chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Gastritis, Gastrointestinal disorder, Hepatobiliary scan, Laboratory test, Ultrasound abdomen
Clinical narrative: Patient experienced severe gastrointestinal symptoms after Gardasil injections. Injections 6/12/07 and 8/14/2007 followed by emergency room visits 8/25/07 and 11/1/07, third injection 12/20/07 followed by emergency room visit and extended hospitalization 2/08.  Severe abdominal pain and vomiting occured each time which would not stop without emergency medical and drug intervention. Multiple diagnostic and lab tests indicated possibility of gall bladder involvement.  Gall bladder was removed 12/5/07. The final Gardasil injection was after gall bladder surgery and another gastrointestinal episode with emergency treatment and a 5 day hospitalization occured after this.  Patient had no history of gall bladder or gastrointestinal symptoms before beginning series of Gardasil injections.  No underlying cause has been clearly established for these conditions, symptoms or multiple episodes by either primary physician, surgeon, gynecologists or gastroenterologist. Tests indicated slow gall bladder emptying, slow gastric emptying and slight gastritis concurrent with these multiple episodes, but patient had no symptoms indicating slow stomach or gallbladder functioning prior to beginning Gardasil. All other tests and screens were negative for anything unusual. Patient has had no recurrence of the symptoms since 2/08, but she is on continuing drug treatment for the gastrointestinal issues.  We are reporting this to assist in identifying any trends related to similar gastrointestinal symptoms, since these conditions are not typical for a 15/16 year old female and the timing of the three injections and the repeated recurrence of these unusual and previously nonexistent symptoms seems a bit more than coincidental.  7/23/08 MR received for several OVs beginning in 11/2007 through 3/2008. Seen 11/7/2007 with c/o 3 episodes of nausea, vomiting and abdominal pain. One episode required IV fluids for dehydration. Pt reports early satiety, weight loss, decreased appetite, fatigue, stress, indigestion, constipation, abdominal bloating, cramping and epigastric pain as well as above.  PE (+) for epigastric and RUQ tenderness otherwise WNL. Endoscopy scheduled. (+) for antritis.  Impression:  Antritis. Pt had Lap chole 12/5/07. Hospital Consult dated 2/7/08 for persistant nausea and vomiting.  Impression:  Persistant nausea and vomiting-etiology unclear.  Abdominal pain, epigastric and LUQ, etiology unclear. Hx antritis. F/U 2/20/08 Impression:  Gastroparesis.  9/8/2008 MR received for multiple Er visits and admission DOS 2/6-11/2008 with D/C DX:  1) Gastric motility disorder. 2) Prolonged vomiting. 3) Dehydration 2' to #2. Hypokalemia 2' to #2.  Pt presented with onset of nausea, vomiting and diarrhea x 3 days. Seen at both PCP office and ER several times prior to admission.   1/25/2010 Follow up: continuing digestive/gastrointestinal problems.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Patient experienced severe gastrointestinal symptoms after Gardasil injections. Injections 6/12/07 and 8/14/2007 followed by emergency room visits 8/25/07 and 11/1/07, third injection 12/20/07 followed by emergency room visit and extended hospitalization 2/08.  Severe abdominal pain and vomiting occured each time which would not stop without emergency medical and drug intervention. Multiple diagnostic and lab tests indicated possibility of gall bladder involvement.  Gall bladder was removed 12/5/07. The final Gardasil injection was after gall bladder surgery and another gastrointestinal episode with emergency treatment and a 5 day hospitalization occured after this.  Patient had no history of gall bladder or gastrointestinal symptoms before beginning series of Gardasil injections.  No underlying cause has been clearly established for these conditions, symptoms or multiple episodes by either primary physician, surgeon, gynecologists or gastroenterologist. Tests indicated slow gall bladder emptying, slow gastric emptying and slight gastritis concurrent with these multiple episodes, but patient had no symptoms indicating slow stomach or gallbladder functioning prior to beginning Gardasil. All other tests and screens were negative for anything unusual. Patient has had no recurrence of the symptoms since 2/08, but she is on continuing drug treatment for the gastrointestinal issues.  We are reporting this to assist in identifying any trends related to similar gastrointestinal symptoms, since these conditions are not typical for a 15/16 year old female and the timing of the three injections and the repeated recurrence of these unusual and previously nonexistent symptoms seems a bit more than coincidental.  7/23/08 MR received for several OVs beginning in 11/2007 through 3/2008. Seen 11/7/2007 with c/o 3 episodes of nausea, vomiting and abdominal pain. One episode required IV fluids for dehydration. Pt reports early satiety, weight loss, decreased appetite, fatigue, stress, indigestion, constipation, abdominal bloating, cramping and epigastric pain as well as above.  PE (+) for epigastric and RUQ tenderness otherwise WNL. Endoscopy scheduled. (+) for antritis.  Impression:  Antritis. Pt had Lap chole 12/5/07. Hospital Consult dated 2/7/08 for persistant nausea and vomiting.  Impression:  Persistant nausea and vomiting-etiology unclear.  Abdominal pain, epigastric and LUQ, etiology unclear. Hx antritis. F/U 2/20/08 Impression:  Gastroparesis.  9/8/2008 MR received for multiple Er visits and admission DOS 2/6-11/2008 with D/C DX:  1) Gastric motility disorder. 2) Prolonged vomiting. 3) Dehydration 2' to #2. Hypokalemia 2' to #2.  Pt presented with onset of nausea, vomiting and diarrhea x 3 days. Seen at both PCP office and ER several times prior to admission.   1/25/2010 Follow up: continuing digestive/gastrointestinal problems.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: After administering the Varicella Vaccine child's left arm the injection site area became red and had raised bumps around injection site.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Chest pain, Computerised tomogram
Clinical narrative: lightheadedness,dizzy,seeing spots,abd pn, nausea,and Left upper quad pain.  After 2nd dose in July of 07 she experienced all of these plus severe hot flashes, sweats,severe muscle pain and weakness, collapsing and passing out as well as chest pain.  She is now sick on a monthly basis and her sickness usually lasts 7-8 days.  She also becomes delusional at times and spacey.  7/14/2008 MR received from PCP from 5/2/2007 through 7/3/2008. HPV #1 5/2/07. Seen 6/15/07 with c/o several week hx of abdominal pain, nausea and fever. PE WNL. Assessment:  Abdominal pain, nausea of ? etiology. Referred to ER PRN. F/U ER visit 6/24/07. PE (+) for abd tenderness, worse in LUQ and epigastric area. (+) guarding. Assess:  Abd pain NYD ? constipation. 7/30/07 2nd HPV. ER visit for abdominal pain 1/24/08 with Assess:  Abdominal pain, possibly due to medication intolerance, benign exam. Hx sinusitis.  Anxiety componant. Seen 2/28/08 where pt became hot, started crying, c/o body aches, felt like passing out.  BS 89. Seen 3/2/2008 w/ c/o constant back pain which radiates to the chest, feeling dizzy. PE (+) for abd tenderness and tenderness over L chest wall, costochondral joint.  DX:  Abd pain LUQ. ? Splenomegaly.  Chest wall pain.  dizziness. Refered to endocrinology clinic.  Seen for unusual spells with features of power, diaphoresis, visual disturbance, abdominal pain, and vomiting. Witnessed absence spell where pt became pale and unresponsive.  BS 87. Pulse 80.  No clear dx. ? conversion rxn. Seen 6/9/08 with R sided abd pain and feeling faint. PE (+) for abd tenderness, perleche. Assessment syncope. 6/30/08 seen w/ c/o dysuria, recuurent back pain with vasomotor symptoms. Paraspinus muscle spasms noted L2-4. 7/3/08 pain and vomiting persist. .
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Delusional perception, Dizziness, Feeling abnormal, Hot flush, Hyperhidrosis
Clinical narrative: lightheadedness,dizzy,seeing spots,abd pn, nausea,and Left upper quad pain.  After 2nd dose in July of 07 she experienced all of these plus severe hot flashes, sweats,severe muscle pain and weakness, collapsing and passing out as well as chest pain.  She is now sick on a monthly basis and her sickness usually lasts 7-8 days.  She also becomes delusional at times and spacey.  7/14/2008 MR received from PCP from 5/2/2007 through 7/3/2008. HPV #1 5/2/07. Seen 6/15/07 with c/o several week hx of abdominal pain, nausea and fever. PE WNL. Assessment:  Abdominal pain, nausea of ? etiology. Referred to ER PRN. F/U ER visit 6/24/07. PE (+) for abd tenderness, worse in LUQ and epigastric area. (+) guarding. Assess:  Abd pain NYD ? constipation. 7/30/07 2nd HPV. ER visit for abdominal pain 1/24/08 with Assess:  Abdominal pain, possibly due to medication intolerance, benign exam. Hx sinusitis.  Anxiety componant. Seen 2/28/08 where pt became hot, started crying, c/o body aches, felt like passing out.  BS 89. Seen 3/2/2008 w/ c/o constant back pain which radiates to the chest, feeling dizzy. PE (+) for abd tenderness and tenderness over L chest wall, costochondral joint.  DX:  Abd pain LUQ. ? Splenomegaly.  Chest wall pain.  dizziness. Refered to endocrinology clinic.  Seen for unusual spells with features of power, diaphoresis, visual disturbance, abdominal pain, and vomiting. Witnessed absence spell where pt became pale and unresponsive.  BS 87. Pulse 80.  No clear dx. ? conversion rxn. Seen 6/9/08 with R sided abd pain and feeling faint. PE (+) for abd tenderness, perleche. Assessment syncope. 6/30/08 seen w/ c/o dysuria, recuurent back pain with vasomotor symptoms. Paraspinus muscle spasms noted L2-4. 7/3/08 pain and vomiting persist. .
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Loss of consciousness, Myalgia, Nausea, Syncope
Clinical narrative: lightheadedness,dizzy,seeing spots,abd pn, nausea,and Left upper quad pain.  After 2nd dose in July of 07 she experienced all of these plus severe hot flashes, sweats,severe muscle pain and weakness, collapsing and passing out as well as chest pain.  She is now sick on a monthly basis and her sickness usually lasts 7-8 days.  She also becomes delusional at times and spacey.  7/14/2008 MR received from PCP from 5/2/2007 through 7/3/2008. HPV #1 5/2/07. Seen 6/15/07 with c/o several week hx of abdominal pain, nausea and fever. PE WNL. Assessment:  Abdominal pain, nausea of ? etiology. Referred to ER PRN. F/U ER visit 6/24/07. PE (+) for abd tenderness, worse in LUQ and epigastric area. (+) guarding. Assess:  Abd pain NYD ? constipation. 7/30/07 2nd HPV. ER visit for abdominal pain 1/24/08 with Assess:  Abdominal pain, possibly due to medication intolerance, benign exam. Hx sinusitis.  Anxiety componant. Seen 2/28/08 where pt became hot, started crying, c/o body aches, felt like passing out.  BS 89. Seen 3/2/2008 w/ c/o constant back pain which radiates to the chest, feeling dizzy. PE (+) for abd tenderness and tenderness over L chest wall, costochondral joint.  DX:  Abd pain LUQ. ? Splenomegaly.  Chest wall pain.  dizziness. Refered to endocrinology clinic.  Seen for unusual spells with features of power, diaphoresis, visual disturbance, abdominal pain, and vomiting. Witnessed absence spell where pt became pale and unresponsive.  BS 87. Pulse 80.  No clear dx. ? conversion rxn. Seen 6/9/08 with R sided abd pain and feeling faint. PE (+) for abd tenderness, perleche. Assessment syncope. 6/30/08 seen w/ c/o dysuria, recuurent back pain with vasomotor symptoms. Paraspinus muscle spasms noted L2-4. 7/3/08 pain and vomiting persist. .
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan, Vaccine positive rechallenge, Visual disturbance, X-ray
Clinical narrative: lightheadedness,dizzy,seeing spots,abd pn, nausea,and Left upper quad pain.  After 2nd dose in July of 07 she experienced all of these plus severe hot flashes, sweats,severe muscle pain and weakness, collapsing and passing out as well as chest pain.  She is now sick on a monthly basis and her sickness usually lasts 7-8 days.  She also becomes delusional at times and spacey.  7/14/2008 MR received from PCP from 5/2/2007 through 7/3/2008. HPV #1 5/2/07. Seen 6/15/07 with c/o several week hx of abdominal pain, nausea and fever. PE WNL. Assessment:  Abdominal pain, nausea of ? etiology. Referred to ER PRN. F/U ER visit 6/24/07. PE (+) for abd tenderness, worse in LUQ and epigastric area. (+) guarding. Assess:  Abd pain NYD ? constipation. 7/30/07 2nd HPV. ER visit for abdominal pain 1/24/08 with Assess:  Abdominal pain, possibly due to medication intolerance, benign exam. Hx sinusitis.  Anxiety componant. Seen 2/28/08 where pt became hot, started crying, c/o body aches, felt like passing out.  BS 89. Seen 3/2/2008 w/ c/o constant back pain which radiates to the chest, feeling dizzy. PE (+) for abd tenderness and tenderness over L chest wall, costochondral joint.  DX:  Abd pain LUQ. ? Splenomegaly.  Chest wall pain.  dizziness. Refered to endocrinology clinic.  Seen for unusual spells with features of power, diaphoresis, visual disturbance, abdominal pain, and vomiting. Witnessed absence spell where pt became pale and unresponsive.  BS 87. Pulse 80.  No clear dx. ? conversion rxn. Seen 6/9/08 with R sided abd pain and feeling faint. PE (+) for abd tenderness, perleche. Assessment syncope. 6/30/08 seen w/ c/o dysuria, recuurent back pain with vasomotor symptoms. Paraspinus muscle spasms noted L2-4. 7/3/08 pain and vomiting persist. .
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthropathy, Renal disorder, Systemic lupus erythematosus
Clinical narrative: Patient development joint symptoms first, near Christmas 2007  Then after several months (March 2008)developed a serious kidney problems and was diagnosed with Lupus erythematous.   She is currently undergoing intermittent chemo treatment with a Pediatric Rheumatologist in Omaha, Nebr.  Date of vaccination was her second HPV(Gardasil) Her first was 8/14/2007 at same clinic, location and same manufacturer of vaccine.   (This may have been reported previously from a relative in the family who is a pharmacist.)
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthropathy, Chemotherapy, Renal disorder, Systemic lupus erythematosus
Clinical narrative: Patient development joint symptoms first, near Christmas 2007  Then after several months (March 2008)developed a serious kidney problems and was diagnosed with Lupus erythematous.   She is currently undergoing intermittent chemo treatment with a Pediatric Rheumatologist in Omaha, Nebr.  Date of vaccination was her second HPV(Gardasil) Her first was 8/14/2007 at same clinic, location and same manufacturer of vaccine.   (This may have been reported previously from a relative in the family who is a pharmacist.)
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Anxiety, Asthenia, Convulsion, Dyskinesia, Electroencephalogram normal
Clinical narrative: Patient received the Gardasil shot around 11:00a.m. on the 27th of November 2007.  Patient received a meningitas shot first, then she got the Gardasil shot.  Immediately after the Gardasil needle was removed from patient's arm patient's pupils got large, her head fell foward, her shoulders started bouncing and her arms where stiff.  The doctors that came in the room stated to me that she just passed out.  The nurse that was in the room administering the shot said that patient had a seizure.  And by all means was the one medical personal who actually seen what all took place.  Patient's episode only lasted but 30 seconds to 1 minute.  Once patient woke up she didn't remember what was going on and felt like she had just woke up from a night of sleep.  Dr. stated questioning patient about when she last ate and tried to do a blood sugar test on her, but by time they found test strips for the machine patient had already been given a soda and pretels.  What really kept me worrying about this shot is when patient started passing out after she got the Gardasil shot.  Two days later patient needed to have blood work drawn for lab work related to her menstal cycle.  She was very anxious about passing out again.  She did start to pass out, but this time her body just really went limp.  Then on 27 December 2007 around 3:30p.m. patient passed out.  I was not around for this one, but as I was told patient's pupils where large again and she started to fall from a standing postion.  She was caught by her grandmother and was layed on a bench.  Patient doesn't recall what happened and again felt like she was waking up from a night sleep.  Then on 27 January 2008 around 9:45a.m. patient was singing at church kneeling next to me.  I noticed her stop singing and put her head down.  I questioned her if she was okay, and she put her finger up to me and then fell out of the pew.  I got patient back up in the pew and a female member of our church who is a nurse came up to help me with patient.  Patient's eyes where large and shifting back and forth.  Her body was still and this lasted again about 30 seconds.  The lady who came to help me was concerened about patient and knew of the other episodes that patient had.  She agreed that she seen a seizure.  After that, Dr. referred patient down to Hospital to see Dr. Patient had a 24 hour EEG on 26 Febuary to 27 Febuary 2008.  Nothing came about from that.  And patient hasn't had any other episodes.  I also will not let her get the Gardasil shot boosters.  I am not risking this.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Eye movement disorder, Fall, Immediate post-injection reaction, Loss of consciousness, Memory impairment
Clinical narrative: Patient received the Gardasil shot around 11:00a.m. on the 27th of November 2007.  Patient received a meningitas shot first, then she got the Gardasil shot.  Immediately after the Gardasil needle was removed from patient's arm patient's pupils got large, her head fell foward, her shoulders started bouncing and her arms where stiff.  The doctors that came in the room stated to me that she just passed out.  The nurse that was in the room administering the shot said that patient had a seizure.  And by all means was the one medical personal who actually seen what all took place.  Patient's episode only lasted but 30 seconds to 1 minute.  Once patient woke up she didn't remember what was going on and felt like she had just woke up from a night of sleep.  Dr. stated questioning patient about when she last ate and tried to do a blood sugar test on her, but by time they found test strips for the machine patient had already been given a soda and pretels.  What really kept me worrying about this shot is when patient started passing out after she got the Gardasil shot.  Two days later patient needed to have blood work drawn for lab work related to her menstal cycle.  She was very anxious about passing out again.  She did start to pass out, but this time her body just really went limp.  Then on 27 December 2007 around 3:30p.m. patient passed out.  I was not around for this one, but as I was told patient's pupils where large again and she started to fall from a standing postion.  She was caught by her grandmother and was layed on a bench.  Patient doesn't recall what happened and again felt like she was waking up from a night sleep.  Then on 27 January 2008 around 9:45a.m. patient was singing at church kneeling next to me.  I noticed her stop singing and put her head down.  I questioned her if she was okay, and she put her finger up to me and then fell out of the pew.  I got patient back up in the pew and a female member of our church who is a nurse came up to help me with patient.  Patient's eyes where large and shifting back and forth.  Her body was still and this lasted again about 30 seconds.  The lady who came to help me was concerened about patient and knew of the other episodes that patient had.  She agreed that she seen a seizure.  After that, Dr. referred patient down to Hospital to see Dr. Patient had a 24 hour EEG on 26 Febuary to 27 Febuary 2008.  Nothing came about from that.  And patient hasn't had any other episodes.  I also will not let her get the Gardasil shot boosters.  I am not risking this.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Musculoskeletal stiffness, Mydriasis
Clinical narrative: Patient received the Gardasil shot around 11:00a.m. on the 27th of November 2007.  Patient received a meningitas shot first, then she got the Gardasil shot.  Immediately after the Gardasil needle was removed from patient's arm patient's pupils got large, her head fell foward, her shoulders started bouncing and her arms where stiff.  The doctors that came in the room stated to me that she just passed out.  The nurse that was in the room administering the shot said that patient had a seizure.  And by all means was the one medical personal who actually seen what all took place.  Patient's episode only lasted but 30 seconds to 1 minute.  Once patient woke up she didn't remember what was going on and felt like she had just woke up from a night of sleep.  Dr. stated questioning patient about when she last ate and tried to do a blood sugar test on her, but by time they found test strips for the machine patient had already been given a soda and pretels.  What really kept me worrying about this shot is when patient started passing out after she got the Gardasil shot.  Two days later patient needed to have blood work drawn for lab work related to her menstal cycle.  She was very anxious about passing out again.  She did start to pass out, but this time her body just really went limp.  Then on 27 December 2007 around 3:30p.m. patient passed out.  I was not around for this one, but as I was told patient's pupils where large again and she started to fall from a standing postion.  She was caught by her grandmother and was layed on a bench.  Patient doesn't recall what happened and again felt like she was waking up from a night sleep.  Then on 27 January 2008 around 9:45a.m. patient was singing at church kneeling next to me.  I noticed her stop singing and put her head down.  I questioned her if she was okay, and she put her finger up to me and then fell out of the pew.  I got patient back up in the pew and a female member of our church who is a nurse came up to help me with patient.  Patient's eyes where large and shifting back and forth.  Her body was still and this lasted again about 30 seconds.  The lady who came to help me was concerened about patient and knew of the other episodes that patient had.  She agreed that she seen a seizure.  After that, Dr. referred patient down to Hospital to see Dr. Patient had a 24 hour EEG on 26 Febuary to 27 Febuary 2008.  Nothing came about from that.  And patient hasn't had any other episodes.  I also will not let her get the Gardasil shot boosters.  I am not risking this.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Balance disorder, Borrelia burgdorferi serology negative, Cytomegalovirus antibody negative
Clinical narrative: Patient recieved her  3rd series of Gardisil May 27 @ her MD office, approx felt dizzy for 2 week duration aftr ( she felt that she had to hold on to the walls when she walked). On friday she made an appt with her Md to be checked.  She was given an appt for June 10th. She was having a hard tiime focusing andwas unable to work because just sitting at her desk made her feel like she was going to faint...  She saw her Pcpand after eval felt she should see a ENTspecialist. Allher blood work was normal but patient was unable to drive or sit up because of the feeling she was going to pass out.  Unable to get an appt promptly with and ENT specialist.  We Wemt to another office for an eval.  She was cleared by ENT.  Patient proceed to feel worse and the stared c/o of arm heaviness that proceeded toleg heavisness.   In discussion with her NOP SHE SUGGEST TO SEE A NEUROLOGIST.  Agin extreme difficult getting appt with specialist.    MRI was ored secondary to dizziness, nausea arm and leg weakness.  MRI negative.  Relieved but still no answer Why a 21 year old active girl is physically debilitated  unable to drive or work etc.  lab work normal ..  After concern and discussion that symptoms are not improving .  NP decied to tx for lyme disease. no improve however now sever joint discomfort     Very scary to see a 21 yr old girl unable to get out of bed . np fevers etc 8/15/08-records received for DOS 6/17/08-C/O dizzy, nausea, headache, feels off balance, intermittent episodes of dizziness followed by nausea. Dizziness occurs primarily when standing. Fatigued, some weakness in arms on and off. Returned from foreign travel one month ago.  Impression: vertigo and nausea.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Disturbance in attention, Dizziness, Impaired driving ability, Impaired work ability, Laboratory test normal
Clinical narrative: Patient recieved her  3rd series of Gardisil May 27 @ her MD office, approx felt dizzy for 2 week duration aftr ( she felt that she had to hold on to the walls when she walked). On friday she made an appt with her Md to be checked.  She was given an appt for June 10th. She was having a hard tiime focusing andwas unable to work because just sitting at her desk made her feel like she was going to faint...  She saw her Pcpand after eval felt she should see a ENTspecialist. Allher blood work was normal but patient was unable to drive or sit up because of the feeling she was going to pass out.  Unable to get an appt promptly with and ENT specialist.  We Wemt to another office for an eval.  She was cleared by ENT.  Patient proceed to feel worse and the stared c/o of arm heaviness that proceeded toleg heavisness.   In discussion with her NOP SHE SUGGEST TO SEE A NEUROLOGIST.  Agin extreme difficult getting appt with specialist.    MRI was ored secondary to dizziness, nausea arm and leg weakness.  MRI negative.  Relieved but still no answer Why a 21 year old active girl is physically debilitated  unable to drive or work etc.  lab work normal ..  After concern and discussion that symptoms are not improving .  NP decied to tx for lyme disease. no improve however now sever joint discomfort     Very scary to see a 21 yr old girl unable to get out of bed . np fevers etc 8/15/08-records received for DOS 6/17/08-C/O dizzy, nausea, headache, feels off balance, intermittent episodes of dizziness followed by nausea. Dizziness occurs primarily when standing. Fatigued, some weakness in arms on and off. Returned from foreign travel one month ago.  Impression: vertigo and nausea.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Nausea, Nuclear magnetic resonance imaging normal, Presyncope, Sensation of heaviness
Clinical narrative: Patient recieved her  3rd series of Gardisil May 27 @ her MD office, approx felt dizzy for 2 week duration aftr ( she felt that she had to hold on to the walls when she walked). On friday she made an appt with her Md to be checked.  She was given an appt for June 10th. She was having a hard tiime focusing andwas unable to work because just sitting at her desk made her feel like she was going to faint...  She saw her Pcpand after eval felt she should see a ENTspecialist. Allher blood work was normal but patient was unable to drive or sit up because of the feeling she was going to pass out.  Unable to get an appt promptly with and ENT specialist.  We Wemt to another office for an eval.  She was cleared by ENT.  Patient proceed to feel worse and the stared c/o of arm heaviness that proceeded toleg heavisness.   In discussion with her NOP SHE SUGGEST TO SEE A NEUROLOGIST.  Agin extreme difficult getting appt with specialist.    MRI was ored secondary to dizziness, nausea arm and leg weakness.  MRI negative.  Relieved but still no answer Why a 21 year old active girl is physically debilitated  unable to drive or work etc.  lab work normal ..  After concern and discussion that symptoms are not improving .  NP decied to tx for lyme disease. no improve however now sever joint discomfort     Very scary to see a 21 yr old girl unable to get out of bed . np fevers etc 8/15/08-records received for DOS 6/17/08-C/O dizzy, nausea, headache, feels off balance, intermittent episodes of dizziness followed by nausea. Dizziness occurs primarily when standing. Fatigued, some weakness in arms on and off. Returned from foreign travel one month ago.  Impression: vertigo and nausea.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Anxiety disorder, Blood test, Convulsion, Dyspnoea, Electrocardiogram
Clinical narrative: Patient had syncope episode, seizure activities,anxiety disorder,twitching of body, fainting spells,headaches, bed wetting,hallucinations. nightmares that woke her from dead sleep. Patient had none of these problems prior to this situation. 07/17/08-records received-DOS 9/5/07-presented to ED with C/O difficulty breathing after runing laps. Sharp pain in head, body numb, staring, unresponsive to stimuli. Assessment:syncopal episode. Presented to ED on 9/7/07 after DC from hospital breathng became rapid and hands tingle and feel painful. Assessment:tingling sensation in hand possible due to hyperventilation representing an anxiety attack or conversion disorder. 9/8/07-presented to ED with C/O a spell-assessment; Hyperventilation syndrome.  1/25/2010 Follow up: The patient is on medication to control the syncope episodes and to help manage her problem. She has to take extreme caustion in regard to her health to avoid having an episode of syncope. She has mornings where she is having an episode and smelling salts have to be used to break her from her episode.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Enuresis, Hallucination, Headache, Headache, Hypoaesthesia
Clinical narrative: Patient had syncope episode, seizure activities,anxiety disorder,twitching of body, fainting spells,headaches, bed wetting,hallucinations. nightmares that woke her from dead sleep. Patient had none of these problems prior to this situation. 07/17/08-records received-DOS 9/5/07-presented to ED with C/O difficulty breathing after runing laps. Sharp pain in head, body numb, staring, unresponsive to stimuli. Assessment:syncopal episode. Presented to ED on 9/7/07 after DC from hospital breathng became rapid and hands tingle and feel painful. Assessment:tingling sensation in hand possible due to hyperventilation representing an anxiety attack or conversion disorder. 9/8/07-presented to ED with C/O a spell-assessment; Hyperventilation syndrome.  1/25/2010 Follow up: The patient is on medication to control the syncope episodes and to help manage her problem. She has to take extreme caustion in regard to her health to avoid having an episode of syncope. She has mornings where she is having an episode and smelling salts have to be used to break her from her episode.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Muscle twitching, Nightmare, Sleep disorder, Staring, Syncope
Clinical narrative: Patient had syncope episode, seizure activities,anxiety disorder,twitching of body, fainting spells,headaches, bed wetting,hallucinations. nightmares that woke her from dead sleep. Patient had none of these problems prior to this situation. 07/17/08-records received-DOS 9/5/07-presented to ED with C/O difficulty breathing after runing laps. Sharp pain in head, body numb, staring, unresponsive to stimuli. Assessment:syncopal episode. Presented to ED on 9/7/07 after DC from hospital breathng became rapid and hands tingle and feel painful. Assessment:tingling sensation in hand possible due to hyperventilation representing an anxiety attack or conversion disorder. 9/8/07-presented to ED with C/O a spell-assessment; Hyperventilation syndrome.  1/25/2010 Follow up: The patient is on medication to control the syncope episodes and to help manage her problem. She has to take extreme caustion in regard to her health to avoid having an episode of syncope. She has mornings where she is having an episode and smelling salts have to be used to break her from her episode.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient had syncope episode, seizure activities,anxiety disorder,twitching of body, fainting spells,headaches, bed wetting,hallucinations. nightmares that woke her from dead sleep. Patient had none of these problems prior to this situation. 07/17/08-records received-DOS 9/5/07-presented to ED with C/O difficulty breathing after runing laps. Sharp pain in head, body numb, staring, unresponsive to stimuli. Assessment:syncopal episode. Presented to ED on 9/7/07 after DC from hospital breathng became rapid and hands tingle and feel painful. Assessment:tingling sensation in hand possible due to hyperventilation representing an anxiety attack or conversion disorder. 9/8/07-presented to ED with C/O a spell-assessment; Hyperventilation syndrome.  1/25/2010 Follow up: The patient is on medication to control the syncope episodes and to help manage her problem. She has to take extreme caustion in regard to her health to avoid having an episode of syncope. She has mornings where she is having an episode and smelling salts have to be used to break her from her episode.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Asthenia, Blood pressure decreased, Dizziness, Hypotension
Clinical narrative: Patient was seen for general physical exam.  She felt dizzy and weak approximately 3-5 minutes after the vaccines were administered (Havrix and Gardasil).  She was placed in the exam room on the bed with the head of bed elevated 30 degrees.  Initial Blood Pressure at time of office visit was 110/80; 5 min after vaccine administration was 70/50; 20 min after vaccine administration was 100/80.  No medications were given.  She was sent home after indicating that she felt better (about 15 min after the last BP reading).
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Injection site pain, Joint stiffness
Clinical narrative: My daughter felt significant pain at the innoculation site.  After a couple of minutes she became dizzy and passed out.  Her eyes were open and her arms were tense and bent at the elbows while she was unconscienous.  This lasted for about a minute.  Afterward, she was perspired and felt weak. We were kept in the doctor's office for about one hour and 15 minutes afterwards.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: My daughter felt significant pain at the innoculation site.  After a couple of minutes she became dizzy and passed out.  Her eyes were open and her arms were tense and bent at the elbows while she was unconscienous.  This lasted for about a minute.  Afterward, she was perspired and felt weak. We were kept in the doctor's office for about one hour and 15 minutes afterwards.
Sex: F
Vaccine: HPV4
Symptoms: Death, Hypersensitivity
Clinical narrative: Information has been received from a physician who was told by a patient's mother that a female patient with a sulfa allergy who on an unspecified date was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported), which was well tolerated. On an unspecified date, the patient was vaccinated with a second dose of GARDASIL (lot number, injection site and route not reported). Subsequently the patient died. The cause of death was reported as allergic reaction to GARDASIL. The physician stated that the patient who died was not her patient and she knew no further details. Follow-up information was received from the physician who reported that a other of one of her patients had said to her, that she "thought" she read this report on the internet. The physician asked the patient's mother to find out where she read the report. The patient's mother could not find the report and did not know where to locate the source information. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope, Tonic clonic movements
Clinical narrative: Information has been received from a registered nurse concerning a female who on 30-JUN-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM.  On 30-JUN-2008 the patient experienced faint and tonic clonic for 10 seconds.  The patient regained consciousness and was observed in the office for 30 minutes.  The patient was given juice and her blood pressure and pulse were monitored.  The patient was discharged home.  The patient recovered from faint and tonic clonic on that same day.  The patient sought medical attention in office.  Upon internal review, tonic clonic was determined to be an other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Cyanosis, Listless, Pallor, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL.  After receiving GARDASIL the patient fainted and had a severe seizure.  The patient was listless and had a dusky color after the seizure.  The physician observed the patient for 1/2 hour and then sent her home accompanied by her mother.  The patient was then sent to a neurologist.  At the time of the report, it was unknown if the patients had recovered from faintness, listless and dusky color.  Upon internal review, seizure was considered to be an other important medical event.  This is one of several reports from the same source.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion induced, Chromosome analysis normal, Drug exposure during pregnancy, Laboratory test normal, Ultrasound scan abnormal
Clinical narrative: Information has been received through the Merck pregnancy registry from a certified nurse midwife concerning a 21 year old female who on 20-FEB-2007 was vaccinated with a first dose of VARIVAX.  Concomitant therapy included vitamins (unspecified).  The patient was pregnant.  The patient's LMP was 03-APR-2007.  The patient's Quad screen was abnormal; it indicated an increased risk for fetal Down 1 in 133.  Fetal biometry was measuring consistent with 16w3d.  This may have reflected a true dating discrepancy however it may have also represented symmetric IUGR.  Therefore her sonogram was moved up.  On 13-AUG-2007 the ultrasound showed: Single live IUP measuring consistent with 16w3d.  A complex cardiac defect was observed on the scan.  The normal four chamber view could not be visualized.  There was a large VSD and a large primum ASD suggesting an atrioventricular canal defect.  The LVOT appears elongated and narrow.  There is a left ventricular echogenic focus.  The aortic arch could not be visualized on the exam.  The ductal arteriosus and descending aorta appeared narrowed.  However, the pulmonary artery appeared dilated and measured 3.7mm.  Heterotaxy was observed with the fetal stomach appearing fluid filled and located on the right.  The kidneys and bowel appeared slightly echogenic and the fetal long bones appeared shortened (<3%).  The nurse reported that the multiple anomalies were not consistent with a syndrome, "little was right and the prognosis was grim".  The above Ultrasound findings and testing results were reviewed with the patient and her partner.  The reporter discussed the significantly increased risk for fetal aneuploidy based on multiple ultrasound markers and major cardiac anomaly detected, indication, risks and benefits of amniocentesis were recommended.  However, after counseling, the patient and her partner decided against further evaluation and wished to pursue termination of pregnancy.  They were aware that the evaluation was incomplete at that time and prognosis, though guarded could not fully be delineated.  The patient and her partner decided to proceed with termination without further evaluation.  On 14-AUG-2007 the patient elected for a termination of the pregnancy.  The fetus was 18 weeks by the LMP, but measured 16 weeks and was small because of the anomalies.  Karotyping was performed on both the patient and her husband and all tests were normal.  As of 26-JUN-2008 the patient was pregnant again.  (Refer to WAES#: 0807USA00561).  Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Oedema, Rash, Skin discolouration, Vasculitis
Clinical narrative: Information has been received from a physician concerning an 86 year old male with mild renal insufficiency who on an unspecified date was vaccinated with the first dose of ZOSTAVAX. Concomitant therapy was not specified. After two days post vaccination, the patient developed rash on his legs. About five days post vaccination, the patient went to Urgent Care because he experienced edema, but had no pain. The physician diagnosed this as small vessel vasculitis. It was the color purple and ran from the feet to the knees as well as the elbows. The outcome was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Chills, Laboratory test, Liver function test, Malaise, Nausea
Clinical narrative: SERIOUSNESS: OTHER - MEDICALLY SIGNIFICANT.  Initial report received 26 June 2008 from a listserve inquiry which had been submitted by a health care professional.  A 21-year-old female patient with no significant medical history, had received a Yellow Fever vaccination (manufacturer, lot number, route/site of administration not reported) 12 days prior to the reporting of the event on 26 June 2008, and within two hours of vaccination, she experienced shaking chills, nausea and visual disturbances.  She also experienced several episodes of fever and chills in the ensuing week along with two near syncopal episodes.  The patient contacted her physician on 25 June 2008, 11 days following vaccination, to inform them of her symptoms.  She had gradual improvement, but still did not feel 100%.  She was evaluated by her physician on the morning of 26 June 2008.  She looked well, in no distress, no rash, no hepatomegaly and no abdominal pain.  Basic laboratory tests and LFTs were run (results not reported) and the patient was discharged.  Later that afternoon, the patient returned to the physician after laying in the sun because she developed a macular rash which covered only sun exposed areas.  The rash spared her hands and feet and had a halo of blanching around the macules.  The patient had no other complaints and the remainder of the examination had been normal.  Corrective treatments included XYZAL.  At the time of the report, the physician was awaiting the results of the laboratory studies.  The physician consulted listserve to obtain additional information pertaining to the patient's symptoms and to inquire if the events experienced by the patient might be associated with yellow fever vaccination.  The physician also requested guidance for the management of the events to prevent further complications.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Pallor, Presyncope, Pyrexia, Rash macular, Tremor
Clinical narrative: SERIOUSNESS: OTHER - MEDICALLY SIGNIFICANT.  Initial report received 26 June 2008 from a listserve inquiry which had been submitted by a health care professional.  A 21-year-old female patient with no significant medical history, had received a Yellow Fever vaccination (manufacturer, lot number, route/site of administration not reported) 12 days prior to the reporting of the event on 26 June 2008, and within two hours of vaccination, she experienced shaking chills, nausea and visual disturbances.  She also experienced several episodes of fever and chills in the ensuing week along with two near syncopal episodes.  The patient contacted her physician on 25 June 2008, 11 days following vaccination, to inform them of her symptoms.  She had gradual improvement, but still did not feel 100%.  She was evaluated by her physician on the morning of 26 June 2008.  She looked well, in no distress, no rash, no hepatomegaly and no abdominal pain.  Basic laboratory tests and LFTs were run (results not reported) and the patient was discharged.  Later that afternoon, the patient returned to the physician after laying in the sun because she developed a macular rash which covered only sun exposed areas.  The rash spared her hands and feet and had a halo of blanching around the macules.  The patient had no other complaints and the remainder of the examination had been normal.  Corrective treatments included XYZAL.  At the time of the report, the physician was awaiting the results of the laboratory studies.  The physician consulted listserve to obtain additional information pertaining to the patient's symptoms and to inquire if the events experienced by the patient might be associated with yellow fever vaccination.  The physician also requested guidance for the management of the events to prevent further complications.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Visual disturbance
Clinical narrative: SERIOUSNESS: OTHER - MEDICALLY SIGNIFICANT.  Initial report received 26 June 2008 from a listserve inquiry which had been submitted by a health care professional.  A 21-year-old female patient with no significant medical history, had received a Yellow Fever vaccination (manufacturer, lot number, route/site of administration not reported) 12 days prior to the reporting of the event on 26 June 2008, and within two hours of vaccination, she experienced shaking chills, nausea and visual disturbances.  She also experienced several episodes of fever and chills in the ensuing week along with two near syncopal episodes.  The patient contacted her physician on 25 June 2008, 11 days following vaccination, to inform them of her symptoms.  She had gradual improvement, but still did not feel 100%.  She was evaluated by her physician on the morning of 26 June 2008.  She looked well, in no distress, no rash, no hepatomegaly and no abdominal pain.  Basic laboratory tests and LFTs were run (results not reported) and the patient was discharged.  Later that afternoon, the patient returned to the physician after laying in the sun because she developed a macular rash which covered only sun exposed areas.  The rash spared her hands and feet and had a halo of blanching around the macules.  The patient had no other complaints and the remainder of the examination had been normal.  Corrective treatments included XYZAL.  At the time of the report, the physician was awaiting the results of the laboratory studies.  The physician consulted listserve to obtain additional information pertaining to the patient's symptoms and to inquire if the events experienced by the patient might be associated with yellow fever vaccination.  The physician also requested guidance for the management of the events to prevent further complications.
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Injection site warmth, Oedema peripheral, Pain, Rash erythematous
Clinical narrative: This report was received from a health professional on 01 July 2008. A 39-year-old female patient received her second intramuscular right deltoid injection of IMOVAX RABIES (lot number A0484) on 17 June 2008. Past medical history included increased cholesterol, fibrocystic breast disease, degenerative arthritis, and allergic conjunctivitis. Previously, she had received an intramuscular gluteal injection of IMOGAM (lot number B0886-5) and a first injection of IMOVAX; dates of administration were not provided. Following her second dose of IMOVAX, the patient began experiencing swelling in her hands and feet. She developed a red, blotchy, raised, itchy rash which was generalized over her entire body. The right deltoid was hot to the touch at the injection site. She subsequently complained of generalized body aches, and numbness in her hands "as if they were falling asleep". No relevant laboratory test results were available, and outcome was unknown to the reporter. Concomitant medications included birth control and AMBIEN.