chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, HEP, HEP
Symptoms: Ascites, Biopsy bone marrow normal, Biopsy liver normal, Biopsy skin normal, Cardiopulmonary failure
Clinical narrative: Information has been received from a pharmacist concerning an infant who was vaccinated with a dose of Recombivax HB (therapy date, lot # not reported). The pharmacist reported that the infant developed multiorgan failure and died thirty days after receiving the Recombivax HB (exact date of the event not reported). The pharmacist did not think the multi-system organ failure was related to the vaccine because of "the timing of the event." No other information was available to report. The reporter considered the event of multiorgan failure as life threatening and disabling. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP, HEP
Symptoms: Convulsion, Death, Dyspnoea, Encephalopathy, Endotracheal intubation
Clinical narrative: Information has been received from a pharmacist concerning an infant who was vaccinated with a dose of Recombivax HB (therapy date, lot # not reported). The pharmacist reported that the infant developed multiorgan failure and died thirty days after receiving the Recombivax HB (exact date of the event not reported). The pharmacist did not think the multi-system organ failure was related to the vaccine because of "the timing of the event." No other information was available to report. The reporter considered the event of multiorgan failure as life threatening and disabling. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP, HEP
Symptoms: General physical health deterioration, Hepatosplenomegaly, Multi-organ failure, Oxygen supplementation, Peritoneal dialysis
Clinical narrative: Information has been received from a pharmacist concerning an infant who was vaccinated with a dose of Recombivax HB (therapy date, lot # not reported). The pharmacist reported that the infant developed multiorgan failure and died thirty days after receiving the Recombivax HB (exact date of the event not reported). The pharmacist did not think the multi-system organ failure was related to the vaccine because of "the timing of the event." No other information was available to report. The reporter considered the event of multiorgan failure as life threatening and disabling. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP, HEP
Symptoms: Platelet count decreased, Platelet transfusion, Pseudomonal sepsis, Pyrexia, Rash
Clinical narrative: Information has been received from a pharmacist concerning an infant who was vaccinated with a dose of Recombivax HB (therapy date, lot # not reported). The pharmacist reported that the infant developed multiorgan failure and died thirty days after receiving the Recombivax HB (exact date of the event not reported). The pharmacist did not think the multi-system organ failure was related to the vaccine because of "the timing of the event." No other information was available to report. The reporter considered the event of multiorgan failure as life threatening and disabling. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP, HEP
Symptoms: Renal failure, Thrombocytopenia
Clinical narrative: Information has been received from a pharmacist concerning an infant who was vaccinated with a dose of Recombivax HB (therapy date, lot # not reported). The pharmacist reported that the infant developed multiorgan failure and died thirty days after receiving the Recombivax HB (exact date of the event not reported). The pharmacist did not think the multi-system organ failure was related to the vaccine because of "the timing of the event." No other information was available to report. The reporter considered the event of multiorgan failure as life threatening and disabling. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP, HEP
Symptoms: Death, Multi-organ failure
Clinical narrative: Information has been received from a pharmacist concerning an infant who was vaccinated with a dose of Recombivax HB (therapy date, lot # not reported). The pharmacist reported that the infant developed multiorgan failure and died thirty days after receiving the Recombivax HB (exact date of the event not reported). The pharmacist did not think the multi-system organ failure was related to the vaccine because of "the timing of the event." No other information was available to report. The reporter considered the event of multiorgan failure as life threatening and disabling. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP, HEP
Symptoms: Anaphylactic reaction, Death, Hypersensitivity, Immediate post-injection reaction
Clinical narrative: Information has been received from a pharmacist concerning an infant who was vaccinated with a dose of Recombivax HB (therapy date, lot # not reported). The pharmacist reported that the infant developed multiorgan failure and died thirty days after receiving the Recombivax HB (exact date of the event not reported). The pharmacist did not think the multi-system organ failure was related to the vaccine because of "the timing of the event." No other information was available to report. The reporter considered the event of multiorgan failure as life threatening and disabling. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Deafness unilateral
Clinical narrative: This case was received from a health professional on 23 May 2008.  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  A 31-year-old female patient, with a history of sulfa and codeine allergies and "gastrointestinal signs and symptoms", received a right deltoid intramuscular injection of ADACEL (lot number C2899AA) on 20 May 2008.  Within 12 hours of vaccination, the patient experienced hearing loss in her right ear, which she described as a fluid sensation.  Treatment included prednisone, and the patient was scheduled for an ENT consult.  The patient also complained of pain at the injection site.  At the time of the report, the event was still resolving.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Deafness unilateral, Ear discomfort, Injection site pain
Clinical narrative: This case was received from a health professional on 23 May 2008.  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  A 31-year-old female patient, with a history of sulfa and codeine allergies and "gastrointestinal signs and symptoms", received a right deltoid intramuscular injection of ADACEL (lot number C2899AA) on 20 May 2008.  Within 12 hours of vaccination, the patient experienced hearing loss in her right ear, which she described as a fluid sensation.  Treatment included prednisone, and the patient was scheduled for an ENT consult.  The patient also complained of pain at the injection site.  At the time of the report, the event was still resolving.
Age: 38.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Eye pain, Migraine, Nausea
Clinical narrative: Pt expierencing servere headaches with nausea, and body aches. Headaches became more severe over the last week. Pt reported to emergency room on 28 May 2008. MRI and CAT scan along with spinal tap where accomplished at ER. Pt has further consultation with neurologist on 30 May 08.
Age: 38.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: CSF test, Computerised tomogram abnormal, Headache, Lumbar puncture, Nausea
Clinical narrative: Pt expierencing servere headaches with nausea, and body aches. Headaches became more severe over the last week. Pt reported to emergency room on 28 May 2008. MRI and CAT scan along with spinal tap where accomplished at ER. Pt has further consultation with neurologist on 30 May 08.
Age: 38.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Pain
Clinical narrative: Pt expierencing servere headaches with nausea, and body aches. Headaches became more severe over the last week. Pt reported to emergency room on 28 May 2008. MRI and CAT scan along with spinal tap where accomplished at ER. Pt has further consultation with neurologist on 30 May 08.
Age: 1.8
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Rash, Rash macular, Wheezing
Clinical narrative: Initial report received 23 May 2008 from a health care professional.  A 21 month-old male patient received an intramuscular right thigh injection of DAPTACEL and 15 to 20 minutes later he developed wheezing, a rash on his chest and back and red blotches.  The patient received corrective treatments with albuterol and prednisone.  The symptoms resolved after treatment and the patient recovered from the event.  The patient had a history of milk allergies and had not been ill at the time of vaccination.  According to the reporter, the patient was new to their practice and they were unsure what vaccines the patient had received in the past.  No further information was provided at the time of the report.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed hives with some itching localized to site of vaccination.  Area was oval shaped with a radius of approximately two inches.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt received ZOSTAVAX at his worksite on Friday, 4-18-08 and developed a rash on his elbows + knees the next morning.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RV5
Symptoms: Crying
Clinical narrative: Inconsolable crying.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Culture stool negative, Diarrhoea, Rotavirus test negative
Clinical narrative: Diarrhea one day post immunizations, lasting 2 weeks.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Prox LUE - painful to touch, red, swollen.  Tenderness & soreness noted yesterday - today redness noted.  Tx - ibuprofen, BENADRYL & ORAPRED.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Faeces discoloured
Clinical narrative: Stools turned dark green.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Hot flush, Hyperhidrosis, Pruritus generalised, Pyrexia
Clinical narrative: Itching from head to toe - vomiting - fever - hot flashes - sweating - swelling - headache.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Vomiting
Clinical narrative: Itching from head to toe - vomiting - fever - hot flashes - sweating - swelling - headache.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None reported. Previous dose of MCV4 given on 11-26-07.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None reported. Previous dose of Tdap given on 8-1-07.
Age: 44.0
Sex: M
Vaccine: HEPAB
Symptoms: Body temperature, Chest discomfort, Cold sweat, Dyspnoea, Feeling abnormal
Clinical narrative: Client is inmate at county prison. Twinrix administered at aproximately 1010 on 05/28/2008.. Client returned to medical at 1220 with c/o feeling cold and a feeling as though he had a "loss of circulation." He also c/o SOB and chest discomfort. His skin was dusky and cold to touch. His entire body was shaking so much that the prison LPN was unable to obtain a B/P. Oral Temp 98.1 F, Pulse 87, O2 sats at 95%. Client was responsive and answered all questions appropriately.Prison LPN administered po Benadryl 50 mg. at approximately 1225. EMS summoned at 1225. O2 stas dropped to 87% on RA before transport to  Hospital at 1238 via stretcher and ambulance. FU with prison staff 05/29/2008- Client returned to prison 05/28/08 with diagnosis from ER as a reaction to Twinrix administered 05/28/08.
Age: 44.0
Sex: M
Vaccine: HEPAB
Symptoms: Feeling cold, Heart rate normal, Nervousness, Oxygen saturation decreased
Clinical narrative: Client is inmate at county prison. Twinrix administered at aproximately 1010 on 05/28/2008.. Client returned to medical at 1220 with c/o feeling cold and a feeling as though he had a "loss of circulation." He also c/o SOB and chest discomfort. His skin was dusky and cold to touch. His entire body was shaking so much that the prison LPN was unable to obtain a B/P. Oral Temp 98.1 F, Pulse 87, O2 sats at 95%. Client was responsive and answered all questions appropriately.Prison LPN administered po Benadryl 50 mg. at approximately 1225. EMS summoned at 1225. O2 stas dropped to 87% on RA before transport to  Hospital at 1238 via stretcher and ambulance. FU with prison staff 05/29/2008- Client returned to prison 05/28/08 with diagnosis from ER as a reaction to Twinrix administered 05/28/08.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 5/21/08 child presented with redness, swelling and warm to the touch at injection site of varicella in right upper arm.  Instructed parent to call pediatrician for possible treatment.  5/22/08 parent of patient reports right arm no longer warm to the touch, redness and swelling almost gone.  Called peds and put cold packs on arm and gave child Ibuprophen as instructed by pediatrician.
Age: 50.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Borrelia burgdorferi serology negative, Joint swelling, Oedema peripheral, White blood cell count normal, X-ray limb abnormal
Clinical narrative: Developed swelling of right knee on 5/23, to urgent care on 5/24, then on 5/25 left knee and hands also swollen. Swelling subsided on 5/26. Swelling resolved on 5/29.
Age: 35.0
Sex: M
Vaccine: DTAP
Symptoms: Pain, Rash
Clinical narrative: Rash developed 12-24 hours after Tdap vaccine.Also complained of "achey" all over.Seen in the ER 48 hours after vaccination.ER gave oral Prednisone 80 mg per day for 5 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: RED, SWOLLEN, FEVERISH,PAINFUL, WITH FLUID FILLED BLISTERS
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Petechiae, Pruritus, Rash
Clinical narrative: Patient complained of right foot itching within 5 minutes of receiving Dtap, IPV and varicella vaccine. Within 8 minutes developed petechial rash under both eyes and on right eyelid.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Herpes zoster
Clinical narrative: Left leg broke out with shingles.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Oedema peripheral, Paraesthesia
Clinical narrative: Pt s/p having stepped on a nail. Pt had no insurance and was sent from MD office with script for Tdap vaccine to public health on 5/28/08. Pt stated she thought she might have had a Td vaccine "a couple of years ago, but not sure". Stated she had told M.D. this and they still wanted her to get the Tdap vaccine that day. Pt called later in evening to Public Health on-call nurse to state her upper arm was red and "swollen to twice it's normal size" and pt had tingling in fingers. Pt was advised by on-call nurse to go to E.R. Per call to MD office by Public Health RN 5/29/08, pt had gone to ER at 2033 5/28/08 where "local reaction" dx'd, pt given rx for Prednisone 20 mg, orally. Pt released and told to F/U w/her M.D. in 1-3 days.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Ear discomfort, Tympanometry
Clinical narrative: Dizziness  ear feels stuffy
Age: 0.42
Sex: F
Vaccine: HEPA, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Hepatitis A vaccine was administered to the patient by mistake, 7 months earlier than the recommended age.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: 5 minutes after vaccine given, patient fainted while seated.  She was aided to the floor where in a supine position she quickly came to.  After 15-20 minutes she felt well enough to sit up.  She was able to walk out of the clinic after another 10 minutes.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Induration, Oedema peripheral, Skin warm, Weight bearing difficulty
Clinical narrative: The day after immunization, patients leg swelled up two times the size of the other leg.The area was very warm to the touch and very red. The area was also hard as a rock. As the day went on the swelling did continue to worsen moving from the thigh area down below the knee area. The patient could not walk on his leg. Treatment for this was Motrin and also Benadryl, along with warm compress. The reaction did last for 2 days after this and then finally went down to normal size.
Age: 0.5
Sex: M
Vaccine: IPV, PNC, RV5, TDAP
Symptoms: Wrong drug administered
Clinical narrative: A 6 month old was given Tdap in error, should have been given DTaP.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth, Pyrexia
Clinical narrative: One week after getting the vaccination, site was swollen, red and hot with little blisters in the redness.  Low grade fever occurred several times.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: Patient had immunizations on 5-19-08 and was found in bed on back today.  7/18/2008 Autopsy report received with COD:  Sudden Unexplained Infant Death. Report states infant had some chest congestion x 2 days for which no medication used for tx. Infant had been acting normally with no other recent c/o. Infant had fed at 1 am and at 4 am parent noted infant was not breathing.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Eye swelling
Clinical narrative: Bilateral eye swelling one day after immunization
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Blood pressure normal, Chest discomfort, Heart rate normal, Immediate post-injection reaction, Injection site erythema
Clinical narrative: nearly immediate local erythema and itching at Hep A vaccine site, extended over entire deltoid area, patient described chest "felt heavy" - given diphenhydramine with resolution of itching, "heavy" chest feeling nearly resolved after approx 90 min,  no stridor, BP, pulse, RR remained normal - discharged home after 2 hours on benedryl, prednisone, cimetidine, patient was asymptomatic 3 hours later - no local reaction at Menactra site L arm
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site pruritus, Local reaction, Oxygen saturation, Respiratory rate
Clinical narrative: nearly immediate local erythema and itching at Hep A vaccine site, extended over entire deltoid area, patient described chest "felt heavy" - given diphenhydramine with resolution of itching, "heavy" chest feeling nearly resolved after approx 90 min,  no stridor, BP, pulse, RR remained normal - discharged home after 2 hours on benedryl, prednisone, cimetidine, patient was asymptomatic 3 hours later - no local reaction at Menactra site L arm
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Scab, Skin lesion
Clinical narrative: 4/15/08 Recieved Zostavax vaccine.  24 days later developed scattered lesions.  A few on arm and a few on legs. She felt it was related to her gluten intolerence.  Her PCP started her on Topicort.  On 5/14/08 she developed 2 areas of lesions right above her RUQ. They gradually spread along the right side to her back. She went to the ED on 5/27/08. She was diagnosed as having Shingles.  She was prescribed Valtrex and given Oxycodone for pain.  As of my interview today the lesions are scabbed and no new outbreaks occuring.  She has postherpetic neuralgia.  Rated a 10 on a pain scale.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blood culture, Chest X-ray, Chills, Culture urine, Diarrhoea
Clinical narrative: Vomiting began @ 12:20 a.m. 5/17 with fever to 105 F and chills. slight diarrhea later on 5/17. Went to ER and given phenergan and antibiotic shot. urinalysis and blood culture drawn. Chest x-ray.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Full blood count, Pyrexia, Urine analysis, Vomiting
Clinical narrative: Vomiting began @ 12:20 a.m. 5/17 with fever to 105 F and chills. slight diarrhea later on 5/17. Went to ER and given phenergan and antibiotic shot. urinalysis and blood culture drawn. Chest x-ray.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Chills, Diarrhoea, Immobile, Nausea, Pain
Clinical narrative: Patient reports that her arm, elbow, neck, and shoulders have been hurting her enough to immobilze her arm since approx. 12 hours after injection.  Within 24 hours of injection patient felt nausea, chills, achy upper torsoe, and she had diarrhea x 2.  Patient reports 48 hours after injection that the nausea and chills are gone but she is still feeling pain that has her immobilizing her arm and she cannot turn her neck from side to side.  Patient was advised to use tylenol or Motrin and seek emergency medical attention if any of these s/s worsened.  Patient also advised to follow up with her primary care providered if s/s are not better in 5 days.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: PATIENT CAME INTO THE OFFICE ON 05/28/08 PRESENTING WITH A RASH, WHICH THE DOCTOR DIAGNIOSED AS CHICKENPOX.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Mass, Skin warm, Swelling
Clinical narrative: Received DTAP, swelling, hot skin, lump developed about 48 hours later. I don't know the outcome yet.
Age: 28.0
Sex: F
Vaccine: YF
Symptoms: Chest pain, Computerised tomogram
Clinical narrative: Acute onset sharp chest pain 1 week after administration of vaccine Feb 08. Given presumptive diagnosis of pericarditis. No clinical evidence of pericarditis on ECG, echo and CT scan. Persistent chest pain not responding to NSAIDS, colchicine or narcotics.  06/12/2008 MR received from2-6/2008 with DX: Pericarditis/ Chronic recurrent pericarditis.  One week after receiving YF vax pt developed sharp Left sided chest pain, worse lying down. DX with pericarditis. Chest pain has continued to recur, and is worse than initial episode. Occasional tachypalpitations. C/o dizziness.  Still w/ sx 6/4/08.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Apnoea, Body temperature increased, Cardiac monitoring, Convulsion, Haematocrit normal
Clinical narrative: Grandmother called clinic 5/12 states baby received immunization 5/8 states on 5/9 baby had first seizure @ 8:30 p.m. followed by second seizure at 10:30 p.m. Took to ER and admitted for observation until 5/11. Grandmother states only test performed were heart monitor. Also states highest temp was 100.9 and  MD @ ER stated seizure could have been from vaccine received 5/8. Asked her to report it to Health Department. States baby okay at home. No other seizures or complications noted.  Discharge Summary:  This 6 month old Female brought to hospital ER with complaint of e episodes of apnea.  D/C Diagnosis:  Witnessed apneic episodes that have resolved with non recurrent during hospitalization;  No consultations of further follow up 5/30/08-records received-DOS 5/9-5/11/08-DC DX:Witnessed apneic episodes that appear to have resolved with none recurrent during hospitalization. Presented to ED with C/O having stopped breathing. Two episodes of apnea witnessed. PE normal. Temperature 100.9.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Haemoglobin normal, Laboratory test normal
Clinical narrative: Grandmother called clinic 5/12 states baby received immunization 5/8 states on 5/9 baby had first seizure @ 8:30 p.m. followed by second seizure at 10:30 p.m. Took to ER and admitted for observation until 5/11. Grandmother states only test performed were heart monitor. Also states highest temp was 100.9 and  MD @ ER stated seizure could have been from vaccine received 5/8. Asked her to report it to Health Department. States baby okay at home. No other seizures or complications noted.  Discharge Summary:  This 6 month old Female brought to hospital ER with complaint of e episodes of apnea.  D/C Diagnosis:  Witnessed apneic episodes that have resolved with non recurrent during hospitalization;  No consultations of further follow up 5/30/08-records received-DOS 5/9-5/11/08-DC DX:Witnessed apneic episodes that appear to have resolved with none recurrent during hospitalization. Presented to ED with C/O having stopped breathing. Two episodes of apnea witnessed. PE normal. Temperature 100.9.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Urticaria
Clinical narrative: HIVE LIKE RASH HAD IMMUNIZATIONS YESTERDAY, NO LOCAL IRRITRATION, RASH ON TORSO
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Patient presented with vesicular rash in classic dermatomal distribution 5/26/08.  Patient had 2 doctoer visits. One urgent care visit 5/27/08 and one with primary MD 5/29/08
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anaphylactic reaction, Arthropod bite, Incisional drainage, Injection site rash, Oedema peripheral
Clinical narrative: This case was reported by a physician and described the occurrence of necrotic lesions in a 6-month-old female subject who was vaccinated with PEDIARIX, GlaxoSmithKline.  Concurrent vaccination included HIB, ROTATEQ and PREVNAR all given on 1 November 2007.  There were no concurrent medications.  On 1 November 2007 the subject received 3rd dose of PEDIARIX at 0.5 ml in the left thigh.  At an unspecified time after vaccination with PEDIARIX, the subject developed a rash in the injection site area.  The rash worsened and developed a large necrotic lesion.  Swelling was reported.  The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention).  The subject was diagnosed with cellulitis and treated with oral clindamycin.  The subject had the area exised and drained and was negative for cellulitis.  The symptoms continued to worsen.  The area was large with a "brown necrotic, depressed center."  The differential diagnosis was a spider bite.  The subject was seen on 8 November 2007 and the area was healing.  She had restarted oral clindamycin after leaving the hospital.  The necrotic lesion and swelling eventually resolved although there was permanent scarring.  The subject suffered a systemic reaction.  The physician considered the events of necrotic lesion and swelling to be possibly related to vaccination with PEDIARIX.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Skin lesion, Skin necrosis
Clinical narrative: This case was reported by a physician and described the occurrence of necrotic lesions in a 6-month-old female subject who was vaccinated with PEDIARIX, GlaxoSmithKline.  Concurrent vaccination included HIB, ROTATEQ and PREVNAR all given on 1 November 2007.  There were no concurrent medications.  On 1 November 2007 the subject received 3rd dose of PEDIARIX at 0.5 ml in the left thigh.  At an unspecified time after vaccination with PEDIARIX, the subject developed a rash in the injection site area.  The rash worsened and developed a large necrotic lesion.  Swelling was reported.  The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention).  The subject was diagnosed with cellulitis and treated with oral clindamycin.  The subject had the area exised and drained and was negative for cellulitis.  The symptoms continued to worsen.  The area was large with a "brown necrotic, depressed center."  The differential diagnosis was a spider bite.  The subject was seen on 8 November 2007 and the area was healing.  She had restarted oral clindamycin after leaving the hospital.  The necrotic lesion and swelling eventually resolved although there was permanent scarring.  The subject suffered a systemic reaction.  The physician considered the events of necrotic lesion and swelling to be possibly related to vaccination with PEDIARIX.
Age: 27.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Axillary pain, Injection site erythema, Injection site oedema, Subcutaneous nodule, Tenderness
Clinical narrative: Received his 4th anthrax vaccine (FAV163, in left deltoid, also received MENACTRA in left arm) on 3/27/08.  In clinic on 3/31 with complaints of tender sub-q nodule (about 2 cm), slight erythema surrounding vaccination site (<1.5), and mild axillary point tenderness, but no enlarged lymph nodes.  No systemic symptoms.  When I spoke to him briefly on 4/8/08, he said the vaccine site symptoms were decreasing.  Symptoms: Edema at injection site 30-50mm, Erythema, Nodule, subcutaneous, Tenderness.
Age: 17.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Body temperature increased, Pruritus, Rash macular
Clinical narrative: Developed temperature to 102 and blotchy rash, fever resolved.  AM developed severe pruritis, not responsive to antihistamine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dry skin, Pruritus, Rash
Clinical narrative: ZOSTAVAX vaccine administered 4/11/08; 4/12/08 pt reported onset of dryness followed by itching, blisters perioral left upper eyelid. No fever, No mucosal; rash persists 2-3 days, followed by dryness for 1 week. Recurred 5/29, 5/24.
Age: 6.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: VARIVAX was ordered by MD/ZOSTAVAX given by error.  Both meds side by side on freezer shelf/Merck contacted/observe child/child was without any side effects after 24 hours.
Age: 6.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: VARIVAX was ordered by MD/ZOSTAVAX given by error.  Both meds side by side on freezer shelf/Merck contacted/observe child/child was without any side effects after 24 hours.
Age: 10.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: VARIVAX was ordered by MD / ZOSTAVAX given by error; Both meds side by side in freezer shelf / Merck contacted / Observe child / child was without any side effects after 24 hours. Follow-up Information 17-JUN-2008: Mother reporting some headache but improving over time and red area at site of injection is also improving over time.
Age: 11.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Varivax was ordered by MD/ZOSTAVAX given by error. Both meds side by side on freezer shelf. Merck contacted, observe child. Child was without any side effects after 24 hours.  Mother reporting some headache but improving with time and red area at injection site and also improving with time.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: After receiving second HPV, later patient had a seizure.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Laboratory test normal
Clinical narrative: After receiving second HPV, later patient had a seizure.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: On 4-17-08 at bedtime noticed red warm area on L deltoid below shot area.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Noticed L facial droop - corner of mouth when eating/smiling x few months, GARDASIL series started 8/07. 7/3/08-office note 5/28/08-presented with left facial droop especially when eating parent noticed it 1-2 months ago. Questionable Bell's palsy vs asymmetry. 7/23/08-records received for DOS 12/21/07-Neurology consult for evaluation of intermittent headache over past 2 years, now increasing in frequency. Headaches throbbing bifrontal involving face bilaterally improve with sleep. Now waking up at night unable to fall back asleep. Impression headaches most likely migrainous in nature with photosensitivity. Facial pain could be related to sinus like pressure. Neurologic exam normal.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Angiogram, Chest X-ray normal, Chills, Dyspnoea, Hyperhidrosis
Clinical narrative: Fever to  102.8, acute dyspnea, chills, sweats, myalgias.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Oxygen saturation normal, Pyrexia, White blood cell count increased
Clinical narrative: Fever to  102.8, acute dyspnea, chills, sweats, myalgias.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving 1st GARDASIL injection while leaving office. Alert x3 after using smelling salt. Patient given juice and observed 15 minutes longer. Patient did not eat breakfast day of appt. Patient stable and left office on her own.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Patient developed severe R facial neuropathic pain (V3 distribution) approximately 2 weeks after receiving vaccination.  Mild improvement with VALTREX.  No lesions ever developed.  After 2 weeks symptoms began to gradually resolve.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received routine immunizations on 5/20/08. Patient's (L) arm red, hot, swollen, tender. Treated with Ceclor.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pallor, Pyrexia, Rash erythematous, Rash macular, Skin lesion
Clinical narrative: Fever, erythematous dull urticarial rash extensive mainly neck and inguinal region as large blotches with small lesions outer abdomen and chest blanching with irregular margin.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Fever, erythematous dull urticarial rash extensive mainly neck and inguinal region as large blotches with small lesions outer abdomen and chest blanching with irregular margin.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Pain in extremity, Skin warm
Clinical narrative: Right upper arm is warm and painful to touch. Has erythema. Was put on Augmentin ES for cellulitis.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Localized swelling, firmness and redness with itching, 12 x 14 cm.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Crying, Erythema, Oxygen saturation decreased, Tremor
Clinical narrative: Pt received vaccines then went home crying at received bath when noticed red all over skin and shaking. Came back to office and EMS called - pulse O2 decreased and shaking - went to ER - woke up with swelling the next day.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: None. MMR vaccine was past expiration date when given. Expired 05-23-08; injected on 5-28-08. Per follow-up: 5/28/08 contacted pt. mother, she reported no adverse reaction. Revaccination in order.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Molluscum contagiosum
Clinical narrative: Left thigh 5.5 x 9.5cm Red; Augmentin ES. 600/5ml 1 tsp po BID - 10days.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Supple, raised warm red lesion 6cm on left arm at injection site.  Treated with cool compress, ibuprofen, BENADRYL, and AUGMENTIN cs 600 x10 days.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Right shoulder, swelling and redness 8cm radius
Age: 8.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration, Limb discomfort, Medication error
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccination error in a 8-year-old male subject who was vaccinated with BOOSTRIX, GlaxoSmithKline.  Previous history of rash with unknown vaccine.  Previous and/or concurrent vaccination included HEP A given on 28 March 2008; POLIO VIRUS given on 28 March 2008; MMR II (strain not specified) given on 28 March 2008; VARIVAX given on 28 March 2008.  On 28 March 2008 at 08:45 the subject received BOOSTRIX (.5 ml, unknown, left arm) and experienced vaccination error.  At the time of the report, no adverse event had been reported.  Follow-up received on 01 April 2008 via the nurse.  The nurse reported that the subject complained that his arm was sore.  The outcome was unknown at the time of reporting.  No further information was reported.
Age: 15.0
Sex: F
Vaccine: TDAP, UNK, VARCEL
Symptoms: Drug exposure during pregnancy, Oedema peripheral
Clinical narrative: This case was reported by a consumer and described the occurrence of pregnancy in a 15-year-old female subject who was vaccinated with BOOSTRIX, GlaxoSmithKline.  A physician or other health care professional has not verified this report.  Previous and/or concurrent vaccination included unspecified vaccines given on 8 April 2008; VARIVAX given on 8 April 2008.  There were no concurrent medications.  On 8 April 2008 the subject received unspecified dose of BOOSTRIX (unknown, unknown arm) while pregnant.  Less than one day after vaccination with BOOSTRIX, the subject experienced swelling on her right arm.  At the time of reporting the outcome of the pregnancy was reported as unresolved.  The outcome of the event of swelling on right arm was unspecified.
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Bacterial culture negative, Blood calcium decreased, Blood chloride increased, Carbon dioxide decreased, Cellulitis
Clinical narrative: Left shoulder abscess. Possible necrotizing fasciitis
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Debridement, Erythema, Full blood count, Induration, Lymphocyte morphology abnormal
Clinical narrative: Left shoulder abscess. Possible necrotizing fasciitis
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Metabolic function test, Monocyte count increased, Neutrophil count increased, Soft tissue infection, Surgery
Clinical narrative: Left shoulder abscess. Possible necrotizing fasciitis
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Swelling, White blood cell count increased
Clinical narrative: Left shoulder abscess. Possible necrotizing fasciitis
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Abscess
Clinical narrative: Left shoulder abscess. Possible necrotizing fasciitis
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Culture wound positive, Erythema, Fasciotomy, Hypoaesthesia, Incision site erythema
Clinical narrative: Left shoulder abscess. Possible necrotizing fasciitis
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Incisional drainage, Induration, Purulent discharge, Staphylococcal infection, Swelling
Clinical narrative: Left shoulder abscess. Possible necrotizing fasciitis
Age: 1.4
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Vaccination failure, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 17 month old male who on 04-MAY-2007 was vaccinated with a dose of VARIVAX (Oka/Merck) (656287/1508F). There was no concomitant medication.  Approximately 04-OCT-2007, the patient developed chicken pox.  The patient had more than 30 vesicular lesions, mostly on his head, arms and upper torso.  No other symptoms were noted.  Medical attention was sought through an office visit.  There was no product quality complaint.  Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: PNC, MMR, PNC, MMR, PNC
Symptoms: Antimicrobial susceptibility test, Blood culture positive, Brain death, CSF culture positive, Culture urine positive
Clinical narrative: Information regarding PREVNAR was received from a physician regarding a female patient who received the fourth dose on 05-May-2008 at 12 months of age and experienced neurogenic septic shock, neurogenic respiratory failure, brain dead, pneumococcal bacteria in blood, vaccine failure and pneumococcal meningitis at 13 months of age. On 11-May-2008, the patient was admitted to the intensive care unit brain dead and in neurogenic respiratory failure. Laboratory results revealed pneumococcal bacteria in blood and a large amount of pneumococcal bacteria that grew in less than eight hours in CSF culture, which led to the additional diagnosis of pneumococcal meningitis. Serotype testing was not performed. An antimicrobial susceptibility test was unremarkable. The physician felt "like this is a vaccine failure". The patient also developed neurogenic septic shock. Treatment included ROCEPHIN and VANCOMYCIN. On 12-May-2008, the patient died. The cause of death were reported as meningitis pneumococcal, respiratory failure, septic shock, vaccination failure, brain death and pneumococcal sepsis. No additional information was available at the time of this report.  6/3/08-records received for DOS 5/11-5/13/08-Date of Death 5/13/08. Final DX: Meningitis secondary to Streptococcus pneumoniae. Gram-positive coccal bacteremia. Admission neurologic examination consistent with brain death, subsequently confirmed. Brain death confirmed by repeat examination and confirmatory tests through course of hospitalization. Admitted via emergency room previously well child until 3/10/08, warm to touch temperature 101, listless and febrile with temperature as high as 104.4. Vomited. Became limp, feet cold, apneic. CPR initiated at home. Cyanotic. Pupils dilated and nonreactive. GCS 3. Heart rate 170 but not palpable pulses. No spontaneous respirations. Intubation, mechanical ventilation.
Age: 1.1
Sex: F
Vaccine: PNC, MMR, PNC, MMR, PNC
Symptoms: Death, Intensive care, Pneumococcal bacteraemia, Respiratory failure, Septic shock
Clinical narrative: Information regarding PREVNAR was received from a physician regarding a female patient who received the fourth dose on 05-May-2008 at 12 months of age and experienced neurogenic septic shock, neurogenic respiratory failure, brain dead, pneumococcal bacteria in blood, vaccine failure and pneumococcal meningitis at 13 months of age. On 11-May-2008, the patient was admitted to the intensive care unit brain dead and in neurogenic respiratory failure. Laboratory results revealed pneumococcal bacteria in blood and a large amount of pneumococcal bacteria that grew in less than eight hours in CSF culture, which led to the additional diagnosis of pneumococcal meningitis. Serotype testing was not performed. An antimicrobial susceptibility test was unremarkable. The physician felt "like this is a vaccine failure". The patient also developed neurogenic septic shock. Treatment included ROCEPHIN and VANCOMYCIN. On 12-May-2008, the patient died. The cause of death were reported as meningitis pneumococcal, respiratory failure, septic shock, vaccination failure, brain death and pneumococcal sepsis. No additional information was available at the time of this report.  6/3/08-records received for DOS 5/11-5/13/08-Date of Death 5/13/08. Final DX: Meningitis secondary to Streptococcus pneumoniae. Gram-positive coccal bacteremia. Admission neurologic examination consistent with brain death, subsequently confirmed. Brain death confirmed by repeat examination and confirmatory tests through course of hospitalization. Admitted via emergency room previously well child until 3/10/08, warm to touch temperature 101, listless and febrile with temperature as high as 104.4. Vomited. Became limp, feet cold, apneic. CPR initiated at home. Cyanotic. Pupils dilated and nonreactive. GCS 3. Heart rate 170 but not palpable pulses. No spontaneous respirations. Intubation, mechanical ventilation.
Age: 1.1
Sex: F
Vaccine: PNC, MMR, PNC, MMR, PNC
Symptoms: Vaccination failure
Clinical narrative: Information regarding PREVNAR was received from a physician regarding a female patient who received the fourth dose on 05-May-2008 at 12 months of age and experienced neurogenic septic shock, neurogenic respiratory failure, brain dead, pneumococcal bacteria in blood, vaccine failure and pneumococcal meningitis at 13 months of age. On 11-May-2008, the patient was admitted to the intensive care unit brain dead and in neurogenic respiratory failure. Laboratory results revealed pneumococcal bacteria in blood and a large amount of pneumococcal bacteria that grew in less than eight hours in CSF culture, which led to the additional diagnosis of pneumococcal meningitis. Serotype testing was not performed. An antimicrobial susceptibility test was unremarkable. The physician felt "like this is a vaccine failure". The patient also developed neurogenic septic shock. Treatment included ROCEPHIN and VANCOMYCIN. On 12-May-2008, the patient died. The cause of death were reported as meningitis pneumococcal, respiratory failure, septic shock, vaccination failure, brain death and pneumococcal sepsis. No additional information was available at the time of this report.  6/3/08-records received for DOS 5/11-5/13/08-Date of Death 5/13/08. Final DX: Meningitis secondary to Streptococcus pneumoniae. Gram-positive coccal bacteremia. Admission neurologic examination consistent with brain death, subsequently confirmed. Brain death confirmed by repeat examination and confirmatory tests through course of hospitalization. Admitted via emergency room previously well child until 3/10/08, warm to touch temperature 101, listless and febrile with temperature as high as 104.4. Vomited. Became limp, feet cold, apneic. CPR initiated at home. Cyanotic. Pupils dilated and nonreactive. GCS 3. Heart rate 170 but not palpable pulses. No spontaneous respirations. Intubation, mechanical ventilation.
Age: 1.1
Sex: F
Vaccine: PNC, MMR, PNC, MMR, PNC
Symptoms: Brain death, CSF culture positive, Electroencephalogram abnormal, Endotracheal intubation, Gram stain positive
Clinical narrative: Information regarding PREVNAR was received from a physician regarding a female patient who received the fourth dose on 05-May-2008 at 12 months of age and experienced neurogenic septic shock, neurogenic respiratory failure, brain dead, pneumococcal bacteria in blood, vaccine failure and pneumococcal meningitis at 13 months of age. On 11-May-2008, the patient was admitted to the intensive care unit brain dead and in neurogenic respiratory failure. Laboratory results revealed pneumococcal bacteria in blood and a large amount of pneumococcal bacteria that grew in less than eight hours in CSF culture, which led to the additional diagnosis of pneumococcal meningitis. Serotype testing was not performed. An antimicrobial susceptibility test was unremarkable. The physician felt "like this is a vaccine failure". The patient also developed neurogenic septic shock. Treatment included ROCEPHIN and VANCOMYCIN. On 12-May-2008, the patient died. The cause of death were reported as meningitis pneumococcal, respiratory failure, septic shock, vaccination failure, brain death and pneumococcal sepsis. No additional information was available at the time of this report.  6/3/08-records received for DOS 5/11-5/13/08-Date of Death 5/13/08. Final DX: Meningitis secondary to Streptococcus pneumoniae. Gram-positive coccal bacteremia. Admission neurologic examination consistent with brain death, subsequently confirmed. Brain death confirmed by repeat examination and confirmatory tests through course of hospitalization. Admitted via emergency room previously well child until 3/10/08, warm to touch temperature 101, listless and febrile with temperature as high as 104.4. Vomited. Became limp, feet cold, apneic. CPR initiated at home. Cyanotic. Pupils dilated and nonreactive. GCS 3. Heart rate 170 but not palpable pulses. No spontaneous respirations. Intubation, mechanical ventilation.