chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning an 80 year old female with a history of breast cancer and cardiac arrhythmia who on 15-MAR-2007 was vaccinated with Pneumovax 23 (lot #655152/0889F), 0.5 ml, IM in the left deltoid.  Concomitant therapy included DEMEROL and LEXAPRO.  The patient was previously vaccinated with Pneumovax 23 in 1997.  On 17-MAR-2007, the patient called the physician's office and reported a swollen, painful left arm with red streaking.  The patient went to the emergency room but left before treatment.  The patient then went home and applied heat to her sore arm.  On 19-MAR-207, the patient called the physician's office to report that her arm was sore but the redness was fading.  Subsequently on an unspecified date, the patient recovered from swollen, painful left arm with red streaking.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Condition aggravated, Laboratory test, Muscular weakness, Neurological examination, Pain in extremity
Clinical narrative: This case was received from another manufacturer (reference number WAES0707USA00713/VAERS # 279407) on 19 July 2007. The following information is verbatim as it appears in the other manufacturer's report: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old female with Guillain-Barre syndrome (diagnosed 13-FEB-2006) experienced aggravated Guillain-Barre syndrome (GBS), arthralgia, myalgia, fatigue, muscular weakness, and pain in arms and legs. It was reported that on 16-MAY-2007, the patient was vaccinated in the left arm with the first dose of Gardasil (lot 4657006/0188U) and vaccinated in the right arm with a dose of Menactra (lot #U2225AA). On 18-MAY-2007, the patient began to experience pain in her arms and legs, arthralgia, myalgia, fatigue and aggravated GBS. The patient was seen by her primary care physician, and subsequently was told 'not to worry about it.' The following day, the patient experienced weakness in the legs. On 22-MAY-2007, the patient was examined by her neurologist. The neurologist's assessment was as follows: 'myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse event reaction. Suspect the patient does not have Guillain-Barre syndrome.  Reflexes normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine medication. Feeling pains very frequently on first few days after injection, peaked on weekend, subsided since Monday. Currently her for follow-up visit because there were concerns it she has a relapse of her GBS which was diagnosed in February 2006. Unspecified labs and muscle testing were performed on the patient. Erythrocyte sedimentation rate (ESR) and C-reactive Protein (CRP) were noted to be normal. The patient's symptoms were being watched to see if they progress into GBS. The patient's outcome was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was unknown. No further information is available."
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, Balance disorder, C-reactive protein normal, Fatigue, Muscular weakness
Clinical narrative: This case was received from another manufacturer (reference number WAES0707USA00713/VAERS # 279407) on 19 July 2007. The following information is verbatim as it appears in the other manufacturer's report: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old female with Guillain-Barre syndrome (diagnosed 13-FEB-2006) experienced aggravated Guillain-Barre syndrome (GBS), arthralgia, myalgia, fatigue, muscular weakness, and pain in arms and legs. It was reported that on 16-MAY-2007, the patient was vaccinated in the left arm with the first dose of Gardasil (lot 4657006/0188U) and vaccinated in the right arm with a dose of Menactra (lot #U2225AA). On 18-MAY-2007, the patient began to experience pain in her arms and legs, arthralgia, myalgia, fatigue and aggravated GBS. The patient was seen by her primary care physician, and subsequently was told 'not to worry about it.' The following day, the patient experienced weakness in the legs. On 22-MAY-2007, the patient was examined by her neurologist. The neurologist's assessment was as follows: 'myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse event reaction. Suspect the patient does not have Guillain-Barre syndrome.  Reflexes normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine medication. Feeling pains very frequently on first few days after injection, peaked on weekend, subsided since Monday. Currently her for follow-up visit because there were concerns it she has a relapse of her GBS which was diagnosed in February 2006. Unspecified labs and muscle testing were performed on the patient. Erythrocyte sedimentation rate (ESR) and C-reactive Protein (CRP) were noted to be normal. The patient's symptoms were being watched to see if they progress into GBS. The patient's outcome was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was unknown. No further information is available."
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Myalgia, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: This case was received from another manufacturer (reference number WAES0707USA00713/VAERS # 279407) on 19 July 2007. The following information is verbatim as it appears in the other manufacturer's report: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old female with Guillain-Barre syndrome (diagnosed 13-FEB-2006) experienced aggravated Guillain-Barre syndrome (GBS), arthralgia, myalgia, fatigue, muscular weakness, and pain in arms and legs. It was reported that on 16-MAY-2007, the patient was vaccinated in the left arm with the first dose of Gardasil (lot 4657006/0188U) and vaccinated in the right arm with a dose of Menactra (lot #U2225AA). On 18-MAY-2007, the patient began to experience pain in her arms and legs, arthralgia, myalgia, fatigue and aggravated GBS. The patient was seen by her primary care physician, and subsequently was told 'not to worry about it.' The following day, the patient experienced weakness in the legs. On 22-MAY-2007, the patient was examined by her neurologist. The neurologist's assessment was as follows: 'myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse event reaction. Suspect the patient does not have Guillain-Barre syndrome.  Reflexes normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine medication. Feeling pains very frequently on first few days after injection, peaked on weekend, subsided since Monday. Currently her for follow-up visit because there were concerns it she has a relapse of her GBS which was diagnosed in February 2006. Unspecified labs and muscle testing were performed on the patient. Erythrocyte sedimentation rate (ESR) and C-reactive Protein (CRP) were noted to be normal. The patient's symptoms were being watched to see if they progress into GBS. The patient's outcome was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was unknown. No further information is available."
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, C-reactive protein normal, Condition aggravated, Fatigue, Guillain-Barre syndrome
Clinical narrative: This case was received from another manufacturer (reference number WAES0707USA00713/VAERS # 279407) on 19 July 2007. The following information is verbatim as it appears in the other manufacturer's report: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old female with Guillain-Barre syndrome (diagnosed 13-FEB-2006) experienced aggravated Guillain-Barre syndrome (GBS), arthralgia, myalgia, fatigue, muscular weakness, and pain in arms and legs. It was reported that on 16-MAY-2007, the patient was vaccinated in the left arm with the first dose of Gardasil (lot 4657006/0188U) and vaccinated in the right arm with a dose of Menactra (lot #U2225AA). On 18-MAY-2007, the patient began to experience pain in her arms and legs, arthralgia, myalgia, fatigue and aggravated GBS. The patient was seen by her primary care physician, and subsequently was told 'not to worry about it.' The following day, the patient experienced weakness in the legs. On 22-MAY-2007, the patient was examined by her neurologist. The neurologist's assessment was as follows: 'myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse event reaction. Suspect the patient does not have Guillain-Barre syndrome.  Reflexes normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine medication. Feeling pains very frequently on first few days after injection, peaked on weekend, subsided since Monday. Currently her for follow-up visit because there were concerns it she has a relapse of her GBS which was diagnosed in February 2006. Unspecified labs and muscle testing were performed on the patient. Erythrocyte sedimentation rate (ESR) and C-reactive Protein (CRP) were noted to be normal. The patient's symptoms were being watched to see if they progress into GBS. The patient's outcome was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was unknown. No further information is available."
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Muscular weakness, Myalgia, Neurological examination normal, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: This case was received from another manufacturer (reference number WAES0707USA00713/VAERS # 279407) on 19 July 2007. The following information is verbatim as it appears in the other manufacturer's report: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old female with Guillain-Barre syndrome (diagnosed 13-FEB-2006) experienced aggravated Guillain-Barre syndrome (GBS), arthralgia, myalgia, fatigue, muscular weakness, and pain in arms and legs. It was reported that on 16-MAY-2007, the patient was vaccinated in the left arm with the first dose of Gardasil (lot 4657006/0188U) and vaccinated in the right arm with a dose of Menactra (lot #U2225AA). On 18-MAY-2007, the patient began to experience pain in her arms and legs, arthralgia, myalgia, fatigue and aggravated GBS. The patient was seen by her primary care physician, and subsequently was told 'not to worry about it.' The following day, the patient experienced weakness in the legs. On 22-MAY-2007, the patient was examined by her neurologist. The neurologist's assessment was as follows: 'myalgias, arthralgias, limb pain and fatigue. Suspect this is a vaccine related adverse event reaction. Suspect the patient does not have Guillain-Barre syndrome.  Reflexes normal. No signs of sensory loss in examination. Complained of joint pains, muscle aches, feeling tired and also felt unsteady when she took her antihistamine medication. Feeling pains very frequently on first few days after injection, peaked on weekend, subsided since Monday. Currently her for follow-up visit because there were concerns it she has a relapse of her GBS which was diagnosed in February 2006. Unspecified labs and muscle testing were performed on the patient. Erythrocyte sedimentation rate (ESR) and C-reactive Protein (CRP) were noted to be normal. The patient's symptoms were being watched to see if they progress into GBS. The patient's outcome was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. The original reporting source was unknown. No further information is available."
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Intussusception, Obstruction, Pyrexia, Small intestinal resection
Clinical narrative: Information has been received from a physician concerning a 2 and a half month old female who was vaccinated with a dose of Rotateq. No lot number was provided. Subsequently, (date not reported), the patient experienced intussusception after receiving the first dose of Rotateq and was hospitalized. Length of stay was unknown. Subsequently, the patient recovered from intussusception. There was no product quality complaint. Intussusception was considered to be immediately life-threatening and an other important medical event. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 and a half month old female who was vaccinated with a dose of Rotateq. No lot number was provided. Subsequently, (date not reported), the patient experienced intussusception after receiving the first dose of Rotateq and was hospitalized. Length of stay was unknown. Subsequently, the patient recovered from intussusception. There was no product quality complaint. Intussusception was considered to be immediately life-threatening and an other important medical event. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 2 and a half month old female who was vaccinated with a dose of Rotateq. No lot number was provided. Subsequently, (date not reported), the patient experienced intussusception after receiving the first dose of Rotateq and was hospitalized. Length of stay was unknown. Subsequently, the patient recovered from intussusception. There was no product quality complaint. Intussusception was considered to be immediately life-threatening and an other important medical event. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Blood potassium increased, Blood sodium decreased, Blood urea normal, Intussusception
Clinical narrative: Information has been received from a physician concerning a 2 and a half month old female who was vaccinated with a dose of Rotateq. No lot number was provided. Subsequently, (date not reported), the patient experienced intussusception after receiving the first dose of Rotateq and was hospitalized. Length of stay was unknown. Subsequently, the patient recovered from intussusception. There was no product quality complaint. Intussusception was considered to be immediately life-threatening and an other important medical event. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laparotomy, Lethargy, Nausea, Obstruction, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 2 and a half month old female who was vaccinated with a dose of Rotateq. No lot number was provided. Subsequently, (date not reported), the patient experienced intussusception after receiving the first dose of Rotateq and was hospitalized. Length of stay was unknown. Subsequently, the patient recovered from intussusception. There was no product quality complaint. Intussusception was considered to be immediately life-threatening and an other important medical event. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Small intestinal anastomosis, Small intestinal resection, Surgery, Urinary system X-ray, Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 and a half month old female who was vaccinated with a dose of Rotateq. No lot number was provided. Subsequently, (date not reported), the patient experienced intussusception after receiving the first dose of Rotateq and was hospitalized. Length of stay was unknown. Subsequently, the patient recovered from intussusception. There was no product quality complaint. Intussusception was considered to be immediately life-threatening and an other important medical event. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 2 and a half month old female who was vaccinated with a dose of Rotateq. No lot number was provided. Subsequently, (date not reported), the patient experienced intussusception after receiving the first dose of Rotateq and was hospitalized. Length of stay was unknown. Subsequently, the patient recovered from intussusception. There was no product quality complaint. Intussusception was considered to be immediately life-threatening and an other important medical event. No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 08-MAY-2007 was vaccinated with a third dose of Rotateq (lot# 656100/1112F). On 21-JUN-2007, the patient experienced intussusception and received a barium enema reduction. The patient was in the hospital for a couple of days. Subsequently, the patient recovered. No product quality complaint was involved. A lot check has been requested. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Burning sensation, Cough, Crying, Dyspnoea, Oral discomfort
Clinical narrative: Initial report received on 24 July 2007 from a health care professional.  A 4 year old patient with no illness at the time of vaccination received a fourth dose, right deltoid injection of IPOL, lot number A0110, a fifth dose, left deltoid injection of Infanrix, lot number AC148056CA; a second dose, right deltoid injection of MMR, lot number 0282U; a second dose, right deltoid injection of Varivax, lot number 1511F; a first dose, left deltoid injection of Havrix, lot number AHAVB172BA; and a third dose, left deltoid injection of Prevnar, lot number B50413K; on 23 July 2007 at 2:45 pm. Immediately post-immunization, the patient experienced coughing. Five minutes post immunization, the roof of his mouth began burning. he then began experiencing wheezing and coughing. He was examined in the doctor's office and treated with an epinephrine injection and a Proventil and normal saline nebulizer treatment. The patient subsequently recovered from the event.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Stomatitis, Wheezing
Clinical narrative: Initial report received on 24 July 2007 from a health care professional.  A 4 year old patient with no illness at the time of vaccination received a fourth dose, right deltoid injection of IPOL, lot number A0110, a fifth dose, left deltoid injection of Infanrix, lot number AC148056CA; a second dose, right deltoid injection of MMR, lot number 0282U; a second dose, right deltoid injection of Varivax, lot number 1511F; a first dose, left deltoid injection of Havrix, lot number AHAVB172BA; and a third dose, left deltoid injection of Prevnar, lot number B50413K; on 23 July 2007 at 2:45 pm. Immediately post-immunization, the patient experienced coughing. Five minutes post immunization, the roof of his mouth began burning. he then began experiencing wheezing and coughing. He was examined in the doctor's office and treated with an epinephrine injection and a Proventil and normal saline nebulizer treatment. The patient subsequently recovered from the event.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Oral discomfort, Wheezing
Clinical narrative: Initial report received on 24 July 2007 from a health care professional.  A 4 year old patient with no illness at the time of vaccination received a fourth dose, right deltoid injection of IPOL, lot number A0110, a fifth dose, left deltoid injection of Infanrix, lot number AC148056CA; a second dose, right deltoid injection of MMR, lot number 0282U; a second dose, right deltoid injection of Varivax, lot number 1511F; a first dose, left deltoid injection of Havrix, lot number AHAVB172BA; and a third dose, left deltoid injection of Prevnar, lot number B50413K; on 23 July 2007 at 2:45 pm. Immediately post-immunization, the patient experienced coughing. Five minutes post immunization, the roof of his mouth began burning. he then began experiencing wheezing and coughing. He was examined in the doctor's office and treated with an epinephrine injection and a Proventil and normal saline nebulizer treatment. The patient subsequently recovered from the event.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Immediate post-injection reaction, Oral discomfort, Wheezing
Clinical narrative: Initial report received on 24 July 2007 from a health care professional.  A 4 year old patient with no illness at the time of vaccination received a fourth dose, right deltoid injection of IPOL, lot number A0110, a fifth dose, left deltoid injection of Infanrix, lot number AC148056CA; a second dose, right deltoid injection of MMR, lot number 0282U; a second dose, right deltoid injection of Varivax, lot number 1511F; a first dose, left deltoid injection of Havrix, lot number AHAVB172BA; and a third dose, left deltoid injection of Prevnar, lot number B50413K; on 23 July 2007 at 2:45 pm. Immediately post-immunization, the patient experienced coughing. Five minutes post immunization, the roof of his mouth began burning. he then began experiencing wheezing and coughing. He was examined in the doctor's office and treated with an epinephrine injection and a Proventil and normal saline nebulizer treatment. The patient subsequently recovered from the event.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Dyspnoea, Stomatitis, Wheezing
Clinical narrative: Initial report received on 24 July 2007 from a health care professional.  A 4 year old patient with no illness at the time of vaccination received a fourth dose, right deltoid injection of IPOL, lot number A0110, a fifth dose, left deltoid injection of Infanrix, lot number AC148056CA; a second dose, right deltoid injection of MMR, lot number 0282U; a second dose, right deltoid injection of Varivax, lot number 1511F; a first dose, left deltoid injection of Havrix, lot number AHAVB172BA; and a third dose, left deltoid injection of Prevnar, lot number B50413K; on 23 July 2007 at 2:45 pm. Immediately post-immunization, the patient experienced coughing. Five minutes post immunization, the roof of his mouth began burning. he then began experiencing wheezing and coughing. He was examined in the doctor's office and treated with an epinephrine injection and a Proventil and normal saline nebulizer treatment. The patient subsequently recovered from the event.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Crying, Dyspnoea, No reaction on previous exposure to drug, Oral discomfort
Clinical narrative: Initial report received on 24 July 2007 from a health care professional.  A 4 year old patient with no illness at the time of vaccination received a fourth dose, right deltoid injection of IPOL, lot number A0110, a fifth dose, left deltoid injection of Infanrix, lot number AC148056CA; a second dose, right deltoid injection of MMR, lot number 0282U; a second dose, right deltoid injection of Varivax, lot number 1511F; a first dose, left deltoid injection of Havrix, lot number AHAVB172BA; and a third dose, left deltoid injection of Prevnar, lot number B50413K; on 23 July 2007 at 2:45 pm. Immediately post-immunization, the patient experienced coughing. Five minutes post immunization, the roof of his mouth began burning. he then began experiencing wheezing and coughing. He was examined in the doctor's office and treated with an epinephrine injection and a Proventil and normal saline nebulizer treatment. The patient subsequently recovered from the event.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Wheezing
Clinical narrative: Initial report received on 24 July 2007 from a health care professional.  A 4 year old patient with no illness at the time of vaccination received a fourth dose, right deltoid injection of IPOL, lot number A0110, a fifth dose, left deltoid injection of Infanrix, lot number AC148056CA; a second dose, right deltoid injection of MMR, lot number 0282U; a second dose, right deltoid injection of Varivax, lot number 1511F; a first dose, left deltoid injection of Havrix, lot number AHAVB172BA; and a third dose, left deltoid injection of Prevnar, lot number B50413K; on 23 July 2007 at 2:45 pm. Immediately post-immunization, the patient experienced coughing. Five minutes post immunization, the roof of his mouth began burning. he then began experiencing wheezing and coughing. He was examined in the doctor's office and treated with an epinephrine injection and a Proventil and normal saline nebulizer treatment. The patient subsequently recovered from the event.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Burning sensation, Cough, Crying, Dyspnoea, Oral discomfort
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 4-year-old male patient who on 23-Jul-2007, received a third dose of Prevnar, along with a fifth dose of Infanrix, a first dose of Havrix, a second dose of Varivax, and a second dose of M-M-R II. On the same day, the child experienced coughing, wheezing, he couldn't catch his breath and the roof of his mouth felt like it was on fire. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 23-Jul-2007. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 23-Jul-2007, the patient received a third dose of Prevnar, along with other childhood vaccines. A few minutes after the injections, the patient experienced coughing. On the way home, the child complained that the roof of his mouth felt like it was on fire. The mother returned to the office. At that time, the child was wheezing and couldn't catch his breath. The child was treated with Proventil and normal saline nebulizer, epinephrine injection and oral Benadryl. After resting and relaxing the child 'felt better' and was sent home. The mother indicated that the child was "fine" when a follow-up phone call was paced later in the evening. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Stomatitis, Wheezing
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 4-year-old male patient who on 23-Jul-2007, received a third dose of Prevnar, along with a fifth dose of Infanrix, a first dose of Havrix, a second dose of Varivax, and a second dose of M-M-R II. On the same day, the child experienced coughing, wheezing, he couldn't catch his breath and the roof of his mouth felt like it was on fire. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 23-Jul-2007. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 23-Jul-2007, the patient received a third dose of Prevnar, along with other childhood vaccines. A few minutes after the injections, the patient experienced coughing. On the way home, the child complained that the roof of his mouth felt like it was on fire. The mother returned to the office. At that time, the child was wheezing and couldn't catch his breath. The child was treated with Proventil and normal saline nebulizer, epinephrine injection and oral Benadryl. After resting and relaxing the child 'felt better' and was sent home. The mother indicated that the child was "fine" when a follow-up phone call was paced later in the evening. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Oral discomfort, Wheezing
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 4-year-old male patient who on 23-Jul-2007, received a third dose of Prevnar, along with a fifth dose of Infanrix, a first dose of Havrix, a second dose of Varivax, and a second dose of M-M-R II. On the same day, the child experienced coughing, wheezing, he couldn't catch his breath and the roof of his mouth felt like it was on fire. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 23-Jul-2007. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 23-Jul-2007, the patient received a third dose of Prevnar, along with other childhood vaccines. A few minutes after the injections, the patient experienced coughing. On the way home, the child complained that the roof of his mouth felt like it was on fire. The mother returned to the office. At that time, the child was wheezing and couldn't catch his breath. The child was treated with Proventil and normal saline nebulizer, epinephrine injection and oral Benadryl. After resting and relaxing the child 'felt better' and was sent home. The mother indicated that the child was "fine" when a follow-up phone call was paced later in the evening. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Immediate post-injection reaction, Oral discomfort, Wheezing
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 4-year-old male patient who on 23-Jul-2007, received a third dose of Prevnar, along with a fifth dose of Infanrix, a first dose of Havrix, a second dose of Varivax, and a second dose of M-M-R II. On the same day, the child experienced coughing, wheezing, he couldn't catch his breath and the roof of his mouth felt like it was on fire. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 23-Jul-2007. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 23-Jul-2007, the patient received a third dose of Prevnar, along with other childhood vaccines. A few minutes after the injections, the patient experienced coughing. On the way home, the child complained that the roof of his mouth felt like it was on fire. The mother returned to the office. At that time, the child was wheezing and couldn't catch his breath. The child was treated with Proventil and normal saline nebulizer, epinephrine injection and oral Benadryl. After resting and relaxing the child 'felt better' and was sent home. The mother indicated that the child was "fine" when a follow-up phone call was paced later in the evening. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Dyspnoea, Stomatitis, Wheezing
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 4-year-old male patient who on 23-Jul-2007, received a third dose of Prevnar, along with a fifth dose of Infanrix, a first dose of Havrix, a second dose of Varivax, and a second dose of M-M-R II. On the same day, the child experienced coughing, wheezing, he couldn't catch his breath and the roof of his mouth felt like it was on fire. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 23-Jul-2007. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 23-Jul-2007, the patient received a third dose of Prevnar, along with other childhood vaccines. A few minutes after the injections, the patient experienced coughing. On the way home, the child complained that the roof of his mouth felt like it was on fire. The mother returned to the office. At that time, the child was wheezing and couldn't catch his breath. The child was treated with Proventil and normal saline nebulizer, epinephrine injection and oral Benadryl. After resting and relaxing the child 'felt better' and was sent home. The mother indicated that the child was "fine" when a follow-up phone call was paced later in the evening. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Crying, Dyspnoea, No reaction on previous exposure to drug, Oral discomfort
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 4-year-old male patient who on 23-Jul-2007, received a third dose of Prevnar, along with a fifth dose of Infanrix, a first dose of Havrix, a second dose of Varivax, and a second dose of M-M-R II. On the same day, the child experienced coughing, wheezing, he couldn't catch his breath and the roof of his mouth felt like it was on fire. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 23-Jul-2007. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 23-Jul-2007, the patient received a third dose of Prevnar, along with other childhood vaccines. A few minutes after the injections, the patient experienced coughing. On the way home, the child complained that the roof of his mouth felt like it was on fire. The mother returned to the office. At that time, the child was wheezing and couldn't catch his breath. The child was treated with Proventil and normal saline nebulizer, epinephrine injection and oral Benadryl. After resting and relaxing the child 'felt better' and was sent home. The mother indicated that the child was "fine" when a follow-up phone call was paced later in the evening. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PPV, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL, DTAP, HEPA, MMR, PNC, VARCEL, DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Wheezing
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 4-year-old male patient who on 23-Jul-2007, received a third dose of Prevnar, along with a fifth dose of Infanrix, a first dose of Havrix, a second dose of Varivax, and a second dose of M-M-R II. On the same day, the child experienced coughing, wheezing, he couldn't catch his breath and the roof of his mouth felt like it was on fire. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 23-Jul-2007. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 23-Jul-2007, the patient received a third dose of Prevnar, along with other childhood vaccines. A few minutes after the injections, the patient experienced coughing. On the way home, the child complained that the roof of his mouth felt like it was on fire. The mother returned to the office. At that time, the child was wheezing and couldn't catch his breath. The child was treated with Proventil and normal saline nebulizer, epinephrine injection and oral Benadryl. After resting and relaxing the child 'felt better' and was sent home. The mother indicated that the child was "fine" when a follow-up phone call was paced later in the evening. No additional information was available at the time of this report.
Age: 11.0
Sex: F
Vaccine: MNQ, TD
Symptoms: Abnormal behaviour, Feeling drunk
Clinical narrative: Five hours after (7:00 p.m.) patient received the vaccines she began acting as if she were drunk.  She kept on giggling for no reason and acting silly.  This continued until she went to sleep at 11:30 p.m.  She woke up at 5:00 a.m. and was back to her normal self.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Lip swelling, Swelling face
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old female with hypothyroidism who on 19-JUL-2007 was vaccinated with a 0.5 ml intramuscularly with a first dose of Gardasil (Lot # 658222/0927U). Concomitant therapy included SYNTHROID. On 20-JUL-2007 the patient developed swelling to her face and lips, shortness of breath, and difficulty breathing. The patient was treated in the emergency room with BENADRYL and Prednisone. Subsequently, the patient recovered. The reporting medical assistant considered swelling of the face and lips, shortness of breath, and difficulty breathing to be another important medical events. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac failure, Cytogenetic analysis, Dyspnoea, Intensive care, Protein total decreased
Clinical narrative: Information has been received from a 25 year old female with a penicillin allergy with a history of appendicitis (age five) and shingles (2005) who on 24-MAY-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included LO/OVRAL. On 25-MAY2007 the patient experienced shortness of breath and was hospitalized. The patient spent four days in the intensive care unit out of the nine days she was hospitalized. On 29-MAY-2007 the patient was diagnosed with a pulmonary embolism and was placed on COUMADIN. It was reported that the patient also developed heart failure "because of the pulmonary embolism". Laboratory data revealed all proteins low. The genetic tests yielded positive results for 2 genetic traits (specific names of the traits are unknown). At the time of report the patient was recovering. No further information is available. 8/15/07-records received DC Summary for DOS 7/23-7/24/07- DC DX: Chest pain not otherwise specified. Palpitations. Hypercoagulable state. Recent pulmonary embolus.VQ Scan low probability for pulmonary embolus. Pain was similar to previous event. Massive pulmonary embolus requiring use of TPA about two months prior. Now on chronic coumadin therapy. DC Summary for DOS 5/29-6/9/07-DC DX Pulmonary embolism with shock, hypotension, syncope and history of oral contraceptive use.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pulmonary embolism
Clinical narrative: Information has been received from a 25 year old female with a penicillin allergy with a history of appendicitis (age five) and shingles (2005) who on 24-MAY-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included LO/OVRAL. On 25-MAY2007 the patient experienced shortness of breath and was hospitalized. The patient spent four days in the intensive care unit out of the nine days she was hospitalized. On 29-MAY-2007 the patient was diagnosed with a pulmonary embolism and was placed on COUMADIN. It was reported that the patient also developed heart failure "because of the pulmonary embolism". Laboratory data revealed all proteins low. The genetic tests yielded positive results for 2 genetic traits (specific names of the traits are unknown). At the time of report the patient was recovering. No further information is available. 8/15/07-records received DC Summary for DOS 7/23-7/24/07- DC DX: Chest pain not otherwise specified. Palpitations. Hypercoagulable state. Recent pulmonary embolus.VQ Scan low probability for pulmonary embolus. Pain was similar to previous event. Massive pulmonary embolus requiring use of TPA about two months prior. Now on chronic coumadin therapy. DC Summary for DOS 5/29-6/9/07-DC DX Pulmonary embolism with shock, hypotension, syncope and history of oral contraceptive use.
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome, Paraesthesia
Clinical narrative: Information has been received from a physician "who heard from a colleague" that a female (age unknown), who was vaccinated with a dose of GARDASIL. Subsequently, a few days after receiving the vaccination the patient experienced a tingling in her leg and she had GUILLIAN BARRE Syndrome. The patient may have had other vaccines that day (unsure of which vaccines). At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review GUILLIAN BARRE Syndrome was considered an important medical event. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Aggression, Amnesia, Delirium, Headache, Intensive care
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no pertinent past medical history who on 20-JUL-2007 was vaccinated with 0.5 ml intramuscularly with a first dose of Gardasil (Lot # 658100/0525U). Concomitant therapy included ADACEL. On 20-JUL-2007 within minutes of receiving the injection the patient fainted onto the floor and was unconscious for a few seconds. The patient was sent to the emergency room. The patient developed a severe headache and amnesia and was hospitalized in the intensive care unit. The patient became combative and delirious and was given two unspecified sedatives and IV ZOFRAN. She was discharged from the hospital within a day or two. On 23-JUL-2007 the patient was seen in the physician's office and was fully recovered. She was referred to a neurologist. The physician considered the patient's fainting, unconsciousness, severe headache, amnesia, combativeness, and delirium to be life threatening and other important medical events. Additional information has been requested.10/03/07-records received-for DOS 7/20/07-Loss of consciousness, now asking repetitive questions, nauseous and seems disoriented. C/O right sided headache. PE oriented to person and time but not place. While in ER became combative uncooperative. DX AMS.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no pertinent past medical history who on 20-JUL-2007 was vaccinated with 0.5 ml intramuscularly with a first dose of Gardasil (Lot # 658100/0525U). Concomitant therapy included ADACEL. On 20-JUL-2007 within minutes of receiving the injection the patient fainted onto the floor and was unconscious for a few seconds. The patient was sent to the emergency room. The patient developed a severe headache and amnesia and was hospitalized in the intensive care unit. The patient became combative and delirious and was given two unspecified sedatives and IV ZOFRAN. She was discharged from the hospital within a day or two. On 23-JUL-2007 the patient was seen in the physician's office and was fully recovered. She was referred to a neurologist. The physician considered the patient's fainting, unconsciousness, severe headache, amnesia, combativeness, and delirium to be life threatening and other important medical events. Additional information has been requested.10/03/07-records received-for DOS 7/20/07-Loss of consciousness, now asking repetitive questions, nauseous and seems disoriented. C/O right sided headache. PE oriented to person and time but not place. While in ER became combative uncooperative. DX AMS.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Aggression, Amnesia, Blood electrolytes normal, Computerised tomogram normal, Delirium
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no pertinent past medical history who on 20-JUL-2007 was vaccinated with 0.5 ml intramuscularly with a first dose of Gardasil (Lot # 658100/0525U). Concomitant therapy included ADACEL. On 20-JUL-2007 within minutes of receiving the injection the patient fainted onto the floor and was unconscious for a few seconds. The patient was sent to the emergency room. The patient developed a severe headache and amnesia and was hospitalized in the intensive care unit. The patient became combative and delirious and was given two unspecified sedatives and IV ZOFRAN. She was discharged from the hospital within a day or two. On 23-JUL-2007 the patient was seen in the physician's office and was fully recovered. She was referred to a neurologist. The physician considered the patient's fainting, unconsciousness, severe headache, amnesia, combativeness, and delirium to be life threatening and other important medical events. Additional information has been requested.10/03/07-records received-for DOS 7/20/07-Loss of consciousness, now asking repetitive questions, nauseous and seems disoriented. C/O right sided headache. PE oriented to person and time but not place. While in ER became combative uncooperative. DX AMS.