chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Eye movement disorder, Feeling abnormal, Hypoaesthesia facial, Impaired driving ability, Lacrimation increased
Clinical narrative: On 9/19/07 client awoke dizzy with balance issues.  Went to work & face felt numb, bruised.  Urgent care gave him VIROXXIOD, an antiviral.  Right eye wont close, needs a patch.  Hard to eat.  Urgent care said Bell's or "Hunts" on 2/27/08 right eye still spastic.  Right side of mouth doesn't work well.  Can't see well enough to drive.  Received his first RECOMBIVAX HB vaccine on 8/22/09.  9/24/09.  Either case called me or his office at work called to let me know that case was having problems.  I spoke wit him and found out the information in box #7.  In addition, he said that he woke up on the morning of 9/19/07 feeling like he was hung over.  (He is sober for 8 years).  He then went to work anyway.  There he felt "strokey", that half of his face felt numb, like a "dead bruise."  He did share that although he was well before this, at age 15 he had encephalitis after a case of mumps.  He was in a coma for 4 days at that time.  After 2 months he thought he was well then, without sequelae.  I consulted with our Health Officer, Dr. MD several times because the patient asked me if the vaccine caused his illness.  On 2/27/08 I called case to see how he was doing and to share our MD's assessment of the situation.  Case said that his right eye was still spastic, that the tear ducts flowed very easily.  The right side of his mouth was difficult to eat with still.  Drinking water on that side was hard to do.  Also, his eyes would fill with water and he could not drive very easily.  Dr. felt that the Bell's palsy type illness did occur in temporal association with the vaccine, but he did not think that the vaccine caused it, although nothing is 100% sure.  Dr. asked what the case's job description included as case was still interested in the second RECOMBIVAX HB vaccine.  Called case on 2/28/09 and case said that he worked as a custodian, picked up litter, cleaned the bathrooms.  Before the palsy he also drove and did deliveries.  He could no longer do that.  As Merck wanted more information, I left a phone message with the case on 9/26/8 asking that he sign an ROI and give me a little more information about himself.  No response from him.  On 6/22/09 I sent the attached letter.  No response.  I faxed a report to the State health dept and one to the Merck company. RN.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Paralysis, Visual impairment
Clinical narrative: On 9/19/07 client awoke dizzy with balance issues.  Went to work & face felt numb, bruised.  Urgent care gave him VIROXXIOD, an antiviral.  Right eye wont close, needs a patch.  Hard to eat.  Urgent care said Bell's or "Hunts" on 2/27/08 right eye still spastic.  Right side of mouth doesn't work well.  Can't see well enough to drive.  Received his first RECOMBIVAX HB vaccine on 8/22/09.  9/24/09.  Either case called me or his office at work called to let me know that case was having problems.  I spoke wit him and found out the information in box #7.  In addition, he said that he woke up on the morning of 9/19/07 feeling like he was hung over.  (He is sober for 8 years).  He then went to work anyway.  There he felt "strokey", that half of his face felt numb, like a "dead bruise."  He did share that although he was well before this, at age 15 he had encephalitis after a case of mumps.  He was in a coma for 4 days at that time.  After 2 months he thought he was well then, without sequelae.  I consulted with our Health Officer, Dr. MD several times because the patient asked me if the vaccine caused his illness.  On 2/27/08 I called case to see how he was doing and to share our MD's assessment of the situation.  Case said that his right eye was still spastic, that the tear ducts flowed very easily.  The right side of his mouth was difficult to eat with still.  Drinking water on that side was hard to do.  Also, his eyes would fill with water and he could not drive very easily.  Dr. felt that the Bell's palsy type illness did occur in temporal association with the vaccine, but he did not think that the vaccine caused it, although nothing is 100% sure.  Dr. asked what the case's job description included as case was still interested in the second RECOMBIVAX HB vaccine.  Called case on 2/28/09 and case said that he worked as a custodian, picked up litter, cleaned the bathrooms.  Before the palsy he also drove and did deliveries.  He could no longer do that.  As Merck wanted more information, I left a phone message with the case on 9/26/8 asking that he sign an ROI and give me a little more information about himself.  No response from him.  On 6/22/09 I sent the attached letter.  No response.  I faxed a report to the State health dept and one to the Merck company. RN.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Renal pain
Clinical narrative: As a regular client of the hospital, I received  the shingles vax and within 2 - 3 days developed severe lower back pain. Next, the pain spread to my right kidney. Next, the pain spread to my whole right abdominal region. Over an approximate nine months period the pain in the lower back slowly went away, followed by the kidney pain. The abdominal pain very slowly ebbed away, but I still to this day have slight remnants. I went to the ER in another city initially. Then, I went through a battery of tests. The tests revealed no abnormalities from the reports I received, but the whole occurrence of this episode was highly unusual in its closeness following my receipt of the vax. I filed a report with the hospital. I have heard nothing back.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reactive protein increased, Complement factor C3 decreased, Complement factor C4 decreased
Clinical narrative: Information has been received from a physician concerning a young female patient (age unknown) who on an unknown date several weeks ago was vaccinated with a dose of GARDASIL (lot, route and site not reported).  The patient's medical history, relevant concomitant medications, relevant past drug history were unknown.  On an unknown date, after receiving GARDASIL, the patient developed seizures.  The physician stated that the seizures were definitely seizures and not another related condition.  On an unknown date, after GARDASIL vaccination,  an magnetic resonance imaging (MRI) showed an acute disseminated encephalomyelitis with possible complications.  The physician was planning on testing the seizures and acute disseminated encephalomyelitis as if these diseases states were happening.  The physician stated that he could not necessarily implicate GARDASIL as the cause of those conditions.  As of 22-AUG-2009, it was unknown if the patient continued to take GARDASIL, and the results of the seizures and acute disseminated encephalomyelitis were unknown.  Upon internal review seizures and acute disseminated encephalomyelitis were considered to be other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Epstein-Barr virus antibody positive, Hepatitis A antibody negative, Hepatitis B antibody negative, Malaise, Metabolic function test normal
Clinical narrative: Information has been received from a physician concerning a young female patient (age unknown) who on an unknown date several weeks ago was vaccinated with a dose of GARDASIL (lot, route and site not reported).  The patient's medical history, relevant concomitant medications, relevant past drug history were unknown.  On an unknown date, after receiving GARDASIL, the patient developed seizures.  The physician stated that the seizures were definitely seizures and not another related condition.  On an unknown date, after GARDASIL vaccination,  an magnetic resonance imaging (MRI) showed an acute disseminated encephalomyelitis with possible complications.  The physician was planning on testing the seizures and acute disseminated encephalomyelitis as if these diseases states were happening.  The physician stated that he could not necessarily implicate GARDASIL as the cause of those conditions.  As of 22-AUG-2009, it was unknown if the patient continued to take GARDASIL, and the results of the seizures and acute disseminated encephalomyelitis were unknown.  Upon internal review seizures and acute disseminated encephalomyelitis were considered to be other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Myalgia, Mycoplasma serology, Pain, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a young female patient (age unknown) who on an unknown date several weeks ago was vaccinated with a dose of GARDASIL (lot, route and site not reported).  The patient's medical history, relevant concomitant medications, relevant past drug history were unknown.  On an unknown date, after receiving GARDASIL, the patient developed seizures.  The physician stated that the seizures were definitely seizures and not another related condition.  On an unknown date, after GARDASIL vaccination,  an magnetic resonance imaging (MRI) showed an acute disseminated encephalomyelitis with possible complications.  The physician was planning on testing the seizures and acute disseminated encephalomyelitis as if these diseases states were happening.  The physician stated that he could not necessarily implicate GARDASIL as the cause of those conditions.  As of 22-AUG-2009, it was unknown if the patient continued to take GARDASIL, and the results of the seizures and acute disseminated encephalomyelitis were unknown.  Upon internal review seizures and acute disseminated encephalomyelitis were considered to be other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Red blood cell sedimentation rate increased, Virus culture negative
Clinical narrative: Information has been received from a physician concerning a young female patient (age unknown) who on an unknown date several weeks ago was vaccinated with a dose of GARDASIL (lot, route and site not reported).  The patient's medical history, relevant concomitant medications, relevant past drug history were unknown.  On an unknown date, after receiving GARDASIL, the patient developed seizures.  The physician stated that the seizures were definitely seizures and not another related condition.  On an unknown date, after GARDASIL vaccination,  an magnetic resonance imaging (MRI) showed an acute disseminated encephalomyelitis with possible complications.  The physician was planning on testing the seizures and acute disseminated encephalomyelitis as if these diseases states were happening.  The physician stated that he could not necessarily implicate GARDASIL as the cause of those conditions.  As of 22-AUG-2009, it was unknown if the patient continued to take GARDASIL, and the results of the seizures and acute disseminated encephalomyelitis were unknown.  Upon internal review seizures and acute disseminated encephalomyelitis were considered to be other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Body temperature increased, C-reactive protein increased
Clinical narrative: Information has been received from a physician concerning a young female patient (age unknown) who on an unknown date several weeks ago was vaccinated with a dose of GARDASIL (lot, route and site not reported).  The patient's medical history, relevant concomitant medications, relevant past drug history were unknown.  On an unknown date, after receiving GARDASIL, the patient developed seizures.  The physician stated that the seizures were definitely seizures and not another related condition.  On an unknown date, after GARDASIL vaccination,  an magnetic resonance imaging (MRI) showed an acute disseminated encephalomyelitis with possible complications.  The physician was planning on testing the seizures and acute disseminated encephalomyelitis as if these diseases states were happening.  The physician stated that he could not necessarily implicate GARDASIL as the cause of those conditions.  As of 22-AUG-2009, it was unknown if the patient continued to take GARDASIL, and the results of the seizures and acute disseminated encephalomyelitis were unknown.  Upon internal review seizures and acute disseminated encephalomyelitis were considered to be other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Complement factor C3, Complement factor C4 decreased, Drug eruption, Gamma-glutamyltransferase increased, Hepatitis A antibody negative
Clinical narrative: Information has been received from a physician concerning a young female patient (age unknown) who on an unknown date several weeks ago was vaccinated with a dose of GARDASIL (lot, route and site not reported).  The patient's medical history, relevant concomitant medications, relevant past drug history were unknown.  On an unknown date, after receiving GARDASIL, the patient developed seizures.  The physician stated that the seizures were definitely seizures and not another related condition.  On an unknown date, after GARDASIL vaccination,  an magnetic resonance imaging (MRI) showed an acute disseminated encephalomyelitis with possible complications.  The physician was planning on testing the seizures and acute disseminated encephalomyelitis as if these diseases states were happening.  The physician stated that he could not necessarily implicate GARDASIL as the cause of those conditions.  As of 22-AUG-2009, it was unknown if the patient continued to take GARDASIL, and the results of the seizures and acute disseminated encephalomyelitis were unknown.  Upon internal review seizures and acute disseminated encephalomyelitis were considered to be other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Hepatitis B antibody, Hepatitis C antibody negative, Hepatomegaly, Hypersensitivity, Malaise
Clinical narrative: Information has been received from a physician concerning a young female patient (age unknown) who on an unknown date several weeks ago was vaccinated with a dose of GARDASIL (lot, route and site not reported).  The patient's medical history, relevant concomitant medications, relevant past drug history were unknown.  On an unknown date, after receiving GARDASIL, the patient developed seizures.  The physician stated that the seizures were definitely seizures and not another related condition.  On an unknown date, after GARDASIL vaccination,  an magnetic resonance imaging (MRI) showed an acute disseminated encephalomyelitis with possible complications.  The physician was planning on testing the seizures and acute disseminated encephalomyelitis as if these diseases states were happening.  The physician stated that he could not necessarily implicate GARDASIL as the cause of those conditions.  As of 22-AUG-2009, it was unknown if the patient continued to take GARDASIL, and the results of the seizures and acute disseminated encephalomyelitis were unknown.  Upon internal review seizures and acute disseminated encephalomyelitis were considered to be other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pain, Pyrexia, Red blood cell sedimentation rate increased, Splenomegaly, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician concerning a young female patient (age unknown) who on an unknown date several weeks ago was vaccinated with a dose of GARDASIL (lot, route and site not reported).  The patient's medical history, relevant concomitant medications, relevant past drug history were unknown.  On an unknown date, after receiving GARDASIL, the patient developed seizures.  The physician stated that the seizures were definitely seizures and not another related condition.  On an unknown date, after GARDASIL vaccination,  an magnetic resonance imaging (MRI) showed an acute disseminated encephalomyelitis with possible complications.  The physician was planning on testing the seizures and acute disseminated encephalomyelitis as if these diseases states were happening.  The physician stated that he could not necessarily implicate GARDASIL as the cause of those conditions.  As of 22-AUG-2009, it was unknown if the patient continued to take GARDASIL, and the results of the seizures and acute disseminated encephalomyelitis were unknown.  Upon internal review seizures and acute disseminated encephalomyelitis were considered to be other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Urticaria, Virus culture negative
Clinical narrative: Information has been received from a physician concerning a young female patient (age unknown) who on an unknown date several weeks ago was vaccinated with a dose of GARDASIL (lot, route and site not reported).  The patient's medical history, relevant concomitant medications, relevant past drug history were unknown.  On an unknown date, after receiving GARDASIL, the patient developed seizures.  The physician stated that the seizures were definitely seizures and not another related condition.  On an unknown date, after GARDASIL vaccination,  an magnetic resonance imaging (MRI) showed an acute disseminated encephalomyelitis with possible complications.  The physician was planning on testing the seizures and acute disseminated encephalomyelitis as if these diseases states were happening.  The physician stated that he could not necessarily implicate GARDASIL as the cause of those conditions.  As of 22-AUG-2009, it was unknown if the patient continued to take GARDASIL, and the results of the seizures and acute disseminated encephalomyelitis were unknown.  Upon internal review seizures and acute disseminated encephalomyelitis were considered to be other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Acute disseminated encephalomyelitis, Convulsion, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physician concerning a young female patient (age unknown) who on an unknown date several weeks ago was vaccinated with a dose of GARDASIL (lot, route and site not reported).  The patient's medical history, relevant concomitant medications, relevant past drug history were unknown.  On an unknown date, after receiving GARDASIL, the patient developed seizures.  The physician stated that the seizures were definitely seizures and not another related condition.  On an unknown date, after GARDASIL vaccination,  an magnetic resonance imaging (MRI) showed an acute disseminated encephalomyelitis with possible complications.  The physician was planning on testing the seizures and acute disseminated encephalomyelitis as if these diseases states were happening.  The physician stated that he could not necessarily implicate GARDASIL as the cause of those conditions.  As of 22-AUG-2009, it was unknown if the patient continued to take GARDASIL, and the results of the seizures and acute disseminated encephalomyelitis were unknown.  Upon internal review seizures and acute disseminated encephalomyelitis were considered to be other important medical event.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5, RV5
Symptoms: Diarrhoea, Weight decreased, Weight increased
Clinical narrative: 2.5 mo Female vaccinated with ROTATEQ-R- vaccine on 08/18/2009 under FDA IND #13843. Patient was called by writer 72 hours after vaccination and was well. However, on follow-up -8/25/09-, the patient's mother related that the infant had loose watery stool for the last three days, starting 8/22/09 with one loose stool, and on 8/23 and 8/24 she had four to five loose stools above her baseline, per day. Patient has been taking formula well with no other symptoms, specifically, no vomiting, no fussiness, and no hematachezia. On the date of follow-up exam, patient has gained weight and had a normal stool in research clinic. Physical exam was normal. Patient's prior weight from 8/18/2009 was 5.68 Kg reflecting no weight loss. The patient's loose stools continued on 8/25 and 8/26/09 with approximately 2 loose stools per day. Then on 8/27/09 the patien't loose stools completely resolved. This may be related to the vaccine oral RotaTeq(R) which the patient had recieved on 8/18/09. Her appetite remained normal and she did not have weight loss as of the clinical exam on 8/25/2009 and had actually gained weight, as noted on intial report. The vaccine was administrated to this patient under FDA IND #13843 with Merck IISP grant funding #35817.
Age: 0.2
Sex: F
Vaccine: RV5, RV5
Symptoms: Diarrhoea, Weight increased
Clinical narrative: 2.5 mo Female vaccinated with ROTATEQ-R- vaccine on 08/18/2009 under FDA IND #13843. Patient was called by writer 72 hours after vaccination and was well. However, on follow-up -8/25/09-, the patient's mother related that the infant had loose watery stool for the last three days, starting 8/22/09 with one loose stool, and on 8/23 and 8/24 she had four to five loose stools above her baseline, per day. Patient has been taking formula well with no other symptoms, specifically, no vomiting, no fussiness, and no hematachezia. On the date of follow-up exam, patient has gained weight and had a normal stool in research clinic. Physical exam was normal. Patient's prior weight from 8/18/2009 was 5.68 Kg reflecting no weight loss. The patient's loose stools continued on 8/25 and 8/26/09 with approximately 2 loose stools per day. Then on 8/27/09 the patien't loose stools completely resolved. This may be related to the vaccine oral RotaTeq(R) which the patient had recieved on 8/18/09. Her appetite remained normal and she did not have weight loss as of the clinical exam on 8/25/2009 and had actually gained weight, as noted on intial report. The vaccine was administrated to this patient under FDA IND #13843 with Merck IISP grant funding #35817.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: local site reaction of erythema and pain lasting 7 days.  20 hours after administration atrial fibrulation that was controlled for over 4 years suddenly occurred several times a day lasting for 45 minutes before self converting.  One event of tachycardia with rate of 222 BPM on day 8.  Flecanide was doubled and when still continued a betablocker was added.  Extreme weakness of legs as well as general anxiety that has not been treated.  First event was triggered by exercise but rest not exercise related.  White lying in bed lyng on left side seems to be associated with more irregular beats.  Seeing anelectrophysiologist in four days.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Atrial fibrillation, Condition aggravated, Injection site erythema, Injection site pain
Clinical narrative: local site reaction of erythema and pain lasting 7 days.  20 hours after administration atrial fibrulation that was controlled for over 4 years suddenly occurred several times a day lasting for 45 minutes before self converting.  One event of tachycardia with rate of 222 BPM on day 8.  Flecanide was doubled and when still continued a betablocker was added.  Extreme weakness of legs as well as general anxiety that has not been treated.  First event was triggered by exercise but rest not exercise related.  White lying in bed lyng on left side seems to be associated with more irregular beats.  Seeing anelectrophysiologist in four days.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Local reaction, Muscular weakness, Tachycardia
Clinical narrative: local site reaction of erythema and pain lasting 7 days.  20 hours after administration atrial fibrulation that was controlled for over 4 years suddenly occurred several times a day lasting for 45 minutes before self converting.  One event of tachycardia with rate of 222 BPM on day 8.  Flecanide was doubled and when still continued a betablocker was added.  Extreme weakness of legs as well as general anxiety that has not been treated.  First event was triggered by exercise but rest not exercise related.  White lying in bed lyng on left side seems to be associated with more irregular beats.  Seeing anelectrophysiologist in four days.
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine used (expired drug administered) A non-serious spontaneous report of administration of expired FluMist was received from a nurse concerning an adult male. Neither medical history nor concomitant medications were reported. On 26-Feb-2009, the patient received expired FluMist vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product complaint investigation results.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Expired vaccine used (Expired drug administered). A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 31-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographic information was received. Additional information was received on 12-May-2009: product complaint investigation results.
Age: 70.0
Sex: F
Vaccine: DT
Symptoms: Arthralgia, Electromyogram, Laboratory test, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: This case was received from a health care professional on 28 July 2009. A 70-year-old female patient, with a history of Bell's Palsy one year ago, received an intramuscular left deltoid injection of DECAVAC (lot number U2346AA) on 07 May 2009. According to the reporter, who was the patient's daughter, the patient had received many previous doses. In July 2009, approximately two months post-vaccination, the patient complained that both arms became painful and difficult to lift. The patient had been seen by her physician; no additional information was available. Follow-up information received on 17 August 2009 from a health care professional, who is the patient's daughter. The patient had no concurrent illnesses at the time of vaccination on 07 May 2009; however she was taking "Anatriptaline" and multiple unknown herbal medications/vitamins at the time. Specific laboratory tests performed were unknown; however the patient had an x-ray of the shoulder, EMG and MRI of the neck (results not reported) and was diagnosed with PMR (polymyalgia rheumatica). The patient was treated with Prednisone. At the time of this report, the patient had not recovered and stated her "muscles are better, but joints still hurt." Contact information for treating physician was provided. Per this new information, this case meets seriousness criteria and is upgraded to serious.
Age: 70.0
Sex: F
Vaccine: DT
Symptoms: Pain in extremity, Polymyalgia rheumatica, X-ray limb
Clinical narrative: This case was received from a health care professional on 28 July 2009. A 70-year-old female patient, with a history of Bell's Palsy one year ago, received an intramuscular left deltoid injection of DECAVAC (lot number U2346AA) on 07 May 2009. According to the reporter, who was the patient's daughter, the patient had received many previous doses. In July 2009, approximately two months post-vaccination, the patient complained that both arms became painful and difficult to lift. The patient had been seen by her physician; no additional information was available. Follow-up information received on 17 August 2009 from a health care professional, who is the patient's daughter. The patient had no concurrent illnesses at the time of vaccination on 07 May 2009; however she was taking "Anatriptaline" and multiple unknown herbal medications/vitamins at the time. Specific laboratory tests performed were unknown; however the patient had an x-ray of the shoulder, EMG and MRI of the neck (results not reported) and was diagnosed with PMR (polymyalgia rheumatica). The patient was treated with Prednisone. At the time of this report, the patient had not recovered and stated her "muscles are better, but joints still hurt." Contact information for treating physician was provided. Per this new information, this case meets seriousness criteria and is upgraded to serious.
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis, Influenza, Upper respiratory tract infection
Clinical narrative: Initial report received on 18 August 2009 from another manufacturer (report number WAES 0907USA05484, document number 45223472) who had received the original report from an anonymous consumer. A female patient (demographics not reported) had received an influenza vaccine ("flu shot") 30 years ago on an unspecified date. The trade name, manufacturer name, route and site of administration were not reported. The next day following vaccination, the patient was sick with the flu, bronchitis and an upper respiratory tract infection (not specified). It was not reported whether any diagnostic tests, or laboratory data were performed, or if the patient had received treatment. The recovery status of the patient was not reported. No contact information for follow-up was provided. No further information is expected. Documents held by sender: None.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial information received on 19 August 2009 from another manufacturer whose initial reporter was a health care professional. A male patient received an influenza vaccine (manufacturer not known) over 20 years ago. Following administration the patient developed Guillain Barre Syndrome. No further information was provided. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report was received 19 August 2009 from another manufacturer (doc number 45223759), who received the report from a health care professional. A patient (demographics not reported) had received an Influenza vaccine (manufacturer and lot number not reported) in 2002 and an unspecified amount of time later, the patient may have developed Guillain Barre Syndrome. According to the reporter, "the patient was treated at the hospital at that time". No additional information was provided at the time of the report. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: Initial report was received 24 August 2009 from another manufacturer (document number 45223857) who received the report from a health care professional. A 12-year-old female patient with a history of a milk allergy, had received an injection of MENACTRA (lot number, route and site of administration not reported), and an injection of "TDAP" (manufacturer, lot number, route and site of administration not reported) early on the morning of 05 August 2009, and an unspecified amount of time later that day, the patient began to have difficulty breathing and her throat began swelling. According to the reporter, after receiving the vaccines, the patient left the office. The patient then went to a fast food restaurant and had a cherry slushy and a burger and she began to experience difficulty breathing and her throat began swelling. The reporting physician did not believe the event was vaccine related because the patient had a milk allergy and the patient's mother had spoken with  a person at the restaurant who said that some milk could have gotten into the slushy. The patient's recovery status was not reported. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Cerebrovascular accident, Dizziness, Gait disturbance, Nerve injury
Clinical narrative: Information has been received via internet concerning a 16 year old female who on unspecified dates was vaccinated with the first two doses of GARDASIL.  Subsequently the patient experienced fainting, stroke, memory loss which was devastating. The patient stated that she could barely walk, she was so dizzy that she would have to just sit down. The patient's mother stated that physician diagnosed her daughter with nerve damage caused by GARDASIL. Upon internal review, stroke was considered an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received via internet concerning a 16 year old female who on unspecified dates was vaccinated with the first two doses of GARDASIL.  Subsequently the patient experienced fainting, stroke, memory loss which was devastating. The patient stated that she could barely walk, she was so dizzy that she would have to just sit down. The patient's mother stated that physician diagnosed her daughter with nerve damage caused by GARDASIL. Upon internal review, stroke was considered an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Arthralgia, Autoimmune disorder, Complex regional pain syndrome, Joint swelling, Oedema peripheral
Clinical narrative: Information has been received from a consumer concerning her daughter (a 15 year old female) with food allergy and asthma "who received all three doses of GARDASIL but received the first dose of GARDASIL in April, 2007. Concomitant therapy included DEPO-PROVERA. Subsequently the patient started to experience severe pain and swelling in her left hand and arm. The patient saw her pediatrician who sent her to a hand specialist and after several visits the patient was given a cortisone shot (manufacturer unspecified) that did not relieve the pain and then she was casted for two weeks and that did not help either, but then the symptoms disappeared. Then in June 2008 the patient woke up and had severe pain and swelling in her right foot. The patient saw her pediatrician who did several X-Rays and blood work and was sent to an orthopedic physician. The orthopedic physician gave the patient another cortisone shot (manufacturer unspecified) but her foot continued to swell to the size of a small football. The patient then continued to have severe pain all over her body and had achy joints. Then in August, 2008 the patient's left foot became swollen with severe pain. The patient was hospitalized for two or three days where they did a lymph scan, bone scan, cardiac series and blood series. The patient then saw a specialist in October, 2008 who diagnosed her with Complex Regional Pain Syndrome, which was an auto immune disease. The consumer reported that the way this syndrome worked was that she went into remission for sometime and then it would come back. The patient still had swollen feet that got very raw and she was given GABAPENTIN (manufacturer unspecified), CYMBALTA (manufacturer unspecified). The consumer reported that the patient saw a Rheumatologist and a pain specialist." Follow up information was received from a Registered Nurse (R.N.) on via telephone. It was reported that the patient received the first (lot# 656050/0245U), second (lot# 657737/0522U) and third (lot# 658560/1062U) dose of GARDASIL on 16-APR-2007, 21-JUN-2007 and on 15-OCT-2007 respectively. Concomitantly received a dose of MENACTRA (lot# U1932AB). Additional information has been requested.  9/4/09 Hospital records received DOS 8/12/08 to 8/14/08. Assessment: 1 - Migratory edema of unclear etiology, 2 - Chronic pain secondary to #1, 3 - Arthralgia. Patient c/o bilateral lower extremity swelling for 10 months. However edema started on the dorsum of her (L) hand. Pain, tingling, swelling of the dorsum of both feet. 'Veins popping up'. Recent weight gain, fatigue, exertional dyspnea, joint stiffness.  10/19/2009 ICD-9 codes received for inpatient stay 8/12-8/14/2008 782.3, 719.49, 704.0, 493.90
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her daughter (a 15 year old female) with food allergy and asthma "who received all three doses of GARDASIL but received the first dose of GARDASIL in April, 2007. Concomitant therapy included DEPO-PROVERA. Subsequently the patient started to experience severe pain and swelling in her left hand and arm. The patient saw her pediatrician who sent her to a hand specialist and after several visits the patient was given a cortisone shot (manufacturer unspecified) that did not relieve the pain and then she was casted for two weeks and that did not help either, but then the symptoms disappeared. Then in June 2008 the patient woke up and had severe pain and swelling in her right foot. The patient saw her pediatrician who did several X-Rays and blood work and was sent to an orthopedic physician. The orthopedic physician gave the patient another cortisone shot (manufacturer unspecified) but her foot continued to swell to the size of a small football. The patient then continued to have severe pain all over her body and had achy joints. Then in August, 2008 the patient's left foot became swollen with severe pain. The patient was hospitalized for two or three days where they did a lymph scan, bone scan, cardiac series and blood series. The patient then saw a specialist in October, 2008 who diagnosed her with Complex Regional Pain Syndrome, which was an auto immune disease. The consumer reported that the way this syndrome worked was that she went into remission for sometime and then it would come back. The patient still had swollen feet that got very raw and she was given GABAPENTIN (manufacturer unspecified), CYMBALTA (manufacturer unspecified). The consumer reported that the patient saw a Rheumatologist and a pain specialist." Follow up information was received from a Registered Nurse (R.N.) on via telephone. It was reported that the patient received the first (lot# 656050/0245U), second (lot# 657737/0522U) and third (lot# 658560/1062U) dose of GARDASIL on 16-APR-2007, 21-JUN-2007 and on 15-OCT-2007 respectively. Concomitantly received a dose of MENACTRA (lot# U1932AB). Additional information has been requested.  9/4/09 Hospital records received DOS 8/12/08 to 8/14/08. Assessment: 1 - Migratory edema of unclear etiology, 2 - Chronic pain secondary to #1, 3 - Arthralgia. Patient c/o bilateral lower extremity swelling for 10 months. However edema started on the dorsum of her (L) hand. Pain, tingling, swelling of the dorsum of both feet. 'Veins popping up'. Recent weight gain, fatigue, exertional dyspnea, joint stiffness.  10/19/2009 ICD-9 codes received for inpatient stay 8/12-8/14/2008 782.3, 719.49, 704.0, 493.90
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test, Chest X-ray, Computerised tomogram, Fatigue, Full blood count
Clinical narrative: Daily intermittent headaches, fatigue, lethargy. Hospitalized 07-1-09 thru 07-6-09. IV TORADOL/COMPAZINE/BENADRYL with no relief. Currently being evaluated.  9/29/09 Neurology Consult (Pediatric Headache Program) received DOS 7/1/09 to 7/20/09. Assessment: New daily persistent headaches of unknown etiology. Patient began to experience a daily headache approximately 3 months ago. Also had cough and sinus congestion which have resolved. Headaches are bitemporal and frontal and throbbing. Phonophobia. Labile affect. Decline in grades, teased at school and has no friends. High arched palate. Nasal voice. 6 days inpatient IV DHE administration. After discharge difficulty sleeping. Profuse vomiting.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Lethargy, Metabolic function test, Mycoplasma serology, Nuclear magnetic resonance imaging
Clinical narrative: Daily intermittent headaches, fatigue, lethargy. Hospitalized 07-1-09 thru 07-6-09. IV TORADOL/COMPAZINE/BENADRYL with no relief. Currently being evaluated.  9/29/09 Neurology Consult (Pediatric Headache Program) received DOS 7/1/09 to 7/20/09. Assessment: New daily persistent headaches of unknown etiology. Patient began to experience a daily headache approximately 3 months ago. Also had cough and sinus congestion which have resolved. Headaches are bitemporal and frontal and throbbing. Phonophobia. Labile affect. Decline in grades, teased at school and has no friends. High arched palate. Nasal voice. 6 days inpatient IV DHE administration. After discharge difficulty sleeping. Profuse vomiting.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Nuclear magnetic resonance imaging brain, Platelet count, Thyroid function test
Clinical narrative: Daily intermittent headaches, fatigue, lethargy. Hospitalized 07-1-09 thru 07-6-09. IV TORADOL/COMPAZINE/BENADRYL with no relief. Currently being evaluated.  9/29/09 Neurology Consult (Pediatric Headache Program) received DOS 7/1/09 to 7/20/09. Assessment: New daily persistent headaches of unknown etiology. Patient began to experience a daily headache approximately 3 months ago. Also had cough and sinus congestion which have resolved. Headaches are bitemporal and frontal and throbbing. Phonophobia. Labile affect. Decline in grades, teased at school and has no friends. High arched palate. Nasal voice. 6 days inpatient IV DHE administration. After discharge difficulty sleeping. Profuse vomiting.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dyspnoea, Throat tightness, Vomiting
Clinical narrative: Received vaccines and left office to go to car in parking lot. Began c/o shortness of breath, throat tightness. Came back inside office. Vomited thick, white, mucous. Received aerosol Rx, Epi, methylpred. Transported to ER by squad at 6 PM.  9/9/09 MR received for DOS 6/15-xx/09 with D/C DX: anaphylactic reaction 2' to vaccines.  Pt presented from PCP's office where pt developed increased work of breathing, coughing, sneezing, hives and thready pulse shortly after receiving several vax. Tx with epi, steroids, nebs and benadryl. Observed and d/c for outpt f/u. ICD9:  999.4, 708.9, V1503, V1501, V1505, E9494
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Pain in extremity, Rheumatoid arthritis
Clinical narrative: My daughter had the series of GARDASIL vaccination on 10/3/2007, 12/14/2007 and 4/25/2008. Starting in October, 2008 she started having pain in her feet and by the end of the college year May/June 2009 the pain had spread to her ankle and knee joints. Later in June the pain had spread to all the joints in her body, to the point she had difficulty getting out of bed in the morning. She has since been diagnosed with rheumatoid arthritis. I heard that one of the possible side effects of the GARDASIL vaccinations is auto-immune diseases, so I thought this should be reported.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test abnormal, Rheumatoid arthritis
Clinical narrative: My daughter had the series of GARDASIL vaccination on 10/3/2007, 12/14/2007 and 4/25/2008. Starting in October, 2008 she started having pain in her feet and by the end of the college year May/June 2009 the pain had spread to her ankle and knee joints. Later in June the pain had spread to all the joints in her body, to the point she had difficulty getting out of bed in the morning. She has since been diagnosed with rheumatoid arthritis. I heard that one of the possible side effects of the GARDASIL vaccinations is auto-immune diseases, so I thought this should be reported.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Kidney infection, Mass
Clinical narrative: My daughter received all three injections of GARDASIL.  Since receiving the last injection,  she has been hospitalized with severe kidney infections and now has an odd mass on her head.  We are seeing a surgeon on Friday 8/28/09 about removing the the mass on her head.  My daughter has NEVER been sick before.  She is 14 years old and only became sick since receiving the GARDASIL vaccine.  Please help us to put an end to this horrible drug.  Thank you.   10/7/09: Vaccine record received for date of service 6/19/08, VAERS updated.  10/26/09:  Urgent Care Records received for date of service 6/25/09 and Hospital Records received for dates of service 4/21/09 to 4/24/09.  Dx:  UTI and Acute R Pyelonephritis.   Assessment:  Admitted for acute R pyelonephritis on 4/21/09 and started on IV antibiotic therapy.  Seen again on 6/25/09 for frequency and burning on urination:   UTI, prescribed amoxicillin.    ICD 9 Codes:  599.0, 041.02, 706.1, 590.80.
Age: 17.0
Sex: F
Vaccine: HPV4, HEP, HPV4
Symptoms: Headache, Musculoskeletal stiffness, Nausea, Neck pain, Similar reaction on previous exposure to drug
Clinical narrative: See copies of pt's record 7/31/09. 8/20/09 Spoke by phone to mother of patient says that patient received #1 HPV on 9-19-08. On Oct/2008 patient was hospitalized for 2 mos with S/S like the S/S she had on 7/31/09 but much worse. According to mom, patient was seen at ER on 7/31/09 but not admitted. According to mom, they were told that the episode of what happened to pt. were not for sure if it was related to HPV vaccine. 17 y/o presents with c/o headache which started on Monday and increased in severity to a 7 out of 10 on pain scale. Pt. reports no blurry vision with headache. Pt. reports the headache is on the (L) side of her head and is dull in description. Pt had one episode of N/V yesterday. Pt. reports headache is about 1 out of ten now. Pt. reports neck stiffness since Monday and has increased. Pt. reports tenderness to touch of her upper neck and pain when putting chin to chest. Pt. has had similar episode in Oct. 2008 and was hospitalized for about 1 1/2-2 months with IV antibiotics (ROCEPHIN) & Acyclovir for what appeared to be HSV-1 encephalitis. Pt had CT scans & MRIs which showed some edema & focal enlargement of the right media temporal lobe. Herpes encephalitis was a consideration. Pt. also had started taking ORTHO-TRICYCLEN & GARDASIL 2 wks prior to incident. Pt also reports taking both drugs again for about 2 wks. Pt has recently returned from band camp.