chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urine analysis
Clinical narrative: Patient reports immediate pain at site of PNEUMOVAX injection, which subsequently worsened within 10 minutes of injection.  Over the next few days, the site became red, hard, and warm and the area of involved tissue increased to a maximum size of about 6 inches around the injection site by 3/8.  About 24 hours after the injection, the patient developed joint pains (knees, elbows, back), chills (no documented fever) and nausea that resolved within 36 hours after the injection.  Patient denies rash otherwise, including lateral hands and feet.  On 3/9, the pain had somewhat improved, but the patient developed numbness and paresthesias in her left fingers and toes, which prompted her to seek medical attention at the NNMC ED.  She was given a prescription for septra and released.  She has been using ibuprofen as needed for the pain.  Patient reports last vaccine was about 20 years ago.  Contacted on 5/11/08 and this a.m. numbness and tingling had resolved.  Redness, warmth and tenderness has decreased to 70% of what was previously noted.  Edema at injection site > 120 mm not beyond elbow decreased ROM and pain.  Erythema extended about 6' surrounding vaccine site.  Tenderness at pneumonia vaccine site (not flu vaccine site).  Paresthesia primarily left pinky and thumb; resolved by 3/11/08.  Joint pain, multiple joints, knees, elbows, back.  Nausea without vomiting.  Chills. FOLLOW UP REPORT: Contacted patient on 4/21/08. She reports vaccine site of her left upper arm has returned to normal. The sensation has returned in her left pinky finger. She denies systemic symptoms.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Eyelid oedema, Rash, Skin disorder
Clinical narrative: Red, blotchy areas noted on scalp, face and trunk of body.  Eye lids puffy.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Crying spell.  Mom stated "crying like I have never heard before."  Cried 5 hours after vaccines.
Age: 4.0
Sex: M
Vaccine: DTAP, DTAPHEPBIP, MMR, VARCEL
Symptoms: No adverse reaction
Clinical narrative: No Adverse Events.
Age: 22.0
Sex: M
Vaccine: MMR, TD
Symptoms: Hypoaesthesia facial
Clinical narrative: 10-08 - Came into clinic numbness from chin to right side of neck.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella zoster virus serology positive
Clinical narrative: Severe episode of shingles, treated with Valtrex.
Age: 1.0
Sex: F
Vaccine: FLUX, HIBV, IPV, MMRV, PNC
Symptoms: Brain stem ischaemia, CSF test normal, Convulsion, Demyelination, Dysphagia
Clinical narrative: Information has been received from the FDA (VAERS# 273306) concerning a 1 year old female with a history of probable social/language delay who on 26-OCT-2006 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655140/0832F).  Suspect vaccination administered on that same day included a dose of PedvaxHIB (OMPC) (manufacturer unknown).  Concomitant vaccinations administered on that same day included a dose of PREVENAR, a dose of IPV (unspecified) and a dose of Flu vaccine (unspecified).  On 05-NOV-2006 the patient experienced seizures post ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655140/0832F) with MRI evidence of brain stem ischemia.  Residual spasticity onset fever 10 days after vaccination.  On 15-MAR-2007 records received from the facility for dates of service of hospitalization for 14 days from 14-NOV-2006 to 28-NOV-2006.  Other symptoms the patient experienced included tongue paralysis, somnolence, musculoskeletal stiffness, dysphagia, demyelination and an (unspecified) neurological symptom.  On 15-MAR-2007 showed an abnormal EEG demonstrating what appeared to be encephalopathic picture associated with spike activity from the left posterior head region.  CSF and lab work did not reveal any conclusive findings.  The patient was not recovered at the time of this report.  One or more of the events required hospitalization and were considered to be immediately life-threatening.  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 agency and was released to the agency.  No further information is available.
Age: 1.0
Sex: F
Vaccine: FLUX, HIBV, IPV, MMRV, PNC
Symptoms: Electroencephalogram abnormal, Encephalopathy, Laboratory test normal, Musculoskeletal stiffness, Neurological symptom
Clinical narrative: Information has been received from the FDA (VAERS# 273306) concerning a 1 year old female with a history of probable social/language delay who on 26-OCT-2006 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655140/0832F).  Suspect vaccination administered on that same day included a dose of PedvaxHIB (OMPC) (manufacturer unknown).  Concomitant vaccinations administered on that same day included a dose of PREVENAR, a dose of IPV (unspecified) and a dose of Flu vaccine (unspecified).  On 05-NOV-2006 the patient experienced seizures post ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655140/0832F) with MRI evidence of brain stem ischemia.  Residual spasticity onset fever 10 days after vaccination.  On 15-MAR-2007 records received from the facility for dates of service of hospitalization for 14 days from 14-NOV-2006 to 28-NOV-2006.  Other symptoms the patient experienced included tongue paralysis, somnolence, musculoskeletal stiffness, dysphagia, demyelination and an (unspecified) neurological symptom.  On 15-MAR-2007 showed an abnormal EEG demonstrating what appeared to be encephalopathic picture associated with spike activity from the left posterior head region.  CSF and lab work did not reveal any conclusive findings.  The patient was not recovered at the time of this report.  One or more of the events required hospitalization and were considered to be immediately life-threatening.  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 agency and was released to the agency.  No further information is available.
Age: 1.0
Sex: F
Vaccine: FLUX, HIBV, IPV, MMRV, PNC
Symptoms: Nuclear magnetic resonance imaging abnormal, Pyrexia, Somnolence, Tongue paralysis
Clinical narrative: Information has been received from the FDA (VAERS# 273306) concerning a 1 year old female with a history of probable social/language delay who on 26-OCT-2006 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655140/0832F).  Suspect vaccination administered on that same day included a dose of PedvaxHIB (OMPC) (manufacturer unknown).  Concomitant vaccinations administered on that same day included a dose of PREVENAR, a dose of IPV (unspecified) and a dose of Flu vaccine (unspecified).  On 05-NOV-2006 the patient experienced seizures post ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655140/0832F) with MRI evidence of brain stem ischemia.  Residual spasticity onset fever 10 days after vaccination.  On 15-MAR-2007 records received from the facility for dates of service of hospitalization for 14 days from 14-NOV-2006 to 28-NOV-2006.  Other symptoms the patient experienced included tongue paralysis, somnolence, musculoskeletal stiffness, dysphagia, demyelination and an (unspecified) neurological symptom.  On 15-MAR-2007 showed an abnormal EEG demonstrating what appeared to be encephalopathic picture associated with spike activity from the left posterior head region.  CSF and lab work did not reveal any conclusive findings.  The patient was not recovered at the time of this report.  One or more of the events required hospitalization and were considered to be immediately life-threatening.  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 agency and was released to the agency.  No further information is available.
Sex: F
Vaccine: PNC
Symptoms: CSF culture positive, Death, Pneumococcal infection, Serology test
Clinical narrative: Information regarding Prevnar was received from a Physician regarding a female patient who experienced pneumococcal disease. The patient received a dose on an unspecified date. The patient's concurrent illness includes cochlea implant (had not received Pneumovax). Concomitant medications were not reported. On an unspecified date, the patient experienced pneumococcal disease and died. The cause of death was reported as pneumococcal infection. CSF culture (results: Streptococcal pneumoniae serotype 19A) was done on an unspecified date. No additional information was available at the time of this report.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial report received from another manufacturer on 27 February 2008. The other manufacturer received the original report from an anonymous patient. An anonymous patient who did not want to provide any demographics, reported that "in the 60's, I got a live flu vaccine and got the flue." The date of vaccination, trade name, manufacturer name, lot number, route and site of administration were not provided. No additional information was provided. The other manufacturer stated they will forward any follow-up they receive.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Initial report received on 05 March 2008 from a nurse. A 13-year-old female patient, with no pre-existing medical conditions, had received an intramuscular right deltoid injection of Menactra (lot number U2403AA); and an intramuscular left deltoid injection of Gardasil (manufacturer Merck, lot number 1267U) on 09 November 2007. The patient received the vaccinations and fainted when leaving the office. The patient was then brought back into the office and put in a reclined position for about 16 minutes; vital signs were stable. The patient left the office without any further symptoms and had recovered from the event. No other relevant medically significant information was provided. The reporter for this case is the same as reported in case 2008-00497 (Case reported in a 17-year-old female patient, who fainted five minutes after she received a concurrent immunization with Menactra vaccine and Gardasil.).
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Erythema, Hypoaesthesia, Injection site erythema, Lip swelling
Clinical narrative: Initial report received on 29 February 2008 from a health care professional. A 45-year-old female patient, with no illness at the time of vaccination, had received a left deltoid injection of Fluzone SV 2007-2008, lot number U2487AA, on 18 October 2007. Within hours post-vaccination, the patient developed diarrhea and numbness and tingling in her arm (specific arm not reported). The next morning, the patient's face was puffy, and her neck appeared "as a sunburn." She had blotchy hives on her abdomen, and her lips were puffy and swollen. The patient also experienced redness at the injection site (onset not specified). The patient self treated with oral Benadryl; and, by six p.m. that day, had improved. She subsequently recovered completely.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Rash macular, Swelling face, Urticaria
Clinical narrative: Initial report received on 29 February 2008 from a health care professional. A 45-year-old female patient, with no illness at the time of vaccination, had received a left deltoid injection of Fluzone SV 2007-2008, lot number U2487AA, on 18 October 2007. Within hours post-vaccination, the patient developed diarrhea and numbness and tingling in her arm (specific arm not reported). The next morning, the patient's face was puffy, and her neck appeared "as a sunburn." She had blotchy hives on her abdomen, and her lips were puffy and swollen. The patient also experienced redness at the injection site (onset not specified). The patient self treated with oral Benadryl; and, by six p.m. that day, had improved. She subsequently recovered completely.
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthralgia, Autoimmune disorder, Cardiac enzymes normal, Chest X-ray
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a male subject of unspecified age who was vaccinated with LYMErix for prophylaxis. A physician or other health care professionals has not verified this report. On an unspecified date the subject received dose of LYMErix (unknown). On an unspecified date after vaccination with LYMErix, the subject experienced arthalgias, fatigue, burning pain, cramping, fevers, rashes, swollen joints, headaches, numbness, vision problems, hearing problems, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated or other mechanism decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 28 February via medical records. The subject had a complex medical history including a "crush injury"/ neck injury in 1980, thoracic outlet syndrome, three carpal tunnel release surgeries, sensory neuroma of the dorsal right hand treated with neurolysis, severe headaches including migraines (onset prior to August 1998), a knee operation, and what appeared to be "partial removal of the first ribs bilaterally". Prior to December 1994 he underwent two cervical fusions (including cervical fusion of C6-7 with complete obliteration of the intervertebral space), thoracotomy, three ulnar nerve surgeries, lumbar fusion/ laminectomy, and arthoscopy of both knees. On 01 May 2002, the subject underwent diagnostic testing due to severe back pain, with findings including mild lumbar spinal stenosis and moderate central spinal stenosis. The subject presented to the emergency room and was hospitalized on 03 June 2004 with an admitting diagnosis of cerebrovascular accident, rule out radiculopathy. Symptoms at the time of admission included left arm weakness and numbness and inability to control movement, and the subject reported a history of chronic pain secondary to a cervical/ lumbar fusion, depression, Lyme disease, and migraines. He was discharged on 04 June 2004. The events of depression, migraines, cervical/ lumbar fusion were assessed to be medical history, and the possible diagnosis of cerebrovascular accident was not confirmed. Therefore, these are assessed to be incidental findings based upon medical review.
Sex: M
Vaccine: LYME
Symptoms: Computerised tomogram, Decreased activity, Echocardiogram, Electrocardiogram, Fatigue
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a male subject of unspecified age who was vaccinated with LYMErix for prophylaxis. A physician or other health care professionals has not verified this report. On an unspecified date the subject received dose of LYMErix (unknown). On an unspecified date after vaccination with LYMErix, the subject experienced arthalgias, fatigue, burning pain, cramping, fevers, rashes, swollen joints, headaches, numbness, vision problems, hearing problems, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated or other mechanism decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 28 February via medical records. The subject had a complex medical history including a "crush injury"/ neck injury in 1980, thoracic outlet syndrome, three carpal tunnel release surgeries, sensory neuroma of the dorsal right hand treated with neurolysis, severe headaches including migraines (onset prior to August 1998), a knee operation, and what appeared to be "partial removal of the first ribs bilaterally". Prior to December 1994 he underwent two cervical fusions (including cervical fusion of C6-7 with complete obliteration of the intervertebral space), thoracotomy, three ulnar nerve surgeries, lumbar fusion/ laminectomy, and arthoscopy of both knees. On 01 May 2002, the subject underwent diagnostic testing due to severe back pain, with findings including mild lumbar spinal stenosis and moderate central spinal stenosis. The subject presented to the emergency room and was hospitalized on 03 June 2004 with an admitting diagnosis of cerebrovascular accident, rule out radiculopathy. Symptoms at the time of admission included left arm weakness and numbness and inability to control movement, and the subject reported a history of chronic pain secondary to a cervical/ lumbar fusion, depression, Lyme disease, and migraines. He was discharged on 04 June 2004. The events of depression, migraines, cervical/ lumbar fusion were assessed to be medical history, and the possible diagnosis of cerebrovascular accident was not confirmed. Therefore, these are assessed to be incidental findings based upon medical review.
Sex: M
Vaccine: LYME
Symptoms: Headache, Hearing impaired, Hypoaesthesia, Joint swelling, Lyme disease
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a male subject of unspecified age who was vaccinated with LYMErix for prophylaxis. A physician or other health care professionals has not verified this report. On an unspecified date the subject received dose of LYMErix (unknown). On an unspecified date after vaccination with LYMErix, the subject experienced arthalgias, fatigue, burning pain, cramping, fevers, rashes, swollen joints, headaches, numbness, vision problems, hearing problems, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated or other mechanism decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 28 February via medical records. The subject had a complex medical history including a "crush injury"/ neck injury in 1980, thoracic outlet syndrome, three carpal tunnel release surgeries, sensory neuroma of the dorsal right hand treated with neurolysis, severe headaches including migraines (onset prior to August 1998), a knee operation, and what appeared to be "partial removal of the first ribs bilaterally". Prior to December 1994 he underwent two cervical fusions (including cervical fusion of C6-7 with complete obliteration of the intervertebral space), thoracotomy, three ulnar nerve surgeries, lumbar fusion/ laminectomy, and arthoscopy of both knees. On 01 May 2002, the subject underwent diagnostic testing due to severe back pain, with findings including mild lumbar spinal stenosis and moderate central spinal stenosis. The subject presented to the emergency room and was hospitalized on 03 June 2004 with an admitting diagnosis of cerebrovascular accident, rule out radiculopathy. Symptoms at the time of admission included left arm weakness and numbness and inability to control movement, and the subject reported a history of chronic pain secondary to a cervical/ lumbar fusion, depression, Lyme disease, and migraines. He was discharged on 04 June 2004. The events of depression, migraines, cervical/ lumbar fusion were assessed to be medical history, and the possible diagnosis of cerebrovascular accident was not confirmed. Therefore, these are assessed to be incidental findings based upon medical review.
Sex: M
Vaccine: LYME
Symptoms: Muscle spasms, Muscular weakness, Pain, Pyrexia, Rash
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a male subject of unspecified age who was vaccinated with LYMErix for prophylaxis. A physician or other health care professionals has not verified this report. On an unspecified date the subject received dose of LYMErix (unknown). On an unspecified date after vaccination with LYMErix, the subject experienced arthalgias, fatigue, burning pain, cramping, fevers, rashes, swollen joints, headaches, numbness, vision problems, hearing problems, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated or other mechanism decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 28 February via medical records. The subject had a complex medical history including a "crush injury"/ neck injury in 1980, thoracic outlet syndrome, three carpal tunnel release surgeries, sensory neuroma of the dorsal right hand treated with neurolysis, severe headaches including migraines (onset prior to August 1998), a knee operation, and what appeared to be "partial removal of the first ribs bilaterally". Prior to December 1994 he underwent two cervical fusions (including cervical fusion of C6-7 with complete obliteration of the intervertebral space), thoracotomy, three ulnar nerve surgeries, lumbar fusion/ laminectomy, and arthoscopy of both knees. On 01 May 2002, the subject underwent diagnostic testing due to severe back pain, with findings including mild lumbar spinal stenosis and moderate central spinal stenosis. The subject presented to the emergency room and was hospitalized on 03 June 2004 with an admitting diagnosis of cerebrovascular accident, rule out radiculopathy. Symptoms at the time of admission included left arm weakness and numbness and inability to control movement, and the subject reported a history of chronic pain secondary to a cervical/ lumbar fusion, depression, Lyme disease, and migraines. He was discharged on 04 June 2004. The events of depression, migraines, cervical/ lumbar fusion were assessed to be medical history, and the possible diagnosis of cerebrovascular accident was not confirmed. Therefore, these are assessed to be incidental findings based upon medical review.
Sex: M
Vaccine: LYME
Symptoms: Rib fracture, Scan brain, Spinal X-ray, Spinal column stenosis, Spinal fusion surgery
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a male subject of unspecified age who was vaccinated with LYMErix for prophylaxis. A physician or other health care professionals has not verified this report. On an unspecified date the subject received dose of LYMErix (unknown). On an unspecified date after vaccination with LYMErix, the subject experienced arthalgias, fatigue, burning pain, cramping, fevers, rashes, swollen joints, headaches, numbness, vision problems, hearing problems, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated or other mechanism decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 28 February via medical records. The subject had a complex medical history including a "crush injury"/ neck injury in 1980, thoracic outlet syndrome, three carpal tunnel release surgeries, sensory neuroma of the dorsal right hand treated with neurolysis, severe headaches including migraines (onset prior to August 1998), a knee operation, and what appeared to be "partial removal of the first ribs bilaterally". Prior to December 1994 he underwent two cervical fusions (including cervical fusion of C6-7 with complete obliteration of the intervertebral space), thoracotomy, three ulnar nerve surgeries, lumbar fusion/ laminectomy, and arthoscopy of both knees. On 01 May 2002, the subject underwent diagnostic testing due to severe back pain, with findings including mild lumbar spinal stenosis and moderate central spinal stenosis. The subject presented to the emergency room and was hospitalized on 03 June 2004 with an admitting diagnosis of cerebrovascular accident, rule out radiculopathy. Symptoms at the time of admission included left arm weakness and numbness and inability to control movement, and the subject reported a history of chronic pain secondary to a cervical/ lumbar fusion, depression, Lyme disease, and migraines. He was discharged on 04 June 2004. The events of depression, migraines, cervical/ lumbar fusion were assessed to be medical history, and the possible diagnosis of cerebrovascular accident was not confirmed. Therefore, these are assessed to be incidental findings based upon medical review.
Sex: M
Vaccine: LYME
Symptoms: Visual disturbance, X-ray
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a male subject of unspecified age who was vaccinated with LYMErix for prophylaxis. A physician or other health care professionals has not verified this report. On an unspecified date the subject received dose of LYMErix (unknown). On an unspecified date after vaccination with LYMErix, the subject experienced arthalgias, fatigue, burning pain, cramping, fevers, rashes, swollen joints, headaches, numbness, vision problems, hearing problems, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated or other mechanism decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 28 February via medical records. The subject had a complex medical history including a "crush injury"/ neck injury in 1980, thoracic outlet syndrome, three carpal tunnel release surgeries, sensory neuroma of the dorsal right hand treated with neurolysis, severe headaches including migraines (onset prior to August 1998), a knee operation, and what appeared to be "partial removal of the first ribs bilaterally". Prior to December 1994 he underwent two cervical fusions (including cervical fusion of C6-7 with complete obliteration of the intervertebral space), thoracotomy, three ulnar nerve surgeries, lumbar fusion/ laminectomy, and arthoscopy of both knees. On 01 May 2002, the subject underwent diagnostic testing due to severe back pain, with findings including mild lumbar spinal stenosis and moderate central spinal stenosis. The subject presented to the emergency room and was hospitalized on 03 June 2004 with an admitting diagnosis of cerebrovascular accident, rule out radiculopathy. Symptoms at the time of admission included left arm weakness and numbness and inability to control movement, and the subject reported a history of chronic pain secondary to a cervical/ lumbar fusion, depression, Lyme disease, and migraines. He was discharged on 04 June 2004. The events of depression, migraines, cervical/ lumbar fusion were assessed to be medical history, and the possible diagnosis of cerebrovascular accident was not confirmed. Therefore, these are assessed to be incidental findings based upon medical review.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse practitioner (also reported as a physician assistant) concerning "an approximately 24 year old" female with a history of seizures, who, on an unspecified date, was vaccinated IM with a first dose of Gardasil.  It was reported by the nurse practitioner that the patient had never been diagnosed with anything.  Within thirty minutes post vaccination the patient experienced a seizure.  The patient was sent to the emergency room.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Upon internal review seizure was considered to be an other important medical event.  Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Convulsion, Developmental delay
Clinical narrative: Patient was a normal 4 month old, no problems during birth.  One week after his 4 month shots, he had his first known seizure.  He continues to have seizures and also developmental delays. 3/20/08-records received-seizure on 11/18/04,  observed moving arms and legs,  in choppy motion, unusual breathing pattern and eyes deviated to left-C/O 2 days of congestion, non productive cough and fever. Routine office visits with no complaints until 6/16/05 C/O ear pain and fussy. Neurology consult 3/19/05-for seizure activity which have been decreasing in frequency. Normal neurologic exam. Follow-up: lack of balance, speech delays.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning her girlfriend's 20 year old daughter with no medical history, who in November 2007, was vaccinated with a first dose of Gardasil. Within 20 minutes post vaccination the patient was in the waiting room and had a seizure. The patient vomited up to 2 or 3 times. An ambulance took the patient to the emergency room. The patient recovered on an unspecified date. No product quality complaint was involved. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Blood culture negative, Culture urine negative, Dehydration, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 6 month old male who was vaccinated PO with a second 2.0 mL dose of Rotateq.  In March 2007, after received the vaccine, the patient experienced persistent vomiting and diarrhea.  The patient was hospitalized for 24 hours.  No further information was provided.  Unspecified medical attention was sought.  The outcome was reported as recovered on 20-MAR-2007.  There was no product quality complaint.  Follow-up information from the reporting physician indicated that the patient was 2 months of age and received all the routine 2 month immunizations.  The patient was not hospitalized.  Lot numbers or additional patient information were unavailable since the physician did not remember the patient.  Additional follow-up information from the physician indicated that the patient was a 22 week old male with gastroesophageal reflux disease who on 02-MAR-2007, was vaccinated with his second dose of Rotateq.  There was no illness at the time of vaccination.  Concomitant vaccinations administered on that same day included the second dose of PedvaxHIB (OMPC) (MSD) (lot# 653770/0407F) in the right thigh, the second dose of DAPTACEL (lot# AC14B0400) in the left thigh, the second dose of IPOL (Vero) (lot# Z0421) in the left thigh, and the second dose of PREVNAR (lot# B08649H) in the left thigh.  Other concomitant drug therapy included AXID.  In March 2007 after vaccination on unspecified date and patient experienced dehydration characterized by fever, vomiting and diarrhea (previously reported).  The patient sought unspecified medical attention and was subsequently hospitalized.  Lab diagnostic studies included all normal results for abdominal ultrasound, abdominal X-ray, blood culture and urine culture.  On 15-MAR-2007 the patient recovered.  Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Pyrexia, Ultrasound abdomen normal, Vomiting, X-ray normal
Clinical narrative: Information has been received from a physician concerning a 6 month old male who was vaccinated PO with a second 2.0 mL dose of Rotateq.  In March 2007, after received the vaccine, the patient experienced persistent vomiting and diarrhea.  The patient was hospitalized for 24 hours.  No further information was provided.  Unspecified medical attention was sought.  The outcome was reported as recovered on 20-MAR-2007.  There was no product quality complaint.  Follow-up information from the reporting physician indicated that the patient was 2 months of age and received all the routine 2 month immunizations.  The patient was not hospitalized.  Lot numbers or additional patient information were unavailable since the physician did not remember the patient.  Additional follow-up information from the physician indicated that the patient was a 22 week old male with gastroesophageal reflux disease who on 02-MAR-2007, was vaccinated with his second dose of Rotateq.  There was no illness at the time of vaccination.  Concomitant vaccinations administered on that same day included the second dose of PedvaxHIB (OMPC) (MSD) (lot# 653770/0407F) in the right thigh, the second dose of DAPTACEL (lot# AC14B0400) in the left thigh, the second dose of IPOL (Vero) (lot# Z0421) in the left thigh, and the second dose of PREVNAR (lot# B08649H) in the left thigh.  Other concomitant drug therapy included AXID.  In March 2007 after vaccination on unspecified date and patient experienced dehydration characterized by fever, vomiting and diarrhea (previously reported).  The patient sought unspecified medical attention and was subsequently hospitalized.  Lab diagnostic studies included all normal results for abdominal ultrasound, abdominal X-ray, blood culture and urine culture.  On 15-MAR-2007 the patient recovered.  Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: YF
Symptoms: Injection site pruritus, Injection site rash, Skin reaction
Clinical narrative: PT REPORTED OF LOCALIZED REACTION TO INJECTION SITE OF RASH AND ITCHINESS. PT REPORTED THAT REACTION OCCURRED WHILE AT HOME.
Age: 13.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Fever, nausea, inj. site very red and swollen.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Joint swelling, Musculoskeletal pain, Oedema peripheral, Pain in extremity
Clinical narrative: On 3/4/08 at 1140 am patient presented at this dept. with complaint of left upper arm and shoulder being very sore, beginning 3/2/08. Upon observation left upper arm and shoulder area appear edematous, feel warm to touch and are very tender to touch. Some redness noted, around deltoid area.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Skin warm, Tenderness
Clinical narrative: On 3/4/08 at 1140 am patient presented at this dept. with complaint of left upper arm and shoulder being very sore, beginning 3/2/08. Upon observation left upper arm and shoulder area appear edematous, feel warm to touch and are very tender to touch. Some redness noted, around deltoid area.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Hours later had pain at injection site and swelling all the way to the elbow that lasted 3-4 days, low fever that lasted 1 day
Age: 1.3
Sex: F
Vaccine: PNC
Symptoms: Erythema, Excoriation, Skin warm
Clinical narrative: Quarter size red area with knot, warm to touch 1/2" away from injection site of left thigh.  Benadryl, Tylenol, Motrin to be given as needed.
Age: 22.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Pruritus
Clinical narrative: Erythema and pruritus on (R) arm from shoulder to forearm, extending to (R_ flank. Lasted 24 hrs, then resolved spontaneously.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Large area of erythema - approximately 5 inches in diameter with some induration.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blood pressure, Fall, Head injury, Heart rate increased, Oxygen saturation
Clinical narrative: child received vaccines listed below, fainted approx 5 mins after his shots, head struck edge of exam table as he fell.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Syncope
Clinical narrative: child received vaccines listed below, fainted approx 5 mins after his shots, head struck edge of exam table as he fell.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Heart rate increased, Hyperhidrosis, Oxygen saturation decreased, Pallor, Syncope
Clinical narrative: Child received vaccines noted below, observed her sibling. Faint, then fainted as well, falling to her anterior abdomen; pale and diaphoretic, pupils equal dram -RN
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Left upper extremity redness, warmth, swelling, mild itching approximately 7cm area.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Cold compress therapy, Erythema, Oedema, Tenderness
Clinical narrative: Erythema, edema, tenderness left upper arm.  Benadryl, cool compresses, observation.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (17x14cm) injection site and surrounding area became pink, warm, swollen and tender.  Discomfort extended beyond the site (left triceps) down the lateral left arm to just above the wrist.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Rash macular, Rash pruritic
Clinical narrative: 1 day history of diffuse mildly pruritic macular eruption on trunk, arms and legs.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Vertigo
Clinical narrative: Constant problems/vertigo.
Age: 71.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient 71 years old given a Tdap vaccine, which is only recommended through age 64 years.  Patient was called and notified of this.  Vaccination was administered on 2-21-08.  Patient was called 3-4-2008 and reported no adverse reactions.  There was not adverse event.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap was given instead of Td.  Pt was 65 years of age when the Tdap was administered. There was no adverse event.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Sore shoulder to elbow, seems weaker than should be. Other arm fine. Noted arm soreness at site for 1-2 days post vaccination. States above symptoms have continued. Declines physician evaluation.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, erythema and warmth involving most of the thigh and buttock at injection site.  Induration and warmth subsiding by day #2.  Exaggerated immune reaction vs. allergy.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: On 2-19-08 received Tdap instead of Td, patient's age is greater than 64 years.  There were no adverse events.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site rash, Urticaria
Clinical narrative: PT was administered the Smallpox vaccine on 3 Mar 2008. This administration was the first vaccination of 15 jabs. PT was diagnosed with a rash surrounding the site of vaccination as well as Urticaria on the chest and stomach 12 Mar 2008. PT has not taken any medication and first noticed the urticaria 11 Mar 2008.
Age: 0.18
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Patient developed loose bloody stools 5 days after vaccination.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Pharyngolaryngeal pain, Pregnancy, Pregnancy test positive
Clinical narrative: Receipt of typhoid and Anthrax vaccine #1 22 March 2007 and AVA #2 on April 5, 2007. She c/o sore throat x 1 wk after AVA #1, no problems with AVA. Pregnancy test during routine deployment screening 4/19/2007 identified positive pregnancy test with bHCG of 8500 on 21 April 2007. Normal delivery 14 Dec 2007. Child with "snorty breathing" x 2 months otherwise healthy.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt given Tdap at age 76 years instead of Td.  There were no adverse reactions.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Administered Tdap instead of Td to a 74 year old patient.  There were no adverse events.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt given Tdap vaccine instead of Td, when the patient was 65 years of age.  There were no adverse events.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient given Tdap instead of recommended Td on 2-6-08.
Age: 17.0
Sex: F
Vaccine: HEPAB, HPV4
Symptoms: Activities of daily living impaired, Crying, Dizziness, Fatigue, Pain
Clinical narrative: Extreme dizziness, vertigo, soreness and fatigue. Patient was in tears, unable to stay awake or do homework. Onset 5-6 hours post injection. Minor fever (99?).
Age: 17.0
Sex: F
Vaccine: HEPAB, HPV4
Symptoms: Pyrexia, Somnolence, Vertigo
Clinical narrative: Extreme dizziness, vertigo, soreness and fatigue. Patient was in tears, unable to stay awake or do homework. Onset 5-6 hours post injection. Minor fever (99?).
Age: 1.66
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Influenza like illness, Insomnia, Irritability, Pyrexia
Clinical narrative: 03/01/2008 Low grade fever and flu like sx.  No flu like sx at this time.  03/02/2008 Behavior change of "fussy", increased irritabilty, not sleeping much, "out of control".  Behavior changes unchaged as of today, 03/12/2008.  Has been seen by family physician times 2 since immunizations were given.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blister, Erythema, Oedema
Clinical narrative: 8 by 8 cm diameter area of erythema and edema with three clear vesicles at Left arm, starting a little over 24 hours after vaccination.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Wwelt size of a nickel, area red with itching.  Reaction occurred am of 3/8/08.
Age: 7.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: none
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Itching developed within 12 hours at the site of the vaccination.  This was followed by redness and swelling and pain the next morning.  Patient seen 64 hours after vaccination with 14.5 x 24cm area of erythema, mild induration, increased warmth and mild tenderness, moderate pruritis around the site of vaccination.  Fever of 100.5 at 48 hours after vaccination.  Missed work for 2 days.  Complained of some difficulty with short term memory.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site warmth, Memory impairment, Pain, Pyrexia, Swelling
Clinical narrative: Itching developed within 12 hours at the site of the vaccination.  This was followed by redness and swelling and pain the next morning.  Patient seen 64 hours after vaccination with 14.5 x 24cm area of erythema, mild induration, increased warmth and mild tenderness, moderate pruritis around the site of vaccination.  Fever of 100.5 at 48 hours after vaccination.  Missed work for 2 days.  Complained of some difficulty with short term memory.
Age: 1.09
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Pharyngolaryngeal pain, Pyrexia, Rash generalised, Vulvovaginal disorder
Clinical narrative: 9 days post vaccine pt. developed rapidly spreading rash over entire body.  She had  fever and sore throat with it as well and severe redness in her vagina lips (not assocoated with diaper rash.  Rash appeared to be chicken pox.  Was treated with Tylenol, Benadryl, Caladryl and oatmeal baths.  The redness in the vagina was treated with 1% cortisone and bagbalm.  The symptoms resolved on the 3rd day.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Gaze palsy, Intensive care, Left ventricular hypertrophy, Oxygen supplementation, Pallor
Clinical narrative: Pt given Pediarix, PCV, HIB, Rotavirus-approx 5 min after vaccine, pt pale, Bil. eye deviation, pulse 60, nonresponsive. O2 given-transferred to ER - transferred to PICU  3/25/08 Reviewed hospital medical records for 3/11-3/13/2008. FINAL DX: ALTE, likely vagal response from vaccines.  No D/C summary available. Records reveal patient experienced crying/screaming immediately s/p vaccine but then turned pale, hypotonia, unresponsive & stopped breathing.  Pulse 60.  Seen in outlying ER & transferred to higher level of care.  Initially in PICU then transferred to floor.  Exam was WNL.  Neuro & cardiac consult done & completely WNL.  No further episodes in hospital.  D/C to home.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt given Pediarix, PCV, HIB, Rotavirus-approx 5 min after vaccine, pt pale, Bil. eye deviation, pulse 60, nonresponsive. O2 given-transferred to ER - transferred to PICU  3/25/08 Reviewed hospital medical records for 3/11-3/13/2008. FINAL DX: ALTE, likely vagal response from vaccines.  No D/C summary available. Records reveal patient experienced crying/screaming immediately s/p vaccine but then turned pale, hypotonia, unresponsive & stopped breathing.  Pulse 60.  Seen in outlying ER & transferred to higher level of care.  Initially in PICU then transferred to floor.  Exam was WNL.  Neuro & cardiac consult done & completely WNL.  No further episodes in hospital.  D/C to home.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cough, Electroencephalogram normal, Full blood count normal, Laboratory test normal, Muscle twitching
Clinical narrative: According to father, had left shoulder twitch and head twitch to left several times a day for 1st 48 hours.  As of today, happens 1 x per day.  EEG normal and neurologist video - no seizure.  Making this report at dad's request.  Also had fever, runny nose, cough.5/15/08-records received for DOS 3/6-3/7/08-DC DX: fever, resolved. Infantile spasms/epilepsy ruled out. Presented with seizure like reaction associated with fever and mild respiratory distress. Had some fever and fussiness several days prior.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: According to father, had left shoulder twitch and head twitch to left several times a day for 1st 48 hours.  As of today, happens 1 x per day.  EEG normal and neurologist video - no seizure.  Making this report at dad's request.  Also had fever, runny nose, cough.5/15/08-records received for DOS 3/6-3/7/08-DC DX: fever, resolved. Infantile spasms/epilepsy ruled out. Presented with seizure like reaction associated with fever and mild respiratory distress. Had some fever and fussiness several days prior.