chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Regurgitation, Speech disorder, Vision blurred
Clinical narrative: Initial information received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS #290355.  The initial reporter to the CDC had been a health care professional.  A 17-year-old male received an intramuscular injection of Menactra (Lot number U2394BA, site of vaccination unknown), an intramuscular injection of Adacel (Lot number C2769AA, site of vaccination unknown) and an intramuscular injection of Twinrix (manufactured by GlaxoSmithKline; Lot number AHABB100AA, site of administration unknown) on 22 August 2007.  On 11 September 2007, 20 days after receiving the vaccines, the patient was diagnosed with possible Guillain-Barre syndrome.  The patient complained of numbness to extremities, difficulty speaking, shortness of breath, trouble swallowing, blurred vision, difficulty walking, weakness throughout the body, bowel problems, regurgitation and difficulty taking deep breaths.  The event required hospitalization.  Recovery status was not reported.  No additional information was provided at the time of this report.
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Guillain-Barre syndrome, Muscular weakness, Neuropathy peripheral
Clinical narrative: Initial information received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS #290355.  The initial reporter to the CDC had been a health care professional.  A 17-year-old male received an intramuscular injection of Menactra (Lot number U2394BA, site of vaccination unknown), an intramuscular injection of Adacel (Lot number C2769AA, site of vaccination unknown) and an intramuscular injection of Twinrix (manufactured by GlaxoSmithKline; Lot number AHABB100AA, site of administration unknown) on 22 August 2007.  On 11 September 2007, 20 days after receiving the vaccines, the patient was diagnosed with possible Guillain-Barre syndrome.  The patient complained of numbness to extremities, difficulty speaking, shortness of breath, trouble swallowing, blurred vision, difficulty walking, weakness throughout the body, bowel problems, regurgitation and difficulty taking deep breaths.  The event required hospitalization.  Recovery status was not reported.  No additional information was provided at the time of this report.
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Asthenia, Dysphagia, Dyspnoea, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Initial information received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS #290355.  The initial reporter to the CDC had been a health care professional.  A 17-year-old male received an intramuscular injection of Menactra (Lot number U2394BA, site of vaccination unknown), an intramuscular injection of Adacel (Lot number C2769AA, site of vaccination unknown) and an intramuscular injection of Twinrix (manufactured by GlaxoSmithKline; Lot number AHABB100AA, site of administration unknown) on 22 August 2007.  On 11 September 2007, 20 days after receiving the vaccines, the patient was diagnosed with possible Guillain-Barre syndrome.  The patient complained of numbness to extremities, difficulty speaking, shortness of breath, trouble swallowing, blurred vision, difficulty walking, weakness throughout the body, bowel problems, regurgitation and difficulty taking deep breaths.  The event required hospitalization.  Recovery status was not reported.  No additional information was provided at the time of this report.
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Hypoaesthesia, Intestinal functional disorder, Regurgitation, Speech disorder, Swelling
Clinical narrative: Initial information received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS #290355.  The initial reporter to the CDC had been a health care professional.  A 17-year-old male received an intramuscular injection of Menactra (Lot number U2394BA, site of vaccination unknown), an intramuscular injection of Adacel (Lot number C2769AA, site of vaccination unknown) and an intramuscular injection of Twinrix (manufactured by GlaxoSmithKline; Lot number AHABB100AA, site of administration unknown) on 22 August 2007.  On 11 September 2007, 20 days after receiving the vaccines, the patient was diagnosed with possible Guillain-Barre syndrome.  The patient complained of numbness to extremities, difficulty speaking, shortness of breath, trouble swallowing, blurred vision, difficulty walking, weakness throughout the body, bowel problems, regurgitation and difficulty taking deep breaths.  The event required hospitalization.  Recovery status was not reported.  No additional information was provided at the time of this report.
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Vision blurred
Clinical narrative: Initial information received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS #290355.  The initial reporter to the CDC had been a health care professional.  A 17-year-old male received an intramuscular injection of Menactra (Lot number U2394BA, site of vaccination unknown), an intramuscular injection of Adacel (Lot number C2769AA, site of vaccination unknown) and an intramuscular injection of Twinrix (manufactured by GlaxoSmithKline; Lot number AHABB100AA, site of administration unknown) on 22 August 2007.  On 11 September 2007, 20 days after receiving the vaccines, the patient was diagnosed with possible Guillain-Barre syndrome.  The patient complained of numbness to extremities, difficulty speaking, shortness of breath, trouble swallowing, blurred vision, difficulty walking, weakness throughout the body, bowel problems, regurgitation and difficulty taking deep breaths.  The event required hospitalization.  Recovery status was not reported.  No additional information was provided at the time of this report.
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Hypoaesthesia, Intestinal functional disorder, Regurgitation, Speech disorder, Vision blurred
Clinical narrative: Initial information received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS #290355.  The initial reporter to the CDC had been a health care professional.  A 17-year-old male received an intramuscular injection of Menactra (Lot number U2394BA, site of vaccination unknown), an intramuscular injection of Adacel (Lot number C2769AA, site of vaccination unknown) and an intramuscular injection of Twinrix (manufactured by GlaxoSmithKline; Lot number AHABB100AA, site of administration unknown) on 22 August 2007.  On 11 September 2007, 20 days after receiving the vaccines, the patient was diagnosed with possible Guillain-Barre syndrome.  The patient complained of numbness to extremities, difficulty speaking, shortness of breath, trouble swallowing, blurred vision, difficulty walking, weakness throughout the body, bowel problems, regurgitation and difficulty taking deep breaths.  The event required hospitalization.  Recovery status was not reported.  No additional information was provided at the time of this report.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, DTAP, HEPA, MNQ
Symptoms: CSF protein increased, CSF white blood cell count increased, Facial palsy, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: This case was received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 290559. A 14-year-old male patient, with a history of obesity, received an injection of Menactra on 22 August 2007 (lot number, route, and site not reported). Additional vaccinations on that date included DTaP and Hepatitis A (manufacturers and lot numbers not reported). On 30 August 2007, he began complaining of crampy leg pain and paraesthesia, with decreased sensation beginning in his lower extremities. On 02 September 2007, he began experiencing difficulty walking; he contacted an urgent care facility, and "was told it was muscle pain and would resolve on its own". The paraesthesia subsequently progressed to involve the upper extremities, and the patient also developed a facial droop. On 10 September 2007 he presented to pediatric urgent care, and at that time was "barely able to walk with crutches, current unable to ambulate for more than three steps without assistance". Physical exam revealed a heart rate of 130, blood pressure 157/80, and the patient was noted to be afebrile. He had no history of previous infection or diarrhea, and had not been ill at the time of vaccination. A lumbar puncture was performed, and laboratory results revealed CSF protein to be 345 mg/dl, and CSF white blood count 7. The patient was diagnosed with Guillain-Barre, and later started on intravenous immunoglobin (IVIG) 48 mg daily for five days. At the time of the report, he was on day three of his inpatient IVIG treatment, and had been hospitalized for eight days. Outcome was reported as "unknown".
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, DTAP, HEPA, MNQ
Symptoms: Heart rate increased, Muscle spasms, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: This case was received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 290559. A 14-year-old male patient, with a history of obesity, received an injection of Menactra on 22 August 2007 (lot number, route, and site not reported). Additional vaccinations on that date included DTaP and Hepatitis A (manufacturers and lot numbers not reported). On 30 August 2007, he began complaining of crampy leg pain and paraesthesia, with decreased sensation beginning in his lower extremities. On 02 September 2007, he began experiencing difficulty walking; he contacted an urgent care facility, and "was told it was muscle pain and would resolve on its own". The paraesthesia subsequently progressed to involve the upper extremities, and the patient also developed a facial droop. On 10 September 2007 he presented to pediatric urgent care, and at that time was "barely able to walk with crutches, current unable to ambulate for more than three steps without assistance". Physical exam revealed a heart rate of 130, blood pressure 157/80, and the patient was noted to be afebrile. He had no history of previous infection or diarrhea, and had not been ill at the time of vaccination. A lumbar puncture was performed, and laboratory results revealed CSF protein to be 345 mg/dl, and CSF white blood count 7. The patient was diagnosed with Guillain-Barre, and later started on intravenous immunoglobin (IVIG) 48 mg daily for five days. At the time of the report, he was on day three of his inpatient IVIG treatment, and had been hospitalized for eight days. Outcome was reported as "unknown".
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, DTAP, HEPA, MNQ
Symptoms: Sensory loss
Clinical narrative: This case was received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 290559. A 14-year-old male patient, with a history of obesity, received an injection of Menactra on 22 August 2007 (lot number, route, and site not reported). Additional vaccinations on that date included DTaP and Hepatitis A (manufacturers and lot numbers not reported). On 30 August 2007, he began complaining of crampy leg pain and paraesthesia, with decreased sensation beginning in his lower extremities. On 02 September 2007, he began experiencing difficulty walking; he contacted an urgent care facility, and "was told it was muscle pain and would resolve on its own". The paraesthesia subsequently progressed to involve the upper extremities, and the patient also developed a facial droop. On 10 September 2007 he presented to pediatric urgent care, and at that time was "barely able to walk with crutches, current unable to ambulate for more than three steps without assistance". Physical exam revealed a heart rate of 130, blood pressure 157/80, and the patient was noted to be afebrile. He had no history of previous infection or diarrhea, and had not been ill at the time of vaccination. A lumbar puncture was performed, and laboratory results revealed CSF protein to be 345 mg/dl, and CSF white blood count 7. The patient was diagnosed with Guillain-Barre, and later started on intravenous immunoglobin (IVIG) 48 mg daily for five days. At the time of the report, he was on day three of his inpatient IVIG treatment, and had been hospitalized for eight days. Outcome was reported as "unknown".
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, DTAP, HEPA, MNQ
Symptoms: Blood pressure, CSF protein increased, CSF white blood cell count increased, Facial palsy, Gait disturbance
Clinical narrative: This case was received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 290559. A 14-year-old male patient, with a history of obesity, received an injection of Menactra on 22 August 2007 (lot number, route, and site not reported). Additional vaccinations on that date included DTaP and Hepatitis A (manufacturers and lot numbers not reported). On 30 August 2007, he began complaining of crampy leg pain and paraesthesia, with decreased sensation beginning in his lower extremities. On 02 September 2007, he began experiencing difficulty walking; he contacted an urgent care facility, and "was told it was muscle pain and would resolve on its own". The paraesthesia subsequently progressed to involve the upper extremities, and the patient also developed a facial droop. On 10 September 2007 he presented to pediatric urgent care, and at that time was "barely able to walk with crutches, current unable to ambulate for more than three steps without assistance". Physical exam revealed a heart rate of 130, blood pressure 157/80, and the patient was noted to be afebrile. He had no history of previous infection or diarrhea, and had not been ill at the time of vaccination. A lumbar puncture was performed, and laboratory results revealed CSF protein to be 345 mg/dl, and CSF white blood count 7. The patient was diagnosed with Guillain-Barre, and later started on intravenous immunoglobin (IVIG) 48 mg daily for five days. At the time of the report, he was on day three of his inpatient IVIG treatment, and had been hospitalized for eight days. Outcome was reported as "unknown".
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, DTAP, HEPA, MNQ
Symptoms: Guillain-Barre syndrome, Heart rate increased, Lumbar puncture, Muscle spasms, Myalgia
Clinical narrative: This case was received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 290559. A 14-year-old male patient, with a history of obesity, received an injection of Menactra on 22 August 2007 (lot number, route, and site not reported). Additional vaccinations on that date included DTaP and Hepatitis A (manufacturers and lot numbers not reported). On 30 August 2007, he began complaining of crampy leg pain and paraesthesia, with decreased sensation beginning in his lower extremities. On 02 September 2007, he began experiencing difficulty walking; he contacted an urgent care facility, and "was told it was muscle pain and would resolve on its own". The paraesthesia subsequently progressed to involve the upper extremities, and the patient also developed a facial droop. On 10 September 2007 he presented to pediatric urgent care, and at that time was "barely able to walk with crutches, current unable to ambulate for more than three steps without assistance". Physical exam revealed a heart rate of 130, blood pressure 157/80, and the patient was noted to be afebrile. He had no history of previous infection or diarrhea, and had not been ill at the time of vaccination. A lumbar puncture was performed, and laboratory results revealed CSF protein to be 345 mg/dl, and CSF white blood count 7. The patient was diagnosed with Guillain-Barre, and later started on intravenous immunoglobin (IVIG) 48 mg daily for five days. At the time of the report, he was on day three of his inpatient IVIG treatment, and had been hospitalized for eight days. Outcome was reported as "unknown".
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, DTAP, HEPA, MNQ
Symptoms: Pain in extremity, Paraesthesia, Sensory loss
Clinical narrative: This case was received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 290559. A 14-year-old male patient, with a history of obesity, received an injection of Menactra on 22 August 2007 (lot number, route, and site not reported). Additional vaccinations on that date included DTaP and Hepatitis A (manufacturers and lot numbers not reported). On 30 August 2007, he began complaining of crampy leg pain and paraesthesia, with decreased sensation beginning in his lower extremities. On 02 September 2007, he began experiencing difficulty walking; he contacted an urgent care facility, and "was told it was muscle pain and would resolve on its own". The paraesthesia subsequently progressed to involve the upper extremities, and the patient also developed a facial droop. On 10 September 2007 he presented to pediatric urgent care, and at that time was "barely able to walk with crutches, current unable to ambulate for more than three steps without assistance". Physical exam revealed a heart rate of 130, blood pressure 157/80, and the patient was noted to be afebrile. He had no history of previous infection or diarrhea, and had not been ill at the time of vaccination. A lumbar puncture was performed, and laboratory results revealed CSF protein to be 345 mg/dl, and CSF white blood count 7. The patient was diagnosed with Guillain-Barre, and later started on intravenous immunoglobin (IVIG) 48 mg daily for five days. At the time of the report, he was on day three of his inpatient IVIG treatment, and had been hospitalized for eight days. Outcome was reported as "unknown".
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Muscle twitching
Clinical narrative: Initial report received from a health care provider on 18 September 2007. A 14-year-old male patient with a history of asthma, had received an intramuscular deltoid injection of Adacel, lot number C2572AA and an intramuscular right deltoid injection of Menactra, lot number U2406AA on 17 September 2007 and 19 hours later experienced "twitching of upper left arm with pain in entire left arm". The patient had no illness at the time of vaccination. It was not reported if the patient had been evaluated by a physician or if they had received any corrective treatment. No additional information was provided and the patient had not recovered from the event at the time of the report.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Muscle twitching, Pain in extremity
Clinical narrative: Initial report received from a health care provider on 18 September 2007. A 14-year-old male patient with a history of asthma, had received an intramuscular deltoid injection of Adacel, lot number C2572AA and an intramuscular right deltoid injection of Menactra, lot number U2406AA on 17 September 2007 and 19 hours later experienced "twitching of upper left arm with pain in entire left arm". The patient had no illness at the time of vaccination. It was not reported if the patient had been evaluated by a physician or if they had received any corrective treatment. No additional information was provided and the patient had not recovered from the event at the time of the report.
Age: 19.0
Sex: F
Vaccine: HEP, MNQ, TDAP, MNQ
Symptoms: Culture, Death, Serology test
Clinical narrative: Initial report received from the food and Drug Administration on 10 October 2007, VAERS ID number 292566. The Food and Drug Administration has been notified of this event from a health care provider. A 19-year-old female patient with no medical history had received an intramuscular left arm injection of Menactra, lot number U2154C on 19 September 2006 and 349 days later developed "fatal meningococcal disease (serogroup C) confirmed by an agency". Laboratory testing included cultures and serogrouping performed by an agency. The patient died on 09 September 2007. No further information was provided.
Age: 19.0
Sex: F
Vaccine: HEP, MNQ, TDAP, MNQ
Symptoms: Culture, Death, Meningococcal infection
Clinical narrative: Initial report received from the food and Drug Administration on 10 October 2007, VAERS ID number 292566. The Food and Drug Administration has been notified of this event from a health care provider. A 19-year-old female patient with no medical history had received an intramuscular left arm injection of Menactra, lot number U2154C on 19 September 2006 and 349 days later developed "fatal meningococcal disease (serogroup C) confirmed by an agency". Laboratory testing included cultures and serogrouping performed by an agency. The patient died on 09 September 2007. No further information was provided.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram normal, Deafness, Nausea, Nuclear magnetic resonance imaging normal, Vertigo
Clinical narrative: Seriousness criteria: other - medically significant.  Initial report received on 05 December 2007 from a health care professional.  A 79-year-old female patient, with no illness at the time of vaccination, had received a right deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number U2450AA, on 11 October 2007.  The patient had a history of diabetes and hypothyroidism.  Within 12-18 hours post-vaccination, the patient experienced nausea, vertigo, and hearing loss in the right ear.  The patient was examined in an emergency room and by an ENT consultant.  CAT scan, MRI, and thyroid tests were negative.  She was treated with Antivert.  Per the reporter, the hearing loss with noise and pressure in the right ear persists.  Diagnosis was sudden onset of right vestibular cochlear insult with significant hearing loss.  At the time of this report, the patient had not recovered.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram normal, Deafness unilateral, Ear discomfort, Nausea, Nuclear magnetic resonance imaging normal
Clinical narrative: Seriousness criteria: other - medically significant.  Initial report received on 05 December 2007 from a health care professional.  A 79-year-old female patient, with no illness at the time of vaccination, had received a right deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number U2450AA, on 11 October 2007.  The patient had a history of diabetes and hypothyroidism.  Within 12-18 hours post-vaccination, the patient experienced nausea, vertigo, and hearing loss in the right ear.  The patient was examined in an emergency room and by an ENT consultant.  CAT scan, MRI, and thyroid tests were negative.  She was treated with Antivert.  Per the reporter, the hearing loss with noise and pressure in the right ear persists.  Diagnosis was sudden onset of right vestibular cochlear insult with significant hearing loss.  At the time of this report, the patient had not recovered.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Thyroid function test normal, Tinnitus, Vertigo
Clinical narrative: Seriousness criteria: other - medically significant.  Initial report received on 05 December 2007 from a health care professional.  A 79-year-old female patient, with no illness at the time of vaccination, had received a right deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number U2450AA, on 11 October 2007.  The patient had a history of diabetes and hypothyroidism.  Within 12-18 hours post-vaccination, the patient experienced nausea, vertigo, and hearing loss in the right ear.  The patient was examined in an emergency room and by an ENT consultant.  CAT scan, MRI, and thyroid tests were negative.  She was treated with Antivert.  Per the reporter, the hearing loss with noise and pressure in the right ear persists.  Diagnosis was sudden onset of right vestibular cochlear insult with significant hearing loss.  At the time of this report, the patient had not recovered.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 65-year-old female who on approximately 21-NOV-2007 (2 weeks ago) was vaccinated with a dose of Zostavax. On approximately 24-NOV-2007 (3 days after vaccination) the patient developed less than 50 lesions on T4 dermatome. She has three large clusters of lesions and intense pain. She was prescribed VALTREX. After starting VALTREX the patient was nauseated. The patient sought medical attention via an office visit. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. The herpes zoster was considered to be disabling by the reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nausea, Pain, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 65-year-old female who on approximately 21-NOV-2007 (2 weeks ago) was vaccinated with a dose of Zostavax. On approximately 24-NOV-2007 (3 days after vaccination) the patient developed less than 50 lesions on T4 dermatome. She has three large clusters of lesions and intense pain. She was prescribed VALTREX. After starting VALTREX the patient was nauseated. The patient sought medical attention via an office visit. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. The herpes zoster was considered to be disabling by the reporter. Additional information has been requested.
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Pleuritic pain, Troponin I increased
Clinical narrative: Patient had onset of pleuritic chest pain on 11Dec09, 9 days after  administration of the small pox vaccine.  Peak troponin I was about 4.  His echo was normal and he responded well to indocin
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Death
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a female infant (between 0 and 6 months) who on 26-NOV-2007, received a first dose of Prevnar along with a dose of Haemophilus Influenzae B (manufacturer unknown), a dose of Pediarix and a dose of Rotarix. On 26-Nov-2007, the patient received a dose of Prevnar along with other childhood vaccines. On 28-Nov-2007, approximately 48 hours post-vaccination, the child died. The cause of death was unknown. An autopsy was performed, but results were not provided. No additional information was available at the time of this report.  1/22/08 Reviewed ER medical records of 11/28/07 which reveal patient found in crib by family.  Transported to ER via EMS & pronounced DOA. 1/24/08 Reviewed pcp medical records which reveal patient in good health on 11/26/07 except for slight weakness of left arm & suspected brachial plexus birth injury.  Note indicates patient received Pediarix, Prevnar, Hib & Rotavirus vaccines but no vax record included w/notes. 2/12/08 Received vax records.  5/6/08 Autopsy report states COD as SIDS.  Manner of death: natural.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Headache, Paraesthesia, Sleep disorder
Clinical narrative: Seriousness criteria: other-medically significant.  Initial non-serious report received from a consumer on 08 November 2007.  A male patient (age and date of birth not reported) had received a dose of flu vaccine (trade name, lot number, route/site of administration not reported) on an unspecified date in 2007 and approximately two weeks post vaccination, he started to develop a tingling sensation in the crown of his head, sometimes accompanied with headaches and dizziness.  The patient had experienced similar symptoms following flu vaccinations the previous two years.  At the time of the report, the symptoms were not yet as severe as last year.  No additional information was provided.  Follow-up information received on 04 December 2007 from the patient.  Following review of the reported events, this case was upgraded to serious.  A 62-year-old male patient had received a left deltoid, intramuscular injection of Fluzone Sv 2007-2008, lot number not reported, on 14 October 2007.  No other vaccines were administered within four weeks of the 14 October 2007 vaccination.  At the time of vaccination, the patient had a staphylococcal infection in his mouth.  Past medical history included leukemia which was in remission.  Other medications at the time of vaccination were none.  Fourteen days post-vaccination, the patient experienced a tingling/numbness sensation in the crown of his head, unspecified effects on balance, and blurry vision.  The current symptoms were reported as moderate to severe and wake the patient at night.  The event required examination by a physician.  At the time of this report, the patient had not recovered.  Contact information was provided for the patient's personal physician.  (The patient had been seen by a neurologist after experiencing events post-vaccination in 2006; and, at that time, an unspecified CAT scan was negative.  Per the reporter, "symptoms" had occurred in 2005 and 2006 following Fluzone vaccination and lasted eight to nine months).  The reporter of this case is the same as for cases 2007-03791 and 2007-03792, which involve the same patient who experienced tingling sensation in the crown of the head, headaches and dizziness following receipt of flu vaccine (trade name not reported) in 2005 and 2006.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Seriousness criteria: other-medically significant.  Initial non-serious report received from a consumer on 08 November 2007.  A male patient (age and date of birth not reported) had received a dose of flu vaccine (trade name, lot number, route/site of administration not reported) on an unspecified date in 2007 and approximately two weeks post vaccination, he started to develop a tingling sensation in the crown of his head, sometimes accompanied with headaches and dizziness.  The patient had experienced similar symptoms following flu vaccinations the previous two years.  At the time of the report, the symptoms were not yet as severe as last year.  No additional information was provided.  Follow-up information received on 04 December 2007 from the patient.  Following review of the reported events, this case was upgraded to serious.  A 62-year-old male patient had received a left deltoid, intramuscular injection of Fluzone Sv 2007-2008, lot number not reported, on 14 October 2007.  No other vaccines were administered within four weeks of the 14 October 2007 vaccination.  At the time of vaccination, the patient had a staphylococcal infection in his mouth.  Past medical history included leukemia which was in remission.  Other medications at the time of vaccination were none.  Fourteen days post-vaccination, the patient experienced a tingling/numbness sensation in the crown of his head, unspecified effects on balance, and blurry vision.  The current symptoms were reported as moderate to severe and wake the patient at night.  The event required examination by a physician.  At the time of this report, the patient had not recovered.  Contact information was provided for the patient's personal physician.  (The patient had been seen by a neurologist after experiencing events post-vaccination in 2006; and, at that time, an unspecified CAT scan was negative.  Per the reporter, "symptoms" had occurred in 2005 and 2006 following Fluzone vaccination and lasted eight to nine months).  The reporter of this case is the same as for cases 2007-03791 and 2007-03792, which involve the same patient who experienced tingling sensation in the crown of the head, headaches and dizziness following receipt of flu vaccine (trade name not reported) in 2005 and 2006.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Seriousness criteria: other - medically significant.  Initial non-serious report received from a consumer on 08 November 2007.  A male patient (age and date of birth not reported) had received a dose of flu vaccine (trade name, lot number, route/site of administration not reported) on an unspecified date in 2005 and developed a tingling sensation in the crown of his head, sometimes accompanied by headaches and dizziness (onset dates not reported).  No additional information was provided at the time of this report.  Follow-up information received on 04 December 2007 from the patient.  Following review of the reported events, this case was upgraded to serious.  An approximately 60-year-old male patient had received an injection of influenza vaccine, manufacturer not reported, lot number not reported, on an unspecified date in 2005.  The symptoms that the patient experienced lasted eight to nine months and had also included a numbness sensation in the crown of his head.  The patient recovered from the event.  Contact information was provided for the patient's personal physician.  The reporter of this case is the same as for cases 2007-03791 and 2007-03793 and involve the same patient who experienced events following influenza vaccination in 2006 and 2007.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Computerised tomogram normal, Dizziness, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Seriousness criteria: other - medically significant.  Initial non-serious report received from a consumer on 08 November 2007.  A male patient (age and date of birth not reported) had received a dose of flu vaccine (trade name, lot number, route/site of administration not reported) on an unspecified date in 2006 and developed a tingling sensation in the crown of his head, sometimes accompanied by headaches and dizziness (onset dates not reported).  The reporter indicated that this sensation lasted for well over eight months, with no further diagnosis from many doctors.  No additional information was provided at the time of this report.  Follow-up information received on 04 December 2007 from the patient.  Following review of the reported events, this case was upgraded to serious.  An approximately 61-year-old male patient had received an injection of influenza vaccine, manufacturer not reported, lot number not reported, on an unspecified date in 2006.  The symptoms that the patient experienced lasted eight to nine months and had also included a numbness sensation in the crown of his head.  The patient was examined by a neurologist, and an unspecified CAT scan was negative.  The patient recovered from the event.  Contact information was provided for the patient's personal physician.  The reporter of this case is the same as for cases 2007-03792 and 2007-03793 and involve the same patient who experienced events following influenza vaccination in 2005 and 2007.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Blood culture, Body temperature increased, Flushing, Injection site inflammation, Moaning
Clinical narrative: Mom states that after vaccinations she gave son 0.4ml of Tylenol. She states that at 11:30pm her fiance noticed that child was flushed and groaning and had a temp of 104 degrees. mom took client to hospital.  Mom states that they gave him Motrin and Benaryl.  She states that they did blood cultures and blood counts. She states they sent her home with instructions to continue giving motrin and tylenol and gave her time intervals and dosage. Since the evening of 12/13 mom states that his color is normal, his temps have been between 97.9 and 100.5 degrees and that the area where he received his shots looks like "bee stings". Blood cultures done inthe emergency room were negative.
Age: 25.0
Sex: F
Vaccine: FLUN3
Symptoms: Paraesthesia, Rash
Clinical narrative: Pt received flumist inhalation on 12/13/2007. Pt c/o if facial tingling within 10 minutes of vaccination. Pt waited in vaccination area for approximately 20 minutes. She then left and returned 20 more minutes later c/o a fine rash on her left arm and face. Pt was instructed to have someone drive her to the clinic.
Age: 39.0
Sex: M
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Infection, Injection site discolouration, Injection site discomfort, Injection site erythema
Clinical narrative: Highly atypical Influenza vaccine.  Vaccine felt like fire going in, and I could feel pain as the serum seeped through the muscle.  Vaccination lasted longer than usual flu vaccine.  Injection site turned red from the moment of injection and began to harden and get warm.  Site closed and never abscessed, but around injection site and satellite areas were painful, hot and red.  I went to the ER.  The next morning still in level 3 pain.  I started Cephalexin, and they gave me a prescription for Bactrim.  I also covered the area with Bactroban ointment and a bandage.  ER staff told me to draw a circle around redness which was about the diameter of a quarter.  I was instructed to start the Bactrim immediately if it escaped the border.  Within hours it had grown beyond the border.  I started the Bactrim along with the Cephalexin.  I felt an extreme level of tiredness, as if my body was having to fight with all it had.  The next day the antibiotics had arrested the growth of the bacteria, and the area started turning a dark purple healing color and redness, tenderness, hardness, and heat went away from main lesion and satellite ones.  I believe that this was an invasive soft tissue infection with no drain that could have become quite serious if the antibiotics had not been started one day after the infection.  I have had many shots, administered allergy shots to myself.  I have never had a shot be so sore for so long, and react the way that did.  If it had only been bacteria from the skin, it probably would have abscessed and not had sub-dermal satellite areas that also never abscessed.  I believe that that shot was contaminated with MRSA.  I don't know if Merck manufacture it, but there is contamination being reported in another of their vaccines.  I feel lucky to be alive.
Age: 39.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Highly atypical Influenza vaccine.  Vaccine felt like fire going in, and I could feel pain as the serum seeped through the muscle.  Vaccination lasted longer than usual flu vaccine.  Injection site turned red from the moment of injection and began to harden and get warm.  Site closed and never abscessed, but around injection site and satellite areas were painful, hot and red.  I went to the ER.  The next morning still in level 3 pain.  I started Cephalexin, and they gave me a prescription for Bactrim.  I also covered the area with Bactroban ointment and a bandage.  ER staff told me to draw a circle around redness which was about the diameter of a quarter.  I was instructed to start the Bactrim immediately if it escaped the border.  Within hours it had grown beyond the border.  I started the Bactrim along with the Cephalexin.  I felt an extreme level of tiredness, as if my body was having to fight with all it had.  The next day the antibiotics had arrested the growth of the bacteria, and the area started turning a dark purple healing color and redness, tenderness, hardness, and heat went away from main lesion and satellite ones.  I believe that this was an invasive soft tissue infection with no drain that could have become quite serious if the antibiotics had not been started one day after the infection.  I have had many shots, administered allergy shots to myself.  I have never had a shot be so sore for so long, and react the way that did.  If it had only been bacteria from the skin, it probably would have abscessed and not had sub-dermal satellite areas that also never abscessed.  I believe that that shot was contaminated with MRSA.  I don't know if Merck manufacture it, but there is contamination being reported in another of their vaccines.  I feel lucky to be alive.
Age: 1.17
Sex: M
Vaccine: FLUX, MMR, VARCEL
Symptoms: Dermatitis, Rash erythematous, Rash maculo-papular, Rash papular
Clinical narrative: diffuse erythematous maculopapular dermatitis requiring no treatment
Age: 0.17
Sex: F
Vaccine: 6VAX-F, RVX
Symptoms: Diarrhoea, Irritability, Rotavirus test, Stomach discomfort
Clinical narrative: My baby has had diarrhea ever since she was administered the rotateq  vaccine.  I have already taken her in to her doctor six times and to a infection specialist two times because her diarrhea does not stop 6 to 7 bowel movements a day, she was crankier because she felt uncomfortable from her stomach. She has already been change from her formula three times. She still has not recovered and its been over a month.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Autopsy, Death, Toxicologic test
Clinical narrative: INFANT DECEASED 16 HRS. POST IMMUNIZATION ADMINISTRATION.  NO ADVERSE SIGNS OR SYMPTOMS DESCRIBED BY MOTHER.  AUTOPSY DID NOT IDENTIFY ANY SIGNS OF ADVERSE REACTION.  12/26/2007 Vax record and MR received from PCP. Vax record as reported on VAERS report.   1/11/2008 Autopsy Report received with Child Fatality Investigation Report.  COD: Sudden Unexpected Death in Infancy. Infant had been sleeping on sofa with mother.  Mother felt child was warm and gave Tylenol.  Respiratory Distress was noted by mom.  EMS notified and CPR initiated however child was pronounced dead upon arrival at medical center. Unsafe sleeping conditions documented. Distinction between SIDS and subtle forms of asphyxia could not be made by autopsy alone.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 1.06
Sex: M
Vaccine: HEP, HIBV, MMR
Symptoms: Abnormal behaviour, Blood test, Delirium, Electroencephalogram abnormal, Encephalitis enteroviral
Clinical narrative: Patient received the Hib, MMR, and DRaP on August 27, 2007.  On August 30, patient had a high fever (102F) and vomited.  Later that evening, he had his first seizure.  On August 31, patient had a seizure that lasted longer that 1 minute, and we took him to the emergency room.  He did not have a fever when he entered the emergency facility.  He had another seizure at the hospital, and was diagnosed with a seizure disorder and sent home.  Through the night on August 31 he had numerous seizures, and was taken to Hospital.  He was admitted.  He was delirious, signing and saying words that were inappropriate.   (for him, I know he was 1 but his language, and signing, at the time were very advanced).  He was tested for encephalitis.  The ER doc continued to say that it looked like patient had Hib.  And he continued to ask us if we'd vaccinated patient.  (ignoring the comments that we'd vaccinated patient just 6 days prior)  Eventually patient's seizures were stopped on Sept 2.  He remains on Keppra, and is tolerating it, but has lost much of his verbal skills.  While he was diagnosed with viral encephalitis -- endero virus, his seizures and illnes were more severe than would normally be seen with endero virus. 12/31/07-records received for DOS 9/1-9/4/07-DC DX: Enterovirus encephalitis. Seizures due to #1.  Became ill morning prior to admission developed fever and seizure. Temperature since onset has been 102. Has had 6-8 seizures lasting less than a minute and resolving spontaneously. Left ward deviation of both eyes, stiffening of all 4 extremities and clenching of jaw, followed by extreme somnolence. 01/10/2010 Still has abnormal EEG that suggests segeuls. Still on keppra 01/19/2010 Still as EEG that indicates Epileptic activity. Has had minor sequel activity. Continues to take Keppra is still showing language delay.
Age: 1.06
Sex: M
Vaccine: HEP, HIBV, MMR
Symptoms: Eye movement disorder, Lumbar puncture, Musculoskeletal stiffness, Pyrexia, Speech disorder
Clinical narrative: Patient received the Hib, MMR, and DRaP on August 27, 2007.  On August 30, patient had a high fever (102F) and vomited.  Later that evening, he had his first seizure.  On August 31, patient had a seizure that lasted longer that 1 minute, and we took him to the emergency room.  He did not have a fever when he entered the emergency facility.  He had another seizure at the hospital, and was diagnosed with a seizure disorder and sent home.  Through the night on August 31 he had numerous seizures, and was taken to Hospital.  He was admitted.  He was delirious, signing and saying words that were inappropriate.   (for him, I know he was 1 but his language, and signing, at the time were very advanced).  He was tested for encephalitis.  The ER doc continued to say that it looked like patient had Hib.  And he continued to ask us if we'd vaccinated patient.  (ignoring the comments that we'd vaccinated patient just 6 days prior)  Eventually patient's seizures were stopped on Sept 2.  He remains on Keppra, and is tolerating it, but has lost much of his verbal skills.  While he was diagnosed with viral encephalitis -- endero virus, his seizures and illnes were more severe than would normally be seen with endero virus. 12/31/07-records received for DOS 9/1-9/4/07-DC DX: Enterovirus encephalitis. Seizures due to #1.  Became ill morning prior to admission developed fever and seizure. Temperature since onset has been 102. Has had 6-8 seizures lasting less than a minute and resolving spontaneously. Left ward deviation of both eyes, stiffening of all 4 extremities and clenching of jaw, followed by extreme somnolence. 01/10/2010 Still has abnormal EEG that suggests segeuls. Still on keppra 01/19/2010 Still as EEG that indicates Epileptic activity. Has had minor sequel activity. Continues to take Keppra is still showing language delay.
Age: 1.06
Sex: M
Vaccine: HEP, HIBV, MMR
Symptoms: Speech disorder, Speech disorder developmental, Vomiting
Clinical narrative: Patient received the Hib, MMR, and DRaP on August 27, 2007.  On August 30, patient had a high fever (102F) and vomited.  Later that evening, he had his first seizure.  On August 31, patient had a seizure that lasted longer that 1 minute, and we took him to the emergency room.  He did not have a fever when he entered the emergency facility.  He had another seizure at the hospital, and was diagnosed with a seizure disorder and sent home.  Through the night on August 31 he had numerous seizures, and was taken to Hospital.  He was admitted.  He was delirious, signing and saying words that were inappropriate.   (for him, I know he was 1 but his language, and signing, at the time were very advanced).  He was tested for encephalitis.  The ER doc continued to say that it looked like patient had Hib.  And he continued to ask us if we'd vaccinated patient.  (ignoring the comments that we'd vaccinated patient just 6 days prior)  Eventually patient's seizures were stopped on Sept 2.  He remains on Keppra, and is tolerating it, but has lost much of his verbal skills.  While he was diagnosed with viral encephalitis -- endero virus, his seizures and illnes were more severe than would normally be seen with endero virus. 12/31/07-records received for DOS 9/1-9/4/07-DC DX: Enterovirus encephalitis. Seizures due to #1.  Became ill morning prior to admission developed fever and seizure. Temperature since onset has been 102. Has had 6-8 seizures lasting less than a minute and resolving spontaneously. Left ward deviation of both eyes, stiffening of all 4 extremities and clenching of jaw, followed by extreme somnolence. 01/10/2010 Still has abnormal EEG that suggests segeuls. Still on keppra 01/19/2010 Still as EEG that indicates Epileptic activity. Has had minor sequel activity. Continues to take Keppra is still showing language delay.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Patient received pneumococcal vaccine on 12/4/07.  Patient phoned the medical centter on 12/7/07 to report that his arm was swollen from his elbow to his shoulder, with pain.  Patient was urged to report to the medical center for evaluation but patient declined.  MD spoke with patient via telephone on 12/11/07 and patient stated his arm swelling was resolving on its own.  This reporter phoned patient on 12/17/07 and patient reported that the swelling was completely resolved without intervention.