/11/09-neurolgoy follow-up, decreased DTRs, positive Babinksi and heel cord tightening.  Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms. Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms.  2/11/09-follow-up visit-over last 2 months has shown no progressive weakness no change in symptoms, wearing ankle-foot orthotics. Feeling well able to walk easier not running. PE: decreased DTRs, positive Babinski and evidence of hell cord tightening. IVIG treatments monthly. Office 3/4/09-Holter monitor showed episode of asymptomatic tachycardia. Impression acquired immune neuropathy versus genetic diseases.  4/13/09 CDC staff, FDA staff and UCSF neurologists reviewed VAERS # 339034 and have concurred that their patient originally diagnosed as CIDP is really juvenile ALS.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Balance disorder, Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram, Gait disturbance, Laboratory test
Clinical narrative: Progressive weakness and muscle atrophy in lower extremities, L>R with intermittent parathesias.  3rd vaccine given around Sept. 9 and unusual gait noticed shortly after. 2/23/09-records received-presented on 11/25/08-with C/O left lower extremity tightness, tingling and leg cramps. Limping. Fainted prior to 12/23/08, weak spells, left leg continue to have tingling. PE developing cavus deformity of foot and muscle wasting of left calf. initial complaint 9/12/08.  Now blance difficulties. Neurolgoy consult 1/20/09-presented with C/O foot weakness and 4 month history of balance problems. Gait changes, waddling. C/O loss of sensation at left big toe, increasing clumisness while walking, including tripping and rolling her ankle. Episode of numbness and tingling of hands when rock climbing, muscle cramps in legs. PE: revealed heel cord tightening, left foot drop.Treated with IVIG. 2/11/09-neurolgoy follow-up, decreased DTRs, positive Babinksi and heel cord tightening.  Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms. Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms.  2/11/09-follow-up visit-over last 2 months has shown no progressive weakness no change in symptoms, wearing ankle-foot orthotics. Feeling well able to walk easier not running. PE: decreased DTRs, positive Babinski and evidence of hell cord tightening. IVIG treatments monthly. Office 3/4/09-Holter monitor showed episode of asymptomatic tachycardia. Impression acquired immune neuropathy versus genetic diseases.  4/13/09 CDC staff, FDA staff and UCSF neurologists reviewed VAERS # 339034 and have concurred that their patient originally diagnosed as CIDP is really juvenile ALS.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Lumbar puncture, Muscle atrophy, Nerve conduction studies, Nuclear magnetic resonance imaging, Syncope
Clinical narrative: Progressive weakness and muscle atrophy in lower extremities, L>R with intermittent parathesias.  3rd vaccine given around Sept. 9 and unusual gait noticed shortly after. 2/23/09-records received-presented on 11/25/08-with C/O left lower extremity tightness, tingling and leg cramps. Limping. Fainted prior to 12/23/08, weak spells, left leg continue to have tingling. PE developing cavus deformity of foot and muscle wasting of left calf. initial complaint 9/12/08.  Now blance difficulties. Neurolgoy consult 1/20/09-presented with C/O foot weakness and 4 month history of balance problems. Gait changes, waddling. C/O loss of sensation at left big toe, increasing clumisness while walking, including tripping and rolling her ankle. Episode of numbness and tingling of hands when rock climbing, muscle cramps in legs. PE: revealed heel cord tightening, left foot drop.Treated with IVIG. 2/11/09-neurolgoy follow-up, decreased DTRs, positive Babinksi and heel cord tightening.  Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms. Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms.  2/11/09-follow-up visit-over last 2 months has shown no progressive weakness no change in symptoms, wearing ankle-foot orthotics. Feeling well able to walk easier not running. PE: decreased DTRs, positive Babinski and evidence of hell cord tightening. IVIG treatments monthly. Office 3/4/09-Holter monitor showed episode of asymptomatic tachycardia. Impression acquired immune neuropathy versus genetic diseases.  4/13/09 CDC staff, FDA staff and UCSF neurologists reviewed VAERS # 339034 and have concurred that their patient originally diagnosed as CIDP is really juvenile ALS.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Walking aid user
Clinical narrative: Progressive weakness and muscle atrophy in lower extremities, L>R with intermittent parathesias.  3rd vaccine given around Sept. 9 and unusual gait noticed shortly after. 2/23/09-records received-presented on 11/25/08-with C/O left lower extremity tightness, tingling and leg cramps. Limping. Fainted prior to 12/23/08, weak spells, left leg continue to have tingling. PE developing cavus deformity of foot and muscle wasting of left calf. initial complaint 9/12/08.  Now blance difficulties. Neurolgoy consult 1/20/09-presented with C/O foot weakness and 4 month history of balance problems. Gait changes, waddling. C/O loss of sensation at left big toe, increasing clumisness while walking, including tripping and rolling her ankle. Episode of numbness and tingling of hands when rock climbing, muscle cramps in legs. PE: revealed heel cord tightening, left foot drop.Treated with IVIG. 2/11/09-neurolgoy follow-up, decreased DTRs, positive Babinksi and heel cord tightening.  Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms. Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms.  2/11/09-follow-up visit-over last 2 months has shown no progressive weakness no change in symptoms, wearing ankle-foot orthotics. Feeling well able to walk easier not running. PE: decreased DTRs, positive Babinski and evidence of hell cord tightening. IVIG treatments monthly. Office 3/4/09-Holter monitor showed episode of asymptomatic tachycardia. Impression acquired immune neuropathy versus genetic diseases.  4/13/09 CDC staff, FDA staff and UCSF neurologists reviewed VAERS # 339034 and have concurred that their patient originally diagnosed as CIDP is really juvenile ALS.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Client developed fever of 103 and vomiting on Wenesday 1-28-09 lasting until Thursday 1-29-09. Treated herself symptomatically and did not seek medical attention
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Parent returned to clinic 1/29/09 with child. Noted edematous/reddened upper Right arm. Extremity freely mobile;child complained of pain & itching at times. Encouraged to continue with comfort measures,(compresses & aspirin-free pain relievers).Incident resolved, per mom ,02/03/09.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oropharyngeal pain, Pyrexia, Varicella
Clinical narrative: Complained of fever last night (2/3/09)and today complains of sore throat, red spots on neck,trunk and arms. Acyclovir 200mg every 4 hrs ordered.  Brother diagnosed with varicella 1/23/09.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Convulsion, Immediate post-injection reaction, Syncope vasovagal
Clinical narrative: HEPATITIS A VACCINE WAS ADMINISTERED IN LEFT ARM, THEN GARDASIL VACCINE WAS ADMINISTERED IN RIGHT ARM AND APPROXIMATELY 5 SECONDS AFTER ADMINISTRATION OF SECOND VACCINE PATIENT HAD A SEIZURE.
Age: 55.0
Sex: U
Vaccine: PNC
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with COPD exacerbation. Vaccination took place on 1/02/2008. According to the physician, the relationship is 'None'. We would be happy to forward the Study's SAE Reporting Form upon request.
Age: 1.33
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: RASH INNER L EAR AND CHEEK. LOCAL REACTION TO INJECTION SITE- REDNESS AND SWELLLING. TO TAKE 5CC OF BENDADRYL Q 6 HRS AND F/U TOMMOROW.  IF WORSE SWELLING ER, CONSIDER STEROID
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted after vaccines
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Physician ordered pneumo vaccine. patient given varicella  Lot # 0994X    Exp: 11 July 2010
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: fever up to 104 24 hours after vaccine administered.  Also had runny nose and mild cough.  No rash.
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, PNC, VARZOS
Symptoms: Lip blister
Clinical narrative: Small blister on the inside, left lower lip. No other adverse reaction noted approximately 24 hours post injection.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure increased, Body temperature, Injected limb mobility decreased, Injection site pain
Clinical narrative: PNEUMOVAX administered at 10:00a on 2/4/09 at Pharmacy to patient.  Wife called at 3:30p and reported husband is experiencing excruciating pain about 1 hour ago.  Denied SOB and rash.  Unable to move arm because of pain.  Informed pt that soreness at site is a common side effect.  Pt denied warmth or swelling at site.  Advised pt to take Ibu or another TYLENOL pill and to call back in 30 min.  Pt's wife called back and husband still experiencing pain after taking another TYLENOL tablet.  Asked wife to check BP.  BP was 191/64.  Pt systolic blood pressure usually around 160's.  Temperature reported at 98F.  Denies any signs of warmth or swelling at the site or SOB and rash.  Because BP so high, advised pt to go to ER (Dr is not in office).  Instructed wife to notify ER that he had a vaccination this morning and had taken 2-500mg APAP with no relief.  Asked wife that I would follow up on Friday with her and fill out VAERS form.
Age: 25.0
Sex: F
Vaccine: HPV4, MMR
Symptoms: Incorrect route of drug administration
Clinical narrative: MMR vaccine administered IM in right deltoid instead of SQ 2 calls made to pt 2/4/09 for f/u - no answer Merck contacted- indicated vaccine may be less effective via IM route but not to revaccinate
Age: 12.0
Sex: M
Vaccine: FLUX, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: 6" area of redness and swelling in Lt arm.  Had Tdap & flu vaccine in same arm.
Age: 1.4
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR
Symptoms: Depressed level of consciousness, Gaze palsy, Grand mal convulsion, Musculoskeletal stiffness
Clinical narrative: Mom reports that patient had sudden onset of episode of "stiffness" tonic state x 2-3 sec.  Followed by generalized clonic-like seizure activity of about 5 sec. duration, plus eye deviation & general obtundation:  patient was afebrile at the time and siggle episode.
Age: 1.1
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Local reaction
Clinical narrative: Mild localized reaction
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Rash pruritic, Skin warm
Clinical narrative: 48 degrees after vaccine given (given 1/30/09).  On 2/1/09 pt. developed "hot, itchy, burning flue rash on thighs, abdomen & back of knees-  Denies any throat swelling or SOB.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 3"x3 1/2" raised tender erythematous reaction at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Pallor
Clinical narrative: Had area of blanchable erythema across left thigh spreading laterally to medially.  Not tender no induration.  Treated with antibiotics in ED- discontinued by me & is recovering.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV, HIBV, PNC, DTAPHEPBIP, DTAPIPV, HIBV, PNC, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of intramuscular formulation administered by other route in a 2-month-old subject of unspecified gender who was vaccinated with KINRIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included HIB vaccine and PEDIARIX, (GlaxoSmithKline) given on 23 January 2009; PREVNAR; non-GSK manufacturer given on 23 January 2009.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV, HIBV, PNC, DTAPHEPBIP, DTAPIPV, HIBV, PNC, RV1
Symptoms: Incorrect route of drug administration, Product taste abnormal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of intramuscular formulation administered by other route in a 2-month-old subject of unspecified gender who was vaccinated with KINRIX, (GlaxoSmithKline).  Previous and/or concurrent vaccination included HIB vaccine and PEDIARIX, (GlaxoSmithKline) given on 23 January 2009; PREVNAR; non-GSK manufacturer given on 23 January 2009.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with KINRIX. On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced injection site redness and swelling The events resolved after two to three days. In the reporter's opinion, the injection site redness was probably related to treatment with KINRIX. The causality of injection site swelling was unknown. It was reported that KINRIX was administered to about 10 subjects and that 7 or 8 of them experienced swelling or redness at the injection site. All have resolved after two to three days. Follow-up received as quality statement prepared on 27 May 2009: The batch of KINRIX meth the requirements of the specifications and a confirmed as suitable for vaccination purpose.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of high erythema in a child subject under the age of 6 years and of unspecified gender who was vaccinated with KINRIX, GalxoSmithKline. Concurrent vaccination included MMR vaccine (manufacturer unspecified) and VARIVAX (Merck) given in an unknown deltoid in January 2009. Concurrent vaccines were given on the same date as KINRIX. In January 2009, the subject received unspecified dose of KINRIX in an unknown thigh. In the evening following KINRIX injection, the subject developed thigh erythema (around the injection site), swelling at the injection site and skin warmth at the injection site. The events worsened the next day and resolved over the next couple of days. The Healthcare professional considered the events were possibly related to vaccination with KINRIX. These events occurred in three different subjects under the  age of 6 years. The children's parent's called to report the events and were told over the phone to treat the redness and swelling with compresses and TYLENOL. The subjects were not seen in the office. Linked cases include A0762587A and A0762589A. Follow-up information received on 27 January 2009 indicated that the subject was 5 year old male. KINRIX was administered to the subject intramuscularly at 0.5 ml in an unspecified date in January 2009. Concurrent MMR vaccine (subcutaneous, 0.5ml) and VARIVAX vaccine (subcutaneous, 0.5ml) were administered on the same date as KINRIX. The events occurred on 03 January 2009 and resolved three days later on 05 January 2009. In the reporter's opinion, the events were related to treatment with KINRIX.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of thigh erythema in a child subject under the age of 6 years and of unspecified gender who was vaccinated with combined KINRIX. Concurrent vaccination included unspecified vaccines given in an unknown deltoid in December 2008 or January 2009. Concurrent vaccines were given on the same date as KINRIX. On an unspecified date (either in December 2008 or January 2009) the subject received unspecified dose of KINRIX in an unknown thigh. In the evening following KINRIX injection, the subject developed thigh erythema (around the injection site), swelling at the injection site and skin warmth at the injection site. The events worsened the next day and resolved over the next couple of days. The healthcare professional considered the events were possibly related to vaccination with KINRIX. These events occurred in three different subjects under the age of 6 years. The children's parents called to report the events and were told over the phone to treat the redness and swelling with compresses and Tylenol. Linked cases include A0762587A and A0762590A. Follow-up information received on 27 January 2009 indicated that the subject was a 4 year old male. KINRIX, 0.5 ml, was administered to the subject on 12 January 2009 along with concurrent Hepatitis A vaccine (intramuscular at 0.5 ml). The events occurred one day following KINRIX administration on 13 January 2009. At the time of reporting, the events were unresolved and considered by the reporter, related to treatment with KINRIX.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLUX, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of thigh erythema in a child subject under the age of 6 years and of unspecified gender who was vaccinated with combined KINRIX, GlaxoSmithKline.  Concurrent vaccination included unspecified vaccines given in an unknown deltoid in December 2008 or January 2009.  Concurrent vaccines were given on the same date as KINRIX.  On an unspecified date (either in December 2008 or January 2009) the subject received unspecified dose of KINRIX in an unknown thigh.  In the evening following KINRIX injection, the subject developed thigh erythema (around the injection site), swelling at the injection site and skin warmth at the injection site.  The events worsened the next day and resolved over the next couple of days.  The healthcare professional considered the events were possibly related to vaccination with KINRIX.  These events occurred in three different subjects under the age of 6 years.  The children's parents called to report the events and were told over the phone to treat the redness and swelling with compresses and Tylenol.  The subjects were not seen in the office.  Linked cases include A0762589A and A0762590A.  Follow-up information received on 27 January 2009 indicated that the subject was a 5 year old female.  Intramuscular KINRIX was administered (0.5 ml) on 05 January 2009.  Concurrent vaccines given on the same date included MMR vaccine, VARIVAX vaccine and flu vaccine (manufacturers unspecified).  Events started one day following administration of KINRIX on 06 January 2009 and resolved three days later on 08 January 2009.  In the reporter's opinion, the events were related to treatment with KINRIX.
Age: 37.0
Sex: M
Vaccine: ANTH, HEP, TYP, HEP, SMALL
Symptoms: Rash erythematous, Skin warm, Tenderness
Clinical narrative: recently received SPV on 6 Jan 09 and approx 10-11 days later he developed a fever and a rash.  He stated the rash was little bumps on his face, arms and torso.  He stated it looked like acne.  Arm swelling and rash have resolved.  He did seek medical care and AHLTA note dated 18 Jan 09 described lesions as macular popular rash with 2 mouth lesions.  He denied chest pain or resp. problems and was dx as having likely viral exanthema and aphthous ulcer.
Age: 37.0
Sex: M
Vaccine: ANTH, HEP, TYP, HEP, SMALL
Symptoms: Aphthous stomatitis, Oedema peripheral, Pyrexia, Rash, Rash macular
Clinical narrative: recently received SPV on 6 Jan 09 and approx 10-11 days later he developed a fever and a rash.  He stated the rash was little bumps on his face, arms and torso.  He stated it looked like acne.  Arm swelling and rash have resolved.  He did seek medical care and AHLTA note dated 18 Jan 09 described lesions as macular popular rash with 2 mouth lesions.  He denied chest pain or resp. problems and was dx as having likely viral exanthema and aphthous ulcer.
Age: 37.0
Sex: M
Vaccine: ANTH, HEP, TYP, HEP, SMALL
Symptoms: Rash papular, Urticaria, Viral skin infection
Clinical narrative: recently received SPV on 6 Jan 09 and approx 10-11 days later he developed a fever and a rash.  He stated the rash was little bumps on his face, arms and torso.  He stated it looked like acne.  Arm swelling and rash have resolved.  He did seek medical care and AHLTA note dated 18 Jan 09 described lesions as macular popular rash with 2 mouth lesions.  He denied chest pain or resp. problems and was dx as having likely viral exanthema and aphthous ulcer.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dysphonia, Electrocardiogram normal
Clinical narrative: Chest pain, hoarse throat 3 hrs after AFLURIA administration. Treated with BENADRYL and SOLUMEDROL and felt better.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Blood culture negative, Culture wound negative, Debridement, Injection site necrosis, Necrotising fasciitis
Clinical narrative: Information has been received from a pharmacist concerning a 52 year old male smoker with a seizure disorder, migraines, alcohol use, depression, and an allergy to codeine, insect stings, mushrooms, trazodone hydrochloride, fish and penicillin who on 27-JAN-2009 was vaccinated IM with a 0.5 ml second dose of PNEUMOVAX 23 (lot # 659921/1697U) in the right shoulder. Patient's first dose of PNEUMOVAX 23 was given in Oct 2002. Secondary suspect vaccine included influenza virus vaccine (unspecified) given in the right shoulder on 27-JAN-2009. Concomitant medications included "list of medications". Subsequently, the patient experienced necrotizing fasciitis, had symptoms of pain, redness, swelling at the injection site, fever, and an elevated white count on the evening of 27-JAN-2009. On 28-JAN-2009 the patient went to emergency room. Blood cultures, "lab test" were performed. On 30-JAN-2009 the patient had surgery and was hospitalized. IV antibiotics were used. Necrotizing fasciitis was considered to be an other important medical event and immediately life-threatening. As of 30-JAN-2009, the patient was recovering. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a pharmacist concerning a 52 year old male smoker with a seizure disorder, migraines, alcohol use, depression, and an allergy to codeine, insect stings, mushrooms, trazodone hydrochloride, fish and penicillin who on 27-JAN-2009 was vaccinated IM with a 0.5 ml second dose of PNEUMOVAX 23 (lot # 659921/1697U) in the right shoulder. Patient's first dose of PNEUMOVAX 23 was given in Oct 2002. Secondary suspect vaccine included influenza virus vaccine (unspecified) given in the right shoulder on 27-JAN-2009. Concomitant medications included "list of medications". Subsequently, the patient experienced necrotizing fasciitis, had symptoms of pain, redness, swelling at the injection site, fever, and an elevated white count on the evening of 27-JAN-2009. On 28-JAN-2009 the patient went to emergency room. Blood cultures, "lab test" were performed. On 30-JAN-2009 the patient had surgery and was hospitalized. IV antibiotics were used. Necrotizing fasciitis was considered to be an other important medical event and immediately life-threatening. As of 30-JAN-2009, the patient was recovering. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Necrotising fasciitis, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 52 year old male smoker with a seizure disorder, migraines, alcohol use, depression, and an allergy to codeine, insect stings, mushrooms, trazodone hydrochloride, fish and penicillin who on 27-JAN-2009 was vaccinated IM with a 0.5 ml second dose of PNEUMOVAX 23 (lot # 659921/1697U) in the right shoulder. Patient's first dose of PNEUMOVAX 23 was given in Oct 2002. Secondary suspect vaccine included influenza virus vaccine (unspecified) given in the right shoulder on 27-JAN-2009. Concomitant medications included "list of medications". Subsequently, the patient experienced necrotizing fasciitis, had symptoms of pain, redness, swelling at the injection site, fever, and an elevated white count on the evening of 27-JAN-2009. On 28-JAN-2009 the patient went to emergency room. Blood cultures, "lab test" were performed. On 30-JAN-2009 the patient had surgery and was hospitalized. IV antibiotics were used. Necrotizing fasciitis was considered to be an other important medical event and immediately life-threatening. As of 30-JAN-2009, the patient was recovering. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Surgery, White blood cell count increased
Clinical narrative: Information has been received from a pharmacist concerning a 52 year old male smoker with a seizure disorder, migraines, alcohol use, depression, and an allergy to codeine, insect stings, mushrooms, trazodone hydrochloride, fish and penicillin who on 27-JAN-2009 was vaccinated IM with a 0.5 ml second dose of PNEUMOVAX 23 (lot # 659921/1697U) in the right shoulder. Patient's first dose of PNEUMOVAX 23 was given in Oct 2002. Secondary suspect vaccine included influenza virus vaccine (unspecified) given in the right shoulder on 27-JAN-2009. Concomitant medications included "list of medications". Subsequently, the patient experienced necrotizing fasciitis, had symptoms of pain, redness, swelling at the injection site, fever, and an elevated white count on the evening of 27-JAN-2009. On 28-JAN-2009 the patient went to emergency room. Blood cultures, "lab test" were performed. On 30-JAN-2009 the patient had surgery and was hospitalized. IV antibiotics were used. Necrotizing fasciitis was considered to be an other important medical event and immediately life-threatening. As of 30-JAN-2009, the patient was recovering. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site erythema
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a 35-year-old female subject who was vaccinated with FLULAVAL. In November 2008 the subject received a dose of FLULAVAL at 0.5 ml. Shortly after vaccinations with FLULAVAL, the subject experienced injection site redness and chills. At the time of reporting the events were resolved.
Age: 2.0
Sex: M
Vaccine: FLUX, VARCEL
Symptoms: Body temperature increased, Bronchial hyperreactivity, Chest X-ray normal, Condition aggravated, Dyspnoea
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 24 month old premature born male (2 month early) with asthma who was vaccinated subcutaneously with a first 0.5 ml dose of VARIVAX "at one year old" (in approximately November 2007). On 05-DEC-2008 the patient received a second dose of VARIVAX. On the same day, he also received a dose of "flu shot" (manufacturer unknown). On 06-DEC-2008 the patient developed fever as high as 103 degrees F, wheezing and shortness of breath. He was seen at an urgent care center and was given antibiotics and "mini-neb" treatments. It was reported that no lab diagnostics studies were performed. The patient was seen in a physician's office since the events had not improved "over the weekend". At the time of the report, 08-DEC-2008, the patient had not recovered. Follow-up information received on 02-FEB-2009 from the L.P.N. indicated that the patient was a premature baby born at 31 weeks gestation. On 05-DEC-2008, at 15:30, the patient was vaccinated in the right thigh with a second dose of VARIVAX (Lot #661008/1317X). It was reported that illness at the time of vaccination included reactive airway disease (RAD) and seasonal allergies. In the afternoon of 06-DEC-2008, the patient developed RAD, fever of 103 and vomited once. Respiratory Syncytial Virus (RSV) test was negative. Chest x-ray showed no active disease. The patient was treated with AUGMENTIN, albuterol (via nebulizer), PEDIAPRED and TYLENOL. It was reported that the patient recovered. His last visit was on 12-DEC-2008. The reporter considered the patient's events to be other important medical events. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLUX, VARCEL
Symptoms: Pyrexia, Respiratory syncytial virus test negative, Seasonal allergy, Vomiting, Wheezing
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 24 month old premature born male (2 month early) with asthma who was vaccinated subcutaneously with a first 0.5 ml dose of VARIVAX "at one year old" (in approximately November 2007). On 05-DEC-2008 the patient received a second dose of VARIVAX. On the same day, he also received a dose of "flu shot" (manufacturer unknown). On 06-DEC-2008 the patient developed fever as high as 103 degrees F, wheezing and shortness of breath. He was seen at an urgent care center and was given antibiotics and "mini-neb" treatments. It was reported that no lab diagnostics studies were performed. The patient was seen in a physician's office since the events had not improved "over the weekend". At the time of the report, 08-DEC-2008, the patient had not recovered. Follow-up information received on 02-FEB-2009 from the L.P.N. indicated that the patient was a premature baby born at 31 weeks gestation. On 05-DEC-2008, at 15:30, the patient was vaccinated in the right thigh with a second dose of VARIVAX (Lot #661008/1317X). It was reported that illness at the time of vaccination included reactive airway disease (RAD) and seasonal allergies. In the afternoon of 06-DEC-2008, the patient developed RAD, fever of 103 and vomited once. Respiratory Syncytial Virus (RSV) test was negative. Chest x-ray showed no active disease. The patient was treated with AUGMENTIN, albuterol (via nebulizer), PEDIAPRED and TYLENOL. It was reported that the patient recovered. His last visit was on 12-DEC-2008. The reporter considered the patient's events to be other important medical events. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, General physical health deterioration, Hypoaesthesia, Paralysis
Clinical narrative: Information has been received from a physician concerning a 42 year old female with multiple sclerosis who on 29-JUL-2008 was vaccinated with a dose of MMR II (661070/0662X). Concomitant therapy included EFFEXOR, "oxybutane" and radiation therapy. Soon after the vaccine, the patient's condition began to rapidly decline. She developed numbness and paralysis from the waist down. The patient sought medical attention by going to the emergency room but was not admitted to the hospital. At the time of reporting the patient was not recovered. The reporter considered worsening of multiple sclerosis to be disabling. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a 19 year old female patient who on 27-JAN-2009 was vaccinated with first dose of GARDASIL (Lot # not reported).  On 27-JAN-2009 after she received the vaccine she fainted immediately.  As she was coming to she could hear the nurse yelling that she was having a seizure and she then fainted a second time.  She came to and fainted a few more times, then she went to the emergency room in an ambulance.  She was not admitted to the hospital and was released a few hours after she had received the vaccine.  On 27-JAN-2009 the patient was recovered.  Patient sought medical attention was at emergency room.  The patient considered seizure and fainted was determined to be other important medical events.  No further information is available.
Age: 17.0
Sex: F
Vaccine: UNK, ANTH, FLUX, HEPAB, JEVX, MEN, MMR, OPV, RAB, SMALL, TTOX, TYP, VARCEL, YF
Symptoms: Activities of daily living impaired, Allergy to vaccine, Alopecia, Antiphospholipid syndrome, Arthritis
Clinical narrative: When I joined in March of 1987 I was a healthy teenager with records to prove it. Sometime between March and May of 1987 I received several vaccinations administered with a air gun injector. The vaccines were mixed with other vaccines, it was done outside, the guns were not cleaned in between recruits and I was given vaccines that I was allergic to. To make things worse I was given enough vaccines for at least 3 people. The best my VA case worker and I can figure out is that I got sick about 1 month from the date of the physical I got in January or February. I was sick the entire time I was there. I had pneumonia, sinus infections, ear infections, seizures, passing out, falling asleep all the time, migraines, shortness of breath, vertigo, vision problems, and that is just a few of the problems that I had. I have been being treated for an epilepsy, clotting disorder, migraines, asthma, arthritis, hearing loss, vision problems, among things from 1987 to the present. I have been diagnosed with APS, Lupus anticoagulant, sleep apnea, epilepsy, asthma, COPD, PTSD, OCD, arthritis of every kind, hearing loss, hair loss, teeth fall out, immune system is very poor, and I am currently being tested for kidney failure, diabetes, and Hepatitis. I take many pills and supplements daily. I cannot do anything that I used to. I have no social life. I am sterile and cannot have children ever and now I am having night terrors. I am sick and tired of my life revolving around pill times, what I can or cannot eat, I can't go to the movies, etc. because of the noise and the large amount of people. I have not been able to drive since 1999 and I cannot work. A knee injury I got will in boot camp will never heal and I cannot have surgery to repair it because of the blood disorder. I saw this claim at the FDA site and I am hoping that there is something that you can do to help me.  2/18/09 Received medical records. FINAL DX: antiphospholipid antibody syndrome w/(+) lupus anticoagulant. Records reveal patient experienced PE approx 1993; CVA approx 1995; TIAs x2; LLE DVT approx 1997.  Hosp admit of 10/2003 for SOB, chest pressure & diaphosesis.  Heme/onc consult done.
Age: 17.0
Sex: F
Vaccine: UNK, ANTH, FLUX, HEPAB, JEVX, MEN, MMR, OPV, RAB, SMALL, TTOX, TYP, VARCEL, YF
Symptoms: Asthma, Cell death, Chronic obstructive pulmonary disease, Coagulopathy, Convulsion
Clinical narrative: When I joined in March of 1987 I was a healthy teenager with records to prove it. Sometime between March and May of 1987 I received several vaccinations administered with a air gun injector. The vaccines were mixed with other vaccines, it was done outside, the guns were not cleaned in between recruits and I was given vaccines that I was allergic to. To make things worse I was given enough vaccines for at least 3 people. The best my VA case worker and I can figure out is that I got sick about 1 month from the date of the physical I got in January or February. I was sick the entire time I was there. I had pneumonia, sinus infections, ear infections, seizures, passing out, falling asleep all the time, migraines, shortness of breath, vertigo, vision problems, and that is just a few of the problems that I had. I have been being treated for an epilepsy, clotting disorder, migraines, asthma, arthritis, hearing loss, vision problems, among things from 1987 to the present. I have been diagnosed with APS, Lupus anticoagulant, sleep apnea, epilepsy, asthma, COPD, PTSD, OCD, arthritis of every kind, hearing loss, hair loss, teeth fall out, immune system is very poor, and I am currently being tested for kidney failure, diabetes, and Hepatitis. I take many pills and supplements daily. I cannot do anything that I used to. I have no social life. I am sterile and cannot have children ever and now I am having night terrors. I am sick and tired of my life revolving around pill times, what I can or cannot eat, I can't go to the movies, etc. because of the noise and the large amount of people. I have not been able to drive since 1999 and I cannot work. A knee injury I got will in boot camp will never heal and I cannot have surgery to repair it because of the blood disorder. I saw this claim at the FDA site and I am hoping that there is something that you can do to help me.  2/18/09 Received medical records. FINAL DX: antiphospholipid antibody syndrome w/(+) lupus anticoagulant. Records reveal patient experienced PE approx 1993; CVA approx 1995; TIAs x2; LLE DVT approx 1997.  Hosp admit of 10/2003 for SOB, chest pressure & diaphosesis.  Heme/onc consult done.