chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Somnolence, Unresponsive to stimuli
Clinical narrative: Approximately 30-60 min after vaccines given pt became unresponsive x 10 min. No cyanosis, was breathing, but did not move or resp. to stimuli. For next 20 min, pt sleepy. After 30 min, pt was back to baseline. Pt referred to ER. NL exam. No testing done.
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Chills, Pyrexia
Clinical narrative: Patient states he had fever and chills beginning the night he had the vaccine and lasting through 7/9/08.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Erythema, Nausea, Oxygen saturation decreased, Urticaria
Clinical narrative: Child began coughing after leaving office.  Became nauseous & arm became red.  Mom brought back to office.  Pulse ox 92%, pt wheezing.  Urticaria shoulder to elbow on L.  Given 30mg PRELONE, 25mg BENADRYL, & 0.5ml albuterol per MD.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Wheezing
Clinical narrative: Child began coughing after leaving office.  Became nauseous & arm became red.  Mom brought back to office.  Pulse ox 92%, pt wheezing.  Urticaria shoulder to elbow on L.  Given 30mg PRELONE, 25mg BENADRYL, & 0.5ml albuterol per MD.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Vaccine given 7/9.  On 7/10, at around 3PM, (26 hours later) - swelling, redness from shoulder to elbow on left.  Swelling twice the size of other arm.  Given Benadryl x 3, Onapred BID x 3d.
Age: 65.0
Sex: M
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: Given Td booster at 1:30pm Thursday.  Whole arm began throbbing approximately 50 hours later and has been constant since.  Neuro exam normal, pain controlled with tramadol!  T3.
Age: 1.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Erythema multiforme, Pyrexia, Rash generalised
Clinical narrative: Fever - rash all over the body, especially arms, legs, torso.  Rash was raised with target lesions, some coalescent, with color changing from slight pink to purplish.  Erythema multiforme.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Oedema peripheral, Pain
Clinical narrative: Mom presented on 7/22/08 concerned about right arm swelling over deltoid for child.  Some pain initially, but had resolved at presenting.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Patient presented to hospital on 7/22/08 with complaints of vomiting and diarrhea, temp 99.9 x 2 days.  Patient received Rotavirus vaccine on 7/18/08 at hospital, on 7/22/08 diagnosed with Rotavirus reaction vs viral, no treatment given.
Age: 5.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Cough, Flushing, Immediate post-injection reaction, Nasal congestion, Ocular hyperaemia
Clinical narrative: Within a few minutes of getting (MMR, IPV and VARIVAX) immunization, patient began coughing, flushed from head to toe then eyes red, nasal congestion.  Benadryl 1 1/2 tsp given.  Coughing increased, nasal congestion increased, scratching head vigorously.  Paramedics called.  Taken to ER.  08/18/2008 MR received for DOS 6/26-27/2008 with D/C DX: Anaphylaxis.  pt presented by ambulance from PCPs office after receiving vaccines. Pt developed lip swelling, rash, cough, congestion and itching within 1 minute of receiving MMR. Pt was walking and became limp and slumped over. Pt wheezing per parent.  Given Epi and Benadryl in office. In ER pt had mildly erythematous throat, erytema of cheeks, chin and ears. Vomited x 1 in ER.  Given albuterol neb, Solumedrol and Zantac IV. Quickly weaned to room air. No further event o/n and d/c home.
Age: 5.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Pruritus
Clinical narrative: Within a few minutes of getting (MMR, IPV and VARIVAX) immunization, patient began coughing, flushed from head to toe then eyes red, nasal congestion.  Benadryl 1 1/2 tsp given.  Coughing increased, nasal congestion increased, scratching head vigorously.  Paramedics called.  Taken to ER.  08/18/2008 MR received for DOS 6/26-27/2008 with D/C DX: Anaphylaxis.  pt presented by ambulance from PCPs office after receiving vaccines. Pt developed lip swelling, rash, cough, congestion and itching within 1 minute of receiving MMR. Pt was walking and became limp and slumped over. Pt wheezing per parent.  Given Epi and Benadryl in office. In ER pt had mildly erythematous throat, erytema of cheeks, chin and ears. Vomited x 1 in ER.  Given albuterol neb, Solumedrol and Zantac IV. Quickly weaned to room air. No further event o/n and d/c home.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccines received in Rt. thigh on 7-18-08 at 3:29.  Ma called 7-21-08 at 3:40 to report entire Rt thigh red & swollen & Rt knee sl. swollen.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Agitation, Body temperature increased, Chapped lips, Conjunctival hyperaemia, Crying
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 4 month old female with a history of c-section at 37 weeks due to calcified placenta who on 21-Aug-2007 was vaccinated with the second dose of oral ROTATEQ (Lot # 657049/0503U). Concomitant therapy included the second dose of ACTHIB (SANOFI PASTEUR) (Lot # UF119AA), IM in the left leg, the second dose of PEDIARIX (GSK) (Lot # AC21B114CA), IM in the right leg and the second dose of PREVNAR (WYETH) (Lot # B47300F), IM in the left leg. On 01-Sep-2007 the patient experienced the onset of agitation, chapped lips, conjunctival hyperaemia, crying, diarrhoea, drug interolance, immunoglobulins, insomnia, irritability, Kawasaki's disease, oedema peripheral, pyrexia, rash, rhinorrhea, skin exfoliation, stomatitis and urinary tract infection and was hospitalized. On 10-Sep-2007, the patient went to the ER for a fever of 103, fussy, crying, decreased sleep and was diagnosed with a UTI and given BACTRIM. The patient went to the doctor's office on 03-Sep-2007 with a diagnosis of drug reaction vs. Early Stevens Johnson vs Kawasaki Disease. The patient was admitted to the hospital for 7 days and was diagnosed with Kawasaki, peeling hand, feet and nail bed. 02-Oct-2007 Reviewed hospital medical records which revealed the patient experienced rash, fever, runny nose, diarrhea, conjunctival injection, oral erythema, cracked lips, swollen hands and feet and fussiness. The patient was admitted from 03-Sep-2007 to 08-Sep-2007. The patient was seen in the ER for UTI and was given IM and oral antibiotic on 30-Aug-2007 and developed rash and fussiness on 01-Sep-2007. The patient returned to the ER for treatment with antibiotic, steroids and antihistamine and discharged to home. There was no response to treatment and was seen by PCP on 03-Sep-2007 who direct admitted the patient. Fever continued for five days. Dermatology and cardiology consults were done. The patient was treated w/IVIG and ASA and improved. She was discharged to home on continued ASA and with cardiac follow-up. Cardiology visit on 09-Oct-2007 revealed echocardiogram to be WNL. Final diagnosis included Kawasaki Disease. Agitation, chapped lips, conjunctival hyperaemia, crying, diarrhoea, drug interolance, immunoglobulins, insomnia, irritability, Kawasakis disease, oedema peripheral, pyrexia, rash, rhinorrhea, skin exfoliation, stomatitis and urinary tract infection were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 291606. A lot check has been requested. Lot check results: A standard lot check investigations was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. No further information is available.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Drug intolerance, Echocardiogram normal, Erythema, Hypersensitivity
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 4 month old female with a history of c-section at 37 weeks due to calcified placenta who on 21-Aug-2007 was vaccinated with the second dose of oral ROTATEQ (Lot # 657049/0503U). Concomitant therapy included the second dose of ACTHIB (SANOFI PASTEUR) (Lot # UF119AA), IM in the left leg, the second dose of PEDIARIX (GSK) (Lot # AC21B114CA), IM in the right leg and the second dose of PREVNAR (WYETH) (Lot # B47300F), IM in the left leg. On 01-Sep-2007 the patient experienced the onset of agitation, chapped lips, conjunctival hyperaemia, crying, diarrhoea, drug interolance, immunoglobulins, insomnia, irritability, Kawasaki's disease, oedema peripheral, pyrexia, rash, rhinorrhea, skin exfoliation, stomatitis and urinary tract infection and was hospitalized. On 10-Sep-2007, the patient went to the ER for a fever of 103, fussy, crying, decreased sleep and was diagnosed with a UTI and given BACTRIM. The patient went to the doctor's office on 03-Sep-2007 with a diagnosis of drug reaction vs. Early Stevens Johnson vs Kawasaki Disease. The patient was admitted to the hospital for 7 days and was diagnosed with Kawasaki, peeling hand, feet and nail bed. 02-Oct-2007 Reviewed hospital medical records which revealed the patient experienced rash, fever, runny nose, diarrhea, conjunctival injection, oral erythema, cracked lips, swollen hands and feet and fussiness. The patient was admitted from 03-Sep-2007 to 08-Sep-2007. The patient was seen in the ER for UTI and was given IM and oral antibiotic on 30-Aug-2007 and developed rash and fussiness on 01-Sep-2007. The patient returned to the ER for treatment with antibiotic, steroids and antihistamine and discharged to home. There was no response to treatment and was seen by PCP on 03-Sep-2007 who direct admitted the patient. Fever continued for five days. Dermatology and cardiology consults were done. The patient was treated w/IVIG and ASA and improved. She was discharged to home on continued ASA and with cardiac follow-up. Cardiology visit on 09-Oct-2007 revealed echocardiogram to be WNL. Final diagnosis included Kawasaki Disease. Agitation, chapped lips, conjunctival hyperaemia, crying, diarrhoea, drug interolance, immunoglobulins, insomnia, irritability, Kawasakis disease, oedema peripheral, pyrexia, rash, rhinorrhea, skin exfoliation, stomatitis and urinary tract infection were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 291606. A lot check has been requested. Lot check results: A standard lot check investigations was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. No further information is available.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Immunoglobulins, Insomnia, Irritability, Kawasaki's disease, Oedema peripheral
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 4 month old female with a history of c-section at 37 weeks due to calcified placenta who on 21-Aug-2007 was vaccinated with the second dose of oral ROTATEQ (Lot # 657049/0503U). Concomitant therapy included the second dose of ACTHIB (SANOFI PASTEUR) (Lot # UF119AA), IM in the left leg, the second dose of PEDIARIX (GSK) (Lot # AC21B114CA), IM in the right leg and the second dose of PREVNAR (WYETH) (Lot # B47300F), IM in the left leg. On 01-Sep-2007 the patient experienced the onset of agitation, chapped lips, conjunctival hyperaemia, crying, diarrhoea, drug interolance, immunoglobulins, insomnia, irritability, Kawasaki's disease, oedema peripheral, pyrexia, rash, rhinorrhea, skin exfoliation, stomatitis and urinary tract infection and was hospitalized. On 10-Sep-2007, the patient went to the ER for a fever of 103, fussy, crying, decreased sleep and was diagnosed with a UTI and given BACTRIM. The patient went to the doctor's office on 03-Sep-2007 with a diagnosis of drug reaction vs. Early Stevens Johnson vs Kawasaki Disease. The patient was admitted to the hospital for 7 days and was diagnosed with Kawasaki, peeling hand, feet and nail bed. 02-Oct-2007 Reviewed hospital medical records which revealed the patient experienced rash, fever, runny nose, diarrhea, conjunctival injection, oral erythema, cracked lips, swollen hands and feet and fussiness. The patient was admitted from 03-Sep-2007 to 08-Sep-2007. The patient was seen in the ER for UTI and was given IM and oral antibiotic on 30-Aug-2007 and developed rash and fussiness on 01-Sep-2007. The patient returned to the ER for treatment with antibiotic, steroids and antihistamine and discharged to home. There was no response to treatment and was seen by PCP on 03-Sep-2007 who direct admitted the patient. Fever continued for five days. Dermatology and cardiology consults were done. The patient was treated w/IVIG and ASA and improved. She was discharged to home on continued ASA and with cardiac follow-up. Cardiology visit on 09-Oct-2007 revealed echocardiogram to be WNL. Final diagnosis included Kawasaki Disease. Agitation, chapped lips, conjunctival hyperaemia, crying, diarrhoea, drug interolance, immunoglobulins, insomnia, irritability, Kawasakis disease, oedema peripheral, pyrexia, rash, rhinorrhea, skin exfoliation, stomatitis and urinary tract infection were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 291606. A lot check has been requested. Lot check results: A standard lot check investigations was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. No further information is available.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Pyrexia, Rash, Rhinorrhoea, Skin exfoliation, Stevens-Johnson syndrome
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 4 month old female with a history of c-section at 37 weeks due to calcified placenta who on 21-Aug-2007 was vaccinated with the second dose of oral ROTATEQ (Lot # 657049/0503U). Concomitant therapy included the second dose of ACTHIB (SANOFI PASTEUR) (Lot # UF119AA), IM in the left leg, the second dose of PEDIARIX (GSK) (Lot # AC21B114CA), IM in the right leg and the second dose of PREVNAR (WYETH) (Lot # B47300F), IM in the left leg. On 01-Sep-2007 the patient experienced the onset of agitation, chapped lips, conjunctival hyperaemia, crying, diarrhoea, drug interolance, immunoglobulins, insomnia, irritability, Kawasaki's disease, oedema peripheral, pyrexia, rash, rhinorrhea, skin exfoliation, stomatitis and urinary tract infection and was hospitalized. On 10-Sep-2007, the patient went to the ER for a fever of 103, fussy, crying, decreased sleep and was diagnosed with a UTI and given BACTRIM. The patient went to the doctor's office on 03-Sep-2007 with a diagnosis of drug reaction vs. Early Stevens Johnson vs Kawasaki Disease. The patient was admitted to the hospital for 7 days and was diagnosed with Kawasaki, peeling hand, feet and nail bed. 02-Oct-2007 Reviewed hospital medical records which revealed the patient experienced rash, fever, runny nose, diarrhea, conjunctival injection, oral erythema, cracked lips, swollen hands and feet and fussiness. The patient was admitted from 03-Sep-2007 to 08-Sep-2007. The patient was seen in the ER for UTI and was given IM and oral antibiotic on 30-Aug-2007 and developed rash and fussiness on 01-Sep-2007. The patient returned to the ER for treatment with antibiotic, steroids and antihistamine and discharged to home. There was no response to treatment and was seen by PCP on 03-Sep-2007 who direct admitted the patient. Fever continued for five days. Dermatology and cardiology consults were done. The patient was treated w/IVIG and ASA and improved. She was discharged to home on continued ASA and with cardiac follow-up. Cardiology visit on 09-Oct-2007 revealed echocardiogram to be WNL. Final diagnosis included Kawasaki Disease. Agitation, chapped lips, conjunctival hyperaemia, crying, diarrhoea, drug interolance, immunoglobulins, insomnia, irritability, Kawasakis disease, oedema peripheral, pyrexia, rash, rhinorrhea, skin exfoliation, stomatitis and urinary tract infection were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 291606. A lot check has been requested. Lot check results: A standard lot check investigations was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. No further information is available.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Stomatitis, Swelling, Urinary tract infection
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 4 month old female with a history of c-section at 37 weeks due to calcified placenta who on 21-Aug-2007 was vaccinated with the second dose of oral ROTATEQ (Lot # 657049/0503U). Concomitant therapy included the second dose of ACTHIB (SANOFI PASTEUR) (Lot # UF119AA), IM in the left leg, the second dose of PEDIARIX (GSK) (Lot # AC21B114CA), IM in the right leg and the second dose of PREVNAR (WYETH) (Lot # B47300F), IM in the left leg. On 01-Sep-2007 the patient experienced the onset of agitation, chapped lips, conjunctival hyperaemia, crying, diarrhoea, drug interolance, immunoglobulins, insomnia, irritability, Kawasaki's disease, oedema peripheral, pyrexia, rash, rhinorrhea, skin exfoliation, stomatitis and urinary tract infection and was hospitalized. On 10-Sep-2007, the patient went to the ER for a fever of 103, fussy, crying, decreased sleep and was diagnosed with a UTI and given BACTRIM. The patient went to the doctor's office on 03-Sep-2007 with a diagnosis of drug reaction vs. Early Stevens Johnson vs Kawasaki Disease. The patient was admitted to the hospital for 7 days and was diagnosed with Kawasaki, peeling hand, feet and nail bed. 02-Oct-2007 Reviewed hospital medical records which revealed the patient experienced rash, fever, runny nose, diarrhea, conjunctival injection, oral erythema, cracked lips, swollen hands and feet and fussiness. The patient was admitted from 03-Sep-2007 to 08-Sep-2007. The patient was seen in the ER for UTI and was given IM and oral antibiotic on 30-Aug-2007 and developed rash and fussiness on 01-Sep-2007. The patient returned to the ER for treatment with antibiotic, steroids and antihistamine and discharged to home. There was no response to treatment and was seen by PCP on 03-Sep-2007 who direct admitted the patient. Fever continued for five days. Dermatology and cardiology consults were done. The patient was treated w/IVIG and ASA and improved. She was discharged to home on continued ASA and with cardiac follow-up. Cardiology visit on 09-Oct-2007 revealed echocardiogram to be WNL. Final diagnosis included Kawasaki Disease. Agitation, chapped lips, conjunctival hyperaemia, crying, diarrhoea, drug interolance, immunoglobulins, insomnia, irritability, Kawasakis disease, oedema peripheral, pyrexia, rash, rhinorrhea, skin exfoliation, stomatitis and urinary tract infection were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 291606. A lot check has been requested. Lot check results: A standard lot check investigations was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Borrelia burgdorferi serology, Brain oedema, Dysarthria
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with herpes who on 12-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL by intramuscular injection (lot number and injection site not reported). Concomitant therapy included ceftriaxone sodium, acyclovir and doxycycline. Subsequently the patient experienced headache and fatigue. The patient left and on 30-JUN-2008, her condition dramatically worsened. The patient was stumbling around and slurring her words. She was admitted to the hospital on 30-JUN-2008 and diagnosed with cerebritis. She remained an inpatient until 18-JUL-2008 and returned. On 19-JUL-2008, th patient was admitted to the hospital. She remained in hospital and then was discharge with a percutaneously inserted central venous catheters (PICC) line. The patient was tested for lime disease (result not specified). The diagnosis was acute disseminated encephalitis. According to the reporter, headache, fatigue, stumbling around, slurring her words, cerebritis and acute disseminated encephalitis were considered to be immediately life-threatening and caused hospitalization. Additional information has been requested.  08/29/2008 MR received for DOS 7/19-21/2008 with DX: Acute cerebellitis.  Pt presented to foreign hospital 7/5/08 with onset of slurred speech and ataxia following several day hx of H/A, decreased appetitite, decreased interaction and exhaustion beginning 6/30/08. Pt admitted to for 2 weeks prior to transfer. When well enough to travel, returned home for remainder of tx. ID consult with impression: Acute cerebellitis ? viral, ?post-vaccine, ?2' to infection. Pt tx with abx, antivirals and steroids. PICC line placed for tx.  By d/c walking unaided, with normal speech.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Encephalitis, Headache, Herpes simplex serology, Lethargy, Mumps antibody test
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with herpes who on 12-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL by intramuscular injection (lot number and injection site not reported). Concomitant therapy included ceftriaxone sodium, acyclovir and doxycycline. Subsequently the patient experienced headache and fatigue. The patient left and on 30-JUN-2008, her condition dramatically worsened. The patient was stumbling around and slurring her words. She was admitted to the hospital on 30-JUN-2008 and diagnosed with cerebritis. She remained an inpatient until 18-JUL-2008 and returned. On 19-JUL-2008, th patient was admitted to the hospital. She remained in hospital and then was discharge with a percutaneously inserted central venous catheters (PICC) line. The patient was tested for lime disease (result not specified). The diagnosis was acute disseminated encephalitis. According to the reporter, headache, fatigue, stumbling around, slurring her words, cerebritis and acute disseminated encephalitis were considered to be immediately life-threatening and caused hospitalization. Additional information has been requested.  08/29/2008 MR received for DOS 7/19-21/2008 with DX: Acute cerebellitis.  Pt presented to foreign hospital 7/5/08 with onset of slurred speech and ataxia following several day hx of H/A, decreased appetitite, decreased interaction and exhaustion beginning 6/30/08. Pt admitted to for 2 weeks prior to transfer. When well enough to travel, returned home for remainder of tx. ID consult with impression: Acute cerebellitis ? viral, ?post-vaccine, ?2' to infection. Pt tx with abx, antivirals and steroids. PICC line placed for tx.  By d/c walking unaided, with normal speech.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Mycoplasma serology, Nuclear magnetic resonance imaging brain, Rubella antibody test
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with herpes who on 12-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL by intramuscular injection (lot number and injection site not reported). Concomitant therapy included ceftriaxone sodium, acyclovir and doxycycline. Subsequently the patient experienced headache and fatigue. The patient left and on 30-JUN-2008, her condition dramatically worsened. The patient was stumbling around and slurring her words. She was admitted to the hospital on 30-JUN-2008 and diagnosed with cerebritis. She remained an inpatient until 18-JUL-2008 and returned. On 19-JUL-2008, th patient was admitted to the hospital. She remained in hospital and then was discharge with a percutaneously inserted central venous catheters (PICC) line. The patient was tested for lime disease (result not specified). The diagnosis was acute disseminated encephalitis. According to the reporter, headache, fatigue, stumbling around, slurring her words, cerebritis and acute disseminated encephalitis were considered to be immediately life-threatening and caused hospitalization. Additional information has been requested.  08/29/2008 MR received for DOS 7/19-21/2008 with DX: Acute cerebellitis.  Pt presented to foreign hospital 7/5/08 with onset of slurred speech and ataxia following several day hx of H/A, decreased appetitite, decreased interaction and exhaustion beginning 6/30/08. Pt admitted to for 2 weeks prior to transfer. When well enough to travel, returned home for remainder of tx. ID consult with impression: Acute cerebellitis ? viral, ?post-vaccine, ?2' to infection. Pt tx with abx, antivirals and steroids. PICC line placed for tx.  By d/c walking unaided, with normal speech.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Dysarthria, Fatigue, Gait disturbance, Headache
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with herpes who on 12-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL by intramuscular injection (lot number and injection site not reported). Concomitant therapy included ceftriaxone sodium, acyclovir and doxycycline. Subsequently the patient experienced headache and fatigue. The patient left and on 30-JUN-2008, her condition dramatically worsened. The patient was stumbling around and slurring her words. She was admitted to the hospital on 30-JUN-2008 and diagnosed with cerebritis. She remained an inpatient until 18-JUL-2008 and returned. On 19-JUL-2008, th patient was admitted to the hospital. She remained in hospital and then was discharge with a percutaneously inserted central venous catheters (PICC) line. The patient was tested for lime disease (result not specified). The diagnosis was acute disseminated encephalitis. According to the reporter, headache, fatigue, stumbling around, slurring her words, cerebritis and acute disseminated encephalitis were considered to be immediately life-threatening and caused hospitalization. Additional information has been requested.  08/29/2008 MR received for DOS 7/19-21/2008 with DX: Acute cerebellitis.  Pt presented to foreign hospital 7/5/08 with onset of slurred speech and ataxia following several day hx of H/A, decreased appetitite, decreased interaction and exhaustion beginning 6/30/08. Pt admitted to for 2 weeks prior to transfer. When well enough to travel, returned home for remainder of tx. ID consult with impression: Acute cerebellitis ? viral, ?post-vaccine, ?2' to infection. Pt tx with abx, antivirals and steroids. PICC line placed for tx.  By d/c walking unaided, with normal speech.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Ataxia, Blood creatinine normal, Blood cyanide, Blood lead, C-reactive protein normal
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with herpes who on 12-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL by intramuscular injection (lot number and injection site not reported). Concomitant therapy included ceftriaxone sodium, acyclovir and doxycycline. Subsequently the patient experienced headache and fatigue. The patient left and on 30-JUN-2008, her condition dramatically worsened. The patient was stumbling around and slurring her words. She was admitted to the hospital on 30-JUN-2008 and diagnosed with cerebritis. She remained an inpatient until 18-JUL-2008 and returned. On 19-JUL-2008, th patient was admitted to the hospital. She remained in hospital and then was discharge with a percutaneously inserted central venous catheters (PICC) line. The patient was tested for lime disease (result not specified). The diagnosis was acute disseminated encephalitis. According to the reporter, headache, fatigue, stumbling around, slurring her words, cerebritis and acute disseminated encephalitis were considered to be immediately life-threatening and caused hospitalization. Additional information has been requested.  08/29/2008 MR received for DOS 7/19-21/2008 with DX: Acute cerebellitis.  Pt presented to foreign hospital 7/5/08 with onset of slurred speech and ataxia following several day hx of H/A, decreased appetitite, decreased interaction and exhaustion beginning 6/30/08. Pt admitted to for 2 weeks prior to transfer. When well enough to travel, returned home for remainder of tx. ID consult with impression: Acute cerebellitis ? viral, ?post-vaccine, ?2' to infection. Pt tx with abx, antivirals and steroids. PICC line placed for tx.  By d/c walking unaided, with normal speech.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Demyelination, Dysarthria, Encephalitis, Haemoglobin normal, Headache
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with herpes who on 12-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL by intramuscular injection (lot number and injection site not reported). Concomitant therapy included ceftriaxone sodium, acyclovir and doxycycline. Subsequently the patient experienced headache and fatigue. The patient left and on 30-JUN-2008, her condition dramatically worsened. The patient was stumbling around and slurring her words. She was admitted to the hospital on 30-JUN-2008 and diagnosed with cerebritis. She remained an inpatient until 18-JUL-2008 and returned. On 19-JUL-2008, th patient was admitted to the hospital. She remained in hospital and then was discharge with a percutaneously inserted central venous catheters (PICC) line. The patient was tested for lime disease (result not specified). The diagnosis was acute disseminated encephalitis. According to the reporter, headache, fatigue, stumbling around, slurring her words, cerebritis and acute disseminated encephalitis were considered to be immediately life-threatening and caused hospitalization. Additional information has been requested.  08/29/2008 MR received for DOS 7/19-21/2008 with DX: Acute cerebellitis.  Pt presented to foreign hospital 7/5/08 with onset of slurred speech and ataxia following several day hx of H/A, decreased appetitite, decreased interaction and exhaustion beginning 6/30/08. Pt admitted to for 2 weeks prior to transfer. When well enough to travel, returned home for remainder of tx. ID consult with impression: Acute cerebellitis ? viral, ?post-vaccine, ?2' to infection. Pt tx with abx, antivirals and steroids. PICC line placed for tx.  By d/c walking unaided, with normal speech.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Liver function test normal, Malaise, Mental impairment, Nuclear magnetic resonance imaging abnormal, Platelet count normal
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with herpes who on 12-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL by intramuscular injection (lot number and injection site not reported). Concomitant therapy included ceftriaxone sodium, acyclovir and doxycycline. Subsequently the patient experienced headache and fatigue. The patient left and on 30-JUN-2008, her condition dramatically worsened. The patient was stumbling around and slurring her words. She was admitted to the hospital on 30-JUN-2008 and diagnosed with cerebritis. She remained an inpatient until 18-JUL-2008 and returned. On 19-JUL-2008, th patient was admitted to the hospital. She remained in hospital and then was discharge with a percutaneously inserted central venous catheters (PICC) line. The patient was tested for lime disease (result not specified). The diagnosis was acute disseminated encephalitis. According to the reporter, headache, fatigue, stumbling around, slurring her words, cerebritis and acute disseminated encephalitis were considered to be immediately life-threatening and caused hospitalization. Additional information has been requested.  08/29/2008 MR received for DOS 7/19-21/2008 with DX: Acute cerebellitis.  Pt presented to foreign hospital 7/5/08 with onset of slurred speech and ataxia following several day hx of H/A, decreased appetitite, decreased interaction and exhaustion beginning 6/30/08. Pt admitted to for 2 weeks prior to transfer. When well enough to travel, returned home for remainder of tx. ID consult with impression: Acute cerebellitis ? viral, ?post-vaccine, ?2' to infection. Pt tx with abx, antivirals and steroids. PICC line placed for tx.  By d/c walking unaided, with normal speech.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Skin lesion, Somnolence, Speech disorder, Vasculitis, White blood cell count normal
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with herpes who on 12-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL by intramuscular injection (lot number and injection site not reported). Concomitant therapy included ceftriaxone sodium, acyclovir and doxycycline. Subsequently the patient experienced headache and fatigue. The patient left and on 30-JUN-2008, her condition dramatically worsened. The patient was stumbling around and slurring her words. She was admitted to the hospital on 30-JUN-2008 and diagnosed with cerebritis. She remained an inpatient until 18-JUL-2008 and returned. On 19-JUL-2008, th patient was admitted to the hospital. She remained in hospital and then was discharge with a percutaneously inserted central venous catheters (PICC) line. The patient was tested for lime disease (result not specified). The diagnosis was acute disseminated encephalitis. According to the reporter, headache, fatigue, stumbling around, slurring her words, cerebritis and acute disseminated encephalitis were considered to be immediately life-threatening and caused hospitalization. Additional information has been requested.  08/29/2008 MR received for DOS 7/19-21/2008 with DX: Acute cerebellitis.  Pt presented to foreign hospital 7/5/08 with onset of slurred speech and ataxia following several day hx of H/A, decreased appetitite, decreased interaction and exhaustion beginning 6/30/08. Pt admitted to for 2 weeks prior to transfer. When well enough to travel, returned home for remainder of tx. ID consult with impression: Acute cerebellitis ? viral, ?post-vaccine, ?2' to infection. Pt tx with abx, antivirals and steroids. PICC line placed for tx.  By d/c walking unaided, with normal speech.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Borrelia burgdorferi serology negative, Cerebellar ataxia, Fatigue, Foreign travel, Headache
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with herpes who on 12-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL by intramuscular injection (lot number and injection site not reported). Concomitant therapy included ceftriaxone sodium, acyclovir and doxycycline. Subsequently the patient experienced headache and fatigue. The patient left and on 30-JUN-2008, her condition dramatically worsened. The patient was stumbling around and slurring her words. She was admitted to the hospital on 30-JUN-2008 and diagnosed with cerebritis. She remained an inpatient until 18-JUL-2008 and returned. On 19-JUL-2008, th patient was admitted to the hospital. She remained in hospital and then was discharge with a percutaneously inserted central venous catheters (PICC) line. The patient was tested for lime disease (result not specified). The diagnosis was acute disseminated encephalitis. According to the reporter, headache, fatigue, stumbling around, slurring her words, cerebritis and acute disseminated encephalitis were considered to be immediately life-threatening and caused hospitalization. Additional information has been requested.  08/29/2008 MR received for DOS 7/19-21/2008 with DX: Acute cerebellitis.  Pt presented to foreign hospital 7/5/08 with onset of slurred speech and ataxia following several day hx of H/A, decreased appetitite, decreased interaction and exhaustion beginning 6/30/08. Pt admitted to for 2 weeks prior to transfer. When well enough to travel, returned home for remainder of tx. ID consult with impression: Acute cerebellitis ? viral, ?post-vaccine, ?2' to infection. Pt tx with abx, antivirals and steroids. PICC line placed for tx.  By d/c walking unaided, with normal speech.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Malaise, Serology abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with herpes who on 12-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL by intramuscular injection (lot number and injection site not reported). Concomitant therapy included ceftriaxone sodium, acyclovir and doxycycline. Subsequently the patient experienced headache and fatigue. The patient left and on 30-JUN-2008, her condition dramatically worsened. The patient was stumbling around and slurring her words. She was admitted to the hospital on 30-JUN-2008 and diagnosed with cerebritis. She remained an inpatient until 18-JUL-2008 and returned. On 19-JUL-2008, th patient was admitted to the hospital. She remained in hospital and then was discharge with a percutaneously inserted central venous catheters (PICC) line. The patient was tested for lime disease (result not specified). The diagnosis was acute disseminated encephalitis. According to the reporter, headache, fatigue, stumbling around, slurring her words, cerebritis and acute disseminated encephalitis were considered to be immediately life-threatening and caused hospitalization. Additional information has been requested.  08/29/2008 MR received for DOS 7/19-21/2008 with DX: Acute cerebellitis.  Pt presented to foreign hospital 7/5/08 with onset of slurred speech and ataxia following several day hx of H/A, decreased appetitite, decreased interaction and exhaustion beginning 6/30/08. Pt admitted to for 2 weeks prior to transfer. When well enough to travel, returned home for remainder of tx. ID consult with impression: Acute cerebellitis ? viral, ?post-vaccine, ?2' to infection. Pt tx with abx, antivirals and steroids. PICC line placed for tx.  By d/c walking unaided, with normal speech.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Jaw disorder, Mumps, Pyrexia, Swelling face, Vaccination failure
Clinical narrative: One week after shot she ran a 102 fever.  Then seem to have a virus.  Saw pediatrician twice.  She then seemed to feel better for 2-3 days.  Then her left side of cheek/jaw swelled causing pain.  Took her to pediatrician and she was diagnosed with mumps.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Abdominal distension, Haematochezia, Intussusception, Vomiting, X-ray abnormal
Clinical narrative: Information has been received from a physician concerning a 5 month old male patient who was vaccinated with a dose of ROTATEQ on an unknown date.  The physician, who works in the emergency room, reported that she was aware of a patient who presented to the emergency room with possible intussusception in JUL-2008.  The patient's symptoms were vomiting, abdominal distention, and blood in the stool.  The emergency room performed an x-ray and determined that the patient had reduced airflow and suspected intussusception.  This adverse event occurred one week after a dose of ROTATEQ.  It is unknown if the adverse event occurred after the first, second, or third vaccination.  The patient was sent to another hospital that specializes in pediatrics but it is unknown if the child was admitted.  No product quality complaint was involved.  Upon internal review, intussusception was considered to be another important medical event.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Disorientation, Face injury, Fall, Mouth injury, Oxygen saturation
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no pertinent medical history and no history of drug reaction or allergies who three to four weeks ago (on approximately 26-JUN-2008 to 03-JUL-2008) was vaccinated with MENACTRA, then she received the first dose of GARDASIL (lot#: 660391/0063X). Immediately after the GARDASIL injection, she fainted. She hit her nose on a foot stool connected to the exam bed. Oxygen was started, blood pressure and oximetry were within normal range. She did not recall where she was but knew her name. She was transported to the hospital by ambulance where an X-ray of nose was negative. She also hit her lip and cracked one tooth. She was later seen by a dentist and the tooth was cemented. The reporter's office called the patient 24 hours later and she was oriented and remembered the situation in the office. Subsequently, the patient recovered. The reporter considered fainting and cracking one tooth to be other important medical events. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Oxygen supplementation, Syncope, Tooth fracture, X-ray normal
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no pertinent medical history and no history of drug reaction or allergies who three to four weeks ago (on approximately 26-JUN-2008 to 03-JUL-2008) was vaccinated with MENACTRA, then she received the first dose of GARDASIL (lot#: 660391/0063X). Immediately after the GARDASIL injection, she fainted. She hit her nose on a foot stool connected to the exam bed. Oxygen was started, blood pressure and oximetry were within normal range. She did not recall where she was but knew her name. She was transported to the hospital by ambulance where an X-ray of nose was negative. She also hit her lip and cracked one tooth. She was later seen by a dentist and the tooth was cemented. The reporter's office called the patient 24 hours later and she was oriented and remembered the situation in the office. Subsequently, the patient recovered. The reporter considered fainting and cracking one tooth to be other important medical events. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 15 year old female who on an unspecified date was vaccinated with her third dose of GARDASIL. Subsequently the patient experienced a seizure. At the time of the report, it was unknown if the patient had recovered from the seizure. Upon internal review, seizure was determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse practitioner for the pregnancy registry for GARDASIL, concerning a female patient with a history of miscarriage who on 22-MAY-2008 was vaccinated with a dose of GARDASIL (lot # 660389/1968U) intramuscularly.  The nurse practitioner reported that on 05-JUN-2008, the patient had a miscarriage.  The last menstrual period and weeks gestation was not reported.  It is unknown if the patient sought medical attention.  A lot check has been initiated.  Upon internal review, miscarriage was considered an other important medical event.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with history of syncope who on 16-JUL-2008 was vaccinated with the first dose of GARDASIL (Lot No. 659962/1740U) IM.  After the first dose of GARDASIL, on 20-JUL-2008, the patient experienced a seizure.  The seizure lasted 3 minutes.  The patient went to the emergency room for an evaluation but was not admitted.  Subsequently, the patient recovered.  Upon internal review, seizure was considered as an other important medical event.  Additional information has been requested.  8/26/08 Reviewed ER medical records of 7/20/08. FINAL DX: seizure, conjunctivitis Records reveal patient experienced grand mal seizure lasting approx 3 min & had transient inability to move arms & legs.  Tachycardic in ER otherwise stable.  D/C to home & referred to neuro for outpatient w/u.  9/2/08 Reviewed neurological consult records of 7/21/2008. FINAL DX: none provided Records reveal patient exprienced witnessed passing out at a friends house after a sleep over.  Had generalized tonic-clonic seizure w/foaming at the mouth, cyanosis, bit her tongue & lasting approx 3 minutes.  CT scan reviewed & concurred WNL.  Suggested MRI/MRA of brain & EEG.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history who on 29-APR-2008 was vaccinated intramuscularly with the 0.5 ml second dose of GARDASIL.  There was no concomitant medication.  The physician reported that the patient had seizures after her second dose of GARDASIL.  On 14-JUN-2008 the patient was taken to the emergency room and had repeated seizures since.  The patient is now under the care of a neurologist.  The patient's seizures persisted.  Upon internal review, seizures were determined to be an other important medical event.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Arthralgia, Fatigue
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history and no history of drug reactions or allergies who on 18-JUN-2007 was vaccinated with the first dose of GARDASIL and on 10-JUN-2008 was vaccinated with the second dose of GARDASIL.  On 10-JUN-2008 the patient was also given MENACTRA.  Ten days after the second dose of GARDASIL (on 20-JUN-2008) the patient experienced joint pain and fatigue.  Seventeen days after the second dose of GARDASIL (on 27-JUN-2008) the patient had a seizure.  No adverse events reported after the first dose of GARDASIL was given.  The patient sought medical attention by calling the physician's office.  The physician reported that she noticed that patients who are given GARDASIL and MENACTRA usually have more side effects.  She further stated she would not be administering the two vaccines together from now on.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested. 8/12/08-records received for DOS 6/27/08-Syncope. Presented after 1 episode found on floor with legs shaking. Vision blurred. Now continues with fatigue and dizziness. Impression: syncopal event induced seizures due to orthostatic hypotension.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Sitting in waiting room- starting feeling "like I'm going to pass out." Pale and sweaty. Patient laid down for app. 15 min. Felt better. Did state she had not eaten this AM.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Patient given Hepatitis A #2 and HPV #3 on 3-28-08.  Patient had positive pregnancy test 4-7-08.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Headache
Clinical narrative: Mom called to report a temp of 101 degrees, a "pounding headache" started middle of the night 7-18-08.  ?Photophobia.