chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: Pt developed swollen L/S spine and bilateral knees, as well as swollen bilateral ears. Also hives on antecubital fossae and popliteal fossae. L/S spine and knees, as well as ears were red and pruritic. Diagnosed serum sickness. 06/07/07-records received:4/16/07 Continues to be ADD symptomatic, increased Adderall XR. On 5/14/07 complained of pain on tailbone, knees, associated with swelling, erythema. Lesions and swelling on lower lip and left ear. Joints are painful and itchy. Bilateral knees edematous, red and warm to touch and somewhat tender. Full range of motion. Left elbow edematous, red and warm to touch and somewhat tender. 5/17/07 Questionable serum sickness. Return visit responsed to steroids. 5/18/07-complained of itchy with wheels on arms and face. 5/29/07-continues to break out in hives in evening only. To see allergist.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Auricular swelling, Blood albumin normal, Blood creatinine normal, Blood electrolytes normal, Blood urea normal
Clinical narrative: Pt developed swollen L/S spine and bilateral knees, as well as swollen bilateral ears. Also hives on antecubital fossae and popliteal fossae. L/S spine and knees, as well as ears were red and pruritic. Diagnosed serum sickness. 06/07/07-records received:4/16/07 Continues to be ADD symptomatic, increased Adderall XR. On 5/14/07 complained of pain on tailbone, knees, associated with swelling, erythema. Lesions and swelling on lower lip and left ear. Joints are painful and itchy. Bilateral knees edematous, red and warm to touch and somewhat tender. Full range of motion. Left elbow edematous, red and warm to touch and somewhat tender. 5/17/07 Questionable serum sickness. Return visit responsed to steroids. 5/18/07-complained of itchy with wheels on arms and face. 5/29/07-continues to break out in hives in evening only. To see allergist.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Erythema, Full blood count normal, Joint swelling, Pruritus, Red blood cell sedimentation rate normal
Clinical narrative: Pt developed swollen L/S spine and bilateral knees, as well as swollen bilateral ears. Also hives on antecubital fossae and popliteal fossae. L/S spine and knees, as well as ears were red and pruritic. Diagnosed serum sickness. 06/07/07-records received:4/16/07 Continues to be ADD symptomatic, increased Adderall XR. On 5/14/07 complained of pain on tailbone, knees, associated with swelling, erythema. Lesions and swelling on lower lip and left ear. Joints are painful and itchy. Bilateral knees edematous, red and warm to touch and somewhat tender. Full range of motion. Left elbow edematous, red and warm to touch and somewhat tender. 5/17/07 Questionable serum sickness. Return visit responsed to steroids. 5/18/07-complained of itchy with wheels on arms and face. 5/29/07-continues to break out in hives in evening only. To see allergist.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Serum sickness, Swelling, Urticaria
Clinical narrative: Pt developed swollen L/S spine and bilateral knees, as well as swollen bilateral ears. Also hives on antecubital fossae and popliteal fossae. L/S spine and knees, as well as ears were red and pruritic. Diagnosed serum sickness. 06/07/07-records received:4/16/07 Continues to be ADD symptomatic, increased Adderall XR. On 5/14/07 complained of pain on tailbone, knees, associated with swelling, erythema. Lesions and swelling on lower lip and left ear. Joints are painful and itchy. Bilateral knees edematous, red and warm to touch and somewhat tender. Full range of motion. Left elbow edematous, red and warm to touch and somewhat tender. 5/17/07 Questionable serum sickness. Return visit responsed to steroids. 5/18/07-complained of itchy with wheels on arms and face. 5/29/07-continues to break out in hives in evening only. To see allergist.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Blood test normal, Erythema, Joint swelling, Lip swelling
Clinical narrative: Pt developed swollen L/S spine and bilateral knees, as well as swollen bilateral ears. Also hives on antecubital fossae and popliteal fossae. L/S spine and knees, as well as ears were red and pruritic. Diagnosed serum sickness. 06/07/07-records received:4/16/07 Continues to be ADD symptomatic, increased Adderall XR. On 5/14/07 complained of pain on tailbone, knees, associated with swelling, erythema. Lesions and swelling on lower lip and left ear. Joints are painful and itchy. Bilateral knees edematous, red and warm to touch and somewhat tender. Full range of motion. Left elbow edematous, red and warm to touch and somewhat tender. 5/17/07 Questionable serum sickness. Return visit responsed to steroids. 5/18/07-complained of itchy with wheels on arms and face. 5/29/07-continues to break out in hives in evening only. To see allergist.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pruritus, Red blood cell sedimentation rate normal, Serum sickness, Skin warm, Tenderness
Clinical narrative: Pt developed swollen L/S spine and bilateral knees, as well as swollen bilateral ears. Also hives on antecubital fossae and popliteal fossae. L/S spine and knees, as well as ears were red and pruritic. Diagnosed serum sickness. 06/07/07-records received:4/16/07 Continues to be ADD symptomatic, increased Adderall XR. On 5/14/07 complained of pain on tailbone, knees, associated with swelling, erythema. Lesions and swelling on lower lip and left ear. Joints are painful and itchy. Bilateral knees edematous, red and warm to touch and somewhat tender. Full range of motion. Left elbow edematous, red and warm to touch and somewhat tender. 5/17/07 Questionable serum sickness. Return visit responsed to steroids. 5/18/07-complained of itchy with wheels on arms and face. 5/29/07-continues to break out in hives in evening only. To see allergist.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Pt developed swollen L/S spine and bilateral knees, as well as swollen bilateral ears. Also hives on antecubital fossae and popliteal fossae. L/S spine and knees, as well as ears were red and pruritic. Diagnosed serum sickness. 06/07/07-records received:4/16/07 Continues to be ADD symptomatic, increased Adderall XR. On 5/14/07 complained of pain on tailbone, knees, associated with swelling, erythema. Lesions and swelling on lower lip and left ear. Joints are painful and itchy. Bilateral knees edematous, red and warm to touch and somewhat tender. Full range of motion. Left elbow edematous, red and warm to touch and somewhat tender. 5/17/07 Questionable serum sickness. Return visit responsed to steroids. 5/18/07-complained of itchy with wheels on arms and face. 5/29/07-continues to break out in hives in evening only. To see allergist.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Adenovirus infection, Appendicectomy, Barium enema, Haematemesis, Haematochezia
Clinical narrative: Information has been received concerning a 25-week-old male with no history or pre-existing conditions who on 13-FEB-2007 was vaccinated PO with a dose of (Lot # 65610/31166F). Concomitant vaccinations that day included a second dose of (DAPTACEL) (Lot # C2553AA), a second dose of ACTHIB (Lot # UF064AA), a second dose of IPOL (Lot # Z0326), and a second dose of PREVNAR (Lot # B36258B). There were no other medication. On 14-APR-2007, 60 days post vaccination, the patient presented with "coffee ground emesis" and bloody stools. The patient's mother brought him to the emergency room, when he was diagnosed with adenovirus and intussusception and was hospitalized. An adenovirus PCR was positive. The IT was unable to reduce with barium enema and was reduced with surgery. The patient was noted to be status/post an appendectomy. The patient recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Intussusception and adenovirus were considered to be life threatening.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Polymerase chain reaction, Surgery, Virus serology test, Vomiting
Clinical narrative: Information has been received concerning a 25-week-old male with no history or pre-existing conditions who on 13-FEB-2007 was vaccinated PO with a dose of (Lot # 65610/31166F). Concomitant vaccinations that day included a second dose of (DAPTACEL) (Lot # C2553AA), a second dose of ACTHIB (Lot # UF064AA), a second dose of IPOL (Lot # Z0326), and a second dose of PREVNAR (Lot # B36258B). There were no other medication. On 14-APR-2007, 60 days post vaccination, the patient presented with "coffee ground emesis" and bloody stools. The patient's mother brought him to the emergency room, when he was diagnosed with adenovirus and intussusception and was hospitalized. An adenovirus PCR was positive. The IT was unable to reduce with barium enema and was reduced with surgery. The patient was noted to be status/post an appendectomy. The patient recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Intussusception and adenovirus were considered to be life threatening.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Nasal aspiration, Surgery
Clinical narrative: Information has been received concerning a 25-week-old male with no history or pre-existing conditions who on 13-FEB-2007 was vaccinated PO with a dose of (Lot # 65610/31166F). Concomitant vaccinations that day included a second dose of (DAPTACEL) (Lot # C2553AA), a second dose of ACTHIB (Lot # UF064AA), a second dose of IPOL (Lot # Z0326), and a second dose of PREVNAR (Lot # B36258B). There were no other medication. On 14-APR-2007, 60 days post vaccination, the patient presented with "coffee ground emesis" and bloody stools. The patient's mother brought him to the emergency room, when he was diagnosed with adenovirus and intussusception and was hospitalized. An adenovirus PCR was positive. The IT was unable to reduce with barium enema and was reduced with surgery. The patient was noted to be status/post an appendectomy. The patient recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Intussusception and adenovirus were considered to be life threatening.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Adenovirus infection, Barium enema, Haematemesis, Haematochezia, Intussusception
Clinical narrative: Information has been received concerning a 25-week-old male with no history or pre-existing conditions who on 13-FEB-2007 was vaccinated PO with a dose of (Lot # 65610/31166F). Concomitant vaccinations that day included a second dose of (DAPTACEL) (Lot # C2553AA), a second dose of ACTHIB (Lot # UF064AA), a second dose of IPOL (Lot # Z0326), and a second dose of PREVNAR (Lot # B36258B). There were no other medication. On 14-APR-2007, 60 days post vaccination, the patient presented with "coffee ground emesis" and bloody stools. The patient's mother brought him to the emergency room, when he was diagnosed with adenovirus and intussusception and was hospitalized. An adenovirus PCR was positive. The IT was unable to reduce with barium enema and was reduced with surgery. The patient was noted to be status/post an appendectomy. The patient recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Intussusception and adenovirus were considered to be life threatening.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Laparotomy, Nasal aspiration, Virus serology test
Clinical narrative: Information has been received concerning a 25-week-old male with no history or pre-existing conditions who on 13-FEB-2007 was vaccinated PO with a dose of (Lot # 65610/31166F). Concomitant vaccinations that day included a second dose of (DAPTACEL) (Lot # C2553AA), a second dose of ACTHIB (Lot # UF064AA), a second dose of IPOL (Lot # Z0326), and a second dose of PREVNAR (Lot # B36258B). There were no other medication. On 14-APR-2007, 60 days post vaccination, the patient presented with "coffee ground emesis" and bloody stools. The patient's mother brought him to the emergency room, when he was diagnosed with adenovirus and intussusception and was hospitalized. An adenovirus PCR was positive. The IT was unable to reduce with barium enema and was reduced with surgery. The patient was noted to be status/post an appendectomy. The patient recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Intussusception and adenovirus were considered to be life threatening.
Age: 0.2
Sex: M
Vaccine: RV5, RV5, RV5
Symptoms: Barium swallow abnormal, Gastrointestinal necrosis, Intussusception, Mass, Surgery
Clinical narrative: Information has been received concerning a 13 week old male, with no medical history, who on 06-FEB-2007 was vaccinated with an oral dose of Rotateq (Lot# 656191/1365F). There was no concomitant medication. On 12-MAR-2007 the patient experienced intussusception and was hospitalized with an extended stay. The patient had surgery for intussusception with removal of necrosed bowel. Subsequently, the patient recovered. The patient's experience was considered to be immediately life-theatening and disabling by the reporter. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: RV5, RV5, RV5
Symptoms: Urinary system X-ray
Clinical narrative: Information has been received concerning a 13 week old male, with no medical history, who on 06-FEB-2007 was vaccinated with an oral dose of Rotateq (Lot# 656191/1365F). There was no concomitant medication. On 12-MAR-2007 the patient experienced intussusception and was hospitalized with an extended stay. The patient had surgery for intussusception with removal of necrosed bowel. Subsequently, the patient recovered. The patient's experience was considered to be immediately life-theatening and disabling by the reporter. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: RV5, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received concerning a 13 week old male, with no medical history, who on 06-FEB-2007 was vaccinated with an oral dose of Rotateq (Lot# 656191/1365F). There was no concomitant medication. On 12-MAR-2007 the patient experienced intussusception and was hospitalized with an extended stay. The patient had surgery for intussusception with removal of necrosed bowel. Subsequently, the patient recovered. The patient's experience was considered to be immediately life-theatening and disabling by the reporter. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: RV5, RV5, RV5
Symptoms: Barium swallow abnormal, Gastrointestinal necrosis, Intussusception, Surgery, Urinary system X-ray
Clinical narrative: Information has been received concerning a 13 week old male, with no medical history, who on 06-FEB-2007 was vaccinated with an oral dose of Rotateq (Lot# 656191/1365F). There was no concomitant medication. On 12-MAR-2007 the patient experienced intussusception and was hospitalized with an extended stay. The patient had surgery for intussusception with removal of necrosed bowel. Subsequently, the patient recovered. The patient's experience was considered to be immediately life-theatening and disabling by the reporter. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, RV5, DTAP, HBHEPB, IPV, RV5
Symptoms: Barium double contrast, Intussusception
Clinical narrative: April 23rd: 8am - awoke screaming in pain, 10am - spitting up yellow/green mucus and saw a physician's assistant who said it was probably gas 7pm - blood in diaper, 10pm - went to ER  April 24: 12am - blood in diaper, 2am - diagnoised with intussuseption, air enema performed to correct it.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, RV5, DTAP, HBHEPB, IPV, RV5
Symptoms: Barium double contrast, Barium enema, Flatulence, Haematochezia, Infantile spitting up
Clinical narrative: April 23rd: 8am - awoke screaming in pain, 10am - spitting up yellow/green mucus and saw a physician's assistant who said it was probably gas 7pm - blood in diaper, 10pm - went to ER  April 24: 12am - blood in diaper, 2am - diagnoised with intussuseption, air enema performed to correct it.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, RV5, DTAP, HBHEPB, IPV, RV5
Symptoms: Intussusception, Laboratory test abnormal, Pain, Screaming
Clinical narrative: April 23rd: 8am - awoke screaming in pain, 10am - spitting up yellow/green mucus and saw a physician's assistant who said it was probably gas 7pm - blood in diaper, 10pm - went to ER  April 24: 12am - blood in diaper, 2am - diagnoised with intussuseption, air enema performed to correct it.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Cellulitis, Erythema, Rash
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report number WAES0705USA00086. The initial reporter to this manufacturer was a physician. "Information has been received from a physician concerning a 6 month old white male with no pre-existing allergies, birth defects, or medical conditions who on 29-MAR-2007 at 6:00 pm was vaccinated PO with a third dose of Rotateq (Lot # 656189/1239F). There was no illnesses at the time of vaccination. Concomitant therapy that day at 6:00pm included a third dose of IPOL (Lot# Z0326-2) administered IM in the left thigh, a third dose of PREVNAR (Lot # B08640H) administered IM in the right thigh, and a third dose of TRIPEDIA (Lot # C2552AA) administered IM in the left thigh. On 30-MAR-2007, one day after vaccination, the patient developed a rash around his rectum. The patient was seen 3 days later and had severe perirectal erythema. This was treated as cellulitis with improvement. No diarrhea was noted. The outcome was recovered on 09-APR-2007. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations. The reporter considered the event to be another important medical event. No additional information is expected." The lot number for Prevnar was also reported as B08670H.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Cellulitis, Erythema, Perianal erythema, Rash
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report number WAES0705USA00086. The initial reporter to this manufacturer was a physician. "Information has been received from a physician concerning a 6 month old white male with no pre-existing allergies, birth defects, or medical conditions who on 29-MAR-2007 at 6:00 pm was vaccinated PO with a third dose of Rotateq (Lot # 656189/1239F). There was no illnesses at the time of vaccination. Concomitant therapy that day at 6:00pm included a third dose of IPOL (Lot# Z0326-2) administered IM in the left thigh, a third dose of PREVNAR (Lot # B08640H) administered IM in the right thigh, and a third dose of TRIPEDIA (Lot # C2552AA) administered IM in the left thigh. On 30-MAR-2007, one day after vaccination, the patient developed a rash around his rectum. The patient was seen 3 days later and had severe perirectal erythema. This was treated as cellulitis with improvement. No diarrhea was noted. The outcome was recovered on 09-APR-2007. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations. The reporter considered the event to be another important medical event. No additional information is expected." The lot number for Prevnar was also reported as B08670H.
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: Groin pain, Headache, Herpes zoster, Laboratory test normal, Meningitis viral
Clinical narrative: Initial report received on 17 May 2007 from another manufacturer, report# WAES0705USA00797. The initial reporter to this manufacturer had been a health care professional. "Initial and follow up information has been received from a physician, concerning a 12 year old female patient with a history of hemolytic uremic syndrome (date unspecified), who on 24-APR-2007 was vaccinated with the first dose, 0.5ml, IM of Gardasil (Lot #656372/0243U). Concomitant therapy included hepatitis A (manufacturer unspecified), PEDVAXHIB and MENACTRA. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of pain from her spine to the right groin; blood work (unspecified) testing was performed, and was negative. On approximately 30-APR-2007 (also reported as "a couple of days later"), the patient "developed herpes zoster on the L3 and L4 dermatomes and pain," and acyclovir was prescribed acetaminophen (TYLENOL) and codeine. On 03-MAY-2007, the patient presented to the ER, "feeling awful and suffering from a massive headache," and was admitted to the hospital. Diagnostic testing included a polymerase chain reaction (PCR) that was negative for herpes and enterovirus, and a lumbar puncture that revealed the presence of "55 lymphocytes and 6 red blood cells;" a diagnosis of viral meningitis was confirmed. At the time of this report, the physician verified that the "patient's symptoms had resolved" (date not specified). The reporter considered the event of viral meningitis to be disabling/incapacitating, and an other important medical event. No further information is expected."
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Initial report received on 17 May 2007 from another manufacturer, report# WAES0705USA00797. The initial reporter to this manufacturer had been a health care professional. "Initial and follow up information has been received from a physician, concerning a 12 year old female patient with a history of hemolytic uremic syndrome (date unspecified), who on 24-APR-2007 was vaccinated with the first dose, 0.5ml, IM of Gardasil (Lot #656372/0243U). Concomitant therapy included hepatitis A (manufacturer unspecified), PEDVAXHIB and MENACTRA. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of pain from her spine to the right groin; blood work (unspecified) testing was performed, and was negative. On approximately 30-APR-2007 (also reported as "a couple of days later"), the patient "developed herpes zoster on the L3 and L4 dermatomes and pain," and acyclovir was prescribed acetaminophen (TYLENOL) and codeine. On 03-MAY-2007, the patient presented to the ER, "feeling awful and suffering from a massive headache," and was admitted to the hospital. Diagnostic testing included a polymerase chain reaction (PCR) that was negative for herpes and enterovirus, and a lumbar puncture that revealed the presence of "55 lymphocytes and 6 red blood cells;" a diagnosis of viral meningitis was confirmed. At the time of this report, the physician verified that the "patient's symptoms had resolved" (date not specified). The reporter considered the event of viral meningitis to be disabling/incapacitating, and an other important medical event. No further information is expected."
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: CSF lymphocyte count, Feeling abnormal, Headache, Herpes zoster, Lumbar puncture
Clinical narrative: Initial report received on 17 May 2007 from another manufacturer, report# WAES0705USA00797. The initial reporter to this manufacturer had been a health care professional. "Initial and follow up information has been received from a physician, concerning a 12 year old female patient with a history of hemolytic uremic syndrome (date unspecified), who on 24-APR-2007 was vaccinated with the first dose, 0.5ml, IM of Gardasil (Lot #656372/0243U). Concomitant therapy included hepatitis A (manufacturer unspecified), PEDVAXHIB and MENACTRA. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of pain from her spine to the right groin; blood work (unspecified) testing was performed, and was negative. On approximately 30-APR-2007 (also reported as "a couple of days later"), the patient "developed herpes zoster on the L3 and L4 dermatomes and pain," and acyclovir was prescribed acetaminophen (TYLENOL) and codeine. On 03-MAY-2007, the patient presented to the ER, "feeling awful and suffering from a massive headache," and was admitted to the hospital. Diagnostic testing included a polymerase chain reaction (PCR) that was negative for herpes and enterovirus, and a lumbar puncture that revealed the presence of "55 lymphocytes and 6 red blood cells;" a diagnosis of viral meningitis was confirmed. At the time of this report, the physician verified that the "patient's symptoms had resolved" (date not specified). The reporter considered the event of viral meningitis to be disabling/incapacitating, and an other important medical event. No further information is expected."
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: Meningitis viral, Pain, Polymerase chain reaction
Clinical narrative: Initial report received on 17 May 2007 from another manufacturer, report# WAES0705USA00797. The initial reporter to this manufacturer had been a health care professional. "Initial and follow up information has been received from a physician, concerning a 12 year old female patient with a history of hemolytic uremic syndrome (date unspecified), who on 24-APR-2007 was vaccinated with the first dose, 0.5ml, IM of Gardasil (Lot #656372/0243U). Concomitant therapy included hepatitis A (manufacturer unspecified), PEDVAXHIB and MENACTRA. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of pain from her spine to the right groin; blood work (unspecified) testing was performed, and was negative. On approximately 30-APR-2007 (also reported as "a couple of days later"), the patient "developed herpes zoster on the L3 and L4 dermatomes and pain," and acyclovir was prescribed acetaminophen (TYLENOL) and codeine. On 03-MAY-2007, the patient presented to the ER, "feeling awful and suffering from a massive headache," and was admitted to the hospital. Diagnostic testing included a polymerase chain reaction (PCR) that was negative for herpes and enterovirus, and a lumbar puncture that revealed the presence of "55 lymphocytes and 6 red blood cells;" a diagnosis of viral meningitis was confirmed. At the time of this report, the physician verified that the "patient's symptoms had resolved" (date not specified). The reporter considered the event of viral meningitis to be disabling/incapacitating, and an other important medical event. No further information is expected."
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: Headache, Meningitis viral, Myalgia, Pain, Rash
Clinical narrative: Initial report received on 17 May 2007 from another manufacturer, report# WAES0705USA00797. The initial reporter to this manufacturer had been a health care professional. "Initial and follow up information has been received from a physician, concerning a 12 year old female patient with a history of hemolytic uremic syndrome (date unspecified), who on 24-APR-2007 was vaccinated with the first dose, 0.5ml, IM of Gardasil (Lot #656372/0243U). Concomitant therapy included hepatitis A (manufacturer unspecified), PEDVAXHIB and MENACTRA. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of pain from her spine to the right groin; blood work (unspecified) testing was performed, and was negative. On approximately 30-APR-2007 (also reported as "a couple of days later"), the patient "developed herpes zoster on the L3 and L4 dermatomes and pain," and acyclovir was prescribed acetaminophen (TYLENOL) and codeine. On 03-MAY-2007, the patient presented to the ER, "feeling awful and suffering from a massive headache," and was admitted to the hospital. Diagnostic testing included a polymerase chain reaction (PCR) that was negative for herpes and enterovirus, and a lumbar puncture that revealed the presence of "55 lymphocytes and 6 red blood cells;" a diagnosis of viral meningitis was confirmed. At the time of this report, the physician verified that the "patient's symptoms had resolved" (date not specified). The reporter considered the event of viral meningitis to be disabling/incapacitating, and an other important medical event. No further information is expected."
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Blood glucose increased, CSF cell count, CSF glucose normal, CSF protein normal, CSF test normal
Clinical narrative: Information has been received from a physician and a registered nurse (RN) concerning an infant who on 09-MAY-2007 was vaccinated PO with a 2.0 mL dose of Rotateq. On 10-MAY-2007, the patient developed intussusception. Unspecified medical attention was sought and the patient was subsequently hospitalized. Surgery was not required as the intussusception was corrected by air enema. Additional information has been requested.
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Chest X-ray normal, Cyanosis, Full blood count, Gastroenteritis viral, Haematocrit normal
Clinical narrative: Information has been received from a physician and a registered nurse (RN) concerning an infant who on 09-MAY-2007 was vaccinated PO with a 2.0 mL dose of Rotateq. On 10-MAY-2007, the patient developed intussusception. Unspecified medical attention was sought and the patient was subsequently hospitalized. Surgery was not required as the intussusception was corrected by air enema. Additional information has been requested.
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Haemoglobin normal, Hyperglycaemia, Lethargy, Leukocytosis, Lymphocyte count increased
Clinical narrative: Information has been received from a physician and a registered nurse (RN) concerning an infant who on 09-MAY-2007 was vaccinated PO with a 2.0 mL dose of Rotateq. On 10-MAY-2007, the patient developed intussusception. Unspecified medical attention was sought and the patient was subsequently hospitalized. Surgery was not required as the intussusception was corrected by air enema. Additional information has been requested.
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Monocyte count normal, Neutrophil count increased, Platelet count increased, Retching, Sepsis
Clinical narrative: Information has been received from a physician and a registered nurse (RN) concerning an infant who on 09-MAY-2007 was vaccinated PO with a 2.0 mL dose of Rotateq. On 10-MAY-2007, the patient developed intussusception. Unspecified medical attention was sought and the patient was subsequently hospitalized. Surgery was not required as the intussusception was corrected by air enema. Additional information has been requested.
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Urine analysis, Vomiting, White blood cell count increased
Clinical narrative: Information has been received from a physician and a registered nurse (RN) concerning an infant who on 09-MAY-2007 was vaccinated PO with a 2.0 mL dose of Rotateq. On 10-MAY-2007, the patient developed intussusception. Unspecified medical attention was sought and the patient was subsequently hospitalized. Surgery was not required as the intussusception was corrected by air enema. Additional information has been requested.
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Barium double contrast
Clinical narrative: Information has been received from a physician and a registered nurse (RN) concerning an infant who on 09-MAY-2007 was vaccinated PO with a 2.0 mL dose of Rotateq. On 10-MAY-2007, the patient developed intussusception. Unspecified medical attention was sought and the patient was subsequently hospitalized. Surgery was not required as the intussusception was corrected by air enema. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Blood glucose decreased, Guillain-Barre syndrome, Laboratory test, Muscular weakness, Red blood cell count normal
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who on 02-MAY-2007, the patient was sitting in fifth period at school and started feeling weak. She could barely walk to the car by the end of the period, and by later that afternoon she was in the emergency room of a hospital. The patient stated "I was getting weak, like it felt weird to walk and to like open the care door." She also stated that "I was fine earlier that day." The patient couldn't move her legs and her arms felt weak. It was reported that the patient's  "legs are paralyzed, her arms are affected and she was very weak in her arms." The patient has to "use a walker and even with that she can't get to the bathroom and she can't stand up at all." The patient was diagnosed with Guillain-Barre syndrome, an acute, autoimmune condition that can lead to paralysis. The patient's Guillain-Barre syndrome persisted. The patient's neurologist felt that Guillain-Barre syndrome was related to therapy with Gardasil. Upon internal review Guillain-Barre syndrome was considered to be an other important medical event. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Red blood cells CSF positive
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who on 02-MAY-2007, the patient was sitting in fifth period at school and started feeling weak. She could barely walk to the car by the end of the period, and by later that afternoon she was in the emergency room of a hospital. The patient stated "I was getting weak, like it felt weird to walk and to like open the care door." She also stated that "I was fine earlier that day." The patient couldn't move her legs and her arms felt weak. It was reported that the patient's  "legs are paralyzed, her arms are affected and she was very weak in her arms." The patient has to "use a walker and even with that she can't get to the bathroom and she can't stand up at all." The patient was diagnosed with Guillain-Barre syndrome, an acute, autoimmune condition that can lead to paralysis. The patient's Guillain-Barre syndrome persisted. The patient's neurologist felt that Guillain-Barre syndrome was related to therapy with Gardasil. Upon internal review Guillain-Barre syndrome was considered to be an other important medical event. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Muscular weakness
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who on 02-MAY-2007, the patient was sitting in fifth period at school and started feeling weak. She could barely walk to the car by the end of the period, and by later that afternoon she was in the emergency room of a hospital. The patient stated "I was getting weak, like it felt weird to walk and to like open the care door." She also stated that "I was fine earlier that day." The patient couldn't move her legs and her arms felt weak. It was reported that the patient's  "legs are paralyzed, her arms are affected and she was very weak in her arms." The patient has to "use a walker and even with that she can't get to the bathroom and she can't stand up at all." The patient was diagnosed with Guillain-Barre syndrome, an acute, autoimmune condition that can lead to paralysis. The patient's Guillain-Barre syndrome persisted. The patient's neurologist felt that Guillain-Barre syndrome was related to therapy with Gardasil. Upon internal review Guillain-Barre syndrome was considered to be an other important medical event. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Asthenia, Autoimmune disorder, Feeling abnormal, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who on 02-MAY-2007, the patient was sitting in fifth period at school and started feeling weak. She could barely walk to the car by the end of the period, and by later that afternoon she was in the emergency room of a hospital. The patient stated "I was getting weak, like it felt weird to walk and to like open the care door." She also stated that "I was fine earlier that day." The patient couldn't move her legs and her arms felt weak. It was reported that the patient's  "legs are paralyzed, her arms are affected and she was very weak in her arms." The patient has to "use a walker and even with that she can't get to the bathroom and she can't stand up at all." The patient was diagnosed with Guillain-Barre syndrome, an acute, autoimmune condition that can lead to paralysis. The patient's Guillain-Barre syndrome persisted. The patient's neurologist felt that Guillain-Barre syndrome was related to therapy with Gardasil. Upon internal review Guillain-Barre syndrome was considered to be an other important medical event. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Monoplegia, Muscular weakness, Walking aid user
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who on 02-MAY-2007, the patient was sitting in fifth period at school and started feeling weak. She could barely walk to the car by the end of the period, and by later that afternoon she was in the emergency room of a hospital. The patient stated "I was getting weak, like it felt weird to walk and to like open the care door." She also stated that "I was fine earlier that day." The patient couldn't move her legs and her arms felt weak. It was reported that the patient's  "legs are paralyzed, her arms are affected and she was very weak in her arms." The patient has to "use a walker and even with that she can't get to the bathroom and she can't stand up at all." The patient was diagnosed with Guillain-Barre syndrome, an acute, autoimmune condition that can lead to paralysis. The patient's Guillain-Barre syndrome persisted. The patient's neurologist felt that Guillain-Barre syndrome was related to therapy with Gardasil. Upon internal review Guillain-Barre syndrome was considered to be an other important medical event. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who on 02-MAY-2007, the patient was sitting in fifth period at school and started feeling weak. She could barely walk to the car by the end of the period, and by later that afternoon she was in the emergency room of a hospital. The patient stated "I was getting weak, like it felt weird to walk and to like open the care door." She also stated that "I was fine earlier that day." The patient couldn't move her legs and her arms felt weak. It was reported that the patient's  "legs are paralyzed, her arms are affected and she was very weak in her arms." The patient has to "use a walker and even with that she can't get to the bathroom and she can't stand up at all." The patient was diagnosed with Guillain-Barre syndrome, an acute, autoimmune condition that can lead to paralysis. The patient's Guillain-Barre syndrome persisted. The patient's neurologist felt that Guillain-Barre syndrome was related to therapy with Gardasil. Upon internal review Guillain-Barre syndrome was considered to be an other important medical event. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cardiac electrophysiologic study normal, Chest pain, Constipation, Dizziness, Electrocardiogram abnormal
Clinical narrative: On 12/07/2006 I received the first shot for the three shot vaccine Gardasil, however, some of the vaccine was discharged and sprayed out of the syringe. For a month later I felt tired and dizzy. On 01/05/2007 I woke to chest pain and a racing heart and was transported by ambulance to the hospital with later discharge. On 01/09/2007 I passed out at my work place and again was transported by ambulance to the hospital they kept me from 01/09/2007 to 01/12/2007. While in the hospital I fainted again. They did the tilt table test and an EPS. Later that month I fainted again. Feb 12, 2007 I fainted, hitting my head and Feb 13, 2007 I fainted again. March 5, 2007 I fainted again injuring my head again and was sent to the ER and had a CT scan and X-Ray of my shoulder. March 14, 2007 fainted again resulting in a black eye. March 15th to the 20th of 2007 I was hospitalized. April 3, 2007, April 17, 2007, April 27, 2007 I fainted again. May 10, 2007 I visited a neurologist at the clinic. As well as May 14 and 15 of 2007. May 19, 2007 fainted again.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram normal, Electroencephalogram, Headache, Insomnia, Palpitations
Clinical narrative: On 12/07/2006 I received the first shot for the three shot vaccine Gardasil, however, some of the vaccine was discharged and sprayed out of the syringe. For a month later I felt tired and dizzy. On 01/05/2007 I woke to chest pain and a racing heart and was transported by ambulance to the hospital with later discharge. On 01/09/2007 I passed out at my work place and again was transported by ambulance to the hospital they kept me from 01/09/2007 to 01/12/2007. While in the hospital I fainted again. They did the tilt table test and an EPS. Later that month I fainted again. Feb 12, 2007 I fainted, hitting my head and Feb 13, 2007 I fainted again. March 5, 2007 I fainted again injuring my head again and was sent to the ER and had a CT scan and X-Ray of my shoulder. March 14, 2007 fainted again resulting in a black eye. March 15th to the 20th of 2007 I was hospitalized. April 3, 2007, April 17, 2007, April 27, 2007 I fainted again. May 10, 2007 I visited a neurologist at the clinic. As well as May 14 and 15 of 2007. May 19, 2007 fainted again.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Tilt table test, Vision blurred
Clinical narrative: On 12/07/2006 I received the first shot for the three shot vaccine Gardasil, however, some of the vaccine was discharged and sprayed out of the syringe. For a month later I felt tired and dizzy. On 01/05/2007 I woke to chest pain and a racing heart and was transported by ambulance to the hospital with later discharge. On 01/09/2007 I passed out at my work place and again was transported by ambulance to the hospital they kept me from 01/09/2007 to 01/12/2007. While in the hospital I fainted again. They did the tilt table test and an EPS. Later that month I fainted again. Feb 12, 2007 I fainted, hitting my head and Feb 13, 2007 I fainted again. March 5, 2007 I fainted again injuring my head again and was sent to the ER and had a CT scan and X-Ray of my shoulder. March 14, 2007 fainted again resulting in a black eye. March 15th to the 20th of 2007 I was hospitalized. April 3, 2007, April 17, 2007, April 27, 2007 I fainted again. May 10, 2007 I visited a neurologist at the clinic. As well as May 14 and 15 of 2007. May 19, 2007 fainted again.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Accidental exposure, Chest pain, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: On 12/07/2006 I received the first shot for the three shot vaccine Gardasil, however, some of the vaccine was discharged and sprayed out of the syringe. For a month later I felt tired and dizzy. On 01/05/2007 I woke to chest pain and a racing heart and was transported by ambulance to the hospital with later discharge. On 01/09/2007 I passed out at my work place and again was transported by ambulance to the hospital they kept me from 01/09/2007 to 01/12/2007. While in the hospital I fainted again. They did the tilt table test and an EPS. Later that month I fainted again. Feb 12, 2007 I fainted, hitting my head and Feb 13, 2007 I fainted again. March 5, 2007 I fainted again injuring my head again and was sent to the ER and had a CT scan and X-Ray of my shoulder. March 14, 2007 fainted again resulting in a black eye. March 15th to the 20th of 2007 I was hospitalized. April 3, 2007, April 17, 2007, April 27, 2007 I fainted again. May 10, 2007 I visited a neurologist at the clinic. As well as May 14 and 15 of 2007. May 19, 2007 fainted again.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electroencephalogram, Fatigue, Head injury, Incorrect dose administered, Loss of consciousness
Clinical narrative: On 12/07/2006 I received the first shot for the three shot vaccine Gardasil, however, some of the vaccine was discharged and sprayed out of the syringe. For a month later I felt tired and dizzy. On 01/05/2007 I woke to chest pain and a racing heart and was transported by ambulance to the hospital with later discharge. On 01/09/2007 I passed out at my work place and again was transported by ambulance to the hospital they kept me from 01/09/2007 to 01/12/2007. While in the hospital I fainted again. They did the tilt table test and an EPS. Later that month I fainted again. Feb 12, 2007 I fainted, hitting my head and Feb 13, 2007 I fainted again. March 5, 2007 I fainted again injuring my head again and was sent to the ER and had a CT scan and X-Ray of my shoulder. March 14, 2007 fainted again resulting in a black eye. March 15th to the 20th of 2007 I was hospitalized. April 3, 2007, April 17, 2007, April 27, 2007 I fainted again. May 10, 2007 I visited a neurologist at the clinic. As well as May 14 and 15 of 2007. May 19, 2007 fainted again.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Medication error, Palpitations, Periorbital haematoma, Syncope, Tilt table test
Clinical narrative: On 12/07/2006 I received the first shot for the three shot vaccine Gardasil, however, some of the vaccine was discharged and sprayed out of the syringe. For a month later I felt tired and dizzy. On 01/05/2007 I woke to chest pain and a racing heart and was transported by ambulance to the hospital with later discharge. On 01/09/2007 I passed out at my work place and again was transported by ambulance to the hospital they kept me from 01/09/2007 to 01/12/2007. While in the hospital I fainted again. They did the tilt table test and an EPS. Later that month I fainted again. Feb 12, 2007 I fainted, hitting my head and Feb 13, 2007 I fainted again. March 5, 2007 I fainted again injuring my head again and was sent to the ER and had a CT scan and X-Ray of my shoulder. March 14, 2007 fainted again resulting in a black eye. March 15th to the 20th of 2007 I was hospitalized. April 3, 2007, April 17, 2007, April 27, 2007 I fainted again. May 10, 2007 I visited a neurologist at the clinic. As well as May 14 and 15 of 2007. May 19, 2007 fainted again.