chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal X-ray, Appendicectomy, Diarrhoea, Hypophagia, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  On 26-AUG-2010 a 20 week old female patient with a history of loose stools for 1 day was vaccinated with the second dose of ROTATEQ (lot number 665254/0200Z) by mouth.  Concomitant therapy given the same day included the second dose of PREVNAR (lot number E52354) given IM in the right leg, the first dose of PENTACEL (lot number C3668AA) given IM in the left leg and the third dose of GENHEVAC B (unspecified) (lot number C5365AA) given by mouth.  On 26-AUG-2010 the patient experienced vomiting and diarrhea, decreased oral intake and no fever.  The patient was evaluated in the emergency department (ED) on 28-AUG-2010 and was diagnosed with intussusception which required surgical reduction and incidental appendectomy and repair of umbilical hernia.  On 28-AUG-2010 the patient was admitted to the hospital with a diagnosis of intussusception for 2 days after receipt of vaccinations.  The patient complained of lethargy, projective vomiting and not feeling well.  Physical exam was positive with periumbilical mass.  Contrast enema was administered and the reduction was unsuccessful.  The patient was sent to the operating room (OR) for diagnostic laparocospy, reduction of intussusception, appendectomy and umbilical hernia repair.  Therapy with antibiotics was given and symptoms improved.  The patient was discharged on 31-AUG-2010.  It was also reported that on 22-SEP-2010 the patient presented at primary care physician (PCP) screaming and bending over.  The patient was fussy for a few days, there was assessment of upper respiratory illness (URI) and abdominal pain per history.  At the time of the report the patient's outcome was unknown.  The listing indicated that one or more of the events required hospitalization, were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID # 402317.  A lot check has been requested.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Research Center and was released.  No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Surgery, Ultrasound abdomen abnormal, Umbilical hernia repair, Vomiting, X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  On 26-AUG-2010 a 20 week old female patient with a history of loose stools for 1 day was vaccinated with the second dose of ROTATEQ (lot number 665254/0200Z) by mouth.  Concomitant therapy given the same day included the second dose of PREVNAR (lot number E52354) given IM in the right leg, the first dose of PENTACEL (lot number C3668AA) given IM in the left leg and the third dose of GENHEVAC B (unspecified) (lot number C5365AA) given by mouth.  On 26-AUG-2010 the patient experienced vomiting and diarrhea, decreased oral intake and no fever.  The patient was evaluated in the emergency department (ED) on 28-AUG-2010 and was diagnosed with intussusception which required surgical reduction and incidental appendectomy and repair of umbilical hernia.  On 28-AUG-2010 the patient was admitted to the hospital with a diagnosis of intussusception for 2 days after receipt of vaccinations.  The patient complained of lethargy, projective vomiting and not feeling well.  Physical exam was positive with periumbilical mass.  Contrast enema was administered and the reduction was unsuccessful.  The patient was sent to the operating room (OR) for diagnostic laparocospy, reduction of intussusception, appendectomy and umbilical hernia repair.  Therapy with antibiotics was given and symptoms improved.  The patient was discharged on 31-AUG-2010.  It was also reported that on 22-SEP-2010 the patient presented at primary care physician (PCP) screaming and bending over.  The patient was fussy for a few days, there was assessment of upper respiratory illness (URI) and abdominal pain per history.  At the time of the report the patient's outcome was unknown.  The listing indicated that one or more of the events required hospitalization, were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID # 402317.  A lot check has been requested.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Research Center and was released.  No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal mass, Appendicectomy, Barium double contrast, Diarrhoea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  On 26-AUG-2010 a 20 week old female patient with a history of loose stools for 1 day was vaccinated with the second dose of ROTATEQ (lot number 665254/0200Z) by mouth.  Concomitant therapy given the same day included the second dose of PREVNAR (lot number E52354) given IM in the right leg, the first dose of PENTACEL (lot number C3668AA) given IM in the left leg and the third dose of GENHEVAC B (unspecified) (lot number C5365AA) given by mouth.  On 26-AUG-2010 the patient experienced vomiting and diarrhea, decreased oral intake and no fever.  The patient was evaluated in the emergency department (ED) on 28-AUG-2010 and was diagnosed with intussusception which required surgical reduction and incidental appendectomy and repair of umbilical hernia.  On 28-AUG-2010 the patient was admitted to the hospital with a diagnosis of intussusception for 2 days after receipt of vaccinations.  The patient complained of lethargy, projective vomiting and not feeling well.  Physical exam was positive with periumbilical mass.  Contrast enema was administered and the reduction was unsuccessful.  The patient was sent to the operating room (OR) for diagnostic laparocospy, reduction of intussusception, appendectomy and umbilical hernia repair.  Therapy with antibiotics was given and symptoms improved.  The patient was discharged on 31-AUG-2010.  It was also reported that on 22-SEP-2010 the patient presented at primary care physician (PCP) screaming and bending over.  The patient was fussy for a few days, there was assessment of upper respiratory illness (URI) and abdominal pain per history.  At the time of the report the patient's outcome was unknown.  The listing indicated that one or more of the events required hospitalization, were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID # 402317.  A lot check has been requested.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Research Center and was released.  No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Gastrointestinal surgery, Hypophagia, Intussusception, Irritability, Laparoscopy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  On 26-AUG-2010 a 20 week old female patient with a history of loose stools for 1 day was vaccinated with the second dose of ROTATEQ (lot number 665254/0200Z) by mouth.  Concomitant therapy given the same day included the second dose of PREVNAR (lot number E52354) given IM in the right leg, the first dose of PENTACEL (lot number C3668AA) given IM in the left leg and the third dose of GENHEVAC B (unspecified) (lot number C5365AA) given by mouth.  On 26-AUG-2010 the patient experienced vomiting and diarrhea, decreased oral intake and no fever.  The patient was evaluated in the emergency department (ED) on 28-AUG-2010 and was diagnosed with intussusception which required surgical reduction and incidental appendectomy and repair of umbilical hernia.  On 28-AUG-2010 the patient was admitted to the hospital with a diagnosis of intussusception for 2 days after receipt of vaccinations.  The patient complained of lethargy, projective vomiting and not feeling well.  Physical exam was positive with periumbilical mass.  Contrast enema was administered and the reduction was unsuccessful.  The patient was sent to the operating room (OR) for diagnostic laparocospy, reduction of intussusception, appendectomy and umbilical hernia repair.  Therapy with antibiotics was given and symptoms improved.  The patient was discharged on 31-AUG-2010.  It was also reported that on 22-SEP-2010 the patient presented at primary care physician (PCP) screaming and bending over.  The patient was fussy for a few days, there was assessment of upper respiratory illness (URI) and abdominal pain per history.  At the time of the report the patient's outcome was unknown.  The listing indicated that one or more of the events required hospitalization, were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID # 402317.  A lot check has been requested.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Research Center and was released.  No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Lethargy, Malaise, Posture abnormal, Screaming, Umbilical hernia repair
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  On 26-AUG-2010 a 20 week old female patient with a history of loose stools for 1 day was vaccinated with the second dose of ROTATEQ (lot number 665254/0200Z) by mouth.  Concomitant therapy given the same day included the second dose of PREVNAR (lot number E52354) given IM in the right leg, the first dose of PENTACEL (lot number C3668AA) given IM in the left leg and the third dose of GENHEVAC B (unspecified) (lot number C5365AA) given by mouth.  On 26-AUG-2010 the patient experienced vomiting and diarrhea, decreased oral intake and no fever.  The patient was evaluated in the emergency department (ED) on 28-AUG-2010 and was diagnosed with intussusception which required surgical reduction and incidental appendectomy and repair of umbilical hernia.  On 28-AUG-2010 the patient was admitted to the hospital with a diagnosis of intussusception for 2 days after receipt of vaccinations.  The patient complained of lethargy, projective vomiting and not feeling well.  Physical exam was positive with periumbilical mass.  Contrast enema was administered and the reduction was unsuccessful.  The patient was sent to the operating room (OR) for diagnostic laparocospy, reduction of intussusception, appendectomy and umbilical hernia repair.  Therapy with antibiotics was given and symptoms improved.  The patient was discharged on 31-AUG-2010.  It was also reported that on 22-SEP-2010 the patient presented at primary care physician (PCP) screaming and bending over.  The patient was fussy for a few days, there was assessment of upper respiratory illness (URI) and abdominal pain per history.  At the time of the report the patient's outcome was unknown.  The listing indicated that one or more of the events required hospitalization, were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID # 402317.  A lot check has been requested.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Research Center and was released.  No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Vomiting, Vomiting projectile, X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  On 26-AUG-2010 a 20 week old female patient with a history of loose stools for 1 day was vaccinated with the second dose of ROTATEQ (lot number 665254/0200Z) by mouth.  Concomitant therapy given the same day included the second dose of PREVNAR (lot number E52354) given IM in the right leg, the first dose of PENTACEL (lot number C3668AA) given IM in the left leg and the third dose of GENHEVAC B (unspecified) (lot number C5365AA) given by mouth.  On 26-AUG-2010 the patient experienced vomiting and diarrhea, decreased oral intake and no fever.  The patient was evaluated in the emergency department (ED) on 28-AUG-2010 and was diagnosed with intussusception which required surgical reduction and incidental appendectomy and repair of umbilical hernia.  On 28-AUG-2010 the patient was admitted to the hospital with a diagnosis of intussusception for 2 days after receipt of vaccinations.  The patient complained of lethargy, projective vomiting and not feeling well.  Physical exam was positive with periumbilical mass.  Contrast enema was administered and the reduction was unsuccessful.  The patient was sent to the operating room (OR) for diagnostic laparocospy, reduction of intussusception, appendectomy and umbilical hernia repair.  Therapy with antibiotics was given and symptoms improved.  The patient was discharged on 31-AUG-2010.  It was also reported that on 22-SEP-2010 the patient presented at primary care physician (PCP) screaming and bending over.  The patient was fussy for a few days, there was assessment of upper respiratory illness (URI) and abdominal pain per history.  At the time of the report the patient's outcome was unknown.  The listing indicated that one or more of the events required hospitalization, were considered to be immediately life-threatening.  The original reporting source was not provided.  The VAERS ID # 402317.  A lot check has been requested.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Research Center and was released.  No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Hypoaesthesia, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient with juvenile rheumatoid arthritis, immune globulin deficiency, hypothyroidism, asthma, mucosal hypertrophy and Glutamic Acid Decarboxylase (GAD), iodine and ZITHROMAX allergies, who on 02-SEP-2010 was vaccinated with a first dose of GARDASIL (Lot# 0450Z Exp. Date Nov-2011), IM, and on 02-NOV-2010 was vaccinated with a second dose of GARDASIL (Lot# 1017Z Exp. Date 13-SEP-2012), IM.  Concomitant therapy included levothyroxine Na, REGLAN, EPIPEN, DULERA, VENTOLIN, NASONEX and amoxicillin.  The nurse stated that "Several weeks later, after the first dose of GARDASIL was administered, the patient experienced scleritis in her eye".  Then immediately after being administered her second dose of GARDASIL the nurse stated the patient developed numbness in her arms and by that evening was in the emergency room with peripheral neuropathy in her trunk and legs.  In approximately November 2010, the patient developed an optic neuropathy, she also missed school and could not see.  The nurse also reported that the patient was treated with NEURONTIN for peripheral neuropathy and indomethacin for the optic scleritis.  Magnetic resonance imaging (MRI) was performed (No results reported).  The patient would be follow-up for a neuroopthamologist".  At the time of the report the patient had not recovered and the third dose of GARDASIL would not be administered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blindness, Hypoaesthesia, Immediate post-injection reaction, Neuropathy peripheral, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient with juvenile rheumatoid arthritis, immune globulin deficiency, hypothyroidism, asthma, mucosal hypertrophy and Glutamic Acid Decarboxylase (GAD), iodine and ZITHROMAX allergies, who on 02-SEP-2010 was vaccinated with a first dose of GARDASIL (Lot# 0450Z Exp. Date Nov-2011), IM, and on 02-NOV-2010 was vaccinated with a second dose of GARDASIL (Lot# 1017Z Exp. Date 13-SEP-2012), IM.  Concomitant therapy included levothyroxine Na, REGLAN, EPIPEN, DULERA, VENTOLIN, NASONEX and amoxicillin.  The nurse stated that "Several weeks later, after the first dose of GARDASIL was administered, the patient experienced scleritis in her eye".  Then immediately after being administered her second dose of GARDASIL the nurse stated the patient developed numbness in her arms and by that evening was in the emergency room with peripheral neuropathy in her trunk and legs.  In approximately November 2010, the patient developed an optic neuropathy, she also missed school and could not see.  The nurse also reported that the patient was treated with NEURONTIN for peripheral neuropathy and indomethacin for the optic scleritis.  Magnetic resonance imaging (MRI) was performed (No results reported).  The patient would be follow-up for a neuroopthamologist".  At the time of the report the patient had not recovered and the third dose of GARDASIL would not be administered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Optic neuropathy
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient with juvenile rheumatoid arthritis, immune globulin deficiency, hypothyroidism, asthma, mucosal hypertrophy and Glutamic Acid Decarboxylase (GAD), iodine and ZITHROMAX allergies, who on 02-SEP-2010 was vaccinated with a first dose of GARDASIL (Lot# 0450Z Exp. Date Nov-2011), IM, and on 02-NOV-2010 was vaccinated with a second dose of GARDASIL (Lot# 1017Z Exp. Date 13-SEP-2012), IM.  Concomitant therapy included levothyroxine Na, REGLAN, EPIPEN, DULERA, VENTOLIN, NASONEX and amoxicillin.  The nurse stated that "Several weeks later, after the first dose of GARDASIL was administered, the patient experienced scleritis in her eye".  Then immediately after being administered her second dose of GARDASIL the nurse stated the patient developed numbness in her arms and by that evening was in the emergency room with peripheral neuropathy in her trunk and legs.  In approximately November 2010, the patient developed an optic neuropathy, she also missed school and could not see.  The nurse also reported that the patient was treated with NEURONTIN for peripheral neuropathy and indomethacin for the optic scleritis.  Magnetic resonance imaging (MRI) was performed (No results reported).  The patient would be follow-up for a neuroopthamologist".  At the time of the report the patient had not recovered and the third dose of GARDASIL would not be administered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Computerised tomogram head, Dizziness, Feeling hot, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient with juvenile rheumatoid arthritis, immune globulin deficiency, hypothyroidism, asthma, mucosal hypertrophy and Glutamic Acid Decarboxylase (GAD), iodine and ZITHROMAX allergies, who on 02-SEP-2010 was vaccinated with a first dose of GARDASIL (Lot# 0450Z Exp. Date Nov-2011), IM, and on 02-NOV-2010 was vaccinated with a second dose of GARDASIL (Lot# 1017Z Exp. Date 13-SEP-2012), IM.  Concomitant therapy included levothyroxine Na, REGLAN, EPIPEN, DULERA, VENTOLIN, NASONEX and amoxicillin.  The nurse stated that "Several weeks later, after the first dose of GARDASIL was administered, the patient experienced scleritis in her eye".  Then immediately after being administered her second dose of GARDASIL the nurse stated the patient developed numbness in her arms and by that evening was in the emergency room with peripheral neuropathy in her trunk and legs.  In approximately November 2010, the patient developed an optic neuropathy, she also missed school and could not see.  The nurse also reported that the patient was treated with NEURONTIN for peripheral neuropathy and indomethacin for the optic scleritis.  Magnetic resonance imaging (MRI) was performed (No results reported).  The patient would be follow-up for a neuroopthamologist".  At the time of the report the patient had not recovered and the third dose of GARDASIL would not be administered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Optic neuritis, Pruritus, Visual field defect, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient with juvenile rheumatoid arthritis, immune globulin deficiency, hypothyroidism, asthma, mucosal hypertrophy and Glutamic Acid Decarboxylase (GAD), iodine and ZITHROMAX allergies, who on 02-SEP-2010 was vaccinated with a first dose of GARDASIL (Lot# 0450Z Exp. Date Nov-2011), IM, and on 02-NOV-2010 was vaccinated with a second dose of GARDASIL (Lot# 1017Z Exp. Date 13-SEP-2012), IM.  Concomitant therapy included levothyroxine Na, REGLAN, EPIPEN, DULERA, VENTOLIN, NASONEX and amoxicillin.  The nurse stated that "Several weeks later, after the first dose of GARDASIL was administered, the patient experienced scleritis in her eye".  Then immediately after being administered her second dose of GARDASIL the nurse stated the patient developed numbness in her arms and by that evening was in the emergency room with peripheral neuropathy in her trunk and legs.  In approximately November 2010, the patient developed an optic neuropathy, she also missed school and could not see.  The nurse also reported that the patient was treated with NEURONTIN for peripheral neuropathy and indomethacin for the optic scleritis.  Magnetic resonance imaging (MRI) was performed (No results reported).  The patient would be follow-up for a neuroopthamologist".  At the time of the report the patient had not recovered and the third dose of GARDASIL would not be administered.  Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: UNK, FLU3, VARZOS
Symptoms: Cyanosis, Hypoaesthesia, Muscle tightness, Nausea, Pain
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old male patient who on approximately 06-DEC-2010 ("last week") was vaccinated with a dose of AFLURIA (manufacturer unknown) in the right arm, and ZOSTAVAX (Merck) in the left arm.  On the same day the patient experienced radiating pain on the right side where the AFLURIA (manufacturer unknown) had been administered.  Then it became pain all over the body.  The patient called his pharmacist, explained the pain and stated that his extremities became blue.  The pharmacist advised the patient to call 911.  The 911 team provided the patient with oxygen and from then on he was feeling better.  The patient decided not to go to the hospital.  On the same day, the patient recovered.  Radiating pain on the right side/pain all over the body and extremities became blue were considered to be important medical events by the reporter.  Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: UNK, FLU3, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old male patient who on approximately 06-DEC-2010 ("last week") was vaccinated with a dose of AFLURIA (manufacturer unknown) in the right arm, and ZOSTAVAX (Merck) in the left arm.  On the same day the patient experienced radiating pain on the right side where the AFLURIA (manufacturer unknown) had been administered.  Then it became pain all over the body.  The patient called his pharmacist, explained the pain and stated that his extremities became blue.  The pharmacist advised the patient to call 911.  The 911 team provided the patient with oxygen and from then on he was feeling better.  The patient decided not to go to the hospital.  On the same day, the patient recovered.  Radiating pain on the right side/pain all over the body and extremities became blue were considered to be important medical events by the reporter.  Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: UNK, FLU3, VARZOS
Symptoms: Cyanosis, Pain
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old male patient who on approximately 06-DEC-2010 ("last week") was vaccinated with a dose of AFLURIA (manufacturer unknown) in the right arm, and ZOSTAVAX (Merck) in the left arm.  On the same day the patient experienced radiating pain on the right side where the AFLURIA (manufacturer unknown) had been administered.  Then it became pain all over the body.  The patient called his pharmacist, explained the pain and stated that his extremities became blue.  The pharmacist advised the patient to call 911.  The 911 team provided the patient with oxygen and from then on he was feeling better.  The patient decided not to go to the hospital.  On the same day, the patient recovered.  Radiating pain on the right side/pain all over the body and extremities became blue were considered to be important medical events by the reporter.  Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Ear discomfort, Musculoskeletal pain, Neck pain, Pruritus
Clinical narrative: Pt received FLUMIST in clinic at approx. 12:15pm. Called clinic about 2 1/2 hrs. later starting her ears were burning and face itching. No other symptoms. Advised 25mg Benadryl by mouth and return to hosp if symptoms do not resolve or get worse. 12/22/10 9:00AM spoke with pt. by phone. C/O neck and shoulder pain this morning no other symptoms.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Rash, Rash macular
Clinical narrative: Patient's daughter asked what medication did pt recently received because pt has a rash.  Patient's bilateral upper extremities and chest area was red, blotchy, and itching.  Stated that the only medication the patient recently received was the pneumococcal vaccine.  Notified Dr.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large area of redness and swellling at injection site.
Age: 0.98
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Pyrexia
Clinical narrative: Woke up not feeling well with fever
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13
Symptoms: Cough, Decreased appetite, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Son son has been sick since the vaccination with vomiting, diarrhea, fever and loss of appetite.  Some of this has been intermittent where he seems to recover for a day and then it starts all over again.  He also has a heavy cough.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the second dose of GARDASIL (lot number not provided). The physician was visiting his dentist and was talking to the dental hygienist about GARDASIL. The dental hygienist said she had a friend whose daughter died after getting the second dose of GARDASIL. It was unknown if the patient sought medical attention. The reporter considered death to be disabling and life-threatening. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, lot number, date of event, hospital name (if applicable), and healthcare provider name and contact information. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune thyroiditis, Fatigue, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female patient with sulfa allergy who on 30-JUN-2010 was vaccinated with a first dose of 0.5 ml of GARDASIL (Lot#Unknown), IM. The nurse practitioner stated that in July 2010 the patient started experiencing ongoing fatigue. In September 2010, the patient was vaccinated with a second dose of 0.5 ml of GARDASIL (Lot#Unknown), IM. There were no laboratories performed. It was reported that the patient had seen multiple other unspecified healthcare providers and the patient was evaluated for Hashimoto's disease and had recently been started on unspecified date and an unspecified dose of SYNTHROID. It was also reported by the nurse practitioner that the patient continued to experience extreme fatigue and the patient's mother believed that it was related to GARDASIL and had her daughter evaluated to investigate other possible causes for the severe fatigue. The patient sought medical attention via office visit. Follow up information has been received from a nurse practitioner who indicated that the patient was a 20 year old female patient who on 30-JUN-2010 was vaccinated IM with the first dose of GARDASIL (Lot # 665759/1377Y) and in September 2010 was vaccinated IM with the second dose of GARDASIL (Lot # 666163/066AZ). Concomitant medications included YAZ. The patient reported significant fatigue since the injection. In July 2010, the patient experienced fatigue. She saw an endocrinologist and was taking SYNTHROID to treat Hashimoto's disease. Prior to treatment the patient's mother called to discuss the association of fatigue to GARDASIL since it was mentioned as a side effect which may require medical intervention. It was reported that the patient did not have any laboratory tests or reports from the endocrinologist. At the time of the report the patient's fatigue and Hashimoto's disease persisted.  The event of fatigue and Hashimoto's disease were considered to be an other important medical event. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Barium double contrast, Blood chloride normal, Blood potassium normal, Blood sodium increased, Carbon dioxide decreased
Clinical narrative: 4 mo old M 5 days after vaccines below dev. emesis 10-15 times, followed by dark stool; following pasty, red streak stool UGI -> NL; u/s -> intussusception; air contrast - reduced; stool guaiac (+); Rota (-).
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Enema administration, Faeces discoloured, Haematochezia, Haematocrit normal, Haemoglobin normal
Clinical narrative: 4 mo old M 5 days after vaccines below dev. emesis 10-15 times, followed by dark stool; following pasty, red streak stool UGI -> NL; u/s -> intussusception; air contrast - reduced; stool guaiac (+); Rota (-).
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Intussusception, Occult blood positive, Platelet count increased, Rotavirus test negative, Ultrasound abdomen abnormal
Clinical narrative: 4 mo old M 5 days after vaccines below dev. emesis 10-15 times, followed by dark stool; following pasty, red streak stool UGI -> NL; u/s -> intussusception; air contrast - reduced; stool guaiac (+); Rota (-).
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting, White blood cell count increased, X-ray gastrointestinal tract normal
Clinical narrative: 4 mo old M 5 days after vaccines below dev. emesis 10-15 times, followed by dark stool; following pasty, red streak stool UGI -> NL; u/s -> intussusception; air contrast - reduced; stool guaiac (+); Rota (-).
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea
Clinical narrative: After receiving the flu shot had chest pain and troubles breathing. Was seen in the Emergency department. Meds given. All symptoms gone after about 48 hours.
Age: 85.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: injection site on arm became hot, red, itchy--the size of her palm
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: SLIGHT SWELLING, ITCHY ON LEFT ARM
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: Fever 101.5 - day after injection - feels bad - no other symptoms.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Albumin CSF increased, Bone scan normal, Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia oral
Clinical narrative: After receiving his flu vaccination, the patient was in his usual state of health until he began to experience bilateral lower extremity weakness and tongue numbness. On initial presentation, due to his history of colon cancer in the past, the primary concern was metastatic disease.  Therefore, full new imaging of neural axis including the brain and entire spine was done.  MRI of the brain was within normal limits for age.  MRI of the spine showed mild degenerative changes with no evidence of any spinal cord or nerve root involvement.  Bone scan of the whole body did not show any metastatic disease. Upon admission, an EMG was performed which was negative for any acute neuropathic changes.  A lumbar puncture was performed which demonstrated albuminocytologic dissociation.  The patient was started on IVIG and completed 5 days of therapy without any adverse reactions.  A repeat EMG was performed 10 days after initial EMG and demonstrated features of Guillain Barre syndome.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Immunoglobulin therapy, Lumbar puncture abnormal, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: After receiving his flu vaccination, the patient was in his usual state of health until he began to experience bilateral lower extremity weakness and tongue numbness. On initial presentation, due to his history of colon cancer in the past, the primary concern was metastatic disease.  Therefore, full new imaging of neural axis including the brain and entire spine was done.  MRI of the brain was within normal limits for age.  MRI of the spine showed mild degenerative changes with no evidence of any spinal cord or nerve root involvement.  Bone scan of the whole body did not show any metastatic disease. Upon admission, an EMG was performed which was negative for any acute neuropathic changes.  A lumbar puncture was performed which demonstrated albuminocytologic dissociation.  The patient was started on IVIG and completed 5 days of therapy without any adverse reactions.  A repeat EMG was performed 10 days after initial EMG and demonstrated features of Guillain Barre syndome.
Age: 64.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cough, Dysphonia, Fatigue, Ocular hyperaemia
Clinical narrative: Hoarseness; 4 days red eye; 3 days cough; 7 days fatigue; 6 days
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Babinski reflex test, CSF white blood cell count negative, Computerised tomogram normal, Dizziness
Clinical narrative: weak, lightheaded all day then proceeded to call 911 in the evening and was paralyzed to all extremities
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Drug screen negative, Lumbar puncture, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Paralysis
Clinical narrative: weak, lightheaded all day then proceeded to call 911 in the evening and was paralyzed to all extremities
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Scan brain
Clinical narrative: weak, lightheaded all day then proceeded to call 911 in the evening and was paralyzed to all extremities
Age: 44.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: CSF test abnormal, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Guillain Barre Syndrome - Ascending Paralysis and numbness - acute inflammatory demyelinating polyradiculopathy 10-14 days after receiving H1N1 Vaccine
Age: 44.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Guillain Barre Syndrome - Ascending Paralysis and numbness - acute inflammatory demyelinating polyradiculopathy 10-14 days after receiving H1N1 Vaccine
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted a few minutes after receiving shots
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Impaired driving ability, Injected limb mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Pain in left shoulder near administration site.  Inability to move arm for days.  When I could finally move it, there was a lot of pain especially anytime I would cross my arm in front of my body and lift up or push down.  Driving w/ my left arm was difficult.  Sleeping on left side caused pain.  Dressing and undressing, especially removing a tight shirt, was excruciating.  Had x ray, MRI, and was sent for physical therapy.  Still recovering.  Feeling some improvement but still having problems.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray
Clinical narrative: Pain in left shoulder near administration site.  Inability to move arm for days.  When I could finally move it, there was a lot of pain especially anytime I would cross my arm in front of my body and lift up or push down.  Driving w/ my left arm was difficult.  Sleeping on left side caused pain.  Dressing and undressing, especially removing a tight shirt, was excruciating.  Had x ray, MRI, and was sent for physical therapy.  Still recovering.  Feeling some improvement but still having problems.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Abasia, Blood test normal, Guillain-Barre syndrome, Muscular weakness, Pain
Clinical narrative: Guillain-Barre Syndrome Severe muscle weakness and pain starting in legs progressing to arms and hands. Unable to walk for several days. Tingling sensation in arms and legs.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Paraesthesia
Clinical narrative: Guillain-Barre Syndrome Severe muscle weakness and pain starting in legs progressing to arms and hands. Unable to walk for several days. Tingling sensation in arms and legs.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Acne, Convulsion, Electroencephalogram abnormal, Epilepsy, Headache
Clinical narrative: Following hpv vaccine (along with meningitis shot) my daughter started having black out episodes later EEG results came back abnormal indicating seizure / epilepsy which she NEVER had before. Other neurological symptoms include: frequency of episodes getting progressively more often, Occasional numbness of face Tingling of arms head aches following seizures
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Hypoaesthesia facial, Loss of consciousness, Paraesthesia
Clinical narrative: Following hpv vaccine (along with meningitis shot) my daughter started having black out episodes later EEG results came back abnormal indicating seizure / epilepsy which she NEVER had before. Other neurological symptoms include: frequency of episodes getting progressively more often, Occasional numbness of face Tingling of arms head aches following seizures
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Dyspepsia, Headache, Lethargy
Clinical narrative: 4:45 PM  headache and indigestion 5:00 PM  cramping and diarrhea 5:15 PM  nausea with no vomiting 6:00 PM dizziness All of the above continued for 24 hours at which time the diarrhea stopped.  Other symptoms continued and are still present along with lethargy at 2:13 PM, 12/29/2010
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Nausea
Clinical narrative: 4:45 PM  headache and indigestion 5:00 PM  cramping and diarrhea 5:15 PM  nausea with no vomiting 6:00 PM dizziness All of the above continued for 24 hours at which time the diarrhea stopped.  Other symptoms continued and are still present along with lethargy at 2:13 PM, 12/29/2010
Age: 49.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Abasia, Joint swelling, Pain
Clinical narrative: Swelling at joints and painful at each move - left wrist, knees, ankles.  Unable to walk and handle things with left hand.  It started with just one left wrist, and worsened to other joints.  Lasted about one and a half month.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M increased, Pyrexia, Rash vesicular
Clinical narrative: Patient presents to the clinic c/o fever and pox-like lesions scattered throughout the body/head.  A total of less than 40 lesions in all.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash pruritic, Scratch, Urticaria
Clinical narrative: Developed bumpy rash around administration site. Progresses down left side arm to hand, itching. On 12/24/2010, rash on right arm which progresses in next days to torso, back, legs to feet. Very itchy. After scratching, developed welts. Went to ED on 12/27/2010. Treated w/ antihistamine, antibiotics, and 2 other unknown meds.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Injection site pain, Pyrexia, Sinus congestion
Clinical narrative: fever 101, sinus congestion and cough. tenderness at injection site
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Began as typical arm pain after shot.  Has continued as pain around injection site and sometimes traveling into neck on shot side.  Pain is primarily experienced when pressure is applied but can occur just in movement.
Age: 53.0
Sex: M
Vaccine: FLUX, PPV, TD
Symptoms: Cellulitis, Erythema, Hyperaesthesia, Nausea, Oedema peripheral
Clinical narrative: Starting the night of 12/23, I developed a fever and my arm grew increasingly sore. By the afternoon of 12/24, my temperature was 102F, inspite of taking Tylenol. The morning of 12/25 my temperature was 103.9F and my arm was red, swollen, and extrememly sensitive to touch. I went to the ER, where they put me on an IV for nausea and pain, but no antibiotics. The next day the red swelling on my arm spread, and went back to the same ER. This time they gave me IV antibiotics and said it looked like cellulitis. I am now recovering at home, taking oral antibiotics. On 12/23/2010 I was given two vaccines in the affected arm (flu and pneumococcal polysaccharide) and Td on the other arm, which had no problem. My doctor suspects the penumococcal vaccine as the problem.
Age: 53.0
Sex: M
Vaccine: FLUX, PPV, TD
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Starting the night of 12/23, I developed a fever and my arm grew increasingly sore. By the afternoon of 12/24, my temperature was 102F, inspite of taking Tylenol. The morning of 12/25 my temperature was 103.9F and my arm was red, swollen, and extrememly sensitive to touch. I went to the ER, where they put me on an IV for nausea and pain, but no antibiotics. The next day the red swelling on my arm spread, and went back to the same ER. This time they gave me IV antibiotics and said it looked like cellulitis. I am now recovering at home, taking oral antibiotics. On 12/23/2010 I was given two vaccines in the affected arm (flu and pneumococcal polysaccharide) and Td on the other arm, which had no problem. My doctor suspects the penumococcal vaccine as the problem.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Lip swelling
Clinical narrative: Noted swelling on right side of upper lip several hours after Flumist. Gave Benadryl and popsicles. No fever or complaints of pain.
Age: 1.25
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Full blood count, Urine analysis
Clinical narrative: Parent heard "strange" sounds coming from baby's crib, went to check on her and observed her having seizure. Took baby to ER, blood work was done, no other tx given
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Paraesthesia, Rash, Skin warm
Clinical narrative: Tingling running up and down the arm that got the shot (left Bicep) hot spot near wrist and back of shoulder, "pins & needles" all up and down my arm. Still have pain, bicep soreness, and skin eruptions at the present time (12/29/2010).
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Brain mass, CSF pressure normal, CSF test, Lumbar puncture normal
Clinical narrative: Optic neuritis of left eye.  Upon waking on 12/12, darkness present in upper left corner of left eye vision, which progressed to gray haze of entire left eye vision over 3 days.  At worse, unable to read with left eye, large shapes only.  Ophthalmology visit on 12/13, 12/15.  Neuro-ophthalmology visit on 12/16, and a 5 day hospital stay from 12/16 to 12/21 treatment with IV steroids (Solu-Medrol).  MRI and other tests are so far negative for multiple sclerosis, or other causes of optic neuritis. Continuing two weeks of oral prednisone at home.  Current vision of left eye is ~90%, slight blurriness remaining.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Optic neuritis, Vision blurred, Visual acuity reduced
Clinical narrative: Optic neuritis of left eye.  Upon waking on 12/12, darkness present in upper left corner of left eye vision, which progressed to gray haze of entire left eye vision over 3 days.  At worse, unable to read with left eye, large shapes only.  Ophthalmology visit on 12/13, 12/15.  Neuro-ophthalmology visit on 12/16, and a 5 day hospital stay from 12/16 to 12/21 treatment with IV steroids (Solu-Medrol).  MRI and other tests are so far negative for multiple sclerosis, or other causes of optic neuritis. Continuing two weeks of oral prednisone at home.  Current vision of left eye is ~90%, slight blurriness remaining.
Age: 38.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia, White blood cell count increased
Clinical narrative: Pain, redness and stiffness at injection site initially by 12/23/2010 fever of 104 white blood cell count in the 19,000s
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Headache, Musculoskeletal stiffness
Clinical narrative: Weakness and shaking in morning. Persistent headache increasing to severe throughout day.  Mild nausea, chills, body aches. Neck stiffness. Severe headache causing dizziness. Treatment: acetaminophen 1000mg morning, ibuprofen 800mg evening.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Tremor
Clinical narrative: Weakness and shaking in morning. Persistent headache increasing to severe throughout day.  Mild nausea, chills, body aches. Neck stiffness. Severe headache causing dizziness. Treatment: acetaminophen 1000mg morning, ibuprofen 800mg evening.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Influenza, Pyrexia, Vomiting
Clinical narrative: Vomiting Flu Symptoms (Fever, Chills, Etc)
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Chest pain, Condition aggravated, Lumbar puncture abnormal
Clinical narrative: Tingling back, chest, arms, head, face. Pain back, chest leg weakness-worse (L). MRI, head, neck. T & L spine. Spinal tap 12-21-10 dx myelitis.