chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Fall, Oedema peripheral, Urticaria, Wrist fracture
Clinical narrative: Patient received the gardasil vaccine on thursday august 23, 2007. on friday she fell and fractured her left wrist. on monday august 27, after a cast was put on her arm she began to have severe hives coming out all over her thys. her fingers were extremly swollen so i took her to the emergency room and they prescibed her predison
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Computerised tomogram abnormal, Convulsion, Crying, Drooling
Clinical narrative: On Aug. 15, 2007 my daughter had what the emergency room listed as a seizure. Around 9:45pm she woke up, quiet type scream and crying, my husband and I tried to wake her and she would "stare", like she wasnt there, or right through us, she would not or could not respond to us.  She cried and turned on her side. We thought she was having a bad dream or had a leg cramp.  We asked her what was wrong, no verbal response, staring, for about 5-10minutes. I felt her head, it was "clamy", and I noticed she had "drooled" and the left side of her face was "droopy".  My husband called 911 and I kept asking her questions to get a response. She did try to respond, but it was like her tongue was "fat", because she was just mumbling, not real words.  The parmedics came and started an IV/did all the tests and suggested we go to emergency to get everything checked out.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram normal, Electroencephalogram, Facial palsy, Full blood count normal, Hepatic enzyme
Clinical narrative: On Aug. 15, 2007 my daughter had what the emergency room listed as a seizure. Around 9:45pm she woke up, quiet type scream and crying, my husband and I tried to wake her and she would "stare", like she wasnt there, or right through us, she would not or could not respond to us.  She cried and turned on her side. We thought she was having a bad dream or had a leg cramp.  We asked her what was wrong, no verbal response, staring, for about 5-10minutes. I felt her head, it was "clamy", and I noticed she had "drooled" and the left side of her face was "droopy".  My husband called 911 and I kept asking her questions to get a response. She did try to respond, but it was like her tongue was "fat", because she was just mumbling, not real words.  The parmedics came and started an IV/did all the tests and suggested we go to emergency to get everything checked out.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Screaming, Sinusitis, Speech disorder, Staring
Clinical narrative: On Aug. 15, 2007 my daughter had what the emergency room listed as a seizure. Around 9:45pm she woke up, quiet type scream and crying, my husband and I tried to wake her and she would "stare", like she wasnt there, or right through us, she would not or could not respond to us.  She cried and turned on her side. We thought she was having a bad dream or had a leg cramp.  We asked her what was wrong, no verbal response, staring, for about 5-10minutes. I felt her head, it was "clamy", and I noticed she had "drooled" and the left side of her face was "droopy".  My husband called 911 and I kept asking her questions to get a response. She did try to respond, but it was like her tongue was "fat", because she was just mumbling, not real words.  The parmedics came and started an IV/did all the tests and suggested we go to emergency to get everything checked out.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Unresponsive to stimuli, Urine analysis normal
Clinical narrative: On Aug. 15, 2007 my daughter had what the emergency room listed as a seizure. Around 9:45pm she woke up, quiet type scream and crying, my husband and I tried to wake her and she would "stare", like she wasnt there, or right through us, she would not or could not respond to us.  She cried and turned on her side. We thought she was having a bad dream or had a leg cramp.  We asked her what was wrong, no verbal response, staring, for about 5-10minutes. I felt her head, it was "clamy", and I noticed she had "drooled" and the left side of her face was "droopy".  My husband called 911 and I kept asking her questions to get a response. She did try to respond, but it was like her tongue was "fat", because she was just mumbling, not real words.  The parmedics came and started an IV/did all the tests and suggested we go to emergency to get everything checked out.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site papule, Injection site rash
Clinical narrative: Erythema/edema of left thigh.  Red raised rash anterior aspect left thigh with small central "bump at area of injection of DTAP vaccine.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient had Prevnar injection on 5/22/07.  Mom phoned on 5/23/07 stating patient has red swollen leg down to knee stating it hurts to walk.  Advised to use warm packs, give Benadryl and advil.  If sx's persist needs office visit to recheck injection site
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cold compress therapy, Cold sweat, Dizziness, Headache, Injection site pain
Clinical narrative: Patient was sitting up in a chair; Gardasil immunization was administered in left upper arm, at approximately 9:15 to or around 9:30am on August 31, 2007.  Immediately following shot:  Arm pain, then very quickly, within 3-5 seconds, dizziness, "rushing feeling" in head and stomach, tunnel vision, headache, altered, blurred vision, extreme nausea, cold sweat, felt as though she would lose consciousness, had to lay down on examining table, on her right side.  Cold compress applied.  Patient stayed conscious, did not vomit.  Within about one-half hour, patient felt recovered, and was able to sit, then stand, then walk, without syptoms or assistance.  Patient left doctors office ambulatory, without assistance.  It appears that there have been no long-term adverse effects at this time, but this remains unclear.  Had she not been at a doctor's office already, she would have been taken to one immediately for these very serious syptoms, hence the answer to question #8.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Mood altered, Nausea, Tunnel vision, Vision blurred
Clinical narrative: Patient was sitting up in a chair; Gardasil immunization was administered in left upper arm, at approximately 9:15 to or around 9:30am on August 31, 2007.  Immediately following shot:  Arm pain, then very quickly, within 3-5 seconds, dizziness, "rushing feeling" in head and stomach, tunnel vision, headache, altered, blurred vision, extreme nausea, cold sweat, felt as though she would lose consciousness, had to lay down on examining table, on her right side.  Cold compress applied.  Patient stayed conscious, did not vomit.  Within about one-half hour, patient felt recovered, and was able to sit, then stand, then walk, without syptoms or assistance.  Patient left doctors office ambulatory, without assistance.  It appears that there have been no long-term adverse effects at this time, but this remains unclear.  Had she not been at a doctor's office already, she would have been taken to one immediately for these very serious syptoms, hence the answer to question #8.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness, Deafness, Dizziness, Headache, Hyperhidrosis
Clinical narrative: On August 21, 2007, patient recieved Gardasil vaccination in left upper arm, while seated on eximaning table.  Immediately felt arm pain, then almost immediately after that, within approximately 2-4 seconds, felt extreme dizziness, had profound headache, and stated that vision "went black" momentarily, and that her hearing also faded out.  Felt as though she would lose consciousness.  Became very nauseated, and had extreme pallor, and profuse sweating.  Was helped to lie down, on her right side, on the examining table on which she was seated.  Hearing returned to normal quickly after this, but dizziness, nausea, headache, and sweating continued for about 15 minutes. Patient then felt able to sit up, but still felt unwell, although no longer felt as though she would lose consciousness.  Drank some sips of water.  Was able to stand and walk within about 15 more minutes, and left doctors office ambulatory and unassisted at approximately 11:00am.  Headache, however, and a minor nausea and extreme fatigue, lasted throughout the rest of the day.  Had patient not already been in a doctor's office, she would have been taken to one for these very serious syptoms, hence the answer to question #8.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Nausea, Pain in extremity, Pallor
Clinical narrative: On August 21, 2007, patient recieved Gardasil vaccination in left upper arm, while seated on eximaning table.  Immediately felt arm pain, then almost immediately after that, within approximately 2-4 seconds, felt extreme dizziness, had profound headache, and stated that vision "went black" momentarily, and that her hearing also faded out.  Felt as though she would lose consciousness.  Became very nauseated, and had extreme pallor, and profuse sweating.  Was helped to lie down, on her right side, on the examining table on which she was seated.  Hearing returned to normal quickly after this, but dizziness, nausea, headache, and sweating continued for about 15 minutes. Patient then felt able to sit up, but still felt unwell, although no longer felt as though she would lose consciousness.  Drank some sips of water.  Was able to stand and walk within about 15 more minutes, and left doctors office ambulatory and unassisted at approximately 11:00am.  Headache, however, and a minor nausea and extreme fatigue, lasted throughout the rest of the day.  Had patient not already been in a doctor's office, she would have been taken to one for these very serious syptoms, hence the answer to question #8.
Age: 58.0
Sex: M
Vaccine: BCG
Symptoms: Biopsy, Nephritis interstitial
Clinical narrative: A 58-year-old male patient, with a history of acute renal failure, was admitted on 08Feb2007 for an unknown reason. In Feb2007, the patient was given live Bacillus of Calmette-Guerin (BCG) vaccine 81mg. The patient's concomitant medications included prednisone, rifampin, isoniazid, and vitamin B6. On 14Feb2007, the physician reported possible BCG induced acute interstitial nephritis. On 15Feb2007, a biopsy was done. On an unknown date, BCG was discontinued and the event did not abate after discontinuing the drug. The patient had no previous history of a reaction to the BCG vaccine. The outcome of the event is unknown.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: A 74-year-old female patient received a 0.5 mL pneumovax injection on 17Jul2007. On 18Jul2007, the patient presented to a triage nurse with redness to left upper arm. There was a large irregular area of redness around the injection site. The patient stated that the area was not painful, but the area itched and was warm to touch. The nurse attributed the event to an allergic reaction. The patient had no history of a previous allergic reaction to a pneumovax injection.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Blood culture, CSF cell count, Chest X-ray, Full blood count, Headache
Clinical narrative: Within 24 hours of injection induration developed over site.  Within 48 hours after inoculation fever developed.  Fever was uncontrolled with either tylenol or motrin. Range was between 100-102.4.  This fever lasted for 5 days.  Severe head ache, injected sclera and blanching rash also accompanied course of fever.  There is still some induration and a red discolleration of skin over injection site.  Over the course of the five days of fever I was seen by the clinic who first administered the immunization (given Bactrum to take at home), and two visits to an ED (given Keflex and Prochlorperazine Mal to take at home).  Additional medications were given to me at the ED through an IV but I am not sure what those medications were.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Metabolic function test, Pallor, Pyrexia
Clinical narrative: Within 24 hours of injection induration developed over site.  Within 48 hours after inoculation fever developed.  Fever was uncontrolled with either tylenol or motrin. Range was between 100-102.4.  This fever lasted for 5 days.  Severe head ache, injected sclera and blanching rash also accompanied course of fever.  There is still some induration and a red discolleration of skin over injection site.  Over the course of the five days of fever I was seen by the clinic who first administered the immunization (given Bactrum to take at home), and two visits to an ED (given Keflex and Prochlorperazine Mal to take at home).  Additional medications were given to me at the ED through an IV but I am not sure what those medications were.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Scan brain, Ultrasound scan
Clinical narrative: Within 24 hours of injection induration developed over site.  Within 48 hours after inoculation fever developed.  Fever was uncontrolled with either tylenol or motrin. Range was between 100-102.4.  This fever lasted for 5 days.  Severe head ache, injected sclera and blanching rash also accompanied course of fever.  There is still some induration and a red discolleration of skin over injection site.  Over the course of the five days of fever I was seen by the clinic who first administered the immunization (given Bactrum to take at home), and two visits to an ED (given Keflex and Prochlorperazine Mal to take at home).  Additional medications were given to me at the ED through an IV but I am not sure what those medications were.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Eye swelling, Palpitations, Pruritus, Rash erythematous
Clinical narrative: Received Tdap vaccine IM in Lt upper arm at approx 1025.  At 1033, bagan to feel palpiations.  At 1036, pruritis to arms and neck, eyes began to swell, red rash developed to arms.  Took Benadryl 25 mg p.o. at approx 1040.  Refused medical care.  Symptoms began subsiding within 20-30 minutes.
Age: 0.92
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Angiogram normal, Arteriogram carotid normal, Aspiration tracheal, Blood product transfusion, Blood test normal
Clinical narrative: Information has been received from a physician concerning an "about 1 year old female" who was on an unspecified date vaccinated with a dose of PROQUAD. Subsequently the patient was diagnosed with "encephalitis". Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint involved. Upon internal review the patient's encephalitis was considered to be an other important medical event. Additional information has been requested.
Age: 0.92
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Cerebral ataxia, Cognitive disorder, Communication disorder, Computerised tomogram normal, Convulsion
Clinical narrative: Information has been received from a physician concerning an "about 1 year old female" who was on an unspecified date vaccinated with a dose of PROQUAD. Subsequently the patient was diagnosed with "encephalitis". Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint involved. Upon internal review the patient's encephalitis was considered to be an other important medical event. Additional information has been requested.
Age: 0.92
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Dysphagia, Echocardiogram abnormal, Encephalitis, Epilepsy, Eye movement disorder
Clinical narrative: Information has been received from a physician concerning an "about 1 year old female" who was on an unspecified date vaccinated with a dose of PROQUAD. Subsequently the patient was diagnosed with "encephalitis". Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint involved. Upon internal review the patient's encephalitis was considered to be an other important medical event. Additional information has been requested.
Age: 0.92
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Gait disturbance, Hemiparesis, Hyporeflexia, Intensive care, Lumbar puncture normal
Clinical narrative: Information has been received from a physician concerning an "about 1 year old female" who was on an unspecified date vaccinated with a dose of PROQUAD. Subsequently the patient was diagnosed with "encephalitis". Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint involved. Upon internal review the patient's encephalitis was considered to be an other important medical event. Additional information has been requested.
Age: 0.92
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Pyrexia, Tricuspid valve incompetence
Clinical narrative: Information has been received from a physician concerning an "about 1 year old female" who was on an unspecified date vaccinated with a dose of PROQUAD. Subsequently the patient was diagnosed with "encephalitis". Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint involved. Upon internal review the patient's encephalitis was considered to be an other important medical event. Additional information has been requested.
Age: 0.92
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Computerised tomogram normal, Developmental delay, Encephalitis, Eye rolling, Hypoventilation
Clinical narrative: Information has been received from a physician concerning an "about 1 year old female" who was on an unspecified date vaccinated with a dose of PROQUAD. Subsequently the patient was diagnosed with "encephalitis". Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint involved. Upon internal review the patient's encephalitis was considered to be an other important medical event. Additional information has been requested.
Age: 0.92
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Inflammation, Lumbar puncture normal, Muscle rigidity, Nervous system disorder, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physician concerning an "about 1 year old female" who was on an unspecified date vaccinated with a dose of PROQUAD. Subsequently the patient was diagnosed with "encephalitis". Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint involved. Upon internal review the patient's encephalitis was considered to be an other important medical event. Additional information has been requested.
Age: 0.92
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Unresponsive to stimuli, X-ray abnormal
Clinical narrative: Information has been received from a physician concerning an "about 1 year old female" who was on an unspecified date vaccinated with a dose of PROQUAD. Subsequently the patient was diagnosed with "encephalitis". Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint involved. Upon internal review the patient's encephalitis was considered to be an other important medical event. Additional information has been requested.
Age: 0.92
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Encephalitis
Clinical narrative: Information has been received from a physician concerning an "about 1 year old female" who was on an unspecified date vaccinated with a dose of PROQUAD. Subsequently the patient was diagnosed with "encephalitis". Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint involved. Upon internal review the patient's encephalitis was considered to be an other important medical event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaemia haemolytic autoimmune
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 12 year old female patient with a history of migraines, meconium aspiration ventilated for 10 days (full term), dehydration (several episodes as a toddler which required ER visits and IV hydration) and upper respiratory tract infection (4 to 6 weeks prior to vaccination), who on 17-JAN-2007 was vaccinated IM into the left arm with a second dose of Gardasil (Lot#653938/0954F). There was no concomitant medication. On 12-FEB-2007, the patient experienced an acute onset of autoimmune hemolytic anemia requiring IV steroids and hospitalization. The patient was found to be anemic at a routine primary care physician visit and was treated with high dose steroids. Two weeks prior to hospitalization the patient had fatigue, pallor and nausea. Laboratory diagnostic studies included blood hemoglobin test of 5.4, blood lactate dehydrogenase test of 493, blood platelet count of 211,000, direct antiglobulin test of IgG anti-e antibody, blood reticulocyte count elevated, total serum bilirubin test of 3.8, white blood cell count of 3.6, whole blood hematocrit of 17. At the time of this report, the patient's outcome was unknown. A lot check will be performed. Fatigue, pallor, nausea and acute onset of autoimmune hemolytic anemia were considered to be life threatening. The original reporting source was not provided. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaemia, Anaemia haemolytic autoimmune, Blood bilirubin increased, Blood immunoglobulin G, Blood lactate dehydrogenase increased
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 12 year old female patient with a history of migraines, meconium aspiration ventilated for 10 days (full term), dehydration (several episodes as a toddler which required ER visits and IV hydration) and upper respiratory tract infection (4 to 6 weeks prior to vaccination), who on 17-JAN-2007 was vaccinated IM into the left arm with a second dose of Gardasil (Lot#653938/0954F). There was no concomitant medication. On 12-FEB-2007, the patient experienced an acute onset of autoimmune hemolytic anemia requiring IV steroids and hospitalization. The patient was found to be anemic at a routine primary care physician visit and was treated with high dose steroids. Two weeks prior to hospitalization the patient had fatigue, pallor and nausea. Laboratory diagnostic studies included blood hemoglobin test of 5.4, blood lactate dehydrogenase test of 493, blood platelet count of 211,000, direct antiglobulin test of IgG anti-e antibody, blood reticulocyte count elevated, total serum bilirubin test of 3.8, white blood cell count of 3.6, whole blood hematocrit of 17. At the time of this report, the patient's outcome was unknown. A lot check will be performed. Fatigue, pallor, nausea and acute onset of autoimmune hemolytic anemia were considered to be life threatening. The original reporting source was not provided. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Haematocrit decreased, Haemoglobin decreased, Nausea, Pallor
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 12 year old female patient with a history of migraines, meconium aspiration ventilated for 10 days (full term), dehydration (several episodes as a toddler which required ER visits and IV hydration) and upper respiratory tract infection (4 to 6 weeks prior to vaccination), who on 17-JAN-2007 was vaccinated IM into the left arm with a second dose of Gardasil (Lot#653938/0954F). There was no concomitant medication. On 12-FEB-2007, the patient experienced an acute onset of autoimmune hemolytic anemia requiring IV steroids and hospitalization. The patient was found to be anemic at a routine primary care physician visit and was treated with high dose steroids. Two weeks prior to hospitalization the patient had fatigue, pallor and nausea. Laboratory diagnostic studies included blood hemoglobin test of 5.4, blood lactate dehydrogenase test of 493, blood platelet count of 211,000, direct antiglobulin test of IgG anti-e antibody, blood reticulocyte count elevated, total serum bilirubin test of 3.8, white blood cell count of 3.6, whole blood hematocrit of 17. At the time of this report, the patient's outcome was unknown. A lot check will be performed. Fatigue, pallor, nausea and acute onset of autoimmune hemolytic anemia were considered to be life threatening. The original reporting source was not provided. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Platelet count normal, Reticulocyte count increased, White blood cell count decreased
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 12 year old female patient with a history of migraines, meconium aspiration ventilated for 10 days (full term), dehydration (several episodes as a toddler which required ER visits and IV hydration) and upper respiratory tract infection (4 to 6 weeks prior to vaccination), who on 17-JAN-2007 was vaccinated IM into the left arm with a second dose of Gardasil (Lot#653938/0954F). There was no concomitant medication. On 12-FEB-2007, the patient experienced an acute onset of autoimmune hemolytic anemia requiring IV steroids and hospitalization. The patient was found to be anemic at a routine primary care physician visit and was treated with high dose steroids. Two weeks prior to hospitalization the patient had fatigue, pallor and nausea. Laboratory diagnostic studies included blood hemoglobin test of 5.4, blood lactate dehydrogenase test of 493, blood platelet count of 211,000, direct antiglobulin test of IgG anti-e antibody, blood reticulocyte count elevated, total serum bilirubin test of 3.8, white blood cell count of 3.6, whole blood hematocrit of 17. At the time of this report, the patient's outcome was unknown. A lot check will be performed. Fatigue, pallor, nausea and acute onset of autoimmune hemolytic anemia were considered to be life threatening. The original reporting source was not provided. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Cough, Ear pain, Eye swelling, Lip swelling, Swollen tongue
Clinical narrative: Patient left our office after receiving her Hepatitis A and Varicella vaccines. 10 minutes later she returned complaining of itching, urticaria, a periorbital edema. She was given Benadryl epinephrine SQ and Decadron IM. Within 5 minute she had edema lips and more around eyes. O2 Sats >95 entire time. No wheezing. Within 5 min from that time her edema her itching started to regress
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Throat irritation, Urticaria, Wheezing
Clinical narrative: Patient left our office after receiving her Hepatitis A and Varicella vaccines. 10 minutes later she returned complaining of itching, urticaria, a periorbital edema. She was given Benadryl epinephrine SQ and Decadron IM. Within 5 minute she had edema lips and more around eyes. O2 Sats >95 entire time. No wheezing. Within 5 min from that time her edema her itching started to regress
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Periorbital oedema, Pruritus, Urticaria
Clinical narrative: Patient left our office after receiving her Hepatitis A and Varicella vaccines. 10 minutes later she returned complaining of itching, urticaria, a periorbital edema. She was given Benadryl epinephrine SQ and Decadron IM. Within 5 minute she had edema lips and more around eyes. O2 Sats >95 entire time. No wheezing. Within 5 min from that time her edema her itching started to regress
Age: 12.0
Sex: M
Vaccine: DTAP, HEPA, MMRV, DTAP, HEPA, MMRV
Symptoms: Wrong drug administered
Clinical narrative: Pt. got DTaP should had Tdap or T.D.
Age: 12.0
Sex: M
Vaccine: DTAP, HEPA, MMRV, DTAP, HEPA, MMRV
Symptoms: Inappropriate schedule of drug administration, Wrong technique in drug usage process
Clinical narrative: Pt. got DTaP should had Tdap or T.D.
Age: 0.16
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Death, Developmental delay, Failure to thrive
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of death due to sepsis in a 2-month-old subject of unspecified gender who was vaccinated with Pediarix for prophylaxis. Concurrent vaccination included live attenuated human rotavirus vaccine (Merck) and Prevnar given on 24 August 2007. On 24 August 2007 the subject received 1st dose of Pediarix at 0.5 ml. On 26 August 2007, 2 days after vaccination with Pediarix, the subject experienced death. No autopsy was performed, but the cause of death was listed as sepsis. The sales representative indicated that the healthcare professional believed that the vaccinations were not the cause of death.
Age: 0.16
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Death, Sepsis
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of death due to sepsis in a 2-month-old subject of unspecified gender who was vaccinated with Pediarix for prophylaxis. Concurrent vaccination included live attenuated human rotavirus vaccine (Merck) and Prevnar given on 24 August 2007. On 24 August 2007 the subject received 1st dose of Pediarix at 0.5 ml. On 26 August 2007, 2 days after vaccination with Pediarix, the subject experienced death. No autopsy was performed, but the cause of death was listed as sepsis. The sales representative indicated that the healthcare professional believed that the vaccinations were not the cause of death.
Age: 0.16
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Death
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of death due to sepsis in a 2-month-old subject of unspecified gender who was vaccinated with Pediarix for prophylaxis. Concurrent vaccination included live attenuated human rotavirus vaccine (Merck) and Prevnar given on 24 August 2007. On 24 August 2007 the subject received 1st dose of Pediarix at 0.5 ml. On 26 August 2007, 2 days after vaccination with Pediarix, the subject experienced death. No autopsy was performed, but the cause of death was listed as sepsis. The sales representative indicated that the healthcare professional believed that the vaccinations were not the cause of death.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Diarrhoea, Electroencephalogram normal, Headache, Lumbar puncture abnormal, Meningitis
Clinical narrative: This case was reported by a health professional on 23 August 2007. An 18-year-old female patient with no reported medical history had received an injection of Menactra, lot number U2339AA on 17 August 2007 and five days later, she developed meningitis leading to hospitalization on 22 August 2007. The patient had been diagnosed with meningitis and was receiving treatment in the intensive care unit. Her condition had been reported as critical. The strain had not been identified at the time of diagnosis and strain identification was pending at the time of the report. No additional information had been provided.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Mental status changes, Nausea, Petechiae, Vomiting
Clinical narrative: This case was reported by a health professional on 23 August 2007. An 18-year-old female patient with no reported medical history had received an injection of Menactra, lot number U2339AA on 17 August 2007 and five days later, she developed meningitis leading to hospitalization on 22 August 2007. The patient had been diagnosed with meningitis and was receiving treatment in the intensive care unit. Her condition had been reported as critical. The strain had not been identified at the time of diagnosis and strain identification was pending at the time of the report. No additional information had been provided.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Meningitis
Clinical narrative: This case was reported by a health professional on 23 August 2007. An 18-year-old female patient with no reported medical history had received an injection of Menactra, lot number U2339AA on 17 August 2007 and five days later, she developed meningitis leading to hospitalization on 22 August 2007. The patient had been diagnosed with meningitis and was receiving treatment in the intensive care unit. Her condition had been reported as critical. The strain had not been identified at the time of diagnosis and strain identification was pending at the time of the report. No additional information had been provided.
Age: 37.0
Sex: F
Vaccine: YF
Symptoms: Headache, Influenza like illness, Lethargy, Nausea, Photophobia
Clinical narrative: Rash on thighs 3-5 hours after receving vaccination. Vaccination was received on July 18, 2007. My employer sent various inter-company e-mails, as well as having In-Flight Supervisors daily brief Flight-Attendants that it IS MANDATORY to have this vaccination otherwise all international qualifications would be taken away.The only destination that requires a yellow fever vaccination for entry is foreign. The airline began flying to a foriegn country in last spring 2007. Two days after, I began to have flu-like symptoms, which was treated with OTC medication. Symptoms subsided only to return two days later. Treated again with OTC medication. Twelve days later (July 30, 2007) I began to have headaches, nauseau, low-grade fevers, and EXTREME lethargy.  I consulted a doctor, (08/09/07) whereby I was checked for meningitis. Was advised to take acetaminophen. On Thursday, 08/30/07, the headaches have returned.  I continue to have the headaches. I seem to have developed some light-sensivity to sunlight as well.
Age: 37.0
Sex: F
Vaccine: YF
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on thighs 3-5 hours after receving vaccination. Vaccination was received on July 18, 2007. My employer sent various inter-company e-mails, as well as having In-Flight Supervisors daily brief Flight-Attendants that it IS MANDATORY to have this vaccination otherwise all international qualifications would be taken away.The only destination that requires a yellow fever vaccination for entry is foreign. The airline began flying to a foriegn country in last spring 2007. Two days after, I began to have flu-like symptoms, which was treated with OTC medication. Symptoms subsided only to return two days later. Treated again with OTC medication. Twelve days later (July 30, 2007) I began to have headaches, nauseau, low-grade fevers, and EXTREME lethargy.  I consulted a doctor, (08/09/07) whereby I was checked for meningitis. Was advised to take acetaminophen. On Thursday, 08/30/07, the headaches have returned.  I continue to have the headaches. I seem to have developed some light-sensivity to sunlight as well.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Injection site nodule, Injection site pain, Injection site swelling, Staphylococcal infection
Clinical narrative: Information has been received from a physician concerning an overweight 10 year old female who on 28-JUL-2007 was vaccinated with the second SC dose of Varivax (Lot# 656922/0450U). Concomitant vaccinations included Gardasil (duration and dose not reported). "Within 24 hours," on 29-JUL-2007 the patient developed a nodule, and local injection site pain and swelling. On 29-JUL-2007 the physician and nurse reported that the patient had MRSA characterized by erythema and was hospitalized. Lab diagnostic studies performed included a TB skin test. The patient was treated with Clindamycin (HCL) 450 mg TID for 5 days. Subsequently, the patient recovered and was discharged from the hospital on 01-AUG-2007. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Tuberculin test
Clinical narrative: Information has been received from a physician concerning an overweight 10 year old female who on 28-JUL-2007 was vaccinated with the second SC dose of Varivax (Lot# 656922/0450U). Concomitant vaccinations included Gardasil (duration and dose not reported). "Within 24 hours," on 29-JUL-2007 the patient developed a nodule, and local injection site pain and swelling. On 29-JUL-2007 the physician and nurse reported that the patient had MRSA characterized by erythema and was hospitalized. Lab diagnostic studies performed included a TB skin test. The patient was treated with Clindamycin (HCL) 450 mg TID for 5 days. Subsequently, the patient recovered and was discharged from the hospital on 01-AUG-2007. There was no product quality complaint. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia, Inappropriate schedule of drug administration, Rotavirus test negative
Clinical narrative: Information has been received from a physician concerning a 6 month old female with no medical history or drug allergies, who "45-46 days ago" on approximately 07-JUL-2007 was vaccinated with her second oral dose of Rotateq. There was no concomitant medications. On approximately 07-JUL-2007 the patient developed blood in her stool and watery diarrhea. Medical attention was sought through via gastroenterology visit. Lab diagnostic studies confirmed that the patient was negative for rotavirus antigen. As of 22-AUG-2007, the diarrhea decreased but the blood continued to be in the patient's stool. Subsequently the patient was noted to be resolving. It was also noted by the physician that there was a longer than recommended interval between first and second dose. There was no product quality complaint. Upon internal review, blood in stool was considered to be an other important medical event. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Immune system disorder, Inappropriate schedule of drug administration, Laboratory test
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male, with a history of asthma and many unknown allergies, who on 26-AUG-2004 was vaccinated with a first dose of Recombivax HB. It was reported that in his third year of his life, approximately 2005, it was discovered that "he was not making antibodies". The patient was seen by allergists, pulmonologists and endocrinologist, and many unknown tests were performed. During 2006 the patient was hospitalized four times. The patient received a second dose of Recombivax on 30 APR 2007. The reporter considered the adverse event "not making antibodies" to be Disabling, Life Threatening, and required hospitalization. At the time of reporting the patient was recovered. Lot numbers were not provided. There was no product quality complaint. Additional information has been received from a registered nurse, who adamantly stated this was not a report of an adverse event with Recombivax, it was strictly a question to inquire about the dosing schedule and whether the extended period between vaccines would change the vaccines effectiveness. The patient was vaccinated on 26-AUG-2004 then again 30-APR-2007 and the final vaccination was on 22-AUG-2007 (LOT # 655565/0007U. The nurse reported that this is a sickly patient with asthma who has a long medical history none of which had anything to do with this vaccine (Lot # 655565/0007U, Batch #0007U).
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count abnormal, Haematocrit decreased, Inappropriate schedule of drug administration, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 79 year old female with chronic lung disease, thyroid disease, and a sulfonamide allergy who in October 2002, was vaccinated with a second dose of Pneumovax 23. On 09-AUG-2007 the patient was vaccinated subcutaneously in the left upper arm with a 0.5mL third dose of Pneumovax 23 (Lot #657525/0554U). Concomitant therapy included gentamicin nebulizer, Synthroid, Evista, Protonix, Norvasc, Zocor, Mobic and aspirin. Subsequently, 24 to 48 hours post vaccination the patient developed a severe localized reaction with redness, swelling, and severe tenderness at the injection site of the left upper arm. The patient developed a 2 inch (also reported as cm) area of necrotic tissue. On 24-AUG-2007 the patient was seen in the doctor's office and was treated with Cifloxin and topical antibiotics. A complete blood cell count was performed with outcome high for white count at 13,300, 90% poly, 4 lymph, and 6 monocytes. Hematocrit was low at 33.8. At the time of the report the patient had not recovered. The reporting physician requested a lot check. The severe localized reaction with redness, swelling, severe tenderness at the injection site of the left upper arm, and the 2 inch of necrotic tissue were considered to be disabling. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Local reaction, Lymphocyte count normal, Monocyte count increased, Necrosis
Clinical narrative: Information has been received from a physician concerning a 79 year old female with chronic lung disease, thyroid disease, and a sulfonamide allergy who in October 2002, was vaccinated with a second dose of Pneumovax 23. On 09-AUG-2007 the patient was vaccinated subcutaneously in the left upper arm with a 0.5mL third dose of Pneumovax 23 (Lot #657525/0554U). Concomitant therapy included gentamicin nebulizer, Synthroid, Evista, Protonix, Norvasc, Zocor, Mobic and aspirin. Subsequently, 24 to 48 hours post vaccination the patient developed a severe localized reaction with redness, swelling, and severe tenderness at the injection site of the left upper arm. The patient developed a 2 inch (also reported as cm) area of necrotic tissue. On 24-AUG-2007 the patient was seen in the doctor's office and was treated with Cifloxin and topical antibiotics. A complete blood cell count was performed with outcome high for white count at 13,300, 90% poly, 4 lymph, and 6 monocytes. Hematocrit was low at 33.8. At the time of the report the patient had not recovered. The reporting physician requested a lot check. The severe localized reaction with redness, swelling, severe tenderness at the injection site of the left upper arm, and the 2 inch of necrotic tissue were considered to be disabling. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 79 year old female with chronic lung disease, thyroid disease, and a sulfonamide allergy who in October 2002, was vaccinated with a second dose of Pneumovax 23. On 09-AUG-2007 the patient was vaccinated subcutaneously in the left upper arm with a 0.5mL third dose of Pneumovax 23 (Lot #657525/0554U). Concomitant therapy included gentamicin nebulizer, Synthroid, Evista, Protonix, Norvasc, Zocor, Mobic and aspirin. Subsequently, 24 to 48 hours post vaccination the patient developed a severe localized reaction with redness, swelling, and severe tenderness at the injection site of the left upper arm. The patient developed a 2 inch (also reported as cm) area of necrotic tissue. On 24-AUG-2007 the patient was seen in the doctor's office and was treated with Cifloxin and topical antibiotics. A complete blood cell count was performed with outcome high for white count at 13,300, 90% poly, 4 lymph, and 6 monocytes. Hematocrit was low at 33.8. At the time of the report the patient had not recovered. The reporting physician requested a lot check. The severe localized reaction with redness, swelling, severe tenderness at the injection site of the left upper arm, and the 2 inch of necrotic tissue were considered to be disabling. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Blood pressure decreased, Loss of consciousness, Syncope
Clinical narrative: Information was obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 16 year old female patient who on 29-MAY-2007 was vaccinated IM in left arm with a dose of Gardasil, lot #657737/0522U. Concomitant suspect therapy administered on the same day included a second dose of Varivax, lot #657102/0455U given in left arm; and Vaqta, lot #657304/0246U. Other concomitant therapy included Menactra. After a few moments of receiving the vaccinations the patient developed syncope and her blood pressure dropped. After the vaccinations she left the room and had loss of consciousness for 10 seconds. Her blood pressure was 88/54. She felt better after resting, and walked out of the office with her mother. She was reported as recovered. The reporter considered decreased blood pressure and syncope to be immediately life-threatening. The original reporting source was not provided. No further information is available. A standard lot check was performed. All in-process quality checks for the lot number 0455U 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 Center for Biologics Evaluation and Research and was released.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Initial and follow-up information has been received from the Merck Pregnancy Registry via a 23 year old female who was vaccinated on an unspecified date with a dose of Gardasil when she was a month pregnant. Subsequently, the patient gave birth to an infant with a cleft palate. At the time of the report the patient had recovered. The infant's outcome is unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose increased, Convulsion, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 23-AUG-2007 was vaccinated with her third dose of Gardasil at approximately 11:40 am. After vaccination, on 23-AUG-2007, the patient was sitting in the waiting room of the physician's office and "passed out." She was woken up with smelling salts and then passed out again and began to have seizure-like movements. The office called the paramedics and when they arrived, they tested her blood sugar and it was 106. They started an intravenous line and took her to a hospital. The office was unable to contact the patient to find out if she was admitted to the hospital or released the same day. The office did state that the patient did not have anything to eat all day. It was unclear as to whether or not the patient had any experiences with the first and second dose of Gardasil (dates of vaccination not provided). "Passed out" and seizure-like movements were determined to be other important medical events by the reporting physician as an IV line was started by the paramedics. Additional information has been requested.