chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Glucose urine absent, Haematocrit decreased, Haemoglobin decreased, Hydronephrosis, Inflammation
Clinical narrative: A serious post-marketed study report of hydronephrosis and ureteric obstruction has been received from a study investigator concerning a four-year old male subject, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history included a left sided abdominal mass found on routine physical examination on 08-Jun-2007 which was diagnosed on 18-Jul-2007 as non-existent, non-functioning, fluid filled space left kidney via renal scan. Concomitant medications were not reported. The subject received FLUMIST 0.25 ml per nostril for influenza immunization on 18-Oct-2007. On 05-Nov-2007, the subject was hospitalized for hydronephrosis and ureteric obstructions. Laparoscopic left simple nephrectomy was performed on the same day. Intra-operative findings included giant hydronephrosis of left kidney with normal ureters suggestive of UPC obstruction and greater than 500 ml of cloudy, but not frankly purulent fluid within the kidney. The patient had uncomplicated surgery with stable vital signs post-operatively. He was discharged from the hospital on 07-Nov-2007. On 19-Nov-2007, the patient was seen at follow-up for possible hypertension secondary to non functioning kidney. Examination revealed an asymptomatic patient, BP of 109/70 and normal examination two-weeks post-surgery. The patient's final pathologic diagnosis was hydronephrosis with interstitial chronic inflammation, fibrosis and glomerular sclerosis, and a haphazard arrangement of smooth muscle proliferation seen in renal pelvis consistent with UPU obstruction of left kidney. The adverse events resolved on 19-Nov-2007. The investigator assessed the events of hydronephrosis and ureteric obstruction as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST. Additional information including hospital records was received on 16 Jan 2009 and incorporated in the narrative: patient's demographics, medical history, suspect drug information, laboratory and diagnostic tests results, adverse events information, outcome of the events.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: International normalised ratio, Laparoscopy, Lymphocyte percentage, Monocyte percentage, Nephrectomy
Clinical narrative: A serious post-marketed study report of hydronephrosis and ureteric obstruction has been received from a study investigator concerning a four-year old male subject, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history included a left sided abdominal mass found on routine physical examination on 08-Jun-2007 which was diagnosed on 18-Jul-2007 as non-existent, non-functioning, fluid filled space left kidney via renal scan. Concomitant medications were not reported. The subject received FLUMIST 0.25 ml per nostril for influenza immunization on 18-Oct-2007. On 05-Nov-2007, the subject was hospitalized for hydronephrosis and ureteric obstructions. Laparoscopic left simple nephrectomy was performed on the same day. Intra-operative findings included giant hydronephrosis of left kidney with normal ureters suggestive of UPC obstruction and greater than 500 ml of cloudy, but not frankly purulent fluid within the kidney. The patient had uncomplicated surgery with stable vital signs post-operatively. He was discharged from the hospital on 07-Nov-2007. On 19-Nov-2007, the patient was seen at follow-up for possible hypertension secondary to non functioning kidney. Examination revealed an asymptomatic patient, BP of 109/70 and normal examination two-weeks post-surgery. The patient's final pathologic diagnosis was hydronephrosis with interstitial chronic inflammation, fibrosis and glomerular sclerosis, and a haphazard arrangement of smooth muscle proliferation seen in renal pelvis consistent with UPU obstruction of left kidney. The adverse events resolved on 19-Nov-2007. The investigator assessed the events of hydronephrosis and ureteric obstruction as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST. Additional information including hospital records was received on 16 Jan 2009 and incorporated in the narrative: patient's demographics, medical history, suspect drug information, laboratory and diagnostic tests results, adverse events information, outcome of the events.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Neutrophil percentage, Nitrite urine absent, Platelet count normal, Protein urine absent, Prothrombin level normal
Clinical narrative: A serious post-marketed study report of hydronephrosis and ureteric obstruction has been received from a study investigator concerning a four-year old male subject, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history included a left sided abdominal mass found on routine physical examination on 08-Jun-2007 which was diagnosed on 18-Jul-2007 as non-existent, non-functioning, fluid filled space left kidney via renal scan. Concomitant medications were not reported. The subject received FLUMIST 0.25 ml per nostril for influenza immunization on 18-Oct-2007. On 05-Nov-2007, the subject was hospitalized for hydronephrosis and ureteric obstructions. Laparoscopic left simple nephrectomy was performed on the same day. Intra-operative findings included giant hydronephrosis of left kidney with normal ureters suggestive of UPC obstruction and greater than 500 ml of cloudy, but not frankly purulent fluid within the kidney. The patient had uncomplicated surgery with stable vital signs post-operatively. He was discharged from the hospital on 07-Nov-2007. On 19-Nov-2007, the patient was seen at follow-up for possible hypertension secondary to non functioning kidney. Examination revealed an asymptomatic patient, BP of 109/70 and normal examination two-weeks post-surgery. The patient's final pathologic diagnosis was hydronephrosis with interstitial chronic inflammation, fibrosis and glomerular sclerosis, and a haphazard arrangement of smooth muscle proliferation seen in renal pelvis consistent with UPU obstruction of left kidney. The adverse events resolved on 19-Nov-2007. The investigator assessed the events of hydronephrosis and ureteric obstruction as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST. Additional information including hospital records was received on 16 Jan 2009 and incorporated in the narrative: patient's demographics, medical history, suspect drug information, laboratory and diagnostic tests results, adverse events information, outcome of the events.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Red blood cell count normal, Red blood cell sedimentation rate increased, Red blood cells urine positive, Renal scan abnormal, Specific gravity urine normal
Clinical narrative: A serious post-marketed study report of hydronephrosis and ureteric obstruction has been received from a study investigator concerning a four-year old male subject, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history included a left sided abdominal mass found on routine physical examination on 08-Jun-2007 which was diagnosed on 18-Jul-2007 as non-existent, non-functioning, fluid filled space left kidney via renal scan. Concomitant medications were not reported. The subject received FLUMIST 0.25 ml per nostril for influenza immunization on 18-Oct-2007. On 05-Nov-2007, the subject was hospitalized for hydronephrosis and ureteric obstructions. Laparoscopic left simple nephrectomy was performed on the same day. Intra-operative findings included giant hydronephrosis of left kidney with normal ureters suggestive of UPC obstruction and greater than 500 ml of cloudy, but not frankly purulent fluid within the kidney. The patient had uncomplicated surgery with stable vital signs post-operatively. He was discharged from the hospital on 07-Nov-2007. On 19-Nov-2007, the patient was seen at follow-up for possible hypertension secondary to non functioning kidney. Examination revealed an asymptomatic patient, BP of 109/70 and normal examination two-weeks post-surgery. The patient's final pathologic diagnosis was hydronephrosis with interstitial chronic inflammation, fibrosis and glomerular sclerosis, and a haphazard arrangement of smooth muscle proliferation seen in renal pelvis consistent with UPU obstruction of left kidney. The adverse events resolved on 19-Nov-2007. The investigator assessed the events of hydronephrosis and ureteric obstruction as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST. Additional information including hospital records was received on 16 Jan 2009 and incorporated in the narrative: patient's demographics, medical history, suspect drug information, laboratory and diagnostic tests results, adverse events information, outcome of the events.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Ultrasound scan abnormal, Ureteric obstruction, Urine analysis abnormal, White blood cell count normal, White blood cells urine positive
Clinical narrative: A serious post-marketed study report of hydronephrosis and ureteric obstruction has been received from a study investigator concerning a four-year old male subject, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history included a left sided abdominal mass found on routine physical examination on 08-Jun-2007 which was diagnosed on 18-Jul-2007 as non-existent, non-functioning, fluid filled space left kidney via renal scan. Concomitant medications were not reported. The subject received FLUMIST 0.25 ml per nostril for influenza immunization on 18-Oct-2007. On 05-Nov-2007, the subject was hospitalized for hydronephrosis and ureteric obstructions. Laparoscopic left simple nephrectomy was performed on the same day. Intra-operative findings included giant hydronephrosis of left kidney with normal ureters suggestive of UPC obstruction and greater than 500 ml of cloudy, but not frankly purulent fluid within the kidney. The patient had uncomplicated surgery with stable vital signs post-operatively. He was discharged from the hospital on 07-Nov-2007. On 19-Nov-2007, the patient was seen at follow-up for possible hypertension secondary to non functioning kidney. Examination revealed an asymptomatic patient, BP of 109/70 and normal examination two-weeks post-surgery. The patient's final pathologic diagnosis was hydronephrosis with interstitial chronic inflammation, fibrosis and glomerular sclerosis, and a haphazard arrangement of smooth muscle proliferation seen in renal pelvis consistent with UPU obstruction of left kidney. The adverse events resolved on 19-Nov-2007. The investigator assessed the events of hydronephrosis and ureteric obstruction as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST. Additional information including hospital records was received on 16 Jan 2009 and incorporated in the narrative: patient's demographics, medical history, suspect drug information, laboratory and diagnostic tests results, adverse events information, outcome of the events.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: X-ray abnormal, pH urine normal
Clinical narrative: A serious post-marketed study report of hydronephrosis and ureteric obstruction has been received from a study investigator concerning a four-year old male subject, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history included a left sided abdominal mass found on routine physical examination on 08-Jun-2007 which was diagnosed on 18-Jul-2007 as non-existent, non-functioning, fluid filled space left kidney via renal scan. Concomitant medications were not reported. The subject received FLUMIST 0.25 ml per nostril for influenza immunization on 18-Oct-2007. On 05-Nov-2007, the subject was hospitalized for hydronephrosis and ureteric obstructions. Laparoscopic left simple nephrectomy was performed on the same day. Intra-operative findings included giant hydronephrosis of left kidney with normal ureters suggestive of UPC obstruction and greater than 500 ml of cloudy, but not frankly purulent fluid within the kidney. The patient had uncomplicated surgery with stable vital signs post-operatively. He was discharged from the hospital on 07-Nov-2007. On 19-Nov-2007, the patient was seen at follow-up for possible hypertension secondary to non functioning kidney. Examination revealed an asymptomatic patient, BP of 109/70 and normal examination two-weeks post-surgery. The patient's final pathologic diagnosis was hydronephrosis with interstitial chronic inflammation, fibrosis and glomerular sclerosis, and a haphazard arrangement of smooth muscle proliferation seen in renal pelvis consistent with UPU obstruction of left kidney. The adverse events resolved on 19-Nov-2007. The investigator assessed the events of hydronephrosis and ureteric obstruction as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST. Additional information including hospital records was received on 16 Jan 2009 and incorporated in the narrative: patient's demographics, medical history, suspect drug information, laboratory and diagnostic tests results, adverse events information, outcome of the events.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Alopecia, Arthralgia, Chest pain, Disturbance in attention, Dizziness
Clinical narrative: Information has been received from an internet report concerning a 16 year old female who in August 2007 received a first dose of GARDASIL and a dose of meningococcal vaccine (unspecified). In October 2007, the patient was vaccinated with a second dose of GARDASIL. The patient did not receive any other shots with her second dose of GARDASIL. It was a month or so after the second dose (in approximately November 2007) that the patient started getting sick. It was reported that the patient "played four sports, danced in her high school's show choir and earned top grades without even trying". The patient, at time of reporting, was exhausted all the time. She was nauseated. She passed out at show choir and blacked out at school. One day her legs went numb. She couldn't walk. It was reported that for a year, the patient had experienced four episodes of temporary paralysis, back spasms so painful "patient would tell her mom 'bye' and stop breathing", hospitalizations, "more 911 calls than the patient could count". Trip after trip to doctors who couldn't seem to find anything wrong. The patient's mother stated that she was convinced the vaccine "turned her perfectly healthy daughter into a chronically ill teenager". It was reported that the patient's hair fell out in clumps. Her nausea was ever present. Her blood pressure dropped dangerously low. She couldn't breathe. Most of the time, the patient couldn't remember what she had read from one day to the next. It was reported that when the patient tried out for basketball at her high school this year, her legs were shaking and she couldn't breathe after two drills. The patient was taking "a handful of pills every day and had to carry a special bag of medical supplies in case she had an 'episode'". It was reported that when the patient had good days, "she knew the twitches in her back and the funny feeling in the back of her head would come back, signaling another episode. Her blood pressure would plummet. She would hear her mother or her boyfriend talking to her, but she wouldn't be able to answer. She would have trouble breathing and she would pass out". Upon internal review, four episodes of temporary paralysis was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Dysmenorrhoea, Dyspnoea, Fatigue, Feeling abnormal, Hypotension
Clinical narrative: Information has been received from an internet report concerning a 16 year old female who in August 2007 received a first dose of GARDASIL and a dose of meningococcal vaccine (unspecified). In October 2007, the patient was vaccinated with a second dose of GARDASIL. The patient did not receive any other shots with her second dose of GARDASIL. It was a month or so after the second dose (in approximately November 2007) that the patient started getting sick. It was reported that the patient "played four sports, danced in her high school's show choir and earned top grades without even trying". The patient, at time of reporting, was exhausted all the time. She was nauseated. She passed out at show choir and blacked out at school. One day her legs went numb. She couldn't walk. It was reported that for a year, the patient had experienced four episodes of temporary paralysis, back spasms so painful "patient would tell her mom 'bye' and stop breathing", hospitalizations, "more 911 calls than the patient could count". Trip after trip to doctors who couldn't seem to find anything wrong. The patient's mother stated that she was convinced the vaccine "turned her perfectly healthy daughter into a chronically ill teenager". It was reported that the patient's hair fell out in clumps. Her nausea was ever present. Her blood pressure dropped dangerously low. She couldn't breathe. Most of the time, the patient couldn't remember what she had read from one day to the next. It was reported that when the patient tried out for basketball at her high school this year, her legs were shaking and she couldn't breathe after two drills. The patient was taking "a handful of pills every day and had to carry a special bag of medical supplies in case she had an 'episode'". It was reported that when the patient had good days, "she knew the twitches in her back and the funny feeling in the back of her head would come back, signaling another episode. Her blood pressure would plummet. She would hear her mother or her boyfriend talking to her, but she wouldn't be able to answer. She would have trouble breathing and she would pass out". Upon internal review, four episodes of temporary paralysis was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Menstruation irregular, Muscular weakness, Myalgia, Nausea, Oxygen consumption decreased
Clinical narrative: Information has been received from an internet report concerning a 16 year old female who in August 2007 received a first dose of GARDASIL and a dose of meningococcal vaccine (unspecified). In October 2007, the patient was vaccinated with a second dose of GARDASIL. The patient did not receive any other shots with her second dose of GARDASIL. It was a month or so after the second dose (in approximately November 2007) that the patient started getting sick. It was reported that the patient "played four sports, danced in her high school's show choir and earned top grades without even trying". The patient, at time of reporting, was exhausted all the time. She was nauseated. She passed out at show choir and blacked out at school. One day her legs went numb. She couldn't walk. It was reported that for a year, the patient had experienced four episodes of temporary paralysis, back spasms so painful "patient would tell her mom 'bye' and stop breathing", hospitalizations, "more 911 calls than the patient could count". Trip after trip to doctors who couldn't seem to find anything wrong. The patient's mother stated that she was convinced the vaccine "turned her perfectly healthy daughter into a chronically ill teenager". It was reported that the patient's hair fell out in clumps. Her nausea was ever present. Her blood pressure dropped dangerously low. She couldn't breathe. Most of the time, the patient couldn't remember what she had read from one day to the next. It was reported that when the patient tried out for basketball at her high school this year, her legs were shaking and she couldn't breathe after two drills. The patient was taking "a handful of pills every day and had to carry a special bag of medical supplies in case she had an 'episode'". It was reported that when the patient had good days, "she knew the twitches in her back and the funny feeling in the back of her head would come back, signaling another episode. Her blood pressure would plummet. She would hear her mother or her boyfriend talking to her, but she wouldn't be able to answer. She would have trouble breathing and she would pass out". Upon internal review, four episodes of temporary paralysis was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Pallor, Personality change, Polycystic ovaries, Tremor, Vision blurred
Clinical narrative: Information has been received from an internet report concerning a 16 year old female who in August 2007 received a first dose of GARDASIL and a dose of meningococcal vaccine (unspecified). In October 2007, the patient was vaccinated with a second dose of GARDASIL. The patient did not receive any other shots with her second dose of GARDASIL. It was a month or so after the second dose (in approximately November 2007) that the patient started getting sick. It was reported that the patient "played four sports, danced in her high school's show choir and earned top grades without even trying". The patient, at time of reporting, was exhausted all the time. She was nauseated. She passed out at show choir and blacked out at school. One day her legs went numb. She couldn't walk. It was reported that for a year, the patient had experienced four episodes of temporary paralysis, back spasms so painful "patient would tell her mom 'bye' and stop breathing", hospitalizations, "more 911 calls than the patient could count". Trip after trip to doctors who couldn't seem to find anything wrong. The patient's mother stated that she was convinced the vaccine "turned her perfectly healthy daughter into a chronically ill teenager". It was reported that the patient's hair fell out in clumps. Her nausea was ever present. Her blood pressure dropped dangerously low. She couldn't breathe. Most of the time, the patient couldn't remember what she had read from one day to the next. It was reported that when the patient tried out for basketball at her high school this year, her legs were shaking and she couldn't breathe after two drills. The patient was taking "a handful of pills every day and had to carry a special bag of medical supplies in case she had an 'episode'". It was reported that when the patient had good days, "she knew the twitches in her back and the funny feeling in the back of her head would come back, signaling another episode. Her blood pressure would plummet. She would hear her mother or her boyfriend talking to her, but she wouldn't be able to answer. She would have trouble breathing and she would pass out". Upon internal review, four episodes of temporary paralysis was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Vomiting, Weight decreased
Clinical narrative: Information has been received from an internet report concerning a 16 year old female who in August 2007 received a first dose of GARDASIL and a dose of meningococcal vaccine (unspecified). In October 2007, the patient was vaccinated with a second dose of GARDASIL. The patient did not receive any other shots with her second dose of GARDASIL. It was a month or so after the second dose (in approximately November 2007) that the patient started getting sick. It was reported that the patient "played four sports, danced in her high school's show choir and earned top grades without even trying". The patient, at time of reporting, was exhausted all the time. She was nauseated. She passed out at show choir and blacked out at school. One day her legs went numb. She couldn't walk. It was reported that for a year, the patient had experienced four episodes of temporary paralysis, back spasms so painful "patient would tell her mom 'bye' and stop breathing", hospitalizations, "more 911 calls than the patient could count". Trip after trip to doctors who couldn't seem to find anything wrong. The patient's mother stated that she was convinced the vaccine "turned her perfectly healthy daughter into a chronically ill teenager". It was reported that the patient's hair fell out in clumps. Her nausea was ever present. Her blood pressure dropped dangerously low. She couldn't breathe. Most of the time, the patient couldn't remember what she had read from one day to the next. It was reported that when the patient tried out for basketball at her high school this year, her legs were shaking and she couldn't breathe after two drills. The patient was taking "a handful of pills every day and had to carry a special bag of medical supplies in case she had an 'episode'". It was reported that when the patient had good days, "she knew the twitches in her back and the funny feeling in the back of her head would come back, signaling another episode. Her blood pressure would plummet. She would hear her mother or her boyfriend talking to her, but she wouldn't be able to answer. She would have trouble breathing and she would pass out". Upon internal review, four episodes of temporary paralysis was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Abasia, Alopecia, Amnesia, Blood pressure decreased, Dyspnoea
Clinical narrative: Information has been received from an internet report concerning a 16 year old female who in August 2007 received a first dose of GARDASIL and a dose of meningococcal vaccine (unspecified). In October 2007, the patient was vaccinated with a second dose of GARDASIL. The patient did not receive any other shots with her second dose of GARDASIL. It was a month or so after the second dose (in approximately November 2007) that the patient started getting sick. It was reported that the patient "played four sports, danced in her high school's show choir and earned top grades without even trying". The patient, at time of reporting, was exhausted all the time. She was nauseated. She passed out at show choir and blacked out at school. One day her legs went numb. She couldn't walk. It was reported that for a year, the patient had experienced four episodes of temporary paralysis, back spasms so painful "patient would tell her mom 'bye' and stop breathing", hospitalizations, "more 911 calls than the patient could count". Trip after trip to doctors who couldn't seem to find anything wrong. The patient's mother stated that she was convinced the vaccine "turned her perfectly healthy daughter into a chronically ill teenager". It was reported that the patient's hair fell out in clumps. Her nausea was ever present. Her blood pressure dropped dangerously low. She couldn't breathe. Most of the time, the patient couldn't remember what she had read from one day to the next. It was reported that when the patient tried out for basketball at her high school this year, her legs were shaking and she couldn't breathe after two drills. The patient was taking "a handful of pills every day and had to carry a special bag of medical supplies in case she had an 'episode'". It was reported that when the patient had good days, "she knew the twitches in her back and the funny feeling in the back of her head would come back, signaling another episode. Her blood pressure would plummet. She would hear her mother or her boyfriend talking to her, but she wouldn't be able to answer. She would have trouble breathing and she would pass out". Upon internal review, four episodes of temporary paralysis was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Fatigue, Hypoaesthesia, Loss of consciousness, Malaise, Muscle spasms
Clinical narrative: Information has been received from an internet report concerning a 16 year old female who in August 2007 received a first dose of GARDASIL and a dose of meningococcal vaccine (unspecified). In October 2007, the patient was vaccinated with a second dose of GARDASIL. The patient did not receive any other shots with her second dose of GARDASIL. It was a month or so after the second dose (in approximately November 2007) that the patient started getting sick. It was reported that the patient "played four sports, danced in her high school's show choir and earned top grades without even trying". The patient, at time of reporting, was exhausted all the time. She was nauseated. She passed out at show choir and blacked out at school. One day her legs went numb. She couldn't walk. It was reported that for a year, the patient had experienced four episodes of temporary paralysis, back spasms so painful "patient would tell her mom 'bye' and stop breathing", hospitalizations, "more 911 calls than the patient could count". Trip after trip to doctors who couldn't seem to find anything wrong. The patient's mother stated that she was convinced the vaccine "turned her perfectly healthy daughter into a chronically ill teenager". It was reported that the patient's hair fell out in clumps. Her nausea was ever present. Her blood pressure dropped dangerously low. She couldn't breathe. Most of the time, the patient couldn't remember what she had read from one day to the next. It was reported that when the patient tried out for basketball at her high school this year, her legs were shaking and she couldn't breathe after two drills. The patient was taking "a handful of pills every day and had to carry a special bag of medical supplies in case she had an 'episode'". It was reported that when the patient had good days, "she knew the twitches in her back and the funny feeling in the back of her head would come back, signaling another episode. Her blood pressure would plummet. She would hear her mother or her boyfriend talking to her, but she wouldn't be able to answer. She would have trouble breathing and she would pass out". Upon internal review, four episodes of temporary paralysis was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Muscle twitching, Nausea, Paralysis, Tremor
Clinical narrative: Information has been received from an internet report concerning a 16 year old female who in August 2007 received a first dose of GARDASIL and a dose of meningococcal vaccine (unspecified). In October 2007, the patient was vaccinated with a second dose of GARDASIL. The patient did not receive any other shots with her second dose of GARDASIL. It was a month or so after the second dose (in approximately November 2007) that the patient started getting sick. It was reported that the patient "played four sports, danced in her high school's show choir and earned top grades without even trying". The patient, at time of reporting, was exhausted all the time. She was nauseated. She passed out at show choir and blacked out at school. One day her legs went numb. She couldn't walk. It was reported that for a year, the patient had experienced four episodes of temporary paralysis, back spasms so painful "patient would tell her mom 'bye' and stop breathing", hospitalizations, "more 911 calls than the patient could count". Trip after trip to doctors who couldn't seem to find anything wrong. The patient's mother stated that she was convinced the vaccine "turned her perfectly healthy daughter into a chronically ill teenager". It was reported that the patient's hair fell out in clumps. Her nausea was ever present. Her blood pressure dropped dangerously low. She couldn't breathe. Most of the time, the patient couldn't remember what she had read from one day to the next. It was reported that when the patient tried out for basketball at her high school this year, her legs were shaking and she couldn't breathe after two drills. The patient was taking "a handful of pills every day and had to carry a special bag of medical supplies in case she had an 'episode'". It was reported that when the patient had good days, "she knew the twitches in her back and the funny feeling in the back of her head would come back, signaling another episode. Her blood pressure would plummet. She would hear her mother or her boyfriend talking to her, but she wouldn't be able to answer. She would have trouble breathing and she would pass out". Upon internal review, four episodes of temporary paralysis was considered to be an other important medical event. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: 08:15 Hep vaccine administered. 08:45 client still in building came to my office stating her right arm was breaking out in a rash and itching real bad. Denied any breathing difficulty. At 08:47 administered diphenhydramine 1cc IM in LD. 09:37 was taken home .
Age: 28.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pruritus, Rash
Clinical narrative: 08:15 Hep vaccine administered. 08:45 client still in building came to my office stating her right arm was breaking out in a rash and itching real bad. Denied any breathing difficulty. At 08:47 administered diphenhydramine 1cc IM in LD. 09:37 was taken home .
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Blood immunoglobulin G decreased, Pneumonia
Clinical narrative: Information has been received from a physician concerning a 32 year old male patient with Wilson's disease and decreased immunoglobulin levels who was vaccinated with 2 doses of PNEUMOVAX 23. Concomitant therapy included "penicillamine" (manufacturer unspecified). The patient underwent lab tests. The results indicated a decrease in immunoglobulin and negative pneumococcal titers. On an unspecified date, the patient developed pneumonia and was hospitalized. The patient had visited office for medical attention. The outcome of the patient's adverse effect was not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Pyrexia, Respiratory arrest
Clinical narrative: Information has been received from a female who on an unspecified date was vaccinated with the first dose of MMR II and "had a reaction like stop breathing and fever up to 104 degrees. Caller doesn't remember any information for second dose". Upon internal review, stop breathing was considered to be an other important medical event. This is one of several reports from the same source. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was intramuscularly vaccinated with the second dose of GARDASIL. Three weeks later the patient developed two seizures. The patient was given anti-seizure medications. At the time of reporting, the patient recovered from seizures. Upon internal review, seizures were considered to be other important medical events. Follow-up information was received from an office manager concerning the 19 years old patient who did not receive GARDASIL in the physician's office and is no longer seen by the physician. The patient's mother mentioned the adverse event to the doctor when she brought the patient's younger sibling for a visit. No further information is available.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Death
Clinical narrative: None stated. 7/20/09 Autopsy report received.  COD: Undetermined.  Manner of Death: Undertermined.  Final dx: Developmentally normal male infant
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Bacteria urine identified, Drug screen positive, Dysphagia, Haemoglobin normal, Muscular weakness
Clinical narrative: Paralysis - entire body - breathing on her own, difficulty swallowing, weakness arm and legs at 2200 then progressed this AM. 2/27/09-records received-for DOS 2/5-2/8/09-DC DX: weakness. Presented with whole body weakness status post Gardasil and Depo provera shot. Initial C/O all over body aches and joint pain. Weakness began in arms.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Paralysis, Urine analysis abnormal, White blood cell count increased
Clinical narrative: Paralysis - entire body - breathing on her own, difficulty swallowing, weakness arm and legs at 2200 then progressed this AM. 2/27/09-records received-for DOS 2/5-2/8/09-DC DX: weakness. Presented with whole body weakness status post Gardasil and Depo provera shot. Initial C/O all over body aches and joint pain. Weakness began in arms.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Admitted to hospital 2/6/9 for intussusception.  3/9/09 Received hospital medical records of 2/6-2/7/2009. FINAL DX: Ileocecal intussusception Records reveal patient experienced irritability, abdominal pain, curling up in a ball then sleeping immediately after.  Vomited at daycare & in evening had bloody stool.  Taken to ER where dx w/IS & enema reduced.  Admitted overnight for observation, did well & d/c to home.
Age: 1.3
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Anorexia, Asthenia, Dermatitis acneiform, Diarrhoea, Ocular hyperaemia
Clinical narrative: Thursday Feb. 5, 2009 fever 102- C was the highest the fever and slight rash on face, no energy, red eyes not eating. Fr. Feb 6, 2009 fever and rash not on face moving to neck and chest. Saturday Feb 7, 2009 no fever but rash moved to chest and back. Urgent care in afternoon for vomiting and diarrhea. Monday Feb 9, 2009 rash still covering body, still not eating, no energy. Tuesday Feb 10, 2009 rash still covering body.
Age: 1.3
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Thursday Feb. 5, 2009 fever 102- C was the highest the fever and slight rash on face, no energy, red eyes not eating. Fr. Feb 6, 2009 fever and rash not on face moving to neck and chest. Saturday Feb 7, 2009 no fever but rash moved to chest and back. Urgent care in afternoon for vomiting and diarrhea. Monday Feb 9, 2009 rash still covering body, still not eating, no energy. Tuesday Feb 10, 2009 rash still covering body.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash pruritic
Clinical narrative: Red pruritic rash encircling entire base of neck developed 48 hours after ZOSTAVAX administered without rash at injection site of R deltoid. Developed several hours after haircut at barber's but no topicals applied and no neck shaving. Improving but remains.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Myalgia, Pregnancy test urine negative, Pyrexia
Clinical narrative: Fever, chills, muscle aches.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness & warmth of left thigh where KINRIX was administered on 2/17/09
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on inner thighs and lower back positive pruritis.
Age: 39.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Urticaria
Clinical narrative: Dizziness, tight chest, hives, and difficulty breathing that lasted for three hours.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Feeling cold, Nausea
Clinical narrative: Nauseated, extremely cold chills, dizziness (these conditions lasted four days).
Age: 41.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Blood glucose increased, Dizziness, Dysphagia, Dyspnoea, Erythema
Clinical narrative: 12:15 - Pt in today for yellow fever and Hep A vaccine for travel to Peru. Vaccine was given (yellow fever) SQ in left arm and Hep A IM in R deltoid at 11:45 am. Pt started c/o feeling tired, then mild SOB, just not being able to take a deep breath. Hives appeared on neck, bright red splotchie but non-puritic. B/P 163/96 P- 110, O2 SAT 99%, lips pink. Doctor notified immediately. 12:20 Epi .3 cc SQ given in L arm, pt. began feeling light headed and dizzy. Transport from immunization room to u/s room via WC. Assisted from chair to wheel chair and then from wheel chair to exam table. Upon transfer from wheel chair to exam table pt reported that her legs were weak feeling and very heavy. Doctor aware of legs feeling weak and very heavy. B/P 168/100 P- 98; O2 Sat 99% lying on exam table with head down and feet elevated. 12:25 Pt remains stable, no change in condition except lips starting to tingle slightly. SOB has subsided some. Spoke with Doctor about pt starting to have some tingling sensations in her lips. Orders received at this time 1 SOLUMEDROL 125 mg IM and 2 BENADRYL 50 mg po (stat). 12:30 BENADRYL 50mg po given and SOLUMEDROL 125 mg IM given in R hip. B/P 155/98 P- 96; O2 Sat 99%. Significant other notified of his need to come to health dept that his wife was having an allergic reaction to the Yellow Fever vaccine. 12:35 Significant other present. Pt reports that she is feeling "some"better. Pt was assisted to semi-fowlers position and was given some coca-cola to sip on. Pt awake, alert, orientated, talking coherently. Color is returning to lips. Hives are faded tremendously and hardly viable. Talking with significant other. 12:50 Pt was noted to take a very deep breath with a sigh and when asked she reported that the SOB, tiredness, and heaviness of her legs were returning. Pt asked to be laid back down in supine position. B/P 152/99 HR - 98. Doctor notified. 12:53 EMS called for a 1018 transport to medical center secondary to an allergic reaction to yellow fever vaccine. 12:55 Pt cont. to be the same, mild SOB, lips tingling, able to talk and communicate. 12:57 B/P 164/103 P - 101 O2 Sat 98%. Pt encouraged to take slow deep breaths. Significant other at bedside. 12:59 Pt c/o being unable to swallow and her tongue was numb. Dr. notified orders recovered 1 Epi .3 SQ (STAT) 13:00 Epi .3 cc SQ given in R arm. Talked with pt and encouraged to calm down and take slow deep breaths. 13:02Pt reports that she is starting to get some feeling back in her tongue. 13:04 Pt remains stable, she reports that the SOB is easing some, the tingling is gone in her tongue. 13:05 EMS arrived. Report given and meds and dosages given.
Age: 41.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Fatigue, Heart rate increased, Hypersensitivity, Hypertension, Hyperventilation
Clinical narrative: 12:15 - Pt in today for yellow fever and Hep A vaccine for travel to Peru. Vaccine was given (yellow fever) SQ in left arm and Hep A IM in R deltoid at 11:45 am. Pt started c/o feeling tired, then mild SOB, just not being able to take a deep breath. Hives appeared on neck, bright red splotchie but non-puritic. B/P 163/96 P- 110, O2 SAT 99%, lips pink. Doctor notified immediately. 12:20 Epi .3 cc SQ given in L arm, pt. began feeling light headed and dizzy. Transport from immunization room to u/s room via WC. Assisted from chair to wheel chair and then from wheel chair to exam table. Upon transfer from wheel chair to exam table pt reported that her legs were weak feeling and very heavy. Doctor aware of legs feeling weak and very heavy. B/P 168/100 P- 98; O2 Sat 99% lying on exam table with head down and feet elevated. 12:25 Pt remains stable, no change in condition except lips starting to tingle slightly. SOB has subsided some. Spoke with Doctor about pt starting to have some tingling sensations in her lips. Orders received at this time 1 SOLUMEDROL 125 mg IM and 2 BENADRYL 50 mg po (stat). 12:30 BENADRYL 50mg po given and SOLUMEDROL 125 mg IM given in R hip. B/P 155/98 P- 96; O2 Sat 99%. Significant other notified of his need to come to health dept that his wife was having an allergic reaction to the Yellow Fever vaccine. 12:35 Significant other present. Pt reports that she is feeling "some"better. Pt was assisted to semi-fowlers position and was given some coca-cola to sip on. Pt awake, alert, orientated, talking coherently. Color is returning to lips. Hives are faded tremendously and hardly viable. Talking with significant other. 12:50 Pt was noted to take a very deep breath with a sigh and when asked she reported that the SOB, tiredness, and heaviness of her legs were returning. Pt asked to be laid back down in supine position. B/P 152/99 HR - 98. Doctor notified. 12:53 EMS called for a 1018 transport to medical center secondary to an allergic reaction to yellow fever vaccine. 12:55 Pt cont. to be the same, mild SOB, lips tingling, able to talk and communicate. 12:57 B/P 164/103 P - 101 O2 Sat 98%. Pt encouraged to take slow deep breaths. Significant other at bedside. 12:59 Pt c/o being unable to swallow and her tongue was numb. Dr. notified orders recovered 1 Epi .3 SQ (STAT) 13:00 Epi .3 cc SQ given in R arm. Talked with pt and encouraged to calm down and take slow deep breaths. 13:02Pt reports that she is starting to get some feeling back in her tongue. 13:04 Pt remains stable, she reports that the SOB is easing some, the tingling is gone in her tongue. 13:05 EMS arrived. Report given and meds and dosages given.