chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cold compress therapy, Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid-swelling with redness. Parent advised to given Children's Motrin as needed and also apply an ice pack to deltoid.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Contraindication to vaccination
Clinical narrative: was given Prevnar. His age is contraindicated
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site induration, Lymphocyte count increased, Monocyte count increased, Penis disorder, Red blood cell sedimentation rate normal
Clinical narrative: Approx 18-24 hrs after vaccines given at courthouse, presented to ER with purple/blue penis and feet; purplish color noted by ER MD. Transient and resolved in ER. WBC 21,000 - 495, 35 lymph, 13 Mono; Atypical lymphs; ESR - 30; Mom saw peds next day - one more episode since ER. Saw MD 4/3, all labs repeated and normal. Left leg with induration but no swelling/cellulitis around injection sites. No fever.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: White blood cell count increased
Clinical narrative: Approx 18-24 hrs after vaccines given at courthouse, presented to ER with purple/blue penis and feet; purplish color noted by ER MD. Transient and resolved in ER. WBC 21,000 - 495, 35 lymph, 13 Mono; Atypical lymphs; ESR - 30; Mom saw peds next day - one more episode since ER. Saw MD 4/3, all labs repeated and normal. Left leg with induration but no swelling/cellulitis around injection sites. No fever.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site pain
Clinical narrative: Pt reported headache, "chattering teeth," soreness at injection site (left deltoid) and soreness extended to left elbow
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: CSF culture negative, CSF test abnormal, CSF white blood cell count increased, Lumbar puncture, Medication error
Clinical narrative: Patient received 1st anthrax vaccination on 4/18/2007.  Vaccination notable for attempted vaccination with frozen vaccine, then vaccinated with new syringe without difficulty.  Patient developed neck and trapezius stiffness on side of injection within 12 hours.  Treated with Toradol 30 mg IM then Motrin and oral narcotic.  Developed photophobia and fever to 102 on 4/26/2007 (8 days after vaccination). LP performed; patient admitted to hospital for IV ceftriaxone and IV vancomycin until culture was negative for bacteria for 48 hrs. 7/20/07 Received medical records from reporter which reveal patient had neck pain & right shoulder pain on 4/19/07. DX w/ neck sprain secondary to injection trauma & muscle spasm.  Received injection for pain & trigger point injection scheduled.  RTC on 4/26/07 for fever of 102, spine pain, headache, photophobia & rash at injection site. DX w/aseptic menintitis & admitted 4/26-4/30/07.  TX w/ IV antibiotics & pain meds.  Progressed well & d/c after 72 hrs of antibiotics & neg cultures.  No meds at d/c. FINAL DX: Aseptic Meningitis & post anthrax myalgia.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Musculoskeletal stiffness, Photophobia, Pyrexia, Red blood cells CSF positive
Clinical narrative: Patient received 1st anthrax vaccination on 4/18/2007.  Vaccination notable for attempted vaccination with frozen vaccine, then vaccinated with new syringe without difficulty.  Patient developed neck and trapezius stiffness on side of injection within 12 hours.  Treated with Toradol 30 mg IM then Motrin and oral narcotic.  Developed photophobia and fever to 102 on 4/26/2007 (8 days after vaccination). LP performed; patient admitted to hospital for IV ceftriaxone and IV vancomycin until culture was negative for bacteria for 48 hrs. 7/20/07 Received medical records from reporter which reveal patient had neck pain & right shoulder pain on 4/19/07. DX w/ neck sprain secondary to injection trauma & muscle spasm.  Received injection for pain & trigger point injection scheduled.  RTC on 4/26/07 for fever of 102, spine pain, headache, photophobia & rash at injection site. DX w/aseptic menintitis & admitted 4/26-4/30/07.  TX w/ IV antibiotics & pain meds.  Progressed well & d/c after 72 hrs of antibiotics & neg cultures.  No meds at d/c. FINAL DX: Aseptic Meningitis & post anthrax myalgia.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Abnormal faeces, Decreased appetite, Diarrhoea, Irritability, Muscle spasms
Clinical narrative: PATIENT EXPERIENCING DECREASED APPETITE AND FUSSINESS OFF/ON X 2 DAYS, THEN UP TO 12 LOOSE SMELLY STOOLS IN 24 HOURS. NO VOMITING SOME CRAMPING NO FEVER
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Tinnitus
Clinical narrative: I recieved the vaccination on Wednesday afternoon.  Thursday morning I woke up with a constant ringing in my left ear, which intensified when others spoke to me but diminished when there was silence.  I have never experienced anything of the sort and so I waited to see if it would regress.  It is now Saturday and it is still the same.  I don't know if I should see a doctor or if I should just wait to see if it goes away over the course of a month or two.  Please advise.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Oedema peripheral, Rash generalised, Rash macular
Clinical narrative: Vaccine administered on 4/26/07.  Developed left arm swelling, redness and tenderness.  4/28/07 visited ER for increasing redness, swelling and tenderness.  No fever, no resp. distress.  Given Clindamycin and discharged with dx of cellulitis.  Returned to ER 4/29/07 with whole body rash, pedal edema, increased left arm swelling, urticaria.  Rash was macular, warm, tender, and erythematous.  No resp. distress, no mucosal lesions.  Given Benadryl and 2 mg/kg of Orapred.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Skin warm, Tenderness, Urticaria
Clinical narrative: Vaccine administered on 4/26/07.  Developed left arm swelling, redness and tenderness.  4/28/07 visited ER for increasing redness, swelling and tenderness.  No fever, no resp. distress.  Given Clindamycin and discharged with dx of cellulitis.  Returned to ER 4/29/07 with whole body rash, pedal edema, increased left arm swelling, urticaria.  Rash was macular, warm, tender, and erythematous.  No resp. distress, no mucosal lesions.  Given Benadryl and 2 mg/kg of Orapred.
Sex: M
Vaccine: MMR
Symptoms: Feeling abnormal, Pain, Rash
Clinical narrative: Pt received the MMR vaccine on 4/3/07, the next day he returned to employee health complaining of a rash, achiness and feeling poorly. He was seen by the occupational med physician and treated with Allegra. He was told to return to work and no further follow up was needed.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Computerised tomogram abnormal, Condition aggravated, Echocardiogram, Electrocardiogram ambulatory abnormal, Exercise electrocardiogram
Clinical narrative: Heart palpitations (PAC); perpetual, severe rhinitis, fatigue, worsening insomnia.  7/17/07 Received medical records which reveal patient experienced palpitations upon awakening 11/17/06.  Seen in ER that day & d/c to home.  Holter monitor done 11/22/06 revealed 1 PVC & occasional PACs.  Cardiology consult done 11/28/06 revealed patient w/high anxiety& no treatable cardiac disease.  FINAL DX: palpitations & anxiety.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Insomnia, Palpitations, Rhinitis, Supraventricular extrasystoles
Clinical narrative: Heart palpitations (PAC); perpetual, severe rhinitis, fatigue, worsening insomnia.  7/17/07 Received medical records which reveal patient experienced palpitations upon awakening 11/17/06.  Seen in ER that day & d/c to home.  Holter monitor done 11/22/06 revealed 1 PVC & occasional PACs.  Cardiology consult done 11/28/06 revealed patient w/high anxiety& no treatable cardiac disease.  FINAL DX: palpitations & anxiety.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Chills, Deafness unilateral, Dizziness, Dry mouth
Clinical narrative: Information has been received from a physician concerning a 30-year-old female with no pre-existing physician diagnosed allergies, birth defects, or medical conditions who on 03-APR-2006 at 1PM (also reported as 05-MAR-2006) was vaccinated in the left arm with a first dose of Varivax (Lot # 649740/0221R) because she had a negative VZV titer. There was no illness at the time of vaccination. There were no concomitant  medications. On 06-MAR-2006, the following day, the patient developed fever, chills, arthralgia, and an earache. On 07-MAR-2006, two days post vaccination, she developed dry mouth and dizziness. On 08-MAR-2006, three days post vaccination, she developed ringing in her ears and a half dozen vesicular lesions around her left ear. She was noted to have decreased hearing and some facial weakness. She was diagnosed as having Ramsay-Hunt Syndrome. The hearing has improved, but she still has some minor facial weakness. Follow up information received from a physician indicated that on 03-APR-2006 at 8PM, the patient developed a fever, myalgias/arthralgias, left Bell's palsy, left hearing loss, and tinnitus. An audiogram showed mild left hearing loss. The patient was treated with acyclovir. The patient developed Ramsay-Hunt syndrome and was treated with corticosteroids. The event was considered to be disabling. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Ear pain, Facial palsy, Facial paresis, Herpes zoster oticus, Hypoacusis
Clinical narrative: Information has been received from a physician concerning a 30-year-old female with no pre-existing physician diagnosed allergies, birth defects, or medical conditions who on 03-APR-2006 at 1PM (also reported as 05-MAR-2006) was vaccinated in the left arm with a first dose of Varivax (Lot # 649740/0221R) because she had a negative VZV titer. There was no illness at the time of vaccination. There were no concomitant  medications. On 06-MAR-2006, the following day, the patient developed fever, chills, arthralgia, and an earache. On 07-MAR-2006, two days post vaccination, she developed dry mouth and dizziness. On 08-MAR-2006, three days post vaccination, she developed ringing in her ears and a half dozen vesicular lesions around her left ear. She was noted to have decreased hearing and some facial weakness. She was diagnosed as having Ramsay-Hunt Syndrome. The hearing has improved, but she still has some minor facial weakness. Follow up information received from a physician indicated that on 03-APR-2006 at 8PM, the patient developed a fever, myalgias/arthralgias, left Bell's palsy, left hearing loss, and tinnitus. An audiogram showed mild left hearing loss. The patient was treated with acyclovir. The patient developed Ramsay-Hunt syndrome and was treated with corticosteroids. The event was considered to be disabling. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Myalgia, Pyrexia, Rash vesicular, Skin lesion, Tinnitus
Clinical narrative: Information has been received from a physician concerning a 30-year-old female with no pre-existing physician diagnosed allergies, birth defects, or medical conditions who on 03-APR-2006 at 1PM (also reported as 05-MAR-2006) was vaccinated in the left arm with a first dose of Varivax (Lot # 649740/0221R) because she had a negative VZV titer. There was no illness at the time of vaccination. There were no concomitant  medications. On 06-MAR-2006, the following day, the patient developed fever, chills, arthralgia, and an earache. On 07-MAR-2006, two days post vaccination, she developed dry mouth and dizziness. On 08-MAR-2006, three days post vaccination, she developed ringing in her ears and a half dozen vesicular lesions around her left ear. She was noted to have decreased hearing and some facial weakness. She was diagnosed as having Ramsay-Hunt Syndrome. The hearing has improved, but she still has some minor facial weakness. Follow up information received from a physician indicated that on 03-APR-2006 at 8PM, the patient developed a fever, myalgias/arthralgias, left Bell's palsy, left hearing loss, and tinnitus. An audiogram showed mild left hearing loss. The patient was treated with acyclovir. The patient developed Ramsay-Hunt syndrome and was treated with corticosteroids. The event was considered to be disabling. Additional information has been requested.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound scan
Clinical narrative: Information has been received from the regulatory agency through the government  concerning a 12 week old female with no medical history or allergies who on 19-MAR-2007 was vaccinated with a first PO dose of Rotateq. Concomitant vaccination administered that day included a IM dose of Pediarix (lot # AC21B069AA), and IM dose of Acthib (lot # UF063AA) and a dose of Prevnar (lot # B08672E). On 27-MAR-2007 the patient experienced intussusception and was hospitalized. On 27-MAR-2007 the patient underwent and ultrasound which had findings consistent with and intussusception. It was reportedly most likely ileal colonic and extended at least to the mis transverse colon. There was a small amount of abdominal ascites. There was no pyloric stenosis. And air reduction was performed. The pressure was maintained between 80 and 120 mm Hg. The intussusception was initially in the proximal transverse colon and immediately reduced to the cecum. However the final reduction could not be achieved despite multiple attempts. At that point anesthesis was called and the patient was intubated and sedated. Repeat insufitation resulted in fairly immediately reduction in the rematin intussusception with filing of the small bowel. The physician could not identify the terminal ileum but there was clear fill of the small bowel. The intussusception was successfully reduced. The patient recovered from intussusception. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information has been requested.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ascites, Intubation, Intussusception, Large intestinal obstruction reduction, Sedation
Clinical narrative: Information has been received from the regulatory agency through the government  concerning a 12 week old female with no medical history or allergies who on 19-MAR-2007 was vaccinated with a first PO dose of Rotateq. Concomitant vaccination administered that day included a IM dose of Pediarix (lot # AC21B069AA), and IM dose of Acthib (lot # UF063AA) and a dose of Prevnar (lot # B08672E). On 27-MAR-2007 the patient experienced intussusception and was hospitalized. On 27-MAR-2007 the patient underwent and ultrasound which had findings consistent with and intussusception. It was reportedly most likely ileal colonic and extended at least to the mis transverse colon. There was a small amount of abdominal ascites. There was no pyloric stenosis. And air reduction was performed. The pressure was maintained between 80 and 120 mm Hg. The intussusception was initially in the proximal transverse colon and immediately reduced to the cecum. However the final reduction could not be achieved despite multiple attempts. At that point anesthesis was called and the patient was intubated and sedated. Repeat insufitation resulted in fairly immediately reduction in the rematin intussusception with filing of the small bowel. The physician could not identify the terminal ileum but there was clear fill of the small bowel. The intussusception was successfully reduced. The patient recovered from intussusception. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information has been requested.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Small intestinal intussusception reduction, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from the regulatory agency through the government  concerning a 12 week old female with no medical history or allergies who on 19-MAR-2007 was vaccinated with a first PO dose of Rotateq. Concomitant vaccination administered that day included a IM dose of Pediarix (lot # AC21B069AA), and IM dose of Acthib (lot # UF063AA) and a dose of Prevnar (lot # B08672E). On 27-MAR-2007 the patient experienced intussusception and was hospitalized. On 27-MAR-2007 the patient underwent and ultrasound which had findings consistent with and intussusception. It was reportedly most likely ileal colonic and extended at least to the mis transverse colon. There was a small amount of abdominal ascites. There was no pyloric stenosis. And air reduction was performed. The pressure was maintained between 80 and 120 mm Hg. The intussusception was initially in the proximal transverse colon and immediately reduced to the cecum. However the final reduction could not be achieved despite multiple attempts. At that point anesthesis was called and the patient was intubated and sedated. Repeat insufitation resulted in fairly immediately reduction in the rematin intussusception with filing of the small bowel. The physician could not identify the terminal ileum but there was clear fill of the small bowel. The intussusception was successfully reduced. The patient recovered from intussusception. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information has been requested.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ascites, Barium double contrast, Intubation, Intussusception, Sedation
Clinical narrative: Information has been received from the regulatory agency through the government  concerning a 12 week old female with no medical history or allergies who on 19-MAR-2007 was vaccinated with a first PO dose of Rotateq. Concomitant vaccination administered that day included a IM dose of Pediarix (lot # AC21B069AA), and IM dose of Acthib (lot # UF063AA) and a dose of Prevnar (lot # B08672E). On 27-MAR-2007 the patient experienced intussusception and was hospitalized. On 27-MAR-2007 the patient underwent and ultrasound which had findings consistent with and intussusception. It was reportedly most likely ileal colonic and extended at least to the mis transverse colon. There was a small amount of abdominal ascites. There was no pyloric stenosis. And air reduction was performed. The pressure was maintained between 80 and 120 mm Hg. The intussusception was initially in the proximal transverse colon and immediately reduced to the cecum. However the final reduction could not be achieved despite multiple attempts. At that point anesthesis was called and the patient was intubated and sedated. Repeat insufitation resulted in fairly immediately reduction in the rematin intussusception with filing of the small bowel. The physician could not identify the terminal ileum but there was clear fill of the small bowel. The intussusception was successfully reduced. The patient recovered from intussusception. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information has been requested.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound scan abnormal
Clinical narrative: Information has been received from the regulatory agency through the government  concerning a 12 week old female with no medical history or allergies who on 19-MAR-2007 was vaccinated with a first PO dose of Rotateq. Concomitant vaccination administered that day included a IM dose of Pediarix (lot # AC21B069AA), and IM dose of Acthib (lot # UF063AA) and a dose of Prevnar (lot # B08672E). On 27-MAR-2007 the patient experienced intussusception and was hospitalized. On 27-MAR-2007 the patient underwent and ultrasound which had findings consistent with and intussusception. It was reportedly most likely ileal colonic and extended at least to the mis transverse colon. There was a small amount of abdominal ascites. There was no pyloric stenosis. And air reduction was performed. The pressure was maintained between 80 and 120 mm Hg. The intussusception was initially in the proximal transverse colon and immediately reduced to the cecum. However the final reduction could not be achieved despite multiple attempts. At that point anesthesis was called and the patient was intubated and sedated. Repeat insufitation resulted in fairly immediately reduction in the rematin intussusception with filing of the small bowel. The physician could not identify the terminal ileum but there was clear fill of the small bowel. The intussusception was successfully reduced. The patient recovered from intussusception. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Intussusception
Clinical narrative: Information has been received from the regulatory agency through the government concerning a 24 week old female with no medical history or allergies who on 16-FEB-2007 was vaccinated with a PO second dose of Rotateq. Concomitant vaccination administered that day included an IM second dose of Pediarix (lot # AC21B070AA), an IM second dose of Acthib (lot # UF051AA) and an IM second dose of Prevnar (lot # B018646F). There was no illness at the time of vaccination. On 09-APR-2007 the patient presented with bloody diarrhea and was diagnosed with intussusception which was surgically reduced. It was reported that there was no known association. The patient recovered. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Intussusception, Surgery
Clinical narrative: Information has been received from the regulatory agency through the government concerning a 24 week old female with no medical history or allergies who on 16-FEB-2007 was vaccinated with a PO second dose of Rotateq. Concomitant vaccination administered that day included an IM second dose of Pediarix (lot # AC21B070AA), an IM second dose of Acthib (lot # UF051AA) and an IM second dose of Prevnar (lot # B018646F). There was no illness at the time of vaccination. On 09-APR-2007 the patient presented with bloody diarrhea and was diagnosed with intussusception which was surgically reduced. It was reported that there was no known association. The patient recovered. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Blister, Oral intake reduced, Pallor, Pyrexia, Rash
Clinical narrative: Low grade fever, decreased oral intake and rash about 12d after vaccine blanching papular rash in crop - 1 mm papules on trunk and arms. - vesicles - crusting, + vesicles and papules in posterior pharynx
Age: 1.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Rash papular
Clinical narrative: Low grade fever, decreased oral intake and rash about 12d after vaccine blanching papular rash in crop - 1 mm papules on trunk and arms. - vesicles - crusting, + vesicles and papules in posterior pharynx
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Convulsion, Pyrexia
Clinical narrative: Per report (patient has switched PMD) patient began with seizure after 4 mo old shots (1st seizure with fever by report, following seizures not with fever pervious MD).
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Diabetes mellitus, Dyspnoea, Gait disturbance, Malaise, Palpitations
Clinical narrative: Administered about Noon 4-26-07 by 6am 4-27-07 raging fever 1004.5, heart palpitations, difficulty breathing or walking. Called MD told if necessary go to ER - felt too sick to drag self to ER. Fever broke around 11PM 4-27-07 down to 101.5 F. Mild fever all day 4-28-07. Diabetes out of control still.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Administered about Noon 4-26-07 by 6am 4-27-07 raging fever 1004.5, heart palpitations, difficulty breathing or walking. Called MD told if necessary go to ER - felt too sick to drag self to ER. Fever broke around 11PM 4-27-07 down to 101.5 F. Mild fever all day 4-28-07. Diabetes out of control still.
Age: 27.0
Sex: F
Vaccine: IPV, YF
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Client call 3 hrs post inj of IPV and Yellow Fever, and C/o dizziness and heart rate 100 beats/min. Denies any other symptoms. Nurse advised client to f/u with PCP, lay down with bilat LE above her heart and to increase fluids. Clients symptoms were resolved x 1 hr after resting and increase of fluids. Client followed up with PCP and no visit necessary.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Chest discomfort, Hypersensitivity, Rhinorrhoea, Sneezing
Clinical narrative: At travel clinic about 10 min after yellow fever vaccine pt started having frequent sneezing and nasal discharge (clear-color), sx continued about 20 min later though "chest felt a little tight, breath sounds clear with good air movement, pt walked to clinic where given IM Benadryl, epinephrine and Solu Medrol. Sent to ER, Pt given IV Tagamet. Discharge with DX allergic reaction.
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Angiogram, Headache, Lumbar puncture, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: Initial report received on 17 April 2007 from a health care professional. An unidentified female patient, whose medical history was not provided, had received a dose of YF-VAX vaccine on an unspecified date. The lot number, route and site of administration were not provided. At an unspecified amount of this later, the patient developed a "low grade fever" (temperature reading not provided) that subsequently resolved; and a headache. "In a few days", the patient was admitted to the hospital for twenty-four hour observation due to fever (temperature not provided). A spinal tap, MRI, and MRA were negative. Laboratory testing was not provided. It was reported that the patient's headache continued to persist two weeks after the administration of the vaccine. At the time of this report, the patient had not recovered.
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Angiogram, Headache, Lumbar puncture, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Initial report received on 17 April 2007 from a health care professional. An unidentified female patient, whose medical history was not provided, had received a dose of YF-VAX vaccine on an unspecified date. The lot number, route and site of administration were not provided. At an unspecified amount of this later, the patient developed a "low grade fever" (temperature reading not provided) that subsequently resolved; and a headache. "In a few days", the patient was admitted to the hospital for twenty-four hour observation due to fever (temperature not provided). A spinal tap, MRI, and MRA were negative. Laboratory testing was not provided. It was reported that the patient's headache continued to persist two weeks after the administration of the vaccine. At the time of this report, the patient had not recovered.
Age: 42.0
Sex: M
Vaccine: TYP
Symptoms: Dyspnoea
Clinical narrative: Initial report received on 18 April 2007 from a physician. A 42-year--old male patient, with no concurrent illnesses, and who had no known drug allergies, had received a dose of Tuberculin PPD, (Manufacturer not provided), and a dose of Typhim Vi vaccine on 17 April 2007. The lot numbers, routes and sites of administration were not provided for either vaccines. The following day, the patient contacted the physician by telephone and reported having difficulty breathing. The patient described it as "mild difficulty with deep inspiration." The patient reported no fever or pain at that time. The patient was going to be evaluated in the physician's office, but the evaluation of that visit was not reported. Per the reporter, the patient had received previous doses of both vaccines, but did not report how many other doses had been received. It was not reported whether any adverse events had occurred with those previous vaccinations. At the time of this report, the patient had not recovered.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated PO with a third dose of Rotateq. Subsequently, about a month after vaccination, the patient experienced intussusception. It was noted that the patient had surgery, but no additional information was available. There was no product quality complaint. Intussusception was considered to be immediately life-threatening and disabling and an other important medical event. Additional information has been requested. 05/02/07-records received for DOS 04/15-04/17/07-DC DX:Intussusception. Presented with sudden onset of emesis and bloody stool. Barium enema and attempt to reduce radiologiclly was unsuccessful. Surgery laprascopic reduction and appendectomy.
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a male patient (age not reported) who on unspecified date was vaccinated with a second dose of Rotateq (Lot # not reported). On 26-MAR-2007 the patient experienced hematochezia. The patient sought unspecified medical attention. Subsequently, the patient recovered from hematochezia. There was no product quality complaint involved. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a patient (age and sex not reported) who on an unspecified date was vaccinated with Rotateq (unknown how many doses of the vaccine the patient received). On 24-APR-2007, the patient experienced intussusception and was admitted to the hospital. The patient had surgery to remedy the situation. The reporter felt that intussusception was not related to therapy with Rotateq. Intussusception was considered to be immediately life-threatening and other important medical event. No further information was available from physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Bruxism, Computerised tomogram normal, Cystitis, Deafness
Clinical narrative: Information has been received from a female consumer who on 30-JAN-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included hormone replacement therapy and "standard medications." Ten days later vaccination, on 09-FEB-2007 the patient was experiencing vertigo, hearing loss and tendonitis. The patient stated that she had to go to the emergency room and get an MRI and CT scan and that she has seen her doctor many times. There was no product quality complaint involved. Additional information was received from the physician. A 60 year old white female with allergies to penicillin, sulfa, cefixime (SUPRAX), levofloxacin (LEVAQUIN), metronidazole (FLAGYL), cefdinir (OMNICEF), ramelton (ROZEREM), duloxetine hydrochloride (CYMBALTA) and doxycycline, was vaccinated with a dose of Zostavax on 30-JAN-2007. On 06-FEB-2007 the patient's ears were plugged "ETD". on 08-FEB-2007 the patient developed cystitis and was treated with azithromycin (Z-PAK), phenazopyridine hydrochloride (PYRIDIUM) and fluconazole (DIFLUCAN). On 20-FEB-2007 the patient was diagnosed with sinusitis and was treated with clarithromycin (BIAXIN), fluticasone propionate (FLONASE), guaifenesin (MUCINEX), acetaminophen (+) propoxyphene napsylate (DARVOCET-N) and "ETD.". On 27-FEB-2007 the patient's prescription was changed to gemifloxacin mesylate (FACTIVE). On 01-MAR-2007 the patient saw an ENT and it was noted that her left arm was blocked, the patient was treated with prednisone. On 04-MAR-2007 the patient fainted at the gym 1 1/2 hours after steam and the patient was dizzy. The patient presented to the ER where a CT scan was "negative." It was reported that since 04-MAR-2007 the patient has been bedridden with dizziness. The patient was again seen on 20-MAR-2007 and ENT had done an MRI which showed that the acoustic nerve was "OK." It was reported that the patient is now with hearing loss, tinnitus and dizziness being treated with hydrochlorothiazide (+)  triamterene (DYAZIDE). Subsequently the patient developed facial pains and was diagnosed with a dental abscess and treated with clindamycin, then ciprofloxacin hydrochloride (CIPRO) and now a mouth piece for teeth grinding. The hydrochlorothiazide (+) trimaterene (DYAZIDE) was stopped and the patient developed severe incapacitating vertigo x 3 days. At the time of the report the patient had some improvement with dizziness, it was possible that her hearing loss was less and she still had tinnitus. The patient had a hearing test with her ENT which showed left hearing loss. At the time of the report the patient had not recovered. No further information was provided. The patient's events were considered disabiling/incapacitating. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Ear discomfort, Facial pain, Limb discomfort, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a female consumer who on 30-JAN-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included hormone replacement therapy and "standard medications." Ten days later vaccination, on 09-FEB-2007 the patient was experiencing vertigo, hearing loss and tendonitis. The patient stated that she had to go to the emergency room and get an MRI and CT scan and that she has seen her doctor many times. There was no product quality complaint involved. Additional information was received from the physician. A 60 year old white female with allergies to penicillin, sulfa, cefixime (SUPRAX), levofloxacin (LEVAQUIN), metronidazole (FLAGYL), cefdinir (OMNICEF), ramelton (ROZEREM), duloxetine hydrochloride (CYMBALTA) and doxycycline, was vaccinated with a dose of Zostavax on 30-JAN-2007. On 06-FEB-2007 the patient's ears were plugged "ETD". on 08-FEB-2007 the patient developed cystitis and was treated with azithromycin (Z-PAK), phenazopyridine hydrochloride (PYRIDIUM) and fluconazole (DIFLUCAN). On 20-FEB-2007 the patient was diagnosed with sinusitis and was treated with clarithromycin (BIAXIN), fluticasone propionate (FLONASE), guaifenesin (MUCINEX), acetaminophen (+) propoxyphene napsylate (DARVOCET-N) and "ETD.". On 27-FEB-2007 the patient's prescription was changed to gemifloxacin mesylate (FACTIVE). On 01-MAR-2007 the patient saw an ENT and it was noted that her left arm was blocked, the patient was treated with prednisone. On 04-MAR-2007 the patient fainted at the gym 1 1/2 hours after steam and the patient was dizzy. The patient presented to the ER where a CT scan was "negative." It was reported that since 04-MAR-2007 the patient has been bedridden with dizziness. The patient was again seen on 20-MAR-2007 and ENT had done an MRI which showed that the acoustic nerve was "OK." It was reported that the patient is now with hearing loss, tinnitus and dizziness being treated with hydrochlorothiazide (+)  triamterene (DYAZIDE). Subsequently the patient developed facial pains and was diagnosed with a dental abscess and treated with clindamycin, then ciprofloxacin hydrochloride (CIPRO) and now a mouth piece for teeth grinding. The hydrochlorothiazide (+) trimaterene (DYAZIDE) was stopped and the patient developed severe incapacitating vertigo x 3 days. At the time of the report the patient had some improvement with dizziness, it was possible that her hearing loss was less and she still had tinnitus. The patient had a hearing test with her ENT which showed left hearing loss. At the time of the report the patient had not recovered. No further information was provided. The patient's events were considered disabiling/incapacitating. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis, Syncope, Tendonitis, Tinnitus, Tooth abscess
Clinical narrative: Information has been received from a female consumer who on 30-JAN-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included hormone replacement therapy and "standard medications." Ten days later vaccination, on 09-FEB-2007 the patient was experiencing vertigo, hearing loss and tendonitis. The patient stated that she had to go to the emergency room and get an MRI and CT scan and that she has seen her doctor many times. There was no product quality complaint involved. Additional information was received from the physician. A 60 year old white female with allergies to penicillin, sulfa, cefixime (SUPRAX), levofloxacin (LEVAQUIN), metronidazole (FLAGYL), cefdinir (OMNICEF), ramelton (ROZEREM), duloxetine hydrochloride (CYMBALTA) and doxycycline, was vaccinated with a dose of Zostavax on 30-JAN-2007. On 06-FEB-2007 the patient's ears were plugged "ETD". on 08-FEB-2007 the patient developed cystitis and was treated with azithromycin (Z-PAK), phenazopyridine hydrochloride (PYRIDIUM) and fluconazole (DIFLUCAN). On 20-FEB-2007 the patient was diagnosed with sinusitis and was treated with clarithromycin (BIAXIN), fluticasone propionate (FLONASE), guaifenesin (MUCINEX), acetaminophen (+) propoxyphene napsylate (DARVOCET-N) and "ETD.". On 27-FEB-2007 the patient's prescription was changed to gemifloxacin mesylate (FACTIVE). On 01-MAR-2007 the patient saw an ENT and it was noted that her left arm was blocked, the patient was treated with prednisone. On 04-MAR-2007 the patient fainted at the gym 1 1/2 hours after steam and the patient was dizzy. The patient presented to the ER where a CT scan was "negative." It was reported that since 04-MAR-2007 the patient has been bedridden with dizziness. The patient was again seen on 20-MAR-2007 and ENT had done an MRI which showed that the acoustic nerve was "OK." It was reported that the patient is now with hearing loss, tinnitus and dizziness being treated with hydrochlorothiazide (+)  triamterene (DYAZIDE). Subsequently the patient developed facial pains and was diagnosed with a dental abscess and treated with clindamycin, then ciprofloxacin hydrochloride (CIPRO) and now a mouth piece for teeth grinding. The hydrochlorothiazide (+) trimaterene (DYAZIDE) was stopped and the patient developed severe incapacitating vertigo x 3 days. At the time of the report the patient had some improvement with dizziness, it was possible that her hearing loss was less and she still had tinnitus. The patient had a hearing test with her ENT which showed left hearing loss. At the time of the report the patient had not recovered. No further information was provided. The patient's events were considered disabiling/incapacitating. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Information has been received from a female consumer who on 30-JAN-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included hormone replacement therapy and "standard medications." Ten days later vaccination, on 09-FEB-2007 the patient was experiencing vertigo, hearing loss and tendonitis. The patient stated that she had to go to the emergency room and get an MRI and CT scan and that she has seen her doctor many times. There was no product quality complaint involved. Additional information was received from the physician. A 60 year old white female with allergies to penicillin, sulfa, cefixime (SUPRAX), levofloxacin (LEVAQUIN), metronidazole (FLAGYL), cefdinir (OMNICEF), ramelton (ROZEREM), duloxetine hydrochloride (CYMBALTA) and doxycycline, was vaccinated with a dose of Zostavax on 30-JAN-2007. On 06-FEB-2007 the patient's ears were plugged "ETD". on 08-FEB-2007 the patient developed cystitis and was treated with azithromycin (Z-PAK), phenazopyridine hydrochloride (PYRIDIUM) and fluconazole (DIFLUCAN). On 20-FEB-2007 the patient was diagnosed with sinusitis and was treated with clarithromycin (BIAXIN), fluticasone propionate (FLONASE), guaifenesin (MUCINEX), acetaminophen (+) propoxyphene napsylate (DARVOCET-N) and "ETD.". On 27-FEB-2007 the patient's prescription was changed to gemifloxacin mesylate (FACTIVE). On 01-MAR-2007 the patient saw an ENT and it was noted that her left arm was blocked, the patient was treated with prednisone. On 04-MAR-2007 the patient fainted at the gym 1 1/2 hours after steam and the patient was dizzy. The patient presented to the ER where a CT scan was "negative." It was reported that since 04-MAR-2007 the patient has been bedridden with dizziness. The patient was again seen on 20-MAR-2007 and ENT had done an MRI which showed that the acoustic nerve was "OK." It was reported that the patient is now with hearing loss, tinnitus and dizziness being treated with hydrochlorothiazide (+)  triamterene (DYAZIDE). Subsequently the patient developed facial pains and was diagnosed with a dental abscess and treated with clindamycin, then ciprofloxacin hydrochloride (CIPRO) and now a mouth piece for teeth grinding. The hydrochlorothiazide (+) trimaterene (DYAZIDE) was stopped and the patient developed severe incapacitating vertigo x 3 days. At the time of the report the patient had some improvement with dizziness, it was possible that her hearing loss was less and she still had tinnitus. The patient had a hearing test with her ENT which showed left hearing loss. At the time of the report the patient had not recovered. No further information was provided. The patient's events were considered disabiling/incapacitating. No further information is available.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Neuralgia, Tinnitus
Clinical narrative: Information has been received from a physician concerning a 65 year old male with neuropathy, hypertension, hyperlipidaemia and allergies to rofecoxib (WAES # 0704USA05632), statins and codeine, who on 16-APR-2007 was vaccinated SC with a 0.5 ml dose of Zostavax (lot # 656861/0329U). Concomitant therapy included Diovan, aspirin and vitamin B complex. On 16-APR-2007 the patient developed extreme neuropathic pain and numbness to his hands and feet after vaccination. He also reported tinnitus. Unspecified medical attention was sought. There were no lab or diagnostic tests performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. The patient's events were considered disabling. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Gaze palsy, Loss of consciousness, Muscle twitching, Oxygen saturation
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 13 year old female patient who on 07-MAR-2007 was vaccinated IM in the right deltoid with the first dose, 0.5ml, of Gardasil (Lot #657006/0188U). There was no concomitant medication. The nurse reported that on 07-MAR-2007, 10 minutes after the vaccine was administered, the patient complained of an upset stomach, and then passed out. The nurse reported that the patient's breathing was normal, but she did not regain conscious or respond to verbal stimulation; "the patient's eyes then "rolled back in her head and she began twitching with seizure like activity." The patient's pulse oximetry results were between 80# to 100%, and oxygen was administered. The nurse stated that 911 was called, and an intravenous line was started with Valium, 10 mg, administered prior to the ambulance arrival. The patient was taken to the ER, but was not admitted, and her symptoms "lasted at least 20 minutes." The nurse confirmed that the patient had recovered on the same day, 07-MAR-2007, and added that on 12-APR-2007, when the patient returned to the office, her exam revealed no symptoms. The nurse considered the events to be life threatening, and an other important medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Oxygen supplementation, Stomach discomfort, Unresponsive to stimuli
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 13 year old female patient who on 07-MAR-2007 was vaccinated IM in the right deltoid with the first dose, 0.5ml, of Gardasil (Lot #657006/0188U). There was no concomitant medication. The nurse reported that on 07-MAR-2007, 10 minutes after the vaccine was administered, the patient complained of an upset stomach, and then passed out. The nurse reported that the patient's breathing was normal, but she did not regain conscious or respond to verbal stimulation; "the patient's eyes then "rolled back in her head and she began twitching with seizure like activity." The patient's pulse oximetry results were between 80# to 100%, and oxygen was administered. The nurse stated that 911 was called, and an intravenous line was started with Valium, 10 mg, administered prior to the ambulance arrival. The patient was taken to the ER, but was not admitted, and her symptoms "lasted at least 20 minutes." The nurse confirmed that the patient had recovered on the same day, 07-MAR-2007, and added that on 12-APR-2007, when the patient returned to the office, her exam revealed no symptoms. The nurse considered the events to be life threatening, and an other important medical event. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: C/O sudden onset of high fever/chills/fatigue. Injection site painful and swollen. 05/23/07-records received C/O fever with chills. Temp in ED 99.4-BP 95/45. C/O pain over left deltoid area where he was given an injection. Some swelling present. Headache diffuse with no visual changes. No nausea or vomiting. Assessment:most likely allergic reaction to tetanus injection. Too soon for cellulitis. PE: Pain and tenderness over left deltoid area.
Age: 1.0
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Blood culture negative, Chest X-ray normal, Cough, Cyanosis, Depressed level of consciousness
Clinical narrative: Evening after vax given fever 103.2, increased RR - seen in urgent care clinic where O2 sat initially 98%, fairly quickly decreased to 40's with cyanosis and child described as being "out of it". No area sz activity. Coughed and then O2 sat increased. TX = O2. Has incurred viral URI. 05/15/07-records recevied for DOS 4/16-4/17/07-DC DX: fever. Syncope and collapse. Severe desaturation event in clinic O2sat 40% on room air. Perioral cyanosis. Non responsive but not apneic. Febrile to 103.
Age: 1.0
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Electrocardiogram normal, Full blood count normal, Influenza serology negative, Oxygen saturation decreased, Oxygen supplementation
Clinical narrative: Evening after vax given fever 103.2, increased RR - seen in urgent care clinic where O2 sat initially 98%, fairly quickly decreased to 40's with cyanosis and child described as being "out of it". No area sz activity. Coughed and then O2 sat increased. TX = O2. Has incurred viral URI. 05/15/07-records recevied for DOS 4/16-4/17/07-DC DX: fever. Syncope and collapse. Severe desaturation event in clinic O2sat 40% on room air. Perioral cyanosis. Non responsive but not apneic. Febrile to 103.