chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: FLUX
Symptoms: Difficulty in walking, Fall, Hypoxia, Respiratory failure, Upper respiratory tract infection
Clinical narrative: One Week of URI symptoms presented to hospital 10/20 S/P fall and difficulty walking. He had respiratory failure and required intubation 10/21, Plasma pheresis and IVIG.  12/29/06 Received medical records from hospital which reveal patient admitted 10/30/06-11/6/06 for severe weakness & respiratory distress.  Patient had been transferred from outlying hospital where he presented on 10/20 s/p fall & difficulty walking one day prior.  Had symptoms of URI for approx 1 week prior & was being treated w/oral antibiotics.  Diagnosis was initially made at outlying hospital & patient received plasmapheresis x 5 cycles, last on 10/26, & was placed on ventilator.  LP done at outlying hospital.  Neuro, cardio & critical care consults done at second hospital.  Patient received IVIG  Received trach & PEG feeding tube.  Transferred to skilled nursing facility still on vent & antibiotics. FINAL DX: Guillain Barre Syndrome; respiratory failure; & pneumonia.
Age: 0.94
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Three days later, Pt heavy loose stool, Diarrhea, low grade temp. Treated for diarrhea.
Age: 0.75
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Two days later, patient having loose stools-(diarrhea). Treating diarrhea.
Age: 0.88
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Patient having low grade temp next day. Two days later, heavy diarrhea and temp. Treating diarrhea.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Patient having fever, next day then two days later having diarrhea.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Flu vaccine given around 5pm on 12/1/06. Mom did not notice problem until Sat morning. Child had hives on arms, legs, and trunk taken to ER. Nothing given. Called Doctor. No reaction at injection site. Received the vaccine last year 2 doses.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Pain, Swelling
Clinical narrative: Patient called health dept on 12/04/06 and verbally reported to nurse complaint of localized adverse reaction to IM injection side on left upper arm. Patient reported "swelling, pain and redness. Patient denies systemic fever.
Age: 1.31
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Varicella rash start Saturday. Fever for 2 days.
Age: 1.01
Sex: F
Vaccine: HBHEPB, PNC, HBHEPB, PNC
Symptoms: Anorexia, Coma, Irritability, Laboratory test abnormal, Pyrexia
Clinical narrative: Information has been received from a pediatrician via manufacturer reported Pharmaceuticals Inc. concerning a 12 month old female who on 07-Mar-2006 was vaccinated IM with a dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine.  Concomitant suspect therapy included an IM dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot#B08643F) given on the same date.  On 10-Mar-2006 the patient developed a febrile seizure and was hospitalized.  The patient was confirmed with rotavirus when hospitalized which was considered an illness at the time of vaccination.  On 12-Mar-2006, the patient recovered and was discharged from the hospital.  The reporting pediatrician considered febrile seizure to be immediately life-threatening.  The reporter indicated that this was one of two patient's who experienced this event following receipt of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot#B08643F).  Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HBHEPB, PNC, HBHEPB, PNC
Symptoms: Febrile convulsion
Clinical narrative: Information has been received from a pediatrician via manufacturer reported Pharmaceuticals Inc. concerning a 12 month old female who on 07-Mar-2006 was vaccinated IM with a dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine.  Concomitant suspect therapy included an IM dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot#B08643F) given on the same date.  On 10-Mar-2006 the patient developed a febrile seizure and was hospitalized.  The patient was confirmed with rotavirus when hospitalized which was considered an illness at the time of vaccination.  On 12-Mar-2006, the patient recovered and was discharged from the hospital.  The reporting pediatrician considered febrile seizure to be immediately life-threatening.  The reporter indicated that this was one of two patient's who experienced this event following receipt of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot#B08643F).  Additional information has been requested.
Age: 1.24
Sex: M
Vaccine: FLU3, HBHEPB, VARCEL, FLU3, HBHEPB, VARCEL
Symptoms: Laboratory test abnormal, Pain, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a 15 month hold white male infant who on 11 Nov 2005 was vaccinated intramuscularly into the right thigh with the third dose of hepatitis B virus vaccine rHBsAg. At that time, the patient was vaccinated subcutaneously into the thigh with the first dose of varicella virus vaccine live and intramuscularly into the left thigh with the second dose of influenza virus vaccine. The patient had no illness at the time of vaccination.  On 14 Nov 2005, the patient was noted to "cry when tries to bear weight on right leg", "won't crawl or walk" and had developed a "fever 102". On 16 Nov 2005, the patient was seen in the office. The patient had laboratory work obtained that revealed an "elevated erythrocyte sedimentation rate" notes as 45 mm/h. At that time, laboratory data was noted to include white blood cell count 5.51 thousand, blood monocyte count 14.7% and serum C-reactive protein test <0.3 mg/dL. The patient sought unspecified medical attention. The patient was recommended to take ibuprofen and use warm compresses. On 18 Nove 2005, the patient recovered from the events.  Additional information is not expected.
Age: 1.24
Sex: M
Vaccine: FLU3, HBHEPB, VARCEL, FLU3, HBHEPB, VARCEL
Symptoms: Difficulty in walking, Pyrexia, Red blood cell sedimentation rate increased, Vaccination complication
Clinical narrative: Information has been received from a physician concerning a 15 month hold white male infant who on 11 Nov 2005 was vaccinated intramuscularly into the right thigh with the third dose of hepatitis B virus vaccine rHBsAg. At that time, the patient was vaccinated subcutaneously into the thigh with the first dose of varicella virus vaccine live and intramuscularly into the left thigh with the second dose of influenza virus vaccine. The patient had no illness at the time of vaccination.  On 14 Nov 2005, the patient was noted to "cry when tries to bear weight on right leg", "won't crawl or walk" and had developed a "fever 102". On 16 Nov 2005, the patient was seen in the office. The patient had laboratory work obtained that revealed an "elevated erythrocyte sedimentation rate" notes as 45 mm/h. At that time, laboratory data was noted to include white blood cell count 5.51 thousand, blood monocyte count 14.7% and serum C-reactive protein test <0.3 mg/dL. The patient sought unspecified medical attention. The patient was recommended to take ibuprofen and use warm compresses. On 18 Nove 2005, the patient recovered from the events.  Additional information is not expected.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia, Irritability, Screaming
Clinical narrative: Information has been received from a physician concerning a 10 week old male with an "unremarkable" medical history who on 06-Oct-2006 was vaccinated with a PO dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Concomitant vaccinations administered that day included a dose of diphtheria toxoid (+) hepatitis B virus rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX), a dose of Hib conj vaccine and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR). On 06-Oct-2006 the patient developed blood in his stool.  Medical attention was sought.  Subsequently, on 09-Oct-2006 the patient recovered.  There was no product quality complaint involved.  Upon internal review.  The patient's adverse experience was considered to be an other important medical event.  Additional information has been requested. (OMIC)
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a 10 week old male with an "unremarkable" medical history who on 06-Oct-2006 was vaccinated with a PO dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Concomitant vaccinations administered that day included a dose of diphtheria toxoid (+) hepatitis B virus rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX), a dose of Hib conj vaccine and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR). On 06-Oct-2006 the patient developed blood in his stool.  Medical attention was sought.  Subsequently, on 09-Oct-2006 the patient recovered.  There was no product quality complaint involved.  Upon internal review.  The patient's adverse experience was considered to be an other important medical event.  Additional information has been requested. (OMIC)
Age: 1.09
Sex: M
Vaccine: FLU3, IPV, MMR, FLU3, IPV, MMR, PNC
Symptoms: Pyrexia, Respiratory failure, White blood cell count increased
Clinical narrative: Seizure related to increase temperature-EMS was called by parents
Age: 1.09
Sex: M
Vaccine: FLU3, IPV, MMR, FLU3, IPV, MMR, PNC
Symptoms: Body temperature increased, Convulsion
Clinical narrative: Seizure related to increase temperature-EMS was called by parents
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Areflexia, Arthropathy, Blood product transfusion, CSF glucose normal, CSF white blood cell count increased
Clinical narrative: Cannot walk.  This is a previously well 13-year old female who yesterday noticed some numbness and tingling of her toes and feet. Today it is extended a little higher,and she has noticed her hands and fingers being somewhat numb. In additions, today she has difficulties feeling her legs and needs to walk with assistance because she claims she has no sensation in her legs. Six days ago, she had symptoms of a headache, nausea, and some nasal discharge. She was seen at the Fairchild Air Force Base clinic and given Zithromax for otitis media. The next day she developed hives and was instructed to stop Zithromas and given Benadryl. The hives diminished and she was given amoxicillin to start the following day. Two days ago, her eyes became somewhat injected and had some mattering. In addition, patient is complaining of some hip and back pain, and her face feels "bruised". She has had emesis twice today but no fever. She has had a facial rash on her right cheek and behind her right ear. Likely early Guillain Barre.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Computerised tomogram abnormal, Cough decreased, Dysstasia, Fall, Gait disturbance
Clinical narrative: Cannot walk.  This is a previously well 13-year old female who yesterday noticed some numbness and tingling of her toes and feet. Today it is extended a little higher,and she has noticed her hands and fingers being somewhat numb. In additions, today she has difficulties feeling her legs and needs to walk with assistance because she claims she has no sensation in her legs. Six days ago, she had symptoms of a headache, nausea, and some nasal discharge. She was seen at the Fairchild Air Force Base clinic and given Zithromax for otitis media. The next day she developed hives and was instructed to stop Zithromas and given Benadryl. The hives diminished and she was given amoxicillin to start the following day. Two days ago, her eyes became somewhat injected and had some mattering. In addition, patient is complaining of some hip and back pain, and her face feels "bruised". She has had emesis twice today but no fever. She has had a facial rash on her right cheek and behind her right ear. Likely early Guillain Barre.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Guillain-Barre syndrome, Headache, Hypokinesia, Increased bronchial secretion, Mechanical ventilation
Clinical narrative: Cannot walk.  This is a previously well 13-year old female who yesterday noticed some numbness and tingling of her toes and feet. Today it is extended a little higher,and she has noticed her hands and fingers being somewhat numb. In additions, today she has difficulties feeling her legs and needs to walk with assistance because she claims she has no sensation in her legs. Six days ago, she had symptoms of a headache, nausea, and some nasal discharge. She was seen at the Fairchild Air Force Base clinic and given Zithromax for otitis media. The next day she developed hives and was instructed to stop Zithromas and given Benadryl. The hives diminished and she was given amoxicillin to start the following day. Two days ago, her eyes became somewhat injected and had some mattering. In addition, patient is complaining of some hip and back pain, and her face feels "bruised". She has had emesis twice today but no fever. She has had a facial rash on her right cheek and behind her right ear. Likely early Guillain Barre.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Motor dysfunction, Muscular weakness, Paraesthesia, Peroneal nerve palsy, Residual urine
Clinical narrative: Cannot walk.  This is a previously well 13-year old female who yesterday noticed some numbness and tingling of her toes and feet. Today it is extended a little higher,and she has noticed her hands and fingers being somewhat numb. In additions, today she has difficulties feeling her legs and needs to walk with assistance because she claims she has no sensation in her legs. Six days ago, she had symptoms of a headache, nausea, and some nasal discharge. She was seen at the Fairchild Air Force Base clinic and given Zithromax for otitis media. The next day she developed hives and was instructed to stop Zithromas and given Benadryl. The hives diminished and she was given amoxicillin to start the following day. Two days ago, her eyes became somewhat injected and had some mattering. In addition, patient is complaining of some hip and back pain, and her face feels "bruised". She has had emesis twice today but no fever. She has had a facial rash on her right cheek and behind her right ear. Likely early Guillain Barre.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Retching, Sinusitis, Staphylococcal infection, Urinary tract infection, Wean from ventilator
Clinical narrative: Cannot walk.  This is a previously well 13-year old female who yesterday noticed some numbness and tingling of her toes and feet. Today it is extended a little higher,and she has noticed her hands and fingers being somewhat numb. In additions, today she has difficulties feeling her legs and needs to walk with assistance because she claims she has no sensation in her legs. Six days ago, she had symptoms of a headache, nausea, and some nasal discharge. She was seen at the Fairchild Air Force Base clinic and given Zithromax for otitis media. The next day she developed hives and was instructed to stop Zithromas and given Benadryl. The hives diminished and she was given amoxicillin to start the following day. Two days ago, her eyes became somewhat injected and had some mattering. In addition, patient is complaining of some hip and back pain, and her face feels "bruised". She has had emesis twice today but no fever. She has had a facial rash on her right cheek and behind her right ear. Likely early Guillain Barre.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Cannot walk.  This is a previously well 13-year old female who yesterday noticed some numbness and tingling of her toes and feet. Today it is extended a little higher,and she has noticed her hands and fingers being somewhat numb. In additions, today she has difficulties feeling her legs and needs to walk with assistance because she claims she has no sensation in her legs. Six days ago, she had symptoms of a headache, nausea, and some nasal discharge. She was seen at the Fairchild Air Force Base clinic and given Zithromax for otitis media. The next day she developed hives and was instructed to stop Zithromas and given Benadryl. The hives diminished and she was given amoxicillin to start the following day. Two days ago, her eyes became somewhat injected and had some mattering. In addition, patient is complaining of some hip and back pain, and her face feels "bruised". She has had emesis twice today but no fever. She has had a facial rash on her right cheek and behind her right ear. Likely early Guillain Barre.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Guillain-Barre syndrome, Urticaria
Clinical narrative: Cannot walk.  This is a previously well 13-year old female who yesterday noticed some numbness and tingling of her toes and feet. Today it is extended a little higher,and she has noticed her hands and fingers being somewhat numb. In additions, today she has difficulties feeling her legs and needs to walk with assistance because she claims she has no sensation in her legs. Six days ago, she had symptoms of a headache, nausea, and some nasal discharge. She was seen at the Fairchild Air Force Base clinic and given Zithromax for otitis media. The next day she developed hives and was instructed to stop Zithromas and given Benadryl. The hives diminished and she was given amoxicillin to start the following day. Two days ago, her eyes became somewhat injected and had some mattering. In addition, patient is complaining of some hip and back pain, and her face feels "bruised". She has had emesis twice today but no fever. She has had a facial rash on her right cheek and behind her right ear. Likely early Guillain Barre.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Severe pain on injection site 6 weeks after flu shot.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Received Rotateq 11/27. 11/29 developed severe green watery diarrhea. No fever, no vomiting. No contact. Breast fed infant. 12/29/06 Received medical records from PCP which reveal patient was well on day of vax with only umbilical hernia & left hydrocele noted.  Next visit is 12/4/06 when had diarrhea x 4 days.  Dx: Rotavirus.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient was given Zostavax and 2 days after injection patient came down with moderate severe case of shingles.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Rash
Clinical narrative: 11-18-06 child developed red spots on face and hands 6 hrs after getting flu shot. Face rash has calmed down, blanches was itchy. Temp 95.1. Eating and drinking ok. Mother called our office after hours. Advised to monitor. Give baking soda or oatmeal baths, may try Benadryl 10 mg every 6 hours Prn.
Age: 7.0
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: (OMIC). A report was received from a physician of seizure coincident with FluMist. A seven year old female with a history of febrile seizures, received FluMist on 9/14/06. The next day she developed a low grade fever and later had an episode of seizure. The events happened while the pt was on vacation with her family. The reporter was notified of the events one week later. According to the reporter, the pts mother called their office to notify them of the event one week after it occurred. The pt was seen by a relative pediatrician who was with them at the time. No treatment was reported. The pt is not taking any anti convulsant medications. The reporter also noted that in the past, the pts mother reported episodes of seizure even with just a low grade fever. The pt recovered from the seizure on 9/15/06 and recovered from the low grade fever on an unreported date. No further episodes of seizure was reported. The reporter also added that the pt received the varicella live vaccine Varivax on the same day that she got FluMist. She also said that in 2004, the pt received FluMist without any reported adverse event. The reporter causality was not provided.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Bacterial infection, Laboratory test abnormal, Myalgia, Rash, Skin discolouration
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no pertinent medical history or drug reactions allergies, who on 11/9/06 was vaccinated at her OB/GYN's office with HPV vaccine. Concomitant therapy included Zyrtec and oral hormonal contraceptives (unspecified). On 11/19/06 the pt developed a rash on the injection site arm, but not at the injections site. On 11/19/06 the pt also experienced extreme myalgia in all four extremities and her hand was discolored (purple). On 11/20/06 lab testing revealed a positive Rapid streptococcal test and the pt was placed on unspecified antibiotics. Other lab findings revealed a neg medical panel, a complete blood count revealed an elevated WBC count with a shift to the left, and a urinalysis was neg but with a trace hemoglobin. At the time of this report, the pt was recovering. The physician felt that one or more of the events were disabling. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no pertinent medical history or drug reactions allergies, who on 11/9/06 was vaccinated at her OB/GYN's office with HPV vaccine. Concomitant therapy included Zyrtec and oral hormonal contraceptives (unspecified). On 11/19/06 the pt developed a rash on the injection site arm, but not at the injections site. On 11/19/06 the pt also experienced extreme myalgia in all four extremities and her hand was discolored (purple). On 11/20/06 lab testing revealed a positive Rapid streptococcal test and the pt was placed on unspecified antibiotics. Other lab findings revealed a neg medical panel, a complete blood count revealed an elevated WBC count with a shift to the left, and a urinalysis was neg but with a trace hemoglobin. At the time of this report, the pt was recovering. The physician felt that one or more of the events were disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 21 year old female with an allergy to penicillin. Who on 8/16/06 was vaccinated with the first dose of HPV vaccine. Concomitant therapy included unspecified birth control pills (since 2005). On 11/22/06 the pt was seen by the physician and was scheduled to receive her second dose of HPV vaccine. At that time the pt reported to the physician that the week prior (date not specified) she had suffered a seizure. The physician clarified that the pt had no prior history of seizures and that the pts general health was very good. The physician did not give the pt the second dose of vaccine because she was unsure if the seizure could have been related to the first dose of the vaccine. At the time of this report the pt had recovered from the seizure. Upon internal review the seizure was felt to be an other important medical event (OMIC). Additional information has been requested.
Age: 0.32
Sex: F
Vaccine: HIBV, PNC, RV5
Symptoms: Diarrhoea, Fungal infection, Medication error, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 16 week old full term female with no medical history or allergies who on 10/23/2006 was vaccinated PO with the first dose of Rotavirus vaccine (lot 654663/0942F). Concomitant vaccinations administered on that same day included a dose of Prevnar and a dose of Hib vaccine. The physician reported that on 10/23/06, the pt developed severe watery, large volume diarrhea and a fever of 101F. On 10/26/06, the pts fever resolved. On 10/27/2006, the pt was examined in the ER where she was given acetaminophen and diaper rash ointment. It was also noted that the pt had developed a secondary yeast infection. On 11/7/06, the pts diarrhea and yeast infection resolved. The physician considered diarrhea, fever and yeast infection to be disabling. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Injection site rash, Wheezing
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with an allergy to amoxicillin who on 10/27/06 was vaccinated IM with the first dose of HPV vaccine (lot 653650/0702F). There was no concomitant medications. On 10/27/06 approx 10 minutes after the injection, the pt started to break out in a rash around the injection site. The pt then started to wheeze. The pt was given Benadryl and Depo Medrol injection. however continued to wheeze. The wheeze was then relieved by a unit of Xopenex nebulizer treatment, but after ten minutes the pt started to wheeze again. The pt went to the ER and was admitted to the hospital. The nurse reported that th event was that of a standard allergic reaction. The pt was released from the hospital the next day, however had to continue with albuterol inhaler and prednisone therapy. The pt recovered by 10/29/06 and had not experienced any further complications. The nurse reported that the pt would not be receiving any further vaccinations with HPV vaccine. The events were felt to be other important medical events (OMIC) and immediately life threatening. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Epistaxis, Headache, Platelet count decreased, Thrombocytopenia
Clinical narrative: Information has been received from a physician concerning a 21 year old female with no history of drug reactions/allergies, and a history of idiopathic thrombocytopenic purpura who on 9/25/06 was vaccinated IM with HPV vaccine (Lot 653735/0688F). There was no concomitant medications. In Sept 2006, a few days after vaccination the pt experienced a headache, nose bleed and developed thrombocytopenia. The pts platelet count on an unspecified date was 43,000. The pt was hospitalized and received platelet transfusion. A CT of the head and lumbar puncture were performed, however the results were unspecified. The pt subsequently recovered on an unspecified date. The reporting physician felt that one or more of the events was an other important medical event (OMIC) and life threatening. Additional Information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 11/21/06 was vaccinated with an initial dose of HPV Vaccine IM in the deltoid. On 11/21/06, after the initial dose, the pt experienced a seizure. The pt was alert shortly after the event and was sent to the emergency department as a precaution. It is unk if the pt was admitted to the hospital. The pt is recovering from seizure. The pt will not continue with subsequent doses of vaccine. Upon internal review, seizure was considered an other important medical event (OMIC). Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Bacterial infection, Blood glucose increased, Carbon dioxide increased, Constipation, Decreased appetite
Clinical narrative: Information has been received from a physician concerning a 9 month old female with a history of facial rash and eye discharge and whose mother was vaccinated with Varicella vaccine while pregnant (WAES0402USA00190) who was vaccinated in the right thigh with a first and second dose of Hep B + Hib vaccine on 10/29/2004 (lot 648422/0091P) and 1/28/05 (lot 648423/0128P). Concomitant therapy on 1/28/05 included a third dose of Daptacel (C2131AA) in the left thigh, a third dose of Prevnar (Lot A5756213) in the right thigh and a second dose of IPOL (lot X1189) in the left thigh. On 5/29/05 the pt developed a fever, a slight runny nose and sneezing. She was treated with Tylenol. On approx 6/1/05 the pts appetite was slightly decreased. On 9/28/05 the pt experienced a febrile seizure and urinary tract infection. Lab test were performed. The basic metabolic panel showed C02 to be low at 16mmol/l. Anion Gap to be high at 20, and glucose to be high at 122 mg/dl. The peripheral blood diagnostic test showed seg to be high at 62%, lymphocytes to be low at 19%, absolute neutrophils to be high at 13.97 10(9)/L, and absolute lymph's to be low at 3.69. C reactive protein was high and positive at 9.2mg/dl. Urinalysis showed the appearance to be S1 cloudy and nitrates to be positive. Microscopic urine analysis showed bacteria to be many. The urine culture with specimen from voided urine showed no growth in 2 days. Urine culture with specimen from urine cath showed >100,000 cfu/ml of E coli. Treatment included 3ML PO of cephalexin (unspecified) 4 times per day for 10 days, 1.2 ml PO of Tylenol every four hours as needed, 5 ml PO of Motrin every six hours as needed. The pt was directed to see her physician the next day. on 10/29/05 it was noted that the pt was constipated and had a fever that was on and off for four days. On 10/1/05 it was noted that the pt had not had a fever for more than 24 hours, her activity was normal and she was urinating well. On 10/2/05 the pts urine culture was repeated, results not reported. She was to complete the cephalexin (unspecified) and imaging was to be done in one month. On 10/11/05 it was reported that the pt has been constipated for 1 day, she was afebrile and cephalexin had been finished.  Information received on 10/27/05 contained the following adverse experienced diarrhea 7/21/05. Upon internal review febrile seizure was determined to be an other important medical event (OMIC). Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Diarrhoea, Febrile convulsion, Laboratory test abnormal, Lymphopenia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 9 month old female with a history of facial rash and eye discharge and whose mother was vaccinated with Varicella vaccine while pregnant (WAES0402USA00190) who was vaccinated in the right thigh with a first and second dose of Hep B + Hib vaccine on 10/29/2004 (lot 648422/0091P) and 1/28/05 (lot 648423/0128P). Concomitant therapy on 1/28/05 included a third dose of Daptacel (C2131AA) in the left thigh, a third dose of Prevnar (Lot A5756213) in the right thigh and a second dose of IPOL (lot X1189) in the left thigh. On 5/29/05 the pt developed a fever, a slight runny nose and sneezing. She was treated with Tylenol. On approx 6/1/05 the pts appetite was slightly decreased. On 9/28/05 the pt experienced a febrile seizure and urinary tract infection. Lab test were performed. The basic metabolic panel showed C02 to be low at 16mmol/l. Anion Gap to be high at 20, and glucose to be high at 122 mg/dl. The peripheral blood diagnostic test showed seg to be high at 62%, lymphocytes to be low at 19%, absolute neutrophils to be high at 13.97 10(9)/L, and absolute lymph's to be low at 3.69. C reactive protein was high and positive at 9.2mg/dl. Urinalysis showed the appearance to be S1 cloudy and nitrates to be positive. Microscopic urine analysis showed bacteria to be many. The urine culture with specimen from voided urine showed no growth in 2 days. Urine culture with specimen from urine cath showed >100,000 cfu/ml of E coli. Treatment included 3ML PO of cephalexin (unspecified) 4 times per day for 10 days, 1.2 ml PO of Tylenol every four hours as needed, 5 ml PO of Motrin every six hours as needed. The pt was directed to see her physician the next day. on 10/29/05 it was noted that the pt was constipated and had a fever that was on and off for four days. On 10/1/05 it was noted that the pt had not had a fever for more than 24 hours, her activity was normal and she was urinating well. On 10/2/05 the pts urine culture was repeated, results not reported. She was to complete the cephalexin (unspecified) and imaging was to be done in one month. On 10/11/05 it was reported that the pt has been constipated for 1 day, she was afebrile and cephalexin had been finished.  Information received on 10/27/05 contained the following adverse experienced diarrhea 7/21/05. Upon internal review febrile seizure was determined to be an other important medical event (OMIC). Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Rhinorrhoea, Sneezing, Urinary tract infection
Clinical narrative: Information has been received from a physician concerning a 9 month old female with a history of facial rash and eye discharge and whose mother was vaccinated with Varicella vaccine while pregnant (WAES0402USA00190) who was vaccinated in the right thigh with a first and second dose of Hep B + Hib vaccine on 10/29/2004 (lot 648422/0091P) and 1/28/05 (lot 648423/0128P). Concomitant therapy on 1/28/05 included a third dose of Daptacel (C2131AA) in the left thigh, a third dose of Prevnar (Lot A5756213) in the right thigh and a second dose of IPOL (lot X1189) in the left thigh. On 5/29/05 the pt developed a fever, a slight runny nose and sneezing. She was treated with Tylenol. On approx 6/1/05 the pts appetite was slightly decreased. On 9/28/05 the pt experienced a febrile seizure and urinary tract infection. Lab test were performed. The basic metabolic panel showed C02 to be low at 16mmol/l. Anion Gap to be high at 20, and glucose to be high at 122 mg/dl. The peripheral blood diagnostic test showed seg to be high at 62%, lymphocytes to be low at 19%, absolute neutrophils to be high at 13.97 10(9)/L, and absolute lymph's to be low at 3.69. C reactive protein was high and positive at 9.2mg/dl. Urinalysis showed the appearance to be S1 cloudy and nitrates to be positive. Microscopic urine analysis showed bacteria to be many. The urine culture with specimen from voided urine showed no growth in 2 days. Urine culture with specimen from urine cath showed >100,000 cfu/ml of E coli. Treatment included 3ML PO of cephalexin (unspecified) 4 times per day for 10 days, 1.2 ml PO of Tylenol every four hours as needed, 5 ml PO of Motrin every six hours as needed. The pt was directed to see her physician the next day. on 10/29/05 it was noted that the pt was constipated and had a fever that was on and off for four days. On 10/1/05 it was noted that the pt had not had a fever for more than 24 hours, her activity was normal and she was urinating well. On 10/2/05 the pts urine culture was repeated, results not reported. She was to complete the cephalexin (unspecified) and imaging was to be done in one month. On 10/11/05 it was reported that the pt has been constipated for 1 day, she was afebrile and cephalexin had been finished.  Information received on 10/27/05 contained the following adverse experienced diarrhea 7/21/05. Upon internal review febrile seizure was determined to be an other important medical event (OMIC). Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Tachycardia, Wheezing
Clinical narrative: 3 hours after injection onset of wheeze, tachycardia 130 dyspnea 911 called, ER eval sx improved without treatment. Waxing waning course. PCP eval next day, EKG, LE Duplex neg. Persistent SX day x 2-3 led to repeat ER eval. Positive D Dimer led to spinal CT. Persistent tachycardia x 3-4 days with exertional dyspnea. Gradual resolution over 12-13 days.  MR received revealing a patient who developed wheezing and the sensation of palpitations and difficulty in breathing, the evening of her flu vax. Pt was brought via ambulance to ER where she began to have chest pressure and nausea. Evaluation was GERD and she was released.  Chest pain occured again the following day and she was evaluated in the office and then sent to another ER where she was admitted. PE: WNL except for a 1-2/6 short systolic ejection murmur along the left sternal border.  Symptoms of chest pressure and tachycardia seem to be related to activity and eating. Improvement noted when leaning forward or lying on left side. Assessment: Chest tightness-unclear etiology (?reactive airway spasm or pericarditis).  Tachycardia of unknown etiology.  PCP MR received with ER notes from first ER visit included. ER visit as noted above. Labs and Diagnostics: all negative. DX:? mild allergic reaction to flu vaccine, ? GERD. F/U visit to PCP on 11/14/2006 where pt. states resolution to chest pain except for occasional transient discomfort with exertion.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, PPV, TDAP
Symptoms: Cellulitis, Injection site reaction, Red blood cell sedimentation rate increased
Clinical narrative: 24 hours after injection developed diffuse cellulitis around injection site of pneumococcal. Clarification from vaccine provider.  Reaction was in left arm (Pneumovax and Adacel). MR reveals an 11 yr old who developed fever and  rash on his Left arm at the site of his Pneumovax and Adecel vax.  HPI: Child woke with pain in both arms the night after vax. and c/o fever.  Mom noticed a rectangular rash at the site of vax. on the left arm.  Seen by PMD and treated with Keflex without improvement.  Fever continued to rise and erythema and pain continued and spread.  ER visit 2 days after vax.   PE showed a 4x5 cm area of erythema, warmth, and tenderness to palpation of the left upper arm.  The patient was febrile.  He was admitted for treatment with IV antibiotics.  Pt. was treated with IV Clindamycin and Vancomycin and released to home after 4 days in stable condition to continue po Clindamycin x 7 days. Discharge DX:  Left arm cellulitis.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Laboratory test abnormal, Pneumonia, Pyrexia
Clinical narrative: Received shots 9/21/06, 3 days later T102 and cough. Temp continued cough worsened. Went to ER. Admitted 10/28 thru 11/01/06. DX RUL Pneumonia. DC DX: Right upper lobe pneumonia. Respiratory distress, resolved. Admitted with C/O fever on admission 104 and shortness of breath.  RX with IV antibiotics.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine given for age on 11-18-06 at approx 10am. No adverse event noted.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: None noted. Received 18 and up vaccine Flulaval instead of Fluzone.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Vaccination complication
Clinical narrative: None noted-did not disclose that she was pregnant at the time of screening. Given Flumist then told she was pregnant 2 months.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine given for age on 11/18/06 at approx 0915. No adverse even noted.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Swelling to Left mid forearm to area just above elbow; redness and warm to touch. Client received flu and Pneumovax on 11/15/06. Visit to physician made for treatment of symptoms and received oral antibiotics-per client report.
Age: 1.07
Sex: M
Vaccine: HBHEPB, MMRV
Symptoms: Rash
Clinical narrative: Rash
Age: 12.0
Sex: F
Vaccine: FLU3, MNQ, TDAP, TTOX
Symptoms: Computerised tomogram head, Dehydration, Electrocardiogram abnormal, Full blood count normal, Laboratory test normal
Clinical narrative: Syncope times 2. MR received for ER visit for syncope x2 one day after flu, Menactra (verified), and Tdap vax.  PMH: 12 yr. with ADD.  PE WNL.   HPI: Child fainted morning after vax. while going to the BR, then fainted again on her way to tell mom.  Taken by ambulance to hosp.  Assessment: Vasogenic syncope, dehydration, muscular disorder
Age: 12.0
Sex: F
Vaccine: FLU3, MNQ, TDAP, TTOX
Symptoms: Muscle disorder, Sinus tachycardia, Syncope, Urine analysis normal
Clinical narrative: Syncope times 2. MR received for ER visit for syncope x2 one day after flu, Menactra (verified), and Tdap vax.  PMH: 12 yr. with ADD.  PE WNL.   HPI: Child fainted morning after vax. while going to the BR, then fainted again on her way to tell mom.  Taken by ambulance to hosp.  Assessment: Vasogenic syncope, dehydration, muscular disorder
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Swelling, redness, red streak down arm
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Throat began tightening up. Used Albuterol and was given Benadryl and oxygen.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Shortness of breath, wheezing 4 hours after vaccination. IV-Solumedrol, Benadryl
Age: 36.0
Sex: M
Vaccine: ANTH, HBPV, HEPA
Symptoms: Amnesia, Disturbance in attention, Fungal infection, Hypertension, Hypoaesthesia
Clinical narrative: Blood pressure (high), loss of concentration, cramp legs, memory loss, memory: trouble remembering recent information. Sleep problems. Numbness and tingling: fingers. Infection fungus in toes.
Age: 36.0
Sex: M
Vaccine: ANTH, HBPV, HEPA
Symptoms: Muscle spasms, Paraesthesia
Clinical narrative: Blood pressure (high), loss of concentration, cramp legs, memory loss, memory: trouble remembering recent information. Sleep problems. Numbness and tingling: fingers. Infection fungus in toes.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Blindness, Constipation, Ear pain, Facial palsy
Clinical narrative: Child had flu shot 10/24/06 and became ill with viral syndrome 10/30 and ear pain on 11/2 and bell's palsy on 11/4/06.  MR received documenting multiple office visits and several ER visits for a 10 yr old boy who developed constipation, abdominal pain and vomiting 1 week s/p flu vax.  This progressed to right sided ear/jaw pain, facial numbness, and asymmetry. 3 weeks s/p vax. he developed pounding headaches and ultimately periodic loss of vision.  Was out of school x 4 weeks. DX: Viral syndrome, Bells Palsy.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Viral infection, Vomiting
Clinical narrative: Child had flu shot 10/24/06 and became ill with viral syndrome 10/30 and ear pain on 11/2 and bell's palsy on 11/4/06.  MR received documenting multiple office visits and several ER visits for a 10 yr old boy who developed constipation, abdominal pain and vomiting 1 week s/p flu vax.  This progressed to right sided ear/jaw pain, facial numbness, and asymmetry. 3 weeks s/p vax. he developed pounding headaches and ultimately periodic loss of vision.  Was out of school x 4 weeks. DX: Viral syndrome, Bells Palsy.
Age: 2.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Redness, swelling and pain at injection site reported 1 day after injection given. These symptoms were in L arm only.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: During mass flu clinic for adults and children an unspecified person gave "Fluarix" to a child meant for adults 18 year old and older by mistake. No known adverse events. No adverse events occured.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dyspnoea, Musculoskeletal stiffness, Syncope vasovagal, Vision blurred
Clinical narrative: Half hour after vaccination experienced visual distribution, neck discomfort, blurred vision, shortness of breath, dyspnea, clammy skin. Discharge ok. Diagnosis: Vasovagal, ER visit. Rest, hydrate. Follow up with facility.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Visual disturbance
Clinical narrative: Half hour after vaccination experienced visual distribution, neck discomfort, blurred vision, shortness of breath, dyspnea, clammy skin. Discharge ok. Diagnosis: Vasovagal, ER visit. Rest, hydrate. Follow up with facility.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Itchy rash 1/2 hour after vaccination with Flushot. Discharged from service. Benadryl  and Prednisone 10mg. Diagnosis-allergic to flu.
Age: 1.27
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: 11/17/06 5pm None. Toddler given adult dose of Fluarix mistakingly given as pediatric vaccine.
Age: 1.91
Sex: F
Vaccine: DT, FLUX, HEPA
Symptoms: Convulsion, Febrile convulsion, Pyrexia
Clinical narrative: 48 hours after receiving Flu shot and Hep A vaccine high fever and seizure occurred. Taken by ambulance to Red Cedar Medical Center. Follow up needed.  MR received detailing an ER visit of a healthy almost 2 year old who appeared to have a generalized seizure which lasted about 2 minutes, 2 days s/p flu and Hep A vax.. Brought in by ambulance with a temp. of 103.4'F rectally. PE was normal although child was subdued possibly due to being post-ictal.  F/U one week later shows no further problems. Assessment:  Febrile Seizure.
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Feeling hot, Injection site reaction
Clinical narrative: Mom describes baseball size area on Left arm at site of Varivax injection. Red and warm. Ice and Advil per doctor. Seen 11/16/06 in Urgent Care.  Prescribed Keflex 500mg cap every 10hours for 10days.
Age: 12.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Rash pruritic
Clinical narrative: 6-8cm mass on left deltoid. Red area around injection site. Slightly pruiritic. Treatment: Claritin 10mg, Prednisone 90mg by mouth every day for 3 days.
Age: 46.0
Sex: F
Vaccine: FLUN3, HEPA, IPV
Symptoms: Diarrhoea, Nausea
Clinical narrative: 11-30-06 PM patient developed diarrhea then later that evening nausea. No vomiting. Today 12/1/06 still has same symptoms but improving did not seek medical attention.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Lymphadenopathy, Oedema, Swelling, Tenderness
Clinical narrative: Local edema, hematoma and reactive axillary adenopthy in 4 palpable pea size nodes. Slight tender, possible allergic reaction may need antibiotics (Duricif) if increase in tenderness or swelling.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Vaccine administrator gave wrong drug to a child that was meant for adults -18 year olds and older by mistake. No known adverse event.  No adverse events occured. 3-28-07.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: During mass flu clinic for adults and children a vaccine administrator by mistake gave a child "Fluarix" which is meant for adults 18 and over.  No known adverse events.  No adverse events occured. 3-28-07.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient reported fever of 102.0 24 hours after flu shot.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Shingles vaccine on Friday afternoon 11/24/06.  On Saturday 11/25/06, red, bumpy rash about 1 inch diameter on forehead at hairline.  Showed it to pharmacist on Sunday.  Emailed Dr on Monday.  Thursday 11/30/06 still there and sore.  Possible shingles.
Age: 0.99
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Bronchiolitis, Convulsion
Clinical narrative: 104 degree temperature. Seizure 12:45 am 11/28/06. Mother stated no treatment. 12/19/06-records received and reviewed. Consultation report  Impression: Febrile seizure. On arrival to ED temp 104.9. After Motrin temp 100.8 CXR: mild peribronchial thickening suggestive of viral bronchiloitis
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Shoulder pain
Clinical narrative: Frozen shoulder requiring physical therapy and anti inflammatory medication.  Remains under treatment.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Two days after injection, experienced muscle pain in localized area of injection and pain up into shoulder blade.  Follow up on 11/16, pain remains, less severe.  Daughter also reacted like this to tetanus.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: Employee states left arm started hurting after injection.  C/O of numbness, pain down left arm.  Hard to lift arm up.  Tried ice.  Cannot take ibuprofen.  Referred to private physician.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reported whole neck and upper thigh area broke out in hives.  Patient only complained of itching and reported taking Benadryl, which was alleviating her symptoms.