chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dysphagia, Dyspnoea, Dysstasia, Eating disorder, Electromyogram
Clinical narrative: Developed progressive lower extremity weakness/numbness requiring intubation 6/30 for respiratory failure. EMG/MRI consistent with GUILLAIN-BARRE Syndrome. Remains intubated in ICU with flaccid paralysis and paresthesias.  8/10/09 PCP medical records received DOS 5/26/09 to 6/9/09. Gardasil administered.  8/17/2009 Received hospital medical records of 6/28-7/30/2009. FINAL DX: Guillain-Barre syndrome; respiratory failure s/p extubation; ventilator assoc acinetobacter & staph aureus pneumonia  Records reveal patient experienced acute onset of progressive ascending LE weakness, areflexia & paresthesia, difficulty swallowing.  Admitted to PICU, LP done & intubated.  Developed neuropathic pain, fever w/(+) resp c/s.  Neuro, Pulm, ID consult done.  Tx w/IVIG w/o improvement, tx w/plasmapheresis x 8, multiple IV antibiotics, tube feedings.  Continued to worsen.   Gradually improved, extubated to RA & diet advanced.  Transferred to inpatient rehab on continued IV antibiotics.  10/16/09 ICD-9 Codes received: 781.2 Abnormality of gait, 357.0 Ac infectious polyneuritis, 518.81 Acute respiratory failure, 997.31 Ventilator assoc pneumonia, 041.85 Infection-gram neg nec, 041.11 MSSA, 599.0 Urin tract Infection NOS, 345.90 Epilepsy NOS-Not intract.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Endotracheal intubation, Feeling abnormal, Gastrointestinal tube insertion, Guillain-Barre syndrome, Heart rate increased
Clinical narrative: Developed progressive lower extremity weakness/numbness requiring intubation 6/30 for respiratory failure. EMG/MRI consistent with GUILLAIN-BARRE Syndrome. Remains intubated in ICU with flaccid paralysis and paresthesias.  8/10/09 PCP medical records received DOS 5/26/09 to 6/9/09. Gardasil administered.  8/17/2009 Received hospital medical records of 6/28-7/30/2009. FINAL DX: Guillain-Barre syndrome; respiratory failure s/p extubation; ventilator assoc acinetobacter & staph aureus pneumonia  Records reveal patient experienced acute onset of progressive ascending LE weakness, areflexia & paresthesia, difficulty swallowing.  Admitted to PICU, LP done & intubated.  Developed neuropathic pain, fever w/(+) resp c/s.  Neuro, Pulm, ID consult done.  Tx w/IVIG w/o improvement, tx w/plasmapheresis x 8, multiple IV antibiotics, tube feedings.  Continued to worsen.   Gradually improved, extubated to RA & diet advanced.  Transferred to inpatient rehab on continued IV antibiotics.  10/16/09 ICD-9 Codes received: 781.2 Abnormality of gait, 357.0 Ac infectious polyneuritis, 518.81 Acute respiratory failure, 997.31 Ventilator assoc pneumonia, 041.85 Infection-gram neg nec, 041.11 MSSA, 599.0 Urin tract Infection NOS, 345.90 Epilepsy NOS-Not intract.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Hypoaesthesia, Hypokinesia, Intensive care, Lumbar puncture, Mobility decreased
Clinical narrative: Developed progressive lower extremity weakness/numbness requiring intubation 6/30 for respiratory failure. EMG/MRI consistent with GUILLAIN-BARRE Syndrome. Remains intubated in ICU with flaccid paralysis and paresthesias.  8/10/09 PCP medical records received DOS 5/26/09 to 6/9/09. Gardasil administered.  8/17/2009 Received hospital medical records of 6/28-7/30/2009. FINAL DX: Guillain-Barre syndrome; respiratory failure s/p extubation; ventilator assoc acinetobacter & staph aureus pneumonia  Records reveal patient experienced acute onset of progressive ascending LE weakness, areflexia & paresthesia, difficulty swallowing.  Admitted to PICU, LP done & intubated.  Developed neuropathic pain, fever w/(+) resp c/s.  Neuro, Pulm, ID consult done.  Tx w/IVIG w/o improvement, tx w/plasmapheresis x 8, multiple IV antibiotics, tube feedings.  Continued to worsen.   Gradually improved, extubated to RA & diet advanced.  Transferred to inpatient rehab on continued IV antibiotics.  10/16/09 ICD-9 Codes received: 781.2 Abnormality of gait, 357.0 Ac infectious polyneuritis, 518.81 Acute respiratory failure, 997.31 Ventilator assoc pneumonia, 041.85 Infection-gram neg nec, 041.11 MSSA, 599.0 Urin tract Infection NOS, 345.90 Epilepsy NOS-Not intract.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, Paralysis, Pneumonia
Clinical narrative: Developed progressive lower extremity weakness/numbness requiring intubation 6/30 for respiratory failure. EMG/MRI consistent with GUILLAIN-BARRE Syndrome. Remains intubated in ICU with flaccid paralysis and paresthesias.  8/10/09 PCP medical records received DOS 5/26/09 to 6/9/09. Gardasil administered.  8/17/2009 Received hospital medical records of 6/28-7/30/2009. FINAL DX: Guillain-Barre syndrome; respiratory failure s/p extubation; ventilator assoc acinetobacter & staph aureus pneumonia  Records reveal patient experienced acute onset of progressive ascending LE weakness, areflexia & paresthesia, difficulty swallowing.  Admitted to PICU, LP done & intubated.  Developed neuropathic pain, fever w/(+) resp c/s.  Neuro, Pulm, ID consult done.  Tx w/IVIG w/o improvement, tx w/plasmapheresis x 8, multiple IV antibiotics, tube feedings.  Continued to worsen.   Gradually improved, extubated to RA & diet advanced.  Transferred to inpatient rehab on continued IV antibiotics.  10/16/09 ICD-9 Codes received: 781.2 Abnormality of gait, 357.0 Ac infectious polyneuritis, 518.81 Acute respiratory failure, 997.31 Ventilator assoc pneumonia, 041.85 Infection-gram neg nec, 041.11 MSSA, 599.0 Urin tract Infection NOS, 345.90 Epilepsy NOS-Not intract.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Posture abnormal
Clinical narrative: Developed progressive lower extremity weakness/numbness requiring intubation 6/30 for respiratory failure. EMG/MRI consistent with GUILLAIN-BARRE Syndrome. Remains intubated in ICU with flaccid paralysis and paresthesias.  8/10/09 PCP medical records received DOS 5/26/09 to 6/9/09. Gardasil administered.  8/17/2009 Received hospital medical records of 6/28-7/30/2009. FINAL DX: Guillain-Barre syndrome; respiratory failure s/p extubation; ventilator assoc acinetobacter & staph aureus pneumonia  Records reveal patient experienced acute onset of progressive ascending LE weakness, areflexia & paresthesia, difficulty swallowing.  Admitted to PICU, LP done & intubated.  Developed neuropathic pain, fever w/(+) resp c/s.  Neuro, Pulm, ID consult done.  Tx w/IVIG w/o improvement, tx w/plasmapheresis x 8, multiple IV antibiotics, tube feedings.  Continued to worsen.   Gradually improved, extubated to RA & diet advanced.  Transferred to inpatient rehab on continued IV antibiotics.  10/16/09 ICD-9 Codes received: 781.2 Abnormality of gait, 357.0 Ac infectious polyneuritis, 518.81 Acute respiratory failure, 997.31 Ventilator assoc pneumonia, 041.85 Infection-gram neg nec, 041.11 MSSA, 599.0 Urin tract Infection NOS, 345.90 Epilepsy NOS-Not intract.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Demyelination, Dysphagia, Dyspnoea, Dysstasia, Eating disorder
Clinical narrative: Developed progressive lower extremity weakness/numbness requiring intubation 6/30 for respiratory failure. EMG/MRI consistent with GUILLAIN-BARRE Syndrome. Remains intubated in ICU with flaccid paralysis and paresthesias.  8/10/09 PCP medical records received DOS 5/26/09 to 6/9/09. Gardasil administered.  8/17/2009 Received hospital medical records of 6/28-7/30/2009. FINAL DX: Guillain-Barre syndrome; respiratory failure s/p extubation; ventilator assoc acinetobacter & staph aureus pneumonia  Records reveal patient experienced acute onset of progressive ascending LE weakness, areflexia & paresthesia, difficulty swallowing.  Admitted to PICU, LP done & intubated.  Developed neuropathic pain, fever w/(+) resp c/s.  Neuro, Pulm, ID consult done.  Tx w/IVIG w/o improvement, tx w/plasmapheresis x 8, multiple IV antibiotics, tube feedings.  Continued to worsen.   Gradually improved, extubated to RA & diet advanced.  Transferred to inpatient rehab on continued IV antibiotics.  10/16/09 ICD-9 Codes received: 781.2 Abnormality of gait, 357.0 Ac infectious polyneuritis, 518.81 Acute respiratory failure, 997.31 Ventilator assoc pneumonia, 041.85 Infection-gram neg nec, 041.11 MSSA, 599.0 Urin tract Infection NOS, 345.90 Epilepsy NOS-Not intract.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Electromyogram abnormal, Endotracheal intubation, Feeling abnormal, Gastrointestinal tube insertion, Guillain-Barre syndrome
Clinical narrative: Developed progressive lower extremity weakness/numbness requiring intubation 6/30 for respiratory failure. EMG/MRI consistent with GUILLAIN-BARRE Syndrome. Remains intubated in ICU with flaccid paralysis and paresthesias.  8/10/09 PCP medical records received DOS 5/26/09 to 6/9/09. Gardasil administered.  8/17/2009 Received hospital medical records of 6/28-7/30/2009. FINAL DX: Guillain-Barre syndrome; respiratory failure s/p extubation; ventilator assoc acinetobacter & staph aureus pneumonia  Records reveal patient experienced acute onset of progressive ascending LE weakness, areflexia & paresthesia, difficulty swallowing.  Admitted to PICU, LP done & intubated.  Developed neuropathic pain, fever w/(+) resp c/s.  Neuro, Pulm, ID consult done.  Tx w/IVIG w/o improvement, tx w/plasmapheresis x 8, multiple IV antibiotics, tube feedings.  Continued to worsen.   Gradually improved, extubated to RA & diet advanced.  Transferred to inpatient rehab on continued IV antibiotics.  10/16/09 ICD-9 Codes received: 781.2 Abnormality of gait, 357.0 Ac infectious polyneuritis, 518.81 Acute respiratory failure, 997.31 Ventilator assoc pneumonia, 041.85 Infection-gram neg nec, 041.11 MSSA, 599.0 Urin tract Infection NOS, 345.90 Epilepsy NOS-Not intract.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Heart rate increased, Hypoaesthesia, Intensive care, Lumbar puncture, Mobility decreased
Clinical narrative: Developed progressive lower extremity weakness/numbness requiring intubation 6/30 for respiratory failure. EMG/MRI consistent with GUILLAIN-BARRE Syndrome. Remains intubated in ICU with flaccid paralysis and paresthesias.  8/10/09 PCP medical records received DOS 5/26/09 to 6/9/09. Gardasil administered.  8/17/2009 Received hospital medical records of 6/28-7/30/2009. FINAL DX: Guillain-Barre syndrome; respiratory failure s/p extubation; ventilator assoc acinetobacter & staph aureus pneumonia  Records reveal patient experienced acute onset of progressive ascending LE weakness, areflexia & paresthesia, difficulty swallowing.  Admitted to PICU, LP done & intubated.  Developed neuropathic pain, fever w/(+) resp c/s.  Neuro, Pulm, ID consult done.  Tx w/IVIG w/o improvement, tx w/plasmapheresis x 8, multiple IV antibiotics, tube feedings.  Continued to worsen.   Gradually improved, extubated to RA & diet advanced.  Transferred to inpatient rehab on continued IV antibiotics.  10/16/09 ICD-9 Codes received: 781.2 Abnormality of gait, 357.0 Ac infectious polyneuritis, 518.81 Acute respiratory failure, 997.31 Ventilator assoc pneumonia, 041.85 Infection-gram neg nec, 041.11 MSSA, 599.0 Urin tract Infection NOS, 345.90 Epilepsy NOS-Not intract.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Developed progressive lower extremity weakness/numbness requiring intubation 6/30 for respiratory failure. EMG/MRI consistent with GUILLAIN-BARRE Syndrome. Remains intubated in ICU with flaccid paralysis and paresthesias.  8/10/09 PCP medical records received DOS 5/26/09 to 6/9/09. Gardasil administered.  8/17/2009 Received hospital medical records of 6/28-7/30/2009. FINAL DX: Guillain-Barre syndrome; respiratory failure s/p extubation; ventilator assoc acinetobacter & staph aureus pneumonia  Records reveal patient experienced acute onset of progressive ascending LE weakness, areflexia & paresthesia, difficulty swallowing.  Admitted to PICU, LP done & intubated.  Developed neuropathic pain, fever w/(+) resp c/s.  Neuro, Pulm, ID consult done.  Tx w/IVIG w/o improvement, tx w/plasmapheresis x 8, multiple IV antibiotics, tube feedings.  Continued to worsen.   Gradually improved, extubated to RA & diet advanced.  Transferred to inpatient rehab on continued IV antibiotics.  10/16/09 ICD-9 Codes received: 781.2 Abnormality of gait, 357.0 Ac infectious polyneuritis, 518.81 Acute respiratory failure, 997.31 Ventilator assoc pneumonia, 041.85 Infection-gram neg nec, 041.11 MSSA, 599.0 Urin tract Infection NOS, 345.90 Epilepsy NOS-Not intract.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Paralysis flaccid, Plasmapheresis, Pneumonia, Posture abnormal, Pyrexia
Clinical narrative: Developed progressive lower extremity weakness/numbness requiring intubation 6/30 for respiratory failure. EMG/MRI consistent with GUILLAIN-BARRE Syndrome. Remains intubated in ICU with flaccid paralysis and paresthesias.  8/10/09 PCP medical records received DOS 5/26/09 to 6/9/09. Gardasil administered.  8/17/2009 Received hospital medical records of 6/28-7/30/2009. FINAL DX: Guillain-Barre syndrome; respiratory failure s/p extubation; ventilator assoc acinetobacter & staph aureus pneumonia  Records reveal patient experienced acute onset of progressive ascending LE weakness, areflexia & paresthesia, difficulty swallowing.  Admitted to PICU, LP done & intubated.  Developed neuropathic pain, fever w/(+) resp c/s.  Neuro, Pulm, ID consult done.  Tx w/IVIG w/o improvement, tx w/plasmapheresis x 8, multiple IV antibiotics, tube feedings.  Continued to worsen.   Gradually improved, extubated to RA & diet advanced.  Transferred to inpatient rehab on continued IV antibiotics.  10/16/09 ICD-9 Codes received: 781.2 Abnormality of gait, 357.0 Ac infectious polyneuritis, 518.81 Acute respiratory failure, 997.31 Ventilator assoc pneumonia, 041.85 Infection-gram neg nec, 041.11 MSSA, 599.0 Urin tract Infection NOS, 345.90 Epilepsy NOS-Not intract.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Respiratory failure
Clinical narrative: Developed progressive lower extremity weakness/numbness requiring intubation 6/30 for respiratory failure. EMG/MRI consistent with GUILLAIN-BARRE Syndrome. Remains intubated in ICU with flaccid paralysis and paresthesias.  8/10/09 PCP medical records received DOS 5/26/09 to 6/9/09. Gardasil administered.  8/17/2009 Received hospital medical records of 6/28-7/30/2009. FINAL DX: Guillain-Barre syndrome; respiratory failure s/p extubation; ventilator assoc acinetobacter & staph aureus pneumonia  Records reveal patient experienced acute onset of progressive ascending LE weakness, areflexia & paresthesia, difficulty swallowing.  Admitted to PICU, LP done & intubated.  Developed neuropathic pain, fever w/(+) resp c/s.  Neuro, Pulm, ID consult done.  Tx w/IVIG w/o improvement, tx w/plasmapheresis x 8, multiple IV antibiotics, tube feedings.  Continued to worsen.   Gradually improved, extubated to RA & diet advanced.  Transferred to inpatient rehab on continued IV antibiotics.  10/16/09 ICD-9 Codes received: 781.2 Abnormality of gait, 357.0 Ac infectious polyneuritis, 518.81 Acute respiratory failure, 997.31 Ventilator assoc pneumonia, 041.85 Infection-gram neg nec, 041.11 MSSA, 599.0 Urin tract Infection NOS, 345.90 Epilepsy NOS-Not intract.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Not an adverse event, but I have had a 5 personal zoster outbreaks in people previously immunized persons and know of 2 others in our community who had the shingles vaccine and still got shingles. Does this shot really work? Is my experience unusual. I have a small practice and I would suspect the failure of the vaccine to prevent shingles in at least 10% and will surely rise as the years go on. I didn't know where to send this report. I hope I have not wasted time.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Confusional state, Dyspnoea, Panic attack
Clinical narrative: Had a panic attack (shortness of breath, confusion) 20 minutes after administration of meds. No hives on swelling noted.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Cyanosis, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: (1) very pale, white - bluish lip - one minute event in a very warm store (2) "Fainting" duration 5 minutes with in 5 hrs. of vaccine
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: TDAP given in left arm 7-13-2009. Pt states arm became red, hot, swollen, tender to touch. Pt started taking Tylenol on 7-14-09. Pt went to ER on 7-16-09. Doctor assessed injection site + diagnosed with cellulitis ER physician gave RX for Bactrium tid.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Rash, Swelling face
Clinical narrative: Facial swelling, rash
Age: 3.0
Sex: F
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events. I gave a Hepatitis A inj instead of DTAP.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red/ swollen left deltoid, warm to touch 5" X 4.5".  Mom advised ice 30 minutes QID/ TYLENOL and MOTRIN for pain
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, MMR
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: Red/ swollen left deltoid, warm to touch 5" X 4.5".  Mom advised ice 30 minutes QID/ TYLENOL and MOTRIN for pain
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin discolouration, Urticaria
Clinical narrative: 6/30 - Small dark bump around right ribcage. 7/2 - Bumps became overlapping welts. - Saw Dr. - Said it looked like shingles. 7/10 - Saw Dr. began aggressive treatment.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: 5 cm X 6 cm erythema, red, tender warm to touch
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Vomiting
Clinical narrative: 4 days after injection, vomited bilious material and had abdominal / cramp.
Age: 20.0
Sex: F
Vaccine: HEPA, MMR, TDAP
Symptoms: Unevaluable event
Clinical narrative: Patient received MMR vaccine on 7/6/09. Pt did not know if she was pregnant. She stated there could be a chance of her being pregnant. Pt was returned to clinic in city for prenatal care.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyskinesia, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: After patient received SUB-Q injection, patient began to stiffen his body while collapsing to the floor. Skilled nurse assisted him to the floor with no incidence if head hitting the floor. While lying on the floor for a short moment patient was exhibiting jerky movements of facial muscles. Patient recovered shortly and acknowledged he was ok.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Electrocardiogram, Hypophagia, Loss of consciousness, Mouth injury
Clinical narrative: On 6/20/09 per parent, client got out of bed at 9:00 Am, without eating or drinking went to use bathroom. Client felt dizzy (told this to Dad), then passed out "for a few seconds" Hit her mouth on bathroom counter. Went to ER for stitches and had EKG (results neg). On menstrual period.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Suture insertion
Clinical narrative: On 6/20/09 per parent, client got out of bed at 9:00 Am, without eating or drinking went to use bathroom. Client felt dizzy (told this to Dad), then passed out "for a few seconds" Hit her mouth on bathroom counter. Went to ER for stitches and had EKG (results neg). On menstrual period.
Age: 1.06
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Computerised tomogram normal, Convulsion, Crying, Dyskinesia, Electroencephalogram normal
Clinical narrative: On 10/11/2007 client had his first convulsive seizure following immunizations.  Mother reported 1 hr. 15 min. post vaccines (HIB, MMRV and Pediatric PNEUMOCOCCAL) while client was at home playing, he stopped and stared, rolled his eyes upward and had rhythmic jerking in all four extremities.  It lasted 1-2 min.  After which he stared for another 2 min. before he "woke up and cried".  No color change.  Mom has never seen a similar episode.  Child had sleep disturbances post event.
Age: 1.06
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Gaze palsy, Laboratory test normal, Sleep disorder, Staring
Clinical narrative: On 10/11/2007 client had his first convulsive seizure following immunizations.  Mother reported 1 hr. 15 min. post vaccines (HIB, MMRV and Pediatric PNEUMOCOCCAL) while client was at home playing, he stopped and stared, rolled his eyes upward and had rhythmic jerking in all four extremities.  It lasted 1-2 min.  After which he stared for another 2 min. before he "woke up and cried".  No color change.  Mom has never seen a similar episode.  Child had sleep disturbances post event.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MMR, VARCEL
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Patient got lightheaded immediately following vaccinations. Sat Pt down, used smelling salt, gave pt sips of ice tea, had pt sit an additional 20 minutes , released to care of father.
Age: 36.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Back pain, Blood test normal, Diarrhoea, X-ray normal
Clinical narrative: Four hours after taking pill # 1 - back & stomach cramps & diarrhea.  @ two hours later, client went to hospital E.R. with "severe "stomach pain (ULQ).  Client stated pain was intermittent from mild to severe.  E.R. nurse stated M.D. was assessing client for pancreatitis but all tests were negative.  E.R. stated client was feeling better.  Client has not returned phone calls as to her outcome.  7-21-09 - client called back she as recovered.  States all blood work & X-rays were normal in E.R.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 18.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, puffiness + warm to touch @ injection site above 30mm of redness. Site is tender to touch @ site of Varicella injection.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling/ redness < 24 hrs after administration of HEP A vaccine right upper arm/ warm compresses TYLENOL PRN
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash papular, Rash pruritic
Clinical narrative: Red papulo-vesicular rashes all over trunk and buttocks, some are extra-pruritic since yesterday; some of the lesions are now crusted. Supportive measures and monitor temperature.
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Red and itchy and a lump at the site.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Dysphagia
Clinical narrative: Difficulty swallowing began 15 minutes after injection was administered Pt. was given BENADRYL.  Patient's condition has improved
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Presented with Health Dept today, 7-24-09 at 10:30 am, with very red, raised, swollen, hot and tender area approx 13cm in diameter, around VZV injection site- upper RT arm. Denied respiratory problems sent to PCP for eval since child with need medical exemption or titers to VZV#2 will not be given.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling and redness/induration (R) upper arm at site of inj measuring 7cmX7cm.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted directly after administration of HPV. Mom and nurse slid her to floor where she regained consciousness. (This was 3rd of 4th shots given)
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Immediate post-injection reaction
Clinical narrative: Patient tolerated the HPV vaccine injection well. However 5 minutes after the vaccine was given she fell to the floor she was awake and alert and aware of her surroundings. Stayed in office for 30 minutes with no tender complication.
Age: 11.0
Sex: F
Vaccine: HPVX, TDAP, VARCEL
Symptoms: Chest pain, Cold sweat, Dizziness, Headache, Nausea
Clinical narrative: clammy skin, right sided chest pain, headache, nausea, dizziness
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING 3CM BY 3CM AT SITE OF INJECTION  TREATED WITH MOTRIN BENEDRYL AND KEFLEX RECOMMENDED APPLY ICE PACK FOR SWELLING AND FOLLOW UP IN 3 DAYS FOR RECHECK.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Dysstasia, Electromyogram, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: I received a flu shot at this clinic on Nov 9, 2007 and 2 weeks later my hands started becoming numb, then my arms and by the next morning my legs were. I became very unstable on my feet, decided to go to the emergency room. I could not even lift my legs or arms to dress myself at this point so a family member hadto dress me. When I reached my front door, my legs gave out and I collapsed. Not able to stand back up, my husband called 911. In the emergency room I was given many test and a Neurologist was called in. He gave me some test and said I had Guillain Barre Syndrome. He gave me some sort of infusions in my IV to start reversing the adverse reactions of the GBS {18 bottles of this, I think} given only at night. I was in the hospital 23 days, receiving therapy daily. After being discharged from the hospital, I had in home therapy because of the paralysis to learn to sit, stand then walk all over again. I couldn't do much of anything for myself for literally about 5 months.  8/24/09 Hospital records recieved DOS 11/21/07 to 12/02/07. Assessment: Guillain-Barre. Acute inflammatory demyelinating polyradiculoneuropathy. Peripheral Neuropathy. Gastrointestinal reflux disease. Insomia. Obesity. Dependent on assistance for activities of daily living. Melanosis coli from chronic laxative use.  Patient felt her body start to tingle, weakness, could not stand up. Presents with difficulty with speech and vision. Tingling in hands. Rapid ascending paralysis, areflexia, and upper respiratory tract infection. IV immunoglobulin administered. C/O pain and anxiety. No bowel movement and has not slept for 11 days. Throbbing leg and back pain.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Hypokinesia, Paralysis
Clinical narrative: I received a flu shot at this clinic on Nov 9, 2007 and 2 weeks later my hands started becoming numb, then my arms and by the next morning my legs were. I became very unstable on my feet, decided to go to the emergency room. I could not even lift my legs or arms to dress myself at this point so a family member hadto dress me. When I reached my front door, my legs gave out and I collapsed. Not able to stand back up, my husband called 911. In the emergency room I was given many test and a Neurologist was called in. He gave me some test and said I had Guillain Barre Syndrome. He gave me some sort of infusions in my IV to start reversing the adverse reactions of the GBS {18 bottles of this, I think} given only at night. I was in the hospital 23 days, receiving therapy daily. After being discharged from the hospital, I had in home therapy because of the paralysis to learn to sit, stand then walk all over again. I couldn't do much of anything for myself for literally about 5 months.  8/24/09 Hospital records recieved DOS 11/21/07 to 12/02/07. Assessment: Guillain-Barre. Acute inflammatory demyelinating polyradiculoneuropathy. Peripheral Neuropathy. Gastrointestinal reflux disease. Insomia. Obesity. Dependent on assistance for activities of daily living. Melanosis coli from chronic laxative use.  Patient felt her body start to tingle, weakness, could not stand up. Presents with difficulty with speech and vision. Tingling in hands. Rapid ascending paralysis, areflexia, and upper respiratory tract infection. IV immunoglobulin administered. C/O pain and anxiety. No bowel movement and has not slept for 11 days. Throbbing leg and back pain.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Glossitis, Injection site erythema, Injection site swelling, Swollen tongue
Clinical narrative: Local reaction at injection sites, redness and swelling.  Swelling of tongue and complaints of tongue "itching".  Patient seen in office 24 hours after administration and treated with Benadryl and Orapred
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had large, swollen, firey red and hot localized reaction around injection site.  Patient was reffered to urgent care where cellulitis was ruled out.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Abnormal behaviour, Staring
Clinical narrative: Per patient's mother, baby had 4 days of "not being herself, staring off into space.  We thought she just had become autistic, but then it went away and she has been fine."  Per Dr., baby ok on exam, done 07/08/09, with negative autism screen. Also, per Dr., we are to hold all vaccines for now.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swollen to softball size, hard, red and warm to touch.  Went to ER and was discharged to home with prescriptions for Crphalexin 500 mg TID and Methylprednisolone 21 day dose pack.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Pallor
Clinical narrative: Immediately after receiving Tdap, Menactra, and HPV  at 3:15 pm patient reported feeling dizzy, weak.  Pale, sweating, no loss of contiousness, pt. placed in supine position on floor with legs elevated.  BP 98/68, p. 88, 3:20 pm reported feeling better, 98/64, p. 84, color improved and able to sit upright. 4 pm, released in care of brother,  pt. advised no driving today, to ER increase symptoms.  Verbalized understanding.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site lymphadenopathy, Injection site pain, Lymphadenopathy
Clinical narrative: Swollen glands around neck, breast and armpit area where injection was adminstered. The area was very tender.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site rash
Clinical narrative: 07-21-09 Given vaccines.  Started with rash on right thigh that mom says is slowly getting bigger.  No fever or no other symptoms
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: C-reactive protein increased, Convulsion, Culture urine negative, Full blood count normal, Laboratory test normal
Clinical narrative: patient had 2 episodes of seizure-like activity, second episode lasting 20 minutes.  patient went to ER and had full sepsis workup over 4 days, CSF, urine, and blood cx negative at 48 hours.  patient still continuously febrile after 5 days. Patient was transferred to our facility for continuing care, with neurology and infectious disease specialists consulted.  8/21/09 MR received for DOS 7/21-23/09 with dx: Sepsis under evaluation. Pt presented with fever, seizures, irritability. T'=103.1 despite anti-pyretics. Began with upper extremity jerking and pallor which resolved.  Later had episode of whole body shaking, unresponsiveness, vomiting and diaphoresis. Admitted with dx: Seizure, R/O Meningitis. R/O Bacteremioa. Transferred to higher level of care on 7/23/09.  9/21/09 Hospital records received DOS 7/23/09 to 7/26/09. Assessment: Aseptic Meningitis. Patient transferred from another facility with history of seizure. Arm began to shake, then entire body, unresponsive and staring. Vomiting. Fever.   ICD-9 Codes: 038.9 Septicemia NOS, 047.9 Viral Meningitis NOS.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: patient had 2 episodes of seizure-like activity, second episode lasting 20 minutes.  patient went to ER and had full sepsis workup over 4 days, CSF, urine, and blood cx negative at 48 hours.  patient still continuously febrile after 5 days. Patient was transferred to our facility for continuing care, with neurology and infectious disease specialists consulted.  8/21/09 MR received for DOS 7/21-23/09 with dx: Sepsis under evaluation. Pt presented with fever, seizures, irritability. T'=103.1 despite anti-pyretics. Began with upper extremity jerking and pallor which resolved.  Later had episode of whole body shaking, unresponsiveness, vomiting and diaphoresis. Admitted with dx: Seizure, R/O Meningitis. R/O Bacteremioa. Transferred to higher level of care on 7/23/09.  9/21/09 Hospital records received DOS 7/23/09 to 7/26/09. Assessment: Aseptic Meningitis. Patient transferred from another facility with history of seizure. Arm began to shake, then entire body, unresponsive and staring. Vomiting. Fever.   ICD-9 Codes: 038.9 Septicemia NOS, 047.9 Viral Meningitis NOS.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: On 7/9/09 Patient received Hep a, Menactra approx. at 3PM.  Mother reports trip to ER around 5:30 due to hives and itching.  States received Benadryl and steroids.  Phone call to health department today to report above and resports child continues with symptoms without resolution from the ER medication. (Mother contacted the Health Dept. on 7/22/09)
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site warmth
Clinical narrative: Varicella administered on 7/22/09.  Noticed red/bumpy silver dollar sized @ site.  7/24/09 came to HD measured 6cm/8cm red/bumpy/warm.
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Inflammation, Injection site erythema, Injection site swelling, Injection site warmth, Rash pruritic
Clinical narrative: Initially patient had a red, swollen, warm to the touch area where the varicella was given in the back of her left arm, that lasted about a week. Starting on 7/7/09 she had a rash across the top of her back, then within 2 days or so it was on her entire back and her chest and stomach. As it seemed to start to fade/go away (which was at least a week or so) then it spread to her upper arms and upper legs, then as it started to fade it went to her lower arms/hands and lower legs/feet, which she still has. It itches occasionally throughout the whole process, sometimes seems "more inflamed" than other times and is warm to the touch. The appearance of the rash the best I could find almost looked like a measles rash. Her doctor did look at the rash and stated that she was unsure what it is, it is probably/could be a vaccine reaction, due to the timing of the vaccines and then the rash.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Chills, Diarrhoea, Malaise, Nausea, Oedema peripheral
Clinical narrative: Client treated at ER for steam burn and received a Td shot.  Later that day, arm swelling, general malaise, diarrhea, nausea, chills, fever onset.  The symptoms continued for about 72 hours.  client was re-evaluated on 7/20/09 at Health Dept. and treatment started.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Client treated at ER for steam burn and received a Td shot.  Later that day, arm swelling, general malaise, diarrhea, nausea, chills, fever onset.  The symptoms continued for about 72 hours.  client was re-evaluated on 7/20/09 at Health Dept. and treatment started.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: OBLONGED SHAPE RED RASH(PATCH)slightly rasied 10.5cm in width and 13.5cm in height on right thigh; patient reports itching and feeling warm at the site
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Occult blood positive
Clinical narrative: positive guiac stool 1 day after rotavirus vaccine given
Age: 37.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Asthenia, Chills, Feeling abnormal, Pyrexia, Tremor
Clinical narrative: 12 hours later started continuous shaking in legs, had chills, and felt feverish.  Symptoms lasted another day.  Today still very spacy, feverish, and weak.  Has taken Tylenol for symptoms.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Swelling, redness at site and upper arm  day after injection;No fever but felt warm day after,No fever no chills 2 days after injection
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: VACCINE WAS GIVEN 2 DAYS AGO.  PT CAME TODAY TO CHECK ON A PPD BUT ALSO HAD REDNESS AND INDURATION, PRURITUS, HEAT ON VACCINATION SITE.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Full blood count, Similar reaction on previous exposure to drug, Streptococcal identification test, Urine analysis
Clinical narrative: TEMP OF 102.1 FOR TWO DAYS. STARTED 5 HOURS AFTER VACCINE ADMIN. OFFICE VISIT NEXT DAY SHOWED NO OTHER SOURCE OF INFECTION. PATIENT WAS WELL BY THE 18TH. PATIENT HAD SIMILAR REACTION IN 2000 REPORT TO VAERS AFTER Td.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Lethargy, Oedema peripheral, Pyrexia, Rash macular
Clinical narrative: Pt. develped redness at site and low grade fever lethargy next am, edema of left arm and red blotchy rash kind of like hives but not raised in the left upper deltoid.  Dr. prescribed alternating tylenol and motrin, also benadryl until improved.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Gaze palsy, Respiratory arrest
Clinical narrative: Parents report (at 4 mo visit) excessive crying after 2 mo shots. Stopping breathing and eyes rolling. Paramedics were called, baby was not transported.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling of thigh, development of erythema 14cm wide.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Patient developed a debilitating headache requiring 0 days bedrest. Patient stated headache was very severe.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Feeding disorder of infancy or early childhood, Lethargy, Pyrexia
Clinical narrative: Lethargy, poor feeding, fever to 103.5 - Given TYLENOL. Rapid recovery this AM.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: (R) arm red, warm to touch, red rash covering deltoid down to halfway mark of upper arm.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hypotonia, Hypotonic-hyporesponsive episode, Immediate post-injection reaction
Clinical narrative: Client talking while receiving vaccinations, upon administering MENACTRA to PD; client became quite upon assessment client flaccid B/P 70/40; immediately lied client down, raised legs, arms wk and voluntary guarding upon reassessment client hyporesponsive, A/0x3, breathing WNL, pulse presentation w/d B/P 102/60, P60, R14, denied pain. States "Hungry" has not eaten lunch, Client cleared by EMT's @ 1400. Client cleared by EMT's.
Age: 14.0
Sex: F
Vaccine: MNQ, TD, VARCEL
Symptoms: Asthenia, Convulsion, Dizziness, Gait disturbance, Gaze palsy
Clinical narrative: 7/24/09 1300 client became pale, L head, wk, eyes rolled, shook 10-15 secs., SZ, laid client down - raised legs, P56 66, B/P 102/60, 1222, client answered questions appropriately, A10x3, radial/dorsal pedis pulse present, able to wiggle fingers, hands, toes, denied pain, denied problems breathing. Stated "didn't know what happened", denied numbness- states "I feel OK", monitored client 30 mins, 4X SZ in client 5yrs., HX SZ's in "aunt and uncle" states client/mom - client ambulated with strayed gait with mom at side with no further incidents. Client stated "had not eaten/hardly drinking by nurse.
Age: 14.0
Sex: F
Vaccine: MNQ, TD, VARCEL
Symptoms: Pallor, Tremor
Clinical narrative: 7/24/09 1300 client became pale, L head, wk, eyes rolled, shook 10-15 secs., SZ, laid client down - raised legs, P56 66, B/P 102/60, 1222, client answered questions appropriately, A10x3, radial/dorsal pedis pulse present, able to wiggle fingers, hands, toes, denied pain, denied problems breathing. Stated "didn't know what happened", denied numbness- states "I feel OK", monitored client 30 mins, 4X SZ in client 5yrs., HX SZ's in "aunt and uncle" states client/mom - client ambulated with strayed gait with mom at side with no further incidents. Client stated "had not eaten/hardly drinking by nurse.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt had received ZOSTAVAX on 7-13-2009.  He reported to his family physician with shingles on 7-21-2009.  Patient did not mention a current shingles outbreak at the time of vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: 4x4 cm erythema around injection site L leg. Positive tenderness, warmth, edema.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Culture stool negative, Diarrhoea, Rotavirus test negative, White blood cells stool positive
Clinical narrative: Developed Inflammatory Diarrhea with 24 hours of vaccine. No fever. Now has chronic Diarrhea for 8 weeks.  8/24/09 Medical records received DOS 5/26/09 to 7/29/09 Assessment: Diarrhea. Presents with green mucousy stools, Diarrhea, "small flecks of 'blood' in stool". Some discomfort before BM. Dropped on growth chart from 90th percentile to 74th percentile. Runny nose and cough. Placed on milk free diet.
Sex: M
Vaccine: HEP
Symptoms: Electroencephalogram normal, Muscle twitching
Clinical narrative: 7-17-09 pt was given Hep B vaccine at his 10:15 AM visit. Began twitching of left leg and arm upon arriving at home. Parents called Rescue Squad around 5 PM and was taken to hospital and was admitted for one day for observation.  8/3/09 MR received for 7/17-18/2209 with dx: neonatal sleep myoclonus.  Pt presented with multiple episodes of twitching/jerking of extremities which began after receiving Hep B vax. Admitted to r/o seizure.  Neuro consult Impression:  likely neonatal sleep myoclonus. ICD9 780.3
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Skin warm, Tenderness
Clinical narrative: Tender, erythematous, slightly warm localized reaction to right SQ right arm.  Erythema 2.5 inches in diameter.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Four hours after injection pt started with redness, swelling & knot at injection site.  Seen in office 48 hrs after injection Dx'd with mild cellulitis.  Pt presented again 72 hrs after injection with redness spreading.  Redness measured 6 inches wide and 7 inches in length.  Pt being treated with KEFLEX 250 mg.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: Site reaction to vaccine in left deltoid approx 24-48 hrs after administration.
Age: 0.7
Sex: M
Vaccine: FLU3
Symptoms: Caesarean section, Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: This case was reported by a pharmacist and described the occurrence of jaundice in an infant male subject whose mother was vaccinated with FLUARIX (GlaxoSmithKline). The reporter was the subject's mother. On 5 November 2008 the subject received unspecified dose of FLUARIX (transplacentary at 21 weeks gestation). The subject was born at 38 weeks gestation with no birth defects noted via cesarean section. The infant weighed nine pounds, 12 ounces, was 20.5 inches in length and had APGAR scores at one minute and five minutes of less than seven (exact score unknown). The infant had no respiratory problems. At an unspecified time after receiving FLUARIX transplacentary, the subject experienced jaundice. The reporter did not consider the jaundice to be serious. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 32.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, HEPAB, MMR, TDAP
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive, Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR II (non-gsk); Merck; unknown given on 4 June 2009; ADACEL (non-gsk); Sanofi; given on 4 June 2009. Concurrent medications included Blood pressure medication. On 4 June 2009, the subject received 1st dose of TWINRIX (unknown, right arm) and experienced vaccine exposure during pregnancy. Immunization series was discontinued. The reporter stated that prior to receiving the TWINRIX vaccine; the subject was given a pregnancy test. The "line initially showed up but then went away". The subject stated that she was just about to start her period, so the vaccine was given. The subject took a pregnancy test within two to three days of receiving the TWINRIX vaccine, and the test came back positive. The reporter stated she thought the subject mentioned that she was on a blood pressure pill but she could not remember for certain, and she did not know the name of the pill. Also, with the concomitant MMR and Tdap vaccines that were give, she did not know the brand names. Follow up received from reporting healthcare professional on 20 July 2009: The subject's last menstrual period occurred on an unknown date. The conception was reported as normal. On an unknown date the subject started spotting and experienced miscarriage. This case was assessed as serious (potentially medically serious) by GSK. The subject was treated with dilation and curettage on 14 July 2009. At the time of reporting, the outcome of the events was unknown.
Age: 32.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, HEPAB, MMR, TDAP
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR II (non-gsk); Merck; unknown given on 4 June 2009; ADACEL (non-gsk); Sanofi; given on 4 June 2009. Concurrent medications included Blood pressure medication. On 4 June 2009, the subject received 1st dose of TWINRIX (unknown, right arm) and experienced vaccine exposure during pregnancy. Immunization series was discontinued. The reporter stated that prior to receiving the TWINRIX vaccine; the subject was given a pregnancy test. The "line initially showed up but then went away". The subject stated that she was just about to start her period, so the vaccine was given. The subject took a pregnancy test within two to three days of receiving the TWINRIX vaccine, and the test came back positive. The reporter stated she thought the subject mentioned that she was on a blood pressure pill but she could not remember for certain, and she did not know the name of the pill. Also, with the concomitant MMR and Tdap vaccines that were give, she did not know the brand names. Follow up received from reporting healthcare professional on 20 July 2009: The subject's last menstrual period occurred on an unknown date. The conception was reported as normal. On an unknown date the subject started spotting and experienced miscarriage. This case was assessed as serious (potentially medically serious) by GSK. The subject was treated with dilation and curettage on 14 July 2009. At the time of reporting, the outcome of the events was unknown.