chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Irritability, Migraine, Muscle fatigue, Muscle spasms
Clinical narrative: ache: joint, acid reflux, anxiety, arrhythmia, high cholesterol, leg cramps, dry mouth, energy loss, muscle fatigue, gastritis, migraines, loud noises, lump in right groin, anxious, angry, irritable mood, numbness tingling fingers, pain lower back, groin, back, joint and muscle, chest, rashes, sleep problem, thirst and tiredness
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia, Paraesthesia, Rash, Sleep disorder, Thirst
Clinical narrative: ache: joint, acid reflux, anxiety, arrhythmia, high cholesterol, leg cramps, dry mouth, energy loss, muscle fatigue, gastritis, migraines, loud noises, lump in right groin, anxious, angry, irritable mood, numbness tingling fingers, pain lower back, groin, back, joint and muscle, chest, rashes, sleep problem, thirst and tiredness
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MEN, PNC, RV5, DTAPHEPBIP, HIBV, MEN, PNC, RV5, TTOX
Symptoms: Autopsy, Death, Metabolic function test, Neurological examination
Clinical narrative: This male subject was enrolled in the prophylactic open study 110870 (MenACWY-TT-057).  On 4 April 2008, he received the 1st dose of HIB-MENCY-TT (IM L thigh) and of PEDIARIX (IM R thigh).  The subject received concomitantly PREVNAR (IM) and ROTATEQ vaccines (po).  Medical conditions at the time of the event included apnea and seizure.  Concomitant medications included PREVACID and KEPPRA.  On 02 July 2008, 89 days after the 1st dose of PEDIARIX, 89 days after the 1st dose of HIB-MENCY-TT, this five-month-old subject died.  The event was disabling, life-threatening, clinically significant (or requiring intervention).  The subject died on 02 July 2008, cause of death is unknown.  An autopsy was performed.  The investigator considered that there was a reasonable possibility that the death nos may have been caused by PEDIARIX and HIB-MENCY-TT.  Investigator Comments: Site was Notified of report of death on 07-03-2008, records have been requested.  All data pending.  07-07-2008.  After PI review, cannot completely rule out vaccine related causality, but not probable.  Subject on anticonvulsants and has underwent metabolic/neurologic work-up with no significant findings.  Possibility of Munchausen by Proxy, but waiting on pending results of physician and ER notes, apnea monitor results and autopsy and toxicology report.  8/22/08 Autopsy states COD as sudden unexpected infant death.  Report also states  Anatomical diagnosis: same as COD & aspiration of vomitus, terminal/subterminal focal bilateral.  Comments: infant had complicated history of seizures, aspiration & apnea which could not be substantiated during multiple hospitalizations & ER visits & Munchausen by proxy was questioned.  Autopsy showed only relatively mild terminal aspiration of vomitus. 8/5/08 Reviewed ER medical records of 7/2/2008 submitted by FDA from manufacturer.  Records reveal patient well known w/history of recurrent episodes of life-threatening events of possible apnea vs seizure over the prior 2 months w/cyanosis, choking & gagging.  Was on apnea/bradycardia monitor at home.  Found by parent vomiting & poorly responsive.  Started CPR & ACLS by EMS.  Arrived in ER in full arrest & unable to resuscitate.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MEN, PNC, RV5, DTAPHEPBIP, HIBV, MEN, PNC, RV5, TTOX
Symptoms: Anion gap normal, Apnoea, Blood chloride normal, Blood glucose increased, Blood potassium increased
Clinical narrative: This male subject was enrolled in the prophylactic open study 110870 (MenACWY-TT-057).  On 4 April 2008, he received the 1st dose of HIB-MENCY-TT (IM L thigh) and of PEDIARIX (IM R thigh).  The subject received concomitantly PREVNAR (IM) and ROTATEQ vaccines (po).  Medical conditions at the time of the event included apnea and seizure.  Concomitant medications included PREVACID and KEPPRA.  On 02 July 2008, 89 days after the 1st dose of PEDIARIX, 89 days after the 1st dose of HIB-MENCY-TT, this five-month-old subject died.  The event was disabling, life-threatening, clinically significant (or requiring intervention).  The subject died on 02 July 2008, cause of death is unknown.  An autopsy was performed.  The investigator considered that there was a reasonable possibility that the death nos may have been caused by PEDIARIX and HIB-MENCY-TT.  Investigator Comments: Site was Notified of report of death on 07-03-2008, records have been requested.  All data pending.  07-07-2008.  After PI review, cannot completely rule out vaccine related causality, but not probable.  Subject on anticonvulsants and has underwent metabolic/neurologic work-up with no significant findings.  Possibility of Munchausen by Proxy, but waiting on pending results of physician and ER notes, apnea monitor results and autopsy and toxicology report.  8/22/08 Autopsy states COD as sudden unexpected infant death.  Report also states  Anatomical diagnosis: same as COD & aspiration of vomitus, terminal/subterminal focal bilateral.  Comments: infant had complicated history of seizures, aspiration & apnea which could not be substantiated during multiple hospitalizations & ER visits & Munchausen by proxy was questioned.  Autopsy showed only relatively mild terminal aspiration of vomitus. 8/5/08 Reviewed ER medical records of 7/2/2008 submitted by FDA from manufacturer.  Records reveal patient well known w/history of recurrent episodes of life-threatening events of possible apnea vs seizure over the prior 2 months w/cyanosis, choking & gagging.  Was on apnea/bradycardia monitor at home.  Found by parent vomiting & poorly responsive.  Started CPR & ACLS by EMS.  Arrived in ER in full arrest & unable to resuscitate.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MEN, PNC, RV5, DTAPHEPBIP, HIBV, MEN, PNC, RV5, TTOX
Symptoms: Blood sodium normal, C-reactive protein increased, Carbon dioxide decreased, Chest X-ray abnormal, Convulsion
Clinical narrative: This male subject was enrolled in the prophylactic open study 110870 (MenACWY-TT-057).  On 4 April 2008, he received the 1st dose of HIB-MENCY-TT (IM L thigh) and of PEDIARIX (IM R thigh).  The subject received concomitantly PREVNAR (IM) and ROTATEQ vaccines (po).  Medical conditions at the time of the event included apnea and seizure.  Concomitant medications included PREVACID and KEPPRA.  On 02 July 2008, 89 days after the 1st dose of PEDIARIX, 89 days after the 1st dose of HIB-MENCY-TT, this five-month-old subject died.  The event was disabling, life-threatening, clinically significant (or requiring intervention).  The subject died on 02 July 2008, cause of death is unknown.  An autopsy was performed.  The investigator considered that there was a reasonable possibility that the death nos may have been caused by PEDIARIX and HIB-MENCY-TT.  Investigator Comments: Site was Notified of report of death on 07-03-2008, records have been requested.  All data pending.  07-07-2008.  After PI review, cannot completely rule out vaccine related causality, but not probable.  Subject on anticonvulsants and has underwent metabolic/neurologic work-up with no significant findings.  Possibility of Munchausen by Proxy, but waiting on pending results of physician and ER notes, apnea monitor results and autopsy and toxicology report.  8/22/08 Autopsy states COD as sudden unexpected infant death.  Report also states  Anatomical diagnosis: same as COD & aspiration of vomitus, terminal/subterminal focal bilateral.  Comments: infant had complicated history of seizures, aspiration & apnea which could not be substantiated during multiple hospitalizations & ER visits & Munchausen by proxy was questioned.  Autopsy showed only relatively mild terminal aspiration of vomitus. 8/5/08 Reviewed ER medical records of 7/2/2008 submitted by FDA from manufacturer.  Records reveal patient well known w/history of recurrent episodes of life-threatening events of possible apnea vs seizure over the prior 2 months w/cyanosis, choking & gagging.  Was on apnea/bradycardia monitor at home.  Found by parent vomiting & poorly responsive.  Started CPR & ACLS by EMS.  Arrived in ER in full arrest & unable to resuscitate.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MEN, PNC, RV5, DTAPHEPBIP, HIBV, MEN, PNC, RV5, TTOX
Symptoms: Cyanosis, Death, Dyspnoea, Granulocyte count, Haematocrit decreased
Clinical narrative: This male subject was enrolled in the prophylactic open study 110870 (MenACWY-TT-057).  On 4 April 2008, he received the 1st dose of HIB-MENCY-TT (IM L thigh) and of PEDIARIX (IM R thigh).  The subject received concomitantly PREVNAR (IM) and ROTATEQ vaccines (po).  Medical conditions at the time of the event included apnea and seizure.  Concomitant medications included PREVACID and KEPPRA.  On 02 July 2008, 89 days after the 1st dose of PEDIARIX, 89 days after the 1st dose of HIB-MENCY-TT, this five-month-old subject died.  The event was disabling, life-threatening, clinically significant (or requiring intervention).  The subject died on 02 July 2008, cause of death is unknown.  An autopsy was performed.  The investigator considered that there was a reasonable possibility that the death nos may have been caused by PEDIARIX and HIB-MENCY-TT.  Investigator Comments: Site was Notified of report of death on 07-03-2008, records have been requested.  All data pending.  07-07-2008.  After PI review, cannot completely rule out vaccine related causality, but not probable.  Subject on anticonvulsants and has underwent metabolic/neurologic work-up with no significant findings.  Possibility of Munchausen by Proxy, but waiting on pending results of physician and ER notes, apnea monitor results and autopsy and toxicology report.  8/22/08 Autopsy states COD as sudden unexpected infant death.  Report also states  Anatomical diagnosis: same as COD & aspiration of vomitus, terminal/subterminal focal bilateral.  Comments: infant had complicated history of seizures, aspiration & apnea which could not be substantiated during multiple hospitalizations & ER visits & Munchausen by proxy was questioned.  Autopsy showed only relatively mild terminal aspiration of vomitus. 8/5/08 Reviewed ER medical records of 7/2/2008 submitted by FDA from manufacturer.  Records reveal patient well known w/history of recurrent episodes of life-threatening events of possible apnea vs seizure over the prior 2 months w/cyanosis, choking & gagging.  Was on apnea/bradycardia monitor at home.  Found by parent vomiting & poorly responsive.  Started CPR & ACLS by EMS.  Arrived in ER in full arrest & unable to resuscitate.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MEN, PNC, RV5, DTAPHEPBIP, HIBV, MEN, PNC, RV5, TTOX
Symptoms: Haemoglobin normal, Lung infiltration, Mean cell volume normal, Pyrexia, Red blood cell count normal
Clinical narrative: This male subject was enrolled in the prophylactic open study 110870 (MenACWY-TT-057).  On 4 April 2008, he received the 1st dose of HIB-MENCY-TT (IM L thigh) and of PEDIARIX (IM R thigh).  The subject received concomitantly PREVNAR (IM) and ROTATEQ vaccines (po).  Medical conditions at the time of the event included apnea and seizure.  Concomitant medications included PREVACID and KEPPRA.  On 02 July 2008, 89 days after the 1st dose of PEDIARIX, 89 days after the 1st dose of HIB-MENCY-TT, this five-month-old subject died.  The event was disabling, life-threatening, clinically significant (or requiring intervention).  The subject died on 02 July 2008, cause of death is unknown.  An autopsy was performed.  The investigator considered that there was a reasonable possibility that the death nos may have been caused by PEDIARIX and HIB-MENCY-TT.  Investigator Comments: Site was Notified of report of death on 07-03-2008, records have been requested.  All data pending.  07-07-2008.  After PI review, cannot completely rule out vaccine related causality, but not probable.  Subject on anticonvulsants and has underwent metabolic/neurologic work-up with no significant findings.  Possibility of Munchausen by Proxy, but waiting on pending results of physician and ER notes, apnea monitor results and autopsy and toxicology report.  8/22/08 Autopsy states COD as sudden unexpected infant death.  Report also states  Anatomical diagnosis: same as COD & aspiration of vomitus, terminal/subterminal focal bilateral.  Comments: infant had complicated history of seizures, aspiration & apnea which could not be substantiated during multiple hospitalizations & ER visits & Munchausen by proxy was questioned.  Autopsy showed only relatively mild terminal aspiration of vomitus. 8/5/08 Reviewed ER medical records of 7/2/2008 submitted by FDA from manufacturer.  Records reveal patient well known w/history of recurrent episodes of life-threatening events of possible apnea vs seizure over the prior 2 months w/cyanosis, choking & gagging.  Was on apnea/bradycardia monitor at home.  Found by parent vomiting & poorly responsive.  Started CPR & ACLS by EMS.  Arrived in ER in full arrest & unable to resuscitate.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MEN, PNC, RV5, DTAPHEPBIP, HIBV, MEN, PNC, RV5, TTOX
Symptoms: Weight gain poor, White blood cell count normal
Clinical narrative: This male subject was enrolled in the prophylactic open study 110870 (MenACWY-TT-057).  On 4 April 2008, he received the 1st dose of HIB-MENCY-TT (IM L thigh) and of PEDIARIX (IM R thigh).  The subject received concomitantly PREVNAR (IM) and ROTATEQ vaccines (po).  Medical conditions at the time of the event included apnea and seizure.  Concomitant medications included PREVACID and KEPPRA.  On 02 July 2008, 89 days after the 1st dose of PEDIARIX, 89 days after the 1st dose of HIB-MENCY-TT, this five-month-old subject died.  The event was disabling, life-threatening, clinically significant (or requiring intervention).  The subject died on 02 July 2008, cause of death is unknown.  An autopsy was performed.  The investigator considered that there was a reasonable possibility that the death nos may have been caused by PEDIARIX and HIB-MENCY-TT.  Investigator Comments: Site was Notified of report of death on 07-03-2008, records have been requested.  All data pending.  07-07-2008.  After PI review, cannot completely rule out vaccine related causality, but not probable.  Subject on anticonvulsants and has underwent metabolic/neurologic work-up with no significant findings.  Possibility of Munchausen by Proxy, but waiting on pending results of physician and ER notes, apnea monitor results and autopsy and toxicology report.  8/22/08 Autopsy states COD as sudden unexpected infant death.  Report also states  Anatomical diagnosis: same as COD & aspiration of vomitus, terminal/subterminal focal bilateral.  Comments: infant had complicated history of seizures, aspiration & apnea which could not be substantiated during multiple hospitalizations & ER visits & Munchausen by proxy was questioned.  Autopsy showed only relatively mild terminal aspiration of vomitus. 8/5/08 Reviewed ER medical records of 7/2/2008 submitted by FDA from manufacturer.  Records reveal patient well known w/history of recurrent episodes of life-threatening events of possible apnea vs seizure over the prior 2 months w/cyanosis, choking & gagging.  Was on apnea/bradycardia monitor at home.  Found by parent vomiting & poorly responsive.  Started CPR & ACLS by EMS.  Arrived in ER in full arrest & unable to resuscitate.
Age: 0.8
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of facial rash in a 9-month-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 25 June 2008 at 09:45 the subject received 3rd dose of ENGERIX B at 0.5 ml in the left thigh. On 26 June 2008, 1 day after vaccination with ENGERIX B, the subject experienced facial rash, abdominal rash and back rash (systemic reaction). The healthcare professional considered the events were clinically significant (or requiring intervention) as treatment with BENADRYL and AVEENO bath were recommended. It was not reported that the subject actually received these treatments. On an unspecified date in June 2008, the events resolved. The healthcare professional considered the events were probably related to vaccination with ENGERIX B.
Age: 0.2
Sex: U
Vaccine: HEP, HIBV, IPV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap given in error, should have been DTaP.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site vesicles, Oedema peripheral
Clinical narrative: Swelling of left arm. Blisters in center of left varicella site.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, PNC
Symptoms: Erythema, Swelling face, Wheezing
Clinical narrative: Patient returned to clinic 30 minutes after vaccine administered. Facial swelling and redness noted. Wheezing with O2 Sat 91. Received nebulizer treatment with XOPENEX .63 and BENADRYL 12.5 mg. After treatment and within 15 min O2 Sat was 97% without wheeze and NAD. Allergist consulted.
Age: 26.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Abdominal pain upper, Arthralgia, Blood test normal, Death of companion, Depression
Clinical narrative: I recieved the guardisil vaccine three shot series. I was also administered one hepatitis A vaccine shot and the heptatis B series at the same time. Since the administration of the guardisil vaccine. I have had an increase in pain levels throughout the body. I have total body aches that are extremely sensitive to touch and hot water. I have trouble closing my hands and weakness in the left and right arms. I have also had severe calf muscle cramping that came on with sudden onset. I also had episodes of depression and directly after the shots were given I had severe stomach cramping and diarrhea. The bowel movements were extreme and very painful my family had to lift me off the toilet. I had dizziness and redness at the injection site. My genital area began chafing and a layer skin peeled off the scrotum and penis. This happened rapidly after the second shot in the series. I continue to have weakness and arthritic type pain my whole body aches since the vaccine. I've had pain in the neck area with no MRI findings. My moods immediately changed after the guardisil series. The loss of a friend seemed to make it worse. I felt fatigued and my pain started increasing. I was prescribed a medication for the painful diarrhea. I've had numerous neurological problems and uncontrollable leg and hand shaking since administration of the vaccine. I have night sweats with an unknown cause.  8/18/2008 MR received from PCP dated 11/7/2006 to 6/30/2008. Pt received HPV4 #1 on 3/8/07 and #2 on 4/30/07. Seen multiple times for multiple sx (see PMH). Seen 7/5/07 for numbness in feet and L leg weakness and knee pain. On PE absent knee reflexes and ankles 1+. Assessment: bilateral knee pain, probably patellofemoral syndrome. Seen 8/7/07 for new skin lesion- a light brown papule on dorsum of L hand-appears benign. Seen 9/7/07 for increasing back pain, shaking, spasms and numbness of legs attributed to PMH of DDD. 3rd HPV4 given. Seen 10/4/07 for new papule on R flank, swollen, tender and draining pus, possible furuncle. Tx with abx. Seen 11/26 with 3 day hx of ankle swelling. Assessment:  Bilateral ankle swelling of uncertain cause- probable side effect of medication. Resolved by Jan 2008.
Age: 26.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Diarrhoea, Dizziness, Fatigue, Frequent bowel movements, Fungal infection
Clinical narrative: I recieved the guardisil vaccine three shot series. I was also administered one hepatitis A vaccine shot and the heptatis B series at the same time. Since the administration of the guardisil vaccine. I have had an increase in pain levels throughout the body. I have total body aches that are extremely sensitive to touch and hot water. I have trouble closing my hands and weakness in the left and right arms. I have also had severe calf muscle cramping that came on with sudden onset. I also had episodes of depression and directly after the shots were given I had severe stomach cramping and diarrhea. The bowel movements were extreme and very painful my family had to lift me off the toilet. I had dizziness and redness at the injection site. My genital area began chafing and a layer skin peeled off the scrotum and penis. This happened rapidly after the second shot in the series. I continue to have weakness and arthritic type pain my whole body aches since the vaccine. I've had pain in the neck area with no MRI findings. My moods immediately changed after the guardisil series. The loss of a friend seemed to make it worse. I felt fatigued and my pain started increasing. I was prescribed a medication for the painful diarrhea. I've had numerous neurological problems and uncontrollable leg and hand shaking since administration of the vaccine. I have night sweats with an unknown cause.  8/18/2008 MR received from PCP dated 11/7/2006 to 6/30/2008. Pt received HPV4 #1 on 3/8/07 and #2 on 4/30/07. Seen multiple times for multiple sx (see PMH). Seen 7/5/07 for numbness in feet and L leg weakness and knee pain. On PE absent knee reflexes and ankles 1+. Assessment: bilateral knee pain, probably patellofemoral syndrome. Seen 8/7/07 for new skin lesion- a light brown papule on dorsum of L hand-appears benign. Seen 9/7/07 for increasing back pain, shaking, spasms and numbness of legs attributed to PMH of DDD. 3rd HPV4 given. Seen 10/4/07 for new papule on R flank, swollen, tender and draining pus, possible furuncle. Tx with abx. Seen 11/26 with 3 day hx of ankle swelling. Assessment:  Bilateral ankle swelling of uncertain cause- probable side effect of medication. Resolved by Jan 2008.
Age: 26.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Groin pain, Hyperaesthesia, Infection, Injection site erythema, Mood altered
Clinical narrative: I recieved the guardisil vaccine three shot series. I was also administered one hepatitis A vaccine shot and the heptatis B series at the same time. Since the administration of the guardisil vaccine. I have had an increase in pain levels throughout the body. I have total body aches that are extremely sensitive to touch and hot water. I have trouble closing my hands and weakness in the left and right arms. I have also had severe calf muscle cramping that came on with sudden onset. I also had episodes of depression and directly after the shots were given I had severe stomach cramping and diarrhea. The bowel movements were extreme and very painful my family had to lift me off the toilet. I had dizziness and redness at the injection site. My genital area began chafing and a layer skin peeled off the scrotum and penis. This happened rapidly after the second shot in the series. I continue to have weakness and arthritic type pain my whole body aches since the vaccine. I've had pain in the neck area with no MRI findings. My moods immediately changed after the guardisil series. The loss of a friend seemed to make it worse. I felt fatigued and my pain started increasing. I was prescribed a medication for the painful diarrhea. I've had numerous neurological problems and uncontrollable leg and hand shaking since administration of the vaccine. I have night sweats with an unknown cause.  8/18/2008 MR received from PCP dated 11/7/2006 to 6/30/2008. Pt received HPV4 #1 on 3/8/07 and #2 on 4/30/07. Seen multiple times for multiple sx (see PMH). Seen 7/5/07 for numbness in feet and L leg weakness and knee pain. On PE absent knee reflexes and ankles 1+. Assessment: bilateral knee pain, probably patellofemoral syndrome. Seen 8/7/07 for new skin lesion- a light brown papule on dorsum of L hand-appears benign. Seen 9/7/07 for increasing back pain, shaking, spasms and numbness of legs attributed to PMH of DDD. 3rd HPV4 given. Seen 10/4/07 for new papule on R flank, swollen, tender and draining pus, possible furuncle. Tx with abx. Seen 11/26 with 3 day hx of ankle swelling. Assessment:  Bilateral ankle swelling of uncertain cause- probable side effect of medication. Resolved by Jan 2008.
Age: 26.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Muscle spasms, Muscular weakness, Neck pain, Neurological symptom, Night sweats
Clinical narrative: I recieved the guardisil vaccine three shot series. I was also administered one hepatitis A vaccine shot and the heptatis B series at the same time. Since the administration of the guardisil vaccine. I have had an increase in pain levels throughout the body. I have total body aches that are extremely sensitive to touch and hot water. I have trouble closing my hands and weakness in the left and right arms. I have also had severe calf muscle cramping that came on with sudden onset. I also had episodes of depression and directly after the shots were given I had severe stomach cramping and diarrhea. The bowel movements were extreme and very painful my family had to lift me off the toilet. I had dizziness and redness at the injection site. My genital area began chafing and a layer skin peeled off the scrotum and penis. This happened rapidly after the second shot in the series. I continue to have weakness and arthritic type pain my whole body aches since the vaccine. I've had pain in the neck area with no MRI findings. My moods immediately changed after the guardisil series. The loss of a friend seemed to make it worse. I felt fatigued and my pain started increasing. I was prescribed a medication for the painful diarrhea. I've had numerous neurological problems and uncontrollable leg and hand shaking since administration of the vaccine. I have night sweats with an unknown cause.  8/18/2008 MR received from PCP dated 11/7/2006 to 6/30/2008. Pt received HPV4 #1 on 3/8/07 and #2 on 4/30/07. Seen multiple times for multiple sx (see PMH). Seen 7/5/07 for numbness in feet and L leg weakness and knee pain. On PE absent knee reflexes and ankles 1+. Assessment: bilateral knee pain, probably patellofemoral syndrome. Seen 8/7/07 for new skin lesion- a light brown papule on dorsum of L hand-appears benign. Seen 9/7/07 for increasing back pain, shaking, spasms and numbness of legs attributed to PMH of DDD. 3rd HPV4 given. Seen 10/4/07 for new papule on R flank, swollen, tender and draining pus, possible furuncle. Tx with abx. Seen 11/26 with 3 day hx of ankle swelling. Assessment:  Bilateral ankle swelling of uncertain cause- probable side effect of medication. Resolved by Jan 2008.
Age: 26.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Pain, Red blood cell sedimentation rate normal, Skin exfoliation, Tendon disorder, Tremor
Clinical narrative: I recieved the guardisil vaccine three shot series. I was also administered one hepatitis A vaccine shot and the heptatis B series at the same time. Since the administration of the guardisil vaccine. I have had an increase in pain levels throughout the body. I have total body aches that are extremely sensitive to touch and hot water. I have trouble closing my hands and weakness in the left and right arms. I have also had severe calf muscle cramping that came on with sudden onset. I also had episodes of depression and directly after the shots were given I had severe stomach cramping and diarrhea. The bowel movements were extreme and very painful my family had to lift me off the toilet. I had dizziness and redness at the injection site. My genital area began chafing and a layer skin peeled off the scrotum and penis. This happened rapidly after the second shot in the series. I continue to have weakness and arthritic type pain my whole body aches since the vaccine. I've had pain in the neck area with no MRI findings. My moods immediately changed after the guardisil series. The loss of a friend seemed to make it worse. I felt fatigued and my pain started increasing. I was prescribed a medication for the painful diarrhea. I've had numerous neurological problems and uncontrollable leg and hand shaking since administration of the vaccine. I have night sweats with an unknown cause.  8/18/2008 MR received from PCP dated 11/7/2006 to 6/30/2008. Pt received HPV4 #1 on 3/8/07 and #2 on 4/30/07. Seen multiple times for multiple sx (see PMH). Seen 7/5/07 for numbness in feet and L leg weakness and knee pain. On PE absent knee reflexes and ankles 1+. Assessment: bilateral knee pain, probably patellofemoral syndrome. Seen 8/7/07 for new skin lesion- a light brown papule on dorsum of L hand-appears benign. Seen 9/7/07 for increasing back pain, shaking, spasms and numbness of legs attributed to PMH of DDD. 3rd HPV4 given. Seen 10/4/07 for new papule on R flank, swollen, tender and draining pus, possible furuncle. Tx with abx. Seen 11/26 with 3 day hx of ankle swelling. Assessment:  Bilateral ankle swelling of uncertain cause- probable side effect of medication. Resolved by Jan 2008.
Age: 26.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Arthralgia, Diarrhoea, Loss of consciousness, Nervous system disorder, Vaccine positive rechallenge
Clinical narrative: I recieved the guardisil vaccine three shot series. I was also administered one hepatitis A vaccine shot and the heptatis B series at the same time. Since the administration of the guardisil vaccine. I have had an increase in pain levels throughout the body. I have total body aches that are extremely sensitive to touch and hot water. I have trouble closing my hands and weakness in the left and right arms. I have also had severe calf muscle cramping that came on with sudden onset. I also had episodes of depression and directly after the shots were given I had severe stomach cramping and diarrhea. The bowel movements were extreme and very painful my family had to lift me off the toilet. I had dizziness and redness at the injection site. My genital area began chafing and a layer skin peeled off the scrotum and penis. This happened rapidly after the second shot in the series. I continue to have weakness and arthritic type pain my whole body aches since the vaccine. I've had pain in the neck area with no MRI findings. My moods immediately changed after the guardisil series. The loss of a friend seemed to make it worse. I felt fatigued and my pain started increasing. I was prescribed a medication for the painful diarrhea. I've had numerous neurological problems and uncontrollable leg and hand shaking since administration of the vaccine. I have night sweats with an unknown cause.  8/18/2008 MR received from PCP dated 11/7/2006 to 6/30/2008. Pt received HPV4 #1 on 3/8/07 and #2 on 4/30/07. Seen multiple times for multiple sx (see PMH). Seen 7/5/07 for numbness in feet and L leg weakness and knee pain. On PE absent knee reflexes and ankles 1+. Assessment: bilateral knee pain, probably patellofemoral syndrome. Seen 8/7/07 for new skin lesion- a light brown papule on dorsum of L hand-appears benign. Seen 9/7/07 for increasing back pain, shaking, spasms and numbness of legs attributed to PMH of DDD. 3rd HPV4 given. Seen 10/4/07 for new papule on R flank, swollen, tender and draining pus, possible furuncle. Tx with abx. Seen 11/26 with 3 day hx of ankle swelling. Assessment:  Bilateral ankle swelling of uncertain cause- probable side effect of medication. Resolved by Jan 2008.
Age: 26.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Wrong technique in drug usage process
Clinical narrative: I recieved the guardisil vaccine three shot series. I was also administered one hepatitis A vaccine shot and the heptatis B series at the same time. Since the administration of the guardisil vaccine. I have had an increase in pain levels throughout the body. I have total body aches that are extremely sensitive to touch and hot water. I have trouble closing my hands and weakness in the left and right arms. I have also had severe calf muscle cramping that came on with sudden onset. I also had episodes of depression and directly after the shots were given I had severe stomach cramping and diarrhea. The bowel movements were extreme and very painful my family had to lift me off the toilet. I had dizziness and redness at the injection site. My genital area began chafing and a layer skin peeled off the scrotum and penis. This happened rapidly after the second shot in the series. I continue to have weakness and arthritic type pain my whole body aches since the vaccine. I've had pain in the neck area with no MRI findings. My moods immediately changed after the guardisil series. The loss of a friend seemed to make it worse. I felt fatigued and my pain started increasing. I was prescribed a medication for the painful diarrhea. I've had numerous neurological problems and uncontrollable leg and hand shaking since administration of the vaccine. I have night sweats with an unknown cause.  8/18/2008 MR received from PCP dated 11/7/2006 to 6/30/2008. Pt received HPV4 #1 on 3/8/07 and #2 on 4/30/07. Seen multiple times for multiple sx (see PMH). Seen 7/5/07 for numbness in feet and L leg weakness and knee pain. On PE absent knee reflexes and ankles 1+. Assessment: bilateral knee pain, probably patellofemoral syndrome. Seen 8/7/07 for new skin lesion- a light brown papule on dorsum of L hand-appears benign. Seen 9/7/07 for increasing back pain, shaking, spasms and numbness of legs attributed to PMH of DDD. 3rd HPV4 given. Seen 10/4/07 for new papule on R flank, swollen, tender and draining pus, possible furuncle. Tx with abx. Seen 11/26 with 3 day hx of ankle swelling. Assessment:  Bilateral ankle swelling of uncertain cause- probable side effect of medication. Resolved by Jan 2008.
Age: 26.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Anxiety, Arthralgia, Blood test, Depression, Diarrhoea
Clinical narrative: I recieved the guardisil vaccine three shot series. I was also administered one hepatitis A vaccine shot and the heptatis B series at the same time. Since the administration of the guardisil vaccine. I have had an increase in pain levels throughout the body. I have total body aches that are extremely sensitive to touch and hot water. I have trouble closing my hands and weakness in the left and right arms. I have also had severe calf muscle cramping that came on with sudden onset. I also had episodes of depression and directly after the shots were given I had severe stomach cramping and diarrhea. The bowel movements were extreme and very painful my family had to lift me off the toilet. I had dizziness and redness at the injection site. My genital area began chafing and a layer skin peeled off the scrotum and penis. This happened rapidly after the second shot in the series. I continue to have weakness and arthritic type pain my whole body aches since the vaccine. I've had pain in the neck area with no MRI findings. My moods immediately changed after the guardisil series. The loss of a friend seemed to make it worse. I felt fatigued and my pain started increasing. I was prescribed a medication for the painful diarrhea. I've had numerous neurological problems and uncontrollable leg and hand shaking since administration of the vaccine. I have night sweats with an unknown cause.  8/18/2008 MR received from PCP dated 11/7/2006 to 6/30/2008. Pt received HPV4 #1 on 3/8/07 and #2 on 4/30/07. Seen multiple times for multiple sx (see PMH). Seen 7/5/07 for numbness in feet and L leg weakness and knee pain. On PE absent knee reflexes and ankles 1+. Assessment: bilateral knee pain, probably patellofemoral syndrome. Seen 8/7/07 for new skin lesion- a light brown papule on dorsum of L hand-appears benign. Seen 9/7/07 for increasing back pain, shaking, spasms and numbness of legs attributed to PMH of DDD. 3rd HPV4 given. Seen 10/4/07 for new papule on R flank, swollen, tender and draining pus, possible furuncle. Tx with abx. Seen 11/26 with 3 day hx of ankle swelling. Assessment:  Bilateral ankle swelling of uncertain cause- probable side effect of medication. Resolved by Jan 2008.
Age: 26.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Dizziness, Fall, Frustration, Gait disturbance, Head injury
Clinical narrative: I recieved the guardisil vaccine three shot series. I was also administered one hepatitis A vaccine shot and the heptatis B series at the same time. Since the administration of the guardisil vaccine. I have had an increase in pain levels throughout the body. I have total body aches that are extremely sensitive to touch and hot water. I have trouble closing my hands and weakness in the left and right arms. I have also had severe calf muscle cramping that came on with sudden onset. I also had episodes of depression and directly after the shots were given I had severe stomach cramping and diarrhea. The bowel movements were extreme and very painful my family had to lift me off the toilet. I had dizziness and redness at the injection site. My genital area began chafing and a layer skin peeled off the scrotum and penis. This happened rapidly after the second shot in the series. I continue to have weakness and arthritic type pain my whole body aches since the vaccine. I've had pain in the neck area with no MRI findings. My moods immediately changed after the guardisil series. The loss of a friend seemed to make it worse. I felt fatigued and my pain started increasing. I was prescribed a medication for the painful diarrhea. I've had numerous neurological problems and uncontrollable leg and hand shaking since administration of the vaccine. I have night sweats with an unknown cause.  8/18/2008 MR received from PCP dated 11/7/2006 to 6/30/2008. Pt received HPV4 #1 on 3/8/07 and #2 on 4/30/07. Seen multiple times for multiple sx (see PMH). Seen 7/5/07 for numbness in feet and L leg weakness and knee pain. On PE absent knee reflexes and ankles 1+. Assessment: bilateral knee pain, probably patellofemoral syndrome. Seen 8/7/07 for new skin lesion- a light brown papule on dorsum of L hand-appears benign. Seen 9/7/07 for increasing back pain, shaking, spasms and numbness of legs attributed to PMH of DDD. 3rd HPV4 given. Seen 10/4/07 for new papule on R flank, swollen, tender and draining pus, possible furuncle. Tx with abx. Seen 11/26 with 3 day hx of ankle swelling. Assessment:  Bilateral ankle swelling of uncertain cause- probable side effect of medication. Resolved by Jan 2008.
Age: 26.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Hypoaesthesia, Loss of consciousness, Mental disorder, Muscle spasms, Muscular weakness
Clinical narrative: I recieved the guardisil vaccine three shot series. I was also administered one hepatitis A vaccine shot and the heptatis B series at the same time. Since the administration of the guardisil vaccine. I have had an increase in pain levels throughout the body. I have total body aches that are extremely sensitive to touch and hot water. I have trouble closing my hands and weakness in the left and right arms. I have also had severe calf muscle cramping that came on with sudden onset. I also had episodes of depression and directly after the shots were given I had severe stomach cramping and diarrhea. The bowel movements were extreme and very painful my family had to lift me off the toilet. I had dizziness and redness at the injection site. My genital area began chafing and a layer skin peeled off the scrotum and penis. This happened rapidly after the second shot in the series. I continue to have weakness and arthritic type pain my whole body aches since the vaccine. I've had pain in the neck area with no MRI findings. My moods immediately changed after the guardisil series. The loss of a friend seemed to make it worse. I felt fatigued and my pain started increasing. I was prescribed a medication for the painful diarrhea. I've had numerous neurological problems and uncontrollable leg and hand shaking since administration of the vaccine. I have night sweats with an unknown cause.  8/18/2008 MR received from PCP dated 11/7/2006 to 6/30/2008. Pt received HPV4 #1 on 3/8/07 and #2 on 4/30/07. Seen multiple times for multiple sx (see PMH). Seen 7/5/07 for numbness in feet and L leg weakness and knee pain. On PE absent knee reflexes and ankles 1+. Assessment: bilateral knee pain, probably patellofemoral syndrome. Seen 8/7/07 for new skin lesion- a light brown papule on dorsum of L hand-appears benign. Seen 9/7/07 for increasing back pain, shaking, spasms and numbness of legs attributed to PMH of DDD. 3rd HPV4 given. Seen 10/4/07 for new papule on R flank, swollen, tender and draining pus, possible furuncle. Tx with abx. Seen 11/26 with 3 day hx of ankle swelling. Assessment:  Bilateral ankle swelling of uncertain cause- probable side effect of medication. Resolved by Jan 2008.
Age: 26.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Nausea, Tendonitis
Clinical narrative: I recieved the guardisil vaccine three shot series. I was also administered one hepatitis A vaccine shot and the heptatis B series at the same time. Since the administration of the guardisil vaccine. I have had an increase in pain levels throughout the body. I have total body aches that are extremely sensitive to touch and hot water. I have trouble closing my hands and weakness in the left and right arms. I have also had severe calf muscle cramping that came on with sudden onset. I also had episodes of depression and directly after the shots were given I had severe stomach cramping and diarrhea. The bowel movements were extreme and very painful my family had to lift me off the toilet. I had dizziness and redness at the injection site. My genital area began chafing and a layer skin peeled off the scrotum and penis. This happened rapidly after the second shot in the series. I continue to have weakness and arthritic type pain my whole body aches since the vaccine. I've had pain in the neck area with no MRI findings. My moods immediately changed after the guardisil series. The loss of a friend seemed to make it worse. I felt fatigued and my pain started increasing. I was prescribed a medication for the painful diarrhea. I've had numerous neurological problems and uncontrollable leg and hand shaking since administration of the vaccine. I have night sweats with an unknown cause.  8/18/2008 MR received from PCP dated 11/7/2006 to 6/30/2008. Pt received HPV4 #1 on 3/8/07 and #2 on 4/30/07. Seen multiple times for multiple sx (see PMH). Seen 7/5/07 for numbness in feet and L leg weakness and knee pain. On PE absent knee reflexes and ankles 1+. Assessment: bilateral knee pain, probably patellofemoral syndrome. Seen 8/7/07 for new skin lesion- a light brown papule on dorsum of L hand-appears benign. Seen 9/7/07 for increasing back pain, shaking, spasms and numbness of legs attributed to PMH of DDD. 3rd HPV4 given. Seen 10/4/07 for new papule on R flank, swollen, tender and draining pus, possible furuncle. Tx with abx. Seen 11/26 with 3 day hx of ankle swelling. Assessment:  Bilateral ankle swelling of uncertain cause- probable side effect of medication. Resolved by Jan 2008.
Age: 18.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Urticaria
Clinical narrative: Mother called and reported that son had hives on trunk and back of body approximately 4 hours after immunizations.  No other unusal exposures.  He had no swelling of lips no wheezing.  Bendryl given be mother.  Spoke with Dr. later in evening symptoms resolving.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: On 12-14-07 pt received 1st HPV dose and parent noted flu like s/s.  On 3-7-08 pt recevied 2nd HPV dose and parent noted fever 101, nausea, body aches, dizziness, and h/a lasting for two days.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: On 12-14-07 pt received 1st HPV dose and parent noted flu like s/s.  On 3-7-08 pt recevied 2nd HPV dose and parent noted fever 101, nausea, body aches, dizziness, and h/a lasting for two days.
Age: 1.19
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Full blood count normal, Inappropriate schedule of drug administration, Pyrexia, Streptococcal identification test, Streptococcal identification test negative
Clinical narrative: Immunizations were given at doctors office on 7/7/08.  Patient woke up on 7/8/08 with fever running between 101-103. No vomiting, diarrhea, or other symptoms.
Age: 12.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Ophthalmological examination, Uveitis
Clinical narrative: HPV #1 administered on 3/3/08 along w/ Td vaccine. Pt diagnosed with intermediate uveitis both eyes 4/30/08.  10/10/07 Reviewed opthamology records of 4/30-5/28/08. FINAL DX: amblyopia, peripheral fibrovitreous with empty vitrous left eye, peripheral uveitis, granuloma Records reveal patient experienced vitreous fibrosis, longstanding floaters of both eyes, seeing 'ghosting around images' x 1 year.  10/3/08 Reviewed PCP medical records of 3/3/08. FINAL DX: none provided Record reveals patient experienced usual state of good health on day of vaccination.  BMI 90% although very active.  No record provided for Td, only HPV. No other records available at this time.  10/17/08 Reviewed additional medical records of 5/1-9/17/2008. FINAL DX: bilateral peripheral uveitis, vitreoretinal disease, bilateral pars planitis, possible familial exudative vitreoretinopathy, keratosis pilaris, mottling of skin over legs.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Convulsion, Gaze palsy, Somnolence
Clinical narrative: PARENT STATES THAT PT HAD A SEIZURE LAST LESS THAN 1 MINUTE.  MOM WAS NOT PRESENT AT THE TIME OF SEIZRE GRANDMOTHER WAS.  PT'S EYES ROLLED INTO BACK OF HEAD AND SNORTED THEN BECAME GROGGY IMMEDIATELY FOLLOWING THESE EVENTS ACCORDING TO MOM.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: NONE.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Very mild soreness at injection site.  Pain = 1 on scale of 1 to 10.  This report is being filed because the patient denied having had a tetanus vaccine in 14 years and did not report receiving a T-DAP vaccine in January of 2008. This record was discovered after administration of vaccine on July 8, 2008. ("onset" is date of discovery)
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed redness swelling at injection site, first noted by mom one day after vaccination.    4 X 5 inch area.
Age: 24.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Chills, Diarrhoea, Headache, Malaise, Nausea
Clinical narrative: fever 100.1 chills, malaise, headache nauses,diarrhea
Age: 24.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Pyrexia
Clinical narrative: fever 100.1 chills, malaise, headache nauses,diarrhea
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: less than 12 hours after vaccine, developed chills myalgias sweats fever. Lasted 3 am until 2 pm.  Examined 2 days later by MD no other source of symptoms
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Band neutrophil count, Chest X-ray normal, Chest discomfort, Electrocardiogram normal
Clinical narrative: Fever, Joints aching, Chest tightness, Chest pressure
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Lymphocyte count, Mononucleosis heterophile test negative, Pyrexia, Streptococcal identification test negative
Clinical narrative: Fever, Joints aching, Chest tightness, Chest pressure
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: White blood cell count normal
Clinical narrative: Fever, Joints aching, Chest tightness, Chest pressure
Age: 1.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Abnormal behaviour, Aphasia, Eating disorder, Laboratory test, Obsessive-compulsive disorder
Clinical narrative: Child lost language, lost eye contact and stopped eating well.  Child stopped sleeping well.  Child developed behavorial issues/meltdowns (up to 50 meltdowns a day).  Child developed routines/rituals.  Child lined-up toys, spun-around in circles and stimms.    Child began early intervention at 2 years of age though Loudoun County.
Age: 1.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Sleep disorder, Staring
Clinical narrative: Child lost language, lost eye contact and stopped eating well.  Child stopped sleeping well.  Child developed behavorial issues/meltdowns (up to 50 meltdowns a day).  Child developed routines/rituals.  Child lined-up toys, spun-around in circles and stimms.    Child began early intervention at 2 years of age though Loudoun County.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Back pain, Myalgia, Pain in extremity
Clinical narrative: Leg muscles sore, back pain anthralgia and myalgia- 2 weeks post injection. Leg muscles still sore as of 7/02//08.