chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Local swelling, Loss of control of legs, Lumbar puncture, Mental disorder, Nausea
Clinical narrative: neuromuscular pain, global weakness, intermittant swelling.  07/23/2008 MR received for DOS 10/19/2007 which include 2 Rheumatology consults, neuro consult, psych consult. Pt presented for Rheum eval 10/19/08 with c/o 6 week hx of pain and sensitivity in her face, jaw neck and thoracic region (burning & tingling) and progressive weakness in her limbs.  Unable to walk without assistance. Pt reports dizziness, vertigo, syncope and photosensitivity. Sleep is disturbed. Several falls. Has sweats. Presents in sunglasses for photophobia and in a w/c. This followed a viral and /or sinus infection 6 weeks prior. PE (+) for anceiform rash on the back, scalp, face, jaw, and neck tenderness, DTRs 1+ arms, unobtainable in legs, decreased strength in arms and legs, unable to walk.  Concern for neurological illness resulted in emergent admission to hospital for further eval. DOS 10/19-24/2007 with DX: weakness.  other dx:  fibromyalgia, migraines, asthma and chronic pain syndrome. Neuro consult as above but able to elicit patellar reflexes. Psych eval to r/o conversion d/o. Requested further eval. 2nd Rheum consult for increased sed rate. Additional sx of touch sensitivity and lower extremity numbness.  Impression:  Elevated Sed rate.  Myalgia and myositis NOS, Headache, Difficulty in walking. Pt had some nausea and vomiting while admitted.  Treated for pain and pt was ambulating on her own by d/c.  No final dx made.  D/C to f/u at home.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nervous system disorder, Neuropathy peripheral, Pain, Pain of skin, Paraesthesia
Clinical narrative: neuromuscular pain, global weakness, intermittant swelling.  07/23/2008 MR received for DOS 10/19/2007 which include 2 Rheumatology consults, neuro consult, psych consult. Pt presented for Rheum eval 10/19/08 with c/o 6 week hx of pain and sensitivity in her face, jaw neck and thoracic region (burning & tingling) and progressive weakness in her limbs.  Unable to walk without assistance. Pt reports dizziness, vertigo, syncope and photosensitivity. Sleep is disturbed. Several falls. Has sweats. Presents in sunglasses for photophobia and in a w/c. This followed a viral and /or sinus infection 6 weeks prior. PE (+) for anceiform rash on the back, scalp, face, jaw, and neck tenderness, DTRs 1+ arms, unobtainable in legs, decreased strength in arms and legs, unable to walk.  Concern for neurological illness resulted in emergent admission to hospital for further eval. DOS 10/19-24/2007 with DX: weakness.  other dx:  fibromyalgia, migraines, asthma and chronic pain syndrome. Neuro consult as above but able to elicit patellar reflexes. Psych eval to r/o conversion d/o. Requested further eval. 2nd Rheum consult for increased sed rate. Additional sx of touch sensitivity and lower extremity numbness.  Impression:  Elevated Sed rate.  Myalgia and myositis NOS, Headache, Difficulty in walking. Pt had some nausea and vomiting while admitted.  Treated for pain and pt was ambulating on her own by d/c.  No final dx made.  D/C to f/u at home.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Photophobia, Pupillary disorder, Skin burning sensation, Swelling face, Syncope
Clinical narrative: neuromuscular pain, global weakness, intermittant swelling.  07/23/2008 MR received for DOS 10/19/2007 which include 2 Rheumatology consults, neuro consult, psych consult. Pt presented for Rheum eval 10/19/08 with c/o 6 week hx of pain and sensitivity in her face, jaw neck and thoracic region (burning & tingling) and progressive weakness in her limbs.  Unable to walk without assistance. Pt reports dizziness, vertigo, syncope and photosensitivity. Sleep is disturbed. Several falls. Has sweats. Presents in sunglasses for photophobia and in a w/c. This followed a viral and /or sinus infection 6 weeks prior. PE (+) for anceiform rash on the back, scalp, face, jaw, and neck tenderness, DTRs 1+ arms, unobtainable in legs, decreased strength in arms and legs, unable to walk.  Concern for neurological illness resulted in emergent admission to hospital for further eval. DOS 10/19-24/2007 with DX: weakness.  other dx:  fibromyalgia, migraines, asthma and chronic pain syndrome. Neuro consult as above but able to elicit patellar reflexes. Psych eval to r/o conversion d/o. Requested further eval. 2nd Rheum consult for increased sed rate. Additional sx of touch sensitivity and lower extremity numbness.  Impression:  Elevated Sed rate.  Myalgia and myositis NOS, Headache, Difficulty in walking. Pt had some nausea and vomiting while admitted.  Treated for pain and pt was ambulating on her own by d/c.  No final dx made.  D/C to f/u at home.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urine analysis
Clinical narrative: neuromuscular pain, global weakness, intermittant swelling.  07/23/2008 MR received for DOS 10/19/2007 which include 2 Rheumatology consults, neuro consult, psych consult. Pt presented for Rheum eval 10/19/08 with c/o 6 week hx of pain and sensitivity in her face, jaw neck and thoracic region (burning & tingling) and progressive weakness in her limbs.  Unable to walk without assistance. Pt reports dizziness, vertigo, syncope and photosensitivity. Sleep is disturbed. Several falls. Has sweats. Presents in sunglasses for photophobia and in a w/c. This followed a viral and /or sinus infection 6 weeks prior. PE (+) for anceiform rash on the back, scalp, face, jaw, and neck tenderness, DTRs 1+ arms, unobtainable in legs, decreased strength in arms and legs, unable to walk.  Concern for neurological illness resulted in emergent admission to hospital for further eval. DOS 10/19-24/2007 with DX: weakness.  other dx:  fibromyalgia, migraines, asthma and chronic pain syndrome. Neuro consult as above but able to elicit patellar reflexes. Psych eval to r/o conversion d/o. Requested further eval. 2nd Rheum consult for increased sed rate. Additional sx of touch sensitivity and lower extremity numbness.  Impression:  Elevated Sed rate.  Myalgia and myositis NOS, Headache, Difficulty in walking. Pt had some nausea and vomiting while admitted.  Treated for pain and pt was ambulating on her own by d/c.  No final dx made.  D/C to f/u at home.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Computerised tomogram, Electromyogram, Lumbar puncture, Myalgia
Clinical narrative: neuromuscular pain, global weakness, intermittant swelling.  07/23/2008 MR received for DOS 10/19/2007 which include 2 Rheumatology consults, neuro consult, psych consult. Pt presented for Rheum eval 10/19/08 with c/o 6 week hx of pain and sensitivity in her face, jaw neck and thoracic region (burning & tingling) and progressive weakness in her limbs.  Unable to walk without assistance. Pt reports dizziness, vertigo, syncope and photosensitivity. Sleep is disturbed. Several falls. Has sweats. Presents in sunglasses for photophobia and in a w/c. This followed a viral and /or sinus infection 6 weeks prior. PE (+) for anceiform rash on the back, scalp, face, jaw, and neck tenderness, DTRs 1+ arms, unobtainable in legs, decreased strength in arms and legs, unable to walk.  Concern for neurological illness resulted in emergent admission to hospital for further eval. DOS 10/19-24/2007 with DX: weakness.  other dx:  fibromyalgia, migraines, asthma and chronic pain syndrome. Neuro consult as above but able to elicit patellar reflexes. Psych eval to r/o conversion d/o. Requested further eval. 2nd Rheum consult for increased sed rate. Additional sx of touch sensitivity and lower extremity numbness.  Impression:  Elevated Sed rate.  Myalgia and myositis NOS, Headache, Difficulty in walking. Pt had some nausea and vomiting while admitted.  Treated for pain and pt was ambulating on her own by d/c.  No final dx made.  D/C to f/u at home.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Swelling
Clinical narrative: neuromuscular pain, global weakness, intermittant swelling.  07/23/2008 MR received for DOS 10/19/2007 which include 2 Rheumatology consults, neuro consult, psych consult. Pt presented for Rheum eval 10/19/08 with c/o 6 week hx of pain and sensitivity in her face, jaw neck and thoracic region (burning & tingling) and progressive weakness in her limbs.  Unable to walk without assistance. Pt reports dizziness, vertigo, syncope and photosensitivity. Sleep is disturbed. Several falls. Has sweats. Presents in sunglasses for photophobia and in a w/c. This followed a viral and /or sinus infection 6 weeks prior. PE (+) for anceiform rash on the back, scalp, face, jaw, and neck tenderness, DTRs 1+ arms, unobtainable in legs, decreased strength in arms and legs, unable to walk.  Concern for neurological illness resulted in emergent admission to hospital for further eval. DOS 10/19-24/2007 with DX: weakness.  other dx:  fibromyalgia, migraines, asthma and chronic pain syndrome. Neuro consult as above but able to elicit patellar reflexes. Psych eval to r/o conversion d/o. Requested further eval. 2nd Rheum consult for increased sed rate. Additional sx of touch sensitivity and lower extremity numbness.  Impression:  Elevated Sed rate.  Myalgia and myositis NOS, Headache, Difficulty in walking. Pt had some nausea and vomiting while admitted.  Treated for pain and pt was ambulating on her own by d/c.  No final dx made.  D/C to f/u at home.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activated partial thromboplastin time, Ammonia increased, Antithrombin III increased, Blood lactic acid normal, C-reactive protein increased
Clinical narrative: Information has been received from a medical officer at CBER, concerning a 14 year old female who on an unknown date was vaccinated with the first dose of GARDASIL. Within 24 hours of the vaccination, the patient experienced immediate asystole followed by transverse myelitis. Upon internal review, immediate asystole and transverse myelitis were considered to be other important medical events. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: CSF culture negative, CSF glucose increased, CSF protein increased, CSF protein normal, Cardiac arrest
Clinical narrative: Information has been received from a medical officer at CBER, concerning a 14 year old female who on an unknown date was vaccinated with the first dose of GARDASIL. Within 24 hours of the vaccination, the patient experienced immediate asystole followed by transverse myelitis. Upon internal review, immediate asystole and transverse myelitis were considered to be other important medical events. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cold agglutinins, Computerised tomogram normal, Electrocardiogram normal, HIV antibody negative, Headache
Clinical narrative: Information has been received from a medical officer at CBER, concerning a 14 year old female who on an unknown date was vaccinated with the first dose of GARDASIL. Within 24 hours of the vaccination, the patient experienced immediate asystole followed by transverse myelitis. Upon internal review, immediate asystole and transverse myelitis were considered to be other important medical events. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Intensive care, International normalised ratio, International normalised ratio increased, Mechanical ventilation, Mycoplasma serology
Clinical narrative: Information has been received from a medical officer at CBER, concerning a 14 year old female who on an unknown date was vaccinated with the first dose of GARDASIL. Within 24 hours of the vaccination, the patient experienced immediate asystole followed by transverse myelitis. Upon internal review, immediate asystole and transverse myelitis were considered to be other important medical events. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myelitis transverse, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain, Pain in extremity, Paralysis
Clinical narrative: Information has been received from a medical officer at CBER, concerning a 14 year old female who on an unknown date was vaccinated with the first dose of GARDASIL. Within 24 hours of the vaccination, the patient experienced immediate asystole followed by transverse myelitis. Upon internal review, immediate asystole and transverse myelitis were considered to be other important medical events. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paralysis flaccid, Protein S normal, Protein total increased, Red blood cell sedimentation rate decreased, Red blood cells CSF positive
Clinical narrative: Information has been received from a medical officer at CBER, concerning a 14 year old female who on an unknown date was vaccinated with the first dose of GARDASIL. Within 24 hours of the vaccination, the patient experienced immediate asystole followed by transverse myelitis. Upon internal review, immediate asystole and transverse myelitis were considered to be other important medical events. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Respiratory failure, Scan brain
Clinical narrative: Information has been received from a medical officer at CBER, concerning a 14 year old female who on an unknown date was vaccinated with the first dose of GARDASIL. Within 24 hours of the vaccination, the patient experienced immediate asystole followed by transverse myelitis. Upon internal review, immediate asystole and transverse myelitis were considered to be other important medical events. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cardiac arrest, Myelitis transverse
Clinical narrative: Information has been received from a medical officer at CBER, concerning a 14 year old female who on an unknown date was vaccinated with the first dose of GARDASIL. Within 24 hours of the vaccination, the patient experienced immediate asystole followed by transverse myelitis. Upon internal review, immediate asystole and transverse myelitis were considered to be other important medical events. No further information is available.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood creatine phosphokinase MB, Body temperature increased, Chest pain, Echocardiogram, Electrocardiogram ST segment elevation
Clinical narrative: Dx w/ pericarditis on 19 July 08 - admitted.  Pt was seen & Dx on the ship.  Still currently at sea.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Heart rate normal, Myoglobin blood increased, Troponin increased, White blood cell count increased
Clinical narrative: Dx w/ pericarditis on 19 July 08 - admitted.  Pt was seen & Dx on the ship.  Still currently at sea.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Pericarditis
Clinical narrative: Dx w/ pericarditis on 19 July 08 - admitted.  Pt was seen & Dx on the ship.  Still currently at sea.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red, raised area, quarter size both legs
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Her rihgt thigh is red and swollen. the red spot is bigger than a quarter size. Her left thigh is ok. We monitored the spot to see if it has gotten bigger. She has not had any fever
Age: 1.25
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen than a quarter size
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: She complained her leg was hurting and showed us her leg. The shot site was swollen and red. She said it was itchy and hurting. We elevated her leg and rubbed around the site and put ice on it
Age: 0.4
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Cough, Pertussis, Polymerase chain reaction
Clinical narrative: Follow-up information, upgrading this case to serious status, has been received that pertains to event details, patient demographics, medical history and product details. Information regarding PREVNAR was received from a healthcare professional regarding a female patient who experienced pertussis/para pertussis. The patient received the first dose on 25-May-2008. The patient also received the second dose of Poliomyelitis Vaccine inactivated (manufacturer unknown) on 25-May-2008. On 28-May-2008, the patient was hospitalized for 2 days with clinical pertussis/para pertussis. The patient is still coughing but slowly improving. The reporter commented that in his opinion, the event was not related to PREVNAR. No additional information was available at the time of this report.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Antibody test abnormal, Blood immunoglobulin A normal, Blood immunoglobulin E normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 29-month-old female patient who experienced negative pneumococcal titer levels and possible lack of effect with a current sinus infection and tonsillitis. The patient received the fourth dose on 29-Dec-2006, at 12 months of age. On 20-Jun-2008, the patient had pneumococcal titer levels down after experiencing multiple recurrent episodes of chronic sinusitis, upper respiratory tract infections, ear infections, coughing and wheezing (no culture reports were provided. Her history also included an unspecified immunodeficiency). The pneumococcal titer results revealed 'negative' pneumococcal titer levels (see laboratory results) (antibody test abnormal). The reporter noted that the titer levels for all other vaccines were 'normal'. The child had an ENT/allergy workup performed (date unspecified). In Jul-2008, the patient was again evaluated in the office with a current sinus infection and tonsillitis. Treatment included antibiotics. The reporter noted a possible lack of PREVNAR effect. The Physician was planning on administering a 5th dose of PREVNAR. The patient's outcome for all events is unknown. No additional information was available at the time of this report.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Cough, Ear infection, Serology negative, Sinusitis, Upper respiratory tract infection
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 29-month-old female patient who experienced negative pneumococcal titer levels and possible lack of effect with a current sinus infection and tonsillitis. The patient received the fourth dose on 29-Dec-2006, at 12 months of age. On 20-Jun-2008, the patient had pneumococcal titer levels down after experiencing multiple recurrent episodes of chronic sinusitis, upper respiratory tract infections, ear infections, coughing and wheezing (no culture reports were provided. Her history also included an unspecified immunodeficiency). The pneumococcal titer results revealed 'negative' pneumococcal titer levels (see laboratory results) (antibody test abnormal). The reporter noted that the titer levels for all other vaccines were 'normal'. The child had an ENT/allergy workup performed (date unspecified). In Jul-2008, the patient was again evaluated in the office with a current sinus infection and tonsillitis. Treatment included antibiotics. The reporter noted a possible lack of PREVNAR effect. The Physician was planning on administering a 5th dose of PREVNAR. The patient's outcome for all events is unknown. No additional information was available at the time of this report.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Vaccination failure, Wheezing
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 29-month-old female patient who experienced negative pneumococcal titer levels and possible lack of effect with a current sinus infection and tonsillitis. The patient received the fourth dose on 29-Dec-2006, at 12 months of age. On 20-Jun-2008, the patient had pneumococcal titer levels down after experiencing multiple recurrent episodes of chronic sinusitis, upper respiratory tract infections, ear infections, coughing and wheezing (no culture reports were provided. Her history also included an unspecified immunodeficiency). The pneumococcal titer results revealed 'negative' pneumococcal titer levels (see laboratory results) (antibody test abnormal). The reporter noted that the titer levels for all other vaccines were 'normal'. The child had an ENT/allergy workup performed (date unspecified). In Jul-2008, the patient was again evaluated in the office with a current sinus infection and tonsillitis. Treatment included antibiotics. The reporter noted a possible lack of PREVNAR effect. The Physician was planning on administering a 5th dose of PREVNAR. The patient's outcome for all events is unknown. No additional information was available at the time of this report.
Age: 24.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Pregnancy test positive
Clinical narrative: Information has been received through the Merck Pregnancy Registry from a physician concerning a 24 year old female who on 17-AUG-2007 (also reported as 07-AUG-2007) was vaccinated with VARIVAX (Oka/Merck) (LOT # 654030/0913F), MMR II and DTaP (manufacturer not reported). The physician reported that the patient learned that she was pregnant after receiving the vaccination with the VARIVAX. Her last menstrual period was 01-AUG-2007. The estimated due date is 07-MAY-2008. Both the vaccination with and pregnancy test were done on 17-AUG-2007. The physician reported that there was no maternal adverse event. The patient contacted the physician. Follow up information has been received from the same physician. The infant was liveborn (weeks gestation not reported). The infant was diagnosed with Triploidy 69 KY (male). It died at 5-6 gestation weeks. Per the physician's discussion with OB there was no evidence it was vaccine related. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Blood test, Bone scan normal, Dehydration, Gait disturbance
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 7 year old male with an allergy to AUGMENTIN who on 11-MAY-2000 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Oka/Merck) (lot no. was reported as 1457T). There was no concomitant medication. On 24-OCT-2006 the patient was seen in the office with pain in right inguinal area and was diagnosed with shingles. The patient was treated with acyclovir. The following day the patient had lesions from his right knee to his foot and pain and difficulty walking on the right leg. On 25-OCT-2006 the patient was admitted to the hospital for twenty four hours. The patient was diagnosed with right leg pain, fever, shingles and limp to right leg. The patient was treated with intravenous fluids (unknown) for dehydration. The patient was seen by an orthopedic doctor. Blood tests were performed and results not reported. Magnetic resonance imaging for right thigh and right lower leg, bone scan and X-ray of lower extremity were all negative. Dermatologist saw the patient and diagnosed the patient with shingles. The patient improved in twenty four hours with acyclovir. In 2006, the patient was recovered. There were no lesions present. The reporter considered pain in right inguinal area, right leg pain, limp to right leg, had a couple of blisters, fever, shingles and dehydration to be disabling, caused a prolonged hospitalization and other important medical events. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Groin pain, Herpes zoster, Nuclear magnetic resonance imaging normal, Pain in extremity, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 7 year old male with an allergy to AUGMENTIN who on 11-MAY-2000 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Oka/Merck) (lot no. was reported as 1457T). There was no concomitant medication. On 24-OCT-2006 the patient was seen in the office with pain in right inguinal area and was diagnosed with shingles. The patient was treated with acyclovir. The following day the patient had lesions from his right knee to his foot and pain and difficulty walking on the right leg. On 25-OCT-2006 the patient was admitted to the hospital for twenty four hours. The patient was diagnosed with right leg pain, fever, shingles and limp to right leg. The patient was treated with intravenous fluids (unknown) for dehydration. The patient was seen by an orthopedic doctor. Blood tests were performed and results not reported. Magnetic resonance imaging for right thigh and right lower leg, bone scan and X-ray of lower extremity were all negative. Dermatologist saw the patient and diagnosed the patient with shingles. The patient improved in twenty four hours with acyclovir. In 2006, the patient was recovered. There were no lesions present. The reporter considered pain in right inguinal area, right leg pain, limp to right leg, had a couple of blisters, fever, shingles and dehydration to be disabling, caused a prolonged hospitalization and other important medical events. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, X-ray limb normal
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 7 year old male with an allergy to AUGMENTIN who on 11-MAY-2000 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Oka/Merck) (lot no. was reported as 1457T). There was no concomitant medication. On 24-OCT-2006 the patient was seen in the office with pain in right inguinal area and was diagnosed with shingles. The patient was treated with acyclovir. The following day the patient had lesions from his right knee to his foot and pain and difficulty walking on the right leg. On 25-OCT-2006 the patient was admitted to the hospital for twenty four hours. The patient was diagnosed with right leg pain, fever, shingles and limp to right leg. The patient was treated with intravenous fluids (unknown) for dehydration. The patient was seen by an orthopedic doctor. Blood tests were performed and results not reported. Magnetic resonance imaging for right thigh and right lower leg, bone scan and X-ray of lower extremity were all negative. Dermatologist saw the patient and diagnosed the patient with shingles. The patient improved in twenty four hours with acyclovir. In 2006, the patient was recovered. There were no lesions present. The reporter considered pain in right inguinal area, right leg pain, limp to right leg, had a couple of blisters, fever, shingles and dehydration to be disabling, caused a prolonged hospitalization and other important medical events. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Fall, Gaze palsy, Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician concerning a 11 year old female with no pertinent medical history, drug reactions or allergies who on 18-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot #660389/1968U).  There was no concomitant medication.  On 18-JUN-2008, within a minute of receiving the vaccination, the patient experienced a seizure like episode.  While sitting on the examination table the patient became very stiff and her eyes rolled back into her head.  The patient then fell backwards, from the sitting position, onto the examination table.  The patient recovered within two minutes.  The patient was at the office.  Upon internal review, the "seizure-like episode" was determined to be an other important medical event.  Follow-up information was received via phone call from a nurse on 18-JUL-2008.  She reported that no labs were performed.  The patient recovered.  She had no further information to add.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Headache
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL IM.  Subsequently, the patient experienced headaches and seizure.  The patient sought unspecified medical attention.  At the time of reporting, the outcome was unknown.  Upon internal review seizure was considered to be an other medical event.  Additional information has been requested. 7/30/08-records received-70/29/07-menstrual cramps better. 1/25/08-birth control Mircette and second HPV vaccine given. 4/28/08-C/O 4 month history of headaches, wakes up in morning with pounding headache, worsens as the day progresses. 5/6/08-Headaches remain same. 6/2/08-continues with headachs and pain behind eyes.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Head injury, Urinary incontinence
Clinical narrative: Information has been received from a registered pharmacist a concerning a 19 or 20 year old of age female pharmacy technician who on an unspecified date was vaccinated with a first dose of GARDASIL and on approximately 15-JUN-2008, one month ago, was vaccinated with the second dose of GARDASIL. On 15-JUL-2008, the patient experienced a seizure after administration of second dose of GARDASIL. The technician hit her head and urinated on herself during the seizure. The seizure occurred while she was working. Paramedics treated her. At the time of reporting, she was alert and improving (recovering). The pharmacist did not know if she was hospitalized. The seizure was considered to be disabling by the reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Convulsion, Dyskinesia, Electroencephalogram normal, Gaze palsy
Clinical narrative: Information has been received from a neurologist concerning a 16 year old female with a history of urinary tract infection, a few weeks before reporting, treated with unnamed medication, who in May 2008, was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  In approximately June 2008, two weeks later, the patient had a syncopal episode, rose to her feet and had another syncope.  This was immediately followed by a seizure with starting, rolling of her eyes, jerking of all limbs lasting for a moment or two.  This was followed by confusion.  An electroencephalogram was performed and resulted negative.  She is scheduled for a computed tomography of her brain.  The physician referred her to the neurologist for medical attention.  Upon internal review, seizure was considered to be an other medical important event.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Staring, Syncope
Clinical narrative: Information has been received from a neurologist concerning a 16 year old female with a history of urinary tract infection, a few weeks before reporting, treated with unnamed medication, who in May 2008, was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  In approximately June 2008, two weeks later, the patient had a syncopal episode, rose to her feet and had another syncope.  This was immediately followed by a seizure with starting, rolling of her eyes, jerking of all limbs lasting for a moment or two.  This was followed by confusion.  An electroencephalogram was performed and resulted negative.  She is scheduled for a computed tomography of her brain.  The physician referred her to the neurologist for medical attention.  Upon internal review, seizure was considered to be an other medical important event.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 21 year old female with no pertinent medical history and no drug reactions/allergies, who on 11-JAN-2008 was vaccinated with the first dose of GARDASIL and on 11-Jul-2008 was vaccinated with the third dose of GARDASIL (Lot # 659968/0847X).  There was no concomitant medication.  The patient went into a seizure episode a minute after administration at the physician's office, and became unconscious for about 30 seconds.  Patient was extremely nervous about receiving shots.  Subsequently, the patient recovered before leaving the office.  Upon internal review, seizure episode was considered to be an other important medical event.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cholecystitis, Infectious mononucleosis
Clinical narrative: Pt received 1st GARDASIL 11-7-07, 2nd GARDASIL 1-29-08, DX with Pancreatitis 5-7-08. x\x of pancreatitis 4-24-08. Recovered 5-21-08 DX with cholecystitis on 5-23-08. 5/7/08 also dx with mono.  08/26/2008 MR received for DOS 5/7-8/2008 with D/C DX:  Acute Pancreatitis.  Nausea with vomiting.  Abdominal pain. Mono. Mesenteric lymphadenopathy. Pt presented to ER with 2 wk hx of nausea with vomiting, fatigue and sore throat. Initially dx with H pylori, now with worsening LUQ pain, N&V.  Increased lipase and amylase on labs.  Tx with IV hydration and abx. Improved and d/c next day.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, 6VAX-F, PNC, DTAPHEPBIP, PNC
Symptoms: Encephalitis post immunisation, Fontanelle bulging, Pyrexia, Somnolence, Vomiting
Clinical narrative: Vomits, somnolence, fever, bulging anterior fontanelle for 3 days.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, 6VAX-F, PNC, DTAPHEPBIP, PNC
Symptoms: Fontanelle bulging, Pyrexia, Somnolence, Vomiting
Clinical narrative: Vomits, somnolence, fever, bulging anterior fontanelle for 3 days.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, 6VAX-F, PNC, DTAPHEPBIP, PNC
Symptoms: Fontanelle bulging, Lumbar puncture normal, Pyrexia, Sepsis, Vomiting
Clinical narrative: Vomits, somnolence, fever, bulging anterior fontanelle for 3 days.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, 6VAX-F, PNC, DTAPHEPBIP, PNC
Symptoms: White blood cell count increased
Clinical narrative: Vomits, somnolence, fever, bulging anterior fontanelle for 3 days.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site haematoma, Injection site inflammation
Clinical narrative: Redness at site of varicella vaccine. Red inflammed area slightly medial to midline with small hematoma at site of injection. No tenderness to palpation. Good femoral pulse in right leg and good perfusion to RLE. Iced immediately, 2 tsp of BENADRYL given in office and child observed for 30-40 min.
Age: 1.3
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incisional drainage, Lymphadenopathy
Clinical narrative: X 2 says after immunizations we noticed a swollen gland after a week kept getting bigger and redder; Doctor gave her antibiotics for 10 days and it got worse so he cut it open and today it is getting back to normal; (noted on screen history of runny nose)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Localized redness in left thigh, no streaks (3x4 cm) non painful (itchy) area was demarcated
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Pyrexia, Rash
Clinical narrative: Rash started 36 hours after immunizations; fever - diarrhea
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Redness 2 x 2 in left deltoid area, no other rashes, redness was demarcated.
Age: 1.3
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site urticaria
Clinical narrative: See attached office note; Unknown what injection caused hives.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Left upper arm, swollen, red, warm to touch; ice arm - 10 minutes on / 10 minutes off - Tylenol as directed. Call MD if swelling worsens or pain increases.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: rash, tiny red bumps on arms, legs, trunk, diaper area. Developed 10 days after receiving VARIVAX. Lasted approx 5 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: (L) deltoid red, bruised and swollen non-tender good ROM, (+) warm-ice, BENADRYL, NSAID or TYLENOL prn.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Scab, Urticaria
Clinical narrative: Reaction from Varicella on (R) arm 10 cm with scab urticaria on arm legs, back.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Decreased appetite, Vomiting
Clinical narrative: Excessive crying approx 3 hours. poor appetite, vomiting
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Blister, Erythema, Oedema peripheral
Clinical narrative: The evening of 07/08/08 pt's (L) arm where pt received Hep A and IPV earlier got red, swollen, and small water blisters in a small area on arm. Pt denies SOB, fever, sore throat or felling ill since shots. (R) arm looks normal. After applying ice packs and taking TYLENOL pt's Sx's went away by 07/11/08 evening.
Age: 22.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Syncope Gastrointestinal (nausea and vomiting)
Age: 20.0
Sex: F
Vaccine: HEP, HEPA, IPV, JEV
Symptoms: Dizziness, Headache, Nausea, Pain, Pyrexia
Clinical narrative: I received a phone call from pt's mother stating pt is out of the country and thinks she is having reaction to JE vaccines. Having pain/headache back of head, fever, hives on chest, nausea, head spinning and feels like she is going to pass out. Sx x2 d at time of phone call. Per return phone call from mother family doctor recommended pt start BENADRYL 50 mg every 6 hr and continue for 2 days.
Age: 20.0
Sex: F
Vaccine: HEP, HEPA, IPV, JEV
Symptoms: Urticaria, Vertigo
Clinical narrative: I received a phone call from pt's mother stating pt is out of the country and thinks she is having reaction to JE vaccines. Having pain/headache back of head, fever, hives on chest, nausea, head spinning and feels like she is going to pass out. Sx x2 d at time of phone call. Per return phone call from mother family doctor recommended pt start BENADRYL 50 mg every 6 hr and continue for 2 days.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Received vaccines 7/15/08 on 7/16/08 site of Hep A left was red; On 7/17/08 9AM site red, warm to touch and rash and swelling toward right site. No pus/drainage, No fever and no significant apparent discomfort.
Age: 1.2
Sex: F
Vaccine: HEPA, MMR, PNC
Symptoms: Diet refusal, Pyrexia
Clinical narrative: Fever 103.9 would not eat or drink fluids
Age: 1.2
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: With in 10 min of immunizations admin. Patient sites bilat swelled, hot to touch with redness, measured <MMR left VL 25mm x 17mm> <varicella lower right VL 38mm x 29mm> Dr. evaluated patient; No concerns-Lungs clear.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received HEP A #1 1/22/08.  She came to office to receive HEP A #2 6/24/08 - after it was given the nurse realized it was only 5 months since HEP A #1 was given and the MD was notified.  Health department contacted - mother notified - will repeat in 6-12 months.  6/24/08 dose not valid.
Age: 50.0
Sex: F
Vaccine: HEPAB, TD
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Lump that was after shot. Was swollen for about 3 weeks. Swelling has gone down, but lump remains. Recommended seeing a doctor for lump. Denied any other symptoms.
Age: 44.0
Sex: M
Vaccine: RAB
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: LOC after given injection for 5 seconds, recovered and was AAOx3, LOC again while conversing.  No control of motor movements until he recovered.  Sat him up in chair, maintained airway, prevented him from falling.
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Immediately after needle removed donor became pale and lost consciousness. She was moved to floor, ice applied to neck. Supportive care. LOC < 1 min. Recovered quickly within 5 min. Suspect vasopressor reaction.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Blood amylase increased, Lipase increased, Parotitis
Clinical narrative: Acute parotitis (KEFLEX x7 days warm compresses)
Age: 4.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Right deltoid immunization site reaction 10x7mm
Age: 1.6
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Skin disorder
Clinical narrative: Indentation to right thigh (anterior) of 1/2cm with lightening of skin color; Mom states she received immunization in that area in March.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Culture, Eye rolling, Fatigue, Irritability
Clinical narrative: 7/10/08 24 hours after vaccine administered, child fussy going for nap.  Mom said child smile blankly, eyes rolled back.  No shaking extremities.  Lazy, tired, temperature 104.3.  Seen at hospital.  No w/u done.  Seen 1/11/08.  Viral NBC persistent fever.  No future seizures.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Urine analysis normal
Clinical narrative: 7/10/08 24 hours after vaccine administered, child fussy going for nap.  Mom said child smile blankly, eyes rolled back.  No shaking extremities.  Lazy, tired, temperature 104.3.  Seen at hospital.  No w/u done.  Seen 1/11/08.  Viral NBC persistent fever.  No future seizures.
Age: 18.0
Sex: F
Vaccine: HEP, TD
Symptoms: Pruritus, Rash macular, Swelling, Urticaria
Clinical narrative: 215PM 7-16-08 sudden swelling, welts, hives, itching on left wrist. Blotches noted down entire left body to left foot at 3-330PM. Took a Benadryl tablet at 345PM and called the health department. Symptoms lasted through 7PM 7-16-08. Left foot and thumb remain itchy on 7-17-08 at 11AM.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Swelling with redness to left deltoid and pain
Age: 10.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Blood pressure decreased, Fall, Pallor, Reaction to previous exposure to any vaccine, Staring
Clinical narrative: Vaso-vagal Syndrome - Patient recovered well - 2-3 mins after receiving 2 inj. - Patient fell to floor - eyes open - staring - not immediately responsive. Skin, pale, warm, dry. Patient started responding approx 5-10 seconds with full mobility and cognition. 24 hrs after incident - mom disclosed patient had same reaction after MMR in 2003 - She marked "No" on screening form.
Age: 10.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Syncope vasovagal, Unresponsive to stimuli
Clinical narrative: Vaso-vagal Syndrome - Patient recovered well - 2-3 mins after receiving 2 inj. - Patient fell to floor - eyes open - staring - not immediately responsive. Skin, pale, warm, dry. Patient started responding approx 5-10 seconds with full mobility and cognition. 24 hrs after incident - mom disclosed patient had same reaction after MMR in 2003 - She marked "No" on screening form.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain on (R) arm after DTaP-MOTRIN, ice advised.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Local reaction, Pain
Clinical narrative: Large, local reaction to DPAT left arm 9 x 11 cm induration, erythema, pain.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Erythema, Headache, Joint swelling, Pyrexia
Clinical narrative: Evening following HEP B, had fever to 103 and headache.  Fever lasted 3 days.  Day 2 following shot both knee pain and redness/swelling, temperature 102.  Day 3 temperature 100.0.  No other illnesses.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Blood glucose increased, Blood magnesium normal, Carbon dioxide abnormal, Electrocardiogram, Heart rate increased
Clinical narrative: Unwitnessed loss of consciousness-mom came into pts room he was lying on floor initially responded to verbal stimuls with eyes opening then was limp with increased HR that would suddenly decreased po moc. Breathing was fine. No Tonic-clonic activity but possibly post-ictal.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Hypotonia, Loss of consciousness, Postictal state
Clinical narrative: Unwitnessed loss of consciousness-mom came into pts room he was lying on floor initially responded to verbal stimuls with eyes opening then was limp with increased HR that would suddenly decreased po moc. Breathing was fine. No Tonic-clonic activity but possibly post-ictal.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Agitation, Crying, Injection site erythema
Clinical narrative: 12:45 pm Infanrix (DTAP) given IM LL.  PPD placed.  Crying subsided after 30 seconds.  1:15 pm became very agitated.  Round roused red areas noted inner thigh left leg.  Doctor attended.  1:25 red areas abating - still crying lesser degree.  Benadryl 12.5mg given po.  1:37 sleeping - no redness on leg.  Epinephrine 1000 0.1 cc given sc.  Walking and baby.  Talking with patient's father.  No further problems.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Fluid retention, Joint swelling, Weight increased, X-ray
Clinical narrative: Approximately 3 weeks after receiving vaccine, began to rapidly retain fluid and have swollen joints.  Very tired.  Before seeking medical attention gained approximately 15-20 lbs of fluid.  Went for blood work to administering facility, several batches of tests.  Was referred to rhematologist, began prednisone.  Again, many batches of tests, no conclusive diagnosis.  Advised vaccine company of reaction, was told not fault of vaccine.  Still undiagnosed, going to clinic August 22.  Taking Plaquenil now, and very high doses of motrin with little to no effect.  Do not have RA antibodies or other factors, only high inflam. levels. 8/4/08-records received-presented on 2/4/08-C/O pain and swelling in joints which began 2 weeks after Gardasil injection on 12/4/07-noted minimal myalgias and arthralgias and in January 2008 significant pain right wrist, hands, elbows, shoulders, ankles and knees. Morning stiffness and 24 pound weight gain with puffiness around ankle. C/O fatigue, poor sleep secondary to pain.  PE: erythema over PIP and MCP, joint swelling. Impression:acute onset inflammatory polyarthritis involving small joints of hands, wrists, feet and ankles. Arthralgia in knees, elbows and shoulders. 2/13/08-Stiffness improved, 8 pound weight loss. 4/7/08-Stiffness much less intense, minimal swelling, tapering steroids. Assessment self limited arthritis resolving slowly. Viral illness versus poststrep inflammatory polyarthritis versus a more chronic process such as rheumatoid arthritis or other autoimmune diseases.   9/25/09 Consultant medical records received DOS 8/20/08 to 6/5/09. Assessement: Unspecified Inflammatory polyarthrophathy.  Patient presents with constant aching pain in all joints. Episodes of diffuse swelling with warmth and redness. Stiff wrists and feet. Morning stiffness. Back pain. Postitive Phalen's sign at median nerve. Synovial thickening peroneal tendons. Mild synovial inflammation both ankles. Scoliosis thoracic spine.
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS AROUND SMALLPOX VACCINATION SITE; QUICKLY SPREADING.