chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Laboratory test
Clinical narrative: Initial report was received 25 August 2009 from a health care professional. A 14-year-old female patient with no pre-existing medical conditions had received a first dose left deltoid injection (route not reported) of ADACEL, Sanofi Pasteur Inc. lot number UF486BA (corresponding Sanofi Pasteur Ltd. lot number C3099), and a first dose left deltoid intramuscular injection of MENACTRA, lot number U3014AA, and a right deltoid injection (route not reported) of VARIVAX (manufacturer Merck), lot number 0805Y on 13 August 2009 and two days later, the patient's mother phoned their physician to tell them that the patient had been taken to the emergency room because she had bruises all over her body. The patient had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient's recovery status was unknown. Follow-up information received on 28 September 2009 from a health care professional . Due to the following information, this case meets seriousness criteria and was upgraded due to hospitalization. The patient was not involved in active sports at the time of vaccinations on 13 August 2009; and had no history of recent injuries. Per the reporter, the exact location of the bruising was on the left external aspect of the thigh (side not reported). When asked if the patient was hospitalized or received treatment, the reporter responded "yes", and stated that  relevant diagnostic tests and laboratory results were held with the hospital; however no contact information for the hospital was provided, and dates of hospitalization were also not reported. At the time of this report, the reporter did not know how long the bruising persisted, or if the patient had recovered. Documents held by sender: None. 10/26/09 Hosp. records received for dates 8/18/09 to 8/20/09. DC DX: acute tonsillitis, acute pharyngitis, transient weakness, possible vax. reaction. Presenting SX: in ER pt. c/o left side muscle weakness, dyspnea, chills, n/v, fatigue, dizzy, hives, bruises, chest pain. Pt. states received vax x3 and developed sx. 24hrs later. Assessment: (+)left side thigh contusions. Pt. admitted for r/o GBS vs. somatization vs. MS vs other neurological deficit.
Age: 10.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Dyspnoea, Swelling face, Throat irritation, Urticaria
Clinical narrative: Hives, itching - length of his body, face, groin, trunk back, ears were burning, feet were on fire, tightness in throat, flare in body - morning fluid reaction, facial, swollen, red - epinephrine injection given - enomorus - fear in patient.
Age: 10.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blood test abnormal, Erythema, Pruritus generalised, Swelling face, Throat tightness
Clinical narrative: Hives, itching - length of his body, face, groin, trunk back, ears were burning, feet were on fire, tightness in throat, flare in body - morning fluid reaction, facial, swollen, red - epinephrine injection given - enomorus - fear in patient.
Age: 10.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives, itching - length of his body, face, groin, trunk back, ears were burning, feet were on fire, tightness in throat, flare in body - morning fluid reaction, facial, swollen, red - epinephrine injection given - enomorus - fear in patient.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Antinuclear antibody, Blood test, Chest pain, Full blood count, Limb discomfort
Clinical narrative: Chest pain, myalgia-severe,back pain, neck pain, muscle pain, stomach aches, chronic migraine headaches, dizziness, hot flashes, sleep issues, elevated SED, Al toxicity
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Metabolic function test, Myalgia, Red blood cell sedimentation rate
Clinical narrative: Chest pain, myalgia-severe,back pain, neck pain, muscle pain, stomach aches, chronic migraine headaches, dizziness, hot flashes, sleep issues, elevated SED, Al toxicity
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain upper, Antinuclear antibody, Back pain, C-reactive protein, Chest pain
Clinical narrative: Chest pain, myalgia-severe,back pain, neck pain, muscle pain, stomach aches, chronic migraine headaches, dizziness, hot flashes, sleep issues, elevated SED, Al toxicity
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Full blood count, Hot flush, Immune system disorder, Metal poisoning
Clinical narrative: Chest pain, myalgia-severe,back pain, neck pain, muscle pain, stomach aches, chronic migraine headaches, dizziness, hot flashes, sleep issues, elevated SED, Al toxicity
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Migraine, Myalgia, Neck pain, Red blood cell sedimentation rate increased, Sleep disorder
Clinical narrative: Chest pain, myalgia-severe,back pain, neck pain, muscle pain, stomach aches, chronic migraine headaches, dizziness, hot flashes, sleep issues, elevated SED, Al toxicity
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Antinuclear antibody, C-reactive protein, Chest pain, Full blood count, Metabolic function test
Clinical narrative: Chest pain, myalgia-severe,back pain, neck pain, muscle pain, stomach aches, chronic migraine headaches, dizziness, hot flashes, sleep issues, elevated SED, Al toxicity
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Muscle tightness, Myalgia, Red blood cell sedimentation rate
Clinical narrative: Chest pain, myalgia-severe,back pain, neck pain, muscle pain, stomach aches, chronic migraine headaches, dizziness, hot flashes, sleep issues, elevated SED, Al toxicity
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Antinuclear antibody, Blood test, Chest pain, Full blood count, Limb discomfort
Clinical narrative: Myalgia-severe, chest pain tightness in lower arms.  10/05/09 Vaccine records received. Medical record received for DOS 7/14/09 - 9/15/09.  Chest pain status post 1st Gardasil vaccine. MD offered office visit but mom delclined.  2nd vaccine and c/o arm and muscle pain all over. Tired muscles. Muscle weakness. Vaginal pain. Lower arm edema. Dysuria. Frontal HA. Nasal d/c alternating from clear to thick. Insomnia s/t pain. C/O swollen back.Abdominal pain. Ibuprofen helped. Reflexes and strength equal bil. Normal sensation.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Metabolic function test, Myalgia, Red blood cell sedimentation rate
Clinical narrative: Myalgia-severe, chest pain tightness in lower arms.  10/05/09 Vaccine records received. Medical record received for DOS 7/14/09 - 9/15/09.  Chest pain status post 1st Gardasil vaccine. MD offered office visit but mom delclined.  2nd vaccine and c/o arm and muscle pain all over. Tired muscles. Muscle weakness. Vaginal pain. Lower arm edema. Dysuria. Frontal HA. Nasal d/c alternating from clear to thick. Insomnia s/t pain. C/O swollen back.Abdominal pain. Ibuprofen helped. Reflexes and strength equal bil. Normal sensation.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain upper, Antinuclear antibody, Back pain, C-reactive protein, Chest pain
Clinical narrative: Myalgia-severe, chest pain tightness in lower arms.  10/05/09 Vaccine records received. Medical record received for DOS 7/14/09 - 9/15/09.  Chest pain status post 1st Gardasil vaccine. MD offered office visit but mom delclined.  2nd vaccine and c/o arm and muscle pain all over. Tired muscles. Muscle weakness. Vaginal pain. Lower arm edema. Dysuria. Frontal HA. Nasal d/c alternating from clear to thick. Insomnia s/t pain. C/O swollen back.Abdominal pain. Ibuprofen helped. Reflexes and strength equal bil. Normal sensation.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Full blood count, Hot flush, Immune system disorder, Metal poisoning
Clinical narrative: Myalgia-severe, chest pain tightness in lower arms.  10/05/09 Vaccine records received. Medical record received for DOS 7/14/09 - 9/15/09.  Chest pain status post 1st Gardasil vaccine. MD offered office visit but mom delclined.  2nd vaccine and c/o arm and muscle pain all over. Tired muscles. Muscle weakness. Vaginal pain. Lower arm edema. Dysuria. Frontal HA. Nasal d/c alternating from clear to thick. Insomnia s/t pain. C/O swollen back.Abdominal pain. Ibuprofen helped. Reflexes and strength equal bil. Normal sensation.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Migraine, Myalgia, Neck pain, Red blood cell sedimentation rate increased, Sleep disorder
Clinical narrative: Myalgia-severe, chest pain tightness in lower arms.  10/05/09 Vaccine records received. Medical record received for DOS 7/14/09 - 9/15/09.  Chest pain status post 1st Gardasil vaccine. MD offered office visit but mom delclined.  2nd vaccine and c/o arm and muscle pain all over. Tired muscles. Muscle weakness. Vaginal pain. Lower arm edema. Dysuria. Frontal HA. Nasal d/c alternating from clear to thick. Insomnia s/t pain. C/O swollen back.Abdominal pain. Ibuprofen helped. Reflexes and strength equal bil. Normal sensation.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Antinuclear antibody, C-reactive protein, Chest pain, Full blood count, Metabolic function test
Clinical narrative: Myalgia-severe, chest pain tightness in lower arms.  10/05/09 Vaccine records received. Medical record received for DOS 7/14/09 - 9/15/09.  Chest pain status post 1st Gardasil vaccine. MD offered office visit but mom delclined.  2nd vaccine and c/o arm and muscle pain all over. Tired muscles. Muscle weakness. Vaginal pain. Lower arm edema. Dysuria. Frontal HA. Nasal d/c alternating from clear to thick. Insomnia s/t pain. C/O swollen back.Abdominal pain. Ibuprofen helped. Reflexes and strength equal bil. Normal sensation.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Muscle tightness, Myalgia, Red blood cell sedimentation rate
Clinical narrative: Myalgia-severe, chest pain tightness in lower arms.  10/05/09 Vaccine records received. Medical record received for DOS 7/14/09 - 9/15/09.  Chest pain status post 1st Gardasil vaccine. MD offered office visit but mom delclined.  2nd vaccine and c/o arm and muscle pain all over. Tired muscles. Muscle weakness. Vaginal pain. Lower arm edema. Dysuria. Frontal HA. Nasal d/c alternating from clear to thick. Insomnia s/t pain. C/O swollen back.Abdominal pain. Ibuprofen helped. Reflexes and strength equal bil. Normal sensation.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC, RV1, HIBV, PPV, RV1
Symptoms: Barium enema, Clostridium difficile toxin test, Diarrhoea, Differential white blood cell count normal, Full blood count normal
Clinical narrative: This case was reported by a pharmacist (subject's mother) and described the occurrence of intussusception in a 9-week old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), Pneumococcal vaccine-unspecified and HIB vaccine (unspecified). On 11 September 2009 at 11:15 the subject received 1st dose of ROTARIX (oral); on 11 September 2009 the subject received unspecified dose of Pneumococcal vaccine-unspecified (unknown) and an unspecified dose of HIB vaccine (unspecified) (unknown). On 11 September 2009, less than one day after vaccination with HIB vaccine (unspecified), Pneumococcal vaccine-unspecified and ROTARIX, the subject experienced diarrhea and six days later was diagnosed with intussusception. Immunization series was discontinued. The subject received the ROTARIX vaccine on 11 September 2009. That same afternoon, the subject developed diarrhea. On the sixth day after receiving the ROTARIX vaccine, the subject began having bloody diarrhea. The subject was taken to the emergency room, but the reporter did not feel that the facility was properly equipped to treat an infant. The subject was taken early the next morning to the pediatrician who suspected intussusception. The subject has been treated by the pediatrician since that time. The subject has required treatment with a barium enema to correct the intussusception. It took four to five days for the bloody diarrhea to subside. However, this past Sunday and today, the subject has had more bloody diarrhea. The pharmacist considered intussusception and diarrhea were clinically significant (or requiring intervention). The subject was treated with Barium enema. At the time of reporting the intussusception and diarrhea were unresolved. The pharmacist considered the intussusception and diarrhea were probably related to vaccination with ROTARIX, Pneumococcal vaccine-unspecified and HIB vaccine (unspecified).  Emergency Department records received 10/12/09.  Date of Service:  9/19/09. Assessment:  Rectal bleeding. Pt. presented to ED with several hour history of bloody stools and three diapers with blood and mucous in stool.  Parents believed that patient had experienced abdominal pain earlier, but it was improved on admission.  Abdomen soft, non-tender to palpation, bowel sounds hyperactive, frank blood noted in stool.  Barium enema done to rule out intussusception, negative.   Patient discharged to home.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC, RV1, HIBV, PPV, RV1
Symptoms: Haematochezia, Occult blood positive, Pyrexia, Urinary system X-ray, X-ray normal
Clinical narrative: This case was reported by a pharmacist (subject's mother) and described the occurrence of intussusception in a 9-week old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), Pneumococcal vaccine-unspecified and HIB vaccine (unspecified). On 11 September 2009 at 11:15 the subject received 1st dose of ROTARIX (oral); on 11 September 2009 the subject received unspecified dose of Pneumococcal vaccine-unspecified (unknown) and an unspecified dose of HIB vaccine (unspecified) (unknown). On 11 September 2009, less than one day after vaccination with HIB vaccine (unspecified), Pneumococcal vaccine-unspecified and ROTARIX, the subject experienced diarrhea and six days later was diagnosed with intussusception. Immunization series was discontinued. The subject received the ROTARIX vaccine on 11 September 2009. That same afternoon, the subject developed diarrhea. On the sixth day after receiving the ROTARIX vaccine, the subject began having bloody diarrhea. The subject was taken to the emergency room, but the reporter did not feel that the facility was properly equipped to treat an infant. The subject was taken early the next morning to the pediatrician who suspected intussusception. The subject has been treated by the pediatrician since that time. The subject has required treatment with a barium enema to correct the intussusception. It took four to five days for the bloody diarrhea to subside. However, this past Sunday and today, the subject has had more bloody diarrhea. The pharmacist considered intussusception and diarrhea were clinically significant (or requiring intervention). The subject was treated with Barium enema. At the time of reporting the intussusception and diarrhea were unresolved. The pharmacist considered the intussusception and diarrhea were probably related to vaccination with ROTARIX, Pneumococcal vaccine-unspecified and HIB vaccine (unspecified).  Emergency Department records received 10/12/09.  Date of Service:  9/19/09. Assessment:  Rectal bleeding. Pt. presented to ED with several hour history of bloody stools and three diapers with blood and mucous in stool.  Parents believed that patient had experienced abdominal pain earlier, but it was improved on admission.  Abdomen soft, non-tender to palpation, bowel sounds hyperactive, frank blood noted in stool.  Barium enema done to rule out intussusception, negative.   Patient discharged to home.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC, RV1, HIBV, PPV, RV1
Symptoms: Barium enema, Diarrhoea, Diarrhoea haemorrhagic
Clinical narrative: This case was reported by a pharmacist (subject's mother) and described the occurrence of intussusception in a 9-week old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), Pneumococcal vaccine-unspecified and HIB vaccine (unspecified). On 11 September 2009 at 11:15 the subject received 1st dose of ROTARIX (oral); on 11 September 2009 the subject received unspecified dose of Pneumococcal vaccine-unspecified (unknown) and an unspecified dose of HIB vaccine (unspecified) (unknown). On 11 September 2009, less than one day after vaccination with HIB vaccine (unspecified), Pneumococcal vaccine-unspecified and ROTARIX, the subject experienced diarrhea and six days later was diagnosed with intussusception. Immunization series was discontinued. The subject received the ROTARIX vaccine on 11 September 2009. That same afternoon, the subject developed diarrhea. On the sixth day after receiving the ROTARIX vaccine, the subject began having bloody diarrhea. The subject was taken to the emergency room, but the reporter did not feel that the facility was properly equipped to treat an infant. The subject was taken early the next morning to the pediatrician who suspected intussusception. The subject has been treated by the pediatrician since that time. The subject has required treatment with a barium enema to correct the intussusception. It took four to five days for the bloody diarrhea to subside. However, this past Sunday and today, the subject has had more bloody diarrhea. The pharmacist considered intussusception and diarrhea were clinically significant (or requiring intervention). The subject was treated with Barium enema. At the time of reporting the intussusception and diarrhea were unresolved. The pharmacist considered the intussusception and diarrhea were probably related to vaccination with ROTARIX, Pneumococcal vaccine-unspecified and HIB vaccine (unspecified).  Emergency Department records received 10/12/09.  Date of Service:  9/19/09. Assessment:  Rectal bleeding. Pt. presented to ED with several hour history of bloody stools and three diapers with blood and mucous in stool.  Parents believed that patient had experienced abdominal pain earlier, but it was improved on admission.  Abdomen soft, non-tender to palpation, bowel sounds hyperactive, frank blood noted in stool.  Barium enema done to rule out intussusception, negative.   Patient discharged to home.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, UNK, HPV4, MNQ
Symptoms: Anxiety, Blindness transient, Immediate post-injection reaction
Clinical narrative: Initial report was received 05 October 2009 from another manufacturer; report # WAES 0909USA04206. The initial reporter to this manufacturer had been health care professional. Verbatim from the report: "Information has been received from a physician concerning a 14 year old female patient with no drug reactions/allergies who was vaccinated IM with the first 0.5 ml dose of GARDASIL "approximately three years ago" in approximately September 2006. Concomitant therapies included MENACTRA and another vaccine (manufacturer unknown). Right after getting the vaccine the patient experienced anxiety and temporary loss of vision. The patient was at the office when it happened. There were no lab diagnostic studies performed. The physician told the patient to remain seated for 10 to 15 minutes and the patient recovered. Upon internal review, temporary loss of vision was determined to be an other important medical event. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available." Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Dizziness, Pruritus
Clinical narrative: Initial case received from a health care professional on 30 September 2009. A 12-year-old male patient experienced itching of his right arm and dizziness five minutes after receiving an intramuscular right deltoid first injection of Menactra (lot number U3011AA) and an intramuscular left deltoid first injection of Adacel (lot number C3098AA). The patient had a history of asthma, arthritis, ADHD (attention deficit and hyperactivity disorder), GERD (gastroesophageal reflux disease) and contact latex allergy. On 28 September, 2009, within five minutes of vaccination, he began scratching his right arm and also reported dizziness. The events subsequently resolved. He was not acutely ill at the time of the vaccinations, and had received five previous doses of DTaP. Concomitant medications included Concerta, Citalopram, Prevacid, Singulair, alcium, Ranitidine, Trazodone, ADVAIR DISKUS, HUMIRA, and Ketoprofen
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Dizziness, Fatigue, Gait disturbance, Headache
Clinical narrative: Extreme soreness at the injection site, but no redness, muscle weakness, dizzyness, joint pain, muscle aches, lowgrade fever (+ 2degrees), severe headache, and overwhelming exhaustion - difficulty walking. Lasted approximately 18 hours.  Peaked 4 hours after onset of symptoms. All symptoms gone by next evening except lingering fatigue and headache, and soreness at the injection site.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Extreme soreness at the injection site, but no redness, muscle weakness, dizzyness, joint pain, muscle aches, lowgrade fever (+ 2degrees), severe headache, and overwhelming exhaustion - difficulty walking. Lasted approximately 18 hours.  Peaked 4 hours after onset of symptoms. All symptoms gone by next evening except lingering fatigue and headache, and soreness at the injection site.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Rash pruritic
Clinical narrative: MY SON BROKE OUT IN WHAT APPEARED TO BE BUG BITES AND HE W AS REAL ITCHY THEN IT SPREAD FROM HIS NECK TO UNDERARMS CHEST SCALP STOMACH LEGS AND FEET
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chest X-ray, Chest discomfort, Chest pain, Cough
Clinical narrative: I started coughing a lot around 3:00p.m. After about thirty minutes of constant coughing I had trouble swallowing and I felt like something hard was stuck in my throat. I was drinking plenty of water not knowing what was causing the problem. Soon after I was getting dizzy and was having a difficult time breathing. My chest felt very tight and it was painful when I would take a deep breath. At this point I was weak and my eyes were red and swollen. I contacted my primary physician and I was told to take 25mg of Benadryl per mouth and to go to the nearest emergency room. I was unable to drive, my co-worker transported me to the hospital. When we arrived at hospital at approximately 4:15p.m. I was very weak, had a lot of chest pain, difficulty breathing and I had a difficult time walking due to the weakness I felt. I was immediately checked in the emergency room and they gave me a cortisone injection intramuscular. They had me under observation and took two radiographs of my chest. After several hours of observation I was released that same night. I was very tired and felt weak, still unable to drive myself home.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dysphagia, Dyspnoea, Eye swelling, Fatigue
Clinical narrative: I started coughing a lot around 3:00p.m. After about thirty minutes of constant coughing I had trouble swallowing and I felt like something hard was stuck in my throat. I was drinking plenty of water not knowing what was causing the problem. Soon after I was getting dizzy and was having a difficult time breathing. My chest felt very tight and it was painful when I would take a deep breath. At this point I was weak and my eyes were red and swollen. I contacted my primary physician and I was told to take 25mg of Benadryl per mouth and to go to the nearest emergency room. I was unable to drive, my co-worker transported me to the hospital. When we arrived at hospital at approximately 4:15p.m. I was very weak, had a lot of chest pain, difficulty breathing and I had a difficult time walking due to the weakness I felt. I was immediately checked in the emergency room and they gave me a cortisone injection intramuscular. They had me under observation and took two radiographs of my chest. After several hours of observation I was released that same night. I was very tired and felt weak, still unable to drive myself home.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Gait disturbance, Impaired driving ability, Ocular hyperaemia
Clinical narrative: I started coughing a lot around 3:00p.m. After about thirty minutes of constant coughing I had trouble swallowing and I felt like something hard was stuck in my throat. I was drinking plenty of water not knowing what was causing the problem. Soon after I was getting dizzy and was having a difficult time breathing. My chest felt very tight and it was painful when I would take a deep breath. At this point I was weak and my eyes were red and swollen. I contacted my primary physician and I was told to take 25mg of Benadryl per mouth and to go to the nearest emergency room. I was unable to drive, my co-worker transported me to the hospital. When we arrived at hospital at approximately 4:15p.m. I was very weak, had a lot of chest pain, difficulty breathing and I had a difficult time walking due to the weakness I felt. I was immediately checked in the emergency room and they gave me a cortisone injection intramuscular. They had me under observation and took two radiographs of my chest. After several hours of observation I was released that same night. I was very tired and felt weak, still unable to drive myself home.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Oropharyngeal pain, Pain, Palpitations
Clinical narrative: At 9:30 pm sudden onset of bad frequent cough. Cough stopped at 10:30. Woke up at 12:30 am with chills, fever, sore throat, racing heart, fast breathing, aches.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory rate increased
Clinical narrative: At 9:30 pm sudden onset of bad frequent cough. Cough stopped at 10:30. Woke up at 12:30 am with chills, fever, sore throat, racing heart, fast breathing, aches.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test normal, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Chills, Nauseas Fever severe headache
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Blood electrolytes normal, Chest X-ray normal, Cough, Culture urine negative
Clinical narrative: Began w/achy feeling in body then approx. 45 min later began to have severe stomach ache and nausea, at about 2:30 pm began to feel swelling in back of throat near soft palate and within 30min swelling traveled further down throat near adams apple area became very hoarse and harsh cough when trying to speak. Called 911/ Tx ED
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Full blood count normal, Influenza serology negative, Nausea, Pain
Clinical narrative: Began w/achy feeling in body then approx. 45 min later began to have severe stomach ache and nausea, at about 2:30 pm began to feel swelling in back of throat near soft palate and within 30min swelling traveled further down throat near adams apple area became very hoarse and harsh cough when trying to speak. Called 911/ Tx ED
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Pharyngeal oedema
Clinical narrative: Began w/achy feeling in body then approx. 45 min later began to have severe stomach ache and nausea, at about 2:30 pm began to feel swelling in back of throat near soft palate and within 30min swelling traveled further down throat near adams apple area became very hoarse and harsh cough when trying to speak. Called 911/ Tx ED
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood culture, C-reactive protein, Erythema, Full blood count, Hypokinesia
Clinical narrative: Approximately 36-48 hrs after vaccination, pt developed swelling and redness and tenderness of the left arm. Upon exam pt was found to have swelling and erythema of approx. 60-75% of his arm from the elbow up. Additionally his elbow was also swollen and had decreased ROM.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Approximately 36-48 hrs after vaccination, pt developed swelling and redness and tenderness of the left arm. Upon exam pt was found to have swelling and erythema of approx. 60-75% of his arm from the elbow up. Additionally his elbow was also swollen and had decreased ROM.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Welt approximately 50 cent size at site of injection. Instructed mother to use hydrocortisone cream at the site.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Eye irritation, Eye pain, Eyelid oedema, Lacrimation increased
Clinical narrative: R eye reactions redness, watery, irration, pain. -similiar reaction, in left eye-lighter reaction. -upper R eyelid was swollen. polydex-eyedrops, polydex ointment, cold compress 2 tylenol, benadryl 25 mgs. Some discomfort was able to sleep. ZADITOR-2 times day in eyes.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia
Clinical narrative: R eye reactions redness, watery, irration, pain. -similiar reaction, in left eye-lighter reaction. -upper R eyelid was swollen. polydex-eyedrops, polydex ointment, cold compress 2 tylenol, benadryl 25 mgs. Some discomfort was able to sleep. ZADITOR-2 times day in eyes.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pustule, Injection site swelling, Lymphadenopathy
Clinical narrative: Noticed onset of pain and swelling of upper arm with pustules at injection site, swollen lymph nodes in R supraclavicular area the morning after administration of vaccine. Pt presented to health services 2 days after vaccination. Tx: CEPHALEXIN and NSAIDS.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Meningitis
Clinical narrative: Information has been received from a physician and a medical student concerning an "about 60 year" old female patient with a history of splenectomy who on 10-AUG-2009 was vaccinated with the first dose of PNEUMOVAX 23. It was reported that on 30-SEP-2009 the patient was diagnosed with meningitis. The patient was hospitalized at an unspecified facility. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dizziness, Dyskinesia, Muscle spasms, Nausea
Clinical narrative: Information has been received from a certified medical assistant concerning a 16 year old female patient with no pertinent medical history and no known drug reactions who on 26-JUN-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# 662404/0312Y). On 26-AUG-2009 the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot# 662404/0312Y). There was no concomitant medication. On 19-SEP-2009 the patient developed "seizure-like activity, muscle spasms, shaking and neurological problems" after administration of GARDASIL. The patient was examined by a neurologist in the emergency room and was treated with muscle relaxers. The neurologist reported that the exam was difficult because the patient was in constant motion, flexing and extending her back. She also experiencing nausea and dizziness. The patient was not admitted to hospital. No laboratory diagnostics studies were performed. At the time of this report, the patient was recovering. Upon internal review, seizure-like activity was determined to be an other important medical event. Additional information has been requested.  10/26/09 Received medical records for DOS 9/22. DIAGNOSIS: Back spasms. Visit to ER after activity precipitated back spasms. Feeling of spasms in arms. PE neg except for erratic twitching movements. Spastic movement of torso. Strength 5+ UE/LE. No ataxia. Romberg (-). Treated in ER with Valium. SX resolved. Referred to neuro.  11/02/09 Medical records recievd for DOS 9/30-10/06. Neuro consult note:   Exhibits flexion at the abdomen and umbilicus with extension and semi-fluid movements. Torso movement only. Lasts up to 24 hrs and during sleep. Back discomfort. Neuro exam WNL.  Previous arm movement issue lasted 4 months and was ilicited by playing the drums. Resolved. Previous EEG WNL. Cardiac echo WNL. B/W unremarkable. Increased DNAse B antibody only. Possible conversion disorder. MRI BRain and spine WNL.  Improved with tx. Referred for counseling.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nervous system disorder, Tremor
Clinical narrative: Information has been received from a certified medical assistant concerning a 16 year old female patient with no pertinent medical history and no known drug reactions who on 26-JUN-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# 662404/0312Y). On 26-AUG-2009 the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot# 662404/0312Y). There was no concomitant medication. On 19-SEP-2009 the patient developed "seizure-like activity, muscle spasms, shaking and neurological problems" after administration of GARDASIL. The patient was examined by a neurologist in the emergency room and was treated with muscle relaxers. The neurologist reported that the exam was difficult because the patient was in constant motion, flexing and extending her back. She also experiencing nausea and dizziness. The patient was not admitted to hospital. No laboratory diagnostics studies were performed. At the time of this report, the patient was recovering. Upon internal review, seizure-like activity was determined to be an other important medical event. Additional information has been requested.  10/26/09 Received medical records for DOS 9/22. DIAGNOSIS: Back spasms. Visit to ER after activity precipitated back spasms. Feeling of spasms in arms. PE neg except for erratic twitching movements. Spastic movement of torso. Strength 5+ UE/LE. No ataxia. Romberg (-). Treated in ER with Valium. SX resolved. Referred to neuro.  11/02/09 Medical records recievd for DOS 9/30-10/06. Neuro consult note:   Exhibits flexion at the abdomen and umbilicus with extension and semi-fluid movements. Torso movement only. Lasts up to 24 hrs and during sleep. Back discomfort. Neuro exam WNL.  Previous arm movement issue lasted 4 months and was ilicited by playing the drums. Resolved. Previous EEG WNL. Cardiac echo WNL. B/W unremarkable. Increased DNAse B antibody only. Possible conversion disorder. MRI BRain and spine WNL.  Improved with tx. Referred for counseling.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site rash, Nausea, Pyrexia
Clinical narrative: Patient c/o localized rash at injection site, fever of 102.5, headache and nausea at 7pm the evening same day vaccine administered, treated with MOTRIN and BENADRYL - no SOB, cough, CP follow up with MD on 10/06/2009.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on back, stomach, legs, arms
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial report received on 28 September 2009 from an investigator in the above mentioned trial. A 67 year old male subject developed high grade fever on 22 September 2009 few hours after receiving an injection of FLUZONE SV 2009-2010 on 22 September 2009. The subject had a medical history of diabetes since 1999 and was on unspecified medication. On 22 September 2009, the subject returned to the site with fever of 101.9 degree Fahrenheit. The investigator referred the subject to the nearest emergency room. The subject received corrective treatment with Magnesium Oxide 400mg orally. The event high grade fever resolved the next day on 23 September 2009. According to the investigator, the event was related to the study vaccine. The serious adverse event did not lead to the termination of the subject from the study. No documents were held by the sender.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Condition aggravated, Diabetes mellitus
Clinical narrative: Initial report was received on 28 September 2009 from a health care professional. A 59-year-old male patient with a history of diabetes and high blood pressure had received an injection of FLUZONE SV 2009-2010, lot number U3184AA, (route and site of administration not reported) on 08 September 2009 and an unspecified amount of time later that same day, he developed higher blood sugar levels in the evening. According to the reporter, levels were "higher than usually are; running about 240". The patient had been taking ADACAN, "Metformin: and "Novalog" concomitantly and he had no concurrent illness and no known allergies. At the time of the report, the patient had not reported to their health care provider and their recovery status was unknown. Documents held by sender: None
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Body temperature increased, Lethargy, Oropharyngeal pain, Pain
Clinical narrative: Initial report received on 01 October 2009 from a consumer, who is a physician. A 48 year old female patient with no reported medical history developed a sore throat, low grade temperature of 99.3 orally, lethargy, and body aches one day after she received FLUZONE No preservative 2009-2010 (lot number U3173DA) intramuscularly in the left deltoid. The symptoms were severe enough to cause loss of work for a few days. The patient was improving, but not fully recovered. The patient reported that the same reaction occurred with a prior influenza vaccine (manufacturer was not provided) which was administered in the late 80's, early 90's. No further information was provided. List of Documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccine positive rechallenge
Clinical narrative: Initial report received on 01 October 2009 from a consumer, who is a physician. A 48 year old female patient with no reported medical history developed a sore throat, low grade temperature of 99.3 orally, lethargy, and body aches one day after she received FLUZONE No preservative 2009-2010 (lot number U3173DA) intramuscularly in the left deltoid. The symptoms were severe enough to cause loss of work for a few days. The patient was improving, but not fully recovered. The patient reported that the same reaction occurred with a prior influenza vaccine (manufacturer was not provided) which was administered in the late 80's, early 90's. No further information was provided. List of Documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Generalized aching, headache, fever.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV1
Symptoms: Crying, Dyspnoea
Clinical narrative: High pitch cry,difficult breathing.Has been hospitalised since then.  11/15 and 11/16/09 Medical records received. Multiple procedure results and ICD9 codes for date range 66/11-7/27.  Infant (approx4-5 months old) in resp failure of unknown etiology. Born at 32 weeks.  L basilar atelectasis. Muscle weakness. CVM titer high. Hematuria.  Endotracheal tube placement. Cytopath showed no viral inclusions. Many acute inflammatory cells.  ICD9 Codes: 789.0, 486.0, 789.3. 518.81 , 511.9, 765.1, 585.2, 348.0, 518.0, 486, 729.5, V50.02, V58.82, V58.81, 786.09, 406.0, 706.09786.05
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives reported all over his body. Took benadryl with relief.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Blood culture negative, Blood test, Chest X-ray normal, Computerised tomogram normal, Convulsion
Clinical narrative: Seizure where eyes rolled back and body became stiff for a minute. On around 8/01/09 I noted some righ arm twitching I wanted to inform the doctor about following the vaccine, then it became more of her whole body becoming jerky and then her first seizure. Admitted into the hospital the seizure were uncontrollable and changing and they  turned into ideopathic infantile spams. She was developing age appropriately prior to her first seizure, and now is delayed with loss of contol of her right side.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Culture urine negative, Developmental delay, Dyskinesia, Electroencephalogram, Gaze palsy
Clinical narrative: Seizure where eyes rolled back and body became stiff for a minute. On around 8/01/09 I noted some righ arm twitching I wanted to inform the doctor about following the vaccine, then it became more of her whole body becoming jerky and then her first seizure. Admitted into the hospital the seizure were uncontrollable and changing and they  turned into ideopathic infantile spams. She was developing age appropriately prior to her first seizure, and now is delayed with loss of contol of her right side.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Hemiparesis, Infantile spasms, Lumbar puncture, Lumbar puncture normal, Metabolic function test
Clinical narrative: Seizure where eyes rolled back and body became stiff for a minute. On around 8/01/09 I noted some righ arm twitching I wanted to inform the doctor about following the vaccine, then it became more of her whole body becoming jerky and then her first seizure. Admitted into the hospital the seizure were uncontrollable and changing and they  turned into ideopathic infantile spams. She was developing age appropriately prior to her first seizure, and now is delayed with loss of contol of her right side.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Muscle twitching, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain abnormal, Urine analysis
Clinical narrative: Seizure where eyes rolled back and body became stiff for a minute. On around 8/01/09 I noted some righ arm twitching I wanted to inform the doctor about following the vaccine, then it became more of her whole body becoming jerky and then her first seizure. Admitted into the hospital the seizure were uncontrollable and changing and they  turned into ideopathic infantile spams. She was developing age appropriately prior to her first seizure, and now is delayed with loss of contol of her right side.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: pH body fluid
Clinical narrative: Seizure where eyes rolled back and body became stiff for a minute. On around 8/01/09 I noted some righ arm twitching I wanted to inform the doctor about following the vaccine, then it became more of her whole body becoming jerky and then her first seizure. Admitted into the hospital the seizure were uncontrollable and changing and they  turned into ideopathic infantile spams. She was developing age appropriately prior to her first seizure, and now is delayed with loss of contol of her right side.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Dysstasia, Eye pain
Clinical narrative: Fever, body aches, soreness and some swelling at injection site; by 9:00 sore eyes, light flashes before eyes, weakness, dizziness with difficulty standing upright; by 3:00 am fever diminished, with drenching sweat, mild stomachache; by 7:00 am all symptoms gone except sore arm and mild stomachache.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Hyperhidrosis, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever, body aches, soreness and some swelling at injection site; by 9:00 sore eyes, light flashes before eyes, weakness, dizziness with difficulty standing upright; by 3:00 am fever diminished, with drenching sweat, mild stomachache; by 7:00 am all symptoms gone except sore arm and mild stomachache.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Visual impairment
Clinical narrative: Fever, body aches, soreness and some swelling at injection site; by 9:00 sore eyes, light flashes before eyes, weakness, dizziness with difficulty standing upright; by 3:00 am fever diminished, with drenching sweat, mild stomachache; by 7:00 am all symptoms gone except sore arm and mild stomachache.
Age: 1.08
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL, FLU3, HEPA, MMR, VARCEL
Symptoms: Dysstasia, Gait disturbance, Pain in extremity
Clinical narrative: MOM CALLED OFFICE STATING HE WOULD NOT STAND OR WALK, PAIN IN LEGS. NO BRUISING OR SWELLING, WAS SEEN IN OFFIC ON 10/9/09 AND NO TREATMENT GIVEN
Age: 1.08
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL, FLU3, HEPA, MMR, VARCEL
Symptoms: Abasia, Crying, Muscle strain, Pyrexia
Clinical narrative: MOM CALLED OFFICE STATING HE WOULD NOT STAND OR WALK, PAIN IN LEGS. NO BRUISING OR SWELLING, WAS SEEN IN OFFIC ON 10/9/09 AND NO TREATMENT GIVEN
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin reaction
Clinical narrative: SKIN REACTION, ERYTHEMA 8CM X 7 1/2CM, NO SIGN INDURATION, NOT PAINFUL, NOT ITCHING
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: edema and redness at injection site, seen on 10/9/2009 and gevin keflex, and told to continue Bendryal
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Eye patch application, Strabismus
Clinical narrative: Parent reports new onset of esotropia. Diagnosis confirmed by pediatric opthamologist-patching of eye began 9/1/2009.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: The patient got a flu vaccine last night and now has significant edema and erythema of his left upper arm.  His brother had a flu vaccine two days before and also had significant erythema and edema.  It has started to go down with Benadryl and cephalexin.  The patient has also had a previous episode of erythema and edema with a vaccination, which was thought to be the polio vaccine.  This same sort of symptoms were present for that. We discussed the ingredients of the flu vaccine and at this point, I do not know what he specifically had that could have caused a reaction.  He has had eggs before and it is unlikely that this is a reaction to eggs.  However, I do not want him to get the injectable flu vaccine any more.  He has had FluMist vaccines in the past.  We will record this as an adverse reaction.  Benadryl is the best thing in the meantime for edema and they will call if it is persisting.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Abasia, Asthenia, Back pain, Blood test normal, CSF test normal
Clinical narrative: Felt tingling of legs that slowly progressed to weakening of her legs. By later that day patient was unable to walk. Brought to hospital and admitted with workup diagnosed as Transverse Myelitis
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Constipation, Culture urine positive, Diplegia, Erythema multiforme, HIV test negative
Clinical narrative: Felt tingling of legs that slowly progressed to weakening of her legs. By later that day patient was unable to walk. Brought to hospital and admitted with workup diagnosed as Transverse Myelitis
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Hepatitis viral test, Herpes simplex serology negative, Hypotonia, Incontinence, Laboratory test normal
Clinical narrative: Felt tingling of legs that slowly progressed to weakening of her legs. By later that day patient was unable to walk. Brought to hospital and admitted with workup diagnosed as Transverse Myelitis
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Lumbar puncture normal, Muscular weakness, Mycoplasma infection, Mycoplasma serology positive, Myelitis transverse
Clinical narrative: Felt tingling of legs that slowly progressed to weakening of her legs. By later that day patient was unable to walk. Brought to hospital and admitted with workup diagnosed as Transverse Myelitis
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Neurogenic bladder, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Felt tingling of legs that slowly progressed to weakening of her legs. By later that day patient was unable to walk. Brought to hospital and admitted with workup diagnosed as Transverse Myelitis
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Ulcer, Urinary tract infection, Urine analysis normal, Viral test negative, Walking disability
Clinical narrative: Felt tingling of legs that slowly progressed to weakening of her legs. By later that day patient was unable to walk. Brought to hospital and admitted with workup diagnosed as Transverse Myelitis
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hyperhidrosis, Injection site erythema, Pallor, Pruritus
Clinical narrative: Employee began to develop pruritus without rash.  Began feeling weak and sweaty.  She started shaking and was reported to become extremely pale.  Felt she was going to pass out.  Was assisted in lying down.  Rested for about one hour and was driven home where she went to bed for the remainder of the night.  Feels her usual self this morning except for a new area of erythema distal to the injection site.  Area not indurated or excessively tender or warm to touch.  Warm pack applied and advised to see MD if area worsens.  Possible cellulitis.