chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Renal failure, Respiratory distress, Sepsis
Clinical narrative: Per admission record report developed Varivax induced varicella, remains hospitalized 9/29/06. Admitting DX: acute respiratory failure. Dependent exposure 8/29-9/4/06 (5 days prior to 9/2 the date of isolation.). Progress note 9/4/06-continues to spike temps 102.2, increased vesicular type lesion on chest/neck all blood cultures negative. Note of 9/5/06-remains on ventilator, continues to develop new lesion. Decreased renal function, temp 103. Impression: sepsis syndrome, RDS. RX with Acyclovir.  12/19/06-per facility, no DC summary Per 60 day follow up: dischared from hospital to home, Nov. 6, 2006.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain, Rash papular, Rash pruritic, Tenderness
Clinical narrative: Several small pruritic papules and tender lt arm axillary lad, noted following Boostrix given 8/12/06. Tylenol or Motrin for pain, Benadryl or Claritin for itch.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Lymphocytosis, Neutropenia, Pyrexia
Clinical narrative: Onset of fever 1 day after 2 month vaccines. Fever persisted 5 days, then abated spontaneously.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Lymphadenopathy
Clinical narrative: Lymph node swelling right side neck presented 9/20/06 size if egg, a febrile, experiencing discomfort.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: Localized reaction (3 1/2 x 3") at injection site Benadryl PO X 1.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pain
Clinical narrative: Experienced muscular pain in entire arm x 1 week c/o dull ache and soreness in elbow currently. This does effect her ability to lift ie mild jug. Instructed to use NSAID's x 7 days and to see PMD PRN.
Age: 0.18
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Screaming
Clinical narrative: Prolonged crying (10 hours).
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Blood creatine phosphokinase increased, Dyspnoea, Hypoaesthesia, Loss of consciousness
Clinical narrative: Symptoms of difficulty breathing, feeling tingly and numb in his arms and upper body. Passing out weakness in his arms, happened on the same day of vaccination. Office notes 9/25-9/26/06: Complains heart seems to beat faster, breathing fast and feels lightheaded. Episode on Friday when he was at track, doing sprints heart beating faster, hard to breathe, fell to ground and passed out then was okay. Occurred again next day while sitting in chair. Tired over weekend, and that is how he acts after that happens. No headaches, no vision changes, feels lightheaded prior to passing out. Hard time sleeping at night, starts thinking about his breathing and then it is harder to sleep. If he gets nervous he will notice that his hands shake. Otherwise he has noticed no tremors. If he is not nervous the hand shaking does not seem to be there. No other jerking movements. PE: WNL. Observed in office and he became anxious and started breathing faster. Heart rate 100 hands seemed shaky, no syncopal episode associated with this.  Discussion that it could be anxiety related.  8/26/06-office visit:observed in ER 2 syncopal episodes. Mom indicated he drinks a lot of sports drinks with high caffeine and Mountain Dew. Recommend avoiding these drinks, referred to neurologists for hand tremors.  ER DOS 9/25/06: DC DX: Syncope and palpitations. Seen in ER for C/O syncope and palpitations. previously seen in ER on 8/10/06 with C/O: Drunk. While at a bonfire patient suddenly started being real tingly and passed out. Hard time breathing. Hyperventilating. States he could not more his arms or feel them, however, he adamantly denies drinking alcohol or taking any medications. Stated had Hep B vaccine on 8/10/06. Fainted while sitting in chair by bonfire. EMS arrived, VS normal, awake except for mild tachycardia and was hyperventilating. Temp 100.0. PE: WNL. Neuro: normal cranial nerves, DTRs equal and symmetrical bilaterally. Normal sensation.  Final impression: syncope and fever most likely secondary to hepatitis B vaccine.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Paraesthesia, Pyrexia, Syncope
Clinical narrative: Symptoms of difficulty breathing, feeling tingly and numb in his arms and upper body. Passing out weakness in his arms, happened on the same day of vaccination. Office notes 9/25-9/26/06: Complains heart seems to beat faster, breathing fast and feels lightheaded. Episode on Friday when he was at track, doing sprints heart beating faster, hard to breathe, fell to ground and passed out then was okay. Occurred again next day while sitting in chair. Tired over weekend, and that is how he acts after that happens. No headaches, no vision changes, feels lightheaded prior to passing out. Hard time sleeping at night, starts thinking about his breathing and then it is harder to sleep. If he gets nervous he will notice that his hands shake. Otherwise he has noticed no tremors. If he is not nervous the hand shaking does not seem to be there. No other jerking movements. PE: WNL. Observed in office and he became anxious and started breathing faster. Heart rate 100 hands seemed shaky, no syncopal episode associated with this.  Discussion that it could be anxiety related.  8/26/06-office visit:observed in ER 2 syncopal episodes. Mom indicated he drinks a lot of sports drinks with high caffeine and Mountain Dew. Recommend avoiding these drinks, referred to neurologists for hand tremors.  ER DOS 9/25/06: DC DX: Syncope and palpitations. Seen in ER for C/O syncope and palpitations. previously seen in ER on 8/10/06 with C/O: Drunk. While at a bonfire patient suddenly started being real tingly and passed out. Hard time breathing. Hyperventilating. States he could not more his arms or feel them, however, he adamantly denies drinking alcohol or taking any medications. Stated had Hep B vaccine on 8/10/06. Fainted while sitting in chair by bonfire. EMS arrived, VS normal, awake except for mild tachycardia and was hyperventilating. Temp 100.0. PE: WNL. Neuro: normal cranial nerves, DTRs equal and symmetrical bilaterally. Normal sensation.  Final impression: syncope and fever most likely secondary to hepatitis B vaccine.
Age: 53.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Hives possibly from flu vaccine reddened patches through out body itching.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw
Clinical narrative: Severe Pain in right jaw 24 hours after injection of Tdap 0.5ml IM in left deltoid. No swelling, fever or other complaints including no pain at site.
Age: 4.0
Sex: F
Vaccine: FLU3, HEPA, IPV, MMRV
Symptoms: Rash maculo-papular, Rash pruritic, Skin discolouration
Clinical narrative: On 9/21/06 developed maculo papular clusters confluent pink non tender but mildly purpuric rash consume anterior chest, and back. Rash intensity varied for first 2-3 days but steadily resolved so that by 9/27/06 the rash was minimal Not erythematous and barely palpable).
Age: 8.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Medication error
Clinical narrative: On 8/21/06 pt age 8 yrs received a Tdap instead of a TD. Pt had not received a Dtap for kindergarten but was too young for Tdap and too old for the Dtap. No reaction to vaccine were reported.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Hypokinesia, Injection site pain, Pallor
Clinical narrative: Client given Adacel on 7/17/06. She called the next day 7/18/06, c/o sore left arm, not red, but had difficulty lifting it. Also c/o being pale, weak and dizzy. Stated she had to spend the day in bed.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Swelling in deltoid region on Saturday. Pt said felt kind of tender. Sunday swelling went down but felt kind of warm to the touch. Monday no swelling in deltoid area but there is redness toward outer aspect of biceps and feels warm to the touch no pain.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Immediately with vaccination with MMRV noticed area of induration about size of quarter which was pink and raised. Called mom on 9/25/06, mom stated pt fine no complaints or concerns.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: After administration of vaccine the injection site immediately formed a wheel the size of a peanut (no shell). Pt stated no complaints a s/s from injection.
Age: 0.19
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV, RV5
Symptoms: Anorexia, Dehydration, Diarrhoea, Gastroenteritis, Lethargy
Clinical narrative: Low grade fever, diarrhea after 48 hours, lethargic, excessive sleeping, dehydration, loss of appetite, and hospitalization with positive rotavirus stool test. DC DX: Rotavirus Gastroenteritis, Dehydration. PMH: GERD recent admission DC date 9/13/06
Age: 0.19
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV, RV5
Symptoms: Pyrexia, Respiratory syncytial virus infection, Somnolence, Viral infection
Clinical narrative: Low grade fever, diarrhea after 48 hours, lethargic, excessive sleeping, dehydration, loss of appetite, and hospitalization with positive rotavirus stool test. DC DX: Rotavirus Gastroenteritis, Dehydration. PMH: GERD recent admission DC date 9/13/06
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: FEVER, SITE WARM TO TOUCH, PAIN NOTED WITH MOVEMENT OF EXTREMITY.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Temperature to 103, malaise, headache, myalgias developing after 48 hours from vaccination.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Received vaccine on 9/28/2006.  On 10/2/2006 Patient reported through a third party that he developed a 'rash' two days later. Asked him (through third party) to go to his doctor.  Doctor stated he had 'hives'.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Diarrhoea, Laboratory test abnormal, Lethargy
Clinical narrative: Mother noticed child was lethargic the morning of 5-15-06. No fever.  He had a seizure around 10:30am, and another seizure on 5-16-06 at 3:00 am. Was hospitalized for 5 days. DC DX: Seizure with new onset. Secondary DX diarrhea. Experienced  afebrile seizure prior with cyanosis prior to admission. During hospital stay, experienced  second seizure observed by nursing staff. Tonoclonic in nature and lasted for 2-3 minutes. Associated with cyanosis. Whether or not there was true apnea is unclear. Had 30 to40 minute postictial state following the event. Neither seizure was treated with epileptic medication. No further seizure events occurred. Placed on antibiotics and Acyclovir for possible viral encephalitis,  both discontinued after 48 hours. Developed diarrhea, stool culture negative.
Age: 0.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Influenza like illness, Swelling
Clinical narrative: 10-02-06 Pneumavax 23 vaccination sq to rt arm and Influenza vaccine IM lt arm in early am. Reported flu like symptoms and swelling and warmth to rt arm symptoms started at about 12 am.
Age: 0.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Influenza like illness, Swelling
Clinical narrative: 10-02-06 Pneumovax 23 vaccination sq to rt arm and Influenza vaccine IM lt arm in early am. Reported flu like symptoms and swelling and warmth to rt arm symptoms started at about 12 am.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Bacterial infection, Coordination abnormal, Encephalitis, Eye movement disorder, Muscle twitching
Clinical narrative: On 8/3/06 took MMR/varicella 1, Hep A, Fever on 8/31, 9/1 next day rash, ER rash spread scarlet fever, Moxifloxacin, 9/5 groggy, eyes turning around. ER Wed06 where she was diagnosed with encephalitis. DC DX for DOS 09/06-09/011/06: Cerebellitis. New onset of inability to stand, face twitching and rapid eye movements. Temp max 100.4 and rash in diaper area. Rash spread over her body and 5 days PTA mother brought her to urgent care center and received amoxicillin. HX: negative for diarrhea, emesis. ER note indicated patient DX with scarlett fever on Thursday. Neuro: started on menigitic doses of ceftriaxone and Acyclovir. Cetriaxone continued until CSF culture negative 48 hours and acyclovir was continued until HSV PCR was negative. Evaluated by ID recommended extensive testing for cause of cerebrillitis. Eye movements and ataxia improved.. Ophto exam much improved with only occasional saccades.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Somnolence
Clinical narrative: On 8/3/06 took MMR/varicella 1, Hep A, Fever on 8/31, 9/1 next day rash, ER rash spread scarlet fever, Moxifloxacin, 9/5 groggy, eyes turning around. ER Wed06 where she was diagnosed with encephalitis. DC DX for DOS 09/06-09/011/06: Cerebellitis. New onset of inability to stand, face twitching and rapid eye movements. Temp max 100.4 and rash in diaper area. Rash spread over her body and 5 days PTA mother brought her to urgent care center and received amoxicillin. HX: negative for diarrhea, emesis. ER note indicated patient DX with scarlett fever on Thursday. Neuro: started on menigitic doses of ceftriaxone and Acyclovir. Cetriaxone continued until CSF culture negative 48 hours and acyclovir was continued until HSV PCR was negative. Evaluated by ID recommended extensive testing for cause of cerebrillitis. Eye movements and ataxia improved.. Ophto exam much improved with only occasional saccades.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Oedema, Pain, Skin hyperpigmentation, Skin ulcer
Clinical narrative: Few hours after receiving the Tdap, she woke up with pain, swelling and hyperpigmented became and crops of vesicles, burn like lesion as reaction to Tdap.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Thermal burn
Clinical narrative: Few hours after receiving the Tdap, she woke up with pain, swelling and hyperpigmented became and crops of vesicles, burn like lesion as reaction to Tdap.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Agitation, Crying, Irritability, Vomiting
Clinical narrative: Mom and Grandmother reported pt vomited 2 oz of formula at 1 pm (9/19/06) few hours after vaccines. Baby became fussy and crying a lot. Vomited 4x no fever.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Chills, Diarrhoea, Urticaria, Vomiting
Clinical narrative: Generalized urticarial rash, abdominal pain, vomiting, diarrhea, chills.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Burning sensation mucosal, Fatigue, Mucous membrane disorder, Oedema
Clinical narrative: Fever to 103, marked UE, chest neck swelling mucosal break down in oropharanx and burning, fatigue and arthralgias (diffusely).
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever to 103, marked UE, chest neck swelling mucosal break down in oropharanx and burning, fatigue and arthralgias (diffusely).
Age: 36.0
Sex: M
Vaccine: FLU3, HEP, SMALL, TYP
Symptoms: Asthenia, Cold sweat, Drooling, Dyspnoea, Eye disorder
Clinical narrative: Pt is a 37 year old male who reported no problems with his health until early Feb 05. He stated he was vaccinated for anthrax and when questioned because his records showed he received small pox and declined anthrax, he stated that he was told to keep the area covered until the scab came off and to take precautions with laundry. He initially reported problems with night sweats and problems breathing and stated he was eventually diagnosed with sarcoidosis. He stated he took steroids and methotrexate and began to feel better and was eventually cleared to deploy with his unit in Oct. He received additional immunizations, but does not recall which ones but stated he had no problems following subsequent immunizations. In Dec 05 he experienced a sudden onset of weakness on the right side of face, along with problems closing his eye, and drooling, He also noted at the same time hearing loss and headaches on the right side of his head. He denied these symptoms prior to the onset of facial weakness and sought immediate medical attention. He was diagnosed with Bells palsy and eventually returned to state side. He reports continued problems with the headaches and facial weakness and states that there is little improvement in his symptoms despite taking the medication. He reports the headaches are no constant, whereas it would have pain free periods the first month, on the right side of his head rated # on scale of 1-10 and 10 being worse. He stated at times the pain may reach 10 and it sometimes wakes him up at night. He stated it is like a giant toothache and is always there, never pain free and stated Midrin helps only a little, He denies photosensitivity, nausea, altered sensation, and neck pain. He stated that his hearing problem started with the onset of his Bells palsy and that he occasionally has ringing in his right ear only, especially when his headache is severe. Clamminess 02/2005, dyspnea (shortness of breath) 02/2005, Facial nerve paralysis/palsy 12/2005, head pain 12/2005 comment rt side of head. Hearing loss 12/2005
Age: 36.0
Sex: M
Vaccine: FLU3, HEP, SMALL, TYP
Symptoms: Facial palsy, Headache, Hypoacusis, Laboratory test abnormal, Night sweats
Clinical narrative: Pt is a 37 year old male who reported no problems with his health until early Feb 05. He stated he was vaccinated for anthrax and when questioned because his records showed he received small pox and declined anthrax, he stated that he was told to keep the area covered until the scab came off and to take precautions with laundry. He initially reported problems with night sweats and problems breathing and stated he was eventually diagnosed with sarcoidosis. He stated he took steroids and methotrexate and began to feel better and was eventually cleared to deploy with his unit in Oct. He received additional immunizations, but does not recall which ones but stated he had no problems following subsequent immunizations. In Dec 05 he experienced a sudden onset of weakness on the right side of face, along with problems closing his eye, and drooling, He also noted at the same time hearing loss and headaches on the right side of his head. He denied these symptoms prior to the onset of facial weakness and sought immediate medical attention. He was diagnosed with Bells palsy and eventually returned to state side. He reports continued problems with the headaches and facial weakness and states that there is little improvement in his symptoms despite taking the medication. He reports the headaches are no constant, whereas it would have pain free periods the first month, on the right side of his head rated # on scale of 1-10 and 10 being worse. He stated at times the pain may reach 10 and it sometimes wakes him up at night. He stated it is like a giant toothache and is always there, never pain free and stated Midrin helps only a little, He denies photosensitivity, nausea, altered sensation, and neck pain. He stated that his hearing problem started with the onset of his Bells palsy and that he occasionally has ringing in his right ear only, especially when his headache is severe. Clamminess 02/2005, dyspnea (shortness of breath) 02/2005, Facial nerve paralysis/palsy 12/2005, head pain 12/2005 comment rt side of head. Hearing loss 12/2005
Age: 36.0
Sex: M
Vaccine: FLU3, HEP, SMALL, TYP
Symptoms: Pain, Sarcoidosis, Sleep disorder, Tinnitus
Clinical narrative: Pt is a 37 year old male who reported no problems with his health until early Feb 05. He stated he was vaccinated for anthrax and when questioned because his records showed he received small pox and declined anthrax, he stated that he was told to keep the area covered until the scab came off and to take precautions with laundry. He initially reported problems with night sweats and problems breathing and stated he was eventually diagnosed with sarcoidosis. He stated he took steroids and methotrexate and began to feel better and was eventually cleared to deploy with his unit in Oct. He received additional immunizations, but does not recall which ones but stated he had no problems following subsequent immunizations. In Dec 05 he experienced a sudden onset of weakness on the right side of face, along with problems closing his eye, and drooling, He also noted at the same time hearing loss and headaches on the right side of his head. He denied these symptoms prior to the onset of facial weakness and sought immediate medical attention. He was diagnosed with Bells palsy and eventually returned to state side. He reports continued problems with the headaches and facial weakness and states that there is little improvement in his symptoms despite taking the medication. He reports the headaches are no constant, whereas it would have pain free periods the first month, on the right side of his head rated # on scale of 1-10 and 10 being worse. He stated at times the pain may reach 10 and it sometimes wakes him up at night. He stated it is like a giant toothache and is always there, never pain free and stated Midrin helps only a little, He denies photosensitivity, nausea, altered sensation, and neck pain. He stated that his hearing problem started with the onset of his Bells palsy and that he occasionally has ringing in his right ear only, especially when his headache is severe. Clamminess 02/2005, dyspnea (shortness of breath) 02/2005, Facial nerve paralysis/palsy 12/2005, head pain 12/2005 comment rt side of head. Hearing loss 12/2005
Age: 0.28
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Decreased appetite, Diarrhoea, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Mom noticed fingertips lump on the right thigh 9/28/06 in am, by the evening lump 2 fingertip size red, swollen, mom stated day of shot baby had diarrhea decreased appetite, fever.
Age: 0.28
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Mom noticed fingertips lump on the right thigh 9/28/06 in am, by the evening lump 2 fingertip size red, swollen, mom stated day of shot baby had diarrhea decreased appetite, fever.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, induration at site, warm to touch came back to office 2 days later use Benadryl, compresses.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Localized edema to area, erythema within 2 minutes of injection, ice pack applied to area.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Myalgia
Clinical narrative: Pt noticed some muscle tenderness at site approx 4-5 hours post injection. Approx 24 hrs later noted increased tenderness. Redness and swelling to site presented in Drs office for evaluation. Initiated Augmentin 875mg BID x 10 days. Benadryl or Claritin PRN.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Tenderness
Clinical narrative: 7cm x 7.5cm redness at injection site with slight induration, mild tenderness, warm to touch 9/23 area of induration has increased, slightly less reddened, area warm to touch, antibiotics prescribed for 7 days Keflex.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin nodule
Clinical narrative: "bumps on back".
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Swelling
Clinical narrative: Left deltoid with erythema, swelling surrounding injection site.  Patient was given MEDROL (pak) 4 mg take as directed ATARAX 25 mg 1 four times a day as needed.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: Left deltoid area with erythema, firm swelling, warm to the touch ATARAX 25 mg 1 four times a day as needed for itching, PREDNISONE (pak) 10 mg 6-D pak was given.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Dermatitis, Rash
Clinical narrative: On 8/28/2006 Patient complained of rash all over body, advised to see primary care physician.  Physician visit on 8/29/06, diagnosis of patient report of physician visit "toxic dermatitis".  The findings could be consistent with a diagnosis eruption or urticarial eruption.
Age: 1.55
Sex: F
Vaccine: DTAP, PNC
Symptoms: Crying, Feeling hot, Pyrexia, Rash, Vomiting
Clinical narrative: Vomited at 6pm 9/27 (after supper) at 10pm 9/27 felt a bit warm.  Awoke times 2 during the night crying which is unusual for child.  At 530 am 9/28 felt warm-temperature was not checked. 100 pm 9/28 rash "red dots" on back, face, legs, right thigh is tender.  Temperature 101 F axillary.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Given MMR left thigh on 9/25/06.  Erythema and swelling left thigh 9/26/06.  Some oozing by site 9/27/06----->AUGMENTIN  syrups.  Clear 9/29/06.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Pyrexia, Vomiting
Clinical narrative: Reaction began 3 hours after vaccines-temperature 100 degrees rectal.  She will sleep 1 1/2 hours and awaken screaming for 20 minutes.  Slept at 3:30 pm to 5:00 pm-awoke screaming 20 minutes.  TYLENOL 8 ml (cry of pain) slept from 6 pm-9 pm cried 20 minutes, TYLENOL again.  Slept 9:30 am-12:30 am cried 20 minutes TYLENOL, slept 1am-5am threw up at 5:15 temperature 101 degrees at 5:20 am slept until 7:30 am temperature 100 degrees at 5:30 am slept 8:30-11:30 am today.  Temperature 101.2 at 1:15 today.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Infection, Pain, Swelling
Clinical narrative: Mom reports that the evening after the immunizations,then patient complained of a lot of pain on Friday he had redness and swelling to elbow and could hardly move arm on Saturday she took patient to emergency room who said arm was infected and gave him CEPHALEXIN.  Mom says problem is improving.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: 24 hours after vaccine administration, patient's left deltoid swollen to size of orange, erythematous, hot to touch.
Age: 1.33
Sex: M
Vaccine: UNK
Symptoms: Erythema, Oedema, Pyrexia
Clinical narrative: 9/28/06 temperature 105 left thigh erythematous edematous MOTRIN every 6-8 hours, BENADRYL every 6 hours, ice comfort given measured region of reaction to flu next day at office or sooner concerns/questions. 9/29/06 afebrile improvement less edema less erythema.
Age: 0.52
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Rash
Clinical narrative: 1 1/2 weeks post MMR vaccine, rash appears on trunk and back.  Immunization clinic referred patient to responsible physician.  No treatment required.  Diagnosis: post MMR vaccine rash.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Nausea, Pharyngolaryngeal pain, Pruritus, Pyrexia
Clinical narrative: 9-11-06 am patient complain of headache, nausea, sore throat and rash to mom.  Stated rash was "red spots and itchy" child did have "fever" per mom < 50 spots.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: 9-11-06 am patient complain of headache, nausea, sore throat and rash to mom.  Stated rash was "red spots and itchy" child did have "fever" per mom < 50 spots.
Age: 1.49
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: rash all over body for 2 days, spreading complain of itchiness.
Age: 1.06
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Skin nodule
Clinical narrative: red bumps started 3 days ago and spreading.  Complain of itchiness.
Sex: U
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: Had Varivax shot on 2/3/06.  Diagnosis: with chicken pox on 9/27/06
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin nodule
Clinical narrative: Red bumps started 3 days ago and spreading.  Complain of itchiness.
Sex: M
Vaccine: DT, VARCEL
Symptoms: Viral infection
Clinical narrative: Varicella right calf and thigh left chest
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Erythema
Clinical narrative: Right upper arm with 2 by 5 cm area of erythema surrounding injection site.  PREDNISONE 9pak) 10 mg 6-D pak was given.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Rash all over body, spreading, complain of itchiness for 2 days.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Rash all over body, spreading times 2 days, complain of itchiness.
Age: 50.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Received Td 9/29 c/o red swollen arm 10/2, Unable to make office apt to ER.
Age: 72.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Swelling
Clinical narrative: Received Td injection 8/11/06 developed fever, swelling to emergency room treated with antibiotics.  Treated 5/15/06.
Age: 23.0
Sex: M
Vaccine: JEV
Symptoms: Dizziness, Euphoric mood
Clinical narrative: Lightheadedness, dizziness, euphoric feeling.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Injection site warmth, Pruritus, Swelling
Clinical narrative: Vaccines given 9/26/06.  Mom called 9/27/06 upper left arm, red, hot, swollen, hard and itchy.
Age: 56.0
Sex: F
Vaccine: TD, TD
Symptoms: Asthenia, Chest discomfort, Muscle spasms
Clinical narrative: Generalized weakness and muscle spasms starting soon after the injection-no rash but had feeling of chest pressure like elephant on chest for two days.
Age: 56.0
Sex: F
Vaccine: TD, TD
Symptoms: Asthenia, Dizziness, Gait disturbance, Headache, Hypoaesthesia
Clinical narrative: Generalized weakness and muscle spasms starting soon after the injection-no rash but had feeling of chest pressure like elephant on chest for two days.
Age: 56.0
Sex: F
Vaccine: TD, TD
Symptoms: Hypokinesia, Injection site pain, Injection site reaction, Muscle spasms, Pain
Clinical narrative: Generalized weakness and muscle spasms starting soon after the injection-no rash but had feeling of chest pressure like elephant on chest for two days.
Age: 56.0
Sex: F
Vaccine: TD, TD
Symptoms: Paraesthesia, Sensation of pressure, Somnolence, Vision blurred
Clinical narrative: Generalized weakness and muscle spasms starting soon after the injection-no rash but had feeling of chest pressure like elephant on chest for two days.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Swelling
Clinical narrative: Right anterior thigh with 6 1/2 cm by 6 cm erythematous swelling.  No drainage notes.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Convulsion
Clinical narrative: Seizure on 9/12/06
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Convulsion
Clinical narrative: At 9:40 am patient had fasting later drawn and Hep A vaccine given and then following patient started seizuring for 10 seconds.  911 called and patient transported per ambulance 509 to hospital per person mentioned request.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Parent states they noticed the swelling redness to leg thigh states child flinched when area was touched referred to provider for further assessment.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Pain, Swelling
Clinical narrative: Vaccines administered Tues 9-26-06 mother stated didn't notice reaction on left leg until pm of 9/28/06 but stated child had complain leg hurting. Mother stated large, red, swollen hot area approximately 3" by 5" on left leg.  Made trip to emergency room.  Treated with BENADRL and cream. Child's weight 84#.
Age: 16.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Unevaluable event
Clinical narrative: Subject 16 year old was inadvertently given a DTap vaccine, this vaccine is recommended under the age of 7 years.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Cellulitis of left arm-treated in emergency room next day with prescription of KEFLEX next day.  Seen in office 2 days later arm still red and swollen.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site induration, Injection site warmth, Myalgia, Swelling
Clinical narrative: Site is red, warm, hard, swollen, sore. Site measures 4" by 3 1/2".  Treatment: KEFLEX 500 mg 1 by mouth twice a day for 7 days and MOTRIN 800 mg twice a day as needed.
Age: 79.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Patient was admitted 9/6/06 and received pneumococcal vaccine in right arm IM.  Patient developed a cellulitis below the level of injection.  Area has been circled by attending physician and is being observed.  Lot number was reported on vaccine sheet as T122106 which may not be correct.  Patient was started on Nafcillin IV 2gm every 4 hours with little improvement.  Patient was started on VANCOMYCIN IV 1 gm every 18 hours and discharged on BACTRIM DS 1 tab by mouth twice a day for 7 days.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Fasciitis, Injection site erythema, Injection site reaction, Rash
Clinical narrative: Pt developed left arm cellulitis triceps fasicitis on 3/24 secondary to pneumovax injection, CT done which showed no collection. Surgery and infectious disease were consulted. Pt initially placed on dicloxacillin 500mg PO QID. Vancomycin 1gm IV and Ciprofloxacin 500 PO W 12 hr were added when erythema did not improve. By 3/26 rash began to recede per 10 records. All previous antibiotics were stopped and Ancef 2gm IV Q 12 hour was started. Pt discharged to home on 4/1 with Afadroxill 1 gram PO BID for 7 days.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Tenderness
Clinical narrative: Received pneumovax vaccination on 3/27 in right upper arm. on 3/28 she developed mild local tenderness at the site and was given Ancef 1gm x 1,but there was no evidence of cellulitis and thus the area improved, she was not continued on antibiotics.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left deltoid redness and swelling.
Age: 1.32
Sex: M
Vaccine: MU
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a consumer concerning a 4 year old male patient's with a history of "eosinophic" colitis and "rash from antibiotics" who on 17-Jan-2002 was vaccinated SC in the left quadricep with a first dose of mumps virus vaccine live (lot#638062/1725K).  There was no concomitant medication and no illness at the time of vaccination.  It was reported that the patient experienced a "vaccination failure".  A titer was done on 07-Jun-2005.  Follow up information from the reporter indicated that the patient had no antibodies for mumps when blood was drawn to check for antibodies "on 8/05".  He did show antibodies to rubella and measles.  It was noted that the vaccines were given separately.  The patient status was reported as not recovered.  There was no product quality complaint involved.  Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: MU
Symptoms: Injection site reaction, Irritability
Clinical narrative: Information has been received from a consumer concerning a 6 year old female with no pertinent medical history and no drug reactions/allergies who in approximately 2001 was vaccinated SC with a dose of mumps virus vaccine live.  There was no concomitant medication.  In approximately 2001, after vaccination, the patient developed an injection site reaction, stopped eating and became more irritable.  Subsequently, about a week after the injection, the patient recovered.  The were no lab diagnostic studies performed.  Unspecified medication attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MU
Symptoms: Parotid gland enlargement
Clinical narrative: Information has been received from a physician concerning a 6 year old male with no known history or allergies who was vaccinated SC with a first and second 0.5 ml dose of mumps virus vaccine live on 15-NOV-2000 and 27-APR-2003, respectively.  There was no concomitant medication.  On 15-MAY-2006 the patient presented with a large parotiditis.  No other symptoms were noted and no treatment was needed.  It was reported that the patient had a positive Mumps IgG.  Symptoms resolved within 4-5 days.  There was no product quality complaint involved.  Additional information has been requested.
Age: 0.41
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Constipation, Haematochezia, Intussusception, Irritability, Laboratory test abnormal
Clinical narrative: Initial report received on 9/27/2006 from another manufacturer, report number WAES0609USA02226. A five month old male pt, with a history of jaundice at birth, nasal congestion, upper respiratory tract infection, bronchiolitis, and eczema, had received the following vaccines on 8/4/06, a second dose of ActHib, lot number U8812AA, in the left thigh, a second dose of DTap in the left thigh, a second dose of IPOL, lot number Y1051, in the right thigh, a second dose of Hepatitis B vaccine, in the right thigh, a second dose of Prevnar lot number B08655E, in the right arm and a second 2.0 ml oral dose of Rotateq lot number 653915/0389F. The trade name, manufacturer name, lot number and route of administration for the DTap was not reported. The lot number and route of administration was not reported for the Hep B vaccine. The routes of administration were not reported for the ActHib, IPOL, and Prevnar. It is significant to note that the pt had previously received a first dose of Rotateq vaccine on 5/23/06, and subsequently developed bronchiolitis in July of 2006. On 9/5/06, 32 days post immunization, the pt developed episodes of vomiting and was hospitalized with a diagnosis of intussusception made via CT scan. An ultrasound was also performed, but the results were not reported. The pt had two air contrast barium enemas which were unsuccessful in reducing the intussusception. Two days later, on 9/7/06, the pt underwent open reduction of the intussusception without losing any bowel as a result of the procedure. The pt was hospitalized for six days and was subsequently discharges to home. At the time of this report, the pt was recovering from these adverse events. The other manufacturer considered the intussusception to be an important medical event (OMIC) (Surgery) and life threatening. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agent. Additional information has been requested by the other manufacturer.
Age: 0.41
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Initial report received on 9/27/2006 from another manufacturer, report number WAES0609USA02226. A five month old male pt, with a history of jaundice at birth, nasal congestion, upper respiratory tract infection, bronchiolitis, and eczema, had received the following vaccines on 8/4/06, a second dose of ActHib, lot number U8812AA, in the left thigh, a second dose of DTap in the left thigh, a second dose of IPOL, lot number Y1051, in the right thigh, a second dose of Hepatitis B vaccine, in the right thigh, a second dose of Prevnar lot number B08655E, in the right arm and a second 2.0 ml oral dose of Rotateq lot number 653915/0389F. The trade name, manufacturer name, lot number and route of administration for the DTap was not reported. The lot number and route of administration was not reported for the Hep B vaccine. The routes of administration were not reported for the ActHib, IPOL, and Prevnar. It is significant to note that the pt had previously received a first dose of Rotateq vaccine on 5/23/06, and subsequently developed bronchiolitis in July of 2006. On 9/5/06, 32 days post immunization, the pt developed episodes of vomiting and was hospitalized with a diagnosis of intussusception made via CT scan. An ultrasound was also performed, but the results were not reported. The pt had two air contrast barium enemas which were unsuccessful in reducing the intussusception. Two days later, on 9/7/06, the pt underwent open reduction of the intussusception without losing any bowel as a result of the procedure. The pt was hospitalized for six days and was subsequently discharges to home. At the time of this report, the pt was recovering from these adverse events. The other manufacturer considered the intussusception to be an important medical event (OMIC) (Surgery) and life threatening. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agent. Additional information has been requested by the other manufacturer.
Age: 0.41
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Bronchiolitis, Intussusception, Vomiting
Clinical narrative: Initial report received on 9/27/2006 from another manufacturer, report number WAES0609USA02226. A five month old male pt, with a history of jaundice at birth, nasal congestion, upper respiratory tract infection, bronchiolitis, and eczema, had received the following vaccines on 8/4/06, a second dose of ActHib, lot number U8812AA, in the left thigh, a second dose of DTap in the left thigh, a second dose of IPOL, lot number Y1051, in the right thigh, a second dose of Hepatitis B vaccine, in the right thigh, a second dose of Prevnar lot number B08655E, in the right arm and a second 2.0 ml oral dose of Rotateq lot number 653915/0389F. The trade name, manufacturer name, lot number and route of administration for the DTap was not reported. The lot number and route of administration was not reported for the Hep B vaccine. The routes of administration were not reported for the ActHib, IPOL, and Prevnar. It is significant to note that the pt had previously received a first dose of Rotateq vaccine on 5/23/06, and subsequently developed bronchiolitis in July of 2006. On 9/5/06, 32 days post immunization, the pt developed episodes of vomiting and was hospitalized with a diagnosis of intussusception made via CT scan. An ultrasound was also performed, but the results were not reported. The pt had two air contrast barium enemas which were unsuccessful in reducing the intussusception. Two days later, on 9/7/06, the pt underwent open reduction of the intussusception without losing any bowel as a result of the procedure. The pt was hospitalized for six days and was subsequently discharges to home. At the time of this report, the pt was recovering from these adverse events. The other manufacturer considered the intussusception to be an important medical event (OMIC) (Surgery) and life threatening. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agent. Additional information has been requested by the other manufacturer.
Age: 0.41
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Vomiting
Clinical narrative: Initial report received on 9/27/2006 from another manufacturer, report number WAES0609USA02226. A five month old male pt, with a history of jaundice at birth, nasal congestion, upper respiratory tract infection, bronchiolitis, and eczema, had received the following vaccines on 8/4/06, a second dose of ActHib, lot number U8812AA, in the left thigh, a second dose of DTap in the left thigh, a second dose of IPOL, lot number Y1051, in the right thigh, a second dose of Hepatitis B vaccine, in the right thigh, a second dose of Prevnar lot number B08655E, in the right arm and a second 2.0 ml oral dose of Rotateq lot number 653915/0389F. The trade name, manufacturer name, lot number and route of administration for the DTap was not reported. The lot number and route of administration was not reported for the Hep B vaccine. The routes of administration were not reported for the ActHib, IPOL, and Prevnar. It is significant to note that the pt had previously received a first dose of Rotateq vaccine on 5/23/06, and subsequently developed bronchiolitis in July of 2006. On 9/5/06, 32 days post immunization, the pt developed episodes of vomiting and was hospitalized with a diagnosis of intussusception made via CT scan. An ultrasound was also performed, but the results were not reported. The pt had two air contrast barium enemas which were unsuccessful in reducing the intussusception. Two days later, on 9/7/06, the pt underwent open reduction of the intussusception without losing any bowel as a result of the procedure. The pt was hospitalized for six days and was subsequently discharges to home. At the time of this report, the pt was recovering from these adverse events. The other manufacturer considered the intussusception to be an important medical event (OMIC) (Surgery) and life threatening. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agent. Additional information has been requested by the other manufacturer.
Age: 0.17
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC
Symptoms: Abscess bacterial, Diarrhoea, Grand mal convulsion, Lethargy, Meningitis
Clinical narrative: Initial report received on 9/27/06 from another manufacturer report number WAES0609USA03786. An 11 week old female pt, with a history of hip dislocation and eczema, had received an IM first dose of injection of ActHib, lot number unknown, an IM first dose injection of Pediarix, lot number unk, an IM first dose injection of Prevnar, lot number B08683A on 8/15/06. Fifteen days post vaccination , on 8/30/06, the pt had received an oral administration of Rotateq, lot number 654504/0695F. Later that evening, the pt developed fever, vomiting and diarrhea. Five days later, the pt had fever, vomiting and lethargy. She was subsequently hospitalized with a diagnosis of group B streptococci meningitis. She was hospitalized for greater than 14 days. At the time of this report, the outcome was unknown.
Age: 0.17
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: Initial report received on 9/27/06 from another manufacturer report number WAES0609USA03786. An 11 week old female pt, with a history of hip dislocation and eczema, had received an IM first dose of injection of ActHib, lot number unknown, an IM first dose injection of Pediarix, lot number unk, an IM first dose injection of Prevnar, lot number B08683A on 8/15/06. Fifteen days post vaccination , on 8/30/06, the pt had received an oral administration of Rotateq, lot number 654504/0695F. Later that evening, the pt developed fever, vomiting and diarrhea. Five days later, the pt had fever, vomiting and lethargy. She was subsequently hospitalized with a diagnosis of group B streptococci meningitis. She was hospitalized for greater than 14 days. At the time of this report, the outcome was unknown.
Age: 0.17
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC
Symptoms: Bacterial infection, Diarrhoea, Lethargy, Meningitis, Pyrexia
Clinical narrative: Initial report received on 9/27/06 from another manufacturer report number WAES0609USA03786. An 11 week old female pt, with a history of hip dislocation and eczema, had received an IM first dose of injection of ActHib, lot number unknown, an IM first dose injection of Pediarix, lot number unk, an IM first dose injection of Prevnar, lot number B08683A on 8/15/06. Fifteen days post vaccination , on 8/30/06, the pt had received an oral administration of Rotateq, lot number 654504/0695F. Later that evening, the pt developed fever, vomiting and diarrhea. Five days later, the pt had fever, vomiting and lethargy. She was subsequently hospitalized with a diagnosis of group B streptococci meningitis. She was hospitalized for greater than 14 days. At the time of this report, the outcome was unknown.