chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Hyperhidrosis, Pain, Pallor, Pyrexia, Sleep disorder
Clinical narrative: 5-16-06 evening developed fever of 104, orally.  Describes it as a "damp fever", very sweaty, pale, body aches.  Did not sleep well for 2 nights, so sweaty she had to lay a towel on the bed.  Uncomfortable.  Better by 5-18-06 in the afternoon.
Age: 65.0
Sex: F
Vaccine: PPV, TD
Symptoms: Cellulitis, Flushing, Hypokalaemia, Hyponatraemia, Injection site erythema
Clinical narrative: Pneumovax given on 5/15/06 right deltoid. 5/16 pt came to MD with right arm erythema and edema at inj site, despite use of acetominophine and ice packs x5.  MD and Allergy MD saw patient and prescribed prednisone 60mg qd. 5/17 the patient returned with increased swelling and erythema to upper arm extending to elbow, erythema to shoulder and side of neck.  Pt face is flushed and states she "does not feel well". No temp, chills or sweats.  Pt stated she did take prednisone as prescribed.  pt admitted to hospital for IV antibiotics, re: cellulitis.
Age: 65.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site swelling, Malaise
Clinical narrative: Pneumovax given on 5/15/06 right deltoid. 5/16 pt came to MD with right arm erythema and edema at inj site, despite use of acetominophine and ice packs x5.  MD and Allergy MD saw patient and prescribed prednisone 60mg qd. 5/17 the patient returned with increased swelling and erythema to upper arm extending to elbow, erythema to shoulder and side of neck.  Pt face is flushed and states she "does not feel well". No temp, chills or sweats.  Pt stated she did take prednisone as prescribed.  pt admitted to hospital for IV antibiotics, re: cellulitis.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: Redness and itching at the vaccine site 48 hours after administration of the vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Injection site erythema, Injection site pain
Clinical narrative: Patient returned to office with 48 hours of vaccination with redness, tenderness, and bruising at the injection site.
Age: 0.38
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Decreased appetite, Hypokinesia, Pain, Pyrexia, Screaming
Clinical narrative: Elevated temperature on and off for 2 days; screaming; decreased movement of legs with screaming on touch or PROM; interrupted sleep with decreased appetite; "not himself".
Age: 45.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Local redness, swelling, and inflamation 5.5cm X 5.5cm.
Age: 9.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, TDAP
Symptoms: Unevaluable event
Clinical narrative: CALLED FOR ADVERSE REACTION.  ADVISED, THERE MAY BE LOCAL SWELLING, REDNESS.  WILL CONTINUE TO MONITOR PATIENT.
Age: 1.04
Sex: M
Vaccine: FLU3, HIBV, MMR, VARCEL
Symptoms: Cough, Eye oedema, Face oedema, Rash erythematous, Rash maculo-papular
Clinical narrative: Vaccines administered 1/26/06. Exactly seven days later child woke up in night around 11 pm with cough that sounded like he was trying to constantly clear his throat. Awoke next morning with white spots on face and back/body but had red, raised areas on back, but not past the waist. Eyes, nose, and lips were swollen. Taken to ER. Given oral steroid at ER. Mom states she gave him more oral steroid at home as doctor ordered. Complete recovery and no further treatment needed. Mom informed nurse of reaction at 15 month visit on 5/10/2006.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Hypersensitivity, Injection site warmth
Clinical narrative: ON 5-16-06 THIS CHILD RECEIVED HER 5 YR VACCINES. ON 5-18-06 THE CHILD RETURNED TO OUR OFFICE WITH LOCAL ALLERGIC REACTION TO THE LEFT THIGH IN WHICH THE DTAP WAS GIVEN.  THE LEFT THIGH HAD GENERALIZED REDNESS, NON-TENDER, NON-FLUCTUANT, SLIGHT WARMTH TO AREA.  SHE WAS GIVEN ZYRTEC, APPLY A COOL COMPRESS TO AREA, AND ADVISED TO CALL IF WORSENS.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Irritability, Lethargy, Skin discolouration, Swelling
Clinical narrative: First & second days:  arm swollen and discolored, fussiness.  Third day: fussy, lethargic, vomiting, diarrhea.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: First & second days:  arm swollen and discolored, fussiness.  Third day: fussy, lethargic, vomiting, diarrhea.
Age: 1.02
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Autism, Bacterial infection, Convulsion, Hypersensitivity, Pyrexia
Clinical narrative: Fever, drop seizure, gut issues with yeast and bacteria, sensitive to gluten and casein, autism diagnosis.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Antinuclear antibody positive, Arthralgia, Arthralgia, Blood immunoglobulin G decreased, Bone marrow failure
Clinical narrative: Fell to floor immediately after receiving box. Over next few days developed joint aches, rash, N/V, HA and eye pain. Became difficulty to walk 7/5 and by mid July, dx w/Lupus. Lost 20#. Tx w/6 mos. 5/30/06 Received medical records from PCP which reveal Patient seen 7/7/03 for possible sun poisoning, working as lifeguard w/o sunscreen.  S/S included nausea, sore throat, swollen lymph nodes, headache & fever.  Had muscle aches x 2 weeks.  Exam revealed red throat (throat c/s neg) and blotchy rash on face & macular rash on txtremities.  Labs were ordered.  Records also included ER record of 7/8/03 which revealed patient had collagen-type disease & bone marrow depressions which was thought to be due to a viral illness. Additional labs were ordered. Patient returned to PCP following day & was referred to specialist./ss. 60 day Follow-up Information 10-OCT-2006: She continues to need medication for lupus and constant monitoring by doctors.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Collagen disorder, Culture negative, DNA antibody positive, Difficulty in walking, Eye pain
Clinical narrative: Fell to floor immediately after receiving box. Over next few days developed joint aches, rash, N/V, HA and eye pain. Became difficulty to walk 7/5 and by mid July, dx w/Lupus. Lost 20#. Tx w/6 mos. 5/30/06 Received medical records from PCP which reveal Patient seen 7/7/03 for possible sun poisoning, working as lifeguard w/o sunscreen.  S/S included nausea, sore throat, swollen lymph nodes, headache & fever.  Had muscle aches x 2 weeks.  Exam revealed red throat (throat c/s neg) and blotchy rash on face & macular rash on txtremities.  Labs were ordered.  Records also included ER record of 7/8/03 which revealed patient had collagen-type disease & bone marrow depressions which was thought to be due to a viral illness. Additional labs were ordered. Patient returned to PCP following day & was referred to specialist./ss. 60 day Follow-up Information 10-OCT-2006: She continues to need medication for lupus and constant monitoring by doctors.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Immediate post-injection reaction, Laboratory test abnormal, Lymphadenopathy, Myalgia
Clinical narrative: Fell to floor immediately after receiving box. Over next few days developed joint aches, rash, N/V, HA and eye pain. Became difficulty to walk 7/5 and by mid July, dx w/Lupus. Lost 20#. Tx w/6 mos. 5/30/06 Received medical records from PCP which reveal Patient seen 7/7/03 for possible sun poisoning, working as lifeguard w/o sunscreen.  S/S included nausea, sore throat, swollen lymph nodes, headache & fever.  Had muscle aches x 2 weeks.  Exam revealed red throat (throat c/s neg) and blotchy rash on face & macular rash on txtremities.  Labs were ordered.  Records also included ER record of 7/8/03 which revealed patient had collagen-type disease & bone marrow depressions which was thought to be due to a viral illness. Additional labs were ordered. Patient returned to PCP following day & was referred to specialist./ss. 60 day Follow-up Information 10-OCT-2006: She continues to need medication for lupus and constant monitoring by doctors.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Oropharyngeal pain, Pharyngeal erythema, Platelet count decreased, Pyrexia
Clinical narrative: Fell to floor immediately after receiving box. Over next few days developed joint aches, rash, N/V, HA and eye pain. Became difficulty to walk 7/5 and by mid July, dx w/Lupus. Lost 20#. Tx w/6 mos. 5/30/06 Received medical records from PCP which reveal Patient seen 7/7/03 for possible sun poisoning, working as lifeguard w/o sunscreen.  S/S included nausea, sore throat, swollen lymph nodes, headache & fever.  Had muscle aches x 2 weeks.  Exam revealed red throat (throat c/s neg) and blotchy rash on face & macular rash on txtremities.  Labs were ordered.  Records also included ER record of 7/8/03 which revealed patient had collagen-type disease & bone marrow depressions which was thought to be due to a viral illness. Additional labs were ordered. Patient returned to PCP following day & was referred to specialist./ss. 60 day Follow-up Information 10-OCT-2006: She continues to need medication for lupus and constant monitoring by doctors.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Rash, Rash macular, Red blood cell sedimentation rate increased, Systemic lupus erythematosus, Vomiting
Clinical narrative: Fell to floor immediately after receiving box. Over next few days developed joint aches, rash, N/V, HA and eye pain. Became difficulty to walk 7/5 and by mid July, dx w/Lupus. Lost 20#. Tx w/6 mos. 5/30/06 Received medical records from PCP which reveal Patient seen 7/7/03 for possible sun poisoning, working as lifeguard w/o sunscreen.  S/S included nausea, sore throat, swollen lymph nodes, headache & fever.  Had muscle aches x 2 weeks.  Exam revealed red throat (throat c/s neg) and blotchy rash on face & macular rash on txtremities.  Labs were ordered.  Records also included ER record of 7/8/03 which revealed patient had collagen-type disease & bone marrow depressions which was thought to be due to a viral illness. Additional labs were ordered. Patient returned to PCP following day & was referred to specialist./ss. 60 day Follow-up Information 10-OCT-2006: She continues to need medication for lupus and constant monitoring by doctors.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Weight decreased, White blood cell count decreased
Clinical narrative: Fell to floor immediately after receiving box. Over next few days developed joint aches, rash, N/V, HA and eye pain. Became difficulty to walk 7/5 and by mid July, dx w/Lupus. Lost 20#. Tx w/6 mos. 5/30/06 Received medical records from PCP which reveal Patient seen 7/7/03 for possible sun poisoning, working as lifeguard w/o sunscreen.  S/S included nausea, sore throat, swollen lymph nodes, headache & fever.  Had muscle aches x 2 weeks.  Exam revealed red throat (throat c/s neg) and blotchy rash on face & macular rash on txtremities.  Labs were ordered.  Records also included ER record of 7/8/03 which revealed patient had collagen-type disease & bone marrow depressions which was thought to be due to a viral illness. Additional labs were ordered. Patient returned to PCP following day & was referred to specialist./ss. 60 day Follow-up Information 10-OCT-2006: She continues to need medication for lupus and constant monitoring by doctors.
Age: 37.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Bacterial infection, Dyspnoea, Guillain-Barre syndrome, Headache
Clinical narrative: Several days of odd sensation of both feet along with weakness of arms but mostly weakness of legs. Sent to ER to be admitted to R/O GBS. Received Adacel for pertussis outbreak.  6/6/06 Received medical records from hospital which reveal patient experienced HA, low back pain radiating to bilateral thigh, numbness & tingling of arms & legs x 3 days.  Difficulty walking & climbing stairs, unable to run or walk fast (patient is regular runner). Treated & released from ER to f/u as outpatient.  O2 sats in ER wer 92% on RA.  Dx: probable GBS 2 wks post vax.  MRI of complete spine revealed disc bulges.  6/6/06 Received medical records from neurologist which reveal patient had nerve conduction studies which showed findings consistent w/demyelinative neuropathy compatible w/GBS.  Treated & permitted to work only 8 hrs daily (patient is an MD)/ss
Age: 37.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia
Clinical narrative: Several days of odd sensation of both feet along with weakness of arms but mostly weakness of legs. Sent to ER to be admitted to R/O GBS. Received Adacel for pertussis outbreak.  6/6/06 Received medical records from hospital which reveal patient experienced HA, low back pain radiating to bilateral thigh, numbness & tingling of arms & legs x 3 days.  Difficulty walking & climbing stairs, unable to run or walk fast (patient is regular runner). Treated & released from ER to f/u as outpatient.  O2 sats in ER wer 92% on RA.  Dx: probable GBS 2 wks post vax.  MRI of complete spine revealed disc bulges.  6/6/06 Received medical records from neurologist which reveal patient had nerve conduction studies which showed findings consistent w/demyelinative neuropathy compatible w/GBS.  Treated & permitted to work only 8 hrs daily (patient is an MD)/ss
Age: 37.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Abasia, Activities of daily living impaired, Areflexia, Back pain, Bacterial infection
Clinical narrative: Several days of odd sensation of both feet along with weakness of arms but mostly weakness of legs. Sent to ER to be admitted to R/O GBS. Received Adacel for pertussis outbreak.  6/6/06 Received medical records from hospital which reveal patient experienced HA, low back pain radiating to bilateral thigh, numbness & tingling of arms & legs x 3 days.  Difficulty walking & climbing stairs, unable to run or walk fast (patient is regular runner). Treated & released from ER to f/u as outpatient.  O2 sats in ER wer 92% on RA.  Dx: probable GBS 2 wks post vax.  MRI of complete spine revealed disc bulges.  6/6/06 Received medical records from neurologist which reveal patient had nerve conduction studies which showed findings consistent w/demyelinative neuropathy compatible w/GBS.  Treated & permitted to work only 8 hrs daily (patient is an MD)/ss
Age: 37.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Dyspnoea, Gait disturbance, Guillain-Barre syndrome, Headache, Hypoaesthesia
Clinical narrative: Several days of odd sensation of both feet along with weakness of arms but mostly weakness of legs. Sent to ER to be admitted to R/O GBS. Received Adacel for pertussis outbreak.  6/6/06 Received medical records from hospital which reveal patient experienced HA, low back pain radiating to bilateral thigh, numbness & tingling of arms & legs x 3 days.  Difficulty walking & climbing stairs, unable to run or walk fast (patient is regular runner). Treated & released from ER to f/u as outpatient.  O2 sats in ER wer 92% on RA.  Dx: probable GBS 2 wks post vax.  MRI of complete spine revealed disc bulges.  6/6/06 Received medical records from neurologist which reveal patient had nerve conduction studies which showed findings consistent w/demyelinative neuropathy compatible w/GBS.  Treated & permitted to work only 8 hrs daily (patient is an MD)/ss
Age: 37.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Intervertebral disc protrusion, Muscular weakness, Nerve conduction studies abnormal, Neuropathy peripheral, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Several days of odd sensation of both feet along with weakness of arms but mostly weakness of legs. Sent to ER to be admitted to R/O GBS. Received Adacel for pertussis outbreak.  6/6/06 Received medical records from hospital which reveal patient experienced HA, low back pain radiating to bilateral thigh, numbness & tingling of arms & legs x 3 days.  Difficulty walking & climbing stairs, unable to run or walk fast (patient is regular runner). Treated & released from ER to f/u as outpatient.  O2 sats in ER wer 92% on RA.  Dx: probable GBS 2 wks post vax.  MRI of complete spine revealed disc bulges.  6/6/06 Received medical records from neurologist which reveal patient had nerve conduction studies which showed findings consistent w/demyelinative neuropathy compatible w/GBS.  Treated & permitted to work only 8 hrs daily (patient is an MD)/ss
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ, TYP, FLU3, MNQ, TYP
Symptoms: Dizziness, Flushing, Headache, Injection site induration, Pain
Clinical narrative: Administration Menactra at 11:00 AM for trip. Came home, pt's arm pain at school. Didn't feel good. Arm ached and felt achy all over. Went to bed, felt hot and horrible all night long, headache, tossed and turned. Didn't feel like a headache. Could get up. When up /// checked temp 103.5F. Given Tylenol, pushed fluids and temp decreased to 99F. Went up again 10:30 AM to >101F. Left arm is very hard. Doesn't wish to ///. Dizzy and continues to achy.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ, TYP, FLU3, MNQ, TYP
Symptoms: Pruritus, Pyrexia, Sleep disorder
Clinical narrative: Administration Menactra at 11:00 AM for trip. Came home, pt's arm pain at school. Didn't feel good. Arm ached and felt achy all over. Went to bed, felt hot and horrible all night long, headache, tossed and turned. Didn't feel like a headache. Could get up. When up /// checked temp 103.5F. Given Tylenol, pushed fluids and temp decreased to 99F. Went up again 10:30 AM to >101F. Left arm is very hard. Doesn't wish to ///. Dizzy and continues to achy.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ, TYP, FLU3, MNQ, TYP
Symptoms: Dizziness, Feeling hot, Headache, Hypokinesia, Injection site pain
Clinical narrative: Administration Menactra at 11:00 AM for trip. Came home, pt's arm pain at school. Didn't feel good. Arm ached and felt achy all over. Went to bed, felt hot and horrible all night long, headache, tossed and turned. Didn't feel like a headache. Could get up. When up /// checked temp 103.5F. Given Tylenol, pushed fluids and temp decreased to 99F. Went up again 10:30 AM to >101F. Left arm is very hard. Doesn't wish to ///. Dizzy and continues to achy.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ, TYP, FLU3, MNQ, TYP
Symptoms: Insomnia, Malaise, Pain, Pyrexia
Clinical narrative: Administration Menactra at 11:00 AM for trip. Came home, pt's arm pain at school. Didn't feel good. Arm ached and felt achy all over. Went to bed, felt hot and horrible all night long, headache, tossed and turned. Didn't feel like a headache. Could get up. When up /// checked temp 103.5F. Given Tylenol, pushed fluids and temp decreased to 99F. Went up again 10:30 AM to >101F. Left arm is very hard. Doesn't wish to ///. Dizzy and continues to achy.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: On 5/13/06-///
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: Swelling, redness of left arm, fever after IM Dtap injection. Taken to ER 5/16/06. Followed up with Dr on 5/17/06. Given cephalexin 250mg 4 x day. On 5/19/06. Grandmother says she is doing much better.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Decreased appetite, Screaming, Vomiting projectile
Clinical narrative: Started inconsolable crying, decreased appetite and projectile vomiting x 2. Cried for 12 hours started 6 hours after Vax.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema
Clinical narrative: Left arm was swollen red induration, below injection site. Local reaction.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Medication error
Clinical narrative: 6x5 an erythema with 3cm Induration and cellulitis on the same day of immunization.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site induration
Clinical narrative: Severe Induration and cellulitis of left thigh spans interior surface 80- 90%. Advil Keflex.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported redness, swelling and warmth at injection site. Warm moist heat to area.
Age: 1.01
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Blister, Erythema, Rash
Clinical narrative: Developed small red itchy spots resembling chicken pox mostly on back few on front torso 5/15/06 despite getting varivax vaccine on 7/11/03. The pediatrician is treating him for chicken pox and prescribed hydroxyine for the itching and mupiro to keep from getting infected.  New spots continued to appear 4 days after. They were small with tiny tiny bubble. He is still recovering. Note teachers at his daycare noted that they were aware of chicken pox going around in other schools.
Age: 1.99
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Pyrexia
Clinical narrative: Immunization administered on 5/12/06. began running low-grade fever on 5/19/06.  The fever turned into a high-grade (104+) the evening of 4/20/06.  We are currently attempting to control the fever with Tylenol and Ibuprofen.  We will take her to the ER if the fever gets out of control.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea, Rash, Swelling face, Wheezing
Clinical narrative: Information has been received from a person working in a physician's office concerning a 5 year old male with an egg allergy who on 21-jun-2005, at 9:30 AM, was vaccinated with a subcutaneous first dose in the right arm of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot# 649509/0773P). Concomitant vaccines administered at the same time included a fifth intramuscular dose in the right arm of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX) (Lot# AC14A010BA) and a fourth intramuscular dose in the right arm of poliovirus vaccine inactivated (Vero) (IPOL) (Lot# 40240-2). There was no illness at the time of vaccination. It was reported that on 21-JUN-2005, at 9:45 AM, the patient experienced wheezing, difficult breathing, a rash everywhere and face that was swollen. Subsequently, the patient recovered. Unspecified medical attention was sought. Additional information is not expected.
Age: 1.33
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling injection site in a 15 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 05Aug05 the subject received 3rd dose of Infanrix in the left thigh (lotAC14006BA- incorrect lot number). On 05Aug05, the subject also received injections in the right thigh with haemophilus influenzae type b conjugate vaccine (PedvaxHIB) and hep B vaccine (manf unspecified). On 06Aug05, 1 day after vaccination with Infanrix, the subject experienced an injection site reaction in the left thigh at the site of the Infanrix administration characterized as swelling, redness and hardness. The subject was seen at a physician's office. The events had improved by 05Dec05. The nurse considered the events to be related to vaccination with Infanrix.
Age: 1.26
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Injection site nodule, Injection site swelling, Pyrexia, Tenderness
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in a 15 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 12Aug05 the subject received the 4th dose of Infanrix in the left thigh (lot AC14006BA incorrect lot number). On 12Aug05, the subject also received vaccination with 7 valent pneumococcal conjugate vaccine (Prevnar) in the right thigh. On 13Aug05, 1 day after vaccination with Infanrix, the subject experienced fever, and an injection site at the site of Infanrix administration described as a lump and swollen and warm and tender to the touch. On 16Aug05, the fever and injection site swelling, warmth and tenderness resolved an only a slight lump remained at the injection site of Infanrix.
Age: 3.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Anaphylactic reaction, Erythema, Eye swelling, Flushing, Hypotension
Clinical narrative: Information has been received from a health professional concerning a 39 month old male who was vaccinated with a SC second dose in the right thigh of MMR (lot # 649230/0027R). Concomitant vaccine administration on the same day included a first IM dose in the left thigh of hepatitis A vaccine (lot # AHAVB032AA). Subsequently the patient experienced an anaphylactic reaction from the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that on 8/17/05, shortly after vaccination, the patient developed respiratory difficulty and small hives. Also he developed flushing of the skin. Oximetry at that point was 90% and he was having mild respiratory distress. He was given diphenhydramine hydrochloride, 1 tsp, oral administration, plus an epinephrine, 0.15mg, IM. The patient responded clinically with increased oxygenation, ease of breathing and the redness decreased. The patient did develop some swelling around his eyes at that point. After about 30 minutes, the patient returned to having respiratory distress. The patient was given a second shot of epinephrine plus dexamethasone, 8 mg, oral administration. The assessment was respiratory difficulty. The patient was sent to a medical center. It was noted that the patient was stable at the time of discharge. Anaphylactic reaction to vaccine was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Hypoxia, Respiratory distress, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 39 month old male who was vaccinated with a SC second dose in the right thigh of MMR (lot # 649230/0027R). Concomitant vaccine administration on the same day included a first IM dose in the left thigh of hepatitis A vaccine (lot # AHAVB032AA). Subsequently the patient experienced an anaphylactic reaction from the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that on 8/17/05, shortly after vaccination, the patient developed respiratory difficulty and small hives. Also he developed flushing of the skin. Oximetry at that point was 90% and he was having mild respiratory distress. He was given diphenhydramine hydrochloride, 1 tsp, oral administration, plus an epinephrine, 0.15mg, IM. The patient responded clinically with increased oxygenation, ease of breathing and the redness decreased. The patient did develop some swelling around his eyes at that point. After about 30 minutes, the patient returned to having respiratory distress. The patient was given a second shot of epinephrine plus dexamethasone, 8 mg, oral administration. The assessment was respiratory difficulty. The patient was sent to a medical center. It was noted that the patient was stable at the time of discharge. Anaphylactic reaction to vaccine was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Hypokinesia, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 4-year-old female with no medical history or allergies who on 26-APR-2005 was vaccinated subcutaneously in the right arm with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 647283/0550P) in preparation for school. Concomitant vaccinations included: diphtheria toxoid (+) pertussis vaccine )unspecified) (+) tetanus toxoid and poliovirus vaccine inactivated (unspecified). On 28-APR-2005 the patient had a fever and redness and swelling in the right upper arm. The patient's mother had also reported that she was "barely able to move her arm or hand". The patient was seen by the physician on the same day and his report states "right arm area was swollen with a redness 5 1/2 inches from shoulder to 1 inch above elbow., tender and firm. the physician recommended acetaminophen (TYLENOL) and a warm or cool bath. No laboratory or diagnostic tests were performed. The R.N. noted that the patient had "no arm complaints". follow-up information indicated that the patient had recovered. On 26-JUL-2005 he patient was seen by the physician for a cough. No outcome was reported. No product quality complaint were involved. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Anorexia, Malaise, Pharyngolaryngeal pain, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 4-year-old male with an egg allergy (epinephrine (EPI-PEN) on hand) who on 07-SEP-2005 at 14:30 pm was vaccinated SC with a 0.5 mL first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 649244/0151R). There was no illness at the time of vaccination. On 17-SEP-2005, the patient developed fever and hives. The patient was taken to the emergency room on 20-Sep-2005 since the rash was allover his body later that day when seen by the physician in the office. The patient was given steroids. At the time of the report, the patient had not recovered. A product quality complaint was not involved.  Follow-up information has been received from a health professional who reported that on 15-SEP-2005, the patient had a fever, sore throat, and was not eating. No rash was noted. On 17-SEP-2005, a throat culture was negative. On 19-SEP-2005, the patient had a fever and slow speech and was taken to the emergency room. On 20-SEP-2005, the patient had a rash, fever, malaise, and slowed speech. A urinalysis was performed (see laboratory section). At the time of the report, it was unknown if the patient recovered. No further information is expected.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Speech disorder, Urticaria
Clinical narrative: Information has been received from a physician concerning a 4-year-old male with an egg allergy (epinephrine (EPI-PEN) on hand) who on 07-SEP-2005 at 14:30 pm was vaccinated SC with a 0.5 mL first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 649244/0151R). There was no illness at the time of vaccination. On 17-SEP-2005, the patient developed fever and hives. The patient was taken to the emergency room on 20-Sep-2005 since the rash was allover his body later that day when seen by the physician in the office. The patient was given steroids. At the time of the report, the patient had not recovered. A product quality complaint was not involved.  Follow-up information has been received from a health professional who reported that on 15-SEP-2005, the patient had a fever, sore throat, and was not eating. No rash was noted. On 17-SEP-2005, a throat culture was negative. On 19-SEP-2005, the patient had a fever and slow speech and was taken to the emergency room. On 20-SEP-2005, the patient had a rash, fever, malaise, and slowed speech. A urinalysis was performed (see laboratory section). At the time of the report, it was unknown if the patient recovered. No further information is expected.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 15 month old Chinese female, who was positive for purified protein derivative of tuberculin and had a negative chest X-ray on "INH", who on 15-SEP-2005, at 2:30 pm was vaccinated with a first 0.5 Ml subcutaneous dose in the left arm of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (Lot# 647114/0485R). There was no illness at the time of vaccination. It was reported that the patient developed a severe rash. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that on 24-SEP-2005, at 9:00 am, the patient had a fever up to 38.8 for two days, and a maculopapular rash on her trunk for six days that was coalescing on her face and spreading to her legs. It was reported that the patient recovered on 29-SEP-2005. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Alopecia, Immune system disorder
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with a shellfish allergy and no medical history, who on 27-SEP-2005 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 646900/0348P). There was no concomitant medication. In October 2005, the patient was diagnosed with alopecia. The doctor who diagnosed the alopecia felt that the alopecia was the result of the vaccination triggering an autoimmune response in this patient. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. It was also noted in 1989, th patient received the first dose of measles virus live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). No product quality complaint was involved. Follow-up information from the nurse practitioner indicated that she did not have any additional information. The nurse practitioner did not see the patient, she saw another provider and the patient's mother reported the information to the nurse practitioner. No further information is available.
Age: 1.25
Sex: M
Vaccine: DT, MMR
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old male who on 12-NOV-2005 was vaccinated SC with a 0.5 mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 649752/0302R). concomitant vaccination that day included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). On 18-NOV-2005 the patient developed a measles like rash. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. The patient was given cortisone cream for the rash. The rash disappeared in a few days. there was no product quality complaint involved. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Pyrexia, Rash macular
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male with no pre-existing allergies, birth defects, or medical conditions who on 20-DEC-205 at 11:00 AM was vaccinated SC in the right thigh with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 649240/0031R). There was no illness at the time of vaccination. Concomitant therapy that day at 11:00 AM included a fourth dose of Hib conj vaccine (tet toxoid) (ACTHIB) (Batch # U5684AA). On 21-DEC-2005 the patient was diagnosed with otitis media. He was taken to the emergency room, and started on a 5-day course of PO zithromax. On 31-DEC-2005 the patient developed a fever of 102 degrees Fahrenheit and maculopapular rash on his anterior and posterior trunk that extended up into his neck and face. Subsequently, the patient recovered on 03-JAN-2006. It was noted that the rash was fading. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations. Additional data has been requested.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Otitis media, Pyrexia, Rash macular
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male with no pre-existing allergies, birth defects, or medical conditions who on 20-DEC-205 at 11:00 AM was vaccinated SC in the right thigh with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 649240/0031R). There was no illness at the time of vaccination. Concomitant therapy that day at 11:00 AM included a fourth dose of Hib conj vaccine (tet toxoid) (ACTHIB) (Batch # U5684AA). On 21-DEC-2005 the patient was diagnosed with otitis media. He was taken to the emergency room, and started on a 5-day course of PO zithromax. On 31-DEC-2005 the patient developed a fever of 102 degrees Fahrenheit and maculopapular rash on his anterior and posterior trunk that extended up into his neck and face. Subsequently, the patient recovered on 03-JAN-2006. It was noted that the rash was fading. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations. Additional data has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site redness in a 4 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 03Jan06 the subject received 5th dose of Infanrix in the left thigh (lot AC14A007AA). On 03Jan06, the subject also received an injection of inactivated poliomyelitis virus vaccine (Ipol) at an unspecified site of injection. On 04Jan06, one day after vaccination with Infanrix, the subject experienced injection site redness and injection site swelling at the site of the Infanrix administration. The nurse described the size of the injection site redness as 6 inches by 4 inches. The events resolved on 05Jan06. The nurse considered the events to possibly be related to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site redness in a 4 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 03Jan06 the subject received 5th dose of Infanrix in the left thigh (lot AC14A007AA). On 03Jan06, the subject also received an injection of inactivated poliomyelitis virus vaccine (Ipol) at an unspecified site of injection. On 04Jan06, one day after vaccination with Infanrix, the subject experienced injection site redness and injection site swelling at the site of the Infanrix administration. The nurse described the size of the injection site redness as 6 inches by 4 inches. The events resolved on 05Jan06. The nurse considered the events to possibly be related to vaccination with Infanrix.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site reaction in a 4 yr old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 11Jan06 the subject received 5th dose of Infanrix in the left thigh (lotAC14A007AA). On 11Jan06, the subject also received injections of inactivated poliomyelitis virus vaccine and measles, mumps and rubella virus vaccine (MMRII). The sites of injection for Ipol and MMR II were not provided. On 13Jan06 two days after vaccination with Infanrix the subject experienced injection site redness at the site of the Infanrix administration. The nurse described the size of the injection site redness as 6 inches by 4 inches. At the time of initial reporting, 13Jan06, the event was ongoing. The nurse considered the event to probably be related to vaccination with Infanrix.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site reaction in a 4 yr old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 11Jan06 the subject received 5th dose of Infanrix in the left thigh (lotAC14A007AA). On 11Jan06, the subject also received injections of inactivated poliomyelitis virus vaccine and measles, mumps and rubella virus vaccine (MMRII). The sites of injection for Ipol and MMR II were not provided. On 13Jan06 two days after vaccination with Infanrix the subject experienced injection site redness at the site of the Infanrix administration. The nurse described the size of the injection site redness as 6 inches by 4 inches. At the time of initial reporting, 13Jan06, the event was ongoing. The nurse considered the event to probably be related to vaccination with Infanrix.
Age: 1.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL, DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Erythema, Rash macular, Rash maculo-papular, Rash morbilliform
Clinical narrative: Measles:Diarrhea Information has been received from a medical assistant and a consumer concerning her son an 18 month old male with penile adhesions, an upper respiratory tract infection and otitis media who on 09-JAN-06 at 14:30 was vaccinated SC in the left arm with a 0.5 ml first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 649755/0380R). Suspect vaccination administered that day at 14:40 included a SC first dose of varicella virus vaccine live (MSD) (lot #651046/0325R) in the right arm, an IM first dose of HIB conj-hepatitis B vaccine (MSD) (lot #650760-297R) in the right thigh, an IM second dose of poliovirus vaccine inactivated (Vero) (IPOL) (lot #Y0424) in the left thigh and IM second dose of diphtheria toxoid (-) pertussis acellular 5 component vaccine (+) tetanus toxoid (DAPTACEL) (lot #C22220AA) in the left thigh and an IM second dose of pneumococcal 4 6 B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot #508636C) in the right thigh. On 10-JAN-2006 the patient experienced fever, rash and server diarrhea. This continued for several days before a "measles rash" formed. The patient experienced the rash on his chest, back, forehead, cheek and buttocks. On 20-JAN-2006 the patient's rash was reported as mostly gone. It was later reported that on 21-FEB-2006 the patient developed a blotchy erytheratis, macular, papular, rash to trunk, extremities, face and neck. Unspecified medical attention was sought. There were no laboratory diagnostic tests performed. At the time of the report the patient was recovering. There was no product quality complaint involved.  Additional information is not expected.
Age: 1.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL, DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Diarrhoea, Otitis media, Penis disorder, Pyrexia, Rash
Clinical narrative: Measles:Diarrhea Information has been received from a medical assistant and a consumer concerning her son an 18 month old male with penile adhesions, an upper respiratory tract infection and otitis media who on 09-JAN-06 at 14:30 was vaccinated SC in the left arm with a 0.5 ml first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 649755/0380R). Suspect vaccination administered that day at 14:40 included a SC first dose of varicella virus vaccine live (MSD) (lot #651046/0325R) in the right arm, an IM first dose of HIB conj-hepatitis B vaccine (MSD) (lot #650760-297R) in the right thigh, an IM second dose of poliovirus vaccine inactivated (Vero) (IPOL) (lot #Y0424) in the left thigh and IM second dose of diphtheria toxoid (-) pertussis acellular 5 component vaccine (+) tetanus toxoid (DAPTACEL) (lot #C22220AA) in the left thigh and an IM second dose of pneumococcal 4 6 B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot #508636C) in the right thigh. On 10-JAN-2006 the patient experienced fever, rash and server diarrhea. This continued for several days before a "measles rash" formed. The patient experienced the rash on his chest, back, forehead, cheek and buttocks. On 20-JAN-2006 the patient's rash was reported as mostly gone. It was later reported that on 21-FEB-2006 the patient developed a blotchy erytheratis, macular, papular, rash to trunk, extremities, face and neck. Unspecified medical attention was sought. There were no laboratory diagnostic tests performed. At the time of the report the patient was recovering. There was no product quality complaint involved.  Additional information is not expected.
Age: 1.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL, DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Rash erythematous, Rash macular, Rash maculo-papular, Upper respiratory tract infection
Clinical narrative: Measles:Diarrhea Information has been received from a medical assistant and a consumer concerning her son an 18 month old male with penile adhesions, an upper respiratory tract infection and otitis media who on 09-JAN-06 at 14:30 was vaccinated SC in the left arm with a 0.5 ml first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 649755/0380R). Suspect vaccination administered that day at 14:40 included a SC first dose of varicella virus vaccine live (MSD) (lot #651046/0325R) in the right arm, an IM first dose of HIB conj-hepatitis B vaccine (MSD) (lot #650760-297R) in the right thigh, an IM second dose of poliovirus vaccine inactivated (Vero) (IPOL) (lot #Y0424) in the left thigh and IM second dose of diphtheria toxoid (-) pertussis acellular 5 component vaccine (+) tetanus toxoid (DAPTACEL) (lot #C22220AA) in the left thigh and an IM second dose of pneumococcal 4 6 B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot #508636C) in the right thigh. On 10-JAN-2006 the patient experienced fever, rash and server diarrhea. This continued for several days before a "measles rash" formed. The patient experienced the rash on his chest, back, forehead, cheek and buttocks. On 20-JAN-2006 the patient's rash was reported as mostly gone. It was later reported that on 21-FEB-2006 the patient developed a blotchy erytheratis, macular, papular, rash to trunk, extremities, face and neck. Unspecified medical attention was sought. There were no laboratory diagnostic tests performed. At the time of the report the patient was recovering. There was no product quality complaint involved.  Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site warmth, Pruritus, Tenderness
Clinical narrative: This case was reported by a pharmacist and described  the occurrence of swelling injection site in a 4 yr old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The subject's medical history included goldenhar's syndrome and asthma. Concurrent medications included Salbutamol sulphate (Albuterol), Budesonide (Pulmicort) and Glycopyrronium bromide (Glycopyrrolate). On 24Jan06 at 4:00PM, the subject received 4th dose of Infanrix in the right leg (lot AC14B013AA). On 24Jan06, the subject also received injections of inactivated poliomyelitis virus vaccine (Ipol, lot Y0265) and measles mumps and rubella vaccine, strain not specified (MMRII; lot 0464R). The injection sites for the Ipol and MMRII were not provided. On 25Jan06 at 3:00PM, 1 day after vaccination with Infanrix, the subject experienced an injection site reaction at the site of admin of Infanrix characterized as swelling, tenderness, warmth, redness, and pruritis. The subject was seen at a physician's office. At the time of initial reporting 01Feb06 the events were ongoing.