chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Torticollis
Clinical narrative: No inflammation at deltoid but very stiff neck & torticollis within 24h. Lasted 72 hour left trapezius & subscapular pain.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient had ZOSTAVAX vaccine administered on Thursday, July 2nd. States that since then has been sore and arching from the waist down especially at night.
Age: 0.6
Sex: M
Vaccine: DTAP
Symptoms: Allergy test negative, Cough, Dyspnoea, Flushing, Urticaria
Clinical narrative: 10 minutes after receiving DTaP, developed cough, wheezing, SOB followed by red flush and hives. Resolved with DECADRON, epinephrine IM, oral BENADRYL.
Age: 0.6
Sex: M
Vaccine: DTAP
Symptoms: Wheezing
Clinical narrative: 10 minutes after receiving DTaP, developed cough, wheezing, SOB followed by red flush and hives. Resolved with DECADRON, epinephrine IM, oral BENADRYL.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Condition aggravated, Dyspnoea, Upper respiratory tract congestion
Clinical narrative: Pt received vaccine on 6/26/09. On 6/28/09 pt c/o chest tightness, shortness of breath, chest congestion & tightness. DX with asthma flare per ER MD.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythematous swelling at site of injection (-) fever (-) systemic symptoms. No other signs.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received DTaP on 6/30/09. c/o pain at injection site approx 4-5PM. Redness began approx 6-7P 6/30/09. Seen in office on 7/1/09 approx 11AM - swelling of the thigh around injection site - 4cm x 5cm redness around injection site warm to touch. Rx - BENADRYL 1 tsp 2x/ml, cephalexin 250 TID x10D, ice pack 2-3x/day. Return to office 7/2/09.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Urticaria
Clinical narrative: Three days after receiving started with hives, they last one day and went away. Pt left with a reddened one inch around hard spot. Advised to use warm moist soaks, and motrin and to call back if worsened.
Age: 66.0
Sex: M
Vaccine: DT
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of arm.
Age: 1.7
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 0 / parent notified of dose given outside of recommended guidelines. 0 reactions reported.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Blister, Erythema, Pruritus, Rash
Clinical narrative: 5/14/09 - Vaccination (itch, no fever); 5/16/09 - 1 spot (arm); 5/18/09 - 5 spots (arm, hip, leg); 5/19/09 = 10-20 (arm, hip, leg, back); 5/20/09 - 30-40 spots; 5/21/09 - 40-50 spots; 5/2209 to 5/30/09 begin to dry up. Spots were red with 1 or more clear blisters.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous
Clinical narrative: Small bump, reddened ongoing after 5 days. No pain.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Dysgeusia, Immediate post-injection reaction, Pallor
Clinical narrative: Patient became extremely pale, lightheaded, experienced "bloody" taste in mouth immediately after having MCV4 administered. Patient was monitored for approximately 20 minutes, was given water to drink, had normal skin color return and left clinic with parent after symptoms resolved. Was advised to seek medical attention if symptoms return or call if has any questions.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site at varicella injection site became red, warm to touch, and raised the day after injection.  Diameter size as big as approx. 3 inches.
Age: 50.0
Sex: F
Vaccine: DTAPH
Symptoms: Hypoaesthesia oral, Injection site pain, Lymphadenopathy, Pain, Paraesthesia
Clinical narrative: On 7-3-09 came to work at 7am with temp over the next three hours of 99.8 to 99.9. At 11am fever became 100.2 and employee was sent home from work. Had pain at site at that time. On Saturday pain was in arm from site to hand and fever to 100.2 continued. On Sunday numbness and tingling from shoulder to hand began and has continued through today. Deltoid and anterior chest muscles at axilla remain achey and sore today but have been painful on Sunday and Monday. Lymph nodes from axilla toward elbow are swollen and very tender to the touch.
Age: 50.0
Sex: F
Vaccine: DTAPH
Symptoms: Pyrexia, Tenderness
Clinical narrative: On 7-3-09 came to work at 7am with temp over the next three hours of 99.8 to 99.9. At 11am fever became 100.2 and employee was sent home from work. Had pain at site at that time. On Saturday pain was in arm from site to hand and fever to 100.2 continued. On Sunday numbness and tingling from shoulder to hand began and has continued through today. Deltoid and anterior chest muscles at axilla remain achey and sore today but have been painful on Sunday and Monday. Lymph nodes from axilla toward elbow are swollen and very tender to the touch.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Mother states has red spots with a white center on left shoulder, left side of back of neck, on her lower scalp and 3 spots under her left armpit.  Parent states approximately 30 total spots.  States itching, no fever, denies loss of appetite and has had regular level of activity.  States child was also walking around in woods over weekend with family and friends. Parent had called MD 7-6-09 to speak with MD about "bumps", was to schedule appt for AM of 7-7-09 and then parent states remembered child getting vaccines and potential for reaction.  Called health dept to report this AM and has chosen to take to MD to diagnose.   Mother reports has treated her with Equate allergy relief 1 tsp=15mg diphenhydramine HCl (orally) X 1 and topical benadryl creme/ gel 2% for itching per instructions on package.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, PPV, VARCEL
Symptoms: Blister, Oedema peripheral, Pyrexia
Clinical narrative: As per phone conversation w/ grandmother on 6/12/09. Patient had swelling to left arm w/blisters (<50). w/fever. Intended to seek medical attention w/PMD.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella, Varicella post vaccine
Clinical narrative: Varicella vaccine breakthrough.  Had varivax x2.  Diagnosed in our office on 6/30/09 with varicella.  Had over 100 lesions.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Dizziness, Fatigue, Injury, Loss of consciousness, Muscle twitching
Clinical narrative: 7/01/2009 Dr. reported that patient had syncope x 2, tiredness, dizziness, swollen/rash on face on 7/1/09 at 1630. Pt. passed out and injured self. Dr. reported left leg paresthesia and twitching.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Paraesthesia, Rash, Swelling face, Syncope
Clinical narrative: 7/01/2009 Dr. reported that patient had syncope x 2, tiredness, dizziness, swollen/rash on face on 7/1/09 at 1630. Pt. passed out and injured self. Dr. reported left leg paresthesia and twitching.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, DTPPHIB, PNC, RV1
Symptoms: Abdominal pain upper, Apparent life threatening event, Cyanosis, Hypoventilation, Screaming
Clinical narrative: Mother states at 7 pm infant began an unusual, ugrent screaming. Her breathing became shallow, bluish color noted around mouth.  Infant taken to Hospital where she stayed overnight.  States was told by physician child  suffered extreme stomach pain, may have been from the Rotavirus vaccine.  Infant recovered completely per mom after that episode.  7/7/09 Hospital records received DOS 5/5/09 to 5/6/09. Assessment: Apparent life-threatening event, abdominal pain by history, evaluate for intussusception. Patient woke up screaming uncontrollably and was inconsolable. 'Stomach felt hard.' Apneic episode, turned blue. Presented at ER pink and no signs of respiratory distress and was easily consolable.   7/31/09 ICD-9 Codes received: 782.5 - cyanosis,  789.00 - abdominal pain unspecified
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Respiration abnormal, Swelling face, Urticaria
Clinical narrative: About 30 minutes after vaccines were given patient developed hives, right facial swelling, and gurgly resperations.  Pt's mother called into clinic, was instructed to call 911 and was transported to the ER where patient was treated with Benadryl and was dischared on Benadryl and three days of oral steriods.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abdominal discomfort, Feeling hot, Oedema peripheral, Pyrexia
Clinical narrative: Left lower extremity swelling from the knee to the thigh, warm to touch, temperaure to 102, upset stomach
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: pt experienced swelling and redness at the site. This worsend into itching and then pain. pt went to the ER and had a follow up appt with us the next day.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of left arm two days following getting vaccinations.RX of Sulfamethoxazole-Trimethoprim 200mg-40mg/5ml oral suspension. 5mL Oral 2 times a day for 10 days
Age: 15.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Pyrexia, Syncope
Clinical narrative: Fever, Headache, Syncope
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: The injection was given on May 1, 2009. Approximately 1 week after receiving the patient's third injection, the patient developed small warts on her hands and fingertips. As of today, July 7, 2009 The warts are still existant.
Age: 9.5
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella vaccine break through. Had 2 doses of varicella vaccine. Diagnosed with varicella in office on 6-25-09.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Blepharospasm, Blood culture negative, CSF culture negative, Culture urine negative, Grand mal convulsion
Clinical narrative: Right tonic-clonic seizure with left facial, eye twitching lasting 2 minutes. Seizure began the evening on the day when vaccines were given, Patient taken to Peditric ER and admitted.  7/8/09 Medical records received DOS 6/30/09 to 7/7/09. Assessment: New onset seizure. Parent reports patient shaking leg fast in her sleep, jerking a lot, trouble waking her up, lip looks crooked. Referred to neurologist for EEG.  7/17/09 Hospital records received DOS 6/30/09 to 7/4/09. Assessment: Seizure-like activity. Presented at ER after seizure-like episode. Fussiness, fell asleep early, jerking movements of trunk, left-side mouth twisting with spitting noises. Rapid twitching of left arm and left leg. Very sleepy and difficult to arouse. Uncomfortable.  8/18/09 ICD-9 Codes: 780.39 Seizure(s) other, 780.60 Fever, 288.60 Leukocytosis unspecified.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Muscle twitching
Clinical narrative: Right tonic-clonic seizure with left facial, eye twitching lasting 2 minutes. Seizure began the evening on the day when vaccines were given, Patient taken to Peditric ER and admitted.  7/8/09 Medical records received DOS 6/30/09 to 7/7/09. Assessment: New onset seizure. Parent reports patient shaking leg fast in her sleep, jerking a lot, trouble waking her up, lip looks crooked. Referred to neurologist for EEG.  7/17/09 Hospital records received DOS 6/30/09 to 7/4/09. Assessment: Seizure-like activity. Presented at ER after seizure-like episode. Fussiness, fell asleep early, jerking movements of trunk, left-side mouth twisting with spitting noises. Rapid twitching of left arm and left leg. Very sleepy and difficult to arouse. Uncomfortable.  8/18/09 ICD-9 Codes: 780.39 Seizure(s) other, 780.60 Fever, 288.60 Leukocytosis unspecified.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Back pain, Headache, Hypoaesthesia facial, Influenza serology, Paraesthesia
Clinical narrative: Pt. came in with headache, pain in lower back, hands and feet where tingly. Could not feel face. Pt was complaining of headache 2 days prior of vaccine given. 7/8/09 Spoke with RN. Child still has sx today, but no worse.  Flu A/B (-). MD thinks it's a virus.  Will f/u next week. 7/13 09 Spoke with RN who spoke with parent. H/A and back pain and other sx have resolved over the w/e.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Developed 2 chickenpox like rashes.  1 on lower left arm and other below neck
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Dtap and MMR where given on 06/29/09 in right thigh. On 07/02/09 pt accompanied mother.Complained of red raised spot on right thigh 9cm x 8cm. Mother was told to ice area 20 min, Q/2hours and massage, return if symptoms become worse or do not improve.
Age: 1.08
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Blister, Injection site erythema, Injection site nodule, Injection site urticaria, Irritability
Clinical narrative: infant had shots app 11 days ago now with redness to right thigh at site of shot and child with low grade fever and fussiness today mom noted  small blisters to back abd and now arms   parents worried                                   a rash is noted that is diffuse in location;  the color is mainly pink;  it is best characterized as vesicular;  at site of injection red raised lump with 3 vesicles   no erythema  no warmth  no fluctuance                                         PLAN  rxn to varicella  no secondary infection noted  course of disease discussed with parents  follow up if increase pain, cont fever, poor po intake
Age: 1.08
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: infant had shots app 11 days ago now with redness to right thigh at site of shot and child with low grade fever and fussiness today mom noted  small blisters to back abd and now arms   parents worried                                   a rash is noted that is diffuse in location;  the color is mainly pink;  it is best characterized as vesicular;  at site of injection red raised lump with 3 vesicles   no erythema  no warmth  no fluctuance                                         PLAN  rxn to varicella  no secondary infection noted  course of disease discussed with parents  follow up if increase pain, cont fever, poor po intake
Age: 66.0
Sex: F
Vaccine: DT
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Arm swelling at injection site - red from shoulder to elbow warm to touch.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Tremor
Clinical narrative: Initial report received on 11 February 2009 from a healthcare professional. A 17-year-old female patient, with an allergy to penicillin, received a first left deltoid intramuscular injection of MENACTRA (lot number U2660BA) on 10 February 2009 at 11:00. The patient had no medical conditions, no concomitant drugs or illness at the time of vaccination. Six hours after vaccination, at 17:00, the patient returned to the physician's office and was observed to have bilateral leg tremors. The patient was sent home and was to be reassessed by the physician the following day. No other information was reported. The patient's recovery status was reported as unknown. Follow-up information received 16 March 2009 from a health care provider who reviewed the case and had no new relevant medically significant information to provide at the time of the report. Follow-up information received 03 April 2009 from a health care provider who reviewed the case and had no new information to provide at the time of the report. Follow up information received 22 June 2009 from a health care professional who reported that the patient recovered on 11 February 2009. No further information was provided. Documents held by sender: None
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm discomfort at injection site in a 4-year-old male subject who was vaccinated with KINRIX, (GlaxoSmithKline).  There were no concomitant medications or vaccinations.  The subject had not experienced drug reactions in the past.  The subject's medical history included febrile seizure and reactive airway disease.  On 12 May 2009 at 10:00 the subject received unspecified dose of KINRIX (0.5 ml, unknown route, left arm).  On 12 May 2009, less than one day after vaccination with KINRIX, the subject experienced arm discomfort at injection site; he complained of his arm bothering him at the injection site. On 14 May 2009, approximately 48 hours after vaccination with KINRIX, the subject experienced injection site reaction with swelling of arm to twice the size of his other arm from his elbow to shoulder, and redness, which was described as "more pink than red" and warm to touch.  The subject had no range of motion problems and was playing and acting fine with no fever.  The subject had not received treatment, but was seen at the doctor's office.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with KINRIX.  Follow-up information received on 29 May 2009 indicated that the events began one day following vaccination with KINRIX on 13 May 2009.  The events were resolved four days later on 16 May 2009.  KINRIX was administered intramuscularly.  The events were considered by the reporter to be related to treatment with KINRIX.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm discomfort at injection site in a 4-year-old male subject who was vaccinated with KINRIX, (GlaxoSmithKline).  There were no concomitant medications or vaccinations.  The subject had not experienced drug reactions in the past.  The subject's medical history included febrile seizure and reactive airway disease.  On 12 May 2009 at 10:00 the subject received unspecified dose of KINRIX (0.5 ml, unknown route, left arm).  On 12 May 2009, less than one day after vaccination with KINRIX, the subject experienced arm discomfort at injection site; he complained of his arm bothering him at the injection site. On 14 May 2009, approximately 48 hours after vaccination with KINRIX, the subject experienced injection site reaction with swelling of arm to twice the size of his other arm from his elbow to shoulder, and redness, which was described as "more pink than red" and warm to touch.  The subject had no range of motion problems and was playing and acting fine with no fever.  The subject had not received treatment, but was seen at the doctor's office.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with KINRIX.  Follow-up information received on 29 May 2009 indicated that the events began one day following vaccination with KINRIX on 13 May 2009.  The events were resolved four days later on 16 May 2009.  KINRIX was administered intramuscularly.  The events were considered by the reporter to be related to treatment with KINRIX.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm discomfort at injection site in a 4-year-old male subject who was vaccinated with KINRIX, (GlaxoSmithKline).  There were no concomitant medications or vaccinations.  The subject had not experienced drug reactions in the past.  The subject's medical history included febrile seizure and reactive airway disease.  On 12 May 2009 at 10:00 the subject received unspecified dose of KINRIX (0.5 ml, unknown route, left arm).  On 12 May 2009, less than one day after vaccination with KINRIX, the subject experienced arm discomfort at injection site; he complained of his arm bothering him at the injection site. On 14 May 2009, approximately 48 hours after vaccination with KINRIX, the subject experienced injection site reaction with swelling of arm to twice the size of his other arm from his elbow to shoulder, and redness, which was described as "more pink than red" and warm to touch.  The subject had no range of motion problems and was playing and acting fine with no fever.  The subject had not received treatment, but was seen at the doctor's office.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with KINRIX.  Follow-up information received on 29 May 2009 indicated that the events began one day following vaccination with KINRIX on 13 May 2009.  The events were resolved four days later on 16 May 2009.  KINRIX was administered intramuscularly.  The events were considered by the reporter to be related to treatment with KINRIX.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: No reaction on previous exposure to drug
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm discomfort at injection site in a 4-year-old male subject who was vaccinated with KINRIX, (GlaxoSmithKline).  There were no concomitant medications or vaccinations.  The subject had not experienced drug reactions in the past.  The subject's medical history included febrile seizure and reactive airway disease.  On 12 May 2009 at 10:00 the subject received unspecified dose of KINRIX (0.5 ml, unknown route, left arm).  On 12 May 2009, less than one day after vaccination with KINRIX, the subject experienced arm discomfort at injection site; he complained of his arm bothering him at the injection site. On 14 May 2009, approximately 48 hours after vaccination with KINRIX, the subject experienced injection site reaction with swelling of arm to twice the size of his other arm from his elbow to shoulder, and redness, which was described as "more pink than red" and warm to touch.  The subject had no range of motion problems and was playing and acting fine with no fever.  The subject had not received treatment, but was seen at the doctor's office.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with KINRIX.  Follow-up information received on 29 May 2009 indicated that the events began one day following vaccination with KINRIX on 13 May 2009.  The events were resolved four days later on 16 May 2009.  KINRIX was administered intramuscularly.  The events were considered by the reporter to be related to treatment with KINRIX.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site haematoma
Clinical narrative: This case was reported by a physician and described the occurrence of bruise injection site in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline).  The subject had no relevant medical history, and had experienced no adverse events following previous vaccinations.  There were no concomitant medications.  Concurrent vaccination included MMRII (Merck) given on 9 April 2009 and VARIVAX (Merck) given on 9 April 2009.  On 9 April 2009 at 15:00 the subject received 2 doses of KINRIX (0.5 ml, unknown route), one in the left leg and one in the right leg.  The order of the vaccinations was not specified.  On 9 April 2009, immediately after vaccination with KINRIX, the subject experienced bruising at both injection sites.  On 9 April 2009, the events were resolved.  Follow up received from reporting physician on 26 May 2009:  The physician considered the events were possibly related to vaccination with KINRIX, and that the events could have been associated with the erroneous administration of KINRIX.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: A 12 year old female patient received a second dose of ADACEL (lot number C3068AA) intramuscularly in the left deltoid and MENACTRA (lot number U2869AA) intramuscularly in the right deltoid on 07 May 2009.  On May 2009 the patient developed a fever, headache, and dizziness.  The recovery status was not reported.  Follow up information received on 26 May 2009 from a health care professional who reported that the patient recovered.  No further information was provided.  Follow up information received on 15 June 2009 from a health care professional who reported that treatment included antipyretics and rest.  The patient's symptoms resolved within 24-48 hours.  The patient is currently asymptomatic.  The patient did not have a prior reaction with the first dose of ADACEL.  No further information was provided.  List of Documents held by Sender:  none.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood product transfusion, CSF protein increased, Computerised tomogram normal, Gait disturbance, Headache
Clinical narrative: Patient came down w/ a "virus" then went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then presented neurological disfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. Took her into the ER. Within 36 hours diagnosed w/ Miller-Fisher Syndrome. Went into intensive care for several days and stayed in the hospital for total of 2 weeks. Still recovering and involved in physical, occupational and speech therapies multiple times per week and still on liquid thickeners.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Oropharyngeal pain, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: Patient came down w/ a "virus" then went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then presented neurological disfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. Took her into the ER. Within 36 hours diagnosed w/ Miller-Fisher Syndrome. Went into intensive care for several days and stayed in the hospital for total of 2 weeks. Still recovering and involved in physical, occupational and speech therapies multiple times per week and still on liquid thickeners.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: Patient came down w/ a "virus" then went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then presented neurological disfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. Took her into the ER. Within 36 hours diagnosed w/ Miller-Fisher Syndrome. Went into intensive care for several days and stayed in the hospital for total of 2 weeks. Still recovering and involved in physical, occupational and speech therapies multiple times per week and still on liquid thickeners.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood test, Borrelia burgdorferi serology, Computerised tomogram, Dehydration, Dyskinesia
Clinical narrative: Patient came down w/ a "virus" then went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then presented neurological disfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. Took her into the ER. Within 36 hours diagnosed w/ Miller-Fisher Syndrome. Went into intensive care for several days and stayed in the hospital for total of 2 weeks. Still recovering and involved in physical, occupational and speech therapies multiple times per week and still on liquid thickeners.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Fatigue, Gait disturbance, Gastroenteritis viral, Intensive care, Miller Fisher syndrome
Clinical narrative: Patient came down w/ a "virus" then went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then presented neurological disfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. Took her into the ER. Within 36 hours diagnosed w/ Miller-Fisher Syndrome. Went into intensive care for several days and stayed in the hospital for total of 2 weeks. Still recovering and involved in physical, occupational and speech therapies multiple times per week and still on liquid thickeners.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Neurological symptom, Nuclear magnetic resonance imaging, Sinusitis, Speech disorder
Clinical narrative: Patient came down w/ a "virus" then went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then presented neurological disfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. Took her into the ER. Within 36 hours diagnosed w/ Miller-Fisher Syndrome. Went into intensive care for several days and stayed in the hospital for total of 2 weeks. Still recovering and involved in physical, occupational and speech therapies multiple times per week and still on liquid thickeners.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood product transfusion, Blood test, Borrelia burgdorferi serology, CSF test abnormal, Computerised tomogram head
Clinical narrative: Patient came down w/ a "virus" then went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then presented neurological disfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. Took her into the ER. Within 36 hours diagnosed w/ Miller-Fisher Syndrome. Went into intensive care for several days and stayed in the hospital for total of 2 weeks. Still recovering and involved in physical, occupational and speech therapies multiple times per week and still on liquid thickeners.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dehydration, Facial paresis, Fatigue, Gait disturbance, Gastroenteritis viral
Clinical narrative: Patient came down w/ a "virus" then went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then presented neurological disfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. Took her into the ER. Within 36 hours diagnosed w/ Miller-Fisher Syndrome. Went into intensive care for several days and stayed in the hospital for total of 2 weeks. Still recovering and involved in physical, occupational and speech therapies multiple times per week and still on liquid thickeners.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Head deformity, Headache, Intensive care, Miller Fisher syndrome, Motor dysfunction
Clinical narrative: Patient came down w/ a "virus" then went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then presented neurological disfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. Took her into the ER. Within 36 hours diagnosed w/ Miller-Fisher Syndrome. Went into intensive care for several days and stayed in the hospital for total of 2 weeks. Still recovering and involved in physical, occupational and speech therapies multiple times per week and still on liquid thickeners.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nervous system disorder, Nuclear magnetic resonance imaging normal, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: Patient came down w/ a "virus" then went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then presented neurological disfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. Took her into the ER. Within 36 hours diagnosed w/ Miller-Fisher Syndrome. Went into intensive care for several days and stayed in the hospital for total of 2 weeks. Still recovering and involved in physical, occupational and speech therapies multiple times per week and still on liquid thickeners.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Sinusitis, Speech disorder, Viral infection, Vomiting
Clinical narrative: Patient came down w/ a "virus" then went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then presented neurological disfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. Took her into the ER. Within 36 hours diagnosed w/ Miller-Fisher Syndrome. Went into intensive care for several days and stayed in the hospital for total of 2 weeks. Still recovering and involved in physical, occupational and speech therapies multiple times per week and still on liquid thickeners.
Age: 1.01
Sex: F
Vaccine: HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A 1 year old female patient received a first time dose of ADACEL (lot number C3005) intramuscularly in the left thigh, MENACTRA (lot number U2910AA) intramuscularly in the right thigh on 15 June 2009 at 3:30 PM.  At 10:00 PM the patient "had the shakes" which lasted until 4:00 AM.  The patient's mother brought the patient to the emergency room following the inadvertent administration of the products.  The patient was treated with a dose of TYLENOL.  The patient's mother stated that the patient "seemed okay, but was not sure".  Recovery status was reported as unknown.  List of Documents held by Sender:  none.  Follow up information received on 15 July 2009 from a health care professional.  Four weeks prior to vaccination, on 18 May 2009 the patient received a second dose of DAPTACEL (lot number C30818A) and PREVNAR (manufacturer Wyeth, lot number D39016) both intramuscularly in the right leg.  On 15 June 2009 the patient received ADACEL in the right leg, previously reported as the left leg and GARDASIL (manufacturer Merck, lot number 0652X) intramuscularly in the left leg.  The patient experienced the shakes off and on through the hours of 10 PM and 4 AM.  During this time the patient did not lose consciousness or retain a fever.  There was no health care professional present during the hours of 10 PM and 4 AM.  The patient does not have a personal or family history of tremors.  No further treatment was received or lab work was completed.  The patient was seen in the emergency room for precautionary measures only.  The child had recovered within a 12 hour period and was without any further incidents.  List of Documents held by Sender: none.
Age: 1.01
Sex: F
Vaccine: HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Tremor, Wrong drug administered
Clinical narrative: A 1 year old female patient received a first time dose of ADACEL (lot number C3005) intramuscularly in the left thigh, MENACTRA (lot number U2910AA) intramuscularly in the right thigh on 15 June 2009 at 3:30 PM.  At 10:00 PM the patient "had the shakes" which lasted until 4:00 AM.  The patient's mother brought the patient to the emergency room following the inadvertent administration of the products.  The patient was treated with a dose of TYLENOL.  The patient's mother stated that the patient "seemed okay, but was not sure".  Recovery status was reported as unknown.  List of Documents held by Sender:  none.  Follow up information received on 15 July 2009 from a health care professional.  Four weeks prior to vaccination, on 18 May 2009 the patient received a second dose of DAPTACEL (lot number C30818A) and PREVNAR (manufacturer Wyeth, lot number D39016) both intramuscularly in the right leg.  On 15 June 2009 the patient received ADACEL in the right leg, previously reported as the left leg and GARDASIL (manufacturer Merck, lot number 0652X) intramuscularly in the left leg.  The patient experienced the shakes off and on through the hours of 10 PM and 4 AM.  During this time the patient did not lose consciousness or retain a fever.  There was no health care professional present during the hours of 10 PM and 4 AM.  The patient does not have a personal or family history of tremors.  No further treatment was received or lab work was completed.  The patient was seen in the emergency room for precautionary measures only.  The child had recovered within a 12 hour period and was without any further incidents.  List of Documents held by Sender: none.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood culture negative, Chest X-ray normal, Computerised tomogram normal, Culture urine negative
Clinical narrative: Nausea and weakness days before menstrual cycle begins since first dose on 5/14/08. Seizure on 07/07/09. Has never had a seizure before. Is not on any prescribed or over-the-counter medications. Has never had any health problems, surgeries or head trauma.  8/4/09 Medical records received DOS 7/8/09 to 7/15/09 Assessment: Grand Mal Seizure. Seen at community hospital previous night post described seizure. Parent reports child made 'gurggle noises' then folded arms and was jerking. Stiff and not responsive. Patient presents with residual headache.  Neuro consult 7/15/09 in f/u to seizure event.  Pt had reported some shakiness to legs prior to event, possible partial seizures. No memory of event.  DX:  Grand Mal seizure.  8/12/09 ER Records recieved DOS 7/7/09. Assessment: Seizure disorder, first onset seizure. After visit to dentist patient was observed to have a sudden onset of seizure-like activity. Making an abnormal noise and 'twitching movements", unresponsive. Transient respiratory distress. Postictal stage in which patient was confused. No incontinence. No recent injury or head trauma. Feels sleepy. Altered mentation. Chest pain.  8/4/09 Medical records received DOS 7/8/09 to 7/15/09 Assessment: Grand Mal Seizure. Seen at community hospital previous night post described seizure. Parent reports child made 'gurggle noises' then folded arms and was jerking. Stiff and not responsive. Patient presents with residual headache. Neuro consult 7/15/09 in f/u to seizure event.  Pt had reported some shakiness to legs prior to event, possible partial seizures. No memory of event.  DX:  Grand Mal seizure. LABS and DIAGNOSTICS: EEG Pending. CT Head and unspecified labs performed at community hospital. PMH: none noted./pc  8/12/09 ER Records recieved DOS 7/7/09. Assessment: Seizure disorder, first onset seizure. After visit to dentist patient was observed to have a sudden onset of seizure-like activity. Making an abnormal noise and 'twitching movements", unresponsive. Transient respiratory distress. Postictal stage in which patient was confused. No incontinence. No recent injury or head trauma. Feels sleepy. Altered mentation. Chest pain.  8/24/09 Neurological consult records received DOS 8/17/09. Patient has no spells, eating, moody, not dizzy, alert. Strenght and gait OK. If no seizures, will wean from meds.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Nausea and weakness days before menstrual cycle begins since first dose on 5/14/08. Seizure on 07/07/09. Has never had a seizure before. Is not on any prescribed or over-the-counter medications. Has never had any health problems, surgeries or head trauma.  8/4/09 Medical records received DOS 7/8/09 to 7/15/09 Assessment: Grand Mal Seizure. Seen at community hospital previous night post described seizure. Parent reports child made 'gurggle noises' then folded arms and was jerking. Stiff and not responsive. Patient presents with residual headache.  Neuro consult 7/15/09 in f/u to seizure event.  Pt had reported some shakiness to legs prior to event, possible partial seizures. No memory of event.  DX:  Grand Mal seizure.  8/12/09 ER Records recieved DOS 7/7/09. Assessment: Seizure disorder, first onset seizure. After visit to dentist patient was observed to have a sudden onset of seizure-like activity. Making an abnormal noise and 'twitching movements", unresponsive. Transient respiratory distress. Postictal stage in which patient was confused. No incontinence. No recent injury or head trauma. Feels sleepy. Altered mentation. Chest pain.  8/4/09 Medical records received DOS 7/8/09 to 7/15/09 Assessment: Grand Mal Seizure. Seen at community hospital previous night post described seizure. Parent reports child made 'gurggle noises' then folded arms and was jerking. Stiff and not responsive. Patient presents with residual headache. Neuro consult 7/15/09 in f/u to seizure event.  Pt had reported some shakiness to legs prior to event, possible partial seizures. No memory of event.  DX:  Grand Mal seizure. LABS and DIAGNOSTICS: EEG Pending. CT Head and unspecified labs performed at community hospital. PMH: none noted./pc  8/12/09 ER Records recieved DOS 7/7/09. Assessment: Seizure disorder, first onset seizure. After visit to dentist patient was observed to have a sudden onset of seizure-like activity. Making an abnormal noise and 'twitching movements", unresponsive. Transient respiratory distress. Postictal stage in which patient was confused. No incontinence. No recent injury or head trauma. Feels sleepy. Altered mentation. Chest pain.  8/24/09 Neurological consult records received DOS 8/17/09. Patient has no spells, eating, moody, not dizzy, alert. Strenght and gait OK. If no seizures, will wean from meds.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Activities of daily living impaired
Clinical narrative: After taking required doses of the Anthrax Vaccine -NUNK- myself and a majority of Soldiers I have spoken with have described decreased ability to remember events, names and  numbers. The decreased mental acuity began for me one year after first receiving the vaccine and has progressively gotten worse with each required booster. I have no laboratory evidence or statistics to back up any claim, X have only anecdotal evidence from observations made of a group of Soldiers with whom I have served and continue to serve with.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pyrexia
Clinical narrative: Narrative: The patient had a mild fever the day after injection then developed a few vesicles on his back. Symptoms:. 1. Mild fever and a few vesicles Suspect Drug # 1 Dosing: Merck Lot # 1551X. Treatment Drugs Used. 1. Valacyclovir Dose: 1 Units. GM Freq: TID Route. PO.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: Anorectal disorder, Gastrooesophageal reflux disease, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Per clinic note on 5/11/09- Patient here today as walk in to clinic complaint of reaction to shingles injection.  States he has been symptomatic with scratchy throat, gastric reflux, pruritis, anus problems, and night sweats.  Also, patient's arm with erythema, pruritis, edema, and pain at injection site.  Discussed with Dr as Dr not available and patient given PREDNISONE 10 mg daily x 5 days.  Instructed in medication use and side effects to report.  Patient to call if no improvement in 2-3 days. Symptoms: 1. erythema, pain pruritis at injection site.  Treatment Drugs Used. 1 - PREDNISONE Dose:  40 Units:  MG Freq:  Every Day Route PO.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pruritus, Night sweats, Pruritus, Throat irritation
Clinical narrative: Per clinic note on 5/11/09- Patient here today as walk in to clinic complaint of reaction to shingles injection.  States he has been symptomatic with scratchy throat, gastric reflux, pruritis, anus problems, and night sweats.  Also, patient's arm with erythema, pruritis, edema, and pain at injection site.  Discussed with Dr as Dr not available and patient given PREDNISONE 10 mg daily x 5 days.  Instructed in medication use and side effects to report.  Patient to call if no improvement in 2-3 days. Symptoms: 1. erythema, pain pruritis at injection site.  Treatment Drugs Used. 1 - PREDNISONE Dose:  40 Units:  MG Freq:  Every Day Route PO.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Feeling hot, Nausea
Clinical narrative: Initial report received on 30 June 2009 from a health care professional. A 47-year-old female patient, who has a history of migraine headaches and allergies to aspirin and antihistamines, had received a dose of ADACEL (lot number, route and site of administration not reported) on 30 June 2009 at 09:30 am. Approximately six hours after vaccination around 16:00 pm the same day, the patient had a feeling of nausea and dizziness, and her chest was feeling warm and it was hard to breath. The patient presented to an urgent care facility as advised by her health care provided and was evaluated by a physician. Treatments received were not reported. No diagnostic tests or laboratory data were reported. At the time of this report, it was unknown whether the patient had recovered. Documents held by sender: None.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Death
Clinical narrative: It was reported from an article published on 29-JUN-2009 that there were 27 deaths in 2008 said to be associated with GARDASIL. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Death
Clinical narrative: It was reported from an article published on 29-JUN-2009 that there were 18 deaths said to be associated with GARDASIL. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first and second dose of GARDASIL on unspecified dates. The patient experienced tonic chronic type seizure activity after getting the second dose of GARDASIL. The patient didn't experience any adverse effect from first dose. Unspecified medical attention was sought. At the time of the report, the patient had recovered. Upon internal review, the tonic chronic type seizure activity was considered as other important medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: No adverse events or treatment needed--adult dose given.  Per CDC no further action required