chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Reaction to previous exposure to any vaccine, Similar reaction on previous exposure to drug, Syncope vasovagal
Clinical narrative: Information has been received from a nurse concerning a female (age unknown) with an history of vasovagal reactions after vaccinations and no allergies, who on 17-MAY-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot#0210U). There was no concomitant medication. The patient experienced a vagal reaction immediately after the injection. The patient sought unspecified medical attention. The patient had recovered on 17-MAY-2007. No product quality complaint was involved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a health professional concerning a 16 year old female with a history of vasovagal reactions after vaccinations and no allergies, who on 17-MAY-2007 at 10:00am was vaccinated intramuscularly in the left deltoid with a 0.5mL first dose of GARDASIL (Lot#0210U). There was no concomitant medication. The patient experienced a vagal reaction immediately after the injection followed by nausea with vomiting 15 minutes post injection. No laboratory diagnostics were performed. The patient had recovered on 17-MAY-2007. No product quality complaint was involved. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dysphonia, Dyspnoea, Panic reaction, Pharyngeal oedema
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female patient with asthma and allergies to Advil, aspirin, and penicillin who on 20-JUN-2007, was vaccinated with a first 0.5ml dose of GARDASIL vaccine (yeast). Concomitant therapy included IMITREX and albuterol. Subsequently, the patient had difficulty breathing and a low oxygen level. Unspecified medical attention was sought. On an unknown date, the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received froma a nurse practitioner concerning a 21 year old female patient with asthma and allergies to ADVIL, aspirin, and penicillin who on 20-JUN-2007 at 9:50 AM  was vaccinated IM into the left arm with a first 0.5ml dose of GARDASIL vaccien (yeast)(lot # 0211U). Concomitant therapy included IMITREX and albuterol. Within one hour, the patient had difficulty breathing, alow oxygen level and difficulty swallowing. It was reported that the patient was taken to the ER and was given predisolone and ZYRTEC IV. The patient was discharged from the ER with oral medication. On an unknown date, the patient recovered. No product quality complaint was inviolved. Additional information  is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dysphagia, Dyspnoea, Oxygen saturation decreased
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female patient with asthma and allergies to Advil, aspirin, and penicillin who on 20-JUN-2007, was vaccinated with a first 0.5ml dose of GARDASIL vaccine (yeast). Concomitant therapy included IMITREX and albuterol. Subsequently, the patient had difficulty breathing and a low oxygen level. Unspecified medical attention was sought. On an unknown date, the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received froma a nurse practitioner concerning a 21 year old female patient with asthma and allergies to ADVIL, aspirin, and penicillin who on 20-JUN-2007 at 9:50 AM  was vaccinated IM into the left arm with a first 0.5ml dose of GARDASIL vaccien (yeast)(lot # 0211U). Concomitant therapy included IMITREX and albuterol. Within one hour, the patient had difficulty breathing, alow oxygen level and difficulty swallowing. It was reported that the patient was taken to the ER and was given predisolone and ZYRTEC IV. The patient was discharged from the ER with oral medication. On an unknown date, the patient recovered. No product quality complaint was inviolved. Additional information  is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Asthenia, Blood pressure decreased, Heart rate decreased, Musculoskeletal stiffness, Pallor
Clinical narrative: Information has been received from a certified medical assistant (CMA), concerning an 18 year old female who on 23-JUN-2007 was vaccinated IM in the right deltoid with the first dose, 0.5ml, of Gardasil (Lot #655503/0012U). Concomitant therapy included Menactra and Varivax (manufacturer unspecified). On 23-JUN-2007, three minutes after vaccination with Gardasil, the patient had an episode of syncope while sitting in the office. The patient was attended to in the office (treatment not specified), and felt better after 10-15 minutes had passes. At the time of this report, the CMA stated the patient was recovering from the event. The CMA reported a similar events of syncope for 2 additional female patients following vaccination with Gardasil (WAES #0706USA04707 and 0706USA04722). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Tremor
Clinical narrative: Information has been received from a certified medical assistant (CMA), concerning an 18 year old female who on 23-JUN-2007 was vaccinated IM in the right deltoid with the first dose, 0.5ml, of Gardasil (Lot #655503/0012U). Concomitant therapy included Menactra and Varivax (manufacturer unspecified). On 23-JUN-2007, three minutes after vaccination with Gardasil, the patient had an episode of syncope while sitting in the office. The patient was attended to in the office (treatment not specified), and felt better after 10-15 minutes had passes. At the time of this report, the CMA stated the patient was recovering from the event. The CMA reported a similar events of syncope for 2 additional female patients following vaccination with Gardasil (WAES #0706USA04707 and 0706USA04722). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a certified medical assistant (CMA), concerning an 18 year old female who on 23-JUN-2007 was vaccinated IM in the right deltoid with the first dose, 0.5ml, of Gardasil (Lot #655503/0012U). Concomitant therapy included Menactra and Varivax (manufacturer unspecified). On 23-JUN-2007, three minutes after vaccination with Gardasil, the patient had an episode of syncope while sitting in the office. The patient was attended to in the office (treatment not specified), and felt better after 10-15 minutes had passes. At the time of this report, the CMA stated the patient was recovering from the event. The CMA reported a similar events of syncope for 2 additional female patients following vaccination with Gardasil (WAES #0706USA04707 and 0706USA04722). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated with a dose of Gardasil. The physician reported that the patient passed out in the parking lot, which was a half hour after vaccination. The physician also reported that "it was a hot day outside." The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested. Initial and follow-up information has been recieved from a physician and a healthcare professional concerning a 14 year old female with asthma who on 12-JUN-2007 at 16:25, was vaccinated IM in the right deltoid with the first dose of GARDASIL (lot 653978/0955P) and vaccinated, in the same arm with a dose of MENACTRA. After vaccination, the patient waited in the office for the recommended 20 minutes. The patient left the office building with no syncope notes at that time. As the patient walked to her car, she fainted in the parking lot. The physican reported that "it was a hot day outside." The patient sought unspecified medical attention. No injuries were noted at the time. On 12-JUN-2007, the patient recovered. No additional information is expected.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Musculoskeletal stiffness, Pallor
Clinical narrative: Information has been received from a certified medical assistant concerning a 10 year old female with a history of seizures and an amoxicillin allergy who on 04-APR-2007 was vaccinated with a first dose of Gardasil (lot# 655503/0012U) IM in the left deltoid. There was no concomitant medication used. On 20-JUN-2007 the patient was administered with a second dose of Gardasil IM in the right deltoid. Three minutes after the administration of the vaccine the patient developed syncope while sitting in the office. Medical attention was sought at the office. The patient better after 10-15 minutes of the adverse experience. The CMA reported that two additional female patients also experienced syncope after vaccination with Gardasil (Lot#655503/0012U) (WAES #0706USA04697. 0706USA04707). Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood cholesterol, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a 10 year old female with a history of seizures and an amoxicillin allergy who on 04-APR-2007 was vaccinated with a first dose of Gardasil (lot# 655503/0012U) IM in the left deltoid. There was no concomitant medication used. On 20-JUN-2007 the patient was administered with a second dose of Gardasil IM in the right deltoid. Three minutes after the administration of the vaccine the patient developed syncope while sitting in the office. Medical attention was sought at the office. The patient better after 10-15 minutes of the adverse experience. The CMA reported that two additional female patients also experienced syncope after vaccination with Gardasil (Lot#655503/0012U) (WAES #0706USA04697. 0706USA04707). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 16-JUN-2007 was vaccinated with a first dose of Gardasil (Lot #658100/0525U). There was no concomitant medication. Subsequently, later that night the patient broke out in hives all over her body. She called the office and the physician advised her to take BENADRYL and "everything was fine." At the time of the report, the patient had recovered. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthma, Urticaria
Clinical narrative: Information has been received from a physician concerning a 25 year old hispanic female with a history of asthma who on 02-APR-2007 was vaccinated with a first dose of Gardasil (lot number 657617/0384U) IM in her left upper arm. Concomitant medication included ZYRTEC, MSD, and PAXIL. The physician reported that the patient was in the office for her second dose of Gardasil on 15-JUN-2007 and reported that on 2-APR-2007 she developed hives on her legs and her asthma started bothering her after receiving the first dose of Gardasil. Medical attention was sought. The patient recovered on an unspecified date from asthma and the hives on her legs. At the time of reporting it was stated that the "patient" is fine now". The office did not administer the second dose after finding out about the patient's experience from the first dose of Gardasil. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthma, Condition aggravated, Urticaria
Clinical narrative: Information has been received from a physician concerning a 25 year old hispanic female with a history of asthma who on 02-APR-2007 was vaccinated with a first dose of Gardasil (lot number 657617/0384U) IM in her left upper arm. Concomitant medication included ZYRTEC, MSD, and PAXIL. The physician reported that the patient was in the office for her second dose of Gardasil on 15-JUN-2007 and reported that on 2-APR-2007 she developed hives on her legs and her asthma started bothering her after receiving the first dose of Gardasil. Medical attention was sought. The patient recovered on an unspecified date from asthma and the hives on her legs. At the time of reporting it was stated that the "patient" is fine now". The office did not administer the second dose after finding out about the patient's experience from the first dose of Gardasil. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Fatigue, Flushing, Hyperhidrosis, Nausea, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 25-JUN-2007 was vaccinated IM in to left arm with a dose of Gardasil lot #654510/0962F. Concomitant therapy included Havrix. On 25-JUN-2007, after receiving the Gardasil, the patient experienced tingling of her left arm and a reaction which appeared as "vagal". She became diaphoretic, pale, sweaty, her eyes were blurry, and she vomited. The physician mentioned that the recovered during the same visit. On 24-JUN-2007, during a follow-up call the patient's mother mentioned that the patient was "tired today". The physician reported that this symptom was "not specific". Unspecified medical attention was sought by the patient. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Visual acuity reduced, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 25-JUN-2007 was vaccinated IM in to left arm with a dose of Gardasil lot #654510/0962F. Concomitant therapy included Havrix. On 25-JUN-2007, after receiving the Gardasil, the patient experienced tingling of her left arm and a reaction which appeared as "vagal". She became diaphoretic, pale, sweaty, her eyes were blurry, and she vomited. The physician mentioned that the recovered during the same visit. On 24-JUN-2007, during a follow-up call the patient's mother mentioned that the patient was "tired today". The physician reported that this symptom was "not specific". Unspecified medical attention was sought by the patient. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Fatigue, Hyperhidrosis, Pallor, Paraesthesia, Syncope vasovagal
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 25-JUN-2007 was vaccinated IM in to left arm with a dose of Gardasil lot #654510/0962F. Concomitant therapy included Havrix. On 25-JUN-2007, after receiving the Gardasil, the patient experienced tingling of her left arm and a reaction which appeared as "vagal". She became diaphoretic, pale, sweaty, her eyes were blurry, and she vomited. The physician mentioned that the recovered during the same visit. On 24-JUN-2007, during a follow-up call the patient's mother mentioned that the patient was "tired today". The physician reported that this symptom was "not specific". Unspecified medical attention was sought by the patient. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Vision blurred, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 25-JUN-2007 was vaccinated IM in to left arm with a dose of Gardasil lot #654510/0962F. Concomitant therapy included Havrix. On 25-JUN-2007, after receiving the Gardasil, the patient experienced tingling of her left arm and a reaction which appeared as "vagal". She became diaphoretic, pale, sweaty, her eyes were blurry, and she vomited. The physician mentioned that the recovered during the same visit. On 24-JUN-2007, during a follow-up call the patient's mother mentioned that the patient was "tired today". The physician reported that this symptom was "not specific". Unspecified medical attention was sought by the patient. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Kawasaki's disease
Clinical narrative: Information has been received from a physician concerning an approximately 3 month old female who, "at two months," on approximately 22-FEB-2007, was vaccinated with a 2 ml oral first dose of Rotateq. It was reported that the patient "received other vaccines but unspecified." "One month after the first dose," on approximately 22-MAR-2007, the patient came down with Kawasaki disease. The patient was treated at the emergency room with IV immune globulin. Subsequently, the patient recovered. It was reported that the second dose of Rotateq at four months. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female patient who on an unspecified date was vaccinated with Gardasil (lot number unknown). The nurse reported that after receiving Gardasil on an unspecified date the patient developed a rash all over the abdomen. Further information was not provided. The outcome was not reported. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a registered nurse concerning a 23 year old female who on 25-APR-2007 was vaccinated with a first dose of GARDASIL (657621/0387U) IM in the deltoid. Follow up information was received from the RN. The patient called the office on 30-APR-2007 and reported that the hives started in arms, legs and face. Also had started "OC's" and has a migraine and heart is racing. The patient had seen a dermatologist and stated that the reaction was to the vaccine. The primary care physician reported that the patient did not have a reaction and diagnosed is as a fungal infection. At the time of reporting the patient had recovered. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fungal infection, Migraine, Palpitations, Rash, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female patient who on an unspecified date was vaccinated with Gardasil (lot number unknown). The nurse reported that after receiving Gardasil on an unspecified date the patient developed a rash all over the abdomen. Further information was not provided. The outcome was not reported. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a registered nurse concerning a 23 year old female who on 25-APR-2007 was vaccinated with a first dose of GARDASIL (657621/0387U) IM in the deltoid. Follow up information was received from the RN. The patient called the office on 30-APR-2007 and reported that the hives started in arms, legs and face. Also had started "OC's" and has a migraine and heart is racing. The patient had seen a dermatologist and stated that the reaction was to the vaccine. The primary care physician reported that the patient did not have a reaction and diagnosed is as a fungal infection. At the time of reporting the patient had recovered. No further information is available.
Age: 0.13
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 week old male who on 22-MAY-2007 was vaccinated with the first dose of Rotateq (LOT# 656104/1167F). There was no concomitant medication. There was no medical history. On 22-JUN-2007 the patient experienced symptoms like vomiting that lasted 3 days. The patient sought unspecified medical attention. No further information is available. This is in follow-up to report (s) previously submitted on 7/16/2007.  Information has been received from a physician concerning a 49 day old male with no pre-existing physician diagnosed allergies, birth defects, and medical conditions who on 22-MAY-2007 was vaccinated PO with the first 2mL dose of ROTATEQ (Lot # 656104/1167F).  There was no illness at the time of vaccination.  Concomitant therapy that day included a second dose of RECOMBIVAXHB (Lot # 653788/0541F) administered IM in the left thigh, a first dose of ACTHIB (Lot # UF086AA) administered IM in the left thigh, a first dose of IPOL (Lot # Z0527) administered SC in the left arm, a first dose of PREVNAR adminstered IM in the right thigh, and a first dose of INFANRIX (Lot # AC14B044AA) administered IM in the left thigh.  There was no other concomitant medication.  On 02-JUN-2007 the patient experienced symptoms like vomiting that lasted 3 days.  The vomiting was noted to be after feeds 03-JUN-2007 to 08-JUN-2007.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  There were no relevant diagnostic tests/laboratory data.  No further information is available.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Fluid replacement, Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 week old female, with no medical history who on 29-MAR-2007 was vaccinated with first dose (Lot # not provided) and 30-MAY-2007 the second dose of Rotateq (LOT# 656104/1167F). Concomitant vaccines administered on 30-MAY-2007 included a second intramuscular dose in the left thigh of diptheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus tozoid (INFANRIX) (Lot# AC1044AA1) a second subcutaneous dose in the left thigh of poliovirus vaccine inactivated (Vero) (IPOL) (Lot# z0527) a second intramuscular dose in the right thigh of Hib conj vaccine (tst toxoid) (ACTHIB) (Lot# IF086AA) and a second intramuscular dose in the right thigh of Pneumovax. There was no illness at the time of vaccination. On 30-MAY-2007 the patient experienced symptoms like vomiting that lasted 2 days. It was reported that the patient had recovered.  No experiences were reported after the first dose. The patient sought unspecified medical attention. There were no laboratory or diagnostic tests performed. Additional information is not expected.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 week old female, with no medical history who on 29-MAR-2007 was vaccinated with first dose (Lot # not provided) and 30-MAY-2007 the second dose of Rotateq (LOT# 656104/1167F). Concomitant vaccines administered on 30-MAY-2007 included a second intramuscular dose in the left thigh of diptheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus tozoid (INFANRIX) (Lot# AC1044AA1) a second subcutaneous dose in the left thigh of poliovirus vaccine inactivated (Vero) (IPOL) (Lot# z0527) a second intramuscular dose in the right thigh of Hib conj vaccine (tst toxoid) (ACTHIB) (Lot# IF086AA) and a second intramuscular dose in the right thigh of Pneumovax. There was no illness at the time of vaccination. On 30-MAY-2007 the patient experienced symptoms like vomiting that lasted 2 days. It was reported that the patient had recovered.  No experiences were reported after the first dose. The patient sought unspecified medical attention. There were no laboratory or diagnostic tests performed. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Lip swelling, Oedema peripheral, Pyrexia, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with a history of spinal fusion who on 12-JUN-2007 was vaccinated with a first dose of Gardasil (Lot # 657868/0523U) 0.5mL IM. Concomitant therapy included MENACTRA. On 12-JUN-2007 within a few minutes after receiving Gardasil the patient experienced syncope. Medical attention was sought. Within a few minutes the patient was awake and able to leave on her own. Later that evening the patient experienced swelling of her lip. Approximately 22 hours later, on approximately 13-JUN-2007 the patient experienced swelling of her hands and feet and hives that would come and go. Approximately 48 hours later, on approximately 15-JUN-2007 the patient developed a fever of 101 degrees F. At the time of reporting the patient recovered from syncope. The outcome of lip swelling edema peripheral, pyrexia and hives was unknown. No further information is available. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Body temperature increased, Lip swelling, Oedema peripheral, Pyrexia, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with a history of spinal fusion who on 12-JUN-2007 was vaccinated with a first dose of Gardasil (Lot # 657868/0523U) 0.5mL IM. Concomitant therapy included MENACTRA. On 12-JUN-2007 within a few minutes after receiving Gardasil the patient experienced syncope. Medical attention was sought. Within a few minutes the patient was awake and able to leave on her own. Later that evening the patient experienced swelling of her lip. Approximately 22 hours later, on approximately 13-JUN-2007 the patient experienced swelling of her hands and feet and hives that would come and go. Approximately 48 hours later, on approximately 15-JUN-2007 the patient developed a fever of 101 degrees F. At the time of reporting the patient recovered from syncope. The outcome of lip swelling edema peripheral, pyrexia and hives was unknown. No further information is available. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with a history of spinal fusion who on 12-JUN-2007 was vaccinated with a first dose of Gardasil (Lot # 657868/0523U) 0.5mL IM. Concomitant therapy included MENACTRA. On 12-JUN-2007 within a few minutes after receiving Gardasil the patient experienced syncope. Medical attention was sought. Within a few minutes the patient was awake and able to leave on her own. Later that evening the patient experienced swelling of her lip. Approximately 22 hours later, on approximately 13-JUN-2007 the patient experienced swelling of her hands and feet and hives that would come and go. Approximately 48 hours later, on approximately 15-JUN-2007 the patient developed a fever of 101 degrees F. At the time of reporting the patient recovered from syncope. The outcome of lip swelling edema peripheral, pyrexia and hives was unknown. No further information is available. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site rash, Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with no pertinent medical history or drug reactions/allergies who on 05-JUN-2007 was vaccinated with first dose of Gardasil (lot number unknown) 0.5 mL IM. There is no concomitant  medication. The consumer reported that on 06-JUN-2007, the next day her daughter broke out in a rash all over her chest. Medical attention was not sought. At the time of reporting, the patient was recovering. No additional information is expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with no pertinent medical history or drug reactions/allergies who on 05-JUN-2007 was vaccinated with first dose of Gardasil (lot number unknown) 0.5 mL IM. There is no concomitant  medication. The consumer reported that on 06-JUN-2007, the next day her daughter broke out in a rash all over her chest. Medical attention was not sought. At the time of reporting, the patient was recovering. No additional information is expected.
Sex: F
Vaccine: HPV4, HPV4, VARCEL
Symptoms: Pain, Pyrexia, Surgery, Swelling
Clinical narrative: Patient was seen on 7/17/07 with (L) arm swelling and warmth and complaints of (L) sided discomfort including face, arm, leg, and back, no other physical findings. Sxs began 7/12/07 and worsened next 5-7 days. No fever but generalized aches.
Sex: F
Vaccine: HPV4, HPV4, VARCEL
Symptoms: Discomfort, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient was seen on 7/17/07 with (L) arm swelling and warmth and complaints of (L) sided discomfort including face, arm, leg, and back, no other physical findings. Sxs began 7/12/07 and worsened next 5-7 days. No fever but generalized aches.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Herpes zoster, Neuralgia, Vertigo
Clinical narrative: Patient had transient dizziness (vertigo) after vaccination, but then developed shingles with significant neuralgia @ 3 months after vaccination.
Age: 58.0
Sex: M
Vaccine: RAB
Symptoms: Abnormal behaviour, Confusional state, Fatigue, Feeling abnormal, Feeling drunk
Clinical narrative: This case was received from a health professional on 06 July 2007. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A 58-year-old male patient with no known medical history had received dose two of Imovax (lot number Z09431) on 18 May 2007. For days later, on 22 May 2007, he began experiencing bizarre behavior, confusion, and "felt like he was drunk". Following administration of dose three, he experienced increased confusion within minutes of vaccination, with neck stiffness, headache, and fatigue. White blood count was 15,000. On 03 July 2007 he began a Medrol pack and noted a slight improvement until he received dose four, when he again began acting bizarre and felt as though he were "in a fog". On 06 July 2007 he saw a neurologist and was started on Prednisone. The patient had not yet recovered. The first dose of Imovax had been administered on 14 May 2007. The reporter also stated that the patient had received an unknown vaccine (Novartis) on 11 May 2007.
Age: 58.0
Sex: M
Vaccine: RAB
Symptoms: Headache, Musculoskeletal stiffness, White blood cell count increased
Clinical narrative: This case was received from a health professional on 06 July 2007. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A 58-year-old male patient with no known medical history had received dose two of Imovax (lot number Z09431) on 18 May 2007. For days later, on 22 May 2007, he began experiencing bizarre behavior, confusion, and "felt like he was drunk". Following administration of dose three, he experienced increased confusion within minutes of vaccination, with neck stiffness, headache, and fatigue. White blood count was 15,000. On 03 July 2007 he began a Medrol pack and noted a slight improvement until he received dose four, when he again began acting bizarre and felt as though he were "in a fog". On 06 July 2007 he saw a neurologist and was started on Prednisone. The patient had not yet recovered. The first dose of Imovax had been administered on 14 May 2007. The reporter also stated that the patient had received an unknown vaccine (Novartis) on 11 May 2007.
Age: 57.0
Sex: M
Vaccine: YF
Symptoms: Diarrhoea, Malaise, Pyrexia
Clinical narrative: Initial report received from a health care professional in the USA on 19/Jun/2006. A 57-year-old male patient developed fevers, malaise and diarrhea after receiving the injection of YF-VAX on 08/Jun/2006. The lot number, route and site of administration were not reported. The reporter refused to provide any further information.
Age: 36.0
Sex: F
Vaccine: FLU3, YF
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin exfoliation
Clinical narrative: A 36 year old, female patient (with a medical history of no known allergies, asthma, eczema, arrhythmias) developed swelling both hands, redness-especially on palms and complained of severe itching of her hands, approximately 12 hours after she received YF-Vax (lot number UE944AA, route of administration not reported) in the left upper arm and Influenza vaccine (manufactured by GSK; lot number 2F600911, route and site of administration not reported) on 28 November 2006. She was seen by a doctor and treated with antihistamines. At the time of the report, it was unknown if the patient recovered. Follow-up information received on 12 January 2007 from a health care professional. It was reported that the YF-Vax was administered subcutaneously in the left arm. The influenza vaccine was administered intramuscularly in the left arm. The patient had previously received an initial dose of influenza vaccine five years previously. As per the reporter, the exact duration of the events was three days. The patient subsequently experienced peeling of the skin from both of her hands 48 hours after the other symptoms in her hand subsided. The peeling of her skin lasted approximately two weeks. The patient was fully recovered from the events at the time of this report. Additional information is not anticipated.
Age: 59.0
Sex: M
Vaccine: TYP, YF
Symptoms: Blood urine, Endoscopy
Clinical narrative: Initial report received on 04 January 2007 from a health care professional. A 59-year-old male patient, with no illness at the time of vaccination, had received a first dose, subcutaneous, left arm injection of YF-VAX, lot number UE944AA; and an intramuscular, left deltoid injection of Typhim VI, lot number Z0664-4; on 03 January 2007. The next day, the patient experienced "blood in his urine" and planned to see his family physician. At the time of this report, the patient had not recovered. Follow-up information received on 21 February 2007. It was not known if the patient had any illness at the time of vaccination. The doctor did a full work up on the patient including endoscopy. All tests were negative. The problem resolved - unknown etiology. The patient recovered without treatment.
Age: 33.0
Sex: F
Vaccine: HEPA, IPV, YF
Symptoms: Drug exposure during pregnancy, Urinary tract infection
Clinical narrative: Initial report received from a nurse in the USA on 16 February 2007. A 33 year old, female patient (with a history of no known allergies) received a 0.5 mL, subcutaneous injection of IPOL (lot number Z0456-2) in the right arm and a 0.5 mL, subcutaneous injection of YF-VAX (lot number UE984AA) in the right arm, on 06 February 2007. She also received a 0.5 mL, intramuscular injection of Havrix (lot number AHAVB118AB) intramuscularly in the right deltoid. She was given these vaccines due to travel overseas. The patient was 2-4 weeks pregnant - determined in ER - as she was seen for a UTI. Her past obstetric history was not provided. Her last menstrual period date and expected date of delivery was not provided. Per the reporter, there was no known adverse event.
Age: 25.0
Sex: F
Vaccine: IPV, MEN, TYP, YF
Symptoms: Back pain, Fatigue, Malaise
Clinical narrative: Initial report received on 05 March 2007 from a health care professional. A 25-year-old female patient had received a first dose injection of YF-Vax, lot number UE984AA, on 26 February 2007. Route and site of administration were not known. The patient had a history of anaphylaxis to steroids and Stevens-Johnson Syndrome (6 years ago) after taking Biaxin. Two days post-immunization, the patient experienced severe fatigue and "just not feeling well." On 04 March 2007, she began experiencing severe back pain which "continues." The patient "called the doctor should be seen by infectious disease doctor." The patient had not been examined by a physician at the time of this report. Recovery status was marked as unknown and not recovered. Follow-up information received on 23 April 2007. The patient also received Typhim Vi (lot number 3001160) per os on 26 February 2007, IPV (lot number Z 548) subcutaneously (site of administration not reported) on 26 March 2007 and Menomune (lot number, route, site and date of administration not reported). She did not have any illness at the time of the vaccinations and she was taking Singulair and Atarax. The patient did not see a physician. On 03 March 2007, she was feeling well, completely recovered.
Age: 20.0
Sex: M
Vaccine: RAB, TYP, YF
Symptoms: Blood immunoglobulin G increased, Body temperature increased, Fatigue, Headache
Clinical narrative: A 20 year old, male patient (with no known allergies) complained of fatigue and headache, approximately 2-3 hours after receiving YF-VAX (lot number UE951AA) intramuscularly in the left deltoid; Imovax (lot number Z0943-11) intramuscularly in the right deltoid and Typhim Vi (lot number Z0664) intramuscularly in the left deltoid, on 06 April 2007. His temperature rose and he went to the hospital and was given O2 and blood work and sent home. He denied any illness at the time of the vaccinations. It was reported that he recovered. Follow-up information received on 08 May 2007. It was reported the patient subsequently received Imovax Rabies (lot number Z0943-1)-dose 2, intramuscularly in the right arm on 13 April 2007 and Imovax Rabies (lot number Z0943-1)-dose 3, intramuscularly in the left arm son 26 April 2007. The patient also had laboratory tests which showed yellow fever antibody IgG.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever, General malaise
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: A case was received from a health care professional in the United States on 11 May 2007. A male patient with no known medical history had received a subcutaneous injection of YF-VAX (batch number UE951AA) on 04 MAY 2007 and 5 days later, on 09 May 2007, experienced pain, redness, and a hard nodule at the injection site. Additional vaccinations received on 04 May 2007 included oral Typhoid (batch number 3001160) and Hepatitis A (batch number not provided). The patient had received one prior dose of Hepatitis A vaccine, and no prior doses of YF-VAX or oral Typhoid. He was not suffering from any illnesses at the time of vaccination. The events had not yet resolved. The reporter stated that the patient's son had received the same vaccinations, and developed the same adverse events; the son's information is captured in case 2007-1745. This case pertains to the father.
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: A male patient with no known medical history had received a subcutaneous injection of YF-VAX (batch number UE951AA) on 04 May 2007 and 5 days later, on 09 May 2007, experienced pain, redness, and a hard nodule at the injection site. Additional vaccinations received on 04 May 2007 included oral Typhoid (Berna, batch number 3001160) and Hepatitis A (Merck, batch number not provided). The patient had received one prior dose of Hepatitis A vaccine, and no prior doses of YF-VAX or oral Typhoid. He was not suffering from any illnesses at the time of vaccination. The events had not yet recovered. The reporter stated that the patient's father had received the same vaccinations, and developed the same adverse events; the father's information is captured in case number 2007-01744. This case pertains to the son.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Left upper arm cellulitis at injection site. Treatment started 7/16/07 with Augmentin 875 mg BID x 10 days
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure fluctuation, Heart rate decreased, Syncope
Clinical narrative: Patient fainted soon after receiving her vaccines she awoke after approx 3 sec and didn't know what happened to her. She then laid down on the table w/feet elevated for approx 15 min and 2 sets of vitals were taken.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: swelling, redness, and pain at injection site
Age: 0.25
Sex: M
Vaccine: DTAP, IPV
Symptoms: Asthenia, Hypotonia
Clinical narrative: Hypotonia and decreased strength noticed to begin 2 days after immunization Hospitalized for evaluation of hypotonia.  09/06/2007 MR received for DOS 6/27-7/03/2007 for c/o sudden onset of progressive weakness beginning 2 days prior.  Parent reports new onset cough, weak suck, decreased energy, and increased gas.     PE WNL except for flat forhead with wide set eyes.  Some abdominal breathing-no retractions. (+) murmur. Moderate head lag.  Brisk patellar reflexes. Proximal muscle weakness.  Weakness and tone improved somewhat during hospitalization but not completely resolved.  Neurology F/U 7/6/2007 still with no definitive DX, possibly post-vaccination hypotonia and encephalopathy rxn. Parents report increased feeding issues with arching and screaming during breastfeeding.   9/10/07 TC to to reporter for update.  After extensive workup, no definite diagnosis discovered.  Reporter MD stated DX was hypotonia as an adverse event following vax.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Pharyngeal oedema, Rash
Clinical narrative: Hep A injection received at approx. 1pm.  At approx. 7pm childs shirt removed and rash noticed covering trunk, front and back.  On one side of face and one arm also.  Child given Beandryl by mom per Dr. recommendation over phone and taken to ER.  Mom states childs throat appeared swollen.  Arrived to St. ER approx. 9pm, give Prednisone x3days.  Mom states rash gone next day.  Was told by ER doctor reaction was probably due to the Hep A vaccination.
Age: 1.1
Sex: F
Vaccine: HBHEPB, HEPA, MMRV, PNC
Symptoms: Death
Clinical narrative: Infant death.  Infant discovered in crib by parents on 7/16/07 expired. No conclusive findings on post.  8/24/07 Received autopsy report which reveals COD as undetermined & manner of death as undetermined.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Nasal congestion, Rash erythematous, Wheezing
Clinical narrative: Patient received Tdap and varicella vaccine on 7/12/2007.  Mom calls clinic on 7/18/2007, reporting day after vaccine pt developed congestion, then two days after vaccination pt developed red bumps on face and yesterday 07/17/07 pt started wheezing.  Parent denies pt has fever. Parent reports she has not taken child to the doctor. This nurse recommends to parent that she take pt to doctor, parent verbalizes she will take child to doctor. Parent instructed to call back clinic after doctor visit and or nurse will follow up with parent.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Diarrhoea, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: pain, swelling at the site, low grade fever,nausea,diarrhea, sore joints, body aches, and tiredness.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: pain, swelling at the site, low grade fever,nausea,diarrhea, sore joints, body aches, and tiredness.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Headache, Injected limb mobility decreased, Injection site erythema, Injection site inflammation, Injection site mass
Clinical narrative: Client received Varicella vaccination in Left Arm, subcutaneous on 7/16/07 around 1100. - Mid day on 7/17/07, client's mother says he came home from camp with headache, sore throat and extreme nausea and went to bed.  - Early AM on 7/18/07, mother checked child's left upper arm because of complaints of being "really painful" with movement.  Mother noted "baseball sized" red area on posterior left upper arm that was "hot to touch".  Child reports not feeling ill on 7/18 but his Left arm just "hurt alot".  Around 8:45 a.m. on 7/18, Mother & child returned to health department for assessment of injection site.  Immunizations nurses X 2 evaulated site and noted a reddened, inflammed area approximately 6 1/2 cm X 7 1/2 cm, round in shape and warm to touch.  Mother & child both verbalized child was not longer "feeling bad" except for his arm.  Child was alert, animated, smiling and visiting with staff.  Mother was told just to monitor site and to notify health department if symptoms changed, child began feeling ill again or injection site worsened.  Mother agreed and left without concern.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site pain, Injection site warmth, Nausea, Pharyngolaryngeal pain
Clinical narrative: Client received Varicella vaccination in Left Arm, subcutaneous on 7/16/07 around 1100. - Mid day on 7/17/07, client's mother says he came home from camp with headache, sore throat and extreme nausea and went to bed.  - Early AM on 7/18/07, mother checked child's left upper arm because of complaints of being "really painful" with movement.  Mother noted "baseball sized" red area on posterior left upper arm that was "hot to touch".  Child reports not feeling ill on 7/18 but his Left arm just "hurt alot".  Around 8:45 a.m. on 7/18, Mother & child returned to health department for assessment of injection site.  Immunizations nurses X 2 evaulated site and noted a reddened, inflammed area approximately 6 1/2 cm X 7 1/2 cm, round in shape and warm to touch.  Mother & child both verbalized child was not longer "feeling bad" except for his arm.  Child was alert, animated, smiling and visiting with staff.  Mother was told just to monitor site and to notify health department if symptoms changed, child began feeling ill again or injection site worsened.  Mother agreed and left without concern.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Headache, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: ON 07-12-07 RECEIVED TDAP AND ON 07-13-07 - RIGHT DELTOID AT INJECTION SITE NOTED WITH REDDNESS, PAIN, LIMIETED ROM, FEVER, H/A, AND NODULE RIGHT AXILLARY AREA.  ON 07-16-07 SEEN VIA PCP
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Nodule, Pyrexia
Clinical narrative: ON 07-12-07 RECEIVED TDAP AND ON 07-13-07 - RIGHT DELTOID AT INJECTION SITE NOTED WITH REDDNESS, PAIN, LIMIETED ROM, FEVER, H/A, AND NODULE RIGHT AXILLARY AREA.  ON 07-16-07 SEEN VIA PCP
Age: 15.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Cold sweat, Dizziness, Pallor, Syncope, Wrong drug administered
Clinical narrative: PATIENT GIVEN tDAP AND MENACTRA IN LEFT DELTOID, HPV IN RIGHT DELTOID.  C/O DIZZINESS, PUT HEAD DOWN.  WITHIN MINUTES, PATIENT GREEN IN COLOR AND VERY CLAMMY.  HEAD PUT FURTHER DOWN.  AFTER SEVERAL MINUTES TRIED TO MOVE CLIENT TO NEXT ROOM TO REST WHEN SHE FAINTED IN HALLWAY.  LOWERED TO GROUND AND FEET PUT UP ON CHAIR.  PULSE AND BLOOD PRESSURE TAKEN.  911 CALLED.  PATIENT SLOWLY OPENED EYES.  STILL CLAMMY AND PALE.  RESCUE ARRIVED, DENIED NEED FOR OXYGEN.  COOL, WET COMPRESS PUT ON FOREHEAD.  PULSE OX 98%, PULSE 60 AND BLOOD PRESSURE 100/60.  SLOWLY ABLE TO GET PATIENT TO SITTING POSITION.  BLOOD PRESSURE TAKEN AGAIN AND PATIENT HELPED INTO CHAIR.  GIVEN WATER TO DRINK.  MOM PRESENT THROUGHOUT INCIDENT.  DENIED NEED FOR TRANSPORT TO ER.  PATIENT REMAINED ON PREMISES FOR ANOTHER 15 MINUTES DRINKING WATER.  NURSE ASSISTED OUT TO HER CAR.  MOM DRIVING, AND MOM WILL BE HOME WITH PATIENT ALL DAY TO OBSERVE.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site anaesthesia, Injection site mass, Paraesthesia
Clinical narrative: 7/01/2007;  2 days following vaccination patient called health department and complained of "lump under left arm followed by numbness/tingling down left arm into 4th and 5th fingers".  Symptoms have continued without relief since 7/1/07.  Patient called private care provider and was instructed ti report to health department.  Denies any recent changes in activities, insect bites, injuries, fever, or any recent illnesses.
Age: 13.0
Sex: F
Vaccine: HPVX, VARCEL
Symptoms: Body temperature increased, Chest pain, Cough, Dyspnoea, Electrocardiogram normal
Clinical narrative: Came to ER at 10:09 7/18/07 with complaints of chest pain of severity of 5 on a scale of 0-5 (5 being worst pain)  Stated it started at 9 a.m. 7/18/07.  VS 100.9 - 111-18  109/73 room air sat was 94%.  Other complaints were cough, headache, and trouble breathing.  EKG was normal - tachy.  Diagnosis by ER physician - mylagia, possible reaction to vaccine.  Given 1 gram tylenol.  Instructed to return if wheezing or rash.