chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain, Pain in jaw, Pruritus, Swelling, Urticaria
Clinical narrative: Information has been received from a physician concerning a 9 year old female patient who on 22-DEC-2008 was vaccinated with the second dose of GARDASIL.  On 31-DEC-2008 the patient experienced red hives on inner thigh and feet.  On 02-JAN-2009 the patient also experienced severe pain in her armpits that moved to the neck and jaw.  Pain intensified in her neck, jaw and lips and moved to the back.  The physician mentioned that the symptoms resembled Kawasaki disease on a lower scale.  At the time of this report, the adverse events persisted.  The patient sought unspecified medical attention.  Upon internal review, Kawasaki disease was determined to be an other important medical event.  Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Kawasaki's disease, Pain, Urticaria
Clinical narrative: Information has been received from a physician concerning a 9 year old female patient who on 22-DEC-2008 was vaccinated with the second dose of GARDASIL.  On 31-DEC-2008 the patient experienced red hives on inner thigh and feet.  On 02-JAN-2009 the patient also experienced severe pain in her armpits that moved to the neck and jaw.  Pain intensified in her neck, jaw and lips and moved to the back.  The physician mentioned that the symptoms resembled Kawasaki disease on a lower scale.  At the time of this report, the adverse events persisted.  The patient sought unspecified medical attention.  Upon internal review, Kawasaki disease was determined to be an other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a registered nurse who reported that the one of her patient's mother reported that there was a female patient who was vaccinated with the third dose of GARDASIL (Lot and route unspecified) and three days later she had a seizure. The nurse reported that the patient was sent by ambulance to the hospital and was hospitalized (duration not reported). The nurse reported that the mother also mentioned that the patient, on an unspecified date, had kidney infection. It was unknown if the kidney infection occurred before the third dose of the vaccine or before of the GARDASIL. As of 13-JAN-2009 the outcome of the patient was unknown. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Convulsion, Kidney infection
Clinical narrative: Information has been received from a registered nurse who reported that the one of her patient's mother reported that there was a female patient who was vaccinated with the third dose of GARDASIL (Lot and route unspecified) and three days later she had a seizure. The nurse reported that the patient was sent by ambulance to the hospital and was hospitalized (duration not reported). The nurse reported that the mother also mentioned that the patient, on an unspecified date, had kidney infection. It was unknown if the kidney infection occurred before the third dose of the vaccine or before of the GARDASIL. As of 13-JAN-2009 the outcome of the patient was unknown. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Convulsion, Electrocardiogram, Electrocardiogram ambulatory, Electroencephalogram normal, Palpitations
Clinical narrative: Information has been received from a registered nurse who reported that the one of her patient's mother reported that there was a female patient who was vaccinated with the third dose of GARDASIL (Lot and route unspecified) and three days later she had a seizure. The nurse reported that the patient was sent by ambulance to the hospital and was hospitalized (duration not reported). The nurse reported that the mother also mentioned that the patient, on an unspecified date, had kidney infection. It was unknown if the kidney infection occurred before the third dose of the vaccine or before of the GARDASIL. As of 13-JAN-2009 the outcome of the patient was unknown. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Headache, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: 1/5/09 received DTAP, IPV, MMR,Volvox and flu 1/6/09 T100.3 1/7/09 0 fever 1/8/09 fever to  104 lasting 3 day associated with headache 1/11/09 blotchy pink rash on trunk last < 2 yo 1/12/09 Barely visible residual rash and febrile.
Age: 25.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis 24 hours after vaccination in left deltoid
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Influenza, Pain, Pyrexia
Clinical narrative: Vaccine injection 3:45p- woke up 9:45 pm same day-fever 102- aches all over body - had headache called doctor next day advised take 2 Tylenol and 3 hrs later, take 2 Ibprophren - alternate until fever gone - Nov 26-came down with bad case of flu .
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose abnormal, Colonoscopy, Dehydration, Diarrhoea, Disorientation
Clinical narrative: 10/07- Vomiting, Diarrhea Daily-No reason hospitalized for dehydration lost 30lbs.  Continued to be sick- Colonoscopy, MRI problems with Blood sugar 12/08- Fluid on knees, All over rash, dizzy and disoriented, UTI's  1/21/09 Received ER medical records of 4/08 through 1/9/2009. 4/30/08 Seen for rectal bleeding probably due to hemorrhoids or anal fissure.  Referred for colonoscopy.  6/25/08 ER visit for HA s/p struck on head accidentally by hand weight. CT scan WNL.  Stable & d/c to home. 9/15/08 ER for fever/chills, cough, diarrhea rash, stuffy nose, ear pain, sore throat.  Had recently been diagnosed w/diabetes & was on oral meds & BCP. 1/9/09 ER for tired, dizzy,numbness, shaking in knees & hands, burry vision, slurred speech.   Had cough, fever, chills, intermittent abd pain, chronic diarrhea. Dx w/mononucleosis.  1/23/09 Received ER medical records of 12/18/2008. FINAL DX: records reveal patient see for diarrhea x 2 weeks, mild dehydration.  Tx w/IVF & d/c to home.  2/2/09 Received ID & Immunology & Endocrine Clinic notes . Endocrine 9/30/2008 FINAL DX: hyperinsulinemia, oligomenorrhea likely POS, snoring, URI, abnormal weight gain Patient was on metformin at this time & checking blood sugars daily.    ID & Immunology 1/20/2009 FINAL DX: severe chronic progressive fatigue syndrome w/chronic diarrhea & abd pain & vomiting, chronic HA, orthostatic dizziness, peripheral neuropathy symptoms, large joint arthralgia, patchy alopecia, weakness, folate deficiency, ?hyperinsulinemia, slight buffalo hump w/elevated ACTH, glucose metabolism abnormality Records indicate patient had fatigue x 2 mo, constant HA & diarrhea, frequent abdominal discomfort, arthralgias large joint w/occasional swelling.  S/S present since 11/2007 following acute illness of vomiting & diarrhea requiring IVF.  Illness lasted approx 1 mo & pt lost 25#.  Since then had decreased energy & frequent URIs, academic decline, unable to participate in sports.  Patches of hair loss, numbness & tingling LEs, intermittent itchy rash.  Referred to Rheum & Endo in addition to further lab studies.  2/3/09 Received PCP medical records of 3/18/08-1/12/09. FINAL DX: Records reveal patient experienced depression, constipation, anal fissure, Depo-Provera contraception, weight gain, stretch marks, URI, pharyngitis, insulin resistance, dysuria, allergies, sinusitis, arthralgia, vomiting, diarrhea, dehydration, intermittent rash, chronic fatigue, pustular scalp lesions, recurrent infections, folate deficiency.  Tx w/antibiotics for RMSF & referred to ID
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Joint effusion, Rash generalised, Urinary tract infection, Vomiting
Clinical narrative: 10/07- Vomiting, Diarrhea Daily-No reason hospitalized for dehydration lost 30lbs.  Continued to be sick- Colonoscopy, MRI problems with Blood sugar 12/08- Fluid on knees, All over rash, dizzy and disoriented, UTI's  1/21/09 Received ER medical records of 4/08 through 1/9/2009. 4/30/08 Seen for rectal bleeding probably due to hemorrhoids or anal fissure.  Referred for colonoscopy.  6/25/08 ER visit for HA s/p struck on head accidentally by hand weight. CT scan WNL.  Stable & d/c to home. 9/15/08 ER for fever/chills, cough, diarrhea rash, stuffy nose, ear pain, sore throat.  Had recently been diagnosed w/diabetes & was on oral meds & BCP. 1/9/09 ER for tired, dizzy,numbness, shaking in knees & hands, burry vision, slurred speech.   Had cough, fever, chills, intermittent abd pain, chronic diarrhea. Dx w/mononucleosis.  1/23/09 Received ER medical records of 12/18/2008. FINAL DX: records reveal patient see for diarrhea x 2 weeks, mild dehydration.  Tx w/IVF & d/c to home.  2/2/09 Received ID & Immunology & Endocrine Clinic notes . Endocrine 9/30/2008 FINAL DX: hyperinsulinemia, oligomenorrhea likely POS, snoring, URI, abnormal weight gain Patient was on metformin at this time & checking blood sugars daily.    ID & Immunology 1/20/2009 FINAL DX: severe chronic progressive fatigue syndrome w/chronic diarrhea & abd pain & vomiting, chronic HA, orthostatic dizziness, peripheral neuropathy symptoms, large joint arthralgia, patchy alopecia, weakness, folate deficiency, ?hyperinsulinemia, slight buffalo hump w/elevated ACTH, glucose metabolism abnormality Records indicate patient had fatigue x 2 mo, constant HA & diarrhea, frequent abdominal discomfort, arthralgias large joint w/occasional swelling.  S/S present since 11/2007 following acute illness of vomiting & diarrhea requiring IVF.  Illness lasted approx 1 mo & pt lost 25#.  Since then had decreased energy & frequent URIs, academic decline, unable to participate in sports.  Patches of hair loss, numbness & tingling LEs, intermittent itchy rash.  Referred to Rheum & Endo in addition to further lab studies.  2/3/09 Received PCP medical records of 3/18/08-1/12/09. FINAL DX: Records reveal patient experienced depression, constipation, anal fissure, Depo-Provera contraception, weight gain, stretch marks, URI, pharyngitis, insulin resistance, dysuria, allergies, sinusitis, arthralgia, vomiting, diarrhea, dehydration, intermittent rash, chronic fatigue, pustular scalp lesions, recurrent infections, folate deficiency.  Tx w/antibiotics for RMSF & referred to ID
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Weight decreased
Clinical narrative: 10/07- Vomiting, Diarrhea Daily-No reason hospitalized for dehydration lost 30lbs.  Continued to be sick- Colonoscopy, MRI problems with Blood sugar 12/08- Fluid on knees, All over rash, dizzy and disoriented, UTI's  1/21/09 Received ER medical records of 4/08 through 1/9/2009. 4/30/08 Seen for rectal bleeding probably due to hemorrhoids or anal fissure.  Referred for colonoscopy.  6/25/08 ER visit for HA s/p struck on head accidentally by hand weight. CT scan WNL.  Stable & d/c to home. 9/15/08 ER for fever/chills, cough, diarrhea rash, stuffy nose, ear pain, sore throat.  Had recently been diagnosed w/diabetes & was on oral meds & BCP. 1/9/09 ER for tired, dizzy,numbness, shaking in knees & hands, burry vision, slurred speech.   Had cough, fever, chills, intermittent abd pain, chronic diarrhea. Dx w/mononucleosis.  1/23/09 Received ER medical records of 12/18/2008. FINAL DX: records reveal patient see for diarrhea x 2 weeks, mild dehydration.  Tx w/IVF & d/c to home.  2/2/09 Received ID & Immunology & Endocrine Clinic notes . Endocrine 9/30/2008 FINAL DX: hyperinsulinemia, oligomenorrhea likely POS, snoring, URI, abnormal weight gain Patient was on metformin at this time & checking blood sugars daily.    ID & Immunology 1/20/2009 FINAL DX: severe chronic progressive fatigue syndrome w/chronic diarrhea & abd pain & vomiting, chronic HA, orthostatic dizziness, peripheral neuropathy symptoms, large joint arthralgia, patchy alopecia, weakness, folate deficiency, ?hyperinsulinemia, slight buffalo hump w/elevated ACTH, glucose metabolism abnormality Records indicate patient had fatigue x 2 mo, constant HA & diarrhea, frequent abdominal discomfort, arthralgias large joint w/occasional swelling.  S/S present since 11/2007 following acute illness of vomiting & diarrhea requiring IVF.  Illness lasted approx 1 mo & pt lost 25#.  Since then had decreased energy & frequent URIs, academic decline, unable to participate in sports.  Patches of hair loss, numbness & tingling LEs, intermittent itchy rash.  Referred to Rheum & Endo in addition to further lab studies.  2/3/09 Received PCP medical records of 3/18/08-1/12/09. FINAL DX: Records reveal patient experienced depression, constipation, anal fissure, Depo-Provera contraception, weight gain, stretch marks, URI, pharyngitis, insulin resistance, dysuria, allergies, sinusitis, arthralgia, vomiting, diarrhea, dehydration, intermittent rash, chronic fatigue, pustular scalp lesions, recurrent infections, folate deficiency.  Tx w/antibiotics for RMSF & referred to ID
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose abnormal, Colonoscopy normal, Dehydration, Disorientation, Dizziness
Clinical narrative: 10/07- Vomiting, Diarrhea Daily-No reason hospitalized for dehydration lost 30lbs.  Continued to be sick- Colonoscopy, MRI problems with Blood sugar 12/08- Fluid on knees, All over rash, dizzy and disoriented, UTI's  1/21/09 Received ER medical records of 4/08 through 1/9/2009. 4/30/08 Seen for rectal bleeding probably due to hemorrhoids or anal fissure.  Referred for colonoscopy.  6/25/08 ER visit for HA s/p struck on head accidentally by hand weight. CT scan WNL.  Stable & d/c to home. 9/15/08 ER for fever/chills, cough, diarrhea rash, stuffy nose, ear pain, sore throat.  Had recently been diagnosed w/diabetes & was on oral meds & BCP. 1/9/09 ER for tired, dizzy,numbness, shaking in knees & hands, burry vision, slurred speech.   Had cough, fever, chills, intermittent abd pain, chronic diarrhea. Dx w/mononucleosis.  1/23/09 Received ER medical records of 12/18/2008. FINAL DX: records reveal patient see for diarrhea x 2 weeks, mild dehydration.  Tx w/IVF & d/c to home.  2/2/09 Received ID & Immunology & Endocrine Clinic notes . Endocrine 9/30/2008 FINAL DX: hyperinsulinemia, oligomenorrhea likely POS, snoring, URI, abnormal weight gain Patient was on metformin at this time & checking blood sugars daily.    ID & Immunology 1/20/2009 FINAL DX: severe chronic progressive fatigue syndrome w/chronic diarrhea & abd pain & vomiting, chronic HA, orthostatic dizziness, peripheral neuropathy symptoms, large joint arthralgia, patchy alopecia, weakness, folate deficiency, ?hyperinsulinemia, slight buffalo hump w/elevated ACTH, glucose metabolism abnormality Records indicate patient had fatigue x 2 mo, constant HA & diarrhea, frequent abdominal discomfort, arthralgias large joint w/occasional swelling.  S/S present since 11/2007 following acute illness of vomiting & diarrhea requiring IVF.  Illness lasted approx 1 mo & pt lost 25#.  Since then had decreased energy & frequent URIs, academic decline, unable to participate in sports.  Patches of hair loss, numbness & tingling LEs, intermittent itchy rash.  Referred to Rheum & Endo in addition to further lab studies.  2/3/09 Received PCP medical records of 3/18/08-1/12/09. FINAL DX: Records reveal patient experienced depression, constipation, anal fissure, Depo-Provera contraception, weight gain, stretch marks, URI, pharyngitis, insulin resistance, dysuria, allergies, sinusitis, arthralgia, vomiting, diarrhea, dehydration, intermittent rash, chronic fatigue, pustular scalp lesions, recurrent infections, folate deficiency.  Tx w/antibiotics for RMSF & referred to ID
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Pathology test, Rash, Urinary tract infection, Vomiting
Clinical narrative: 10/07- Vomiting, Diarrhea Daily-No reason hospitalized for dehydration lost 30lbs.  Continued to be sick- Colonoscopy, MRI problems with Blood sugar 12/08- Fluid on knees, All over rash, dizzy and disoriented, UTI's  1/21/09 Received ER medical records of 4/08 through 1/9/2009. 4/30/08 Seen for rectal bleeding probably due to hemorrhoids or anal fissure.  Referred for colonoscopy.  6/25/08 ER visit for HA s/p struck on head accidentally by hand weight. CT scan WNL.  Stable & d/c to home. 9/15/08 ER for fever/chills, cough, diarrhea rash, stuffy nose, ear pain, sore throat.  Had recently been diagnosed w/diabetes & was on oral meds & BCP. 1/9/09 ER for tired, dizzy,numbness, shaking in knees & hands, burry vision, slurred speech.   Had cough, fever, chills, intermittent abd pain, chronic diarrhea. Dx w/mononucleosis.  1/23/09 Received ER medical records of 12/18/2008. FINAL DX: records reveal patient see for diarrhea x 2 weeks, mild dehydration.  Tx w/IVF & d/c to home.  2/2/09 Received ID & Immunology & Endocrine Clinic notes . Endocrine 9/30/2008 FINAL DX: hyperinsulinemia, oligomenorrhea likely POS, snoring, URI, abnormal weight gain Patient was on metformin at this time & checking blood sugars daily.    ID & Immunology 1/20/2009 FINAL DX: severe chronic progressive fatigue syndrome w/chronic diarrhea & abd pain & vomiting, chronic HA, orthostatic dizziness, peripheral neuropathy symptoms, large joint arthralgia, patchy alopecia, weakness, folate deficiency, ?hyperinsulinemia, slight buffalo hump w/elevated ACTH, glucose metabolism abnormality Records indicate patient had fatigue x 2 mo, constant HA & diarrhea, frequent abdominal discomfort, arthralgias large joint w/occasional swelling.  S/S present since 11/2007 following acute illness of vomiting & diarrhea requiring IVF.  Illness lasted approx 1 mo & pt lost 25#.  Since then had decreased energy & frequent URIs, academic decline, unable to participate in sports.  Patches of hair loss, numbness & tingling LEs, intermittent itchy rash.  Referred to Rheum & Endo in addition to further lab studies.  2/3/09 Received PCP medical records of 3/18/08-1/12/09. FINAL DX: Records reveal patient experienced depression, constipation, anal fissure, Depo-Provera contraception, weight gain, stretch marks, URI, pharyngitis, insulin resistance, dysuria, allergies, sinusitis, arthralgia, vomiting, diarrhea, dehydration, intermittent rash, chronic fatigue, pustular scalp lesions, recurrent infections, folate deficiency.  Tx w/antibiotics for RMSF & referred to ID
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: Within 24 hours of HPV dose given on 08/27/2008 - Had rash over trunk of body, Lasting 3 days did not seek medical attention. Within 24 hrs after 6/25/2008 vaccinations- had high fever, muscle aches 3-5 days, did not seek medical attention.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site erythema, Injection site pruritus, Nausea, Pruritus
Clinical narrative: 1/9/09 0830 Pt. called to report that she had a rapid heart rate which started approximately 1/2 hr after receiving the vaccine and lasted for approximately 2hrs. Around 7pm that evening she felt nauseated and felt itchy on her face and arms. The vaccination site became red and itchy with 2 red areas about the diameter of a half dollar. She feels better today 1/9/09 but still feels itchy on her arms and face with a little nausea. Advised her to contact her PMD.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: patient developed a 1"x1 1/2" induration that is red and warm where an ADACEL injection was given.
Age: 0.1
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Culture stool negative, Haematochezia, Mucous stools
Clinical narrative: Bloody, mucousy stools after ROTATEQ vaccine x 2 weeks.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 24 hrs after UMM placed erythema, tenderness and warmth occurred- 9cm X 6 cm oral paten, resolving after 2 more days. At visit 5 days later paten of  non- raised pink skin 6X 5cm, Now NT
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Child received PEDIARIX/PREVNAR 1/09/2009 at 09:25 per / LPN- 1/10/2009 Mon report swelling, redness at site and thigh swollen 1/12/09 "doing better"
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Started 10-15 min after getting vaccines small white raised bumps. Lasted about 3 weeks itching 0 treatment
Age: 62.0
Sex: U
Vaccine: TD
Symptoms: Injection site mass
Clinical narrative: Large lump- size of "grape" in arm - where shot administered for one week - then thereafter, remains a lump "pea" size in upper left arm.
Age: 0.2
Sex: F
Vaccine: HBHEPB
Symptoms: Injection site erythema, Irritability, Somnolence, Stomach discomfort, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 8 week old daughter who on 11-DEC-2007 was vaccinated with a dose of COMVAX (Lot # not mentioned).  The reporter reported that  after her daughter had her injection the injection site had a red welt at the injection site.  Her daughter was irritable, sleeping more and had upset stomach.  A telephone call was made to get more information.  No other information was available at the time of this report.  Unspecified medical attention was sought.  The patient had not recovered.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a friend of the family's child who on an unspecified date was vaccinated with MMR II, and developed autism. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Bronchospasm, Ocular hyperaemia, Rash
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient with no pertinent medical history and no known drug allergy who on 07-JAN-2009 was vaccinated with the first IM dose of GARDASIL (lot # 659184/0843X).  Concomitant therapy included hormonal contraceptives (unspecified).  On 07-JAN-2009 the patient experienced redness of the eye, bronchospasms and rash pennciallian.  The patient went to ER (it was not known if the patient was admitted).  At the time of this report, the physician stated that the patient was fine.  Redness of the eye, bronchospasms and rash pennciallian were considered to be immediately life-threatening.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blood creatine phosphokinase increased, Fibromyalgia, Insomnia, Pain
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no previous medical, family, or social history who on 19-NOV-2007 was vaccinated with a first dose of GARDASIL IM. The patient's mother told the physician that a few weeks after the GARDASIL, the patient had body aches and generalized pain. The patient was seen by her pediatrician and a neurologist, and they both thought that it was from GARDASIL. The neurologist had diagnosed the patient with fibromyalgia. CPK was elevated. At the time of reporting, the patient was being treated with cyclobenzapine hydrochloride (MSD), melatonin, imipramine, and chiropractic therapy for the pain and insomnia. The patient has missed many days from school and volleyball because of the fibromyalgia. At the time of reporting, fibromyalgia persisted. The reporter considered fibromyalgia to be disabling. Additional information has been requested.  1/29/09-According to the general practitioner, fibromyalgia persisted while insomnia was being controlled on medication (not recovered).Onset Date: Approximately December 2007 ("a few weeks after Gardasil", per pt's mother) 2/17/09-records received for DOS 7/23/08-neurology notes-C/O muscle aches and pains as well as sleep disturbance. Previously evaluated on 5/12/08, continues with pain on an almost daily basis. However no discomfort in past few days. Impression:history of severe pain in legs and arms and along cervical spine. Sleep disturbance resolved with use of Seroquel. No neurological cause of pain. No rheumatology consult at this time due to insurance issues.
Age: 19.0
Sex: F
Vaccine: DTAP, HPV4, MEN
Symptoms: Convulsion, Dizziness, Feeling hot, Loss of consciousness
Clinical narrative: Information has been received from a health professional concerning a 19 year old female patient who on 17-DEC-2008 was vaccinated with the first dose of GARDASIL IM into her right arm (lot # 661766/0652X). On 17-DEC-2008 the patient also received MENACTRA and Tdap in her left upper arm. On 17-DEC-2008 ("a few seconds later") the patient experienced convulsed and passed out. The patient stated that she didn't feel funny after the first two shots. When she received GARDASIL she felt a rush of warmth in her arm then she experienced lightheaded and blacked out. At the time of reporting, the patient had recovered. It is unknown if the patient sought medical attention. Upon internal review, convulsed was determined to be an other important medical event. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Encephalitis viral, Mental status changes, Pyrexia, Viral DNA test positive
Clinical narrative: Information has been received from a physician and a hospital medical librarian concerning a 59 year old female who on 30-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# not provided).  On 01-JAN-2009 the patient developed fever, joint aches, and mental status changes.  The patient was admitted to the hospital.  She was subsequently diagnosed with viral encephalitis.  The physician stated that the patient's cerebral spinal fluid had been sent for varicella zoster virus identification polymerase chain reaction testing and it came back positive for varicella zoster virus.  Some of the spinal fluid was still frozen and kept in the freezer if further test needed to be done.  The patient's viral encephalitis persisted.  Additional information has been requested. 2/3/09-records received for DOS 1/8-1/9/09 DC DX: Viral meningeal encephalitis unknown etiology. Mental status changes and fever secondary to #1. Fever resolved, and mental status changes improved. Admitted for evalutaion of one week of fevers, joint aches and 2-3 days increasing mental changes with word finding difficulties, confusion and balance issues.On 1/1/09 fevers, chilling, arthralgias migratory fashion.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Encephalitis viral
Clinical narrative: Information has been received from a physician and a hospital medical librarian concerning a 59 year old female who on 30-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# not provided).  On 01-JAN-2009 the patient developed fever, joint aches, and mental status changes.  The patient was admitted to the hospital.  She was subsequently diagnosed with viral encephalitis.  The physician stated that the patient's cerebral spinal fluid had been sent for varicella zoster virus identification polymerase chain reaction testing and it came back positive for varicella zoster virus.  Some of the spinal fluid was still frozen and kept in the freezer if further test needed to be done.  The patient's viral encephalitis persisted.  Additional information has been requested. 2/3/09-records received for DOS 1/8-1/9/09 DC DX: Viral meningeal encephalitis unknown etiology. Mental status changes and fever secondary to #1. Fever resolved, and mental status changes improved. Admitted for evalutaion of one week of fevers, joint aches and 2-3 days increasing mental changes with word finding difficulties, confusion and balance issues.On 1/1/09 fevers, chilling, arthralgias migratory fashion.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Encephalitis viral, Mental status changes, Pyrexia, Viral DNA test positive
Clinical narrative: Was informed by physician office that pt had been hospitalized for viral encephalitis and onset of symptoms was 2 days post vaccination
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Encephalitis viral
Clinical narrative: Was informed by physician office that pt had been hospitalized for viral encephalitis and onset of symptoms was 2 days post vaccination
Sex: F
Vaccine: VARCEL
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a female who was vaccinated with VARIVAX (Merck). It was reported that the patient was tested for chickenpox titers and there was no sign of them so the physician started VARIVAX (Merck) series. Then the patient became pregnant around the time she received the second dose of VARIVAX (Merck). No further adverse event information provided. Follow-up information was received from the physician who reported that the patient elected to terminate the pregnancy. No details were provided. Upon internal review, the elective abortion was considered to be other important medical event. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Hemiparesis, Muscular weakness
Clinical narrative: Within 30 minutes of vaccination to the left upper arm, patient felt weakness in right side (muscular and joint) from right hip to knee; weakness lasted 45 min to an hour.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: The patient presented with swelling and redness on upper arm approx 2 inches from injection site 1 day post-injection.  Her upper arm was hot and painful to touch, and she report she was ill the night of the injection with a temperature, aches, runny nose, and sore throat.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Rhinorrhoea, Skin warm, Swelling
Clinical narrative: The patient presented with swelling and redness on upper arm approx 2 inches from injection site 1 day post-injection.  Her upper arm was hot and painful to touch, and she report she was ill the night of the injection with a temperature, aches, runny nose, and sore throat.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Lymphadenopathy, Oedema peripheral, Pyrexia
Clinical narrative: Patient presented with cellulitis of right arm associated with swelling and axillary lymphadeopathy.  Patient reported fever, chills at home.
Age: 24.0
Sex: F
Vaccine: DTPIPV
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: I HAD SEVERE PAIN AT THE SITE OF INJETION FROM 1/13/09(DAY OF VACCINATION) TO 1/14/09...MORE THAN 36 HRS....WITH SITE (LEFT DELTOID)PAIN , I HAD MODERATE TO SEVERE HEAD ACHE AND WHOLE BODY PAIN. I HAD TO STAY HOME 1/14/09 ALL DAY TOOK TYLENOL EVERY 4 HRS. WENT TO SLEEP 1/14 FELT MUCH BETTER ON 1/15/09. VACCINE MANUFACTURER: sanofi pasteur
Age: 1.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Patient had a rash on the thighs and face.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Abdominal pain upper
Clinical narrative: Abdominal pain/stomach cramps for 2 hours. No treatment given.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Disorientation, Thinking abnormal
Clinical narrative: Was disoriented, unable to answer questions appropriately for 45 minutes. Went to ER and was seen by triage nurse, then symptoms resolved and patient was sent home without any testing or treatment.
Age: 5.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: PT RECEIVED EXPIRED FLUMIST LOT 500548P EXP DATE 12/18/2008.  NO REPORTED ADVERSE EVENTS TO DATE OF COMPLETING REPORT.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test negative, Eye swelling, Rash
Clinical narrative: Reported rash & periorbital swelling beginning 11/6/08 - Adverse reaction reported to Employee Health on 11/7/08 - referred to Nurse Practitioner at the Employee Care Center - Rx for Medrol Dose pack & Benadryl. F/U appt. with Dr. 11/10/08 Rx: Prednisone 20 mg qd X 7 days.  Reevaluated 11/17/08 & Prednisone 10 mg 6 additional tablets Rx for tapering. Referral to allergist, who thought it might be thimerosol or latex reaction.  Insert supplied and product identified as preservative and latex free.  1/5/09 Patch testing for several likely allergens conducted by Dr. Results were negative for all patch tests.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Pain, Paraesthesia
Clinical narrative: Patient reported burning and stinging in her hand starting several hours after she received the vaccine on 12/30/2008. The next day she said that the symptoms were less bothersome but still occurred periodically. On 1/16/2009 she reported the symptoms occurred less frequently, but added that she felt a tingling in her elbow and sometimes in her hand. She experiences the tingling in her right arm mostly after holding heavy items such as her books across her college campus. NOTE: this is her first MMR, she had the Measles disease as a child, and received the Rubella and Mumps vaccines in separate shots.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Local reaction, Rash generalised
Clinical narrative: Pt experienced large local reaction as well as a "rash all over".
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient came to clinic today and presented with a possible reaction to the flu vaccine. The flu shot was administered on October 9, 2008. The patient had a quarter sized, red, swollen area on right upper arm at site of injection. Patient stated that her arm had been like this since she recieved her flu shot in October.
Age: 0.17
Sex: F
Vaccine: PNC, RV5
Symptoms: Decreased appetite, Diarrhoea, Irritability
Clinical narrative: Patient developed watery diarrhea 1/2/09. The diarrhea lastd until 1/6/09. Patient also developed irritability and a decrease in appetite.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Body temperature, Chest X-ray normal, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Patient came to Health Center at 12:06 pm on 1/16/09, 9 days after injections.  Stated "prolonged hard lump on my right arm where I got the pneumonia shot.  Lump is smaller now than it has been.  Edges of lump are itchy. Area is still red. Now I also have a rash, mostly on my chest".  Temp - 98.0 F; Pulse - 72; Resp - 20; B/P - 118/72. 3 cm firm lump at injection site, erythema at site, no drainage. Urticaria chest area only. Patient seen by FNP, for further evaluation and treatment.  Local reaction improving over time. Rash probably not related to adverse reaction, however, included in possible reported symptoms.  Patient agreed to apply heat to area, benedryl PRN, bactrim for delayed reaction if worsening in size, heat, tenderness or redness.  Prescriptions written for prednisone 10 mg: 2 tabs today and tomorrow, then one daily until gone; #10 and bactrim DS 800-160; 1 tab q 12 hours; #20. Follow up PRN.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pruritus, Local reaction, Rash, Urticaria
Clinical narrative: Patient came to Health Center at 12:06 pm on 1/16/09, 9 days after injections.  Stated "prolonged hard lump on my right arm where I got the pneumonia shot.  Lump is smaller now than it has been.  Edges of lump are itchy. Area is still red. Now I also have a rash, mostly on my chest".  Temp - 98.0 F; Pulse - 72; Resp - 20; B/P - 118/72. 3 cm firm lump at injection site, erythema at site, no drainage. Urticaria chest area only. Patient seen by FNP, for further evaluation and treatment.  Local reaction improving over time. Rash probably not related to adverse reaction, however, included in possible reported symptoms.  Patient agreed to apply heat to area, benedryl PRN, bactrim for delayed reaction if worsening in size, heat, tenderness or redness.  Prescriptions written for prednisone 10 mg: 2 tabs today and tomorrow, then one daily until gone; #10 and bactrim DS 800-160; 1 tab q 12 hours; #20. Follow up PRN.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Mass, Rash
Clinical narrative: Patient came to Health Center at 12:06 pm on 1/16/09, 9 days after injections.  Stated "prolonged hard lump on my right arm where I got the pneumonia shot.  Lump is smaller now than it has been.  Edges of lump are itchy. Area is still red. Now I also have a rash, mostly on my chest".  Temp - 98.0 F; Pulse - 72; Resp - 20; B/P - 118/72. 3 cm firm lump at injection site, erythema at site, no drainage. Urticaria chest area only. Patient seen by FNP, for further evaluation and treatment.  Local reaction improving over time. Rash probably not related to adverse reaction, however, included in possible reported symptoms.  Patient agreed to apply heat to area, benedryl PRN, bactrim for delayed reaction if worsening in size, heat, tenderness or redness.  Prescriptions written for prednisone 10 mg: 2 tabs today and tomorrow, then one daily until gone; #10 and bactrim DS 800-160; 1 tab q 12 hours; #20. Follow up PRN.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Eye pruritus, Eye swelling
Clinical narrative: eyes itching, tightness in chest, cough, swelling around his eyes and a bit of difficulty breathing. It was about 4 hours after the shot.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Had 1st HPV on November 4th, 2008.  she stated she didn't know she was pregnant.  Had a miscarrieage in December. (Came in today becase she is due her 2nd dose.)
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Blood bicarbonate decreased, Convulsion, Full blood count normal, Nuclear magnetic resonance imaging normal, Toxicologic test normal
Clinical narrative: Patient had an afebrile seizure event lasting 2-3 minutes the evening after receiving influenza A and Hepatitis A vaccine at her PMDs on 1/14/09.  She was seen in the ED and sent home.  She had 4 more recurrent seizures, all lasting less than 5 minutes over the next 24 hours.  She was admitted to to the pediatric ward and underwent testing which showed a normal MRI.  She was started on leviteracitam and D/C'd home.  No abnormalities or source of seizures were identified, however, given the timing of the vaccines, a report was submitted. 2/17/09-records received for DOS 1/15/09-C/O fall from chair, hit head, eyes rolled up to back of her head, tonic-clonic movements. Presented to ED . At home had two more seizures the next day, crying hard before each seizure. Seen in ED and observed overnight.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Urine analysis normal
Clinical narrative: Patient had an afebrile seizure event lasting 2-3 minutes the evening after receiving influenza A and Hepatitis A vaccine at her PMDs on 1/14/09.  She was seen in the ED and sent home.  She had 4 more recurrent seizures, all lasting less than 5 minutes over the next 24 hours.  She was admitted to to the pediatric ward and underwent testing which showed a normal MRI.  She was started on leviteracitam and D/C'd home.  No abnormalities or source of seizures were identified, however, given the timing of the vaccines, a report was submitted. 2/17/09-records received for DOS 1/15/09-C/O fall from chair, hit head, eyes rolled up to back of her head, tonic-clonic movements. Presented to ED . At home had two more seizures the next day, crying hard before each seizure. Seen in ED and observed overnight.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fever, body aches, chills, dizziness
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism, Convulsion, Pyrexia
Clinical narrative: Information has been received from a consumer concerning a 13 month old male with no medical history or drug allergy who on 05-JUN-2006 was vaccinated with MMR II (lot # 649829/0376R). Suspect therapy included VARIVAX (lot # 652665/1025R). On 05-JUN-2006 the patient experienced seizure and fever. The patient recovered from seizure and fever on 06-JUN-2006. She also reported that the patient was diagnosed with autism when the patient was 19 months old. The patient did not perform any lab diagnostics studies. The patient still had the autism. The physician saw the patient. Upon internal review the patient's seizure and autism were both determined to be other important medical events. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Diarrhoea
Clinical narrative: Information has been received from a pharmacist concerning a 90 year old female patient who was vaccinated with a dose of ZOSTAVAX (lot# not provided). On 25-DEC-2008 the patient developed diarrhea and was admitted to the hospital for the diarrhea. At the time of the report the patient may still have been hospitalized. Follow up information received from the pharmacist who reported that the doctors determined that diarrhea resulted from bacterial infection and not from administration of ZOSTAVAX (Merck), given on 16-DEC-2008 subcutaneously. Patient was treated with antibiotics and then released approximately 3 days later. The pharmacists talked to the care giver to see how the patient was feeling and the care giver told him that the diarrhea could have also come from long term use of ulcer medicine, which in turn destroyed the "good" bacteria needed for digestion. She was "doing as good as expected" and it was determined that there were no ill effects from vaccination with ZOSTAVAX. On an unspecified date, the patient recovered. No further information is available.
Sex: F
Vaccine: PNC
Symptoms: Developmental delay
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a consumer regarding a female patient who experienced developmental delays. The patient received a dose on an unspecified date. Additional suspect medication included HIBTITER. The patient experienced developmental delays on an unspecified date. The child is now 7 years old. No further information was provided.
Age: 48.0
Sex: M
Vaccine: LYME
Symptoms: Asthenia, Impaired work ability, Mobility decreased, Musculoskeletal pain, Night sweats
Clinical narrative: This case was reported by a lawyer and described the occurrence of arm pain in a 48-year-old male subject who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. According to an interview between the subject and attorney(s), on 13 May 1999 or 14 May 1999, the subject received 1st dose of LYMERIX (unknown). On 14 June 1999, 1 month after vaccination with LYMERIX, the subject presented for his second dose of LYMERIX and reported progressively worsening arm pain. The arm pain subsequently became "debilitating", and he presented to the emergency room. Treatment included Oxycodone, and he was prescribed a "hand splint to keep his arm from curling in". He reported that the pain subsequently spread to his entire body including the neck, back and shoulders. He was out of work due to pain until September 1999. Additional problems included night sweats, difficulty opening his hand, cold intolerance in his left arm and hand, and occasional shoulder pain. At the time of reporting the events were unresolved.
Age: 48.0
Sex: M
Vaccine: LYME
Symptoms: Pain, Pain in extremity, Temperature intolerance
Clinical narrative: This case was reported by a lawyer and described the occurrence of arm pain in a 48-year-old male subject who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. According to an interview between the subject and attorney(s), on 13 May 1999 or 14 May 1999, the subject received 1st dose of LYMERIX (unknown). On 14 June 1999, 1 month after vaccination with LYMERIX, the subject presented for his second dose of LYMERIX and reported progressively worsening arm pain. The arm pain subsequently became "debilitating", and he presented to the emergency room. Treatment included Oxycodone, and he was prescribed a "hand splint to keep his arm from curling in". He reported that the pain subsequently spread to his entire body including the neck, back and shoulders. He was out of work due to pain until September 1999. Additional problems included night sweats, difficulty opening his hand, cold intolerance in his left arm and hand, and occasional shoulder pain. At the time of reporting the events were unresolved.
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthralgia, Autoimmune disorder, Cognitive disorder, Deep vein thrombosis
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced joint pain, stiffness, headaches, flu-like symptoms, fatigue, tingling in extremities, vision problems, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMERIX. 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 12 January 2009 via medical records. The subject received his first, second, and third doses of LYMERIX all in 2001. A few months after the second or third dose of LYMERIX. He developed skin rashes, shoulder pain, and tingling and numbness in the fingers and hands that subsequently progressed. In 2002 or 2003 he developed headaches. In 2003 or 2004 he developed leg cramps and deep vein thrombosis. In 2003, 2004, or 2005 he experienced fatigue and poor sleep. In 2005 or 2006 he experienced "black-outs". On an unknown date (possibly prior to LYMERIX vaccination), he developed an "intravenal occlusion of retina in both eyes". Treatment included anti-fungal/anti-bacterial creams and COUMADIN. With the exception of the skin rashes, headaches, and black-outs, the events were unresolved at the time of this report. The subject reported that "one eye has cleared up" and that the right eye was back to 20/20 vision, while the left eye remained blurry. The events of deep vein thrombosis and black-outs were assessed to be medically significant by GSK.