chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Muscle spasms, Myalgia, Rash, Sleep disorder
Clinical narrative: Fatigue-loss memory-skin rashes, muscle pain-headache-loss vision-high pressure-cramps on arms-sleep disturbances
Age: 25.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Body temperature increased, Injection site bruising, Injection site swelling
Clinical narrative: Bruising and swelling in affected area. With warm temperature. (Left arm - swollen from shoulder to mid forearm).
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Injection site pain, Syncope
Clinical narrative: Area where shot was given (sore). Very dizzy for 2.5 to 3 week (fainted 1st). Reported adverse symptoms to Employee Health in March 2007 when contacted to receive #3 Hep B injection.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Injection site swelling
Clinical narrative: Temp 102 through night. Given Tylenol every 4 hours, decreased by 3:30pm. Left leg swelling with decrease in swelling by 3:30pm. Crying for 8 hours-difficult to console. Ok with comfort by 10am, ok and happy by 3:30pm 3/9/07.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache, fatigue, muscle aches
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Dysaesthesia, Hypoaesthesia, Neuropathy
Clinical narrative: Tdap after injection patient woke up with neuropathy in Left shoulder and neck-has persisted for 2 weeks with dysesthesia and numbness of Left traezius muscle area.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dermatitis, Full blood count, Metabolic function test, Monocyte count increased, Rash
Clinical narrative: 3/21/07 Afebrile, Rash on face: looks like rhino derm more than shingles". Treated 1% HC cream and f/up next wk.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Red blood cell sedimentation rate normal, White blood cell count
Clinical narrative: 3/21/07 Afebrile, Rash on face: looks like rhino derm more than shingles". Treated 1% HC cream and f/up next wk.
Age: 0.51
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: 1st seizure 7 days after vaccines.
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles in right leg S2 distribution.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Irritability, Pyrexia
Clinical narrative: Pt developed "2/12" area of redness around injection site, was cranky, had fever. Now 3 days later area improving. Given Tylenol.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR
Symptoms: Rash macular
Clinical narrative: Shots on 03/12/07. On Tues 03/13/07 there was a red hot spot about the size tennis ball on her left thigh. On Wed 03/14/07 it grew to the size of just bigger than a soft ball. Given med to see if it will help.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Pt, am 11 year old female, received DTaP on 03/14/07, instead of Tdap. Tdap was ordered by MD. No adverse events.
Age: 37.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Large red, hard bump at area os inoculation. (Pain associated with bump). Large bump still present 7 days later (appears bruised).
Age: 5.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: Mumps
Clinical narrative: Mumps
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Back pain, Dizziness, Headache, Heart rate increased
Clinical narrative: I received the vaccine on Friday the 23rd.  Since, I have had pain in my arm.  But I have also had a headache that comes back after I take Tylenol, pain in my upper back and neck, nausea, stomach ache, some dizziness, and faster than my normal heart beat.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Mitral valve prolapse, Nausea, Neck pain, Pain in extremity, Tachycardia
Clinical narrative: I received the vaccine on Friday the 23rd.  Since, I have had pain in my arm.  But I have also had a headache that comes back after I take Tylenol, pain in my upper back and neck, nausea, stomach ache, some dizziness, and faster than my normal heart beat.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, PNC
Symptoms: Anorexia, Body temperature increased, Crying, Full blood count, Rash
Clinical narrative: TEMP. 0VER FOUR DAYS AS HIGH AS 103 TREATED WITH TYLENOL AND MOTRIN.HAD CRYING FOR EIGHT TO TEN HOURS UNABLE TO SATISFY. WOULD NOT TAKE LIQUIDS NOR EAT.DEVELOPED RASH PRIOR TO TEMP.RASH REMAINED AFTER TEMP WAS NORMAL.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Idiopathic thrombocytopenic purpura, Mouth haemorrhage, Mouth ulceration, Purpura, Rectal haemorrhage
Clinical narrative: ITP (PLATELET COUNT 8000 ON ADMISSION), MULTIPLE ORAL ULCERATIONS/BLEEDING, PUPURIC SPOTS ON ARMS AND LEGS, RECTAL BLEEDING. 7/26/07-records received.for DOS 03/24-04/04/07-DC DX: Idiopathic thrombocytopenia. Hemolytic anemia. Admitted with sore throat and bleeding for a day. Known to have extensive oropharyngeal petechiae and extensive bleeding in extremities.  Treated with IV gamma globulin and changed to steroids. Developed hemolytic anemia. Week prior to hospitalization, upper respiratory symptoms, self administered Levaquin. Noticed progressive hemorrhagic blisters throughout mouth. Ulcers started day she started taking Levaquin.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Diarrhoea haemorrhagic, Intussusception, Ultrasound abdomen, Vomiting
Clinical narrative: 3/18/07 went to Hospital ER for vomiting and bloody diarrhea. Diagnosed with intussusception. Treated with reduction twice. Hospitalized 3/18-3/20/07. 04/02/07-ER and Diagnostic records received from facility. US:Instussusception identified in left upper quadrant of abdomen. Reduction with therapeutic enema. Recurrance seen on US in small ileocolic intussusception at level of cecum. Second therapeutic enema.  Presented with abdominal pain positive bloody stools, nonbilious emesis. Labs: WNL.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Oedema peripheral
Clinical narrative: R arm local swelling                                                                                          Apply Cold compress Prn Return if symptoms worsen
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Herpes zoster, Varicella
Clinical narrative: CHILD PREVIOUSLY VACCINATED AGAINST VZV WAS DIAGNOSED WITH HERPES ZOSTER ON 10/11/06.  NO LABORATORY TESTING WAS PERFORMED AND CHILD'S HISTORY OF VARICELLA DISEASE WAS UNKNOWN.  CHILD WAS SEEN BY A PHYSICIAN ON 10/12/06 AND TREATED WITH ACYCLOVIR.  THE RASH RESOLVED WITHOUT FURTHER COMPLICATION.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Condition aggravated, Convulsion, Dyskinesia, Pyrexia
Clinical narrative: Patient received regular 2 mo. immunizations on 3/19/2007. Mother reported a hx of seizures on vaccine administration questionaire form. Mother reported no illness on the day of vaccination and that child had received Hep. B vaccine at birth with no complications. Child received vaccine between 9am and 11am. Mother reports that approximately 3 hours post immunization, child developed a fever of 102 degrees and did have approximately 6-8 episodes of seizure activity with jerking motions in the infants body. Mom reports ambulance called and infant transported to Hospital and was admitted there x 3 days. Child stable at this time and home with Mom. Child's pediatrician, per Mom, states no further immunizations for child until further notice.  03/28/2007 MR received for a 3 day hospitalization for fever and seizures on the evening of her 2 month vax.  Child felt hot to touch, and had a decreased appetite.  Infant had 6 seizures prior to ER visit.  ER temp was 101.7'F rectally.  PE:  WNL except eyelashes coated with yello-green discharge. Treated with IVF and antibiotics. One brief seizure during hospitalization. Discharge DX:  1) Sepsis ruled out. 2) Seizure disorder. 3)  Dacryostenosis.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness noted at site of injection - size of "grapefruit"  No tenderness, no itching.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Haematochezia, Irritability, Occult blood negative
Clinical narrative: Pt had significant abdominal pain/fussiness.  MOC reported blood in stool - went to ED where stool heme negative and AXR not c/w intussusception.
Age: 0.33
Sex: M
Vaccine: HEP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Vaccine positive rechallenge, Vomiting projectile
Clinical narrative: Pt had episode of forcefull vomiting,decreased PO and diarhea lasting aruond one week following first admin of Rotateq on 1/25/07. When Rotateq was given again on 3/19/07 pt also had vomiting and diarhea but this time it only lasted 3 days. Both times smtx started w/i 24 hrs of vaccine.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Left arm swollen and red (10cm X 5cm)
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient experienced a Herpes Zoster rash within 36 hours of receiving a Zostavax vaccination. Rash enlarged and spread over right side of back, under arm and across chest for three more days before beginning to heal and recede. Injection was administered in right deltoid.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Induration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: PT WAS SEEN IN OUR OFFICE ON 3/26/2007 FOR REDDENED AREA AROUND THE INJECTION SITE. PT C/O SITE ITCHING AND HURTING. PER MD, UPPER OUTER RT THIGH RED, WARM SWOLLEN, TENDER, AREA OF INDURATION 2.5 INCHES BY 2.5 INCHES. SIGNIFICANT LOCALIZED HYPERSENSITIVITY REACTION TO VARICELLA VACCINE. PT TO APPLY ICE X15MIN PER HOUR PRN, TO TAKE CLARINEX RT 2.5MG PO Q24 HRS AND MOTRIN 200MG PO Q6 HRS UNTIL REACTION GONE X24 HRS. NO MORE VARICELLA VACCINE IN FUTURE.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: PT WAS SEEN IN OUR OFFICE ON 3/26/2007 FOR REDDENED AREA AROUND THE INJECTION SITE. PT C/O SITE ITCHING AND HURTING. PER MD, UPPER OUTER RT THIGH RED, WARM SWOLLEN, TENDER, AREA OF INDURATION 2.5 INCHES BY 2.5 INCHES. SIGNIFICANT LOCALIZED HYPERSENSITIVITY REACTION TO VARICELLA VACCINE. PT TO APPLY ICE X15MIN PER HOUR PRN, TO TAKE CLARINEX RT 2.5MG PO Q24 HRS AND MOTRIN 200MG PO Q6 HRS UNTIL REACTION GONE X24 HRS. NO MORE VARICELLA VACCINE IN FUTURE.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Compression fracture, Continuous positive airway pressure, Dizziness, Fatigue
Clinical narrative: 1. Extremely severe migraine attacks - Jan 2003 - Throbbing pain - lasted two days - migraines every week or two after first severe attack - got shot of Toradol to ease pain and started using Relpax to control future attacks.  2. Severe migraine attack on the following dates with duration - numerous dates and every month since Jan 2003 at least twice a month lasting 4 to 12 hours - Still suffer attacks at present. 3. Severe Obstructive Sleep Apnea - First diagnosed as mild on 23 Apr 2003 but was not satisfied becasue I was always sleepy in the daytime and sweat profusly at night - retested on 4 Aug 2005 - diagnosed with severe Obstructive Sleep Apnea and was prescribed a CPAP with a setting of 14 daily to sleep. Continues to present date.  4. Chronic fatigue and aching joints and muscles - Started in Jun 2003 and worsened over the years to present - consulted with doctors in Jun 2003 for retirement physical and with PCM after retirement on numerous dates and was prescibed Tramadol or Hydrocodone for relief. Visited neurologist in March 2007 and diagnosed with Fibromyalgia. Doctor stated I have had it for some time but other doctors do not believe in it or would not diagnose it. Under doctors care for medication for restless leg syndrome and therapy to help cope with chronic pain and suffering.  03/27/2007 Brief MR received from neurologist for visit of 03/16/2006 where pt. reports better sleep with wrist splints without paresthesias of the hands.  Restless leg syndrome improved.  Still having leg pain.  Assessment:  Carpal Tunnel Syndrome. Restless Leg Syndrome.  Lumbar radiculopathy.  04/04/2007 MR received for multiple OVs from 5/2004 to 9/2006.  Problem lists include hypertension, hyperlipidemia, migraine headaches, fatigue, leg and back pain, atypical chest pain.  Prescribed CPAP in 4/2005     DX:  Sleep Apnea.  Carpal Tunnel Syndrome.  Daytime fatigue and tiredness 2' to sleep apnea.  Morbid Obesity. DJD.  GERD. Lumbago. Peripheral Neuropathy.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Fibromyalgia, Hyperhidrosis, Intervertebral disc protrusion, Myalgia
Clinical narrative: 1. Extremely severe migraine attacks - Jan 2003 - Throbbing pain - lasted two days - migraines every week or two after first severe attack - got shot of Toradol to ease pain and started using Relpax to control future attacks.  2. Severe migraine attack on the following dates with duration - numerous dates and every month since Jan 2003 at least twice a month lasting 4 to 12 hours - Still suffer attacks at present. 3. Severe Obstructive Sleep Apnea - First diagnosed as mild on 23 Apr 2003 but was not satisfied becasue I was always sleepy in the daytime and sweat profusly at night - retested on 4 Aug 2005 - diagnosed with severe Obstructive Sleep Apnea and was prescribed a CPAP with a setting of 14 daily to sleep. Continues to present date.  4. Chronic fatigue and aching joints and muscles - Started in Jun 2003 and worsened over the years to present - consulted with doctors in Jun 2003 for retirement physical and with PCM after retirement on numerous dates and was prescibed Tramadol or Hydrocodone for relief. Visited neurologist in March 2007 and diagnosed with Fibromyalgia. Doctor stated I have had it for some time but other doctors do not believe in it or would not diagnose it. Under doctors care for medication for restless leg syndrome and therapy to help cope with chronic pain and suffering.  03/27/2007 Brief MR received from neurologist for visit of 03/16/2006 where pt. reports better sleep with wrist splints without paresthesias of the hands.  Restless leg syndrome improved.  Still having leg pain.  Assessment:  Carpal Tunnel Syndrome. Restless Leg Syndrome.  Lumbar radiculopathy.  04/04/2007 MR received for multiple OVs from 5/2004 to 9/2006.  Problem lists include hypertension, hyperlipidemia, migraine headaches, fatigue, leg and back pain, atypical chest pain.  Prescribed CPAP in 4/2005     DX:  Sleep Apnea.  Carpal Tunnel Syndrome.  Daytime fatigue and tiredness 2' to sleep apnea.  Morbid Obesity. DJD.  GERD. Lumbago. Peripheral Neuropathy.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Restless legs syndrome, Sleep apnoea syndrome, Somnolence
Clinical narrative: 1. Extremely severe migraine attacks - Jan 2003 - Throbbing pain - lasted two days - migraines every week or two after first severe attack - got shot of Toradol to ease pain and started using Relpax to control future attacks.  2. Severe migraine attack on the following dates with duration - numerous dates and every month since Jan 2003 at least twice a month lasting 4 to 12 hours - Still suffer attacks at present. 3. Severe Obstructive Sleep Apnea - First diagnosed as mild on 23 Apr 2003 but was not satisfied becasue I was always sleepy in the daytime and sweat profusly at night - retested on 4 Aug 2005 - diagnosed with severe Obstructive Sleep Apnea and was prescribed a CPAP with a setting of 14 daily to sleep. Continues to present date.  4. Chronic fatigue and aching joints and muscles - Started in Jun 2003 and worsened over the years to present - consulted with doctors in Jun 2003 for retirement physical and with PCM after retirement on numerous dates and was prescibed Tramadol or Hydrocodone for relief. Visited neurologist in March 2007 and diagnosed with Fibromyalgia. Doctor stated I have had it for some time but other doctors do not believe in it or would not diagnose it. Under doctors care for medication for restless leg syndrome and therapy to help cope with chronic pain and suffering.  03/27/2007 Brief MR received from neurologist for visit of 03/16/2006 where pt. reports better sleep with wrist splints without paresthesias of the hands.  Restless leg syndrome improved.  Still having leg pain.  Assessment:  Carpal Tunnel Syndrome. Restless Leg Syndrome.  Lumbar radiculopathy.  04/04/2007 MR received for multiple OVs from 5/2004 to 9/2006.  Problem lists include hypertension, hyperlipidemia, migraine headaches, fatigue, leg and back pain, atypical chest pain.  Prescribed CPAP in 4/2005     DX:  Sleep Apnea.  Carpal Tunnel Syndrome.  Daytime fatigue and tiredness 2' to sleep apnea.  Morbid Obesity. DJD.  GERD. Lumbago. Peripheral Neuropathy.
Age: 26.0
Sex: M
Vaccine: DTAP
Symptoms: Body temperature increased, Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Afternoon after vaccine, upper arm tender reddened. 24 hours later, arm reddened, temp 101.2; seen in Emergency Dept 3/22/07 at 6:30 AM.  Dx cellulitis and given Keflex 500mg BID.  Did not improve; again seen in Emergency Dept 3/24/07 1:00 AM.  Admitted to hospital with increased pain and swelling. Given IV Ancef, Benadryl and Prednisone. Discharged 3/25/07 at 11:00 AM.  06/04/2007 MR received for o/n hospitalization for reaction to DTaP vax. Swelling and pain were noted in the area of the injection 2 days after receipt.  Seen in ER on 3/22/2007 and started on Keflex.  Returned to ER after pain and swelling were increasing despite tx. Txd with IV antibiotics and prednisone.  PE: WNL except thickening and swelling of subcutaneous tissues of the right deltoid.  Tenderness, warmth, and erythema noted. Assessment:  ?Cellulitis. ? allergic reaction.
Age: 26.0
Sex: M
Vaccine: DTAP
Symptoms: Tenderness
Clinical narrative: Afternoon after vaccine, upper arm tender reddened. 24 hours later, arm reddened, temp 101.2; seen in Emergency Dept 3/22/07 at 6:30 AM.  Dx cellulitis and given Keflex 500mg BID.  Did not improve; again seen in Emergency Dept 3/24/07 1:00 AM.  Admitted to hospital with increased pain and swelling. Given IV Ancef, Benadryl and Prednisone. Discharged 3/25/07 at 11:00 AM.  06/04/2007 MR received for o/n hospitalization for reaction to DTaP vax. Swelling and pain were noted in the area of the injection 2 days after receipt.  Seen in ER on 3/22/2007 and started on Keflex.  Returned to ER after pain and swelling were increasing despite tx. Txd with IV antibiotics and prednisone.  PE: WNL except thickening and swelling of subcutaneous tissues of the right deltoid.  Tenderness, warmth, and erythema noted. Assessment:  ?Cellulitis. ? allergic reaction.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Cellulitis, Computerised tomogram, Convulsion, Fall
Clinical narrative: Pt received Tdap on Monday. Went to work that night although in pain. Took Tylenol with some relief. Took another Tylenol at end of shift and then went home and took a Percocet for the pain. Tuesday, called in sick and went to ER with arm swelling, temp 100.5, pain into neck from injection site. Dx with cellulitis and was hospitalized w/IV antibiotics. WBC's elevated. Pt fell while in Er--she states they had given her Morphine and Phenergan and when she stood up she passed out and hit her head. She states she did NOT have a seizure but ER staff said she did. When she lost conciousness she had "twitching" in her legs and was incontinent. ER staff thought she might have had hypotonic respiratory distress and did a CAT scan to r/o PE. Pt states she is doing much better and most of the sx have resolved.  05/22/2007 MR received for 2 night hospital stay for c/o R shoulder rash which extends up to the neck.  Admitted for tx of cellulitis, pt. had a seizure while OOB to the BR.  Pt fell to the floor and her lower extremities  began shaking.  Incontinent of urine.  Pt. c/o fever, chills, and R arm/shoulder pain increased with ROM. Pt also complained of SOB with decreased O2 sats-mildly hypoxic on RA.  PE: WNL except R shoulder rash 8x5cm.  Txd with Abx. Principal DX:  Right shouder cellulitis.  Hypoxic respiratory insufficiency.   2' DX:  Possible isolated seizure.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Head injury, Injection site pain, Loss of consciousness, Muscle twitching, Neck pain
Clinical narrative: Pt received Tdap on Monday. Went to work that night although in pain. Took Tylenol with some relief. Took another Tylenol at end of shift and then went home and took a Percocet for the pain. Tuesday, called in sick and went to ER with arm swelling, temp 100.5, pain into neck from injection site. Dx with cellulitis and was hospitalized w/IV antibiotics. WBC's elevated. Pt fell while in Er--she states they had given her Morphine and Phenergan and when she stood up she passed out and hit her head. She states she did NOT have a seizure but ER staff said she did. When she lost conciousness she had "twitching" in her legs and was incontinent. ER staff thought she might have had hypotonic respiratory distress and did a CAT scan to r/o PE. Pt states she is doing much better and most of the sx have resolved.  05/22/2007 MR received for 2 night hospital stay for c/o R shoulder rash which extends up to the neck.  Admitted for tx of cellulitis, pt. had a seizure while OOB to the BR.  Pt fell to the floor and her lower extremities  began shaking.  Incontinent of urine.  Pt. c/o fever, chills, and R arm/shoulder pain increased with ROM. Pt also complained of SOB with decreased O2 sats-mildly hypoxic on RA.  PE: WNL except R shoulder rash 8x5cm.  Txd with Abx. Principal DX:  Right shouder cellulitis.  Hypoxic respiratory insufficiency.   2' DX:  Possible isolated seizure.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Respiratory distress, White blood cell count increased
Clinical narrative: Pt received Tdap on Monday. Went to work that night although in pain. Took Tylenol with some relief. Took another Tylenol at end of shift and then went home and took a Percocet for the pain. Tuesday, called in sick and went to ER with arm swelling, temp 100.5, pain into neck from injection site. Dx with cellulitis and was hospitalized w/IV antibiotics. WBC's elevated. Pt fell while in Er--she states they had given her Morphine and Phenergan and when she stood up she passed out and hit her head. She states she did NOT have a seizure but ER staff said she did. When she lost conciousness she had "twitching" in her legs and was incontinent. ER staff thought she might have had hypotonic respiratory distress and did a CAT scan to r/o PE. Pt states she is doing much better and most of the sx have resolved.  05/22/2007 MR received for 2 night hospital stay for c/o R shoulder rash which extends up to the neck.  Admitted for tx of cellulitis, pt. had a seizure while OOB to the BR.  Pt fell to the floor and her lower extremities  began shaking.  Incontinent of urine.  Pt. c/o fever, chills, and R arm/shoulder pain increased with ROM. Pt also complained of SOB with decreased O2 sats-mildly hypoxic on RA.  PE: WNL except R shoulder rash 8x5cm.  Txd with Abx. Principal DX:  Right shouder cellulitis.  Hypoxic respiratory insufficiency.   2' DX:  Possible isolated seizure.
Age: 19.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Incorrect dose administered, No adverse effect
Clinical narrative: No adverse events.Was given the pediatric dose of havrix instead of the adult dose
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Blood test, Cellulitis, Induration, Oedema peripheral, Pyrexia
Clinical narrative: Left Arm began to swell day of vaccination. Swelled to 3 times normal size of arm, "hard as rock" and hot.  Child also experienced fever 101.7. Admitted to hospital and was given antibiotics.  MD diagnosed as Cellulitis.  Today still with Fever.  04/02/2007 MR received for a 2 day hospitalization (3/22-24/2007)  for c/o redness, swelling, and soreness of the right arm where vax. were given the day before.  The child is febrile and is having malaise, and had nausea and vomiting.  PE:  Definite area of redness, swelling, and tenderness from the right deltoid down to the elbow.  Warm and tender to touch.   Txd with IV antibiotics. Impression:  Cellulitis of Right shoulder, probably 2' to an immunization.  Mild eczema.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Skin warm, White blood cell count normal
Clinical narrative: Left Arm began to swell day of vaccination. Swelled to 3 times normal size of arm, "hard as rock" and hot.  Child also experienced fever 101.7. Admitted to hospital and was given antibiotics.  MD diagnosed as Cellulitis.  Today still with Fever.  04/02/2007 MR received for a 2 day hospitalization (3/22-24/2007)  for c/o redness, swelling, and soreness of the right arm where vax. were given the day before.  The child is febrile and is having malaise, and had nausea and vomiting.  PE:  Definite area of redness, swelling, and tenderness from the right deltoid down to the elbow.  Warm and tender to touch.   Txd with IV antibiotics. Impression:  Cellulitis of Right shoulder, probably 2' to an immunization.  Mild eczema.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Cellulitis, Poor quality drug administered
Clinical narrative: Left Arm began to swell day of vaccination. Swelled to 3 times normal size of arm, "hard as rock" and hot.  Child also experienced fever 101.7. Admitted to hospital and was given antibiotics.  MD diagnosed as Cellulitis.  Today still with Fever.  04/02/2007 MR received for a 2 day hospitalization (3/22-24/2007)  for c/o redness, swelling, and soreness of the right arm where vax. were given the day before.  The child is febrile and is having malaise, and had nausea and vomiting.  PE:  Definite area of redness, swelling, and tenderness from the right deltoid down to the elbow.  Warm and tender to touch.   Txd with IV antibiotics. Impression:  Cellulitis of Right shoulder, probably 2' to an immunization.  Mild eczema.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Right arm swollen, red and hot, day after vaccination.  Complained of site being "itchy" on 03/25/07.  Redness decreased.  No Md visit.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Tenderness, Urticaria
Clinical narrative: Red area at site of immunization on right thigh. Has "large red welt like bump, very tender and covers a 5-6" area"
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Swelling face, Wheezing
Clinical narrative: APPROXIMATELY 5 MINUTES AFTER ADMINISTERING VARICELLA VACCINE WHILE WAITING IN THE WAITING AREA PER PATIENTS MOTHER SHE BEGAN FACIAL SWELLING AND COUGHING.  911 CALLED, 02 ADMINISTERED 5L VIA MASK-FACIAL SWELLING NOTED UNDER R EYE WITH SLIGHT WHEEZING ON EXAM BY ARNP.  CHILD TRANSPORTED TO ER VIA AMBULANCE.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMRV, PNC
Symptoms: Crying, Listless, Pyrexia
Clinical narrative: Vaccines were given at 3pm. Child cried unconsoleably until 8pm.  Fever 103.2F, listless. Mom called ER & was given a nurse hot-line. Gave Tylenol alternating with Motrin. Child went to sleep. When awake fever down & no crying.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Injection site swelling, Livedo reticularis, Pyrexia, Skin warm
Clinical narrative: Child woke up from bap with low grade fever 100.6, slight swelling at injection sites. Mother gave 1 tsp of children's Tylenol. Fever came down. Today child has mottling of skin along upper arms bilaterally. No severe swelling, limb is warm to touch.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Hyperhidrosis, Pallor, Presyncope
Clinical narrative: BECAME DIAPHOETIC AND VERY PALE. NEAR SYNCOPE
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Oesophageal obstruction, Vomiting
Clinical narrative: Pt. received Tdap on 3/16/07. Some arm swelling 3/18/07. Had episodes of vomiting. Since that time has difficulty eating-feeling like stuck in esophagus. Father pointed to epigastric area. Relieved by antiacids & soft diet.
Age: 0.68
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Blood culture, Calcium ionised, Clonic convulsion, Clostridium difficile toxin test, Culture stool
Clinical narrative: APPROXIMATELY 2 HOURS AFTER VACCINES ADMINISTERED THE PATIENT DEVELOPED FEVER (105 DEGREES), ASSOCIATED VOMITING X 3, AND DIARRHEA X 1.  SOON AFTER ONSET OF FEVER HE DEVELOPED CLONIC SEIZURES X 3, INVOLVING ARMS, LEGS, AND TRUNK.  HIS EYES ROLLED BACK AND HAD ALLEGED CYANOSIS OF LIPS.  THESE LASTED APPROX. 2 MINUTES.  HE AWOKE IMMEDIATELY THEREAFTER.--PER PARENTS.  3/28/07 Received medical records from hospital which reveal patient experienced bilat otitis media w/mucopurulent rhinitis treated w/antibiotics & resolving on the day of vax.  Approx 2 hrs s/p vax, had fever of 105 w/ vomiting/diarrhea & tonic clonic seizures x 3 w/ central cyanosis. Admitted 3/23/07-3/24/07 & progressed well w/only 1 temp spike & associated seizure.  FINAL DX: Febrile seizures s/p vaccination; vomiting/diarrhea, resolved; bilat otitis media, resolved.
Age: 0.68
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Culture urine, Cyanosis, Diarrhoea, Eye rolling, Full blood count
Clinical narrative: APPROXIMATELY 2 HOURS AFTER VACCINES ADMINISTERED THE PATIENT DEVELOPED FEVER (105 DEGREES), ASSOCIATED VOMITING X 3, AND DIARRHEA X 1.  SOON AFTER ONSET OF FEVER HE DEVELOPED CLONIC SEIZURES X 3, INVOLVING ARMS, LEGS, AND TRUNK.  HIS EYES ROLLED BACK AND HAD ALLEGED CYANOSIS OF LIPS.  THESE LASTED APPROX. 2 MINUTES.  HE AWOKE IMMEDIATELY THEREAFTER.--PER PARENTS.  3/28/07 Received medical records from hospital which reveal patient experienced bilat otitis media w/mucopurulent rhinitis treated w/antibiotics & resolving on the day of vax.  Approx 2 hrs s/p vax, had fever of 105 w/ vomiting/diarrhea & tonic clonic seizures x 3 w/ central cyanosis. Admitted 3/23/07-3/24/07 & progressed well w/only 1 temp spike & associated seizure.  FINAL DX: Febrile seizures s/p vaccination; vomiting/diarrhea, resolved; bilat otitis media, resolved.
Age: 0.68
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Metabolic function test, Pyrexia, Rotavirus test, Stool analysis, Urine analysis
Clinical narrative: APPROXIMATELY 2 HOURS AFTER VACCINES ADMINISTERED THE PATIENT DEVELOPED FEVER (105 DEGREES), ASSOCIATED VOMITING X 3, AND DIARRHEA X 1.  SOON AFTER ONSET OF FEVER HE DEVELOPED CLONIC SEIZURES X 3, INVOLVING ARMS, LEGS, AND TRUNK.  HIS EYES ROLLED BACK AND HAD ALLEGED CYANOSIS OF LIPS.  THESE LASTED APPROX. 2 MINUTES.  HE AWOKE IMMEDIATELY THEREAFTER.--PER PARENTS.  3/28/07 Received medical records from hospital which reveal patient experienced bilat otitis media w/mucopurulent rhinitis treated w/antibiotics & resolving on the day of vax.  Approx 2 hrs s/p vax, had fever of 105 w/ vomiting/diarrhea & tonic clonic seizures x 3 w/ central cyanosis. Admitted 3/23/07-3/24/07 & progressed well w/only 1 temp spike & associated seizure.  FINAL DX: Febrile seizures s/p vaccination; vomiting/diarrhea, resolved; bilat otitis media, resolved.
Age: 0.68
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: APPROXIMATELY 2 HOURS AFTER VACCINES ADMINISTERED THE PATIENT DEVELOPED FEVER (105 DEGREES), ASSOCIATED VOMITING X 3, AND DIARRHEA X 1.  SOON AFTER ONSET OF FEVER HE DEVELOPED CLONIC SEIZURES X 3, INVOLVING ARMS, LEGS, AND TRUNK.  HIS EYES ROLLED BACK AND HAD ALLEGED CYANOSIS OF LIPS.  THESE LASTED APPROX. 2 MINUTES.  HE AWOKE IMMEDIATELY THEREAFTER.--PER PARENTS.  3/28/07 Received medical records from hospital which reveal patient experienced bilat otitis media w/mucopurulent rhinitis treated w/antibiotics & resolving on the day of vax.  Approx 2 hrs s/p vax, had fever of 105 w/ vomiting/diarrhea & tonic clonic seizures x 3 w/ central cyanosis. Admitted 3/23/07-3/24/07 & progressed well w/only 1 temp spike & associated seizure.  FINAL DX: Febrile seizures s/p vaccination; vomiting/diarrhea, resolved; bilat otitis media, resolved.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Decreased appetite, Dehydration, Emotional distress, Screaming
Clinical narrative: This case was reported by a consumer, who was the subject's mother, and described the occurrence of dehydration in a 7-month-old female subject who was vaccinated with Pediarix for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included seizure disorder. Concurrently the subject was reported to have also received other "immunization shots" along with Pediarix at 7 months of age (vaccines were unspecified). On an unspecified date the subject received the 1st dose of Pediarix (unspecified dosing). Within 24 hours after vaccination with Pediarix, the subject experienced screaming, refusal to eat and an inability to be consoled. The mother reported that "due to her (daughter's) seizure disorder (they) went to (an) emergency room earlier then (she) usually would." After five hours of screaming, her daughter was admitted to the hospital "only at that point because she was dehydrated from refusing to eat". The subject was hospitalized for tow days. no specified treatment or diagnostic details were provided. There was no mention that the subject experienced seizure. At the time of reporting the outcome of the events were unspecified. The reporter noted about the cause of events that the "pediatrician feels it was the immunization as there were no other symptoms.
Age: 5.5
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid area with warmth and swelling radiates to full arm
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Hypotension, Lethargy, Pruritus, Rash
Clinical narrative: Pt c/o itching, rash & lethargy. Pt was seen at ED found to be hypotensive
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypotonic-hyporesponsive episode, Screaming
Clinical narrative: Vaccinated with Pediarix, Prevnar and Hib on 3/22/07-same evening woke up from sleep screaming, afterwards calmed down but later became hyporesponsive for 5-10 mins. No convulsions
Age: 1.7
Sex: F
Vaccine: DTAP
Symptoms: Rash vesicular
Clinical narrative: Immunization Dtap 3/21, rash 3/24-vesiculopapular. Prescribed Benadryl 3/26/07.
Age: 70.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site. Keflex 500 mg by mouth 4 times a day for 10 days. Elevate, warm pack.
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: Chills, Headache
Clinical narrative: Complained of headache and chills lasting about 3-5 hours until he went to bed. He states he woke in the morning feeling fine.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling, hardness from left shoulder down to elbow times 4 days. Ice to area as necessary, Benadryl cream as necessary, Tylenol.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Inconsolable crying began at 7:30am on 3-22-07 and lasted at least 12 hours
Age: 1.33
Sex: M
Vaccine: HEPA, IPV, VARCEL
Symptoms: Convulsion
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of seizure in a 16-month-old male subject who was vaccinated with Havrix, for prophylaxis. The subject had no prior history of seizure, nor did the subject have a family history of seizure. On 03 February 2006, the subject received the 1st dose of Havrix. On 03 February 2006, the subject also received IPOL (unknown manufacturer) and Varivax (unknown manufacturer). On 03 February 2006, within five minutes after vaccination with Havrix, the subject experienced a seizure. At the time of initial reporting, 07 February 2006, the event was unresolved. The physician considered the seizure to possibly be related to vaccination with Havrix. Comment: Seizure was assessed as medically serious.
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Hepatic enzyme increased
Clinical narrative: This case was reported by a nurse and described the occurrence of elevated liver enzymes in a 54-year-old male subject who was vaccinated with Havrix, for prophylaxis. Medical history included non-smoker and non-drinker. On 26 May 2005, the subject received the 1st dose of Havrix (lot AHAVB043BA). On 26 May 2005, the subject was also vaccinated with Typhim VI, (lot Y0794) and YF-Vax (lot UE498AA). On 28 December 2005, the subject received the 2nd dose of Havrix (lot AHAVB066AB). On an unspecified date in January 2006, less than one month after the 2nd dose of Havrix, the subject experienced elevated liver enzymes. The elevated liver enzymes resolved on an unspecified date after 08 February 2006 and before 24 February 2006. The nurse considered the event to be related to vaccination with Havrix. Comment: Elevated liver enzymes was assessed as medically serious.
Age: 58.0
Sex: F
Vaccine: HEPA, TTOX
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site soreness in a 58-year-old female subject who was vaccinated with Havrix, for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. Concurrent medications included Imitrex, Valium, Fiorinal, Lescol, Folgard, Evista, Effexor, Levoxyl, Armour Thyroid, Metrogel, Dhea, Multivitamins, CoQ10, Garlic, Omega 3 and Melatonin. On 06 March 2006 at 4:30 p.m., the subject received 1st dose of Havrix "in the gluteal region." The recommended site of administration of Havrix is the deltoid region. On 06 March 2006, less than one day after vaccination with Havrix, the subject experienced injection site soreness. The subject was seen at a physician's office. At the time of initial reporting, 08 March 2006, the outcome of the injection site soreness  was not reported.
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased, Fatigue, Pyrexia, Rash, Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 54-year-old male subject who was vaccinated with hepatitis A vaccine (manufacturer unspecified) for prophylaxis. The report is a friend of the subject. A physician or other health care professional has not verified this report. Medical history included "allergic reactions to vaccine and medications." On an unspecified date in February 2006 the subject received 1st dose of hepatitis A vaccine, the subject experienced fever, fatigue, and rash. Approximately 2 weeks later on an unspecified date between 01 March 2006 and 07 March 2006, the subject experienced swelling. The subject was seen at a physician's office and "worked from home for a few days following the vaccination." The outcome of the events was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Drug ineffective, Hepatitis A antibody negative, Vaccination complication
Clinical narrative: This case was reported by a physician to a sales representative and described a child of unspecified gender who did not respond to immunization with Havrix, for prophylaxis. On an unspecified date in 2005, the subject received 2nd dose of Havrix "according to schedule." On an unspecified date in 2006 before 12 April 2006, less than one year after vaccination with Havrix, a hepatitis A antibody titer was negative.
Sex: U
Vaccine: HEPA
Symptoms: Drug ineffective, Hepatitis A antibody negative, Vaccination failure
Clinical narrative: This case was reported by a physician to a sales representative and described a child of unspecified gender who did not respond to immunization with Havrix, for prophylaxis. On an unspecified date in 2005, the subject received 2nd dose of Havrix "according to schedule." On an unspecified date in 2006 before 12 April 2006, less than one year vaccination with Havrix, a hepatitis A antibody titer was negative.
Age: 35.0
Sex: U
Vaccine: HEPA
Symptoms: Drug ineffective, Hepatitis A antibody negative, Vaccination failure
Clinical narrative: This case was reported by a physician to a sales representative and described a 35-year-old subject of unspecified gender who did not respond to immunization with Havrix, for prophylaxis. On an unspecified date in 2005, the subject received 2nd dose of Havrix "according to schedule." On an unspecified date in February 2006, less than one year after vaccination with Havrix, a hepatitis A antibody titer was negative.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Arterial disorder, Pain in extremity, Swelling
Clinical narrative: This case was reported by a physician and described the occurrence of swelling of arteries in neck in a 20-year-old female subject who was vaccinated with Havrix, for prophylaxis. The reporter is the parent of the subject. The subject's medical history included penicillin allergy. Concurrent medications included Advair. On 14 June 2006 the subject received 1st dose of Havrix in the left arm. On an unspecified date on or after 14 June 2006 and on or before 16 June 2006, less than one week after vaccination with Havrix, the subject experienced carotid artery swelling, "cervical puffiness" and arm pain. The subject was seen at a physician's office. At the time of initial reporting, 16 June 2006, the events were ongoing. The physician considered the events were possibly related to vaccination with Havrix.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Lip swelling, Somnolence, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of urticarial rash on legs in a 34-year-old female subject who was vaccinated with Havrix, for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not provided. On 13 March 2001, the subject received a dose of "hepatitis A 1 mL" (unknown manufacturer; lot number appeared to be 1365K/603) without incident. On 13 February 2006, the subject received an unspecified dose of Havrix (1 ml, unknown; lot number: AHAVA31BB). On 14 February 2006, one day after vaccination with Havrix, the subject developed urticarial rash on her legs, arms, abdomen, around her lips, and occasional swelling of the lips. She had no respiratory distress, no shortness of breath, no fever, no wheezing, and no chest congestion. She was given various antihistamines from different physicians since this happened, but she had never really been free of the hives for any period of time since 14 February 2006. The physician reported that she does get relief of the hives from Allegra 180 mg daily. She had been taking Zyrtec, but this made her sleepy, so she remained with the one medication that helped her, Allegra. The reporter wrote: "While I know it is possible that her hives could be from something else, this has been looked into and worked up by another allergist here." At the time of reporting, the events were unresolved.  A product complaint was associated with this case.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives in a 7-year-old female subject who was vaccinated with Havrix, for prophylaxis. The subject has no significant medical history, no concurrent conditions and no history of drug allergies. The subject was not receiving concurrent medication. On 23 August 2006 the subject received 1st dose of Havrix at 720 elisa units, intramuscularly, in the left thigh. An unspecified amount of time following administration of Havrix, on 23 August 2006 (same day of vaccination), the subject developed hives on her left leg only. At the time of reporting the event was unresolved. Follow-up information was received on 18 September 2006. According to the vaccinating physician, the subject experienced hives and urticaria on 28 August 2006, five days after vaccination with Havrix. The events resolved on 04 September 2006. As a result of the events, the immunization series with Havrix was discontinued. The reporting physician considered the hives and urticaria were related to vaccination with Havrix.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Oedema peripheral, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of facial rash in a 22 month old male subject who was vaccinated with Havrix, for prophylaxis. On an unspecified date before 07 September 2006, the subject received Havrix at 0.5 ml, intramuscularly in the right thigh. "A couple of hours later," following vaccination with Havrix, the subject experienced facial rash and arm swollen. The subject developed hives. At the time of initial reporting, 07 September 2006, the outcome of the events was not reported. Report received. Follow-up information received on 22 September 2006 indicated that the onset of the earliest sign or symptom was 04 August 2006. The events completely resolved (date not provided). In the reporter's opinion, the events were related to treatment with Havrix.
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis C virus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of worsening of hepatitis C virus in a male subject of unspecified age who was vaccinated with Havrix, for prophylaxis. The subject's medical history included hepatitis C infection. The  healthcare professional reported on 06 September 2006 that the subject's hepatitis C viral load had been "stable for the last year." On an unspecified date in 2006, before 06 September 2006, the subject received a dose of Havrix (1440 elisa unit; dose number and lot number not provided). Approximately 3 weeks later after vaccination with Havrix, on an unspecified date in 2006, on or before 06 September 2006, the subject's hepatitis C viral load "doubled." At the time if initial reporting, 06 September 2006, the outcome of the event was not reported.
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: Somnolence, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of urticaria in a 46-year-old male subject who was vaccinated with Havrix, for prophylaxis. Medical history included anxiety and heartburn. Concurrent medications included Zoloft and Nexium.  On 24 August 2006 at 5:00 p.m., the subject received 1st dose of Havrix (1 ml, intramuscular, left arm). On an unspecified date in September 2006, on or prior to 12 September 2006, less than one month after vaccination with Havrix, the subject experienced urticaria. The subject was treated with Benadryl, "which temporarily improved the symptoms, but caused drowsiness". At the time of reporting, "the symptoms persisted and the prescriber was considering alternate treatment medications". As a result of this event, the immunization series with Havrix was discontinued. The physician considered the urticaria was probably related to vaccination with Havrix. Follow-up was received by the subject on 06 November 2006. On 18 September 2006, the subject was treated with fexofenadine. The outcome of the events following treatment with fexofenadine was not reported.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 3-year-old female subject who was vaccinated with Havrix, for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On 13 September 2006 the subject received 1st dose of Havrix. The consumer  reported that no other vaccinations were administered on 13 September 2006. "About a day later, " on an unspecified date in September 2006, the subject experienced fever. The subject seen in an emergency department. At the time of initial reporting, 22 September 2006, the outcome of the fever was not reported.
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased, Laboratory test, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a male child of unspecified age who was vaccinated with Havrix for prophylaxis. A physician or other health care professional has not verified this report. On 13 September 2006 the subject received a dose of Havrix (dose number not provided). "About a day later, " on an unspecified date in September 2006, the subject experienced a fever "that ranged from 103 to 104 degrees Fahrenheit." The subject was seen in an emergency department and was subsequently hospitalized. The consumer reported that, "various tests were run, but everything was negative and the patient was discharged." At the time of initial reporting 22 September 2006 the outcome of the fever was not reported.