chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Full blood count, Joint swelling, Laboratory test, Oedema peripheral, Red blood cell sedimentation rate
Clinical narrative: Serum Sickness developed one week after given Hepatitis A vaccine.  She initially had severe hives, followed by extreme swelling of extremities, blue extremities.  Urgent care was sought and patient was treated with steroids and antihistamines.  Patient was unable to walk for two days due to pain and swelling of joints. She began sitting 2 days after the event and walking three days after the event. Patient had significantly decreased appetite for 2 days.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Serum sickness, Urticaria
Clinical narrative: Serum Sickness developed one week after given Hepatitis A vaccine.  She initially had severe hives, followed by extreme swelling of extremities, blue extremities.  Urgent care was sought and patient was treated with steroids and antihistamines.  Patient was unable to walk for two days due to pain and swelling of joints. She began sitting 2 days after the event and walking three days after the event. Patient had significantly decreased appetite for 2 days.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of the use of expired vaccine in a 25-year-old male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 22 February 2008 at 10:30 the subject received 3rd dose of Engerix B at 1.0 ml in the left arm.  On 22 February 2008, after vaccination with Engerix B, it was noted that the vaccine administered to the subject had expired.  The healthcare professional considered the event was clinically significant (or requiring intervention).  No adverse events were reported.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Medication error, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccination error in a 51-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Previous and/or concurrent vaccination included Twinrix; GlaxoSmithKline; unknown; unknown given in January 2008.  On 15 February 2008, the subject received unspecified dose of Engerix B (20 mcg, intramuscular, left arm).  On 15 February 2008, the subject experienced vaccination error and wrong vaccine administered.  The nurse reported that the subject started the Twinrix series one month prior to this report.  The nurse reported, "on 15 February 2008, they made a mistake and gave Engerix-B instead of Twinrix, for the second dose."  No clinical events were reported.  The healthcare professional considered the events were clinically significant (or requiring intervention).
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Pyrexia, Renal function test normal
Clinical narrative: Fever 2 days after vaccine with diffuse arthralgias. 3/7/08-records received for DOS 2/24-2/26/08-Seen in ED with tonic-clonic seizure, fever to 102.4 the night before. Eyes deviated left and upwards, right hand twitching, right arm and right leg. Unresponsive. In ED right side flaccid and left side still twitching.  3/24/08-DC Summary received-DOS 2/24-2/2708-DC DX: Complex febrile seizure.
Age: 41.0
Sex: M
Vaccine: FLU3, HEP, HEPA, MMR, TDAP
Symptoms: Generalised erythema, Pruritus generalised
Clinical narrative: Client reports itching in hands, feet, elbows and other joints, intermittent, reports very intense.  9-10 scale of 1-10 with 1 being tolerable, 10 being intense.  States began on 2/26/08.  Only took 2 typhoid capsules, stopped when complaints began.  Also reports itching and redness of ears.  Denies swelling or fever.  Instructed to contact physician.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA, PNC
Symptoms: Erythema, Induration
Clinical narrative: ER visit 2-22-08.  Complained of redden, firm area, left thigh onset 2-22-08 AM.  No fever.  Area left thigh 3x8cm per ER doctor.  Treatment: warm compresses septra susp.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Gardasil was given on righ upper arm on 2/26/08.  Went to ER.  Started to have swelling, redness, pain on injection site.  Don't have date client went to ER.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Inappropriate schedule of drug administration
Clinical narrative: Received vaccine #3 on 2/20/08.  Tolerated well.  Friday PM, had diarrhea for 24 hours.  No fever.  Seen at clinic.  Reassured patient.  She is a teacher and could have easily picked up a viral illness.  Doing well now.
Age: 9.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Left outer arm red and warm slight induration 2" x 1"2"
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Swelling
Clinical narrative: Reaction to Dtap, swelling.  Apply warm compress.
Age: 10.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Body temperature increased
Clinical narrative: Patient presented to clinic on 2/22/08 with history of fever 24-48 hours.  Lesions x 1 diameter.  Upon exam patient had 98 vesicles scattered over body but primarily on the torso.  Aveeno baths, calamine lotion, Tylenol and isolation was recommended.  2/27/08 P/C to mom "doing better."
Age: 4.0
Sex: U
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: RIGHT LEG LOCAL REACTION - 2 INCHES AROUND; LEFT LEG LOCAL REACTION - 1 INCH AROUND; RED AND HOT; NO FEVER
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis
Clinical narrative: Localized cellulitis within 24 hours
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Vaccines admin 2/19/08. Patient returned to office 2/21/08 at 0830 with swelling, redness, and tenderness in right thigh. No streaking noted. Dr prescribed Cefzil for potential cellulitis. Patient's mother took patient to ER later that night 2/2 increasing redness and tightness in thigh. ER records state patient prescribed Benadryl TID and warm compresses. Patient afebrile.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cough, Nausea, Pain
Clinical narrative: Fever 101-102, body aches, dry cough, nausea.  Started 1 day after Pneumovax and lasted 5-6 days.
Age: 2.0
Sex: M
Vaccine: DTAPH, HEP, HEPA
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Right thigh swollen, red. Patient fussy, slight fever, 99deg; Family Physician prescribed antibiotics. Red and swollen from hip to above knee (inner thigh to hip area); dx: cellulitis
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction, Pain, Pruritus, Urticaria
Clinical narrative: Severe local reaction about 3" Per mom "baseball size welt," was painful 2/6/08 and on 2/8/08 "itchy"
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Erythema, Rash
Clinical narrative: Red spot on back on right side in middle of back.  Feels like a sunburn.  On bra line.  Raised a little, no bumps, no blisters.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Pyrexia, Rash, Varicella
Clinical narrative: Chicken pox disease - onset of fever 2/25/08 with fever bumps spreading onto tummy, back and legs
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, IPV
Symptoms: Erythema
Clinical narrative: 3" redness (right arm) onset 2/23/08.  Resolved 2/26/08.  Minimal redness (left arm) 2/23/08.  Resolved 2/26/08.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Febrile convulsion, Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Large 17cm x 20cm area of redness and induration of left thigh.  Patient developed fever and had 1st febrile seizure.  02/29/2008 MR received for DOS 2/21-22/2008 with DX: Febrile Seizure and vaccination reaction. Child presented to ER after an episode of body shaking and back arching lasting ~ 1 minute. Temp was 103'F. Pt vomited prior to arrival in ED. Redness, swelling and warmth noted on L thigh. Txd with Tylenol, Motrin, and Rocephin and d/cd next day.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Left deltoid pain and in approximately 2 days pain to elbow approximately 2 days pain down to wrist.  On approximately 1/15/08 developed discomfort in antecubital space.  He still has discomfort in left deltoid and left antecubital space lasting approximately 2 minutes at a time several times per day.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Skin burning sensation
Clinical narrative: Burning on skin around right eye, across bridge of nose and part of left eye. Iced area and symptoms stopped after 45 minutes.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed a rash both hands 1 week after Zostavax injection, he tried hydrocortisone that made the rash worse. I saw him today and the rash is almost gone.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Blood pressure, Dizziness, Head injury, Headache, Loss of consciousness
Clinical narrative: Hep A given without inudent, within 5-10 minutes after injection.  On walking out of office, became dizzy and passed out, struck head on wall, taken to room and layed down.  While recovering after several minutes, pale, regular rhythm, BP 88/54.  Color improved after 15 minutes.  Complained of headache, blood pressure up 92/60.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Pallor
Clinical narrative: Hep A given without inudent, within 5-10 minutes after injection.  On walking out of office, became dizzy and passed out, struck head on wall, taken to room and layed down.  While recovering after several minutes, pale, regular rhythm, BP 88/54.  Color improved after 15 minutes.  Complained of headache, blood pressure up 92/60.
Age: 13.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Dizziness, Pallor
Clinical narrative: Given Varivax and given Hep A with incident. Sister passed out. Then patient became dizzy and pale. Laid down and color and dizziness improved after 5-10 min. Pulse reg. No LOC.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Injection site swelling, Tenderness
Clinical narrative: Swelling on the injection site, very tender and red size 4x3 1/2 inch rt arm.
Age: 9.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pain, edema, redness at injection site running down patient's arm.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: On 6/12/07, the patient received a tetanus shot. It is not indicated in the chart where the patient received the vaccine and the lot #, expiration date, and manufacturer of the product are unknown. The patient came to the ER on 6/14/07 with an erythematous, warm, raised rash on the left arm around the injection site (size was 4 cm). The patient was observed and discharged home.
Age: 0.34
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Ear infection, Pyrexia, Screaming
Clinical narrative: After his 4 month shots, he got a fever and screamed all night and then after a couple of days went to the doctor for a double ear infection.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Ear infection, Ear, nose and throat examination, Pyrexia, Screaming
Clinical narrative: After his 6 month shots, he got a fever and screamed a high pitched scream all night and when on vacation a few days later he was diagnosed with a double ear infection.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Aphasia, Autism spectrum disorder, Computerised tomogram, Ear infection, Mixed receptive-expressive language disorder
Clinical narrative: He recieved these shots and again got a fever, high pitched scream and a few days later a double ear infection. Then he began to lose his speech, eye contact, and receptive language. He was later diagnosed with PDD-NOS, on the autism spectrum.  3/25/08 Reviewed developmental pediatrician medical records which consisted of H&P & vax records. FINAL DX: neurological disorder, developmental language disorder, PDD. Records reveal patient was in early intervention school & ST when evaluated on 4/12/2004.  Behaviors included: hyperactivity, self stimulation, repetitive movements & sounds, difficult to control.  Recommended continued early intervention, ST/OT. 4/8/08 Reviewed peds neurologist report of 2/3/2003. FINAL DX: PDD/autistic disorder. Record reveals patient experienced  developmental delays, speech loss at approx 12-20 mo, loss of social skills, poor eye contact, parallel or individual play. Patient was able to follow simple commands & cooperate w/examination.  Noted to have mild hypotonicity.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Neurological examination, Pyrexia, Screaming
Clinical narrative: He recieved these shots and again got a fever, high pitched scream and a few days later a double ear infection. Then he began to lose his speech, eye contact, and receptive language. He was later diagnosed with PDD-NOS, on the autism spectrum.  3/25/08 Reviewed developmental pediatrician medical records which consisted of H&P & vax records. FINAL DX: neurological disorder, developmental language disorder, PDD. Records reveal patient was in early intervention school & ST when evaluated on 4/12/2004.  Behaviors included: hyperactivity, self stimulation, repetitive movements & sounds, difficult to control.  Recommended continued early intervention, ST/OT. 4/8/08 Reviewed peds neurologist report of 2/3/2003. FINAL DX: PDD/autistic disorder. Record reveals patient experienced  developmental delays, speech loss at approx 12-20 mo, loss of social skills, poor eye contact, parallel or individual play. Patient was able to follow simple commands & cooperate w/examination.  Noted to have mild hypotonicity.
Age: 1.18
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Cough, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Approximately 10 minutes after vaccinations given nurse was called to waiting room where child was found to be coughing and audibly wheezing.  Child taken to exam room and Benadryl 12.5 mg given po.  Color pink and child irritable staff but appropriate with parent.  Child and mother waited 20 minutes in office and then instructed to go to the emergency room.  Child continued to have audible wheezing. Upon arrival to ER back of left arm was swollen, red and hot.  ER physician informed mother that the shot given in this arm should not be repeated.
Age: 1.18
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Oedema peripheral, Respiratory therapy, Wheezing
Clinical narrative: Approximately 10 minutes after vaccinations given nurse was called to waiting room where child was found to be coughing and audibly wheezing.  Child taken to exam room and Benadryl 12.5 mg given po.  Color pink and child irritable staff but appropriate with parent.  Child and mother waited 20 minutes in office and then instructed to go to the emergency room.  Child continued to have audible wheezing. Upon arrival to ER back of left arm was swollen, red and hot.  ER physician informed mother that the shot given in this arm should not be repeated.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Headache, Loss of consciousness, Mydriasis, Pallor, Tinnitus
Clinical narrative: 20 minutes after receiving the injection, my child told me that she couldn't see and that her ears were ringing.  She was extremely pale and her pupils were fully dialated.  She passed out and was assisted by a nurse at the doctor's office.  No further treatment was administered.  My child complained of an moderate headache that evening.  All symptoms were resolved by this morning.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Visual disturbance
Clinical narrative: 20 minutes after receiving the injection, my child told me that she couldn't see and that her ears were ringing.  She was extremely pale and her pupils were fully dialated.  She passed out and was assisted by a nurse at the doctor's office.  No further treatment was administered.  My child complained of an moderate headache that evening.  All symptoms were resolved by this morning.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Blood creatine phosphokinase normal, Cardiac enzymes normal, Chest X-ray normal, Chest pain, Electrocardiogram
Clinical narrative: Patient received vaccination 2/11/08 Left deltoid.  2/13/08 pt began to experience pain left shoulder.  Patient has had no trauma or injury to shoulder area recent or history.  2/19/08 pain became severe radiating into chest and left arm. Patient was taken to the ER. EKG showed no changes, normal chest xray, Cardiac enzymes x 1 normal and shoulder xray showed no abnormalities.  Patient discharged with Medrol dose pack, hydocodone 5/500, and cyclobenzaprine 10 mg. Pain began in left calf 2/23. Shoulder pain more severe, pain at rest and movement, and awakens from sleep. 2/25/08 left calf swelling, calf cool to touch, pedal pulses strong, foot warm and pink.  No muscular weakness noted in legs or arms. Saw APN at health care system 2/25.  Negative Duplex doppler left leg.  Solumedrol IM given, increased dosage on hydrocodone and refill for cyclobenzaprine, discharged home with no diagnosis, referral to orthopedics placed.  2/27/08  calf pain milder, shoulder pain more severe with no relief.  Back to facility in LR. Xray left shoulder and lab drawn (unsure of lab? RA, Sed rate possible, but no CBC or Lytes?) chest xray reported normal. APN did no physical assessment except pedal pulse check (no auscultation of lung fields, no recent Upper Respiratory Infection, no cough,) Discharged with diagnosis of Pleurisy, added Naproxsyn PO QID with referral to Vascular Surgery for pain in calf. Multiple requests made to assess for flu vaccination report, only comments those are "very rare". (My assessment at home revealed-Lung sounds with no friction rub, no diminished sounds, clear in all fields on expiration and inspiration, no cough. Pedal pulses 2+ dorsalis pedis and posterior tibia bilateral, foot warm and pink. ) Shrug test negative for rotator cuff tear with normal abduction.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Insomnia, Laboratory test, Musculoskeletal pain, Oedema peripheral, Pain in extremity
Clinical narrative: Patient received vaccination 2/11/08 Left deltoid.  2/13/08 pt began to experience pain left shoulder.  Patient has had no trauma or injury to shoulder area recent or history.  2/19/08 pain became severe radiating into chest and left arm. Patient was taken to the ER. EKG showed no changes, normal chest xray, Cardiac enzymes x 1 normal and shoulder xray showed no abnormalities.  Patient discharged with Medrol dose pack, hydocodone 5/500, and cyclobenzaprine 10 mg. Pain began in left calf 2/23. Shoulder pain more severe, pain at rest and movement, and awakens from sleep. 2/25/08 left calf swelling, calf cool to touch, pedal pulses strong, foot warm and pink.  No muscular weakness noted in legs or arms. Saw APN at health care system 2/25.  Negative Duplex doppler left leg.  Solumedrol IM given, increased dosage on hydrocodone and refill for cyclobenzaprine, discharged home with no diagnosis, referral to orthopedics placed.  2/27/08  calf pain milder, shoulder pain more severe with no relief.  Back to facility in LR. Xray left shoulder and lab drawn (unsure of lab? RA, Sed rate possible, but no CBC or Lytes?) chest xray reported normal. APN did no physical assessment except pedal pulse check (no auscultation of lung fields, no recent Upper Respiratory Infection, no cough,) Discharged with diagnosis of Pleurisy, added Naproxsyn PO QID with referral to Vascular Surgery for pain in calf. Multiple requests made to assess for flu vaccination report, only comments those are "very rare". (My assessment at home revealed-Lung sounds with no friction rub, no diminished sounds, clear in all fields on expiration and inspiration, no cough. Pedal pulses 2+ dorsalis pedis and posterior tibia bilateral, foot warm and pink. ) Shrug test negative for rotator cuff tear with normal abduction.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Physical examination normal, Pleurisy, Ultrasound Doppler normal, X-ray limb normal
Clinical narrative: Patient received vaccination 2/11/08 Left deltoid.  2/13/08 pt began to experience pain left shoulder.  Patient has had no trauma or injury to shoulder area recent or history.  2/19/08 pain became severe radiating into chest and left arm. Patient was taken to the ER. EKG showed no changes, normal chest xray, Cardiac enzymes x 1 normal and shoulder xray showed no abnormalities.  Patient discharged with Medrol dose pack, hydocodone 5/500, and cyclobenzaprine 10 mg. Pain began in left calf 2/23. Shoulder pain more severe, pain at rest and movement, and awakens from sleep. 2/25/08 left calf swelling, calf cool to touch, pedal pulses strong, foot warm and pink.  No muscular weakness noted in legs or arms. Saw APN at health care system 2/25.  Negative Duplex doppler left leg.  Solumedrol IM given, increased dosage on hydrocodone and refill for cyclobenzaprine, discharged home with no diagnosis, referral to orthopedics placed.  2/27/08  calf pain milder, shoulder pain more severe with no relief.  Back to facility in LR. Xray left shoulder and lab drawn (unsure of lab? RA, Sed rate possible, but no CBC or Lytes?) chest xray reported normal. APN did no physical assessment except pedal pulse check (no auscultation of lung fields, no recent Upper Respiratory Infection, no cough,) Discharged with diagnosis of Pleurisy, added Naproxsyn PO QID with referral to Vascular Surgery for pain in calf. Multiple requests made to assess for flu vaccination report, only comments those are "very rare". (My assessment at home revealed-Lung sounds with no friction rub, no diminished sounds, clear in all fields on expiration and inspiration, no cough. Pedal pulses 2+ dorsalis pedis and posterior tibia bilateral, foot warm and pink. ) Shrug test negative for rotator cuff tear with normal abduction.
Age: 30.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash generalised, Rash pruritic, Secondary transmission
Clinical narrative: This alleged reaction may have been reported previously (10/07?) on a VAERS Report by the administering Nurse.  Mother states that shortly after her child received the vaccines in the Immunization Clinic, she breastfed her and within 5 minutes the mother broke out in an itchy rash.  The mother returned to the clinic the following day (10-25-07) and a generalized rash on the mother was observed by the nurse and Dr.  She was referred to the ER and hospitalized (?Where).  Mother returned to the clinic yesterday (2-27-08) and states she is now bringing the child to clinic and her child, nor she has had any further reactions to any vaccines.  She is interested in how she can receive financial compensation and was referred to the Nat'l Vaccine Injury Compensation Program.  3/14/08 Reviewed ER medical records which reveal patient seen 10/25/07 for development of hives, itching & SOB after breastfeeding infant following vaccination.  Tx w/steroids & Benadryl.  Improved & d/c to home on continued meds.   FINAL DX: allergic reaction. Had worsening s/s & returned to ER on 10/26/07 w/generalized red raised itchy rash.  Was taking meds as rx & not breastfeeding as instructed on 10/25.  Tx w/stronger steroids & benadryl around the clock.  Improved & d/c to home.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Autopsy
Clinical narrative: Sudden infant death syndrome occurred on 3-2-05. Immunizations were given on 2-28-05.    2/29/08 Autopsy report states COD & manner of death as Undetermined.  Reviewed autopsy report which states patient had been fed & placed in crib on back.  Found approx 12 hrs later, on stomach at other end of crib, face to the side.  Unable to resuscitate w/CPR at scene & in ER.  Fire department did carbon monoxide testing of residence which was neg.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Irritability
Clinical narrative: Mom noted small red dot on lt upper thigh on 2/24/08 was also fussy, site progressivly enlarge with redness and slight swelling. Child conntinue with fussy, but no fevers noted and site without warmth to touch. To office on 2/26/08 with 1x3/4 inch red bumpy area to lt upper thigh, although not warm to touch.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Eye pain, Headache, Hypoaesthesia, Nausea, Vision blurred
Clinical narrative: Patient received vaccine @ 0745 on 2/27/08.  Approximately 1030, she developed pain behind the eyes with blurred vision, severe head ache, numbness in the hands, and nausea which worsened through the day and then began to alleviate at 0500 this morning.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Asthenia, Confusional state, Disturbance in attention, Dizziness
Clinical narrative: Patient vaccinated 2/26/2008-that night at 11:30 pm she got dizzy, weak, sweaty she just went to bed.  The next morning she went to work, could not concentrate had trouble entering data and broke out in hives.  Today she has a raised red area at injection site and redness to the elbow the confusion has almost resolved she complains of fatigue and muscle aches she did not work today. No Benadryl was taken due to sedation.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hyperhidrosis, Injection site erythema, Myalgia, Urticaria
Clinical narrative: Patient vaccinated 2/26/2008-that night at 11:30 pm she got dizzy, weak, sweaty she just went to bed.  The next morning she went to work, could not concentrate had trouble entering data and broke out in hives.  Today she has a raised red area at injection site and redness to the elbow the confusion has almost resolved she complains of fatigue and muscle aches she did not work today. No Benadryl was taken due to sedation.
Age: 33.0
Sex: F
Vaccine: DTP
Symptoms: Ageusia, Anosmia
Clinical narrative: LOSS OF TASTE AND SMELL WITH A TETANUS/PERTUSSIS VACCINE GIVEN ON 12/22/06--THE LOSS PERSISTS AND MAY WELL BE PERMANENT (THERE HAS BEEN A PARTIAL, BUT NOT A FULL RECOVERY)
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: Death 2/6/08.  3/18/08 Reviewed autopsy report which states COD as SIDS. Autopsy states patient found face down atop baby blankets on floor.  Autopsy findings insufficient to explain death.  PMH: viral URI 1/2008.  No other recent illlness or sick contacts.  Birth history unremarkable.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Laceration, Lip repair, Mouth injury, Syncope, Tooth injury
Clinical narrative: CHILD FAINTED AND HIT HER TOOTH AND MOUTH AND GOT A LACERATION ON LOWER LIP.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: Erythema, Hypersensitivity, Hypotonia
Clinical narrative: Gave vaccination without complication in L thigh. Mother called approximately 45 minutes later to say that her daughter was in the backseat of the car and that her cheeks were very red and she was slumped over. She said she had "to speak very loudly for her to respond". She was told to stop and call 911 if daughter was unresponsive or otherwise drive to ER. She was seen at ER and given the diagnosis of "allergic reaction to vaccine". She was given Benadryl; redness resolved and responded well.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Listless, Musculoskeletal stiffness, Pyrexia, Tinnitus
Clinical narrative: Patient states she experienced headache, ringing of ears, stiff neck, listlessness and fever the day after receiving vaccines.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives in face/neck area. Not life threatening, but more than annoying. First noticed about 8 hours after immuniztion on 02/06/08. Lasted until midday 02-10-08. Used home remedies to relieve discomfort. Would have contacted physician if hives had continued past weekend.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Erythema multiforme
Clinical narrative: This case was reported by a physician, via sales representative and described the occurrence of erythema multiforme in a 7-week-old female subject who was vaccinated with Pediarix (GlaxoSmithKline). Previous and/or concurrent vaccination included Rotateq (Merck); oral given the same day in 2008. In 2008, the subject received 1st dose of Pediarix (.5 ml, unknown). In 2008, within 24 hours after vaccination with Pediarix, the subject experienced erythema multiforme. This case was assessed as medically serious by GSK. In 2008, the erythema multiforme was resolved. The physician considered the event was probably related to vaccination with Pediarix.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Rash maculo-papular
Clinical narrative: Macular papular rash all over the body including the face, not the palm or foot.  Not associated with tongue or lips.  No respiratory problems.  Normal PO intake.
Age: 5.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Hep A Vaccine #1, Varicella #2, and Influenza vaccine administered at 9:20AM. Presented to the clinic at 1:20PM after 20" onset of generalized hives with itching. No dyspnea. Hives resolved with 12.5 MG Diphenhydramine IM. Went home with Rx for 6.25 MG PO Q 6HRS for 24 hours then Q6HRS PRN. Anticipate f/up phone call tonight and in AM.
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Erythema
Clinical narrative: Large red area in deltoid (entire deltoid) within 24 hours.  Benadryl anti inflammatory.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: 2 days after receiving flu shot, hot, red, swollen, tender, no fever or chill, loss of use of arm.  Full range of motion of shoulder.
Age: 1.2
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Ecchymosis, Erythema, Nodule
Clinical narrative: redness, ecchymosis to surrounding areas 2-3cm diameter small palp nodule <5mm. -appear tid. On Antibiotics.
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin infection, Swelling
Clinical narrative: Redness/swelling of (R) shoulder deltoid area post vaccination (subcutaneous injection) given 2/26/08. Infected skin, Keflex 200mg PO QID x 10 days.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Anxiety, Crying, Personality change, Pyrexia, Rash papular
Clinical narrative: Faint papular rash on cheeks - low grade fever to 100, significant personality change - cried + 2 hours for no reason, increased anxiety, inane questions: "What do trees have to do with life?"
Age: 41.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Body temperature increased, Vaccination failure, Varicella
Clinical narrative: Patient states he had full blown chickenpox following vaccine on 6/12/06.  He went to ER and was given prescription for Valtrex.  Temperature 101, 20-25 pox on back, face, armpits.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient received Td on 2/25/08, reported increasing pain, fever, swelling, induration left injection site 1 day after receiving vaccine.  Doctor diagnosis cellulitis.  Treated with Levaquin 500mg for 7 days.
Age: 1.05
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Hypersensitivity, Injection site reaction, Urticaria
Clinical narrative: Immediate sensitivity reaction on lower left thigh, at site of varicella vaccine (10cm x 8cm urticarial rash). In about 10 min, pt then developed hives on face, involving eyelids, cheeks with multiple urticarial spots, darkening of oral mucosa. Treated with Be3nadryl 125 mg PO and Epinephrine 0.11mg subcutaneous injection.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Injection site mass, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Pal (L) leg, shoulder and neck - said started few days after shot. No fever - orally, or at injection site, no redness as far as client can see, a little "bump" at injection site.
Age: 51.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Pt received anthrax #2 on 14 April 2007 in his left arm. With 60 sec. he had sharp pain from injection site to left wrist with tingling in his figners. This subsided in about one minute. About 2 hours his left arm felt achy. He later noticed about 3 inches of redness and swelling around the injection site. Later in the evening there was an increase in redness and swelling. The next am he had difficulty lifting his left arm and the redness was moving to the elbow. April 16 2007 pt went to his PCP due to swelling and redness below the elbow and restriction in moving his left shoulder. The swelling and redness continued to the left wrist. The redness and swelling resolved in about 3 weeks. He has continued to have intermittent tingling and achy pain radiating from above his left wrist to his left ring and pinky finger.
Age: 51.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Pt received anthrax #2 on 14 April 2007 in his left arm. With 60 sec. he had sharp pain from injection site to left wrist with tingling in his figners. This subsided in about one minute. About 2 hours his left arm felt achy. He later noticed about 3 inches of redness and swelling around the injection site. Later in the evening there was an increase in redness and swelling. The next am he had difficulty lifting his left arm and the redness was moving to the elbow. April 16 2007 pt went to his PCP due to swelling and redness below the elbow and restriction in moving his left shoulder. The swelling and redness continued to the left wrist. The redness and swelling resolved in about 3 weeks. He has continued to have intermittent tingling and achy pain radiating from above his left wrist to his left ring and pinky finger.
Age: 17.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Acute lymphocytic leukaemia, Blood uric acid increased, CSF glucose normal, CSF protein normal, CSF test normal
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with heavy menstruation periods, drug hypersensitivity to ibuprofen, and penicillin allergy who on 18-SEP-2007 was vaccinated IM with a first dose of 0.5 mL of Gardasil (lot # 658219/0680U). On 06-DEC-2007 she received her second dose of Gardasil (lot# 659437/1266U). Concomitant therapy included FLUZONE and SEASONIQUE. The physician reported that the patient was diagnosed with Acute Lymphoblastic Leukemia (ALL) after blood work on 12-FEB-2008 which showed "blasts in her smear". Her symptoms began two months after she received her second dose of Gardasil. On 05-FEB-2008 symptoms were described as feeling tired for a few days. It was reported that the patient sought medical attention on 08-FEB-2008. The patient was hospitalized for worsening symptoms. On 19-FEB-2008 she had started unspecified antineoplastic chemotherapy. The reporter considered Acute Lymphoblastic Leukemia (ALL) to be disabling and life threatening. The reporter considered ALL to be other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Fatigue, Full blood count abnormal, Neutrophil count decreased, Platelet count decreased, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with heavy menstruation periods, drug hypersensitivity to ibuprofen, and penicillin allergy who on 18-SEP-2007 was vaccinated IM with a first dose of 0.5 mL of Gardasil (lot # 658219/0680U). On 06-DEC-2007 she received her second dose of Gardasil (lot# 659437/1266U). Concomitant therapy included FLUZONE and SEASONIQUE. The physician reported that the patient was diagnosed with Acute Lymphoblastic Leukemia (ALL) after blood work on 12-FEB-2008 which showed "blasts in her smear". Her symptoms began two months after she received her second dose of Gardasil. On 05-FEB-2008 symptoms were described as feeling tired for a few days. It was reported that the patient sought medical attention on 08-FEB-2008. The patient was hospitalized for worsening symptoms. On 19-FEB-2008 she had started unspecified antineoplastic chemotherapy. The reporter considered Acute Lymphoblastic Leukemia (ALL) to be disabling and life threatening. The reporter considered ALL to be other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Transfusion, White blood cell count decreased
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with heavy menstruation periods, drug hypersensitivity to ibuprofen, and penicillin allergy who on 18-SEP-2007 was vaccinated IM with a first dose of 0.5 mL of Gardasil (lot # 658219/0680U). On 06-DEC-2007 she received her second dose of Gardasil (lot# 659437/1266U). Concomitant therapy included FLUZONE and SEASONIQUE. The physician reported that the patient was diagnosed with Acute Lymphoblastic Leukemia (ALL) after blood work on 12-FEB-2008 which showed "blasts in her smear". Her symptoms began two months after she received her second dose of Gardasil. On 05-FEB-2008 symptoms were described as feeling tired for a few days. It was reported that the patient sought medical attention on 08-FEB-2008. The patient was hospitalized for worsening symptoms. On 19-FEB-2008 she had started unspecified antineoplastic chemotherapy. The reporter considered Acute Lymphoblastic Leukemia (ALL) to be disabling and life threatening. The reporter considered ALL to be other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Acute lymphocytic leukaemia, Blast cell count increased, Fatigue, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with heavy menstruation periods, drug hypersensitivity to ibuprofen, and penicillin allergy who on 18-SEP-2007 was vaccinated IM with a first dose of 0.5 mL of Gardasil (lot # 658219/0680U). On 06-DEC-2007 she received her second dose of Gardasil (lot# 659437/1266U). Concomitant therapy included FLUZONE and SEASONIQUE. The physician reported that the patient was diagnosed with Acute Lymphoblastic Leukemia (ALL) after blood work on 12-FEB-2008 which showed "blasts in her smear". Her symptoms began two months after she received her second dose of Gardasil. On 05-FEB-2008 symptoms were described as feeling tired for a few days. It was reported that the patient sought medical attention on 08-FEB-2008. The patient was hospitalized for worsening symptoms. On 19-FEB-2008 she had started unspecified antineoplastic chemotherapy. The reporter considered Acute Lymphoblastic Leukemia (ALL) to be disabling and life threatening. The reporter considered ALL to be other important medical event. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: HIVES ALL OVER BODY, VERY ITCHY,SORENESS.USED BENADRYL WITH MILD RELIEF
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: HIVES ALL OVER BODY, VERY ITCHY,SORENESS.USED BENADRYL WITH MILD RELIEF
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nausea, Ultrasound scan, Vomiting
Clinical narrative: Initial and follow-up information has been received from a physician for the Pregnancy Registry for GARDASIL concerning a 25 year old female with maternal obesity (270 pounds) and a history of atypical squamous cells of undetermined significance (ASCUS) pap smear, no previous pregnancies, and anorexia at age 14 who on 26-FEB-2007 was vaccinated with her first dose of GARDASIL (Lot # 654540/1162F). On 17-APR-2007, the patient was vaccinated with second dose of hepatitis B vaccine, recomb (RECOMBIVAX HB). Concomitant therapy during the pregnancy included promethazine hydrochloride (PHENERGAN). The physician reported that the patient was in her early pregnancy and is going to see an OB/GYN physician, but has not done so yet. Her last-menstrual period was 01-MAR-2007 with estimated conception in mid March, but the patient's period was light so they are not sure until they get an ultrasound. Estimated date of delivery 06-DEC-2007. Follow-up information was received from the physician via telephone. The physician reported the OB/GYN physician's name. The patient had her first appointment on 26-APR-2007 and was scheduled for ultrasound on 22-MAY-2007. Follow-up information was received from the physician. On 01-AUG-2007 the patient had an ultrasound which was normal. She declined a maternal serum alpha-fetoprotein (MSAFP) test. The patient was prescribed promethazine hydrochloride (PHENERGAN) for nausea and vomiting. During labor/delivery, the baby had "non-reassuring" fetal heart tones. On 17-DEc-2007, at 40 weeks from LMP, the mother delivered a normal female baby via C-section. There were no congenital anomalies. Birth weight was 8 pounds 4 ounce, length 20 inches, apgar score was 8/10. Maternal obesity of 270 pounds was reported informed the outcome of the pregnancy. Upon internal review, the non-reassuring fetal heart tones was considered to be an Other Important Medial Event. No additional information is expected.
Sex: U
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: SERIOUSNESS: OTHER - MEDICALLY SIGNIFICANT.  Initial report received from a health care professional on 26/Feb/2008.  A child experienced a seizure after receiving Daptacel.  The patient's recovery status was unknown at the time of the report.  No further information was provided.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Convulsion, Lumbar puncture
Clinical narrative: Pt had a seizure Friday 2-22-08 Temp taken by EMS 100.3 rectal. Pt transported to ER and admitted. LP and CT scan done results not available at this time. Follow up by Dr on 2-25-08 with normal exam. Suggested neurology follow-up, EEG if appropriate.  3/19/08 Reviewed hospital medical records of 2/22-2/23/2008. FINAL DX: Complex febrile consulsions, viral syndrome, right serous otitis media. Records reveal patient experienced fever.  Found to be jerking, posturing, foaming at mouth, unresponsive & w/eyes deviated to the right during nap, lasting approx 8-10 min.  Exam in ER revealed lethargy, eyes glazed over, irritable when awake.  Pulse ox in ER was 90% & temp 100.3.  Older sibling w/URI.  Peds neuro consult done.  Improved w/no further seizure activity noted.  D/C to home on oral antibiotics & to f/u w/peds neuro for EEG.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient experienced outbreak of Shingles/Herpes Zoster 6 weeks after receiving Zostavax in V1 distribution
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Gardasil dose #3 given twice within seven days. Student asked if had been to MD for vaccine stated no. Parent had signed permit for third dose of Gardasil.After admistration of dose, student stated "oh I had some shots last week".On checking with Community Clinic it was learned that the student did receive the third dose seven days pior to the dose given on 2/28/08.CDC Hotline called for direction. No adverse reaction noted.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mother reported swelling, itching, and redness. Mother reports he was taken to Pediatrician and given medication. Patient still had some swelling on 2/28/2008.
Age: 31.0
Sex: F
Vaccine: ANTH, HEP, TDAP
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pt received Tdap, Hep B and anthrax on 20Feb08 and found out that she is pregnant on 21 Feb08. Pt answered question on screening form regarding pregnancy as "no".
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dyspnoea, Local swelling, No reaction on previous exposure to drug
Clinical narrative: Delayed reporting by Parent-  Parent reported 4 hrs after vaccine administration, child experienced severely swollen neck and difficulty breathing. Child was treated in the local emergency room and given 3 days of steroids and benadryl. One PMD follow up appt.  Parent was told it was probably a reaction to Pertussis although she had never had any reactions with previous doses of DTP.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Client was given DTAP instead of TDAP
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Axillary mass
Clinical narrative: Small lump under left arm that is approx. the size of a quarter.  No itching or bruising at the site.  Member was firing M4, M-9, & MCS 870 Modular Combat Shotgun from 0715 to 2359 with both arms on the 27th of Feb 2008.  No other problems with vaccination site at this time.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: After recieving tetanus shot site became very red/ swollen, hot to touch, and very tender to touch.Also developed red streaks. Saw MD and put on antibiotics.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Ultrasound scan normal
Clinical narrative: After recieving tetanus shot site became very red/ swollen, hot to touch, and very tender to touch.Also developed red streaks. Saw MD and put on antibiotics.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Patient woke up on 2-29-08 with Baseball size red raised area on right arm where injection was given(per patients mom).  Also complains of headache and nausea.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5
Symptoms: Abdominal pain upper, Cough, Dehydration, Diarrhoea, Pyrexia
Clinical narrative: Adverse events occurred both during 4 month administration and 6 month administration. Patient experienced severe vomiting and diarrhea during 4 month administration and was hospitalized for 2 days for dehydration.  I was told by the physician that it was not the vaccine, however patient experienced the exact same symptoms after ther 6 month administration.  She has experienced severe vomiting, diarrhea, fever, stomach pain, coughing, and congestion.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5
Symptoms: Respiratory tract congestion, Vaccine positive rechallenge, Vomiting
Clinical narrative: Adverse events occurred both during 4 month administration and 6 month administration. Patient experienced severe vomiting and diarrhea during 4 month administration and was hospitalized for 2 days for dehydration.  I was told by the physician that it was not the vaccine, however patient experienced the exact same symptoms after ther 6 month administration.  She has experienced severe vomiting, diarrhea, fever, stomach pain, coughing, and congestion.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Employee was given varivax vaccine on 2/19/08. She states that 2 days ago she developed a "mosquito bite" like area at site of injection. States the site is itchy and tender but has decreased in size since she first noticed it. Covered with bandaid and told to take tylenol or advil prn.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: erythema multiforme minor started  4  days post mmr vzv dpt