chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Blister, Erythema
Clinical narrative: Pt Lt upper arm was red and had blister. Pt was given oral antibiotic and Topical cream.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pharyngolaryngeal pain, Pyrexia, Skin discolouration
Clinical narrative: 6-22-07 mom called to report redness and SW at injection site, denied fever, hives, difficulty breathing. R thigh. 6/25/07 Mom brought pt in fever 101-102 and sore throat days 4&5 after vaccines. Temp 98 this morning. R lat thigh has approx 7cm area of red/purple discoloration, mildly swollen and mildly warm.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Skin warm, Swelling
Clinical narrative: 6-22-07 mom called to report redness and SW at injection site, denied fever, hives, difficulty breathing. R thigh. 6/25/07 Mom brought pt in fever 101-102 and sore throat days 4&5 after vaccines. Temp 98 this morning. R lat thigh has approx 7cm area of red/purple discoloration, mildly swollen and mildly warm.
Age: 16.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site swelling
Clinical narrative: 06-25-07 11:45 Varicella vaccination of 1ml was given to Lt upper arm SQ (instead of 0.5ml) Pt. tol. shot well sm area of swelling at injection site neta. instructed to use cool wash cloth  or may use ice for swelling. 1600 mother was called at home and explained event and that should not have adverse effect to vaccine. May swell at site, but shouldn't be problem.
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Child's leg was red and swollen, with complaints of pain and itching
Age: 6.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Lethargy, Pyrexia
Clinical narrative: Fever for 24hrs after imm. and lethargy.
Age: 0.8
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Sm - pinpoint rash all over. No fever. Had cold sx earlier in week. Child not ill appearing.
Age: 1.67
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: ALLERGIC REACTION TO DTAP, HIB, PCV, HEPA- ALL AREAS WHERE VACCINES WERE GIVEN WERE SWOLLEN, BUMPY, RED, HOT TO THE TOUCH
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Chills, Dehydration, Nausea, Pyrexia
Clinical narrative: Vaccine administered 06/04/07 and reported symptoms on 06/13/07.  Complained of nausea, fever, chills and weakness which began on 06/10/07.  Seen in Emergency Dept 06/13/07 and received IV therapy for dehydration.  MD advised not to continue with 3rd dose in the series.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cold compress therapy, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Parents noticed large, red area on left deltoid area 6/14/07 11:00 a.m approx. 5 inches x 6 inches, hard, red, hot.  Painful with movement and touch.  Low grad fever 100.5.  No other symptoms.  Ice applied.  Recommended Motrin, ice.  Drew line around redness.  Advised if no improvement by tomorrow 6/16/07 go to provider (DR.)Seen in our office 6/15/07.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Parents noticed large, red area on left deltoid area 6/14/07 11:00 a.m approx. 5 inches x 6 inches, hard, red, hot.  Painful with movement and touch.  Low grad fever 100.5.  No other symptoms.  Ice applied.  Recommended Motrin, ice.  Drew line around redness.  Advised if no improvement by tomorrow 6/16/07 go to provider (DR.)Seen in our office 6/15/07.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Arthropathy, Diarrhoea
Clinical narrative: FRECUENTLY DIARREA / MUSCULAR JOINTS DISCONFORT
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Cold compress therapy, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: left arm red, itchy swelling the size of an orange.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Blister, Injection site desquamation, Injection site erythema, Skin exfoliation
Clinical narrative: Left upper arm redness 4-5 inch diameter with 1 blister larger than a quarter and 2" irregular shape.  Rt upper arm redness 3-4 inch diameter, no blister, but 1/4 inch size area skin starting to slough.  Denies fever, tiredness, irritability.  Had not received ProQuad before, but has had a dose of MMR and  a dose of Varicella in the past.
Age: 13.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Body temperature increased, Cough, Nasal congestion, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: Began with sore throat, then 8 hours later 102.7 temp. Then runny nose and congestion. Now cough.  This happen 1 1/2 day after Menatra shot and Varivax Shot.  Temp down at 100 on Mon 6/25/07.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Patient received the vaccine, menactra, and the following day developed hives, intermittent, that responded nicely to benadryl.  The hives were whole body, not localized to the injection site.  I saw her again 4 days after the vaccine was administered with persistent but intermittent hives.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Fever, myalgia, erythema at injection site
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: She received 3 vaccines, the last of which was HPV.  After the third vaccination, she had a syncopal episode and it took approximately 3 minutes to regain consciousness.  She was mentally alert and feeling fine by the time she left the clinic 15 minutes later.  We elevated her feet and gave her something to drink.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Injection site vesicles, Lip blister
Clinical narrative: Outbreak of Herpes Simplex.  10 blisters around mouth, one blister on right side of face and one blister at injection site.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Nonstop crying for 3.5 hours, approx 48 hours after receiving all scheduled 2 month vaccinations.  Tried infant Motrin, which had no visible effect.  Baby was unable to be comforted and did not stop crying for 3.5 hours, then finally calmed to sleep.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, OPV, RV5, UNK
Symptoms: Decreased appetite, Gastroenteritis viral, High-pitched crying, Lethargy, Pyrexia
Clinical narrative: Patient recieved shots and oral vaccine at approximately 2-300pm. By 800pm his appetite had decreased tremendously. He had a fever, and was drowsy. Next morning at approximately 600 he only nursed for 5 mins, unlike his normal 20 mins. He was vomiting, fever and was lethargic. He normally eats every 2-3 hours, but this day he didn't eat again until approx 100pm. Again, only for about 5-10 mins. He still had fever and lethargic.I called doctor's office. He had a high squealing cry also. His doctor wanted to see him, so patient was brought to office, in which the diagnosis was a reaction to his vaccines. Two doctors on staff agreed, and sent patient home with instructions to come back following day for a weight check. He was to have pedialyte and tylenol for fever. At his weight check (in which he loss a few ounces)Dr changed his diagnosis to stomach bug. That evening, patient began having diahreah which has NOT stopped since. It's been almost a week.  I am not happy, so wanted to TELL THE TRUTH and have this  incident reported. I do NOT want patient vaccinated further, because I feel this is his SECOND reaction.  At birth he recieved the HepB vaccine at 400pm. By 800pm he was feverish and had diahreah. Second day he woke up he was coughing, wheezing, runny nose, and fever still present. He was diagnosed with a 'cold' which later was changed to RSV. He was PREFECTLY FINE until that first vaccine. He is 2 months old and has been sick MORE than he's been healthy and both times he got sick was after vaccines. I did not report the first reaction because they made it sound like the two were not related. They gave me the SAME bag of lies/garbage when Dr changed his diagnosis from reaction to vaccine to stomach flu, so thefore I felt it neceesarty to report this incident.  He recieved 4 injections and 1 oral vaccine. the paper lists: Dtap, IPV, Prevaar, Comvax, and Rotateq.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, OPV, RV5, UNK
Symptoms: Respiratory syncytial virus infection, Somnolence, Vomiting
Clinical narrative: Patient recieved shots and oral vaccine at approximately 2-300pm. By 800pm his appetite had decreased tremendously. He had a fever, and was drowsy. Next morning at approximately 600 he only nursed for 5 mins, unlike his normal 20 mins. He was vomiting, fever and was lethargic. He normally eats every 2-3 hours, but this day he didn't eat again until approx 100pm. Again, only for about 5-10 mins. He still had fever and lethargic.I called doctor's office. He had a high squealing cry also. His doctor wanted to see him, so patient was brought to office, in which the diagnosis was a reaction to his vaccines. Two doctors on staff agreed, and sent patient home with instructions to come back following day for a weight check. He was to have pedialyte and tylenol for fever. At his weight check (in which he loss a few ounces)Dr changed his diagnosis to stomach bug. That evening, patient began having diahreah which has NOT stopped since. It's been almost a week.  I am not happy, so wanted to TELL THE TRUTH and have this  incident reported. I do NOT want patient vaccinated further, because I feel this is his SECOND reaction.  At birth he recieved the HepB vaccine at 400pm. By 800pm he was feverish and had diahreah. Second day he woke up he was coughing, wheezing, runny nose, and fever still present. He was diagnosed with a 'cold' which later was changed to RSV. He was PREFECTLY FINE until that first vaccine. He is 2 months old and has been sick MORE than he's been healthy and both times he got sick was after vaccines. I did not report the first reaction because they made it sound like the two were not related. They gave me the SAME bag of lies/garbage when Dr changed his diagnosis from reaction to vaccine to stomach flu, so thefore I felt it neceesarty to report this incident.  He recieved 4 injections and 1 oral vaccine. the paper lists: Dtap, IPV, Prevaar, Comvax, and Rotateq.
Age: 0.39
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Blood test normal, Canavan disease, Computerised tomogram normal, Convulsion, Electroencephalogram normal
Clinical narrative: Pt. started with seizures ~ 5 hrs after DTaP, IPV, Prevnar and Hib (second round). Initially afebrile, developed fever ~ 1 hr. after seizures started. Was postictal, admitted to the hospital for observation and evaluation. CT scan negative, bloodwork (incl. LFTs, Lactate, Ammonia, Pyruvate) negative. Had two more seizures overnight, loaded with Fosphenytoin, discharged on phenobarbital after Neurology consultation. EEG and MRI in hospital negative. Patient had been followed by Neurology for macrocephaly and  gross motor delay, also some hypotonia. In process of further evaluation through geneticist.  7/3/07 Received PCP medical records which reveal patient experienced an abnormally large head, head shaking & extradural hydrocephalus as revealed by neuro exam 4/30/07.  On 6/20/07 s/p vax, awoke from nap shaking & very fussy then became semiconscious by time arrived at PCP office.  Admitted to hospital for seizure/neuro w/u.  Had additional witnessed seizures while hospitalized & tx w/antiseizure meds.   Referred for genetic testing. FINAL DX: Canavan Disease. 8/3/07 Received hospital medical records which reveal patient experienced seizures x 1 day w/eye deviation, shaking & decreased LOC.  Seen in PMD office in post ictal state w/horizontal nystagmus.  Admitted 6/20-6/22.  Tx w/dilantin. No further seizure activity in hosptal.  To f/u w/neuro & PCP. FINAL DX: Seizures. 02/02/2010 Currently on Phenobarbital no further seizure activity. in process of wearing off Phenobarbital by neurology. Has been diagnosed with Canavan Disease in interim. Investigation started in hospital after primary seizure led to diagnosis of Canavan.
Age: 0.39
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Hypokinesia, Hypotonia, Macrocephaly, Neurological examination, Nuclear magnetic resonance imaging normal
Clinical narrative: Pt. started with seizures ~ 5 hrs after DTaP, IPV, Prevnar and Hib (second round). Initially afebrile, developed fever ~ 1 hr. after seizures started. Was postictal, admitted to the hospital for observation and evaluation. CT scan negative, bloodwork (incl. LFTs, Lactate, Ammonia, Pyruvate) negative. Had two more seizures overnight, loaded with Fosphenytoin, discharged on phenobarbital after Neurology consultation. EEG and MRI in hospital negative. Patient had been followed by Neurology for macrocephaly and  gross motor delay, also some hypotonia. In process of further evaluation through geneticist.  7/3/07 Received PCP medical records which reveal patient experienced an abnormally large head, head shaking & extradural hydrocephalus as revealed by neuro exam 4/30/07.  On 6/20/07 s/p vax, awoke from nap shaking & very fussy then became semiconscious by time arrived at PCP office.  Admitted to hospital for seizure/neuro w/u.  Had additional witnessed seizures while hospitalized & tx w/antiseizure meds.   Referred for genetic testing. FINAL DX: Canavan Disease. 8/3/07 Received hospital medical records which reveal patient experienced seizures x 1 day w/eye deviation, shaking & decreased LOC.  Seen in PMD office in post ictal state w/horizontal nystagmus.  Admitted 6/20-6/22.  Tx w/dilantin. No further seizure activity in hosptal.  To f/u w/neuro & PCP. FINAL DX: Seizures. 02/02/2010 Currently on Phenobarbital no further seizure activity. in process of wearing off Phenobarbital by neurology. Has been diagnosed with Canavan Disease in interim. Investigation started in hospital after primary seizure led to diagnosis of Canavan.
Age: 0.39
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Postictal state, Pyrexia
Clinical narrative: Pt. started with seizures ~ 5 hrs after DTaP, IPV, Prevnar and Hib (second round). Initially afebrile, developed fever ~ 1 hr. after seizures started. Was postictal, admitted to the hospital for observation and evaluation. CT scan negative, bloodwork (incl. LFTs, Lactate, Ammonia, Pyruvate) negative. Had two more seizures overnight, loaded with Fosphenytoin, discharged on phenobarbital after Neurology consultation. EEG and MRI in hospital negative. Patient had been followed by Neurology for macrocephaly and  gross motor delay, also some hypotonia. In process of further evaluation through geneticist.  7/3/07 Received PCP medical records which reveal patient experienced an abnormally large head, head shaking & extradural hydrocephalus as revealed by neuro exam 4/30/07.  On 6/20/07 s/p vax, awoke from nap shaking & very fussy then became semiconscious by time arrived at PCP office.  Admitted to hospital for seizure/neuro w/u.  Had additional witnessed seizures while hospitalized & tx w/antiseizure meds.   Referred for genetic testing. FINAL DX: Canavan Disease. 8/3/07 Received hospital medical records which reveal patient experienced seizures x 1 day w/eye deviation, shaking & decreased LOC.  Seen in PMD office in post ictal state w/horizontal nystagmus.  Admitted 6/20-6/22.  Tx w/dilantin. No further seizure activity in hosptal.  To f/u w/neuro & PCP. FINAL DX: Seizures. 02/02/2010 Currently on Phenobarbital no further seizure activity. in process of wearing off Phenobarbital by neurology. Has been diagnosed with Canavan Disease in interim. Investigation started in hospital after primary seizure led to diagnosis of Canavan.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Rash vesicular
Clinical narrative: Vesicular collarettes & budding red based papules in different stages on face/head/ arms torso.  Some with overlying eschar and more with yellow crusts esp right auricula.
Age: 1.0
Sex: M
Vaccine: SMALL
Symptoms: Blister
Clinical narrative: Suspected accidental innoculation of vaccinia vaccine (smallpox vaccine) from father to his son. Father had vaccine placed approximately 10 days prior to the development of a lesion described as a "mosquito bite" by the parents on 23 June. By 25 June, the rash had gotten slightly larger and fluid-filled, so the parents became concerned that the father's vaccine had been spread. The patient is otherwise asymtpomatic and has no other problems at this time besides the rash on his right calf. It appears like a collection of several small vessicles approx 2-3mm diam without any erythema on his right calf.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Employee stated that her vaccinated arm was very sore for 2 weeks after vaccine was administered.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Influenza like illness, Malaise
Clinical narrative: Patient felt very sick the evening the vaccine was given.  She felt dizzy,severe flu like symptoms.
Age: 1.12
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Autism, Developmental delay, Disturbance in social behaviour, Drug toxicity, Ear tube insertion
Clinical narrative: Patient received all of his vaccines on schedule as we were instructed to do.  After his shots at 18 months he went from a normal, healthy, alert child who was meeting all developmental mile stones and growing at an above average rates to being withdrawn, severely developmentally delayed, lost language, developed sensory problems and lost social skills.  between 1 and 1/2 AND 2 years we had his hearing tested again and again.  His pediatrician insisted he had always been a normal child and that he was fine.  After his 2 years shots we all but lost him as a connected individual.  He was diagnosed with autism by 2 1/2.  We did testing that indicated he had toxic mercury levels along with other toxins.  His body was no longer able to absorb nutrients properly.  Although he has made great strides he remains handicapped and severely behind his peers. His growth has also sharply declined.  I reported rashes and low grade fevors to his pediatrician following his immunizations.  They were dismissed as an normal occurence.   7/6/07 Received vax records & VAERS database updated w/info.  10/19/07 Reviewed former pcp medical records from 7/2002-9/2004 which reveal patient experienced recurrent bilateral otitis media, URI, viral syndrome, conjunctivitis, pharyngitis, gastroenteritis, asthma, sinusitis, bronchiolitis, strep tonsillitis, allergies. Had PE tubes placed.  Parents had testing done 2003 due to concerns of speech delay, lack of eye contact & lack of socialability.  Hearing test was WNL.  Started on early intervention services for what pcp states as autism. 1/11/2010 Patient continues to suffer from impairments in sensory integration, language development and social development.  02/02/2010 Patient has never attained expected development milestones as he was before his adverse reaction. He has shown growth yet remains struggling with enormous social, language and sensory delays and impairments. he requires constant supervision and intense intervention. He also continues to have slowed physical growth. He went from being off the growth charts to falling below the 25th percentile.
Age: 1.12
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Growth retardation, Malabsorption, Metal poisoning, Pyrexia, Rash
Clinical narrative: Patient received all of his vaccines on schedule as we were instructed to do.  After his shots at 18 months he went from a normal, healthy, alert child who was meeting all developmental mile stones and growing at an above average rates to being withdrawn, severely developmentally delayed, lost language, developed sensory problems and lost social skills.  between 1 and 1/2 AND 2 years we had his hearing tested again and again.  His pediatrician insisted he had always been a normal child and that he was fine.  After his 2 years shots we all but lost him as a connected individual.  He was diagnosed with autism by 2 1/2.  We did testing that indicated he had toxic mercury levels along with other toxins.  His body was no longer able to absorb nutrients properly.  Although he has made great strides he remains handicapped and severely behind his peers. His growth has also sharply declined.  I reported rashes and low grade fevors to his pediatrician following his immunizations.  They were dismissed as an normal occurence.   7/6/07 Received vax records & VAERS database updated w/info.  10/19/07 Reviewed former pcp medical records from 7/2002-9/2004 which reveal patient experienced recurrent bilateral otitis media, URI, viral syndrome, conjunctivitis, pharyngitis, gastroenteritis, asthma, sinusitis, bronchiolitis, strep tonsillitis, allergies. Had PE tubes placed.  Parents had testing done 2003 due to concerns of speech delay, lack of eye contact & lack of socialability.  Hearing test was WNL.  Started on early intervention services for what pcp states as autism. 1/11/2010 Patient continues to suffer from impairments in sensory integration, language development and social development.  02/02/2010 Patient has never attained expected development milestones as he was before his adverse reaction. He has shown growth yet remains struggling with enormous social, language and sensory delays and impairments. he requires constant supervision and intense intervention. He also continues to have slowed physical growth. He went from being off the growth charts to falling below the 25th percentile.
Age: 1.12
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Sensory disturbance, Social avoidant behaviour, Speech disorder developmental, Speech disorder developmental
Clinical narrative: Patient received all of his vaccines on schedule as we were instructed to do.  After his shots at 18 months he went from a normal, healthy, alert child who was meeting all developmental mile stones and growing at an above average rates to being withdrawn, severely developmentally delayed, lost language, developed sensory problems and lost social skills.  between 1 and 1/2 AND 2 years we had his hearing tested again and again.  His pediatrician insisted he had always been a normal child and that he was fine.  After his 2 years shots we all but lost him as a connected individual.  He was diagnosed with autism by 2 1/2.  We did testing that indicated he had toxic mercury levels along with other toxins.  His body was no longer able to absorb nutrients properly.  Although he has made great strides he remains handicapped and severely behind his peers. His growth has also sharply declined.  I reported rashes and low grade fevors to his pediatrician following his immunizations.  They were dismissed as an normal occurence.   7/6/07 Received vax records & VAERS database updated w/info.  10/19/07 Reviewed former pcp medical records from 7/2002-9/2004 which reveal patient experienced recurrent bilateral otitis media, URI, viral syndrome, conjunctivitis, pharyngitis, gastroenteritis, asthma, sinusitis, bronchiolitis, strep tonsillitis, allergies. Had PE tubes placed.  Parents had testing done 2003 due to concerns of speech delay, lack of eye contact & lack of socialability.  Hearing test was WNL.  Started on early intervention services for what pcp states as autism. 1/11/2010 Patient continues to suffer from impairments in sensory integration, language development and social development.  02/02/2010 Patient has never attained expected development milestones as he was before his adverse reaction. He has shown growth yet remains struggling with enormous social, language and sensory delays and impairments. he requires constant supervision and intense intervention. He also continues to have slowed physical growth. He went from being off the growth charts to falling below the 25th percentile.
Age: 1.92
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Fever ranging from 101-104 beginning on ninth day after vaccine and lasting 5 days.  Tylenol given to reduce fever.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Activities of daily living impaired, Blood test, Deafness, Dizziness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of flushing in a 48-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis. Concurrent medical conditions included high blood pressure . Concurrent medications included unknown medication (Toporoal) and Benicar. On 27 October 2006 at 08:00 the subject received 1st dose of Fluarix in the left arm. On 27 October 2006, 90 minutes after vaccination with Fluarix, the subject experienced flushing, nausea and dizziness. Thirty minutes later, the subject experienced vomiting and hearing loss. The subject was unable to drive and activities of daily living became impaired. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject was treated with unknown medications. At the time of reporting the events were unresolved.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Impaired driving ability, Nausea, Neurological examination, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of flushing in a 48-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis. Concurrent medical conditions included high blood pressure . Concurrent medications included unknown medication (Toporoal) and Benicar. On 27 October 2006 at 08:00 the subject received 1st dose of Fluarix in the left arm. On 27 October 2006, 90 minutes after vaccination with Fluarix, the subject experienced flushing, nausea and dizziness. Thirty minutes later, the subject experienced vomiting and hearing loss. The subject was unable to drive and activities of daily living became impaired. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject was treated with unknown medications. At the time of reporting the events were unresolved.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of flushing in a 48-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis. Concurrent medical conditions included high blood pressure . Concurrent medications included unknown medication (Toporoal) and Benicar. On 27 October 2006 at 08:00 the subject received 1st dose of Fluarix in the left arm. On 27 October 2006, 90 minutes after vaccination with Fluarix, the subject experienced flushing, nausea and dizziness. Thirty minutes later, the subject experienced vomiting and hearing loss. The subject was unable to drive and activities of daily living became impaired. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject was treated with unknown medications. At the time of reporting the events were unresolved.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Aortic dilatation, Blood culture negative, C-reactive protein normal, CSF culture negative, Chapped lips
Clinical narrative: Information has been received from the FDA (VAERS # 279257) through the CDC concerning a 2-month-old female with a history of prematurity and no other pre-existing illnesses who on 01-MAY-2007 was vaccinated with a dose of Rotateq (Lot # 655405/1113F). Concomitant vaccinations that day included a dose of PEDIARIX (Lot # AC21B097AB), A dose of ACTHIB (Lot # UE989AA), and a dose of PREVNAR (Lot # B36258F). On 02-MAY-2007, 1 day post vaccination (also reported as 2 days post vaccination), the patient developed a fever of 102.2 degrees Fahrenheit and a rash which started under the band-aids which had been placed on her thighs over the vaccine administration sites. The patient was seen in the hospital on 05-MAY-2007 for febrile illness and possible sepsis. Subsequently, the patient developed a red, "angry", confluent rash across her chest and under a tape at an IV site on her left arm. Conjunctival inflammation (conjuctival hyperaemia) and crying were noted. The patient would not feed, and an NG tube was placed. The patient had a fever for 5 days firmly generalized rash, chapped lips with redness, conjunctival inflammation, and generalized edema of her hands and feet. Echocardiogram showed mild ectasia of the left coronary artery (aortic dilatation), although measurements of the coronary artery were not provided. On 29-MAY-2007, records were received from a hospitalization from 05-MAY-2007 to 14-MAY-2007. Discharge diagnosis was Kawasaki's Disease and anaemia (was noted to be stable). Laboratory data showed a very high C-reactive protein (presuming that the units were mg/dl) and elevated platelet count. This is consistent with diagnosis of Kawasaki disease. The last CBC showed a normalized white count of 13600. Hemoglobin and hematocrit were 7.8 and 23.5. Platelets were 643000. Differential was normal. From the information provided, it was noted that the diagnosis of Kawasaki Disease seemed appropriate. The patient was transferred due to the development of pancytopenia. The diagnosis of pancytopenia was noted to be not supported by the data provided. The patient received intravenous gammaglobulin. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool negative, Echocardiogram abnormal, Erythema, Inflammation, Kawasaki's disease
Clinical narrative: Information has been received from the FDA (VAERS # 279257) through the CDC concerning a 2-month-old female with a history of prematurity and no other pre-existing illnesses who on 01-MAY-2007 was vaccinated with a dose of Rotateq (Lot # 655405/1113F). Concomitant vaccinations that day included a dose of PEDIARIX (Lot # AC21B097AB), A dose of ACTHIB (Lot # UE989AA), and a dose of PREVNAR (Lot # B36258F). On 02-MAY-2007, 1 day post vaccination (also reported as 2 days post vaccination), the patient developed a fever of 102.2 degrees Fahrenheit and a rash which started under the band-aids which had been placed on her thighs over the vaccine administration sites. The patient was seen in the hospital on 05-MAY-2007 for febrile illness and possible sepsis. Subsequently, the patient developed a red, "angry", confluent rash across her chest and under a tape at an IV site on her left arm. Conjunctival inflammation (conjuctival hyperaemia) and crying were noted. The patient would not feed, and an NG tube was placed. The patient had a fever for 5 days firmly generalized rash, chapped lips with redness, conjunctival inflammation, and generalized edema of her hands and feet. Echocardiogram showed mild ectasia of the left coronary artery (aortic dilatation), although measurements of the coronary artery were not provided. On 29-MAY-2007, records were received from a hospitalization from 05-MAY-2007 to 14-MAY-2007. Discharge diagnosis was Kawasaki's Disease and anaemia (was noted to be stable). Laboratory data showed a very high C-reactive protein (presuming that the units were mg/dl) and elevated platelet count. This is consistent with diagnosis of Kawasaki disease. The last CBC showed a normalized white count of 13600. Hemoglobin and hematocrit were 7.8 and 23.5. Platelets were 643000. Differential was normal. From the information provided, it was noted that the diagnosis of Kawasaki Disease seemed appropriate. The patient was transferred due to the development of pancytopenia. The diagnosis of pancytopenia was noted to be not supported by the data provided. The patient received intravenous gammaglobulin. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Oedema peripheral, Pyrexia, Rash
Clinical narrative: Information has been received from the FDA (VAERS # 279257) through the CDC concerning a 2-month-old female with a history of prematurity and no other pre-existing illnesses who on 01-MAY-2007 was vaccinated with a dose of Rotateq (Lot # 655405/1113F). Concomitant vaccinations that day included a dose of PEDIARIX (Lot # AC21B097AB), A dose of ACTHIB (Lot # UE989AA), and a dose of PREVNAR (Lot # B36258F). On 02-MAY-2007, 1 day post vaccination (also reported as 2 days post vaccination), the patient developed a fever of 102.2 degrees Fahrenheit and a rash which started under the band-aids which had been placed on her thighs over the vaccine administration sites. The patient was seen in the hospital on 05-MAY-2007 for febrile illness and possible sepsis. Subsequently, the patient developed a red, "angry", confluent rash across her chest and under a tape at an IV site on her left arm. Conjunctival inflammation (conjuctival hyperaemia) and crying were noted. The patient would not feed, and an NG tube was placed. The patient had a fever for 5 days firmly generalized rash, chapped lips with redness, conjunctival inflammation, and generalized edema of her hands and feet. Echocardiogram showed mild ectasia of the left coronary artery (aortic dilatation), although measurements of the coronary artery were not provided. On 29-MAY-2007, records were received from a hospitalization from 05-MAY-2007 to 14-MAY-2007. Discharge diagnosis was Kawasaki's Disease and anaemia (was noted to be stable). Laboratory data showed a very high C-reactive protein (presuming that the units were mg/dl) and elevated platelet count. This is consistent with diagnosis of Kawasaki disease. The last CBC showed a normalized white count of 13600. Hemoglobin and hematocrit were 7.8 and 23.5. Platelets were 643000. Differential was normal. From the information provided, it was noted that the diagnosis of Kawasaki Disease seemed appropriate. The patient was transferred due to the development of pancytopenia. The diagnosis of pancytopenia was noted to be not supported by the data provided. The patient received intravenous gammaglobulin. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anaemia, Aortic dilatation, Aortic valve incompetence, Blood culture negative, Body temperature increased
Clinical narrative: Information has been received from the FDA (VAERS # 279257) through the CDC concerning a 2-month-old female with a history of prematurity and no other pre-existing illnesses who on 01-MAY-2007 was vaccinated with a dose of Rotateq (Lot # 655405/1113F). Concomitant vaccinations that day included a dose of PEDIARIX (Lot # AC21B097AB), A dose of ACTHIB (Lot # UE989AA), and a dose of PREVNAR (Lot # B36258F). On 02-MAY-2007, 1 day post vaccination (also reported as 2 days post vaccination), the patient developed a fever of 102.2 degrees Fahrenheit and a rash which started under the band-aids which had been placed on her thighs over the vaccine administration sites. The patient was seen in the hospital on 05-MAY-2007 for febrile illness and possible sepsis. Subsequently, the patient developed a red, "angry", confluent rash across her chest and under a tape at an IV site on her left arm. Conjunctival inflammation (conjuctival hyperaemia) and crying were noted. The patient would not feed, and an NG tube was placed. The patient had a fever for 5 days firmly generalized rash, chapped lips with redness, conjunctival inflammation, and generalized edema of her hands and feet. Echocardiogram showed mild ectasia of the left coronary artery (aortic dilatation), although measurements of the coronary artery were not provided. On 29-MAY-2007, records were received from a hospitalization from 05-MAY-2007 to 14-MAY-2007. Discharge diagnosis was Kawasaki's Disease and anaemia (was noted to be stable). Laboratory data showed a very high C-reactive protein (presuming that the units were mg/dl) and elevated platelet count. This is consistent with diagnosis of Kawasaki disease. The last CBC showed a normalized white count of 13600. Hemoglobin and hematocrit were 7.8 and 23.5. Platelets were 643000. Differential was normal. From the information provided, it was noted that the diagnosis of Kawasaki Disease seemed appropriate. The patient was transferred due to the development of pancytopenia. The diagnosis of pancytopenia was noted to be not supported by the data provided. The patient received intravenous gammaglobulin. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: C-reactive protein increased, CSF cell count normal, CSF culture negative, Chapped lips, Conjunctival hyperaemia
Clinical narrative: Information has been received from the FDA (VAERS # 279257) through the CDC concerning a 2-month-old female with a history of prematurity and no other pre-existing illnesses who on 01-MAY-2007 was vaccinated with a dose of Rotateq (Lot # 655405/1113F). Concomitant vaccinations that day included a dose of PEDIARIX (Lot # AC21B097AB), A dose of ACTHIB (Lot # UE989AA), and a dose of PREVNAR (Lot # B36258F). On 02-MAY-2007, 1 day post vaccination (also reported as 2 days post vaccination), the patient developed a fever of 102.2 degrees Fahrenheit and a rash which started under the band-aids which had been placed on her thighs over the vaccine administration sites. The patient was seen in the hospital on 05-MAY-2007 for febrile illness and possible sepsis. Subsequently, the patient developed a red, "angry", confluent rash across her chest and under a tape at an IV site on her left arm. Conjunctival inflammation (conjuctival hyperaemia) and crying were noted. The patient would not feed, and an NG tube was placed. The patient had a fever for 5 days firmly generalized rash, chapped lips with redness, conjunctival inflammation, and generalized edema of her hands and feet. Echocardiogram showed mild ectasia of the left coronary artery (aortic dilatation), although measurements of the coronary artery were not provided. On 29-MAY-2007, records were received from a hospitalization from 05-MAY-2007 to 14-MAY-2007. Discharge diagnosis was Kawasaki's Disease and anaemia (was noted to be stable). Laboratory data showed a very high C-reactive protein (presuming that the units were mg/dl) and elevated platelet count. This is consistent with diagnosis of Kawasaki disease. The last CBC showed a normalized white count of 13600. Hemoglobin and hematocrit were 7.8 and 23.5. Platelets were 643000. Differential was normal. From the information provided, it was noted that the diagnosis of Kawasaki Disease seemed appropriate. The patient was transferred due to the development of pancytopenia. The diagnosis of pancytopenia was noted to be not supported by the data provided. The patient received intravenous gammaglobulin. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Coronary artery disease, Crying, Culture stool negative, Echocardiogram abnormal, Feeding disorder of infancy or early childhood
Clinical narrative: Information has been received from the FDA (VAERS # 279257) through the CDC concerning a 2-month-old female with a history of prematurity and no other pre-existing illnesses who on 01-MAY-2007 was vaccinated with a dose of Rotateq (Lot # 655405/1113F). Concomitant vaccinations that day included a dose of PEDIARIX (Lot # AC21B097AB), A dose of ACTHIB (Lot # UE989AA), and a dose of PREVNAR (Lot # B36258F). On 02-MAY-2007, 1 day post vaccination (also reported as 2 days post vaccination), the patient developed a fever of 102.2 degrees Fahrenheit and a rash which started under the band-aids which had been placed on her thighs over the vaccine administration sites. The patient was seen in the hospital on 05-MAY-2007 for febrile illness and possible sepsis. Subsequently, the patient developed a red, "angry", confluent rash across her chest and under a tape at an IV site on her left arm. Conjunctival inflammation (conjuctival hyperaemia) and crying were noted. The patient would not feed, and an NG tube was placed. The patient had a fever for 5 days firmly generalized rash, chapped lips with redness, conjunctival inflammation, and generalized edema of her hands and feet. Echocardiogram showed mild ectasia of the left coronary artery (aortic dilatation), although measurements of the coronary artery were not provided. On 29-MAY-2007, records were received from a hospitalization from 05-MAY-2007 to 14-MAY-2007. Discharge diagnosis was Kawasaki's Disease and anaemia (was noted to be stable). Laboratory data showed a very high C-reactive protein (presuming that the units were mg/dl) and elevated platelet count. This is consistent with diagnosis of Kawasaki disease. The last CBC showed a normalized white count of 13600. Hemoglobin and hematocrit were 7.8 and 23.5. Platelets were 643000. Differential was normal. From the information provided, it was noted that the diagnosis of Kawasaki Disease seemed appropriate. The patient was transferred due to the development of pancytopenia. The diagnosis of pancytopenia was noted to be not supported by the data provided. The patient received intravenous gammaglobulin. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Gastrointestinal tube insertion, Haematocrit decreased, Haemoglobin decreased, Injection site erythema, Kawasaki's disease
Clinical narrative: Information has been received from the FDA (VAERS # 279257) through the CDC concerning a 2-month-old female with a history of prematurity and no other pre-existing illnesses who on 01-MAY-2007 was vaccinated with a dose of Rotateq (Lot # 655405/1113F). Concomitant vaccinations that day included a dose of PEDIARIX (Lot # AC21B097AB), A dose of ACTHIB (Lot # UE989AA), and a dose of PREVNAR (Lot # B36258F). On 02-MAY-2007, 1 day post vaccination (also reported as 2 days post vaccination), the patient developed a fever of 102.2 degrees Fahrenheit and a rash which started under the band-aids which had been placed on her thighs over the vaccine administration sites. The patient was seen in the hospital on 05-MAY-2007 for febrile illness and possible sepsis. Subsequently, the patient developed a red, "angry", confluent rash across her chest and under a tape at an IV site on her left arm. Conjunctival inflammation (conjuctival hyperaemia) and crying were noted. The patient would not feed, and an NG tube was placed. The patient had a fever for 5 days firmly generalized rash, chapped lips with redness, conjunctival inflammation, and generalized edema of her hands and feet. Echocardiogram showed mild ectasia of the left coronary artery (aortic dilatation), although measurements of the coronary artery were not provided. On 29-MAY-2007, records were received from a hospitalization from 05-MAY-2007 to 14-MAY-2007. Discharge diagnosis was Kawasaki's Disease and anaemia (was noted to be stable). Laboratory data showed a very high C-reactive protein (presuming that the units were mg/dl) and elevated platelet count. This is consistent with diagnosis of Kawasaki disease. The last CBC showed a normalized white count of 13600. Hemoglobin and hematocrit were 7.8 and 23.5. Platelets were 643000. Differential was normal. From the information provided, it was noted that the diagnosis of Kawasaki Disease seemed appropriate. The patient was transferred due to the development of pancytopenia. The diagnosis of pancytopenia was noted to be not supported by the data provided. The patient received intravenous gammaglobulin. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Mitral valve incompetence, Oedema peripheral, Pancytopenia, Platelet count increased, Pyrexia
Clinical narrative: Information has been received from the FDA (VAERS # 279257) through the CDC concerning a 2-month-old female with a history of prematurity and no other pre-existing illnesses who on 01-MAY-2007 was vaccinated with a dose of Rotateq (Lot # 655405/1113F). Concomitant vaccinations that day included a dose of PEDIARIX (Lot # AC21B097AB), A dose of ACTHIB (Lot # UE989AA), and a dose of PREVNAR (Lot # B36258F). On 02-MAY-2007, 1 day post vaccination (also reported as 2 days post vaccination), the patient developed a fever of 102.2 degrees Fahrenheit and a rash which started under the band-aids which had been placed on her thighs over the vaccine administration sites. The patient was seen in the hospital on 05-MAY-2007 for febrile illness and possible sepsis. Subsequently, the patient developed a red, "angry", confluent rash across her chest and under a tape at an IV site on her left arm. Conjunctival inflammation (conjuctival hyperaemia) and crying were noted. The patient would not feed, and an NG tube was placed. The patient had a fever for 5 days firmly generalized rash, chapped lips with redness, conjunctival inflammation, and generalized edema of her hands and feet. Echocardiogram showed mild ectasia of the left coronary artery (aortic dilatation), although measurements of the coronary artery were not provided. On 29-MAY-2007, records were received from a hospitalization from 05-MAY-2007 to 14-MAY-2007. Discharge diagnosis was Kawasaki's Disease and anaemia (was noted to be stable). Laboratory data showed a very high C-reactive protein (presuming that the units were mg/dl) and elevated platelet count. This is consistent with diagnosis of Kawasaki disease. The last CBC showed a normalized white count of 13600. Hemoglobin and hematocrit were 7.8 and 23.5. Platelets were 643000. Differential was normal. From the information provided, it was noted that the diagnosis of Kawasaki Disease seemed appropriate. The patient was transferred due to the development of pancytopenia. The diagnosis of pancytopenia was noted to be not supported by the data provided. The patient received intravenous gammaglobulin. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash erythematous, Sepsis, White blood cell count increased
Clinical narrative: Information has been received from the FDA (VAERS # 279257) through the CDC concerning a 2-month-old female with a history of prematurity and no other pre-existing illnesses who on 01-MAY-2007 was vaccinated with a dose of Rotateq (Lot # 655405/1113F). Concomitant vaccinations that day included a dose of PEDIARIX (Lot # AC21B097AB), A dose of ACTHIB (Lot # UE989AA), and a dose of PREVNAR (Lot # B36258F). On 02-MAY-2007, 1 day post vaccination (also reported as 2 days post vaccination), the patient developed a fever of 102.2 degrees Fahrenheit and a rash which started under the band-aids which had been placed on her thighs over the vaccine administration sites. The patient was seen in the hospital on 05-MAY-2007 for febrile illness and possible sepsis. Subsequently, the patient developed a red, "angry", confluent rash across her chest and under a tape at an IV site on her left arm. Conjunctival inflammation (conjuctival hyperaemia) and crying were noted. The patient would not feed, and an NG tube was placed. The patient had a fever for 5 days firmly generalized rash, chapped lips with redness, conjunctival inflammation, and generalized edema of her hands and feet. Echocardiogram showed mild ectasia of the left coronary artery (aortic dilatation), although measurements of the coronary artery were not provided. On 29-MAY-2007, records were received from a hospitalization from 05-MAY-2007 to 14-MAY-2007. Discharge diagnosis was Kawasaki's Disease and anaemia (was noted to be stable). Laboratory data showed a very high C-reactive protein (presuming that the units were mg/dl) and elevated platelet count. This is consistent with diagnosis of Kawasaki disease. The last CBC showed a normalized white count of 13600. Hemoglobin and hematocrit were 7.8 and 23.5. Platelets were 643000. Differential was normal. From the information provided, it was noted that the diagnosis of Kawasaki Disease seemed appropriate. The patient was transferred due to the development of pancytopenia. The diagnosis of pancytopenia was noted to be not supported by the data provided. The patient received intravenous gammaglobulin. Additional information has been requested.