chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular
Clinical narrative: Right lower back - few small red raised bumps. Left front chest 1 small / pinpoint raised red bump. Mom gave Benadryl P.O. after onset of symptoms.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Erythema, Malaise, Oedema peripheral, Pyrexia
Clinical narrative: Pt received ADACEL RA upper deltoid, PNEUMOVAX RA lower deltoid.  On 11/4/08 since vaccinations febrile, chilling. Has not felt well since.  Negative cough, negative vomiting or diarrhea.  RA lower redened size of tennis ball, red streak going inward around arm.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Skin striae
Clinical narrative: Pt received ADACEL RA upper deltoid, PNEUMOVAX RA lower deltoid.  On 11/4/08 since vaccinations febrile, chilling. Has not felt well since.  Negative cough, negative vomiting or diarrhea.  RA lower redened size of tennis ball, red streak going inward around arm.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Dizziness, Dyspnoea, Musculoskeletal pain
Clinical narrative: C/O pain left shoulder, et with deep breath -dizziness assisted to lie down-ice bag applied to shoulder-skin w/d, BP 100/60 P-72 regular. Encouraged Mom to give Ibuprofen/TYLENOL when gets home. Reported ate only 2 donuts this AM-enc. to eat also. 2 pm Mother reports is fine.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache, chills, fatigue, fever (highest 103.2 F). These symptoms lasted 4-5 days. Still had headache 8/18/08.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm with erythema, warmth + swelling - vaccines given 8-6-08, signs and symptoms started 8-7-08. Motrin, Benadryl icepacks.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Pyrexia
Clinical narrative: Patient immediately began to feel tired. He also developed a headache and a low-grade fever (99.0F) within 2 hours of receiving immunization. Patient felt better later in the evening of 8/12/08.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Headache, Malaise, Neck pain, Oropharyngeal pain
Clinical narrative: Headache, fever 101.0F, neck ached, slight sore throat, very tired. Hold not feel well for 2 days.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Headache, fever 101.0F, neck ached, slight sore throat, very tired. Hold not feel well for 2 days.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: Pt. on 7/23/05-1445- after receiving immunizations on 7/21/08.  C/o pain in LUE.  Pts. LUE had an area of approx 5 in x 3 in around injection site that was red in color & warm to touch.  Small bubble where injection was.  Had received VARICELLA on LUE.  Saw PCP on 7/23/08- States reaction to VARICELLA.  7/25/08 no s/s left.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Fear, Head lag, Hyperventilation, Pallor
Clinical narrative: Very fearful - Hyperventilating - trembling before injection. Became faint approx 3 min after inj. Placed in shock position, color returned slowly, got patient sitting position approx 5 min later became faint pale - head dropped back. Nonresponsive, couldn't /// type reaction. Placed in shock positition . A fam response to mother. ///// EMS called for assistance.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Very fearful - Hyperventilating - trembling before injection. Became faint approx 3 min after inj. Placed in shock position, color returned slowly, got patient sitting position approx 5 min later became faint pale - head dropped back. Nonresponsive, couldn't /// type reaction. Placed in shock positition . A fam response to mother. ///// EMS called for assistance.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haemorrhage, Injection site vesicles
Clinical narrative: Patient's mother reported that child had a small bleed after needle was removed pressure and cotton ball was applied by RN. The child removed band aid at 48 hrs, a small soft blister was seen approx 10mm away from injection site.
Age: 36.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Laboratory test, Myalgia
Clinical narrative: Patient states developed muscle and joint aches the following day after receiving a Tetanus vaccine. Stated by 4:00 PM on 1/4/09 his joints began to ache and by 7:00 PM he felt worse. He follows up with his own Physician in 2 weeks.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Headache, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Mother states" child can not move her RUE at all: C/O RUE being very sore C/O nausea +HA. Temp 99 f. Given children Ibuprofen. Mother states minimal redness with pinhead sized swelling at injection site. Ibuprofen, ice pack to site ex movement of RUE.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Pain in extremity
Clinical narrative: Mother states" child can not move her RUE at all: C/O RUE being very sore C/O nausea +HA. Temp 99 f. Given children Ibuprofen. Mother states minimal redness with pinhead sized swelling at injection site. Ibuprofen, ice pack to site ex movement of RUE.
Age: 23.0
Sex: U
Vaccine: HPV4, VARCEL
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Was given HPV during her pregnancy she was apx 6wks gestation. She was also given varicella at hospital. When she was apx 5 week gestation
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Got vaccination 10-27-2008. 10-29-08 arm started aching. 10-30-08, arm swollen clear down into hand and up thru shoulder into neck.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Disturbance in attention, Dysgraphia, Eye pain
Clinical narrative: Headache, weakness, decreased concentration, writing illegible, chills, stiffness lower extremities, muscle aching, fever 101 (although this was taken after client took hot bath for chills), eyes aching, nausea.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Heart rate decreased, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Headache, weakness, decreased concentration, writing illegible, chills, stiffness lower extremities, muscle aching, fever 101 (although this was taken after client took hot bath for chills), eyes aching, nausea.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Headache, weakness, decreased concentration, writing illegible, chills, stiffness lower extremities, muscle aching, fever 101 (although this was taken after client took hot bath for chills), eyes aching, nausea.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Erythema, Tenderness
Clinical narrative: Redness, Tenderness, difficulty breathing.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at swelling from top of knee up leg on next day.
Age: 0.4
Sex: M
Vaccine: DTAPH, DTAPHEPBIP, PNC
Symptoms: Wrong drug administered
Clinical narrative: Incorrect immunization administered TRIHIBIT/DTAP/HIB given instead of ACTHIB HIB
Age: 1.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash
Clinical narrative: Redness/ Rash immediately around MMR at varicella injection site.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Body temperature increased
Clinical narrative: Mother called clinic at 5:15 pm  7/8/08 stating child had temp 101F this am. She has given Motrin and Tylenol and now at 5:15 Pt temp 101.2 even though Tylenol brought tempt down this am, told to cont. Tylenol Motrin, spoke to mother 7/10/2008 she stated temp completely resolved by 7/9/08 and child has no problems.
Age: 10.0
Sex: F
Vaccine: YF
Symptoms: Dizziness
Clinical narrative: 10 Minutes after administering vaccine patient c/o dizziness. H20 given and Pt jacket removed with recovery.
Age: 10.0
Sex: F
Vaccine: IPV, TDAP
Clinical narrative: TDAP administered 6 mo too soon per vaccination scheduling guide lines
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mother noticed last NOC right thigh to knee swollen + red. 0 hot to touch, but is tender child does walk, but with slight limp. Advised to give Ibuprofen and use cool packs for swelling and pain. If s/s worsen seek medical attention from primary care physician.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Chest X-ray normal, Cough, Eye discharge, Respiratory syncytial virus test negative
Clinical narrative: 101-102 Temp- eyes matted - clear nasal discharge - cough - Sx lasted 2 days - to ER Fri, Amoxicillin, and cough med- Dr said ok to proceed with next series
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rhinorrhoea
Clinical narrative: 101-102 Temp- eyes matted - clear nasal discharge - cough - Sx lasted 2 days - to ER Fri, Amoxicillin, and cough med- Dr said ok to proceed with next series
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Lip swelling, Urticaria
Clinical narrative: W/ 1st dose broke out in hives, w/2nd dose lips swelled as well as mouth.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Herpes zoster, Rash erythematous, Rash maculo-papular
Clinical narrative: Erythematous Maculopapular rash appreciated in the L2-L3 distribution of the R leg. Largest patch 6cm in diameter. DX shingles. TX Acyclovier 300mg QID X 5 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MEA, VARCEL
Symptoms: Rash
Clinical narrative: Rash over abdomen, onset 1-22-09.
Age: 9.0
Sex: M
Vaccine: FLUN3, VARCEL
Symptoms: Chest pain, Pruritus, Rash generalised
Clinical narrative: FLUMIST and VARIVAX vaccine were administered. Pt c/o chest pain at home. Pt returned to office, BP was taken and was monitored. c/o rash on body and itchy hands.
Age: 58.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Back pain, Influenza like illness, Injection site rash, Myalgia, Ocular hyperaemia
Clinical narrative: Morning of 1-16-2009 noticed back pain, throughout that morning developed what felt like a mild fevers and generalized muscles aches "flu-like" feelings. Took an Aleve and felt a little better. On Sat, 1-17 noticed a rash at the injection site. Sunday 1-18 noticed rash on trunk. New rash has resolved, eyes are still bloodshot and have been since Sunday.
Age: 58.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: Morning of 1-16-2009 noticed back pain, throughout that morning developed what felt like a mild fevers and generalized muscles aches "flu-like" feelings. Took an Aleve and felt a little better. On Sat, 1-17 noticed a rash at the injection site. Sunday 1-18 noticed rash on trunk. New rash has resolved, eyes are still bloodshot and have been since Sunday.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Patient has about 2in erythema and slight swelling advice to apply ice pack patient denies any pain
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Patient received pediatric dose of ADACEL. No adverse reaction.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Medication error, No adverse event
Clinical narrative: Received DPH and IPV. Reporting medication error. To date , no reported adverse reaction from IPV over vaccination. Born 3wk's premature.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Nausea, Tinnitus, Vomiting
Clinical narrative: C1 woke up at 5pm with vomiting. Feels like she could faint. Complains of ears ringing and continued nausea.-1.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: Redness-itching-blistering at injection site at about 12 hours after injection-warm compress. BENADRYL PRN.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Red swollen arm - about size of baseball, hot tender. Started 1day after shot and lasted 4-5 days.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Nausea
Clinical narrative: Onset of nausea, dizziness within 30 sec of vaccine administration (HPV) symptoms persisted for full 48hrs per Pt symptoms were severe.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Rash, Skin warm, Swelling
Clinical narrative: Pt. given Tdap in left upper arm-IM 12/15/08. Pt called Tues - achiness Monday night-on AM Tues-L arm red, warm, rash, swelling took BENADRYL Tues night & Wed to Tx Sx- and to sleep. Had red cuff like around upper L arm 20 cm X 10 cm pat seen in office 12/19 prescribed ALEVE -states sx decreased denies SOB-pt was eval by PA, called on 12/31 to confirm next app- stated rash, better, slight elevation. Evaluation by MD/ cont. Tx Sx go to ER if Sx increase.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: B-lymphocyte count decreased, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, Blood product transfusion, Cerebral haemorrhage
Clinical narrative: It was reported in a published article, title as stated above that a 13 month old female with adenosine deaminase (ADA) deficiency and a history of recurrent sinopulmonary infections, refractory oral candidiasis and poor weight gain on an unspecified date was vaccinated with VARIVAX (Merck) and MMR II. Four weeks after vaccination, the patient presented to an outside hospital with fever, cough and vesicular rash. She was transferred to the reporter's institution for respiratory failure and progression of her rash. Initial laboratory results revealed a low absolute lymphocyte count of 371 cells*10(-6)/L, with low absolute T, B and NK cell subsets, as well as low IgG (124 mg/dL) and IgM (18 mg/dL). Evaluation for SCID etiology revealed ADA deficiency with elevated deoxyadenosine nucleotides and homozygosity for the Leu 107>Pro mutation in ADA exon 4, previously found in other ADA-SCID patients. She was treated with broad-spectrum antivirals, antifungals, and antibiotics, intravenous preparations of immune globulin (IVIG), PEG-ADA, and pooled irradiated leukocytes from healthy donors with recent zoster infection. Skin lesions were positive for varicella, and bronchoalveolar lavages (BAL) were positive by PCR or culture for measles, mumps, and rubella. The vaccine infections were cleared with lymphocyte infusions and antiviral therapies. She succumbed after 40 days to a cerebral hemorrhage during extracorporeal membrane oxygenation. CDC evaluations of BAL and vesicle samples confirmed that all 4 viruses were vaccine strains. Genetic sequencing also confirmed that she carried a severe ADA enzyme mutation (L 107P). A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Condition aggravated, Cough, Death, Laboratory test abnormal, Lymphocyte count decreased
Clinical narrative: It was reported in a published article, title as stated above that a 13 month old female with adenosine deaminase (ADA) deficiency and a history of recurrent sinopulmonary infections, refractory oral candidiasis and poor weight gain on an unspecified date was vaccinated with VARIVAX (Merck) and MMR II. Four weeks after vaccination, the patient presented to an outside hospital with fever, cough and vesicular rash. She was transferred to the reporter's institution for respiratory failure and progression of her rash. Initial laboratory results revealed a low absolute lymphocyte count of 371 cells*10(-6)/L, with low absolute T, B and NK cell subsets, as well as low IgG (124 mg/dL) and IgM (18 mg/dL). Evaluation for SCID etiology revealed ADA deficiency with elevated deoxyadenosine nucleotides and homozygosity for the Leu 107>Pro mutation in ADA exon 4, previously found in other ADA-SCID patients. She was treated with broad-spectrum antivirals, antifungals, and antibiotics, intravenous preparations of immune globulin (IVIG), PEG-ADA, and pooled irradiated leukocytes from healthy donors with recent zoster infection. Skin lesions were positive for varicella, and bronchoalveolar lavages (BAL) were positive by PCR or culture for measles, mumps, and rubella. The vaccine infections were cleared with lymphocyte infusions and antiviral therapies. She succumbed after 40 days to a cerebral hemorrhage during extracorporeal membrane oxygenation. CDC evaluations of BAL and vesicle samples confirmed that all 4 viruses were vaccine strains. Genetic sequencing also confirmed that she carried a severe ADA enzyme mutation (L 107P). A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash vesicular, Respiratory failure, T-lymphocyte count decreased, Varicella
Clinical narrative: It was reported in a published article, title as stated above that a 13 month old female with adenosine deaminase (ADA) deficiency and a history of recurrent sinopulmonary infections, refractory oral candidiasis and poor weight gain on an unspecified date was vaccinated with VARIVAX (Merck) and MMR II. Four weeks after vaccination, the patient presented to an outside hospital with fever, cough and vesicular rash. She was transferred to the reporter's institution for respiratory failure and progression of her rash. Initial laboratory results revealed a low absolute lymphocyte count of 371 cells*10(-6)/L, with low absolute T, B and NK cell subsets, as well as low IgG (124 mg/dL) and IgM (18 mg/dL). Evaluation for SCID etiology revealed ADA deficiency with elevated deoxyadenosine nucleotides and homozygosity for the Leu 107>Pro mutation in ADA exon 4, previously found in other ADA-SCID patients. She was treated with broad-spectrum antivirals, antifungals, and antibiotics, intravenous preparations of immune globulin (IVIG), PEG-ADA, and pooled irradiated leukocytes from healthy donors with recent zoster infection. Skin lesions were positive for varicella, and bronchoalveolar lavages (BAL) were positive by PCR or culture for measles, mumps, and rubella. The vaccine infections were cleared with lymphocyte infusions and antiviral therapies. She succumbed after 40 days to a cerebral hemorrhage during extracorporeal membrane oxygenation. CDC evaluations of BAL and vesicle samples confirmed that all 4 viruses were vaccine strains. Genetic sequencing also confirmed that she carried a severe ADA enzyme mutation (L 107P). A copy of the published article is attached as further documentation of the patient's experience.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray abnormal, Chest pain, Computerised tomogram abnormal, Dizziness, Dyspnoea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with no known allergy who on 01-JUL-2008 was vaccinated in the left arm with the third dose of GARDASIL (lot# 659180/1758U) (route of administration not reported). The patient was vaccinated with the first and the second dose of GARDASIL on 04-DEC-2007 and 29-FEB-2008 respectively. On 28-AUG-2008 the patient experienced chest pain, shortness of breath, lightheadedness and dizziness. The patient was accepted by emergency room. Chest X-ray test indicated a "fullness" by the heart. On 30-AUG-2008 a computerized axial tomography (CAT) scan was performed and early Stage 2 Hodgkin's lymphoma was the official diagnosis received on 24-SEP-2008. The patient was hospitalized. Patient is currently undergoing treatment at the clinic. Prior to the beginning of the 3 shot series of GARDASIL, the patient had a chest X-ray, and the chest X-ray showed no signs of Hodgkin's Lymphoma. Other lab tests also included positron emission tomography (PET) scan, lymph node biopsy, bone marrow biopsy and blood work. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The reporter considered the adverse experiences to be life threatening. The original reporting source was not provided. The VAERS ID# is 332094. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hodgkin's disease stage II
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with no known allergy who on 01-JUL-2008 was vaccinated in the left arm with the third dose of GARDASIL (lot# 659180/1758U) (route of administration not reported). The patient was vaccinated with the first and the second dose of GARDASIL on 04-DEC-2007 and 29-FEB-2008 respectively. On 28-AUG-2008 the patient experienced chest pain, shortness of breath, lightheadedness and dizziness. The patient was accepted by emergency room. Chest X-ray test indicated a "fullness" by the heart. On 30-AUG-2008 a computerized axial tomography (CAT) scan was performed and early Stage 2 Hodgkin's lymphoma was the official diagnosis received on 24-SEP-2008. The patient was hospitalized. Patient is currently undergoing treatment at the clinic. Prior to the beginning of the 3 shot series of GARDASIL, the patient had a chest X-ray, and the chest X-ray showed no signs of Hodgkin's Lymphoma. Other lab tests also included positron emission tomography (PET) scan, lymph node biopsy, bone marrow biopsy and blood work. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The reporter considered the adverse experiences to be life threatening. The original reporting source was not provided. The VAERS ID# is 332094. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy heart abnormal, Cancer in remission, Hodgkin's disease
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 17-SEP-2007, a 15 year old female with penicillin allergy was vaccinated with the third dose of GARDASIL (lot#: 656371/0181U) in the right arm. Concomitant therapy included SEASONIQUE oral for contraception. On 11-AUG-2008, core biopsy was performed. On 17-AUG-2008 the patient was diagnosed with Hodgkins Lymphoma. Hodgkins Lymphoma was considered to be immediately life-threatening. It was also reported that the patient had a previous vaccine illness of Hodgkins Lymphoma in the patient. The original reporting source was not provided. The VAERS ID # is 332906. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. No further information is available. She is currently in remission from cancer- but will not be cured for 5 years.
Age: 1.9
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Aphasia, Cognitive disorder, Decreased appetite, Encephalitis
Clinical narrative: A serious spontaneous report of accidental exposure, encephalitis, "possibly having absent seizures" and runny nose has been received from a Registered Nurse (the patient's mother) concerning a 23-month-old female.  Medical history and concomitant medications were not reported.  On 12-Nov-2008, the patient's father received FLUMIST.  The patient did not receive FLUMIST.  On 24-Nov-2008, the patient developed a runny nose that was "off and on" and lasted until 01-Dec-2008.  On 04-Dec-2008, the patient began experiencing "neurological difficulties".  She developed ticks described as blinking with facial movements, shoulder movements down to her fingers, and toes twitching.  She had sensitivity to light and "bad" fevers which were 101-102 degrees F with treatment with acetaminophen.  She had cognitive and speech loss for 4 to 5 days where she was not able to speak like she normally did, she could not say "apple" which she could easily say previously and she would say "what's that?" to things that she previously knew.  She was not eating, only wanted to nurse, was not sleeping and was irritable.  She was not lethargic.  The patient went to the pediatrician on 05-Dec-2008 and 10-Dec-2008.  She was prescribed amoxicillin and the patient's mother was told only to give it to her if she got worse.  The patient started getting better so she never received amoxicillin.  On 17-Dec-2008, the patient was seen by a neurologist.  The neurologist indicated it was possibly encephalitis but there was no way to know because the patient's symptoms were resolving.  A brain magnetic resonance imaging on 18-Dec-2008 was normal.  There was no spinal tap or electroencephalography done.  The patient recovered except for having occasional headaches at night.  In follow up, the patient's mother indicated she was also "possibly having absent seizures" during the day so she was scheduled for an overnight EEG in March 2009.  The patient's mother indicated that the neurologist reviewed the chronology of the events and indicated that it could have been from exposure to the father after receiving FLUMIST.  The sponsor considered the events of encephalitis and "possibly having absent seizures" to be serious (important medical events).  Additional information received on 21-Jan-2009 and incorporated in the narrative included final diagnosis and the patient's current status.  The mother indicated the neurologist felt the patient's experience was encephalitis.
Age: 1.9
Sex: F
Vaccine: FLUN3
Symptoms: Excessive eye blinking, Headache, Insomnia, Irritability, Muscle twitching
Clinical narrative: A serious spontaneous report of accidental exposure, encephalitis, "possibly having absent seizures" and runny nose has been received from a Registered Nurse (the patient's mother) concerning a 23-month-old female.  Medical history and concomitant medications were not reported.  On 12-Nov-2008, the patient's father received FLUMIST.  The patient did not receive FLUMIST.  On 24-Nov-2008, the patient developed a runny nose that was "off and on" and lasted until 01-Dec-2008.  On 04-Dec-2008, the patient began experiencing "neurological difficulties".  She developed ticks described as blinking with facial movements, shoulder movements down to her fingers, and toes twitching.  She had sensitivity to light and "bad" fevers which were 101-102 degrees F with treatment with acetaminophen.  She had cognitive and speech loss for 4 to 5 days where she was not able to speak like she normally did, she could not say "apple" which she could easily say previously and she would say "what's that?" to things that she previously knew.  She was not eating, only wanted to nurse, was not sleeping and was irritable.  She was not lethargic.  The patient went to the pediatrician on 05-Dec-2008 and 10-Dec-2008.  She was prescribed amoxicillin and the patient's mother was told only to give it to her if she got worse.  The patient started getting better so she never received amoxicillin.  On 17-Dec-2008, the patient was seen by a neurologist.  The neurologist indicated it was possibly encephalitis but there was no way to know because the patient's symptoms were resolving.  A brain magnetic resonance imaging on 18-Dec-2008 was normal.  There was no spinal tap or electroencephalography done.  The patient recovered except for having occasional headaches at night.  In follow up, the patient's mother indicated she was also "possibly having absent seizures" during the day so she was scheduled for an overnight EEG in March 2009.  The patient's mother indicated that the neurologist reviewed the chronology of the events and indicated that it could have been from exposure to the father after receiving FLUMIST.  The sponsor considered the events of encephalitis and "possibly having absent seizures" to be serious (important medical events).  Additional information received on 21-Jan-2009 and incorporated in the narrative included final diagnosis and the patient's current status.  The mother indicated the neurologist felt the patient's experience was encephalitis.
Age: 1.9
Sex: F
Vaccine: FLUN3
Symptoms: Nervous system disorder, Nuclear magnetic resonance imaging normal, Photophobia, Pyrexia, Rhinorrhoea
Clinical narrative: A serious spontaneous report of accidental exposure, encephalitis, "possibly having absent seizures" and runny nose has been received from a Registered Nurse (the patient's mother) concerning a 23-month-old female.  Medical history and concomitant medications were not reported.  On 12-Nov-2008, the patient's father received FLUMIST.  The patient did not receive FLUMIST.  On 24-Nov-2008, the patient developed a runny nose that was "off and on" and lasted until 01-Dec-2008.  On 04-Dec-2008, the patient began experiencing "neurological difficulties".  She developed ticks described as blinking with facial movements, shoulder movements down to her fingers, and toes twitching.  She had sensitivity to light and "bad" fevers which were 101-102 degrees F with treatment with acetaminophen.  She had cognitive and speech loss for 4 to 5 days where she was not able to speak like she normally did, she could not say "apple" which she could easily say previously and she would say "what's that?" to things that she previously knew.  She was not eating, only wanted to nurse, was not sleeping and was irritable.  She was not lethargic.  The patient went to the pediatrician on 05-Dec-2008 and 10-Dec-2008.  She was prescribed amoxicillin and the patient's mother was told only to give it to her if she got worse.  The patient started getting better so she never received amoxicillin.  On 17-Dec-2008, the patient was seen by a neurologist.  The neurologist indicated it was possibly encephalitis but there was no way to know because the patient's symptoms were resolving.  A brain magnetic resonance imaging on 18-Dec-2008 was normal.  There was no spinal tap or electroencephalography done.  The patient recovered except for having occasional headaches at night.  In follow up, the patient's mother indicated she was also "possibly having absent seizures" during the day so she was scheduled for an overnight EEG in March 2009.  The patient's mother indicated that the neurologist reviewed the chronology of the events and indicated that it could have been from exposure to the father after receiving FLUMIST.  The sponsor considered the events of encephalitis and "possibly having absent seizures" to be serious (important medical events).  Additional information received on 21-Jan-2009 and incorporated in the narrative included final diagnosis and the patient's current status.  The mother indicated the neurologist felt the patient's experience was encephalitis.
Age: 1.9
Sex: F
Vaccine: FLUN3
Symptoms: Secondary transmission, Tic
Clinical narrative: A serious spontaneous report of accidental exposure, encephalitis, "possibly having absent seizures" and runny nose has been received from a Registered Nurse (the patient's mother) concerning a 23-month-old female.  Medical history and concomitant medications were not reported.  On 12-Nov-2008, the patient's father received FLUMIST.  The patient did not receive FLUMIST.  On 24-Nov-2008, the patient developed a runny nose that was "off and on" and lasted until 01-Dec-2008.  On 04-Dec-2008, the patient began experiencing "neurological difficulties".  She developed ticks described as blinking with facial movements, shoulder movements down to her fingers, and toes twitching.  She had sensitivity to light and "bad" fevers which were 101-102 degrees F with treatment with acetaminophen.  She had cognitive and speech loss for 4 to 5 days where she was not able to speak like she normally did, she could not say "apple" which she could easily say previously and she would say "what's that?" to things that she previously knew.  She was not eating, only wanted to nurse, was not sleeping and was irritable.  She was not lethargic.  The patient went to the pediatrician on 05-Dec-2008 and 10-Dec-2008.  She was prescribed amoxicillin and the patient's mother was told only to give it to her if she got worse.  The patient started getting better so she never received amoxicillin.  On 17-Dec-2008, the patient was seen by a neurologist.  The neurologist indicated it was possibly encephalitis but there was no way to know because the patient's symptoms were resolving.  A brain magnetic resonance imaging on 18-Dec-2008 was normal.  There was no spinal tap or electroencephalography done.  The patient recovered except for having occasional headaches at night.  In follow up, the patient's mother indicated she was also "possibly having absent seizures" during the day so she was scheduled for an overnight EEG in March 2009.  The patient's mother indicated that the neurologist reviewed the chronology of the events and indicated that it could have been from exposure to the father after receiving FLUMIST.  The sponsor considered the events of encephalitis and "possibly having absent seizures" to be serious (important medical events).  Additional information received on 21-Jan-2009 and incorporated in the narrative included final diagnosis and the patient's current status.  The mother indicated the neurologist felt the patient's experience was encephalitis.
Age: 1.1
Sex: M
Vaccine: DTAP, FLUX, HIBV, PNC
Symptoms: Lipoatrophy, Pain, Skin atrophy, Skin discolouration, Skin disorder
Clinical narrative: Initial report received on 13 January 2009 from another manufacturer, report number A0761372A.  The initial reporter to this manufacturer had been a health care professional.  Verbatim from the report:  "This case was reported by a physician and described the occurrence of fat atrophy in a 13-month-old male subject who was vaccinated with INFANRIX and ACTHIB.  The subject's medical history included cleft lip, cleft lip repair and renal problems.  Concurrent vaccination included influenza virus vaccine (manufacturer unspecified) and PREVNAR given on 29 September 2008.  Concurrent medications included Enalapril.  On 29 September 2008 the subject received 4th dose of INFANRIX (right thigh) and unspecified dose of ACTHIB (right thigh).  On 29 September 2008, less than one day after vaccination with INFANRIX, at an unspecified time after vaccination with ACTHIB, the subject experienced fat atrophy, skin discoloration, skin indentation and pain.  A physician reported that he gave a 13-month-old subject his 4th dose of INFANRIX vaccine and the subject developed a small purple spot that enlarged and became pitted over the course of one month.  There may have even some pain associated with the area, but the physician was not certain.  The subject also received an ACTHIB vaccine in the same thigh and separate location that day.  The physician is not certain if the site was of the INFANRIX or of the ACTHIB.  At the time of the report, the area had not improved or worsened but currently appeared to be a discolored, indentured area where the subcutaneous fatty tissue had atrophied leaving muscle directly covered with "thin parchment like skin".  At the time of reporting the events were unresolved.  The physician considered the events were possibly related to vaccination with INFANRIX and ACTHIB.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Autopsy, Death, Intussusception, Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse concerning a 13 weeks old female with a history of premature birth at 35 weeks, patient was a twin and no known allergies, who on 18-NOV-2008 was vaccinated with the first dose of ROTATEQ (lot no. 661037/0641X) oral administration. Concomitant therapy included PEDVAXHIB, PREVNAR, poliovirus vaccine (UNSPECIFIED) and DTaP (UNSPECIFED). The nurse reported that on 04-DEC-2008 the patient was found unresponsive in her crib and was taken to the local emergency room. The patient was pronounced deceased in the emergency room and a preliminary autopsy report revealed Intussusception. The cause of death was intussusception. Final autopsy report is pending. Intussusception was considered to be immediately life-threatening and disabling. Additional information was received from the nurse who explained that the patient was put down for a nap and was unresponsive when the parents checked on her. The nurse reported that the patient had no symptoms of Intussusception, and it was not determined until the autopsy. The patient was otherwise healthy. The nurse also reported that the patient had a twin sister who received ROTATEQ at the same time. It was reported that the twin is fine. Additional information has been requested. A lot check has been initiated.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Death, Intussusception, Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse concerning a 13 weeks old female with a history of premature birth at 35 weeks, patient was a twin and no known allergies, who on 18-NOV-2008 was vaccinated with the first dose of ROTATEQ (lot no. 661037/0641X) oral administration. Concomitant therapy included PEDVAXHIB, PREVNAR, poliovirus vaccine (UNSPECIFIED) and DTaP (UNSPECIFED). The nurse reported that on 04-DEC-2008 the patient was found unresponsive in her crib and was taken to the local emergency room. The patient was pronounced deceased in the emergency room and a preliminary autopsy report revealed Intussusception. The cause of death was intussusception. Final autopsy report is pending. Intussusception was considered to be immediately life-threatening and disabling. Additional information was received from the nurse who explained that the patient was put down for a nap and was unresponsive when the parents checked on her. The nurse reported that the patient had no symptoms of Intussusception, and it was not determined until the autopsy. The patient was otherwise healthy. The nurse also reported that the patient had a twin sister who received ROTATEQ at the same time. It was reported that the twin is fine. Additional information has been requested. A lot check has been initiated.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pruritus generalised
Clinical narrative: Shingles vaccine was administered by the office nurse on the morning of 01/22/09.  Exceptional itching, pain, tenderness, and soreness at the sight of the injection and the area around it (about 4 Sq. in.)became severe late evening of 01/24/09.  That continued through 01/25/09. Problem began to abate late evening of 01/26/09.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram, Diagnostic procedure, Eye swelling, Facial pain, Headache
Clinical narrative: Initial report received on 15 January 2009 from a consumer. A 65-year-old patient, who had no concurrent illnesses, but who has allergy to tree pollen, plums, hazelnuts and Red Delicious apples, had received on 15 December 2008 a dose of FLUZONE SV 2008-2009 (lot number U2803AA). The route and site of administration was not provided. The patient had not received any other vaccinations within four weeks of 15 December 2008; and had not experienced any adverse events with prior vaccination including several flu vaccines. The patient was taking PRILOSEC at the time of vaccination on 15 December 2008; however the indication for this medication was not provided. Approximately one week after receiving the FLUZONE vaccine, the patient starting having eye and facial swelling with facial numbness and pain on the right side of his face. He also experienced headache. Per the patient, he subsequently developed a "shadow" in his peripheral vision which has continued to worsen. He stated he had lost 80% of vision of the right eye. The patient was evaluated by a health care professional and had numerous tests/procedures including a Magnetic Resonance Imaging (MRI) test and computed axial tomography (CAT) scan; however the results were not provided. the patient is to be evaluated by a neuro-ophthalmolosgist the week of 19 January 2009. It was not reported whether the patient had received any treatment at this time, or if any diagnostic laboratory data had been performed. At the time of this report, it was "unknown" whether the patient had recovered. Documents held by sender: None.  2/5/09 Received PCP, vaccine ophtho & neurooptho medical records of 12/15/08-1/27/2009.  Ophtho records reveal patient seen 1/2/09 for c/o floaters OD x 1 week which worsened over next 6 days with vision decrease OD.  Dx: vitreous detachment/floater OD & subsequent non-arteritic anterior ischemic optic neuropathy.   PCP records of 1/8/09-1/27/09 reveal patient in usual state of health except for vision decrease OD.  RTC 1/27 & dx w/anxiety disorder generalized.  Neuro-ophtho records of 1/22/09 FINAL DX: anterior ischemic optic neuropathy, right side; disk at risk, left eye; no evidence of corneal anesthesia either side; & history of low-normal BP.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia facial, Nuclear magnetic resonance imaging, Swelling face, Visual acuity reduced, Visual field defect
Clinical narrative: Initial report received on 15 January 2009 from a consumer. A 65-year-old patient, who had no concurrent illnesses, but who has allergy to tree pollen, plums, hazelnuts and Red Delicious apples, had received on 15 December 2008 a dose of FLUZONE SV 2008-2009 (lot number U2803AA). The route and site of administration was not provided. The patient had not received any other vaccinations within four weeks of 15 December 2008; and had not experienced any adverse events with prior vaccination including several flu vaccines. The patient was taking PRILOSEC at the time of vaccination on 15 December 2008; however the indication for this medication was not provided. Approximately one week after receiving the FLUZONE vaccine, the patient starting having eye and facial swelling with facial numbness and pain on the right side of his face. He also experienced headache. Per the patient, he subsequently developed a "shadow" in his peripheral vision which has continued to worsen. He stated he had lost 80% of vision of the right eye. The patient was evaluated by a health care professional and had numerous tests/procedures including a Magnetic Resonance Imaging (MRI) test and computed axial tomography (CAT) scan; however the results were not provided. the patient is to be evaluated by a neuro-ophthalmolosgist the week of 19 January 2009. It was not reported whether the patient had received any treatment at this time, or if any diagnostic laboratory data had been performed. At the time of this report, it was "unknown" whether the patient had recovered. Documents held by sender: None.  2/5/09 Received PCP, vaccine ophtho & neurooptho medical records of 12/15/08-1/27/2009.  Ophtho records reveal patient seen 1/2/09 for c/o floaters OD x 1 week which worsened over next 6 days with vision decrease OD.  Dx: vitreous detachment/floater OD & subsequent non-arteritic anterior ischemic optic neuropathy.   PCP records of 1/8/09-1/27/09 reveal patient in usual state of health except for vision decrease OD.  RTC 1/27 & dx w/anxiety disorder generalized.  Neuro-ophtho records of 1/22/09 FINAL DX: anterior ischemic optic neuropathy, right side; disk at risk, left eye; no evidence of corneal anesthesia either side; & history of low-normal BP.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blindness unilateral, Computerised tomogram, Ear pain, Nasopharyngitis, Nuclear magnetic resonance imaging
Clinical narrative: Initial report received on 15 January 2009 from a consumer. A 65-year-old patient, who had no concurrent illnesses, but who has allergy to tree pollen, plums, hazelnuts and Red Delicious apples, had received on 15 December 2008 a dose of FLUZONE SV 2008-2009 (lot number U2803AA). The route and site of administration was not provided. The patient had not received any other vaccinations within four weeks of 15 December 2008; and had not experienced any adverse events with prior vaccination including several flu vaccines. The patient was taking PRILOSEC at the time of vaccination on 15 December 2008; however the indication for this medication was not provided. Approximately one week after receiving the FLUZONE vaccine, the patient starting having eye and facial swelling with facial numbness and pain on the right side of his face. He also experienced headache. Per the patient, he subsequently developed a "shadow" in his peripheral vision which has continued to worsen. He stated he had lost 80% of vision of the right eye. The patient was evaluated by a health care professional and had numerous tests/procedures including a Magnetic Resonance Imaging (MRI) test and computed axial tomography (CAT) scan; however the results were not provided. the patient is to be evaluated by a neuro-ophthalmolosgist the week of 19 January 2009. It was not reported whether the patient had received any treatment at this time, or if any diagnostic laboratory data had been performed. At the time of this report, it was "unknown" whether the patient had recovered. Documents held by sender: None.  2/5/09 Received PCP, vaccine ophtho & neurooptho medical records of 12/15/08-1/27/2009.  Ophtho records reveal patient seen 1/2/09 for c/o floaters OD x 1 week which worsened over next 6 days with vision decrease OD.  Dx: vitreous detachment/floater OD & subsequent non-arteritic anterior ischemic optic neuropathy.   PCP records of 1/8/09-1/27/09 reveal patient in usual state of health except for vision decrease OD.  RTC 1/27 & dx w/anxiety disorder generalized.  Neuro-ophtho records of 1/22/09 FINAL DX: anterior ischemic optic neuropathy, right side; disk at risk, left eye; no evidence of corneal anesthesia either side; & history of low-normal BP.